Tips for Conducting Multicenter Medical Education Research

Tips for Conducting Multicenter Medical Education ResearchFrancis Nuthalapaty, MDAssociate Professor of Obstetrics and GynecologyUniversity of South Carolina School of Medicine GreenvilleClaudette Shephard, MDAssociate Professor of Obstetrics and GynecologyUniversity of Tennessee - MemphisJulie DeCesare, MDAssociate Professor of Obstetrics and GynecologyFlorida State University College of Medicine2016 CREOG & APGO Annual MeetingHyatt Regency New Orleans | New Orleans, LA

DisclosureThe presenters have no relevant conflicts of interest to disclose

Learning ObjectivesUnderstand the practical steps to initiating research collaborations (structure, governance and funding)Understand the requirements and challenges in assuring research complianceIdentify the options for generating scholarship and how to assign authorship

ResearchIdeaCollaboratorsDissemination

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Case Scenario Part 1You are a Residency Program Director or Clerkship Director attending the annual CREOG / APGO Meeting. You just came up with an idea for a possible curricular change that you want to implement. You also want to try and study the change and see if it produces a difference. But you are not sure if anyone has tried it before and you also dont know if people will find it useful. What are the first steps you would take once you get home to flesh out your idea?

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Inspiration for your Ideas

Learners

Patients

Partners

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The Research ProcessDefineResearchQuestionConductLiteratureReviewRefineResearchQuestion

No holein theliteratureHolein theliterature

FINER Research QuestionsF FeasibleI InterestingN NovelE EthicalR - Relevant

The Research ProcessDefineResearchQuestionConductLiteratureReviewRefineResearchQuestionDesignStudy

No holein theliteratureHolein theliterature

Case Scenario Part 2You now have a FINER research question and youre ready to begin designing your study. What should be your next step?

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TimeResearchIdea

5 Critical Areas to Implement Effective Time Management-CarnegieAttitude and StressPlanningPrioritizingOrganizing Leadership and Coordination

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Governing Your Time5 Critical Areas to Implement Effective Time Management

Attitude and StressPlanningPrioritizingOrganizing Leadership and Coordination

Schedule time to commit to this 13

Governing Your TimeResearch coordinator with structured emails and reminders thru out the projectMinimize distractions and dedicate protected time in your schedule to work on your projectChoose collaborative partners wiselyUse organization tools (doodle poll to schedule conference calls) and online document storage systems (box.com, dropbox) to promote efficiency

Schedule time to commit to this 14

Governing Your Time

Research coordinator with structured emails and reminders thru out the projectMinimize distractions and dedicate protected time in your schedule to work on your projectChoose collaborative partners wiselyUse organization tools (doodle poll to schedule conference calls) and online document storage systems (box.com, dropbox) to promote efficiency

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Case Scenario Part 3You now have a draft study design that outlines your population, interventions, controls, outcome measures and timeline (PICOT). What should be your next step?

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Time

FundingResearchIdea

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Finding the FundingDirect CostsBudget line items that support performing the scope of the work and are reasonable, easily identifiable and allocable to the projectIndirect CostsExpenditures that cannot be allocated to the specific project. Usually expressed as percentage of the the direct costs.

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Finding the FundingEquipmentSuppliesParticipant support costsFacilities feesTechnologyTravelConsultant servicesSalaries and wagesFringe benefitsSubawards / Subcontracting

Examples of Direct Costs

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Finding the FundingDepartmentInstitution / School of MedicineOffice of PhilanthropyCommunitySpecialty SocietiesAcademic OrgsAdvocacy OrgsGovernment Agencies

Sources of Funding

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Case Scenario Part 4You were successful in obtaining an unrestricted educational grant. Your study requires a population of 30 learners, but you have only 6 learners at your site. What should be your next steps?

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Time

Funding

ResearchIdeaCollaborators

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Building Your TeamWhat is the best governance structure for a multicenter study (who do you need)?How do you estimate how many additional sites are required?Is geographic proximity important?How do you approach other sites for collaboration?What is a partnership agreement and what should it contain?

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Case Scenario Part 5You now have a research collaborative consisting of a total of 8 centers. They have all reviewed the protocol and signed a collaborative agreement. What should be your next steps?

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Time

Funding

ResearchIdeaCollaborators

Compliance

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Clearing Compliance

Educational Research involves Human SubjectsObligations of Investigators to the Institution(s)Common IRB Protocol?Need lead institutionShould be decided in early stages of the research

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Clearing ComplianceTo your own IRB be True

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Human Subject ResearchCollaborative Agreements Centralized IRBs

http://www.hhs.gov/ohrp/policy/ohrpregulations.pdfClearing Compliance

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Case Scenario Part 5Your study is now up and running. One of the members of your team has been underperforming (missing deadlines and failing to show up). When you address your concerns with him, he reports to your Chairman that you have been grossly mismanaging the study finances and using coercive tactics to make him participate. What should be your next step?

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Time

Funding

ResearchIdeaCollaborators

Compliance

Detractors

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Dealing with DetractorsWhat kinds of detractors can impede good research?How can you anticipate and protect yourself and your work from detractors?

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Dealing with DetractorsSourcesPeersCollaboratorsResearch StaffDepartmental AdministrationInstitutional Administration

TypesOver commitmentProfessional jealousyPersonal stressorsBudgetary constraintsChanging priorities

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Dealing with DetractorsSet clear expectations in collaborative agreementsClearly document all meetings with signed/dated minutesSave all project-related email correspondenceAvoid informal conversations but if they happen, document follow-up with an email

Primary Prevention

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Dealing with DetractorsReview your collaborative agreementsContact your IRB and ask for guidanceAddress concerns as a team issue, rather than as an individual issueFocus on facts rather than interpretations

Deliberate Response

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Time

Funding

ResearchIdeaCollaborators

Compliance

Detractors

Dissemination

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Disseminating the WorkLocal / RegionalGrand RoundsStudent / Resident Research DaysMedical SocietiesNational / InternationalResearch Poster/Oral at Academic meetingFaculty Development WorkshopPeer-review publicationMedEdPORTAL

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Time

Funding

ResearchIdeaCollaborators

Compliance

Detractors

Dissemination

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Time

Funding

ResearchIdeaCollaborators

Compliance

Detractors

Dissemination

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FINER Research QuestionsFeasible:Can be investigated with available:TimeMoneySpaceOther resources

FINER Research QuestionsInteresting:Interesting to youInteresting to others in the fieldNovel:Will answers to the question advance knowledge in the field?

FINER Research QuestionsEthical:Will any physical or psychological harm come to anyone as a result of the research?Protect participants from harmEnsure confidentiality of dataAvoid knowing deception of participantsRelevant:How might answers to this question improve educational practice?

Clearing ComplianceWhat kinds of studies need to have Human Subjects Protection reviewWhat are the options for review when doing a multicenter study?How do you train the investigators at the other sites?How do you track compliance?

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Disseminating the WorkWhat are the ways in which you can disseminate your work?What journals are the best for OBGYN educational studies?

Grand rounds, local medical societies, academic meetingsStretch a project into many opportunities- start with the preliminary findings on a poster, then final work with oral presentationHave your article written at the time of oral- use critique and feed back to finalize your ideas and submit45