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2
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2009Researcher Academic
2009Researcher Academic Researcher-Academic
Town MeetingResearcher-Academic
Town Meeting
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Laura JusticeThe Ohio State Universityy
2009 Researcher‐Academic Town MeetingNov 18 2009
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to describe the needs and challenges of clinical h d h h h bpractice research and how they might be
addressed by individuals who want to pursue h f hthis type of research
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Preschoolers’ literacy skills are consistently and significantly l d l related to later
reading achievement
Storch & Whitehurst, 2002
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Preschoolers with 101214161820
20Typical
Left: Upper-case alphabetBelow:
language impairment (LI) consistently exhibit lags in development of
02468
10
7
LIBelow: Name-writing
lags in development of early literacy skills, particularly print 10
12
p y pknowledge
2
4
6
8
11 Typical
LI
06
Cabell, Justice, Zucker, & McGinty, 2009
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Language difficulties and lags in print knowledge often co‐occur in larger population of young p p y gchildren considered “at‐risk” (estimated profile at 16%) 16%)
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Early lags in early literacy skills for children with LI contribute to long‐term risks in greading achievement
Skibbe, Grimm, Stanton-Chapman, Justice, Pence, & Bowles, 2008
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520Reading in Grade 5
This cascade of effects results in functional 510
515
520
results in functional disadvantages in reading outcomes for 500
505
510LI (n=145)
Peers gchildren with a history of LI
490
495
500(n=653)
490
Skibbe, Grimm, Stanton-Chapman, Justice, Pence, & Bowles, 2008
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11
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Identification Research
FeasibilityResearch
EfficacyResearch
Meta‐Analyses Scale‐UpResearchResearch Research Research Research
Identification of key mechanisms through which hild d l
Early tests of intervention potential
True tests of intervention potential
(d i d t
Unbiased estimates of effects as
t d
Estimates of effects when
implemented in i t f ti children develop
early literacy skills during
literacy events
(designed to make strong
causal inferences)
aggregated across studies
variety of routine settings; tests of
moderationy
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60
80
100
0
20
40
very hungry caterpillar
spot bakes a cake
Justice, Skibbe, Canning, & Lankford, 2005
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fi i i
0 05
0.06
fixations on narrative text
0 03
0.04
0.05
0 01
0.02
0.03
0
0.01
verbatim reading talking about talking about print pointing to printpictures
Justice, Pullen, & Pence, 2009
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0.78 h l
gain scores
0 4
0.5
0.6
738 preschoolers
random assignment to
0.2
0.3
0.4random assignment to reading conditions: print focus
0
0.1ppicture focus
24 small‐group reading sessions in Head Start
Justice & Ezell, 2002
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8 K t h i hi h36
Grade 1 Woodcock Johnson-III Test of Achievement84 preK teachers in high‐risk classrooms
30
32
34Grade 1 Woodcock Johnson-III Test of Achievement
HDRRLDPRHDPR
random assignment to reading conditions: everyday regular reading (HDRR) 24
26
28
ome
Scor
e
everyday regular reading (HDRR)everyday print referencing (HDPR)twice‐weekly print referencing (LDPR)
18
20
22Out
co
4‐6 children randomly selected and tracked for 3 years (n = 12
14
16
years (n =
Piasta, Justice, & Kaderavek, 2009
Letter-Word Identification
Spelling Passage Comprehension
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ES Estimate = .51
95% CI 0 28 to 0 7395% CI 0.28 to 0.73(p < .0001)
(Based on 4 studies with print knowledge as DV)
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From Librarians to Ladies (First Ladies of Ohio, that is)…
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S i i t l ti h i t tiSome issues in translating research into practice:
Storybook features affect intervention yimplementation (session dose)
Session dose affects child gainsSession dose affects child gains
Outcomes attenuated or non‐existent for some subgroups of childrensubgroups of children
Some parents cannot complete this intervention p p(attrition estimates of 28%)
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25
20
15
Begin Intervention
5
10g
Complete Intervention
0
5
Print Focus Picture Focus
Justice, Skibbe, McGinty, Piasta, & Petrill, 2009
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b t f th l d i f “ li i l h” th t a subset of the larger domain of “clinical research” that investigates methods to:
(a) prevent disorders, (b) improve the accuracy and precision of diagnostic
and screening materials and screening materials, (c) enhance the effectiveness of therapeutic
interventions, and (d) i i h b fi i f i id d (d) optimize the cost‐benefit ratio of services provided
by audiologists and speech‐language pathologists
(ASHA, 2009)
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Research that is directly relevant to the methods and outcomes
f l lof clinical practiceand
h h h diff iResearch that examines the diffusion, dissemination, and implementation of
l lclinical practices
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hResearch Practice
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T2T1 T2
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Translation ResearchTypes Sample QuestionTranslationPhase
ResearchTypes Sample Question
T1 Basic Research: What are the mechanisms through which Translation to Humans
Basic research of many types, Phase I and II trials
young children develop print knowledge?
