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CLINICAL RESEARCH SKILLS

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Title: CLINICAL RESEARCH SKILLS


1
RESEARCH DESIGN
  • STUDY DESIGN will depend on the specific goal of
    the study

2
RESEARCH DESIGN
  • SINGLE-CASE DESIGNS
  • 1 or more individuals or a group over a time
    period
  • Pre / post-tests
  • GROUP DESIGNS
  • Several participants studied and assigned to
    conditionsbetween-group design
  • Random assignment
  • Can be true, quasi or observational

3
RESEARCH DESIGN
  • A well-designed experiment is one in which
    competing hypotheses that might explain results
    are made relatively implausible or ruled out
    (VALIDITY).
  • TYPES OF DESIGNS
  • TRUE EXPERIMENTS maximum control over
    independent variable random assignment
  • QUASI EXPERIMENTS all features cannot be
    controlled non random assignment
  • OBSERVATIONAL STUDIES e.g. case- control study

4
EXPERIMENTAL METHOD
  • 4 GOALS OF RESEARCH
  • DESCRIPTION OBSERVATIONAL SURVEY RESEARCH
  • PREDICTION CORRELATIONAL RESEARCH
  • EXPLANATION EXPERIMENTAL METHOD

5
EXPERIMENTAL METHOD
  • WHY PSYCHOLOGISTS CONDUCT EXPERIMENTS?
  • RESEARCHERS CONDUCT EXPERIMENTS TO TEST
    HYPOTHESES ABOUT THE CAUSES OF BEHAVIOUR
  • EXPERIMENTS ALLOW RESEARCHERS TO DECIDE WHETHER A
    TREATMENT OR PROGRAM EFFECTIVELY CHANGES BEHAVIOUR

6
EXPERIMENTAL METHOD
  • LOGIC OF EXPERIMENTAL RESEARCH
  • RESEARCHERS MANIPULATE AN IV IN AN EXPERIMENT TO
    OBSERVE THE EFFECT ON BEHAVIOUR, AS ASSESSED BY
    THE DV
  • CONTROL IS THE ESSENTIAL INGREDIENT OF
    EXPERIMENTS WHICH IS GAINED THROUGH MANIPULATION,
    HOLDING CONDITIONS CONSTANT, AND BALANCING

7
EXPERIMENTAL METHOD
  • EXPERIMENTAL CONTROL ALLOWS RESEARCHERS TO MAKE
    THE CAUSAL INFERENCE THAT THE IV CAUSED THE
    OBSERVED CHANGES IN THE DV
  • AN EXPERIMENT HAS INTERNAL VALIDITY WHEN IT
    FULFILLS 3 CONDITIONS
  • Covariation (when one changes,the other also
    changes)
  • Time-order relationship (one comes before the
    other)
  • Elimination of plausible alternative causes (no
    confounds)

8
EXPERIMENTAL METHOD
  • WHEN CONFOUNDING OCCURS, A PLAUSIBLE ALTERNATIVE
    EXPLANATION FOR THE OBSERVED COVARIATION EXISTS,
    AND THEREFORE, THE EXPERIMENT LACKS INTERNAL
    VALIDITY
  • PLAUSIBLE ALTERNATIVE EXPLANATIONS ARE RULED OUT
    BY HOLDING CONDITIONS CONSTANT AND BALANCING

9
EXPERIMENTAL METHOD
  • DESCRIBE A RESEARCH SITUATION IN WHICH THESE
    CONDITIONS ARE NOT MET
  • THREATS TO INTERNAL VALIDITY
  • HISTORY (due to some other event other than the
    treatment)
  • MATURATION (due to the fact that the participants
    changed over time)

10
EXPERIMENTAL METHOD
  • HOW ABOUT A RESEARCH SITUATION WHICH MEETS THESE
    CRITERIA?
  • LOFTUS BURNS (1982) EXPERIMENT INVESTIGATING
    EFFECT OF WITNESSING A MENTALLY SHOCKING EVENT ON
    THE PARTICIPANTS MEMORY FOR INFORMATION THAT WAS
    PRESENTED IN THE FILM SECONDS BEFORE THE VIOLENT
    SCENE (PG. 226-7, SHAUGNESSY)

