Managerial Epidemiology: Assignment Week 4
Case Study: Chapters 8 to 10
Objective: The students will complete a Case study assignments that give the opportunity to synthesize and apply the thoughts learned in this and previous coursework to examine a real-world scenario. This scenario will illustrate through example the practical importance and implications of various roles and functions of a Health Care Administrator. The investigative trainings will advance students’ understanding and ability to contemplate critically about Experimental Study Designs, Measures of Effect, Data interpretation issues, and their problem-solving skills. As a result of this assignment, students will be better able to comprehend, scrutinize and assess respectable superiority and performance by all institutional employees.
ASSIGNMENT GUIDELINES (10%):
Students will critically measure the readings from Chapters 8 to 10 in your textbook. This assignment is planned to help you examination, evaluation, and apply the readings and strategies to your Health Care organization and Managerial Epidemiology.
You need to read the article (in the additional weekly reading resources localize in the Syllabus and also in the Lectures link) assigned for week 4 and develop a 3 page paper reproducing your understanding and capability to apply the readings to your Health Care organization and Epidemiology. Each paper must be typewritten with 12-point font and double-spaced with standard margins. Follow APA format when referring to the selected articles and include a reference page.
EACH PAPER SHOULD INCLUDE THE FOLLOWING:
1. Introduction (25%) Provide a short-lived outline of the significance (not a description) of each Chapter and articles you read, in your own words that will apply to the case study presented.
2. Your Critique (50%): Case Study
“Gastroenteritis following a retirement party at the State Capitol” 1 Outbreak Summary Approximately 300 persons attended a retirement party at the Nebraska State Capitol held on May 27, 2017. Most of the attendees worked in the Capitol. A private caterer (Caterer A) prepared and served food for the reception. Based on initial telephone interviews of persons reporting illness, the predominant symptoms were nausea and diarrhea, and the incubation period was approximately 24-30 hours. The following foods were served at the retirement reception: Swedish meatballs, taco dip, crab dip, a vegetable tray and herbed ranch dip, cake, nuts and mints. The vegetable tray consisted of cucumbers, broccoli, cauliflower, carrots, celery, green peppers, and radishes. All foods were prepared onsite on the day of the reception with the exception of the nuts, which were purchased by a coworker, and the mints, which were made by a coworker. The Swedish meatballs consisted of ground beef, ground pork, sour cream and flour. The meatballs were cooked twice. The taco dip contained layers of cream cheese mixed with salsa, ground beef, tomatoes, lettuce, onion, cheese and salsa. The taco dip was prepared manually by Caterer A in the kitchen at the State Capitol, and was not cooked after assembly. The crab dip contained canned real crab, cream cheese and ketchup. The investigators received completed surveys from 227 attendees. Of those 227 attendees, 128 (56%) persons reported a gastrointestinal illness within 72 hours of the reception. The average interval between time of food consumption and onset of illness was 32.3 hours (range 6 to 67 hours). Table 1 shows the symptoms reported by ill attendees. The duration of symptoms generally lasted 24 to 36 hours. One person reported being symptomatic for five days. Eight persons sought medical treatment, mostly for re-hydration therapy. Persons working in the security office at the State Capitol ate samples of the items served at the reception except the taco dip. None of the people from this office reported illness.
Table 1: Distribution of Symptoms Reported in Persons Meeting the Case-definition.
Symptom Number (%)
Nausea 117 (92.9%)
Diarrhea 111 (88.1%)
Abdominal Cramps 92 (74.2%)
Vomiting 90 (72.0%)
Headache 87 (70.7%)
Chills 73 (59.8%)
Muscle aches 72 (59.5%)
Sweats 67 (55.4%)
Bloody diarrhea 0 (0%)
CASE STUDY CHALLENGE
1. What were the main finding in the case study?
2. What are the Conclusions from these findings?
3. What are the increased risk for people to get gastroenteritis?
3. Conclusion (15%)
Fleetingly recapitulate your thoughts & assumption to your critique of the case study and provide a possible outcome for the Managerial epidemiology and this case study. How did these articles and Chapters influence your opinions about study designs?