T2 Clinical Research: To what extent does use of a printT2Translation to Patients
Clinical Research:Phase III and IV trials, validity studies, meta‐analysis, systematic reviews
To what extent does use of a print‐referencing reading style causally impact children’s growth in print knowledge?
T3 & T4Translation to P i
Clinical and CommunityPractice ResearchDi i i h
What variables influence intervention implementation by various stakeholders? H i h i i b dd d i hi Practice Dissemination research,
implementation research, diffusion research
How is the intervention embedded within different organizational cultures?
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This hierarchy does not Quality
systematic reviewThis hierarchy does not include issues ofdiffusion,
systematic review
Quality randomized
controlled trial,dissemination, and implementation Quasi‐experimental
studies
Poor randomized controlled trials and systematic reviews
Theory
Individual case control studies
Case series
Expert opinion
“Evidence‐based!” exclamation
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Diffusion ResearchDiffusion ResearchFocuses on the conditions that increase or decrease the likelihood that a new practice will be adopted by various stakeholders stakeholders
Dissemination ResearchFocuses on the processes and variables that influence padoptions of new practices by various stakeholders
Implementation ResearchFocuses on the movement of new practices into actual Focuses on the movement of new practices into actual delivery contexts, including how these are integrated into existing organizations
National Cancer Institute, 2009
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What specific family‐level conditions moderate the What specific family level conditions moderate the impacts of Intervention A on child gains?
How can Intervention A be tailored to meet the needs of families experiencing these conditions?
What barriers impact the diffusion of Intervention A into a community? Into a school? Into a home?into a community? Into a school? Into a home?
Can alternative means be used to get Intervention A gto children? Do effects hold?
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The Causality Continua
Case Study Research
FeasibilityResearch
EfficacyResearch
Meta‐Analyses
Scale‐UpResearch
Th U f S lf Th Effi f A M A l i A h i i A The Use of Conversation
Analysis to Guide Individualized
Self‐Administered Cued Naming Therapy: A
The Efficacy of a Semantic Cueing Procedure on
Naming
A Meta‐Analysis of Studies Carried Out
between 1946
Aphasia in Acute Stroke:
Incidence, Determinants,
Advice to Carersand Evaluate Change in
Aphasia A Case
pySingle‐
Participant Investigation of a Computer Based
gPerformance of Adults With
Aphasia (Lowell et al 1995)
94and 1988
Concerned with the Efficacy of Speech and
,and Recovery(Pederson et al.,
2004)Aphasia: A Case Study (Booth & Perkins, 1999)
Computer‐Based Therapy Program
Replicated in
et al., 1995) Speech and Language Therapy for
Aphasic Patients Four Cases
(Ramsberger & Marie, 2007)
(Whurr et al., 1992)
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The Translational Continua
Case Study Research
FeasibilityResearch
EfficacyResearch
Meta‐Analyses
Scale‐Up Research
Diffusion‐Dissemination‐Implementation Implementation
Research
The Use of ConversationAnalysis to
Self‐Administered Cued Naming
The Efficacy of a Semantic Cueing
A Meta‐Analysis of
Studies Carried
Aphasia in Acute Stroke: Incidence, y
Guide Individualized Advice to Carers and
l
gTherapy: A Single‐
Participant Investigation
f
gProcedure on
Naming Performance of Adults With h ll
Out between 1946 and 1988 Concerned with the Efficacy of
h d
,Determinants, and Recovery(Pederson et al., 2004)
Evaluate Change in Aphasia: A Case Study (Booth &
of a Computer‐
Based Therapy Program
Aphasia (Lowell et al., 1995)
Speech and Language Therapy for Aphasic
Patients (Whurr(Booth & Perkins, 1999)
Program Replicated in Four Cases (Ramsberger& Marie,
Patients (Whurret al., 1992
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fA solid body of T2‐T4 work is required to
Ensure that persons get the best care possible (focus on implementation of existing t t t th th d l i )treatments rather than developing new ones)
h i i b i k iTo ensure that investments in T1 (basic) work is realized
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T l ti l Diffi lti f E t t Lit t Translational Difficulties of Extant Literature:
1. Majority of participants in our studies are idealized j y p pversions of service recipients (artificial samples)
