RESEARCH

CLINICAL RESEARCH
• a structured process of investigating facts
and theories and exploring connections
between them

• determines the safety and effectiveness of

medications, devices, diagnostic
products and treatment regimens intended
for human use.
 EVIDENCE-BASED PRACTICE
“conscientious, explicit and judicious use of
current best evidence in making decisions
about the care of individual patients.” – Sackett
and colleagues
EVIDENCE-BASED PRACTICE
 STEPS IN EBP
a clinical problem is identified and an answerable research
question is formulated.

a systematic literature review is conducted and best evidence

collected

the research evidence is summarized and critically analysed.

the research evidence is synthesized and applied to clinical

practice
COMPONENTS OF A GOOD CLINICAL
QUESTION:

P • What is the target population?

I • What is the intervention being

considered?

C • What comparison or control

condition is being considered?

O • What are the outcomes of

interest?
COMPONENTS OF A GOOD CLINICAL
QUESTION:

EXAMPLE:
In an elderly patient two-months post stroke, is
partial body weight-supported treadmill training
more effective than traditional gait training with
full weight-bearing for improving walking speed,
endurance and balance?
LEVELS OF
EVIDENCE
LEVELS OF EVIDENCE
 SYSTEMATIC REVIEW
◉Comprehensive review of the medical
literature

◉Systematically search, identify,

appraise and summarize all literature
SYSTEMATIC REVIEW
 META-ANALYSIS
◉Estimate of effect size by combining the results
of several RCTs to determine overall effectiveness
of treatment

◉Advantage:
Increase power by increasing sample size
Improves estimates of effect size
Resolves uncertainty
Improve generalizability of findings
META-ANALYSIS
 RANDOMIZED CONTROLLED
TRIAL (RCT)
◉Experimental research
◉Uses randomization
◉Relative effect of a specific intervention compared
to a control condition

Experi
Control
mental
group
group
RANDOMIZED CONTROLLED
TRIAL (RCT)
 LONGITUDINAL STUDY
◉Repeated observations of the same
variables over long periods of time
◉Advantage: can accumulate data through
documentation of growth and change on
the same individual
◉Collected in time sequence
 COHORT STUDY
◉Longitudinal, observational study

◉Individuals with risk factors are followed

overtime to compare the occurrence of a disease
in the exposed group to that of the group of
unexposed individuals.

◉Advantage: has the ability to determine the

onset of condition
 CROSS SECTIONAL STUDY
◉Studies different individuals from different
stratified groups at one point in time and
drawing conclusions by comparing their
characteristics

◉Advantage: not threatened by testing or

history effects
 CASE CONTROL STUDY
◉Retrospective, observational study

◉Individuals who already have a disease

are matched with a comparison group of
individuals without disease.

◉Advantage: samples easily gathered

CASE CONTROL STUDY
CASE REPORT OR CASE SERIES
◉Case Report: In-depth description of an
individual’s condition or response to
treatment.

◉Case Series: collection of observation of

similar cases.

◉Used to generate hypotheses/theories for

future research
CASE REPORT OR CASE SERIES
 SINGLE SUBJECT
EXPERIMENTAL DESIGN
◉Allows us to draw conclusions about the
effects of treatment based on a single patient
under controlled conditions

\ A-B design
◉2 phases
◉Pretreatment/baseline phase followed by
treatment phase
 SINGLE SUBJECT
EXPERIMENTAL DESIGN
\ A-B-A design (multiple baseline design)
◉3 phases
◉Baseline phase -> treatment phase -> 2nd
baseline phase

\ A-B-A-B (multiple baseline)

◉Baseline -> treatment -> baseline -> treatment
 DATA
COLLECTION
 TYPES OF DATA
◉Continuous data
◉Discrete data
◉Dichotomous data

◉Qualitative data
◉Quantitative data
 SCALES OF MEASUREMENT

NOIR
•Nominal
•Ordinal
•Interval
•Ratio
SAMPLING
 PROBABILITY SAMPLING
•Simple random sampling - subjects have an
equal chance of being selected
 PROBABILITY SAMPLING
•Systematic sampling- taking every nth
subject from the population
 PROBABILITY SAMPLING
•Stratified random sampling - population is
divided into homogenous subgroups/strata
 PROBABILITY SAMPLING
•Cluster sampling- population is divided into clusters
NON-PROBABILITY SAMPLING
•Convenience sampling - Subjects are
chosen based on their availability

