Exam 2 Flashcards

1
Q

Design classification degree of experimental control

A
  • in a true experimental design, subjects are RANDOMLY assigned to at least 2 COMPARISON groups
  • experiment enables control over most threats to INTERNAL VALIDITY and provides the strongest evidence for CAUSAL relationships
  • randomized control trial (RCT) is the gold standard of true experimental design
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2
Q

Are quasi-experimental designs true experiments?

A
  • NO

- because they lack randomization and comparison groups

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3
Q

Types of group assignment for design classifications

A
  • completely randomized design
  • randomized block design
  • repeated-measures design
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4
Q

Completely randomized design group assignment

A
  • between subject design

- subjects assigned to groups based on a randomization process

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5
Q

Randomized block design group assignment

A
  • subjects classified according to an attribute (blocking variable) (i.e. males vs females)
  • then randomized to treatment groups (i.e. males get control and random group as well as females)
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6
Q

Repeated-measures design group assignment

A
  • within-subjects design

- subjects act as own control

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7
Q

Variation with number of independent variables/factors

A
  • single-factor designs have one independent variable

- multi-factor designs have 2+ independent variables

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8
Q

Single-factor design (one-way design) for independent groups

A
  • 1 independent variable is investigated

- 1 or more dependent variables

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9
Q

Pretest-Posttest control groups design

A
  • RCT with 2 groups based on random assignment
  • independent groups = treatment arms
  • testing pre- and post-treatment
  • changes in experimental group are attributable to the treatment
  • establishes cause-and-effect relationship
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10
Q

2-group pretest-posttest design

A
  • comparison group receives a second form of the intervention
  • 2 experimental groups formed by random assignment
  • control group is not feasible or ethical
  • compares new treatment with standard care
  • can quantify the difference between pre and post by “delta” or the change
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11
Q

For GroupXTime interaction

A
  • looks at if there is any change between the time (pre vs post) and comparing the groups’ changes to each other
  • can also use a 2-way mixed design
  • main effects: groups, time
  • interaction: groupsXtime
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12
Q

Multi-group pretest-posttest control group design

A
  • multiple intervention groups
  • includes a control group
  • conclude that treatment 1 is better than treatment 2 or vice versa AND that it is or is not better than no treatment
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13
Q

Internal validity with pretest and post-test designs

A
  • strong internal validity
  • initial EQUIVALENCE of groups can be established by pretest scores (important for inferring causality)
  • SELECTION BIAS controlled because of random assignments
  • HISTORY, MATURATION, TESTING, INSTRUMENTATION EFFECTS SHOULD AFFECT ALL GROUPS EQUALLY
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14
Q

Analysis of pretest-posttest designs

A
  • often analyzed using CHANGE scores (diff between posttest and pretest)
  • also can use analysis of covariance (ANCOVA) to compare posttest scores (using pretest scores as covariates)
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15
Q

Posttest only control group design

A
  • same as pretest-posttest control group design, EXCEPT NO PRE-TEST
  • used when dependent variables can only be assessed following treatment (i.e. length of stay in hospital)
  • used when pretest is impractical or detrimental
  • is an experimental design involving randomization and comparison groups (STRONG INTERNAL VALIDITY)
  • assumes groups are equivalent prior to treatment (works best with large samples to increase probability of equivalency)
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16
Q

Multi-factor design for independent groups

A
  • single factor designs have 1 independent variable (with 1+ levels), and do not account for interactions of severable variables
  • multi-factor designs have 2+ independent variables
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17
Q

Factorial Design

A
  • incorporates 2+ independent variables, with subjects randomly assigned to various combinations of levels of the two variables
  • two-way (two-factor) design has 2 independent variables
  • three-way (three-factor) design has 3 independent variables
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18
Q

Repeated measures Design

A
  • up to now considered 2 independent GROUPS
  • experimental and control groups created by RANDOM ASSIGNMENT and by BLOCKING
  • can also use repeated measures design where one group of subjects is tested under ALL CONDITIONS, each subject acting as their OWN CONTROL (aka within-subject desgin)
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19
Q

