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DATA ANALYSES I

NURSING RESEARCH REVIEW

Prof. Rodemel Mar C. Maceda, BSN, RN


Research Specialist & Executive Board Member
FILIPINO NURSES SOCIETY IN SAUDI ARABIA
Objectives
 Research Variables
 Operational Definitions
 Research Designs
 Research Samples/Sampling Methods
 Journal Club
 Discussion Questions
 Research Design Selection Assignment
What is meant by approach?

It is the whole design including;


assumptions, the process of inquiry,
the type of data collected and the
measuring of findings.
Quantitative approach is the
ability to be measured.
Quantitative research is similar to
traditional scientific methods
 Stating in advance the hypothesis and
research question.
 Determine the methods of data
collection and analysis.
 The findings are presented in
statistical language.
Quantitative research is similar to
traditional scientific methods (cont.)
 Quantitative approach to research involves
data collection methods such as structured
questionnaire, interviews and
observations together with other tools.

 On the other hand, in depth interviews and


unstructured observations are associated
with qualitative research.

 Researches have to choose methods which


are appropriate for answering their
questions.
Quantitative research features
 Henwood and Pidgeon 1993, stated that
quantitative research deals with
quantities and numbers while qualitative
research deals with quality and
description which is too simple and
unhelpful.

 The purpose of quantitative research is to


measure concepts or variables that are
predetermined objectively and to
examine the relationship between them
numerically and statistically.
Measurement in Quantitative Research
The following criteria should be
fulfilled:

- Validity
- Objectivity (reliability)
- Accuracy
- Precision
Objective Measurement in Quantitative
Research
 Objectivity means that the
researchers stands outside the
phenomena they study. Data collected
are free from bias.

 Objectivity is ensured by many ways


e.g. structured questions,
representative sampling and
randomization.
Objective Measurement in Quantitative
Research (cont.)

 Sometimes, researchers may study


concepts e.g. pain, attitudes and fatigue.
In such cases, scales are constructed e.g.
self-esteem scale as subjective measures
are crude and not accurate.

 Objective measures are more valid and


reliable than subjective measures, the
later depend on self reports.
Types of Quantitative Data

 Data are used to classify groups.


 Examples; numbers, amounts,
prevalence, incidence.
 Variables can be classified as
physical (wt.& Ht.), physiological
(attitude, anxiety), social……etc.
Quantitative research features
(cont.)
 Quantitative research studies the
relationship between concepts and
variables e.g. the relation between
social support and quality of life.

 Randomized control trials rely on


quantitative measure to determine if
the interventions have the desired
effects. Although qualitative methods
may be used to explore some issues
related to intervention.
Quantitative research features
(cont.)
 It is clear that quantitative research
can provide data to describe the
distribution of a characteristic or
attributes in population, explore the
relationships between them and
determine cause and effect
relationship.
Quantitative Research Example
 The use of sedation tool in the ICU
setting and its ability to predict
driprivan usage.
 The study employs the use of a valid
and reliable sedation tool.
 Data collection was structured and
standardized.
 Data are analyzed by statistical tests.
Quantitative approach as deductive
 An approach which tests the researchers’
hypothesis in quantitative studies are
termed deductive.
As such approach tests whether variables
are correlated or one affects another e.g.
nutritional status and pressure ulcers, or
factors related to tobacco use.

Some quantitative studies are inductive


as they lead to formation of new
questions ( generate new hypothesis )
Quantitative research Main
feature
 Quantitative research is described as
producing generalisable findings
through randomization and
representative sampling.

However, the study is no less


quantitative if a random
representative sample is not used.
Data Collection in Quantitative
Research
 Questionnaire
 Observation schedules
 Instruments to measure
physiological and biomedical
indicators
 All the above methods should be
pre-determined, structured and
standardized.
Value of Quantitative Research to
Nursing
 Help nurses to grasp the reality as
measurement is central to every
thing that nurses do; symptoms,
relief, improvement in patients i.e.
physical, physiological and
psychosocial phenomena.
 Provide data for many questions that
arise during practice.
 Useful in identifying trends.
Value of Quantitative Research to
Nursing ( cont. )
 Needs assessment of patients
and nurses.
 Evaluations of interventions.
 Measuring the competence and
skills.
 Useful for providing decision
makers with required
information.
Limitations of Quantitative
Approach
 It is difficult to understand human
phenomena e.g. when studying human
behavior, it is possible only to study what is
observable. So the phenomena is revealed
partially.
 Some researches claim that many
influences affect people’s response to
questions i.e. it is not purely objective.
 Some standardized scales may be
interpreted differently by participants.
What Is Quantitative Research?
 Systematic study of one or more problems,
usually posed as research questions germane to
a specific discipline.