Evaluation will be based on how clearly you respond to the above, in particular:
a) The clarity with which you critique the case study;
b) The depth, scope, and organization of your paper; and,
c) Your conclusions, including a description of the impact of these Case study on any Health Care Setting.
ASSIGNMENT DUE DATE:
The assignment is to be electronically posted no later than noon on Saturday, February 1st, 2020.
Chapter 8
Experimental Study
Designs
Learning Objectives (abridged)
• State how study designs compare with respect
to validity of causal inference
• Distinguish between a controlled experiment
and a quasi-experiment
• Describe the scope of intervention studies
• Define the term controlled clinical trials and give
examples
• Explain the phases in testing a new drug or
vaccine
Learning Objectives (abridged)
• Discuss blinding and crossover in
clinical
trials.
• Define what is meant by community
trials.
• Discuss ethical aspects of
experimentation with human subjects.
True Experimental Studies
• Most convincing for conferring
evidence of associations between
risk factors and outcomes
• Manipulation of study factor and
randomization
of subjects
• An example is a randomized clinical
trial.
Women’s Health Initiative
• Hormone Replacement Therapy (HRT)
– Epidemiologic studies had shown that HRT
use had significant benefits against coronary
heart
disease.
– Clinical trials had failed to demonstrate any
benefit.
– Large body of epidemiologic research had
observed that women who took HRT had
elevated risks of breast cancer.
Women’s Health Initiative
• Hormone Replacement Therapy (HRT)
– To resolve the question of risks versus benefits of
HRT, a clinical trial was conducted.
– Demonstrated that:
• the epidemiologic findings on cancer were
generally accurate
• the benefits on cardiovascular disease had
been overestimated
– Results
• Use of HRT decreased 40%-80% after the trial
was stopped
Quasi-
Experiment/Community Trial
• Ranked immediately below
controlled experiments in rigor
• Investigator is unable to randomly
allocate subjects to the conditions.
• There may be contamination across
the conditions of the study.
Intervention Studies
• An investigation involving intentional
change in some aspect of the status
of subjects
• Used to test efficacy of preventive or
therapeutic measures
• Manipulation of the study factor and
randomization of study subjects
Intervention Studies
• Two categories:
– Clinical trials (focus on the individual)
– Community trial or community
intervention (focus on the group or
community.
• NOTE: Controlled clinical trials may
be conducted both at the individual
and community levels.
Clinical Trials: Definition
• A research activity that involves the
administration of a test regimen to
humans to evaluate its efficacy and safety
• Wide variation in usage:
– The first use of the term was for studies in
humans without any control treatment
– Now denotes a rigorously designed and
executed experiment involving RANDOM
ALLOCATION of test and control treatments
Characteristics of Clinical
Trials
• Carefully designed and rigidly enforced
protocol
• Tightly controlled in terms of eligibility,
delivery of the intervention, and monitoring
out outcomes
• Duration ranges from days to years
• Participation is generally restricted to a
highly selected group of individuals.
Characteristics of
Clinical Trials
• Once subjects agree to participate,
they are randomly assigned to one of
the study groups, e.g., intervention or
control (placebo)
History of Clinical Trials
• In 1537, Ambroise Paré applied
experimental treatment for battlefield
wounds.
• East India Shipping Company (1600)
found that lemon juice protected against
scurvy.
• James Lind (1747) used the concurrently
treated control group method.
History of Clinical Trials
• Edward Jenner’s efforts to develop a
smallpox vaccine in the late 18th century
• Most recent historical developments
include the use of multicenter trials.