Advantage of repeated measures design

A
  • subject differences are controlled
  • differences between experimental and control groups are nullified because no groups used
  • physiological and other factors remain CONSTANT throughout experiment
  • subjects acting as their own controls provides most equivalent “Comparison group” possible
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20
Q

Disadvantages of repeated measures designs

A
  • LEARNING/PRACTICE effects when one person repeats measurements over and over
  • CARRYOVER effects when exposed to multiple treatment conditions (must allow enough time for dissipation of previous effects)
  • may NOT be TRUE EXPERIMENTS because NO RANDOMIZED COMPARISON GROUPS
  • however, if they incorporate randomization of the order of repeated treatments/interventions then can be considered experiment
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21
Q

Single-factor designs for repeated measures

A
  • one-way repeated measures design
  • one group of subjects is exposed to all levels of one independent variable
  • has element of looking like an experiment because randomized order of who gets what experiment in which order
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22
Q

Solution to problem of order effects

A
  • randomize order of conditions/interventions for each subject so there is no bias in choosing order of testing
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23
Q

two-way design with 2 REPEATED MEASURES for multi-factor designs

A
  • 2 repeated measures (=2 independent variables….i.e. type of lift and orthosis)
  • each person exposed to 4 test conditions (2-way design…2X2 design)
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24
Q

Mixed Design for multi-factor repeated measures

A
  • 2 independent variables (i.e. exercise is IND factor (experimental and contorl), and time is REPEATED factor (3 time periods during tests))
  • 2 way design or 2X3 design
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25
Q

Multi-factor designs

A
  • two-way design with 2 repeated measures

- mixed design

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26
Q

Group variable

A
  • independent factor/variable

- this is because has 2 levels independently

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27
Q

Time variable

A
  • is a repeated factor

- because measures at time 1, time 2, time 3, etc

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28
Q

Two-way factorial design

A
  • incorporates TWO INDEPENDENT VARIABLES
  • effect of INTENSITY (vigorous/moderate) on exercise behavior
  • effect of LOCATION (home/community center) on exercise behavior
  • 2X2 design means (2 independent variables and 2 levels of each independent variable = 4 groups total)
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29
Q

Main Effects of a twoo-way factorial design

A
  • is there an effect of moderate versus vigorus exercise
  • is there an effect of exercising at home or in community?
  • this examines the MAIN EFFECT of each independent variable
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30
Q

Interactions of Two-way factorial design

A
  • can examine INTERACTION EFFECTS between 2 independent variables
  • effect of 1 variable varies at different LEVELS of the second variable
  • i.e. maybe moderate exercise is more effective in changing exercise behavior but only when performed at a community center
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31
Q

Randomized Block Design

A
  • used when there is a concern that an extraneous factor such as GENDER might INFLUENCE DIFFERENCES BETWEEN GROUPS
  • build the variable into the design as an independent variable
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32
Q

Quai-experimental designs

A
  • similar to experimental designs but lack random assignment, comparison group, or both
  • may involve non-equivalent groups
  • may be a reasonable alternative to RCT
  • conclusions drawn must take into account biases of the sample
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33
Q

One-group designs pretest-posttest

A
  • effect of treatment is determined by change in pre and post scores
  • pretest –> intervention –> posttest
  • vulnerable to threats to internal validity because no control group (i.e. history, maturation, testing)
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34
Q

One-way repeated measure design over time

A
  • effect of treatment over time
  • pretest –> intervention –> postest 1–> postest 2
  • no control group so internal validity threatened
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35
Q

Mulit-group design pretest-posttest

A
  • non-equivalent pretest-posttest control group design
  • similar to pretest-posttest experimental design EXCEPT subjects not assigned to groups randomly (i.e. volunteers self-select groups)
  • EXP: pretest-intervention-posttest
  • CONTROL: pretest-nointervention-posttest
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36
Q

