2 0 1 1 2 0 1 1 Researcher-Academ ic Researcher-Academ ic Tow n Meeting Tow n Meeting
+ Training the Next Generation of Clinical Researchers Melissa C. Duff, PhD, CCC-SLP Researcher-Academic Town Meeting 2011 ASHA Convention San Diego, CA
+ Strategies for a career in clinical research � The early years…. � Training and building a foundation for a clinical research career Clinical research Building a foundation Training
+ Phases of clinical research • Pre-trial studies I • Feasibility studies II II • Early efficacy studies III III • Later efficacy studies IV IV • Effectiveness studies V (Fey & Finestack, 2009; Robey, 2004)
+ Phases of clinical research • Pre-trial studies I • Feasibility studies II II • Early efficacy studies III III • Later efficacy studies IV IV • Effectiveness studies V (Fey & Finestack, 2009; Robey, 2004)
+ “… a decade of foundational work before you start intervention studies” � Understanding the problem/ population � Experience and access to population � Data analysis and management � Developing and validating measurement � Establishing a track record of publications � Establishing a track record of funding � Building infrastructure and team of collaborators http:/ / www.cc.nih.gov/ training/ training/ ippcr/ IPPCRSch11-12.pdf
+ Training Doctoral, post-doctoral, early stage investigators
+ Interdisciplinary & Collaborative Training Models � Communication Sciences & Disorders � Developmental science/ psychology � Neuroscience/ neurology � Medicine � Otolaryngology � Education/ special education � Linguistics � Engineering � Gerontology
+ Interdisciplinary & Collaborative Training Models � Formal � Dual degrees, interdisciplinary programs and training grants � Informal � Individually organizing interdisciplinary training experience, selecting mentors � Barriers to Interdisciplinary/ Collaborative Training � Institutional/ departmental obstacles � Physical distance � Lack of a shared terminology and methods � Lack of funding to support � Poor communication between mentors � Opportunities from Obstacles � Knowledge and expertise in new set of skills and methods � Developing diverse communication and presentation styles � Additional peers to vet projects and opportunities for acculturation
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+ Post-doctoral training � TIME! � To publish your dissertation � To read, read, read! � To acquire new skills and methods � To get grant writing experience (NIH NRSA F32) � To build a publication record � To start new projects and collect new data (pre-trial; feasibility) � To start mentoring students � To get mentor training � To begin new collaborations � Setting LLL � In field vs. out of field � Lab vs. clinical setting � Mentor � Clinician-researcher � Skilled grant writer
www.lrp.nih.gov +
+ Early Stage Investigators � Increased mentoring opportunities � ASHA Mentoring Academic-Research Careers (MARC) � ASHA Lessons for Success Research Workshop (LfS) � ASHA Clinical Practice Research Institute (CPRI) � Increase opportunities for mentored experience in clinical research � ASHFoundation Clinical Research Grant (mentored treatment research) � NIH K Awards � Establishing independence � Defining roles on collaborative teams � Tenure
+ Building a foundation http:/ / elite.tamucc.edu
+ Building a foundation � A foundation of work to support early stage and future clinical research � Developing a strategy for productivity and funding while building a programmatic line of research � Feasibility and development studies � Building a population base, infrastructure, and a team
+ Building a foundation Iowa Traumatic Brain Injury Registry
+ Building a foundation Iowa Traumatic Brain Injury Registry Population • Neuropsychological Characterization • Neuroanatomical
+ Building a foundation Iowa Traumatic Brain Injury Registry • Discourse Foundational • Social Behavior/ perception Empirical/ Feasibility • Learning/ memory Studies • Activity sensors Population • Neuropsychological Characterization • Neuroanatomical
+ Building a foundation Iowa Traumatic Brain Injury Registry • Outcome/ Longitudinal work Clinical Practice • Intervention Research • Controlled Trials • Discourse Foundational • Social Behavior/ perception Empirical/ Feasibility • Learning/ memory Studies • Activity sensors Population • Neuropsychological Characterization • Neuroanatomical
