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Where am I, and who are you?Developing Research Competencies:
Charting the Course des Anges Cruser, Ph.D., MPAAssociate Professor & Administrative Director ORC
Keith Watson, DO Associate Dean for Graduate Medical EducationOUCOM/Centers for Osteopathic Research and
Education
Rorie Lee, PhD, MPH, CHESAssistant Family Practice Residency DirectorUNECOM
des Anges Cruser, Ph.D., MPA
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What’s the purpose?
• Share information about research training activities
• Stimulate collaborative discussions about the need and vision for training in the conduct of research
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What should I expect?KEITH WATSON
Broad perspective of trends in research training in osteopathic medical education & the relationship between evidence-based medicine and research training
NEXTEach of us will present
information about what we are doing in providing research training
10 MINUTES
KEITH WATSON Lead a discussion involving
you in identifying the conditions that constrain and those that promote the provision of research training to medical students, residents, and in post-graduation professional development venues.
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Research Competency Challenges
Promoting wishes and understanding challenges
D. Keith Watson, D.O., FACOS
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What is Research? (What is Research Education?)
• Do all the blind men describe the elephant in the same terms?
• Do all the players mean the same thing when referencing ‘research’ or research education?– accrediting bodies– specialty colleges– program directors– trainees– osteopathic medical schools– clinical faculty– basic science faculty– etc.)
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Goals for Research Education
• Meet the program requirements for a research product
• Meet the AOA Competencies which require research
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Goals for Research Education
• Develop informed consumers of research outcomes
• Equip physicians to become active participants in research trials and studies
• Prepare Osteopathic Physicians to be Project/Primary Investigators for quality research initiatives
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Informed Consumer of Research Outcomes
Active Participant in Research
Studies
Project Investigator
Goals
All
Most
Some
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“Research” and “Research Education”
• Evidence Based Medicine• Bench projects• Clinical trials
– Prospective?
– Retrospective?
– Randomized/controls?
• Case reports• Statistics course• Literature review• Journal Clubs
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Evidence Based Medicine - Assumptions
• Volume of published material is too great to assimilate/evaluate
• Much published material is – Out of date– Not based on valid research design– Not applicable to the current patient care need under
study– Not likely to make a real difference in patient care
outcome• Most clinicians will NOT be trained or able to do
in-depth research• Clinicians need a mechanism to strategically
manage this information
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Evidence Based Medicine—Current Trends
• Utilize auxiliary information services to screen literature in a reliable way from many perspectives-– Patient Oriented Evidence that Matters (POEMS) =
InfoPOEMS (InfoRetriever)– Up-to-Date– “Just in time” information at the point of care
• Critically assess literature and data ABOUT:– Diagnosis – Treatment recommendations– Laboratory/radiologic test necessity and accuracy– Pharmaceutical rep/sales information
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Application of “Evidence Based Medicine” to Practice
• Research MAY define “best practice”for population under study
• Consideration of Patient Issues which demand priority against the ‘best practice’ because of individual variation/need
• Clinical judgment
ALL Must be Weighed for Ideal Patient Outcome
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“Research” and “Research Education”
• Evidence Based Medicine• Bench projects• Clinical trials
– Prospective?
– Retrospective?
– Randomized/controls?
• Case reports• Statistics course• Literature review• Journal Clubs
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Educational Model Assumption
• Reading and classroom work
• Volume of patients seen
• “Show me your references……”
• “See one, do one, teach one”
• etc
= Clinical CompetenceX
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Educational Model Assumption
• Take a statistics course
• Do a literature review• Write a case report• Learn to read/critique
journal articles• Do a research
‘project’
= “Research Competence”X
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What are the basic research competencies ALL DOs need to practice contemporary medicine?