Multi-group design posttest only control group design

A
  • static group comparison
  • EXP: intervention–postest
  • CON: no intervention–postest
  • NOTICE NO PRETEST
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37
Q

Single subject designs

A
  • draw conclusion on treatment effects based on 1 patient’s response
  • controlled experimental approach
  • independent variable is treatment
  • dependent variable is target behavior (outcome)
  • also called (N of 1 study, or time series designs)
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38
Q

Structure of a single subject study

A
  • Repeated Measurements: Each session; observe trends
    At least 2 testing phases: Baseline and Intervention
  • Target behavior is measured across both phases on multiple occasions
  • Baseline phase: state of target behavior over time in the absence of treatment (control conditions)
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39
Q

How do single subject designs differ from traditional experimental designs?

A

-Multiple assessments in baseline and intervention phases

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40
Q

Ethical issues regarding baseline conditions

A
  • withholding treatment
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41
Q

When treatment starts, any change from baseline to intervention phase is attributed to what?

A
  • the intervention
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42
Q

Baseline data

A
  • comparison for evaluating potential cause and effect relationship between intervention and target behavior
  • Baseline period = A
  • Intervention period = B
  • A-B design
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43
Q

Baseline characteristics

A
  • 2 baseline data characteristics are important for interpreting clinical outcomes
  • Stability (consistency of response over time): stable or variable
  • Trend: accelerating or decelerating
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44
Q

Length of phases

A
  • best to have equal phase length
  • often 1 week per phase (take daily measurements, minimum of 3-4 per phase)
  • greater number of data points easier it will be to identify trends
  • often measures can be taken more frequently than daily if behavior changes rapidly
  • More than a single session
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45
Q

Target Behaviors

A
  • Choose clinically relevant outcomes measures for a particular patient
  • i.e. Strength, ROM, Gait speed, Balance measures, Pain
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46
Q

Limitations of A-B design

A
  • Experiments can control for threats to internal validity
  • To do this in the A-B single subject design is more challenging
  • Other treatments/events (history effects)
  • What other evidence can we include to strengthen design control ?
  • to increase confidence that treatment caused the changes in target behavior
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47
Q

Additional control for A-B design

A
  • Replication of effects
  • Repeat phases
  • withdrawal designs—treatment: no treatment
  • Withdrawing and reinstating baseline and treatment conditions
  • Withdraw intervention and show that target behavior occurs only in presence of treatment
  • 2nd baseline period (A-B-A design)
  • Could also include a 2nd intervention phase (A-B-A-B design—see over)
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48
Q

Visual Data Analysis

A
  • Level (last data point of a phase to first data point of next phase)
  • Trend (direction of change in a phase)
  • Accelerating or decelerating
  • Slope of a trend (rate of change in the data)
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49
Q

Single Subject Data Generalization

A
  • Single subject research can provide data for clinical decision making
  • Not enough to show effect during intervention period on a single patient
  • Must also be able to show changes in the target behavior will occur in other individuals
  • Generalization: external validity for the single case
  • Assume treatment will be effective in others with similar characteristics
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50
Q

Observational Designs

A
  • no manipulation of variables as in experimental designs

- exploratory or descriptive

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51
Q

Exploratory Research

A
  • systematic investigation of RELATIONSHIPS among variables (i.e. association of leg weakness and falls)
  • not used to establish cause-and-effect relationships between variables
52
Q

What are the 2 ways to conduct exploratory research?

