Clinical Research Oriented Workshop Notes of Dec 4 09

Clinical Research Oriented Workshop (CROW) Meeting: Dec 4, 2009

Present: Abby Crocker, Kim Dittus, Amanda Kennedy, Rodger Kessler, Ben Littenberg, Connie van Eeghen
Absent: Matt Bovee, Liz Chen, Kairn Kelley, Charlie MacLean, Maria Ramos, Alan Rubin

1. Start up: Updates on where we are and what we’re doing next

2. Roundtable, with update, short term goals, long term goals
a. Connie: Spires of Excellence – Public Health Input – resulted in a wide ranging conversation about the strategic purpose of the UVM administration, past processes that were similar, the significance for the CCTS, and the impact on our role as largely independently funded researchers. The outcome is that Connie will submit her letter, primarily as a way of expressing her own interest in public health related research and to share that interest with the community of like-minded researchers and administrative leaders at UVM. (We also talked a lot about how to make the process of sharing our own work, within the CCTS and across UVM, more systematic without killing it with protocols. As with much else about CCTS, this is an unfolding set of answers about this new program.)
b. Connie: AHRQ Informed Consent Toolkit. The toolkit provides advice to:
i. Raise awareness among researchers
ii. Access resources about IC available on the web and through specific agencies
iii. Create mechanisms for change: education – especially around common concerns, advisory councils
iv. Improve the process, addressing:
1. The research culture within an organization
2. The need to train staff
3. Physical environment of consent
4. Plan to promote comprehension: translations, interpreters
5. Process of reading with potential subjects
6. Need for allowing time
7. Verifying understanding through teach-back (process example)
v. The toolkit provides a checklist, a “researcher’s certification tool,” to assist researchers in accomplishing IC. It provides sample forms which conform with regulations re: informed consent and HIPAA.
vi. Suggestions:
1. Use to update educational course materials we currently offer
2. Pass on to IRB for their consideration
3. Explore the possibility of a grant to study our use of IC and the application of ways to improve
vii. Next step: ask Alan Rubin about discussion at a Friday seminar. (He said yes; Connie will follow up with Nancy Stalnaker, Alan will follow up with Alan Wortheimer or Rob McCauly.)

3. Next Fellows Meeting(s): October 23, 2009 from 9:30 – 11:00 a.m., at Given Courtyard Level 4
a. Dec 11: blog seminar (Ben); state and national datasets for secondary data analysis – Abby (no Kim); calendar for next semester (Kairn)
b. Future agenda to consider:
i. Dec 18 (no Connie)
ii. Dec 25: no Workshop
iii. Jan 1: no Workshop
iv. Jan 8: ???
v. Skype demo: Connie & Matt? Wait until Amanda K is back. Or do twice?
vi. 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)
vii. Workshop’s WIP (the history document) – discuss goals and progress, make recommendations, review and modify document, add Fellows’ orientation

4. Fellows document – nothing new this time

Recorder: Connie van Eeghen

Video Instructions for the new NIH forms

Here is a useful video describing the recent changes to NIH forms, including the new page limits and required sections. There are big changes to the Research, Biosketch, and Environment sections. Study up!

Faculty Publications

Congratulations to CTS faculty Liz Chen and Neil Sarkar on their recent publication:


Journal of Biomedical Informatics, In Press, Corrected Proof, Available online 20 October 2009
http://dx.doi.org/10.1016/j.jbi.2009.10.003

MeSHing molecular sequences and clinical trials: A feasibility study

Elizabeth S. Chen^a, b, d and Indra Neil Sarkar^{a, c, d, ,} 

^aCenter for Clinical and Translational Science, University of Vermont, Burlington, VT, USA

^bDivision of General Internal Medicine, Department of Medicine, University of Vermont, Burlington, VT, USA

^cDepartment of Microbiology and Molecular Genetics, University of Vermont, Burlington, VT, USA

^dDepartment of Computer Science, University of Vermont, Burlington, VT, USA

Received 3 September 2009.  

Available online 20 October 2009. 