• Be an informed consumer of research publications– Individual study question– Meta-analysis– Population vs. individual application
• Know basic statistical terminology • Know basic study design and inherent flaws• Common wisdom: “Don’t need to DO
research, just be educated about it”XXXChallenge to the concept XXX
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Recommended Minimum Standard for Research Competency in OME
• End of medical school years 1-2:– History of osteopathic research– Knowledge of research vocabulary– Ability to do a literature search– Knowledge of basic statistics– Understanding of research problems uniquely
osteopathic (OMT)– Awareness of support resources available
consistent with level of competency expected
Ref: OCCTIC III Fall 2001, ECOP Fall 2001, AOA BOR Nov 2002Louisa Burns ORC March 2003
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Recommended Minimum Standard for Research Competency in OME
• End of medical school years 3-4:– Ability to review and summarize journal
articles– Ability to formulate a research
question/hypothesis– Awareness of support resources available
consistent with level of competency expected
Ref: OCCTIC III Fall 2001, ECOP Fall 2001, AOA BOR Nov 2002Louisa Burns ORC March 2003
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Recommended Minimum Standard for Research Competency in OME
• End of post-graduate years 1-3:– Understand the process of design and
implementation of a research project– Ability to critique journal articles– Ability to write a manuscript suitable for
publication or a grant application– Awareness of support resources available
consistent with level of competency expected
Ref: OCCTIC III Fall 2001, ECOP Fall 2001, AOA BOR Nov 2002Louisa Burns ORC March 2003
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Challenges• Volume of published studies
– Emerging methods to deal with it
• Osteopathic profession’s urgency to focus on OPP research
• Unclear specialty college requirements for resident research
• Untrained (uniformed) program inspectors about research expectations
• Poor trainee writing skills• Untrained program directors (faculty mentors)• Ill defined IRB functions
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Challenges• To Identify competency ‘outcomes’
that are realistic to measure– Define the appropriate achievement for
each level of the continuum
• To start research education in UGME
• To distinguish research from research education
• Fund sufficient infrastructure
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Challenges
• Funding for research infrastructure– OPTI inherently disadvantaged to provide from member
dues/fees• Few sufficiently organized to obtain federal grant funds
independent of the COM (grants management issues).• Some may fund startup activity from foundations with little
chance for converting to ‘hard dollars’
– COMs not a likely source for GME trainees• Difficulty in providing faculty research resources now• Growth of grant supported infrastructure will be difficult to
expand to GME sites/programs• Conversion to hard dollar support not easy
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Challenges
• Funding/Creating Research Education Infrastructure– Where/everywhere in the curriculum
continuum?– Definitions and common objective terms for
curriculum committees– Aligning agreement of curriculum committees
from:• COMS• Specialty Colleges (RESCs)• OPTIs (OGME Committees/Research Committees)
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Informed Consumer of Research Outcomes
Active Participant in Research
Studies
Project Investigator
Goals
All
Most
Some
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Where we were (2000)
OUCOM – UME– Summer Undergraduate Research Fellowship
(for ~ 8 OU undergraduates BEFORE acceptance to OUCOM—Eight week program)
– PMPH curriculum included research concepts– Summer Research Experience (10 weeks/~10
students) for select COM students who have finished Year 1
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Where we were (2000)
CORE GME – 76 programs + 12 internships (~550 FTEs)– Multiple paper requirements from specialty colleges, struggle with
identifying uniform resources/access to help– 10/12 hospitals had functional IRBs
Some had Federal Wide Assurance, none had reciprocal agreements with Ohio University IRB
– Two RPACs had a resident paper presentation day– No RPAC or program required IRB approval of research BEFORE
the project began– CORE Research Committee had SOME seed money but proposals
coming forward were not Written well Had poor study design (if any) Had few program directors/faculty who could mentor well
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Approach to GME Research
Require all hospitals to have an IRB and obtain FWA—and an Inter-Institutional agreement with OU IRB
Apply for grant funding and hire a Director for CORE Research with both statistical experience and project completion experience
Attempt to meet specialty college requirements as written for a meaningful research product for each resident
Provide a forum(s) for well conceived and completed projects to be presented
“Raise the bar” expectations at the RPAC level for program directors and trainees regarding research education and project completion
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What we learned
IRB concepts are not common knowledge or high priority in community hospitals
Program directors place little emphasis and allow little time for trainee research activities– Specialty college requirements are too non-specific and give little
direction for PDs GME trainees have difficulty with writing skills
– Few know the elements of a research proposal– Few could list the usual sections of a journal article – Fewer could write a coherent project argument based on a bona-fide
literature search Few PDs or trainees understood the ‘life-cycle’ of an idea to
completed project or the steps to take/or where to turn for help Virtually ALL TRAINEES want to be involved and do a good job
with a research project….and will do so if given the tools.
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Where we are (2004) OUCOM--UME
SURF Program continues for pre-admission activity
Summer Research Experience continues for select group of Yr 1-Yr 2 students
The PMPH course (old curriculum) has now been replaced in the new Clinical Presentation Continuum (CPC) with 22 contact hours of epidemiology, statistics, Evidence Based Medicine principles, and population impact presentations.– CPC is case based and small group oriented with select
lecture/problem presentation sessions.
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Where we are (2004)CORE GME Research
Full time Director of CORE Research (grant funded)– Support staff = nil
All CORE Hospitals now have a functional IRB and an FWA status. Some have I-I agreements with OU IRB
Extensive faculty development programs for Program Directors have heightened research awareness and sparked support
Wide dissemination of posters/training materials/etc have helped educate and give direction.