A
  • retrospectively and prospectively
53
Q

Prospective conduction of exploratory research

A
  • variables measured in the present and follow subjects in study
54
Q

Retrospective conduction of exploratory research

A
  • Use of data that have already been collected
  • Medical records, databases
  • Researcher can’t control data collection methods
  • Prospective studies are more reliable than retrospective studies
55
Q

Longitudinal research

A
  • follow a cohort over time taking repeated measurements
  • can observe growth and change in individuals over time
  • often involve large cohorts followed over long periods of time (i.e. framingham heart study)
  • threats to internal validity relate to repeat testing and attrition
56
Q

Cross-sectional research

A
  • gather data as a “snap shot” in time
  • very efficient
  • all subjects tested more or less at same time
57
Q

Correlational Study

A
  • foundation of exploratory studied is process of correlation (degree of association)…covariation in data (extent to which one variable varies with another variable)
  • purpose is to describe the nature of existing relationship among variables
  • look at several variables at once to see which are related
  • can make predictions (predictive correlation study) based on observed relationships between variables
  • cholesterol level: age, diet, gender, genetics
  • Regression (stats procedure)
58
Q

Case-control study

A
  • retrospective
  • look at exposure to some sort of substance/condition (i.e smoking/vs not smoking, exercise/vs no exercise)
  • example Q: is there a relationship between heart disease and smoking
  • group 1: heart disease
  • group 2: no heart disease
  • not randomized
59
Q

Purpose of a case-control study

A
  • to determine if the frequency of an exposure (i.e. poor nutrition) is different in cases and controls
  • Choice of controls is critical: Match cases and controls for age, gender, SES etc
60
Q

Selection bias with case-control study

A
  • choose cases and controls regardless of exposure history

- Beware of misclassification (ie cases and controls)

61
Q

Observation bias with case-control study

A
  • difference in the way info about disease or exposure is obtained from the groups
62
Q

Interviewer bias with case-control study

A
  • person collecting data elicits, records or interprets info differently from cases and controls
63
Q

Recall bias with case-control study

A
  • subjects remember exposure differently than the reality
64
Q

Cohort Studies

A
  • follows a group(s) overtime (prospective)
  • group 1: exercisers
  • group 2: sedentary (matched)
  • look at rate of falls overtime
  • ## not randomized
65
Q

Causality in observational studies

A
  • RCT (experimental): cause and effect relationships
  • case control and cohort studies do not involve experiments or manipulation of variables
  • causation (cause and effect i.e. did the exposure cause disease) is established by other methods
66
Q

Causality

A
  • Establish a time sequence: exposure precedes disease
  • Strength of association: relative risk
  • Biologic credibility
  • Consistency with other studies
  • Dose-response relationship
  • 3 of 5 met= strong cause
67
Q

Methodological studies use correlational

A
  • use correlational methods to examine reliability and validity of measuring instruments
68
Q

Historical studies and correlation

A
  • reconstruct the past on the basis of archives and other records to suggest relationships of historical interest to a discipline
69
Q

Survey

A
  • a series of questions

- questionnaire (written or electronic)

70
Q

Surveys can be used in what studies

A
  • experimental
  • exploratory
  • descriptive
71
Q

Interview

A
  • ask questions and record answers

- structured and unstructured

72
Q

Structured Interview

A
  • standard set of questions
  • same questions in same order to all subjects
  • same response choices
73
Q

Unstructured Interview

A
  • less formal
  • open ended
  • conversational
  • often used in qualitative studies
74
Q

Questionnaires

A
  • structured surveys
  • self administered
  • computerized or pen/pencil
  • efficient as completed on subject’s own time
  • reduced bias from interactions with an interviewer
  • disadvantage is the potential for misunderstanding or interpreting questions
  • mail, electronic distribution
75
Q

Return rate on Questionnaires

A
  • low return rates
  • 30-60%
  • limit external validity of results
76
Q

Data collected via interview or questionnare are based on what

A
  • sekf-reported data
  • no direct observation by the researcher of the subject’s behavio
  • potential for bia or inaccuracy
  • recall bias
77
Q

Survey Design

A
  • delineate the overall research question
  • what are the objectives of the study?
  • outline of the questionnaire (relate to objectives)
  • review existing instruments
  • write questions that address each of the objectives
78
Q

What should you do with the first draft of a survey?

A
  • distribute a draft to colleagues
  • ask for feedback
  • revise
  • distribute again
  • helps establish content validity of the instrument
  • should also do a pilot test on small sample (5-10)
79
Q

Do surveys need a consent form?