•Purposive sampling - Subjects are

hand-picked on a basis of a specific
criteria
NON-PROBABILITY SAMPLING
•Quota sampling - Getting an
adequate number of subjects in each
strata

•Snowball sampling - existing subjects

are asked to identify names of other
potential participants (referral system)
VALIDITY AND
RELIABILITY
 VALIDITY
\ Face Validity
◉Test appears to measure what it’s supposed to
measure

\ Content Validity
◉measurement reflects the meaningful
elements of a concept
 VALIDITY
\ Construct Validity
◉To measure abstract concept
◉A theoretical construct is measured by a test
or measurement.

a. Convergent

b. Divergent
 VALIDITY
\ Concurrent Validity
◉Comparing measurements to a gold standard

\ Predictive Validity
◉Measurement is considered to be valid
because it is predictive of a future
behavior/event
 VALIDITY
\ Internal Validity
• the intervention being evaluated (independent
variable) is the cause of the outcome and not a
result of extraneous factors

\ External Validity
◉Results of the study are generalizable to the
population
THREATS TO
VALIDITY
 THREATS TO VALIDITY
 Sampling Bias:
• systematic sampling error

 Failure to exert rigid control over subjects:

• intervening variables interact with the
dependent variable

 Pre-test influence on post test:

• learning effect as result of taking test
 THREATS TO VALIDITY
 Measurement instrument is not
accurate

 Multiple treatment interference:

• more than one treatment is being given to
the subjects at the same time

 Experimenter bias
 THREATS TO VALIDITY
 Hawthorne effect:
• the subject's knowledge of participation
in an experiment influences the results
of a study.

 Placebo effect:
• subjects respond to a dummy treatment
with positive effects
 RELIABILITY
\ Intrarater reliability
• repeated measures made by the same
person over time

\ Interrater reliability
• measurements made by more than one
person
 RELIABILITY
\ Test-retest reliability
• repeated measures made by the same
individual on separate occasions

\ Split-half reliability
• Test is split in half
• Reliability of the first half is compared to the
second half.
 STATISTICAL
MEASURES OF
VALIDITY
 STATISTICAL MEASURES OF
VALIDITY
\ Sensitivity
• Percentage of people who test positive for a
specific disease among a group of people who
have the disease

\ Specificity
• percentage of people who test negative for a
specific disease among a group of people who
do not have the disease
 STATISTICAL MEASURES OF
VALIDITY
\ True Positive
• Individuals are correctly identified as
having the target condition

\ True Negative
• Individuals are correctly identified as
not having the target condition
 STATISTICAL MEASURES OF
VALIDITY
\ False Negative
• Indicates that a person does not have a specific
disease or condition when the person does have
the disease or condition

\ False Positive
• Indicates that a person has a specific disease or
condition when the person actually does not have
the disease or condition
 STATISTICAL MEASURES OF
VALIDITY
\ Negative Predictive value
• Ability of a diagnostic test to correctly determine
the proportion of patients without the disease
from all patients with negative results

\ Positive Predictive value

• Ability of a diagnostic test to correctly determine
the proportion of patients with the disease from all
the patients with positive test results
 COMPUTATION
Screening
Dx (+) Dx (-)
Result
A B
Positive a+b
True (+) False (+)
C D
Negative c+d
False (-) True (-)
a+c b+d
 SAMPLE PROBLEM
Screening Dx (+) Dx (-)
Result
Positive 10 2 a+b
True (+) False (+)
Negative 2 6 c+d
False (-) True (-)
a+c b+d
EXPERIMENTAL
RESEARCH
 EXPERIMENTAL CONTROLS
 Blinding
–Single blind: subject is unaware of research
hypothesis and the group to which they were
assigned

–Double blind: subject and some members of the

research team are unaware

–Triple blind: subject, some members of the

research team and data analyzers are unaware
INDEPENDENT VS. DEPENDENT
VARIABLE
\ Independent variable
–presumed to have caused or influenced the
dependent variable
–What is controlled or manipulated

\ Dependent variable
–Response or outcome assumed to be caused
by the effect of the independent variable
 HYPOTHESIS
•A tentative statement to explain certain
observations or facts that requires further
experimentation to be verified

\ Alternate Hypothesis (Ha or H1)

•There is a true difference between groups, therefore
treatment was effective

\ Null Hypothesis (Ho)