– Instrumental in the development of
treatments for infectious diseases and
recently in chronic diseases that are of
noninfectious origin
Prophylactic and Therapeutic
Trials
• A prophylactic trial evaluates the
effectiveness of a substance that is used
to prevent disease; it can also involve a
prevention program.
• A therapeutic trial involves the study of
curative drugs or a new surgical procedure
to improve the patient’s health.
Outcomes of Clinical Trials
• Referred to as clinical end points
• May include rates of disease, death, or
recovery
• The outcome of interest is measured in
the intervention and control arms of the
trial to evaluate efficacy–these must be
measured in a comparable manner.
Examples of Clinical Trials
• Medical Research Council Vitamin
Study—studied role of folic acid in
preventing neural tube defects.
• South Bronx, NY, STD Program—
evaluated effectiveness of education
efforts to prevent spread of sexually
transmitted diseases (STDs).
Blinding (Masking)
• To maintain the integrity of a study and
reduce the potential for bias, the
investigator may utilize one of two popular
approaches:
–Single-blind design: subject unaware of
group
assignment
–Double-blind design: Neither subject nor
experimenter is aware of group
assignment
Phases of Clinical Trials
• Before a vaccine, drug, or treatment can
be licensed for general use, it must go
through several stages of development.
• This lengthy process requires balance to:
– protect the public from a potentially
deleterious vaccine
– satisfy the urgent needs for new vaccines
Stages in the Development of A
Vaccination Program
• Pre-licensing evaluation of vaccine
– Phase I trials: Safety of adult volunteers
– Phase II trials: Immunogenicity and reactogenicity in
the target population.
– Phase III trials: protective efficacy
• Post-licensing evaluation
– Safety and efficacy of vaccine
– Disease surveillance
– Serologic surveillance
– Measurement of vaccine coverage
Phase IV Trials
• There can be more than three phases in a
clinical trial.
• Phase IV trials involve post-marketing
research to gather more information about
risks and benefits of a drug.
Randomization
• Method of choice for assigning subjects to
the treatment or control conditions of a
clinical trial.
• Non-random assignment may cause
mixing of the effects of the intervention
with differences (e.g., demographic)
among the participants of the trial.
Crossover Designs
• Any change of treatment for a patient in a
clinical trial involving a switch of study
treatments
• In planned crossovers a protocol is
developed in advance, and the patient
may serve as his or her own control.
• Unplanned crossovers exist for various
reasons, such as patient’s request to
change treatment.
Ethical Aspects of Human
Experimentation
• Benefits must outweigh risks.
• Ethical issues:
– Informed consent
– Withholding treatment known to be effective
– Protective the interests of the individual
patient
– Monitoring for side effects
– Deciding when to withdraw a patient
Reporting the Results of
Clinical Trials
• The CONSORT Statement is a
protocol that guides the reporting of
randomized trials by providing a 22-
item checklist and a flowchart.
Summary of Clinical Trials
• Strengths:
– Provide the greatest control over:
• the amount of exposure
• the timing and frequency of exposure
• the period of observation
– Ability to randomize reduces the likelihood
that groups will differ significantly.
Summary of Clinical Trials
(cont’d)
• Limitations:
– Artificial setting
– Limited scope of potential impact
– Adherence to protocol is difficult to
enforce
– Ethical dilemmas
Community Trials
• Community intervention trials determine the
potential benefit of new policies and programs
• Intervention: Any program or other planned
effort designed to produce changes in a target
population
• Community refers to a defined unit, e.g., a
county, state, or school district
Community Trials (cont’d)
• Start by determining eligible communities and
their willingness to participate
• Collect baseline measures of the problem to be
addressed in the intervention and control
communities
• Use a variety of measures, e.g., disease rates,
knowledge, attitudes, and practices
Community Trials (cont’d)
• Communities are randomized and followed over
time
• Outcomes of interest are measured
Examples of Community Trials
• North Karelia Project
• Minnesota Heart Health Program
• Stanford Five-City Project
• Pawtucket Heart Health Program
• Community Intervention Trial for Smoking
Cessation (COMMIT)
• Project Respect
Summary of Community Trials:
Advantages
• They represent the only way to estimate
directly the impact of change in behavior
or modifiable exposure on the incidence of
disease.