+ Thank you. k
Training the Next Generation of Clinical Researchers M A R Y P A T M O E L L E R , P H . D . R E S E A R CH E R - A CA D E M I C T O W N M E E T I N G A S H A N A T I O N A L CO N V E N T I O N S A N D I E G O , CA N O V E M B E R 16 , 2 0 11
Overview: My charge 23 � Discuss strategies for preparing researchers to contribute to knowledge in prevention, assessment and treatment � Three premises related to: � The need for clinical practice research to progress through system atic phases - How did our early w ork support a larger, m ulti-center investigation related to CPR? � The im portance of research collaborations in CPR – What have w e discovered about m aintaining successful collaborations? � Ingredients for developing a career focused on CPR – What has w orked from our perspective? Overview
Background: An Early Wake-Up Call!! 24 � USPSTF Systematic Review (2004) � “The evidence is insufficient to recommend for or against routine screening of newborns for hearing loss… ” � This motivated outcomes studies (some population-based) � Major research needs remain… � In a new genera tion of children, with earlier access to better technologies… � In general, there are few studies documenting the effica cy a nd effectiv eness of interv entions for this population of children � Clinical practice research represents a critica l need if we are to harness the potential of newborn hearing screening Overview
Premise 1 25 T O S T R E N G T H E N T H E E V I D E N CE B A S E , T H E R E I S A P R E S S I N G N E E D T O A P P R O A CH CP R T H R O U G H S Y S T E M A T I C S T A G E S . Premise 1
Prem ise 1: To strengthen the evidence base, there is a pressing need to approach CPR through systematic stages. 26 Gather Pre-trial studies empirical justification for later, Feasibility Studies more costly studies Early Efficacy Studies Major gaps Later Efficacy Studies in intervention research Effectiveness Studies (Fey & Finestack, 2009; Robey, 2004) Premise 1a
Building on a foundation of early-phase studies… 27 � Longitudinal studies of early-identified children with hearing loss � Language Development Lab + Hearing Aid Research Lab � Identification of factors influencing early outcomes � Identifying risks, developing sensitive measures, recognizing gaps Moeller, et al. Ear & Hearing (2007) Stelmachowicz, et al., Ear & Hearing (2001) Premise 1b
Need to apply health outcomes research methods to a population sample… 28 In a low-incidence, challenging-to-recruit population It is going to take a village!! Step 1: Forming a team with overlapping & complementary interests, goals and skills Longitudinal, health-outcomes research expertise Child language research expertise Operational Infrastructure Biostatistics & Data management Outcomes research related to clinical management of children with HL Expertise in pediatric hearing loss & pediatric amplification Population access Premise 1c PIs: J. Bruce Tomblin & M.P. Moeller
To address the more complicated story… 29 Multi-center, m ulti-d iscip lina ry longitud ina l outcom es stud y Audiologic Educational Clinical Intervention Intervention Moderators Mediators & Hearing Audible Speec h Ac ademic / Outcomes Loss Hear ing L anguage Psyc ho-Soc ial Non-clinical Hearing Aid Use Home Environment Moderators 30 6 child ren w ho a re ha rd of hea ring; 112 child ren w ith norm a l hea ring Premise 1d Tomblin, et al, 2008
Identifying vulnerabilities: Phonology & Syntax? 30 140 88.8 120 100 Standard Score 80 NH (n=39) 60 HH (n=95) 40 20 0 Basic Concepts Syntax Pragmatics Composite CASL at Age 4 years p s < .002 Premise 1e
Premise 2 31 T O M A I N T A I N S T R O N G CO L L A B O R A T I O N S , CO N S I D E R A D O P T I N G M O D E L S F R O M T H E F I E L D O F L E A D E R S H I P . Premise 2
Behaviors of Effective Teams 32 Committed to achieving Invest in Focus on clear goals quality control Results & project Hold one tracking another Lack of accountable territoriality across sites Commit Mine the • Ground rules for conflict Engage in Conflict inclusive communication • Strengths-based management Develop Trust Premise 2a Adapted from: Lencioni (2002) The Five Dysfunctions of a Team
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