•The difference between groups occurred by chance
 P-VALUE AND ALPHA LEVEL
\ p-value
• probability that a particular statistical
result could have happened by chance

\ Alpha level (a level)

• significance level.
• Standard for rejecting the null hypothesis
• 0.05 or 0.01
 P-VALUE AND ALPHA LEVEL

•p < alpha = reject null hypothesis

•p > alpha = null hypothesis is not

rejected
 ERRORS
•Standard Error
–Expected chance variation among the
means, the result of sampling error
TYPE I ERROR (ALPHA ERROR)
•Wrongly deciding to reject the null
hypothesis

•False positive

•“mayabang”
TYPE II ERROR (BETA ERROR)
•Wrongly deciding to accept the null
hypothesis

•False negative

•“pa-humble/martyr”
 DECREASING ERRORS:
•Increase sample size

•Use random selection

•Use valid measures

DESCRIPTIVE
STATISTICS
 MEASURES OF CENTRAL
TENDENCY
\ Mean: average
–For interval or ratio data
\ Median: divides a distribution into 2 equal halve
–Midpoint
–Ordinal data
\ Mode: value that occurs most frequently
–Nominal data
 MEASURES OF VARIABILITY
\ Range
• the difference between the highest score and the lowest
score
\ Percentiles
•divide data into 100 equal portions
\ Quartiles
•divide distribution into 4 equal parts
\ Standard Deviation
•determination of variability of scores (difference) from the
mean
 KURTOSIS
•“Peakedness”

•Normal- bell-
shaped curve
–mean, median and
mode are the same
 NORMAL DISTRIBUTION
•68% of all values fall within one SD above and
below the mean

•95% of all values fall within two SD above and

below the mean

•99% of all values fall within three SD above

and below the mean
NORMAL DISTRIBUTION
 SKEWNESS
•Asymmetry in the shape of a distribution
Suppose a random sample of 100 12-year old boys
were chosen and the heights of these 100 boys were
recorded. The sample height is 64 inches, and the
sample standard deviation is 5 inches. You may
assume heights of 12 year-old boys are normally
distributed. Which interval below includes
approximately 95% of the heights of 12 year-old boys?

a. 63 to 65 inches
b. 54 to 74 inches
c. 39 to 89 inches
d. 59 to 69 inches
INFERENTIAL
STATISTICS
 INFERENTIAL STATISTICS
•Use sample data to make inferences
about the population

•Allows us to estimate population

characteristics from sample data
PARAMETRIC VS. NONPARAMETRIC

Parametric Nonparametric
• Interval and ratio • Nominal or ordinal
data data
• Population is • Non-normal
distribution, small
normally sample size
distributed
• Do not assume
• Homogeneity of Homogeneity of
variance variance
 STEPS
1. What are the independent and
dependent variables?
2. What is the scale of measurement of
the study variables?
3. How many samples/groups are in
the design?
WHAT ARE THE INDEPENDENT AND
DEPENDENT VARIABLES?
•Independent Variable
–Manipulated variable

•Dependent Variable
–Response variable
 WHAT IS THE SCALE OF MEASUREMENT
OF THE STUDY VARIABLES?

•Parametric
–Interval/ratio

•Nonparametric
–Nominal, ordinal
PARAMETRIC
STATISTICS
 T-TEST
•T-test assesses whether the means of two
groups are statistically different from each
other.
 2 INDEPENDENT SAMPLE T-TEST
•used when testing 2 independent
groups
 EXAMPLE
•Researchers compare the mean blood
pressure of patients who received a
new drug treatment vs. those who
received a placebo (a sugar pill).
 PAIRED/DEPENDENT T-TEST
•Compares the difference between 2
matched samples
•Repeated measures or paired data
•Within subjects design
 EXAMPLE
•A researcher compares the mean test
scores before (pre-test) and after (post-
test) the subjects completed in a test
preparation course. They want to see if our
test preparation course improved people's
score on the test.
ANALYSIS OF VARIANCE (ANOVA)
•Test the equality of means between 3 or
more populations by analyzing sample
variance
•(N) population distribution and
population variance is equal
 ONE-WAY ANOVA
• Similar to independent t-test
• Sample data are separated into different
groups on the basis of 1 characteristic
 EXAMPLE
•Researchers compares the mean level of
prejudice of first-years, sophomores,
juniors, and seniors. Mean level of
prejudice is our dependent variable, and
years in college is our independent
variable.
REPEATED-MEASURES ANOVA
•Uses the same subjects with every
condition of the research, including
the control