11
EXPERIMENTAL METHOD
  • CONTROL TECHNIQUES
  • Students viewing exact same film except for
    critical incident, given same instructions,
    received same questionnaire at the end (holding
    conditions constant)
  • However researchers only hold conditions constant
    that we CHOOSE toSO ONE MUST ALWAYS BE ALERT TO
    POSSIBILITY THAT THERE MAY BE OTHER CONFOUNDS WE
    DID NOT ANTICIPATE
  • Make sure that 1 grp is not smarter, more
    attentive, more motivated, have more women
    (balancing) which occurs through RANDOM
    ASSIGNMENT (random groups design)
  • STRETCHING EXERCISE PG. 229, SHAUGNESSY

12
INDEPENDENT GROUPS DESIGN
  • EACH GRP OF PARTICIPANTS REPRESENTS A DIFFERENT
    CONDITION AS DEFINED BY THE IV (E.G. EYEWITNESS
    BEHAVIOUR EXPERIMENT)
  • Random groups design is needed to BALANCE
    individual differences

13
INDEPENDENT GROUPS DESIGN
  • RANDOM GROUPS DESIGN
  • Comparable groups of individuals are formed and
    the groups are treated the same in all respects
    except that each grp receives only ONE level of
    the INDEPENDENT VARIABLE
  • This allows for causal inferences
  • Random assignment is used to form comparable
    groups by balancing or averaging subject
    characteristics (individual differences) across
    the conditions of the IV manipulation

14
INDEPENDENT GROUPS DESIGN
  • RANDOM GROUP DESIGN contd
  • Block randomization balances subject
    characteristics and potential confoundings that
    occur during the time in which the experiment is
    conducted, and creates groups of equal sizes
  • ONE PARTICIPANT IS ASSIGNED TO EACH CONDITION IN
    THE BLOCK BEFORE A 2ND ONE IS ASSIGNED IN ANY ONE
    CONDITION

15
INDEPENDENT GROUP DESIGN
  • BLOCK RANDOMIZATION
  • If we want to have 20 participants in each of 3
    conditions, then there would be 20 blocks in the
    block-randomized schedule
  • Essentially, we take the first 3 people and
    randomly assign them to each condition, then the
    next 3 until youve done this 20 times
  • Groups are tested in blocks, not based on the IV
    thereby creating a balance

16
INDEPENDENT GROUPS DESIGN
  • BLOCK RANDOMIZATION
  • ADVANTAGES
  • PRODUCES GROUPS OF EQUAL SIZE
  • BECAUSE EXPERIMENTS CAN TAKE A LONG TIME TO
    COMPLETE, PARTICIPANTS CAN BE AFFECTED BY EVENTS
    THAT OCCUR DURING THIS TIME, BLOCK RANDOMIZATION
    HELPS TO CONTROL FOR THESE TIME-RELATED EVENTS
    BECAUSE PARTICIPANTS ARE ASSIGNED TO CONDITIONS
    ONE BLOCK AT A TIME

17
INDEPENDENT GROUPS DESIGN
  • BALANCES CHANGES IN EXPERIMENTERS
  • BALANCES CHANGES IN THE POPULATIONS FROM WHICH
    PARTICIPANTS ARE DRAWN
  • DISADVANTAGE
  • CAN GET COMPLICATED WHEN DEALING WITH MULTIPLE
    EXTRANEOUS VARIABLES
  • STRETCHING EXERCISE PG. 229, SHAUGNESSY

18
INDEPENDENT GROUPS DESIGN
  • THREATS TO INTERNAL VALIDITY
  • TESTING INTACT GROUPS (formed prior to start of
    experiment)
  • SOLUTION DONT DO IT IN A RANDOM GROUPS DESIGN
  • EXTRANEOUS VARIABLES (potential variables are not
    directly of interest to the researcher but that
    could still be sources of confounding in the
    experiment)
  • SOLUTION BLOCK RANDOMIZATION

19
INDEPENDENT GROUPS DESIGN
  • SUBJECT LOSS
  • MECHANICAL when a participant fails to complete
    the experiment because of equipment failure (low
    threat to internal validity)
  • SELECTIVE destroys comparability of groups
    (e.g. pg. 235, Shaugnessy)
  • SOLUTION NONE EXPERIMENT IS UNINTERPRETABLE
  • PREVENTIVE STEPS 1. pretest to screen for
    possible losses 2. pretest then drop a comparable
    person from control grp

20
INDEPENDENT GROUPS DESIGN
  • PARTICIPANT EXPERIMENTER EXPECTATIONS
  • Demand characteristics
  • SOLUTION PLACEBO CONTROL
  • Experimenter effects
  • SOLUTION DOUBLE BLIND PROCEDURES