A
  • no.

- just by filling it out and sending it back is consent enough

80
Q

Scales

A
  • provide rating of degree to which subject possesses a characteristic/attitude/value
81
Q

Likert Scale

A
  • strongly agree, agree, neutral, disagree, strongly disagree
  • likert scales coded 1-5
  • calculate overall score by adding answers
  • 1 item does not carry more weight than others
82
Q

Types of scales

A
  • likert

- visual analong

83
Q

Visual analog scale

A
  • place mark on 100 mm line
84
Q

Delphi technique

A
  • experts complete multiple (i.e. 3 rounds of questionnaries)
  • researcher reviews and distributes findings after each round
  • eventually come to consensus on an issue
  • i.e. what should entry level knowledge be for a particular topic
85
Q

Analysis of survey data

A
  • code the data
  • i.e. male 1, female 0
  • fear of falling 1, no fear 0
86
Q

descriptive statistics summarize responses

A
  • mean age; years of education; etc
  • categorical data: frequency/percentages: 25 males (33% sample),
  • scores on a scale may be summed
  • i.e. mean ABC 84%
87
Q

Systematic Reviews ask what

A
  • extremely specific types of questions
88
Q

Systematic Reviews

A
  • a systematic review involves the application of scientific strategies, in ways that limit bias, to the assembly, critical appraisal, and then synthesis of all relevant studies that address a specific clinical question
89
Q

Systematic Review Process

A
  • picture on slide 4

- systematic reviews week7

90
Q

Narrative vs. Systematic Reviews

A
  • narrative: broad questions, search strategy and selection of articles not usually described, appraisal not always rigorous, conclusions usually qualitative/descriptive
  • systematic: focused question, search strategy described in detail, rigorous selection based on specific criteria, very rigorous appraisal, conclusions maybe qualitative or quantitative
91
Q

Selection Criteria for Systematic Process

A
  • subjects of the review are the studies
  • specify inclusion/exclusion critera
  • based on types of studies, types of participants, types of interventions, types of outcome measures
92
Q

Question for Systematic Process

A
  • Question is very specific

- Well described purpose statement

93
Q

grey literature

A
  • unpublished studies
94
Q

Evaluate Methodologic Quality

A
  • evaluate quality of selected studies (critical review, record on a form, evaluate quality of design and data analysis)
95
Q

Types of study Bias

A
  • selection bias
  • performance bias
  • attrition bias
  • detection bias
96
Q

Selection Bias

A
  • did we pick the groups of control and experimental equally?
97
Q

Performance Bias

A
  • expect to see certain performance from one group over another
98
Q

Attrition Bias

A
  • did one group have a higher # of dropouts than the other?
99
Q

Detection Bias

A
  • idk.
100
Q

Jaded Scale

A
  • 3 questions
  • was study randomized? (1 pt if yes)
  • was study described as double blind? (1 pt yes)
  • was there a description of qwthdrawals and droupouts? (1 pt if yes)
101
Q

PEDro Scale

A
  • 11 items

- similar to jaded scale

102
Q

Data Synthesis of Methodologic Quality

A
  • Heterogeneity (dissimilarity) or homogeneity of the included studies (variability across studies)
  • Composition of treatment groups: Inclusion /exclusion criteria
  • Design of study: Including length of follow up
  • Management of patients: Treatments provided, Presence of complications
103
Q

Analysis/synthesis of findings

A
  • overall conclusions based on quality of evidence obtained

- often summarize findings in a table

104
Q

Meta-Analysis

A
  • a name that is given to any review article in which the results of several independent studies are combined statistically to produce a single estimate of the effect of a particular intervention
105
Q

Forest Plots

A
  • Represents the overall result of the meta-analysis
  • square is the outcome for that study [relative risk (RR)]; size of square relates to weighting of study based on sample size
  • line represents confidence interval (CI) around the RR
  • diamond is combined overall estimate of results [includes pooled point estimate (center of diamond) and CI (horizontal tips of diamond)]
  • If a CI of a result crosses the line of no effect, then either a significant difference does not exist b/w the treatment and the control or the sample size was too small to show an effect
106
Q

Homogeneity in Meta-Analysis

A
  • results of each individual trial are mathematically compatible with the results of the other trial
107
Q

If the CIs do not overlap in a meta-analysis

A
  • heterogeneous study

- no common treatment effect across the studies

108
Q

Descriptive Research describes what about populations?