Abstract

The centralized and public availability of molecular sequence and clinical trial data presents an opportunity to identify potentially valuable linkages across the bench-to-bedside “T1” translational barrier. In this study, we sought to leverage keyword metadata (Medical Subject Heading [MeSH] descriptors) to infer relationships between molecular sequences and clinical trials, as indexed by GenBank and ClinicalTrials.gov. The results of this feasibility study found that approximately 30% of sequences in GenBank could be linked to trials and over 90% of trials in ClinicalTrials.gov could be linked to sequences through MeSH descriptors. In a cursory evaluation, we were able to consistently identify meaningful linkages between molecular sequences and clinical trials. Based on our findings, there may be promise in subsequent studies aiming to identify linkages across the T1 translational barrier using existing large repositories.

Tweeting for Health

Recently, I blogged about collecting data from patients via brief text messages (SMS) over their cell phones. Today, we have communication in the opposite direction: sending prompts to patients to encourage certain behavior.

Text-Message Reminders to Improve Sunscreen Use: A Randomized, Controlled Trial Using Electronic Monitoring
April W. Armstrong, MD; Alice J. Watson, MD, MPH; Maryanne Makredes, MD; Jason E. Frangos, MD; Alexandra B. Kimball, MD, MPH; Joseph C. Kvedar, MD
Arch Dermatol. 2009;145(11):1230-1236.

This group sent the local weather report along with a reminder to wear sunscreen to 35 adults via their cell phones. After 6 weeks, sunscreen usage was 56% vs 30% among 35 control subjects (P<.001). The NNT (Number-Needed-to-Text) was a very low 3.8, suggesting that about 1 in 4 subjects responded to the messages. This is remarkably high success rate for such a low cost intervention and suggests that text messages might have broader applicability in health behavior change.

What other areas would benefit from a periodic cell phone reminder?  Where won't it work?

Research Directions in Understanding and Visualizing Rural Health Access and Traffic Safety

"Research Directions in Understanding and Visualizing Rural Health Access and Traffic Safety" Dr. Thomas Horan Associate Professor, Claremont Graduate University & Research Director, Center for Excellence in Rural Safety, University of Minnesota (UVM Class of '81) Monday, December 7th 10:00 to 11:00 a.m. Decision Theater, Farrell Hall UVM Trinity Campus (Directions) Please join us if you can. For more information, you may contact Richard Watts at RWatts@uvm.edu Metered parking, bike parking and CCTA bus service are all available. The Davis Center and Farrell Hall are wheelchair accessible.

Free, Public Use data from AHRQ

Lots of new data available from Uncle Sam for investigators to work with:

AHRQ is pleased to announce the recent release of the following data products and publications:
MEPS Data:
MEPS HC-113: 2007 Full Year Consolidated Data File
Release Date: November 2009
Released as an ASCII file (with related SAS and SPSS programming statements) and a SAS transport dataset, this public use file provides information collected on a nationally representative sample of the civilian non-institutionalized population of the United States for calendar year 2007. This file consists of MEPS survey data obtained in Rounds 3, 4, and 5 of Panel 11 and Rounds 1, 2, and 3 of Panel 12 (i.e., the rounds for the MEPS panels covering calendar year 2007) and consolidates all of the final 2007 person-level variables onto one file. This file contains the following variables previously released on HC-107: survey administration, language of interview variable, demographics, parent identifiers, health status, disability days variables, access to care, employment, quality of care, patient satisfaction, health insurance and use variables. The HC-113 file also includes these variables: income variables and expenditure variables. The data is on the MEPS Web site at: http://www.meps.ahrq.gov/mepsweb/data_stats/download_data_files_detail.jsp?cboPufNumber=HC-113
MEPS HC-112: 2007 Medical Conditions File
Release Date: November 2009
This public use data file provides information on household-reported medical conditions collected on a nationally representative sample of the civilian noninstitutionalized population of the United States for the 2007 MEPS Household Component. Released as an ASCII file (with SAS and SPSS programming statements, and also in SAS transport format), this public use file provides information on the household-reported medical conditions reported in the 2007 portion of Round 3 and Rounds 4 and 5 for Panel 11, as well as Rounds 1 and 2 and the 2007 portion of Round 3 for Panel 12 (i.e., rounds for MEPS panels covering calendar year 2007). ICD-9 and Clinical Classification Codes are provided. The data is on the MEPS Web site at: http://www.meps.ahrq.gov/mepsweb/data_stats/download_data_files_detail.jsp?cboPufNumber=HC-112
MEPS HC-110I: Appendix to MEPS 2007 Event Files
Release Date: November 2009
This public use release is one in a series of public use event files drawn from the 2007 Medical Expenditure Panel Survey (MEPS) Household (HC) and Medical Provider Components (MPC). This release contains 2 data files each of which is provided as an ASCII file with SAS and SPSS programming statements and as a SAS transport file. File 1 is used for linking the MEPS 2007 condition file (HC-112) with the MEPS 2007 event files (HC-110A through HC-110H); File 2 is used for linking the MEPS 2007 prescribed medicines event file (HC-110A) with other 2007 event files. This release also includes two tables provided as PDF files: Table 1, the "MEPS 2007 Condition-Event Frequency" table contains unweighted and weighted counts of records on the MEPS 2007 event files for each of the condition, procedure and clinical classification codes on the MEPS 2007 condition file; Table 2, the "MEPS 2007 Utilization and Expenditures Summary" table contains statistics for all of the utilization and expenditure variables contained on the MEPS 2007 person-level and event-level files. The data is on the MEPS Web site at: http://www.meps.ahrq.gov/mepsweb/data_stats/download_data_files_detail.jsp?cboPufNumber=HC-110I
MEPS HC-036: MEPS 1996-2007 Pooled Estimation Linkage File
Release Date: November 2009
This file is provided for use with pooled data from the MEPS FY 1996, 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, and 2007 public use files (HC-012, HC-020, HC-028, HC-038, HC-050, HC-060, HC-070, HC-079, HC-089, HC-097, HC105, and HC-113 respectively). Released as an ASCII file (with SAS programming statements) and in SAS transport format, this person-level file contains 1996-2007 combined variance stratum and PSU variables, along with the standard MEPS person ID variables for linking with the 1996-2007 MEPS person-level public use files. There is one record for each of the 202,468 persons who are on the MEPS FY 1996-2007 public use files. The data is on the MEPS Web site at: http://www.meps.ahrq.gov/mepsweb/data_stats/download_data_files_detail.jsp?cboPufNumber=HC-036
MEPS HC-036BRR: MEPS 1996-2007 Replicates for Calculating Variances File
Release Date: November 2009
This file is provided for use with pooled or individual year data from the MEPS FY 1996, 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2005, 2006, and 2007 public use files (HC-012, HC-020, HC-028, HC-038, HC-050, HC-060, HC-070, HC-079, HC-089, HC-097, HC-105, and HC-113 respectively). Released as an ASCII file (with SAS programming statements) and in SAS transport format, this person-level file contains the standard MEPS person ID variables for linking with the 1996-2007 MEPS person-level public use files and a set of 128 half sample indicators enabling the user to perform a balanced repeated replication (BRR) to calculate standard errors. There is one record for each of the 202,468 persons who are on the MEPS FY 1996-2007 public use files. The 1996-2007 combined variance stratum and PSU variables are released on HC-036. The data is on the MEPS Web site at: http://www.meps.ahrq.gov/mepsweb/data_stats/download_data_files_detail.jsp?cboPufNumber=HC-036BRR
Tabular Data:
2007 New MEPS Household Prescribed Drug Estimates: Top Prescribed Drugs by Total Expenditures and Top Prescribed Drugs by Total Purchases
Release Date: November 2009
The tables are available on the MEPS Web site at: http://www.meps.ahrq.gov/mepsweb/data_stats/quick_tables_results.jsp?component=1&subcomponent=0&year=2007&tableSeries=5&searchText=%251.%25&searchMethod=1

2007 New MEPS Household Prescribed Drug Estimates: Top Therapeutic Classes, by Total Expenditures and Total Purchases
Release Date: November 2009
The tables are available on the MEPS Web site at: http://www.meps.ahrq.gov/mepsweb//data_stats/quick_tables_results.jsp?component=1&subcomponent=0&year=2007&tableSeries=5&searchText=%252.%25&searchMethod=1
Tables of Insurance Component National-Level Summary for Series III and IV from the 2008 MEPS Insurance Component Survey
Release Date: November 2009
The tables are available on the MEPS Web site at: http://www.meps.ahrq.gov/mepsweb/data_stats/quick_tables_results.jsp?component=2&subcomponent=1&year=2008&tableSeries=-1&tableSubSeries=&searchText=%25IV.%25%2C%25III.%25%2CIII%2CIV&searchMethod=3&Action=Search
MEPS Publications:
Statistical Brief #269: Diabetes Management: Tests and Treatments among the Adult U.S. Civilian Noninstitutionalized Population, 2007
Release Date: November 2009   
This Statistical Brief uses data from the Household Component of the 2007 Medical Expenditure Panel Survey (MEPS-HC) to estimate the health status, preventive health practices, and treatment regimens of adults who reported having been diagnosed with diabetes. Rates at which persons with diabetes obtain preventive medical care and recommended tests are presented. The full Statistical Brief is available on the MEPS Web site at: http://www.meps.ahrq.gov/mepsweb/data_stats/Pub_ProdResults_Details.jsp?pt=Statistical%20Brief&opt=2&id=934
 