 Quantitative research methods include


experiments, surveys, correlational studies, and
other methods such as
meta-analysis and psychometric evaluations.
What Is Statistics?

 Branch of applied mathematics that deals


with collecting, organizing & interpreting
data using well-defined procedures in
order to make decisions.
Quantitative
Methods/Designs
Schemata

 Group 1: O1 X1 O2
 Group 2: O1 X2 O2
 Where O= Observation
 Where X= Treatment

24
Types of Clinical Trials (1)
 Treatment trials test experimental
treatments, behavioral therapies, new
combinations of drugs, or new approaches
to surgery or radiation therapy

 Prevention trials look for better ways to


prevent disease in people who have never
had the disease or to prevent a disease
from returning
 These approaches may include medicines,
vitamins, vaccines, minerals, or lifestyle changes

25
Types of Clinical Trials (2)
 Diagnostic trials are conducted to find better
tests or procedures for diagnosing a particular
disease or condition

 Screening trials test the best way to detect


certain diseases or health conditions

 Quality of life trials (also called supportive


care trials) explore ways to improve comfort
and the quality of life for individuals with a
chronic illness

Quantitative Research 26
Sample
 Decide inclusion and exclusion
criterion
 Example of inclusion criterion: “All newly
diagnosed head and neck cancer patients
with squamous cell carcinoma that smoke”
 Example of exclusion criterion: “Those who
are terminally ill, mentally or cognitively
unstable, pregnant, etc.”

 Exclusion criterion control for errors


27
Randomization (1)
 Assigned to groups by method similar to
“flipping a coin”
 If randomization works, groups will be the
same/comparable
 The larger the sample, the greater the
likelihood of equal group
 Results should show that the demographic
characteristics between groups are similar
 If groups are similar, do not need to control for
extraneous variables

Quantitative Research
28
Randomization (2)

 Some times cannot randomize people (e.g.,


cross-contamination or “system”
interventions)
 Can randomize hospitals, or units instead
 For example, testing clinical reminder systems

 Once randomized, always randomized


 Subjects are treated as part of that group,
even if they die, are lost to follow up, or
withdraw
29
Member/Fidelity Checks
 Did the investigator make sure the
intervention was delivered as it was
supposed to be delivered?

 Becomes more of an issue when


having multiple sites with multiple
providers of the intervention
 Important to provide training and
booster sessions and making spot
checks
30
Blinding
 Un-blinded: Everyone knows treatment
 Single Blinded: Researcher or patient does
not know treatment
 Double Blinded: Neither researcher or
patient knows treatment

 Why blinding?
 Many people believe they feel better if they are
given something
 This is the placebo effect

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Double Blind Example
 Patient:
 Patient agrees that he will be randomized to
one of 4 smoking cessation treatments
 None of these 4 smoking cessation
treatments are known to be better than the
other
 Provider:
 Providers do not know that patients are
assigned to groups
 Hire different people to run each group and
do not tell them about the study
32
Intervention/Treatment
 Treatment versus placebo
 Treatment versus standard of
care

 Treatments should be made to


be as same as possible
 For example, new drug versus
sugar pill

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Four Arm Study Example: Factorial
Design

Cessation counseling and meds Cessation counseling only

40% quit rate 10% quit rate

Cessation meds only Placebo group


Nothing or
35% quit rate Blank patch + Attention Control

6% quit rate

Quantitative Research
34
Outcome Variable
 The outcome variable should be the same as
pretreatment measure
 For example,
 Pretreatment: Smoked within the last 24 hours
 Post treatment: Smoked within the last 24 hours at
the 7th day and the 30th days

 Could have short-term and long term


outcomes
 Short-term: Quit rate
 Medium-term: 1-year quality of life
 Long-term: Survival rate
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Phases of Clinical Trials
 Phase I trials (a pilot study): Researchers test an
experimental drug or treatment in a small group of
people (5-60 subjects) for the first time to
 Evaluate its safety
 Determine a safe dosage range
 Identify side effects