2 Majority of efficacy trials have inflated effects2. Majority of efficacy trials have inflated effects
3. Majority of efficacy trials (academic clinical settings) have limited validity for the “blue settings) have limited validity for the “blue highways” (practitioners and clients across the United States)
Westfall, Mold, &
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Identifying a new treatment or assessment Identifying a new treatment or assessment option is only the very first step
The end point in ‘bench‐to‐bedside’ research is the starting point in dissemination researchVery few scientific discoveries actually move into clinical Very few scientific discoveries actually move into clinical practice (5% of highly promising genomic findings)
d f k d d lAmount and type of work needed to translate basic findings into clinical practice has been sorely under estimatedsorely under‐estimated
Khoury et al., 2007; Westfall, Mold, & Fagnan, 2007; Woolf, 2008
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Ensures that persons get the best care possible
focus on implementation of existing treatments rather than developing new ones
Ensures that investments in T1 (basic) work are realized
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under‐powered (can only detect large effects, lots of measurement error)g
involve exploratory work when unnecessary (strong theory, prior evidence)
f flittle attention to moderators and mediators of intervention impacts (for whom and under what conditions interventions “work”)
few replication studies by independent researchersfew replication studies by independent researchers
few longitudinal studies of intervention impacts
few studies of movement of validated treatments into real delivery contexts
participants and settings don’t resemble who/where SLPs serve (artificial sample)p p g / ( p )
limited attention to multi‐level influences on interventions
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The clinical applicability of a specific body of work (including The clinical applicability of a specific body of work (including basic research) is very limited because we don’t know how to
translate (diffuse and disseminate) findings:
“There is science in what we do, yes, but also habit, intuition, and sometimes plain old guessing The gap between what and sometimes plain old guessing… The gap between what
we know and what we aim for persists. And this gap complicates everything we do.”
‐Atul Gawande, Complications (2002)
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Money
Skill
Tradition
T2 Studies
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fVast majority of research money is invested in basic research1.5% of NIH biomedical research funding is for dissemination research (Woolf, 2008)▪ Clinical and Translational Science Awards (2% of budget)
Federal AHRQ allocation = 1% of NIH budgetT l i R h i P i (TRIP I d II % f ▪ Translating Research into Practice (TRIP I and II; 1‐2% of budget)
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Specialized research skills▪ recruiting and maintaining very large samples▪ recruiting and maintaining very large samples▪ involving field partners and organizations▪ multiple methods Multiple disciplines/collaborationsMultiple disciplines/collaborations▪ Epidemiology▪ Public policy ▪ Financingg▪ Organizational theory▪ Educational leadership▪ Systems redesign
S i l th l▪ Sociology, anthropologyMessiness▪ Infrastructure constraints▪ Organizational inertia▪ Organizational inertia▪ Moving targets
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Our research community has percentageOur research community has largely pursued basic research and applied basic research 50
60
percentage
53 group‐design efficacy/effectiveness trials b d 20
30
40
between 1997 and 2007 published in ASHA journals (140 issues) 0
10
20
Justice, Nye, Schwarz, McGinty, & Rivera, 2008
percentage
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W t We cannot move from the bench t th b d id to the bedside… and beyond…
il h until we have a solid corpus of
k b ldT2 work to build upon
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fIn the interest of the persons we serve, clinical practice research needs to “come out from under
h h d f b hthe shadow of T1” (basic research) (Woolf, 2007)
Clinical practice research offers great promise for closing the gap between habit, intuition, and closing the gap between habit, intuition, and guessing and providing the most effective treatments for communication disorders. treatments for communication disorders.