21
DATA ANALYSIS
  • DATA ANALYSIS involves 3 stages
  • 1. getting to know the data
  • What is going on in the data set
  • Look for errors
  • Make sure the data make sense
  • 2. summarizing the data
  • Use descriptive statistics and graphs
  • 3. confirming what the data reveal
  • Seek evidence for what the data tell us what can
    we conclude using various stat techniques

22
DATA ANALYSIS
  • DESCRIBING THE RESULTS
  • USING MEAN, STANDARD DEVIATIONS
  • EFFECT SIZE (strength of relationship between IV
    and DV)
  • META-ANALYSIS (uses measures of effect size to
    summarize the results of many experiments
    investigating the same IV or DV)

23
DATA ANALYSIS
  • CONFIRMING WHAT THE RESULTS REVEAL
  • Researchers use inferential stats to determine
    whether an IV has a reliable effect on a DV
  • 2 methods used to make inferences NHST and CI

24
DATA ANALYSIS
  • NULL HYPOTHESIS SIGNIFICANCE TESTING (NHST)
  • Used to determine whether mean differences among
    groups in an experiment are greater than the
    differences that are expected simply because of
    error variation
  • Assumes first that the groups do not differ
  • Because decisions about outcomes are based on
    probabilities, Type I (rejecting true H0) or Type
    II (failing to reject a false H0) errors may
    occur

25
DATA ANALYSIS
  • NHST contd
  • When results are statistically significant, we
    know that the smaller the exact probability fo
    the observed outcome, the greater is the
    probability that an exact replication will
    produce a statistically significant finding
  • Doesnt mean that results will be replicated 95
    of the time (with alpha.05)
  • Always report exact probability of results when
    carrying out NHST

26
DATA ANALYSIS
  • NHST contd
  • Choose level of significance BEFORE beginning
    your experiment
  • Type I alpha level
  • Can be reduced by lowering alpha level but this
    increases probability of a Type II error
  • Two possible results
  • 1. reject the null
  • 2. fail to reject the null (WE RARELY ACCEPT THE
    HO)

27
DATA ANALYSIS
  • NHST contd
  • Because of Type I II errors, researchers rarely
    use the word prove and instead use consistent
    with hypothesis or confirms/supports the
    hypothesis
  • STATISTICAL INFERENCE CAN NEVER REPLACE
    REPLICATION AS THE BEST TEST OF THE RELIABILITY
    OF AN EXPERIMENTAL OUTCOME

28
DATA ANALYSIS
  • CONFIDENCE INTERVALS
  • Researchers determine whether an IV has had an
    effect on behaviour by examining whether the CIs
    for different samples in an experiment overlap
  • When CIs do not overlap, we can be confident that
    the population means for the 2 groups differ

29
DATA ANALYSIS
  • ESTABLISHING EXTERNAL VALIDITY
  • Generalizability (e.g. use of college students)
  • In theory-testing other types of experiments,
    researchers may choose to emphasize internal
    validity over external validity
  • Other researchers may choose to increase external
    validity using sampling or replication

30
DATA ANALYSIS
  • ESTABLISHING EXTERNAL VALIDITY
  • Conducting field experiments is one way that
    researchers can increase the external validity of
    their research in real-world settings
  • Conceptual replication increases external
    validity
  • REPLICATING SAME VARIABLES OF INTEREST IN
    DIFFERENT SAMPLES e.g. insults lead to aggression
    in 5 yr olds and then, in 35 years olds (change
    nature of insult used in experiment)

31
DATA ANALYSIS
  • ESTABLISHING EXTERNAL VALIDITY
  • Partial replication can help establish external
    validity
  • E.g. doing a study in a public school and then in
    a private school

32
MATCHED GROUPS DESIGN
  • Used to create comparable groups when there are
    too few participants available for random
    assignment or to work effectively
  • Or when different levels of IV are needed and
    repeated measures design will not be effective
  • Random groups design individual differences
    average out across groups

33
MATCHED GROUPS DESIGN
  • Researcher makes groups equivalent by matching
    participants
  • Pretest task is usually used to match
    participants
  • Best if task is one that uses the same task that
    will used in the experiment itself
  • Less preferred is a similar task when the primary
    DV cannot be used (e.g. if it would familiarize
    participants to task)

34
NATURAL GROUPS DESIGN
  • INDIVIDUAL difference variables (participant
    variables) are selected rather than manipulated
    to form natural groups designs
  • E.g. religion, gender, age, personality traits,
    divorce, victims of abuse
  • Have to be careful of making causal statements
    (has the time-order condition or elimination of
    plausible alternatives been met?)