 Phase II trials (a larger pilot study): The experimental


study drug or treatment is given to a larger group of
people (100 subjects) to see if it is effective and to
further evaluate its safety

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Phases of Clinical Trials
 Phase III trials (RCT): The experimental study drug or
treatment is given to large groups of people (200-3,000
subjects) to
 Confirm its effectiveness
 Monitor side effects
 Compare it to commonly used treatments
 Collect information that will allow the experimental drug or
treatment to be used safely

 Phase IV trials (implementation research):


 Post marketing studies
 Delineate additional information, including: the drug's risks,
benefits, and optimal use

Quantitative Research 37
Non-Randomized Comparison
Group

 Next best thing to RCT


 Used when we cannot randomize our
subjects
 For example, due to cross-contamination,
or facility- or community-level
interventions

 Make sure groups are as similar as


possible
38
Case Control Study
 Quick and dirty, but able to obtain lots of
information
 Used in epidemiology to look at exposures
 Retrospective or prospective
 Has a comparison group

 Sometimes, does not control for extraneous


variables
 Sometimes, controls for by matching
 Sometimes, nested in a larger study (e.g.,
nested case control)
39
Non-Matched Case Control
Example

Worked in Coal Did not work in


Mine Coal Mine
N=20 N=20
Black Lung-Yes 10 0

Black Lung-No 10 20

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Matched Case Control Examples
 Example 1: Want to look at the beta
carotene blood levels of the head-neck
cancer patients, smokers compared to non
smokers
 Match on age, gender, race, BMI, fruit and
vegetable intake, cancer site, cancer stage
 Please also see next slide
 Example 2: Want to look at the effect of
Doulas on birth outcomes for pregnant
adolescents
 Match on age, race, BMI, provider type,
gestational age, pregnancy complications 41
Matched Case Control Example

Smoked Not Smoke


N=30 N=30

Beta carotene 50% 50%


High

Beta carotene 50% 50%


Low

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Historical Controls
 Not the best design
 Better than no comparison group
 Look at a group before an intervention
was implemented compared to after an
intervention was implemented
 Comparison not at same time

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Historical Control
 Example 1:
 Initiation of skin to skin contact following delivery on
temperature, breast feeding rates and blood sugar
 Looks at those outcome prior to the intervention and
then after this intervention was initiated
 Example 2:
 Blood Stream Infections rates before and after a new
protocol implemented
 Compare old rates to new rates
 Ob. 1 Ob. 2 Ob. 3 O4 Int. Ob. 5 Ob. 6 Ob.7
 Where Ob=Observation of infection rate
 Where Int.= New Protocol(Intervention)

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One Group Pre-post Design

 Group 1 X Group 2
 Used in nursing
 Not a rigorous design because there is no
comparison group
 Biggest draw back is it cannot control for
historical effect

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Cross-Sectional Design
 Takes a measure of a population at a
certain point in time (e.g., a survey
research)
 Descriptive
 Are easy, fast, and inexpensive
 Can determine prevalence of disease
 Can look at associations between variables
 Cannot determine cause and effect

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Cohort Study
 Time series, longitudinal, repeated measures
 Repeated cross-sectional measures over time
 Ob. 1 Ob. 2 Ob. 3
 Could have a repeated measures design with
a comparison group
 Can determine changes in population
 Can determine cause and effect
 Are expensive and take a long time

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Definitions
 Causality
 Correlation between 2 factors
 Cause must precede effect
 Cause is always present when effect occurs
 Multi-causality (e.g., smoking, diet, and
genes all may cause heart disease)
 Probability
 Bias-slant from truth
 Reduce bias by blinding or
randomization
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Summary of Quantitative Designs
 Experimental
 RCT
 Cross-over RCT
 Quasi-experimental
 Nonrandomized comparison group
 Nonrandomized cross-over
 Case control (matched or non-matched)
 Historical control
 One group pre-post design
 Cross-sectional (slice in time)
 Cohort (repeated measure)
 Nested (one study nested in another)

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Hawthorne Effect
 Example:
 Implemented an intervention to see if it could
increase the workers’ productivity in a factory
 Watched workers to see if the intervention worked
and it did
 Then, watched workers, who did not have the
intervention, and found that their productivity rose
too

 Hawthorne effect: Attention alone produces results

 That is why we try to use an equal attention control


design

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Validity-Truth or Accuracy of Claim

 Validity: Are you measuring what you


say you are measuring?

