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    POTH 4 0 1

    Resear ch Met h od s

    Introduction to Research

    Dr. Ana Maria Rodriguez

    Acknowledgement to Dr. Nancy Mayoand Dr Judith Soicher

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    Learning Objectives

    Understand the role of research inevidence-based practice

    Identify different types and spheres ofrehabilitation research

    Understand the stages of the health

    research cycleIdentify the components and formulate

    clinical and research questions related torehabilitation

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    W hy do r esea rch?

    Hyppocratic Oath (460-370 BC):

    I will apply measures for the benefit ofthe sick according to my ability andjudgment; I will keep them from harmand injustice.

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    Ev id en ce- based Pr act ice

    Health professionals must use the best practicesavailable not to inflict harm on patients.

    The integration of the best research evidencewith clinical expertise and patients values

    Our professional responsibility :

    Research is the means by which we test thebeliefs that we are improving patients lives withour interventions.

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    What is Evidence-Based Practice

    Evidence-based medicine (EBM) is theconscientious, explicit and judicious use ofcurrent best evidence in making decisions about

    the care of individual patients.

    The practice of EBM means integrating individual

    clinical expertise with the best available externalclinical evidence from systematic researchSackett et al. BMJ 312:71, 1996

    Slide from Aliki Thomas, OCC1 545 notes, 2010

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    Clinical decisionsabout clienttreatment

    Pat ien t

    i n p u t

    Evidence

    Cl in ic ian 'sj u dg m en t

    Research ev id ence is on lyone e lem en t i n a com p lex set

    o f r e lat i onsh ips

    ( Dav i do f f , 1999 )

    ExperienceKnowledgeExpertise in a domain

    Research studiesPublished work

    ObjectivesInterestsExpectations

    3 main components of EBP

    Slide from Aliki Thomas, OCC1 545 notes, 2010

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    A pr o fession a l r espon sib i l i t y

    It is not good enough to simply report thatpatients are doing better or are satisfiedwith our services.

    Demanded by patients and third-partypayers.

    We must be willing to search, and in manyinstances, to create the evidence about thevalues of our practices and m o d if y o u rp rac t i ces in response to this evidence.

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    Lear n ing abou t

    r eh ab i l i t a t i on r esear ch i s

    n o t an easy t ask

    New sets of knowledge and skills that are

    different to the typical set of skills commonlylearned in rehabilitation.

    Leads to the re-examination of the status-quo.

    Can lead to doubt about previous learning.

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    Research in Rehab i l i t a t ion

    Careful examination and systemicevaluation of the subject at hand.

    A friendly, welcoming attituderegarding change.

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    Research:

    Challenges the status-quo:

    Identifying gaps in knowledge

    Collective wisdom has notalways been carefully

    reviewed.

    Novel treatments.

    Creative

    Systematic:

    Much of our clinicalknowledge is anecdotal.

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    What is research about?

    Research is about answering importantand interesting questions (not aboutcollecting data)

    Without bias

    With precision

    Bias is about how close you can get to thetruth related to design

    Precision is about how much uncertaintyremains - related to sample size

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    Bias vs. Precision

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    Bias vs. Precision

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    Get t i n g i t r i g h t

    Research is about getting the right answer, not

    just any answer

    The right answer is hard to find

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    Types of Research Questions

    How does theworld work?

    What does theworld look like?

    How to make theworld better?

    Populationhealth/healthservices

    Mechanisms/determinants

    Evaluativeresearch

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    Most Com m on in Rehab i l i t a t i on

    Mechanisms

    Determinants

    Evaluation

    (Measurement)

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    Bio log i ca l / Ph ysio log i ca l

    Mechan isms Identified using a series of experiments

    Highly controlled

    Small studies in selected samples to reduceextraneous variables

    Replication is important

    Outcomes physiological in nature

    Used to build a theory

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    Det er m in an t s o f h e al t h

    Factors that influence a disease or health state

    Could be environmental, sociodemographic,psychosocial, etc.

    Observational studies with larger samples

    Used to build / test theory

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    Ev alu at iv e Resear ch

    How to make ______________ better?

    cells, tissues, organs

    individuals

    groups

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    Tar get s fo r Eva lu a t ive Research

    Organ or tissue

    Rehabilitation Strategy

    Rehabilitation Intervention

    Rehabilitation Program

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    Medical Model

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    Definition of RehabilitationStrategies

    Single modalities(approaches ortechniques) thatseek to normalizebody structures orphysiologicalfunction at thetissue or organ

    level such asmuscle, articularstructures, brain,heart, lung or skin

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    Ex am ples o f Rehab i l i t a t i on

    St ra teg ies

    Dietary restrictions

    Medications

    Exercise

    Biofeedback

    Body-weight support

    Application of an orthosis

    Physical modalities

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    Def in i t i on o fRehab i l i t a t i on

    I n t e r v e n t i o n

    A selection of

    approaches ortechniques that seekto normalize anindividuals capacity

    for activity

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    Ex am p les o f I n t er v en t i on s

    Physical activityBalance training

    Healthy eating

    Stress reduction

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    Def in i t i on o f

    Reh ab i l i t a t i on Pr og r amRehabilitation

    programs comprise anumber ofinterventions thatseek to normalize(for individuals with a

    particular healthcondition)participation in familyand community life

    and quality of life

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    Ex am p les of Pr og r am s

    Stroke Rehabilitation (stroke unit,early supported discharge)

    Spinal Cord Rehabilitation

    TBI

    Work hardening . Etc.