A
  • characterictics
  • behaviors
  • conditions
109
Q

Descriptive Research

A
  • may involve prospective or retrospective data collection
  • design may be longitudinal or cross-sectional
  • surveys and secondary analyses of clinical databases often used as data sources for analysis
110
Q

Categories of descriptive research

A
  • developmental research
  • normative studies
  • qualitative research
  • descriptive surveys
  • case studies / case reports
111
Q

Developmental Research

A
  • involves description of developmental change and sequencing of behaviors in people over time (i.e. motor development in children, lifespan)
  • longitudinal methods involve collecting data over time…focus on natural history of a disease
  • can also use cross-sectional methods and study different age groups at a point in time
112
Q

Normative Studies

A
  • purpose is to describe typical or standard values for characteristics of a population
  • describes norms as a mean and a range of acceptable values
  • norms are used as a basis for prescribing interventions
113
Q

Qualitative Research

A
  • describes how individuals perceive their own experiences within a specific social context (what it means to live with a SCI)
  • helps us understand the patient’s view of the world (important in designing interventions)
  • data collected by interviews and observation (participant observation & field observation: non-participant)
114
Q

Descriptive Surverys

A
  • often used as a source of data to collect info about a specific group
  • to describe their characteristics, or risk for disease, or other attributes
115
Q

Case Studies

A
  • important for developing a clinical knowledge base
  • in-depth description of a person’s condition or response to treatment
  • case series involves observations in a number of similar cases
  • often involve unusual diagnoses that are challenging
  • may highlight avenues for future research
116
Q

Case studies Format

A
  • comprehensive description of the subjects background, present status, and responses to intervention
117
Q

Introduction of Case Studies Format

A
  • introduction describes background literature to the patient’s problem
118
Q

Patient History of Case Studies Format

A
  • problems
  • symptoms
  • prior treatments
  • demographic and social info
119
Q

Results of Case Studies Format

A
  • patient’s response and any follow-up data
120
Q

Discussion of Case Studies Format

A
  • interpretation of outcomes and conclusions
121
Q

Critically Appraised Topic (CAT)

A
  • brief summary of a search and critical appraisal of literature on a clinical question
  • standardized format
  • provides statement of clinical relevance
  • initiated by a patient encounter usually due to gap in knowledge
  • search for and appraises best evidence
  • summarizes evidence
  • integrates evidence with clinical expertise
  • suggest how info can be applied to practice
  • usually 1-2 pages, concise
122
Q

When applying literature to patients what do you look at

A
  • systematic review
  • and then CAT
  • both look at evidence that could apply literature to your patient
123
Q

Systematic Review

A
  • involves review involves the application of scientific strategies, in ways that limit bias, to the assembly, critical appraisal, and synthesis of all relevant studies that address a specific clinical question
124
Q

Format of a CAT

A
  • Title
  • Author/date
  • Clinical scenario (description of case that prompted the question)
  • Clinical question (PICO format)
  • Clinical bottom line (summary of how results can be applied)
  • Search history/strategy
  • Citations
  • Summary of the study/ies (design; sample; intervention; outcome measures; data analysis)
  • Summary of the evidence (results summarized)
  • Critical comments on the study (internal/external and statistical validity of the study)
125
Q

Using CATs

A
  • useful at point of care
  • can be created out of case conferences
  • CAT banks established by institutions
  • limited shelf life as new evidence becomes available
  • not as rigorous as a systematic review
  • 1-2 references and do not represent full scope of the literature on a topic