 Reliability: Does the measure give the


same result each time it measures the
same thing?

51
Internal and External Validity and
Methods of Control
INTERNAL/EXTERNAL VALIDITY AND THE
METHODS OF CONTROL

INTERNAL
EXTERNAL
VALIDITY
VALIDITY
Are the findings due to the
Can I generalize
independent variable?
the results to
another group?

Selection Bias

Mortality Effects of Randomization


Selection

Homogenous
Samples
Maturation
Consistency in
Data Collection

Effects of
Instrumentation Testing
Manipulationof the
independent
Variable

Testing
Reactivity

History
Quantitative Research 52
More About Validity
 Note that the question under the term
“internal validity” on the diagram (the
previous slide)
 This is the first question for us to
consider before we “consume” research
and use a study for clinical practice
 How do we know that what the
researcher found is really the result of
what she did?

53
Internal Validity
 If internal validity is not strong, it means
that something other than the variable
we studied may have made the
difference

 As a reader of research, you should


always be looking for explanations for
the findings, other than the one the
researcher is giving you

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Internal Validity
 How will we know that if we find differences in the
groups that they are most likely due to the rest
period?
 Selection bias: Low risk due to random assignment, but still
there due to small sample size
 Mortality: Moderate threat, not because clients might die
but because they might drop out or not do what is
necessary and have to be dropped
 Maturation: Low threat, no known maturation in this area
 Instrumentation: Low to moderate threat since different
people will be documenting over the period and recording
may be inconsistent
 Testing: Low threat, all patients will have data recorded
 History: Low threat, should affect both groups equally.
Quantitative Research 55
External Validity

 Note the question under “external validity” on


your diagram (Slide #34)
 Assessing the threats to external validity
helps us to consider how well this study could
relate to other groups, not just the one
studied
 External versus internal validity:
 Internal validity deals with the inside of the study
 External validity deals with outside the study
 External validity is about the ability to generalize a
study’s findings to another group

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External Validity
 How well can we apply the results of this
study to clients over 60 yrs in other nursing
homes?
 Effects of selection: High since only 1 nursing
home will be used, nursing homes could differ
easily in factors that might affect the results
 Effects of Testing: Moderate threat the limitation
of 1 site again means that we can’t be too sure
any findings aren’t due to other factors
 Reactivity: Low to moderate threat, clients &
staff in this nursing home may react differently
than clients/staff in other nursing homes
Quantitative Research 57
Methods of Control
 Methods used
 Random Assignment
 Manipulation of the independent variable: e.g., one
group gets the rest period the other doesn’t
 Data consistency: An operational definition that is
easily understood is given for “rest periods”
 A few other things that could be done
depending on resources available
 Random sampling from a state wide or national
ranking
 Homogenous grouping with same size nursing homes
or limiting types of clients
 Consistency in data collection with training of staff
and developing a set form/procedure for data
collection
Quantitative Research 58
Randomization
 Randomization
 Two kinds of randomization:
 Random sampling
 Every person in a population must have
an equal chance of getting into the
sample
 Random assignment
 Each person in a sample must have an
equal chance of getting into the
experimental and control group
 That is, they are randomly placed in
one of the groups
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Randomization
 Researcher must actually go through
some randomization process
 For example, number each potential subject,
and then pull numbers from a box or use a
random table to determine assignment to a
group

 Randomization is a very strong and


positive control method
 Randomization can always strengthen a
study

60
Homogenous Sampling
 Trying to make your sample as much alike
is helpful in studies
 because it can minimize the possibility
extraneous variables have affected the results
 However, it also has limitations
 Because it makes generalization more difficult
since the study population is smaller and applies
to fewer people
 It can also make it more difficult to get enough
people in the study
 So, homogenous sampling increases
internal validity, but decreases external
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Consistency in Data Collection
 The researcher needs to make the
process the same for everyone in
the sample

 In reality, this can be difficult,


because many studies use a
number of individuals to collect
data and it is easy to have
variances