Several forums for presentation have been created– RPAC Research Days– OOA Convention– OUCOM Research Day– Research days at CORE hospitals opened to other institution’s
resident participation…..
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Where we are (2004)CORE GME Research
Resident projects are ‘guided’ through a central process of writing, IRB approval and data management– Current work in progress = ~100 active projects in the cue for
IRB and completion (up from only 4 in January of 2003) Four of eight RPACs held Senior Paper presentations
(with judged outcomes) this Spring– Case reports were not encouraged– Many well designed retrospective chart reviews were
completed– SEVERAL prospective multi-arm studies were completed and
reported with small but significant outcomes.
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What we have learned
The culture must change on many fronts at the same time– One ‘Director’ can’t do it alone
GME trainees must bring research education WITH them to their residencies
Specialty colleges presently do not have realistic expectations about quality research or research education
Our trainees WANT to do quality research work and applaud our efforts…….but remain critical of the lack of infrastructure available to them.
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Where we would like to go….
Integrated continuum of research education from UME through CME….
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Core Research Competencies II
Scholarship and Research Training at the Residency Level
Rorie Lee, Ph.D, MPH, CHES
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Elements of Successful Residency Research Environments
Define research broadly Require projects Focus on clinically-relevant research/EBM Research committee Integrate curriculum
DeHavenMJ, Wison GR, O'Connor-Kettlestrings P.Fam Med 1998:30(7): 501-7.
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Elements of Successful Residency Research Environments
Program director support Time Didactics: planned curriculum, journal club Faculty involvement: mentors, research
committee, support with design/statistics Opportunities for presenting/forums
DeHavenMJ, Wison GR, O'Connor-Kettlestrings P.Fam Med 1998:30(7): 501-7.
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UNECOM GME Programs
Internship Residencies in FP, NMM, Combined
FP/NMM Most but not all interns linked to our
residencies 3-year federal training grant to develop EBM
and research curriculum components for FP & Combined residencies
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The Research-Oriented Curriculum at UNECOM
Incorporates elements of Evidence-Based Medicine, informatics, and research skills.
Takes broad view of research and scholarly activity, similar to Boyer’s expanded definition of scholarship*: Discovery Integration
Application Teaching
Planned links with AOA Core Competencies
*Boyer EL Scholarship reconsidered: Priorities of the professoriate. (1990)
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Curriculum Components
Longitudinal curriculum Residents work with faculty mentors to
develop, propose, complete, and present research project (original or building on previous research)
Research training Faculty development
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Expectations of Residents
Competence in using the medical library and evidence-based electronic resources
Awareness of the basic principles of study design, performance, analysis, and reporting.
Participation in scholarly activity including research Production of scientific paper suitable for publication
and acceptable to specialty college
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Implementation
Projects begin in 2nd year of residency training
Project must be completed in 3rd year of training (4th year for Combined residents)
Residents present projects to peers and as part of Annual OPTI Research Forum
Residents encouraged to present projects at state/regional/national conferences
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Implementation PGY 2
Resident chooses initial topic(s) Program Director approves topic Presents preliminary proposal (following
Outline) to Mentor group Mentor assigned once proposal approved
– Detailed study proposal prepared – Proposal submitted to IRB– Start project
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Implementation PGY 3
Data collection & analysis Draft of paper submitted Paper revised
– Peer presentation– OPTI/regional/professional presentation
Final paper approved by Program Director, Review Committee & submitted to specialty college
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Mentors
Residency faculty take lead role Basic science and other clinical faculty also
involved Resident progress is tracked using Checklist Time is difficult to find
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What we’ve learned so far
Successive approximation: take small steps Internal feedback/review helpful Faculty & residents need accessible support Integrating EBM & clinically applied research
important in residency training Finding time is difficult but can be done Define “research” broadly: approach both
projects and people inclusively
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Challenges
Expand core research mentor group & research training
Continue promoting research collaboration Involve faculty in additional scholarly
activities Sustain support once current funding
ends/obtain additional external funding
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Training clinician researchers: Inside the box looking out
or outside the box looking back in?
des Anges Cruser, Ph.D., MPA
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The Osteopathic Research CenterFOUNDED
January 2002
$275,000 per year for four yearsAACOM, AOA, AOF
Additional Resources Generated $2M varying duration over 2 to 4 yearsAnd Pending applications of $4.8 M
over 3 to 4 years in duration
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PURPOSE
Facilitate the collective efforts of the osteopathic profession
to investigate the mechanism of action and clinical
efficacy of Osteopathic Manipulative Medicine
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Advisors
Boyd Bowden, D.O.John Crosby, J.D. Leonard Finkelstein, D.O. V. James Guillory, D.O.,
MPH Felix Rogers, D.O. Michael Samuels, Dr. P.H.