The Quality of Behavioral Healthcare

Please disseminate throughout your organization! Time is Running Out! Don't miss out on your chance to present your work to a nationwide audience of professionals like you in a warm, beautiful beach environment. The deadline for submissions is 5PM EST on Monday, December 7, 2009. Call for Abstracts The gaps between research, practice and policy, in all configurations, significantly impair the rapidity of progress for improving health care quality. Given the tremendous disease burdens associated with drug abuse, problem alcohol and mental health conditions, and the impact of these conditions on other medical disorders, greater research focus is needed to align consumer preferences and values in care, improved care coordination across providers and service sectors, implementation strategies and workforce development to accelerate the adoption of evidence-based practices, and approaches highlighting how purchasers and employers might encourage delivery of high-quality behavioral healthcare. This scientific conference will encourage linkages between these often separate areas of behavioral services research into a more integrative behavioral health services research (BHSR) platform. This second year of a 3-year NIDA R13 scientific conference grant (with additional support provided by NIMH and NIAAA), continues the effort to 1) develop a collaborative and strategic research agenda to improve the quality of behavioral healthcare to people (across the life span) who suffer from drug abuse, problematic alcohol use, and mental health problems, and, 2) engage and partner researchers and other key stakeholders such as afflicted individuals, families, providers, policymakers, and communities to contribute to and implement a quality improvement agenda. A 'virtual collaboratory' will also be used to connect conference participants and to encourage and support the development of new research teams. Currently there is no one place for addictions, mental health and alcohol services researchers to meet exclusively and at one time on shared priority topics germane to behavioral health services research (BHSR). No professional group or association for BHSR exists. Common problems abound and often work does not cross the disciplines, so this 2010 scientific conference will highlight innovative strategies to improve the quality of behavioral healthcare focusing on a broad range of research examining issues of access to care and care coordination, the implementation of evidence-based practices, improvements in the measurement of quality outcomes, and, financing methods and systems change focused on improving care quality. The conference will be held on Clearwater Beach (FL) on April 13-14, 2010, with preconference methods workshops taking place on the afternoon of April 12th. The Sandpearl Resort (www.sandpearl.com) will be the setting for this year's meeting. Individual paper, poster, think tank and symposia abstracts are being solicited. Please consider submitting an abstract to the conference through our website athttp://bhsr.fmhi.usf.edu All abstract submissions must be received by December 7, 2009 at 5pm EST. Visit us at http://bhsr.fmhi.usf.edu Confirmed Pre-Conference Workshops: John Skvoretz, PhD, Department of Sociology, University of South Florida Nothing But Net(works): Basic Methods Hendricks Brown, PhD, University of Miami Miller School of Medicine Designing the Next Stage of Effectiveness and Implementation Research to Meet the Needs of Communities and Institutions Confirmed Plenary Presenters: Carolyn M. Clancy, MD, Director, AHRQ, DHHS Wilson Compton, MD, Director, DESPR, NIDA Invited Plenary Presenters: Richard Frank, PhD, Deputy Assistant Secretary, Assistant Secretary for Planning & Evaluation, DHHS Mark Willenbring, MD, Director, Division of Treatment and Recovery Research, NIAAA Redonna Chandler, PhD, Branch Chief, NIDA Services Research Branch David Chambers, PhD, Branch Chief, NIMH Division of Services and Intervention Research Sincerely, Alex Harris, Ph.D. Scientific Conference Co-Chair, Center for Health Care Evaluation, VA Palo Alto Health Care System Enola Proctor, Ph.D. Scientific Conference Co-Chair, School of Social Work, Washington University Junius Gonzales, M.D., M.B.A. University of South Florida, R13 Principal Investigator