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The Five Elements of Design
 Setting:
 Example: A 110 bed long term care facility in the Midwest, the
study will be done from February to April 2009
 Population:
 Example: All the clients over 60 years of age who are in nursing
homes
 Subjects:
 Example: 60 clients who are willing to participate in a nursing
home where the researcher works. Half will be randomly
assigned to an experimental group who will take the rest period,
half will be assigned to a control group
 Instrument used to collect data:
 Example: Data collection sheet developed for this study includes
demographic data, activity in the afternoon and fall data from
medical records
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Study Conditions
 Example:
 The RN assigned to the units will establish a
protocol to insure that clients in the
experimental group get a 1 hour rest period
each afternoon between the hours of 1 and 3
pm
 The operational definition of a rest period is: A
one-hour period where the client remains in bed
with no verbal or other mentally stimulating
activities
 Clients in the comparison group will be encouraged to
spend time in the TV area or in the therapy rooms
 They will not be allowed to return to bed, but may
return to their own room 64
Statistics
Purpose of Statistics
 To describe & summarize information, thereby
reducing it to smaller, more meaningful sets of
data

 To make predictions or to generalize about


occurrences based on observations

 To identify associations, relationships or


differences between sets of observations
Main Types of Statistics

 Descriptive Statistics

 Inferential Statistics
Descriptive Statistics
 Descriptive Statistics involves organizing,
summarizing & displaying data to make
them more understandable.

 Most common statistics used are


frequencies, percents, measures of central
tendency, summary tables, charts &
figures.
Inferential Statistics
 Inferential Statistics: a set of statistical
techniques that provides predictions about
population characteristics based on information
from a sample drawn from that population.

 Inferential statistics report the degree of


confidence of the sample statistic that predicts
the value of the population parameter.
Definitions

 Population parameter is the term used to


describe a characteristic of a population.

 Statistic is an estimate of the population,


calculated from data in a sample drawn
from the population.
Comparison of
Central Tendency Measures

 In a perfect world, the mean, median


& mode would be the same.
 However, the world is not perfect &
very often, the mean, median and
mode are not the same
Variability
 A quantitative measure of the degree to
which scores in a distribution are spread
out or are clustered together;
 Types of variability include:
 Standard Deviation: a measure of the
dispersion of scores around the mean
 Range: Highest value minus the lowest
value
 Interquartile Range: Range of values
extending from 25th percentile to 75th
percentile
Summary

 No study is 100% valid


 Most studies have some aspect of
various threats present
 The more control, the less this occurs
 But controlling the threats must be
balanced with the resources and
realities of the research environment
as well as with the skill of the
researcher
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Data Results

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Reliability

 Statistical significance
 p value
 95% Confidence Interval (95% CI)
 Magnitude of effect:
 Dichotomous outcomes:
 Odds Ratio (OR):
 Risk Reduction:
▪ Absolute Risk Reduction (ARR)
▪ Relative Risk Reduction (RRR)
▪ Number needed to treat (NNT)
 Relative Risk (RR)
 Continuous outcomes: 75
 Mean (median) difference
“p” value
 Probability :
 Likelihood of an outcome occurring
by chance
 By convention, “p < .05” is considered
“statistically significant”
 Researcher’s hypothesis is
supported!
 There is 95% certainty that the
outcome did not occur by chance
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“p” value

 p >0.05 → “Statistically NOT


significant” (NS)
 not acceptable
 p <0.05 → “Statistically significant”
 acceptable
 p <0.01 → “Statistically significant”
 very
 p <0.001 → “Statistically significant”
 extremely
 Therefore, smaller the p value, greater
the certainty 77
Reading the “p” value
 Indicates whether the research hypotheses
are:
 Supported if statistically significant
 Not supported if statistically not
significant
 Limitation of “p value”:
 Hard to understand; easy to
misinterpret.
 Emphasizes testing of hypotheses
 Therefore, “Confidence Interval”
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Confidence Interval (CI)
 Precision of estimates
 Confidence intervals tell us the upper and
lower possibilities of our statistical
estimates

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95% Confidence Interval (95% CI)

80
95% CI

 Range within which it is 95% certain to


contain the true value
 Lower limits & upper limits.
 Focus on the worst number.
 If the worst number is still pretty
good, then the result is robust.