Brian Degenhardt,D.O. John K. Lynch, D.O. Boyd Buser, D.O. J. Justin McCormick, Ph.D. Michael J. Patterson, Ph.D.Douglas Wood, D.O., Ph.D.Collaborative Mentors and Partners: UNTHSC, ATSU, PCOM,
UNECOM, AZCOM, WVCOM
In: Epidemiology, Physiology, Anatomy, Pulmonary Medicine….
&
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SPECIFIC AIMSAim 1. Develop and sustain the infrastructure necessary to support the mission.
Aim 2. Develop OMM research training opportunities.
Aim 3. Conduct research into the mechanisms of action and clinical efficacy of OMM.
Aim 4. Facilitate inter-institutional research collaborations.
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Examples of Activities• OMM Research Think Tank: establish overall direction of
the research initiatives, develop standards for research design and methodology, provide educational seminars to enhance the confidence and competence of new and established researchers.
• Research Collaboration: review and recommend procedures in blinding, placebo control, inter-rater reliability and validity, ethics, safety, OMM protocols, methodology, outcome measures, and statistical analysis
• Products: Newsletter, manuals, proposals, Focused Research Forums
.
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Research Local and Inter-institutional
PregnancyCarpal Tunnel SyndromeLymphSympathetic Nervous
SystemCOPDEducationalLow Back PainFibromyalgiaPost CABG
Pneumonia
Multiple Sclerosis & Exercise
Low Back Pain
Otitis Media
NCCAM Developmental Center
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Research Training
Local and National Programs
AOA Research Conference
OCCTIC
Research Fellowships in Family Medicine and OMM
Pre and Post Doctoral
Master’s of Science in Clinical Research & Education
Continuous or in three 4-month blocks
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Clinical, Teaching and Research
18+ at various stages of the program
Goals and products
Research enhancement meetings
Formal coursework
Attend research conferences
Rotate through IRB
Present poster, participate in a panel discussion
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Guideposts in Developing the Research Training Programs
NIH Standards
Different organizations have different rules
Human Subjects Protection
The integrity of the research design
The total human energy of research work
Role of the student or resident physician
Role of the PI, the CRC, the research team
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Collaborative Osteopathic Research Training Initiative Proposal
NIH recognizes a decline in the number of successful physician PI applications
NIH strongly recommends partnerships between basic scientists and clinical researchers
NIH begins to recognize Osteopathic Medicine as a unique profession in health care
The Osteopathic Medical Community recognizes the need for organized approach to teaching research competencies
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FACTORS PROMPTING THE DISCUSSION
•Graduating COM classes rate research competencies among weakest component of their medical education.
• The demands of medical school and residency programs constrain the infusion of research training
•The imperative remains.
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HISTORICAL CONTEXT
October 2003: SOMA petitioned OHF for support to develop research curricula in COMs
OHF agreed to need, recommended COMs collaborate, and would consider a funding request for a collaborative commitment from COMs
Spring 2004: AACOM and the ORC approach OHF with a proposal for a National Osteopathic Research Training Initiative
NIH/NCCAM announces funding availability to support research curriculum development
ORC opens broader dialogue with the Board of Deans
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Module IBASIC RESEARCH COMPETENCIES
Module IIADVANCED RESEARCH
COMPETENCIES
Module IIIMentored Clinical
Research Scientist-Practitioner
A Simple Model of Competency Based Research Training
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MODULE I
A FOCUS ON THE MEDICAL STUDENT
PRIMARY AIMS:
1. Instill an appreciation for the role of research in osteopathic medicine,
2. Prepare the student for evidence based medicine practice,
3. Equip the student with basic competencies to read, interpret, discuss, and participate in clinical research.
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MODULE II
A FOCUS ON THE RESIDENT OR POST GRADUATE WITH EXISTING BASIC RESEARCH COMPETENCIES
PRIMARY AIMS:
1. Takes the aspiring researcher to the next level of research activity,
2. Supports the process of developing a research proposal,
3. Guides participation or leadership in preliminary or pilot research project
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Modules I and II
may be provided together in
a pre-doctoral fellowship,
a residency program
a faculty development program
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METHODS
Classroom didactics
Electronic-based media for self study
Mentorship
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NIH-NCCAM RFA: 15 September 2004
Year 1: Planning & Development $100,000
Years 2-4: Implement, Evaluate, Sustain $200,000/yr
AIMS:1. Increase quality and quantity of research content of curricula
2. Enhance exposure to, understanding and appreciation of
Evidenced-based biomedical research literature
and
Approaches to advancing scientific knowledge