35
NATURAL GROUPS DESIGNS
  • To draw causal inferences in a natural groups
    design
  • Individual differences must be studied in
    combination with IVs that can be manipulated
    (complex design)

36
REPEATED MEASURES DESIGN
  • Also called WITHIN-SUBJECTS
  • Independent grp has CONTROL, cannot totally
    eliminate indiv diff, only balance
  • Repeated measures participants serve as their
    own control, no problems with individual diff but
    with PRACTICE EFFECTS, but can also be balanced

37
REPEATED MEASURES DESIGN
  • Why use this design?
  • When few participants are available
  • Conduct experiment more efficiently /
    conveniently
  • Increase sensitivity of experiment
  • Ability to detect effect of IV on DV even if its
    a small one (which is affected by individual
    diff)
  • Study changes in participants behaviour over
    time
  • E.g. learning experiment or longitudinal study

38
REPEATED MEASURES DESIGN
  • CREATING A WITHIN-SUBJECTS DESIGN, HELPS LIMIT
    THE CONFOUND OF THE PARTICIPANT VARIABLE BY USING
    EITHER
  • 1. MATCHED-GROUPS DESIGN (PAIRING PARTICIPANTS
    WHO MATCH ON THE PARTICIPANT VARIABLE
  • 2. REPEATED MEASURES DESIGN (TESTING
  • SAME PARTICIPANTS UNDER ALL LEVELS OF A
  • FACTOR)

39
REPEATED MEASURES DESIGN
  • MATCHED-GROUPS
  • WORK BEST WHEN THERE IS ONLY 1 MAJOR PARTICIPANT
    VARIABLE TO CONTROL
  • REPEATED MEASURES
  • WHEN PARTICIPANT VARIABLES ARE A CONCERN, USUALLY
    MANY VARIABLES ARE AN ISSUE SO REPEATED MEASURES
    IS BEST

40
REPEATED MEASURES DESIGN
  • E.G. we are testing peoples dress code and their
    comfort level in social settings.
  • Great differences exist in reasons why ppl would
    feel uncomfortable (shyness, past social
    experiences etc.), so we decided to use a
    repeated measures design
  • How could we set this up?

41
REPEATED MEASURES DESIGN
  • Problem of PRACTICE EFFECTS
  • Change in participants performance across
    conditions because of repeated testing (and not
    because of IV)
  • Threatens internal validity when different
    conditions of IV are presented in the same order
    to all participants

42
REPEATED MEASURES DESIGN
  • Order effects
  • Influence on scores that arises from completing a
    particular order
  • Participants may change over the course of the
    experiment due to practice, fatigue, carry-over
    effects or response sets (e.g. they may feel more
    comfortable on the 2nd test condition because of
    practice)
  • Individuals change over time due to subject
    history, maturation (which affects internal
    validity)
  • SO TO COUNTERACT, WE BALANCE THEIR INFLUENCE

43
REPEATED MEASURES DESIGN
  • 2 types of repeated measures designs
  • COMPLETE
  • PRACTICE EFFECTS FOR EACH PARTICIPANT ARE
    BALANCED FOR EACH PARTICIPANT by administering
    the conditions to each participant several times
    using different orders each time
  • INCOMPLETE
  • ORDER OF ADMINISTERING THE CONDITIONS IS VARIED
    ACROSS PARTICIPANTS RATHER THAN FOR EACH
    PARTICIPANT

44
REPEATED MEASURES DESIGN
  • Methods for balancing PRACTICE effects in THE
    COMPLETE DESIGN
  • 1. Block Randomization
  • Each condition must be repeated several times
    before we can expect practice effects to be
    balanced / average out when this is not
    possible
  • 2. ABBA Counterbalancing
  • Presenting conditions in one sequence, followed
    by opposite of that sequence can use ABCCBA

45
REPEATED MEASURES DESIGN
  • Methods for balancing PRACTICE effects in THE
    INCOMPLETE DESIGN
  • Each participant is given treatment only once and
    practice effects are balanced ACROSS
    participants, rather than for each participant
  • Each condition must be presented in each ordinal
    position (1st, 2nd) equally often
  • Best method to balance with 4 or less conditions
    is to use ALL POSSIBLE ORDERS of the conditions
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