    Geriatric Day program

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    Rehabilitation Model

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    Pr og r ession o f ResearchStages

    MechanismRehabilitation

    strategyRehabilitationintervention

    Rehabilitationprogram

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    Rehab i l i t a t ion Research Cy cle

    Consequences ofdisease

    Mechanism

    Strategy

    Intervention

    Program

    Implementation

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    Cy cle o f Reh ab i l i t a t ion Resear ch

    Consequences ofDisease

    Bio-psycho-social

    mechanisms

    Strategy

    Intervention

    Program

    Implementation

    Population health

    Basic science /

    determinants of health

    Evaluative Research

    Health services

    Research/

    Knowledge

    Translation

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    Ex am ple o f r esear ch cy cle inac t ion

    Mechanisms of gait and posture translate intostrategies

    Strategies are tested for safety and efficacy

    Strategies are incorporated into interventions

    Interventions are evaluated for their ability toimprove the individual (without harm)

    Interventions are bundled into programswhere they can do the most good, for thegreatest number of people at the least cost

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    Resear ch Cy cle

    Burden of disease

    Mechanisms/Associations

    Efficacy

    Effectiveness

    Efficiency

    Implementation

    After P Tugw ell, 1985

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    Th e 3 Es

    Eff icacy does more good than harm whendelivered exactly as directed, i.e. under

    optimal conditions

    Ef fec t iveness does more good than harmwhen delivered under usual conditions (e.g.fluctuating patient compliance)

    Eff ic iency considers cost and resources

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    Resear ch i s abou t Re lat ion sh ips

    Links one variable or factor to another

    One variable is thought (hypothesized) tobe associated with or cause the secondvariable

    Note that association and causation aredifferent

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    Va r i ab l e

    A property or characteristic that can bemeasured and that varies across people,places, and time

    Term used in research methods andstatistics

    Examples ?

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    Term s u sed t o descr ibe Re lat ion sh ips

    Disc ip l ine Cause Ef fec t

    Epidemiology Exposure* Outcome*

    Medical/clinical Risk factor Disease

    Psychology Independent Dependent

    Statistical Stimulus Response

    Mathematical X y

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    Outcome

    Characteristic of an individual that isexpected to change owing to an

    intervention or exposure

    Adapted from Dr. Nancy Mayo

    www.clinepi.mcgill.ca/610/Lecture3Measures_Rehab_Mayo_Print.pdf, accessed 1/27/11

    http://www.clinepi.mcgill.ca/610/Lecture3Measures_Rehab_Mayo_Print.pdfhttp://www.clinepi.mcgill.ca/610/Lecture3Measures_Rehab_Mayo_Print.pdfhttp://www.clinepi.mcgill.ca/610/Lecture3Measures_Rehab_Mayo_Print.pdf
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    The Research Quest ion

    (= Objective/Purpose/Goal)

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    Why is the Research Question soimportant ?

    Research is about answering important and interesting

    questions

    Research is not about collecting data

    Good research questions are about what you WANT TOKNOW

    Not about WHAT YOU WANT TO DO

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    In order to get the right

    answer at the endwemust ask the right

    question at the beginning

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    Nancy E. Mayo

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    A Framework for Asking

    QuestionsPopulation

    I ntervention (Exposure level 1)

    Comparison (Exposure level 2)

    Outcome

    T imePICOT (PECOT)

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    PICOT Format

    In people with ______________________ (P)

    Does a new intervention ______________ (I)

    In Comparison to usual care __ ________ (C)

    Affect outcome characteristic __________ (O)

    At Time __________________________ (T)

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    PECOT Format

    In people with ______________________ (P)

    Does a higher level of an exposure _____ (Exposure level 1)

    In Comparison to a lower level of exposure (Exposure level 2)

    Affect outcome characteristic __________ (O)

    At Time __________________________ (T)

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    A Good Question is:

    CLEAR

    Population,Intervention/Exposure,Outcome

    Time may notbe relevant insome studies

    OPERATIONAL

    A study could bedesigned

    A results tablecould be drafted

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    You be the judge ..

    The aim of our study was to measurequality oflife (QOL) in a clinic-based sample of childrenwho had a diagnosis of attention deficit (ADHD),and to considerthe impact of symptom severity

    on Quality of Life

    Population:

    Intervention or Exposure:

    Comparator:

    Outcome:

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    Or ..

    In children with AHDH, theobjectives of this study were: To determine the level of quality of life scores

    To estimate the association of symptom severity withquality of life

    Actually 2 separate objectives, as

    each will have its own statisticalanalysis and results table

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    Population:

    Intervention orExposure:

    Comparator:

    Outcome:

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    How do w e cond uc t Resear ch?

    During this course, you will be learn how todistinguish between the different types of studies.

    You should also be able to identify theappropriateness and the strengths and weakness ofeach design

    You should be able to apply different study designs tothe same research question

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    Ty pes o f Research Qu est ion s &Des igns

    How does theworld work?

    What does theworld look like?

    How to make theworld better?

    Observational design

    e.g. estimating

    relationships, associationsor mechanisms

    Observational designe.g. estimating

    relationships, associationsor mechanisms

    Experimental designe.g. estimating the effect

    of a treatment orintervention; also called

    evaluative research

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    Tw o b r oad Ca tego r ies of St ud y

    Des igns

    Observa t iona l

    These types of designare those where youobserve but dontintervene

    Exper imen ta l

    These are designswhere you interveneand record what

    happens

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    Hier a rchy o f St ud y Typ es

    Descriptive

    Case report

    Case seriesSurvey

    Analytic

    ObservationalCross sectional

    Case-control

    Cohort studies

    ExperimentalRandomized

    controlled trials

    Quasi-

    experimentalCross-over

    Single subject