81
t Test

PLACEBO ALBUMIN
n 3500 3500
mean 28 30

95% CI 27.7-28.3 29.7-30.3

p < 0.0001

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Effect of Sample Size Reduction

PLACEBO ALBUMIN
n 350 350
mean 28 30

95% CI 27.0-29.0 29.0-31.0

p = 0.008

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Reducing Sample Size (again)

PLACEBO ALBUMIN
n 35 35
mean 28 30

95% CI 24.6-31.4 26.6-33.4

p =0.41
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95% CI
 The narrower the CI, the more precise the
result, and the more confident we are
about the true result.
 The wider the CI, the less confident we
are about the true result.
 It depends on the sample size!

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Magnitude of effect (effect size)

 “How big is the difference?”


 Absolute true effect can never be known.
 CI (confidence interval): the range within which
the true effect likely lies.
 Summary statistics:
 OR, RRR, RR, or mean difference

86
Odds
 Ratio of events to non-events
 If the event rate for a disease is 0.1
(10%), its non-event rate is 0.9.
 Thus, its odds are 1/9 or 0.111

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Odds Ratio (OR)
 The ratio of the odds of the event in the
experimental group divided by the odds of
the event in the control group
 OR of “1” means there is “No difference”

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Odds Ratio (OR)
 Smoking and lung cancer

 The odds of smoking in lung cancer


patients is 12 times that in control

89
Example: OR & 95%CI
 Nurses’ smoking cessation interventions
has shown that nurses are effective in
motivating smokers to quit. (Rice & Stead,
Cochrane 2004)
 OR (95% CI)= 1.47 (1.29,
1.68)

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Examples: OR & 95%CI
 Odds of quitting with nursing intervention
is 1.47 X that without nursing intervention
 95% certain that the true OR is between
1.29 and 1.68 (in worst case, OR is 1.29)

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Systematic Review (SR)
 “Shortcut” which practitioner can use to
answer specific questions relating to
clinical management
 Steps 2 & 3 are done (most
laborious tasks of searching
and critical appraisal are
already done by the reviewer)

92
Meta Analysis
 Process of statistically combining the
results from a number of studies
 Used in SR (Systematic Reviews)
 Very powerful

93
Example: Meta-analysis
 Strong evidence that interventions
directed towards individual smokers
increase the likelihood of quitting
smoking. These include advice from a
health professional, individual and group
counseling and pharmacological treatment
to overcome nicotine addiction.
(Workplace interventions for smoking
cessation, Moher et al., Cochrane 2005)

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Workplace interventions for smoking cessation (Moher et
al., Cochrane 2005)

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Workplace interventions for smoking cessation (Moher et
al., Cochrane 2005)

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RRR vs. ARR
% reduction in  Absolute
experimental difference in the
group event rate event rate
compared to the between control
event rate in group and
control group experimental
group

97
Risk Reduction

Control “Experimental” Absolute


Group Group Risk Reduction

No Rx Rx Difference

Mortality 44% 25% 19%

98
Mean (median) difference
 If outcomes are continuous variables, then
mean (or median) difference will be
reported.
 Mean difference (mean effect size):
 E.g. BP, blood glucose, healthcare
cost
 Median difference (median effect size):
 E.g. length of hospitalization, survival
days
 Point of no difference: “0” 99
Assessment criteria of RCT
 Screening question:
 Ask a clearly focused question?
 Was study design appropriate?
 Detailed question:
 Randomized?
 Blinded?
 Dropout rate?

100
Factors that may decrease the strength of
evidence (RCT)

 Poor quality of implementation


 High likelihood of bias:

 Randomization?
 Drop-out rate?
 Indirectness of evidence
 Differing population

101
Main factors that may increase the strength
of evidence

 Large “magnitude of effect”:


 Observational study begin as
low-quality evidence, but the
quality may be upgraded on
the basis of large magnitude of
effect

102
Determining recommendations (“Strong” vs
“Weak”)
 “1” : Strong recommendation
 “2”: Weak recommendation
 Factors determining recommendations:

 Quality of evidence
 Relative importance of outcomes
 Absolute magnitude of effect
 Precision of the estimates of the
effects
 Costs 103
Example: Recommendation
 Key recommendations are listed by
category:
 Grade 1 A:
 Strong recommendation
 High quality of evidence
 Grade 2 B:
 Weak recommendation
 Moderate quality of evidence

104

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