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Laura [email protected]
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Nancy Tye-Murray, Ph.D.Washington University School of Medicine
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Raise awareness about what faculty might do to encourage and nurture student’s interest in applied researchin applied researchConsider a model for developing a career in clinical practice researchclinical practice researchAffirm that careers in clinical practice research are viable
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No undergraduate student starts out
ti t b wanting to be a clinical researcher in audiologyin audiology
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Frustration with teaching methods that didn’t seem to be didn t seem to be workingObservation that many yveteran teachers seemed to have lost their vim and vigor for their vim and vigor for teaching
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Audiology/AR practicaInstrumentation classJulia and Jerry* Text book research Text book research* A flaky ideaResearch assistantships
d* Cadavers & cats, grants & graphsIndependent readings seminarCognitive psychology
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Practica: Exposure early on to clinical practice, opportunity to learn what
i
Research assistantships:Living the day-to-day life of a scientist
excites youClasses: “I can do this” and “I want to do this”
Readings: Gaining exposure to the scientific method; nurturing interests
One-on-one interactions with professors: Learn what they do and how they do it;
Psychology (and other disciplines): Exposure to top-notch behavioral
Importantly, learn that they value your contributions and your abilities to perform
research; information about the perceptual systems; the importance of cross-pollinationpollination
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A blueprint for developing a careerA blueprint for developing a careerTeaching them before they leave our tutelage
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Select a patient population
Develop a coherent plan;build on your
base
Identify a clinical servicethat you would like to provideBegin data collection; that you would like to provide,
improve, and/or assess or a theoretical issue
that excites you
every patient presents anopportunity
Obtain funding and develop
l b t
Formulate a research question
and design ana laboratory and design anexperiment
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Assess your current job.Assess your current job.Assess patient availability; look for niche topics.Assess challenges and opportunities.
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Is there a service that you want to include Is there a service that you want to include but don’t have the resources to do so?Is there a service or intervention that you want to create or alter?Has your experience led you to hypothesize about mechanisms or processes? about mechanisms or processes? Translational research means moving from basic science to clinical practice AND moving f li i l ti t b i ifrom clinical practice to basic science.
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Do your homework Read read and then Do your homework—Read, read, and then read some more; attend conferences; trawl outside of your field.Network, especially within your academic setting; e.g., clinical psychologist, cognitive psychologist; psychometrician; statistician; psychologist; psychometrician; statistician; second language learning expert; speech-language pathologist; psychosocial therapist; otolaryngologist; anesthesiologist; otolaryngologist; anesthesiologist; neuroscientist; fellow audiologist.
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Read successful grant applications and develop an eye for what Read successful grant applications and develop an eye for what works.Hang out with people who know how to write grant applications Grant writing is a craft that can be learned not a applications. Grant writing is a craft that can be learned, not a talent that you have or don’t have.Consider first fishing at a small pond and moving into larger waters later Pilot data lead to larger projectswaters later. Pilot data lead to larger projects.Follow the instructions! And if they tell you to jump through a hoop, jump through the hoop.Pay attention to the details.
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Procure space.Get the best equipment you can afford.Hire great people and let them do what they Hire great people and let them do what they do best.Expect excellence.Create safeguards.
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Every patient can provide a data point.Every patient can provide a data point.Resources are available for recruiting participants.Community outreach can be effective and can also be cost-free.
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Where have you come from, where are you Where have you come from, where are you going?What’s your 1-year plan, 3-year plan, and even 5-year plan?
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Example:p
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Patient Population
Service & Interest
Building
Research Question
Data Collection
Funding & Lab
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Adults with profound Adults with profound hearing loss who receive cochlear receive cochlear implants
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Service: Provide aural Service: Provide aural rehabilitation to new implant recipientsp p
Research interests:AV speech perception
Conversational flfluencyPerceptual learning
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dDoes computerized speechreading/ communication communication strategies training work?work?
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Funding Funding DRFEaster Seals SocietyUniversity of Iowa Video studio
Fi t l b Y t t First lab: You got to start somewhere….
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Hung a sign on an under-used closet and voila!
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Cochlear implant recipients across Iowa
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GrantsGrants
Computerized auditory training (stemming from interests in perceptual learning)p p g)
Auditory discourse comprehension (stemming from interest in conversational fluency)
Children’s audiovisual speech perception and lexicon development (stemming from interest in audiovisual perception)audiovisual perception)
Audiovisual speech perception and aging (Stemming from interest in audiovisual perception and audiovisual perception and perceptual learning)
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Speechreading tests for both adults and children “C ti M d E ” “Conversation Made Easy”; “Communication Training” manualsDi h i Discourse comprehension tests for adults, auditory and audiovisual
d dComputerized auditory training programs based on 2nd language learning principlesprinciplesIndices to gauge integrationMethods to assess conversational fluencyPsychosocial workshops
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Next step: to assess the effects of training working memory and of auditory training on discourse comprehension and to finalize standardized test lists of auditory discourse
hcomprehension.Next step: to compare the effects of
multiple versus single talkers for persons with hearing loss and to determine benefits for patients who have aphasia.
Next step: to develop an index of integration that can be used for clinical and research purposes.
Next step: to standardized tests of speechreading and to study performance as a function of maturation and hearing loss and to continue to study audiovisual lexicon development.
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