•Within subjects
 EXAMPLE
•Suppose we are interested in whether the
effect of a weight loss method will weaken
over time. 30 subjects' weight information
were recorded 3 times. Their weight loss
after adopting this method for one month,
three months and half a year was stored in
a worksheet.
 TWO-WAY ANOVA
•examines the influence of different
categorical independent variable on
one dependent variable
 EXAMPLE
•Researchers are testing the depression level of
people who are taking anti-depressant drugs at
different dosages. They also want to know if
gender plays an influence in it.
0 mg 25 mg 50 mg

9 7 4
MEN
8 7 2

7 6 3

8 7 4
WOMEN
7 6 3

9 6 3
 ANCOVA
•A parametric test used to compare two
or more treatment groups or conditions
while also controlling for the effects of
intervening variables
 EXAMPLE
◉We wanted to compare the effect of two teaching
strategies on clinical performance of students in their first
year of clinical training. We hypothesize that training with
videotaped cases will be more effective than discussion and
reading groups. We randomly assigned 12 students to 2
groups. We are concerned however, that the students’
academic performance would be a potential confounding
factor in making this comparison, based on the assumption
that there is correlation between academic and clinical
performance. Therefore we would want to know if GPA is
evenly distributed.
 PEARSON CORRELATION
•Measures the magnitude and direction
of the linear relationship of two
variables on the interval scale (or ratio)
NONPARAMETRIC
STATISTICS
 CHI-SQUARE TEST
•Nonparametric test of significance
used to compare data in the form of
frequency counts occurring in two or
more mutually exclusive categories
 EXAMPLE
•Polling responses from people of
different nationalities to see if one's
nationality affects the response
 MANN-WHITNEY U TEST
•2 independent samples

•Ordinal data
 EXAMPLE
A researcher is interested in the effect of body
position on a person’s ability to relax, as measured
by EMG biofeedback from the frontalis muscle. To
study this question, 11 subjects are randomly
assigned to two groups in a pretest-posttest design,
with one group positioned supine, the other sitting.
Results are recorded as changes in microvolt activity.
The researcher hypothesizes that the positions will
facilitate different levels of relaxation (a
nondirectional hypothesis)
WILCOXON SIGNED RANK TEST
•Compares 2 dependent samples

•Within subjects

•Ordinal level data

 EXAMPLE
We are interested in the effect of knee angle on
knee extensor strength. Using a manual muscle
test (MMT), we will study 10 patients, six
months following a total knee replacement.
MMT grades are recorded from 0 (no muscle
activity) to 12 (normal strength). We
hypothesize that knee extensor strength will be
different with the knee in 90 degrees and 15
degrees of flexion.
 KRUSKAL-WALLIS TEST
•3 or more independent samples that
come from the same population
•Ordinal data
 EXAMPLE
We want to study the effect of three modalities
for relieving chronic low back pain. We
randomly assign 17 subjects (N=17) to receive
ice (n=6), hot pack (n=6), or ultrasound (n=5).
Pain is measured in a visual analog scale from
0mm (pain-free) to 100mm (severe pain).
Scores are recorded as the change in level of
pain from pre-treatment to post treatment
levels.
 FRIEDMAN TEST
•Used to detect differences in treatments
across multiple test attempts
•Repeated measures ANOVA
•Ordinal data
 EXAMPLE
◉We are interested in the effect of shoulder
angle on shoulder flexion strength. Using a
manual muscle test (MMT), we will study 6
patients. MMT grades are recorded from 0 (no
muscle activity) to 5 (normal strength). We
hypothesize that shoulder flexion strength will
be different with the shoulder in 30 degrees, 90
degrees and 120 degrees of flexion.
 SPEARMAN RANK
CORRELATION COEFFICIENT
•Tests the association between 2
variables
•Ordinal level data
Ex: Correlate MMT grades with Functional
Scores (FIM)
 Comparison Parametric Nonparametric
2 independent Unpaired t- Mann-Whitney U
groups
Statistical
test
Tests
2 related scores Paired t-test Wilcoxon Signed Rank
Test, Sign Test
3 or more One-way Kruskal Wallis
independent groups ANOVA
3 or more related Repeated Friedman
scores measures
ANOVA
Association Pearson Spearman Correlation
between 2 variables Correlation
THANKS!