Summary of Community Trials:
Disadvantages
• They are inferior to clinical trials with respect to
ability to control entrance into study, delivery of
the intervention, and monitoring of outcomes.
• Fewer study units are capable of being
randomized, which affects comparability.
• They are affected by population dynamics,
secular trends, and nonintervention influences.
Four Stages of Evaluation
• Formative: Will all plans and procedures
work as conceived?
• Process: Is the program serving the
target group as planned?
• Impact: Has the program produced any
changes among the target group?
• Outcome: Did the program accomplish
its ultimate goal?
Overview of Quasi-Experimental
Study Designs
Type of Study Design Group(s) Pretest Intervention Posttest
Posttest only Intervention O X X
(has only one group)
Pretest/Posttest Intervention X X X
(has only one group)
Pretest/Posttest/Control Intervention X X X
(has two groups) Control X O X
Solomon Four-Group Intervention 1 X X X
(has four groups) Intervention 2 O X X
Control 1 X O X
Control 2 O O X
Note. O = not used; X = used.
• Posttest only–observations are made only
after the program has been delivered.
• Pretest/Posttest–baseline and follow-up
observations are made.
• Pretest/Postest/Control–observations are
made in both intervention and control
groups before and after the program.
Quasi-Experimental Designs
(cont’d)
• Solomon Four-Group assignment:
– Used to overcome the Hawthorne Effect.
– Uses four equivalent groups, two
intervention and two control:
• Two are observed before and after intervention.
• Two are observed only after intervention.
Chapter 9
Measures of Effect
Learning Objectives
• Explain the meeting of absolute and relative
effects
• Calculate and interpret the following
measures: risk difference, population risk
difference, etiologic fraction, and population
etiologic fraction
• Discuss the role of statistical tests in
epidemiologic research
• Apply Hill’s criteria for evaluation of
epidemiologic associations
Effect Measure
• A quantity that measures the effect of
a factor on the frequency or risk of a
health outcome
Three Effect Measures
• Attributable Fractions
– Measure the fraction of cases due to a
factor.
• Risk and Rate Differences
– Measure the amount a factor adds to
the risk or rate of a disease.
• Risk and Rate Ratio
– Measure the amount by which a factor
multiplies the risk or rate of disease.
Absolute vs. Relative Effects
• Absolute
– Attributable risk is also known as a rate
difference or risk difference.
– Population risk difference
• Relative
– Relative risk
– Etiologic fraction
– Population etiologic fraction
Risk Difference (Attributable
Risk)
• Risk difference–the difference
between the incidence rate of
disease in the exposed group (Ie)
and the incidence rate of disease in
the nonexposed group (Ine).
• Risk difference = Ie – Ine
Calculation of Risk Difference
• For women younger than age 75, the
incidence (Ie) of hip fractures per 100,000
person-days was highest in the winter
(0.41), and the incidence (Ine) was lowest
in the summer (0.29). The risk difference
between the two seasons (Ie – Ine) was 0.41
– 0.29, or 0.12 per 100,000 person-days.
Population Risk Difference
• Measures the benefit to the
population derived by modifying a
risk factor.
Etiologic Fraction
• Defined as the proportion of the rate
in the exposed group that is due to
the exposure.
• Also termed attributable proportion or
attributable fraction.
Population Etiologic Fraction
• Provides an indication of the effect of
removing a particular exposure on the
burden of disease in the
population.
• Also termed attributable fraction in the
population.
Statistical Measures of Effect
• Significance tests
• The P value
• Confidence interval
Null Hypothesis
• Underlying all statistical tests is a null
hypothesis, which states that there is
no difference among the groups being
compared.
• The parameters may consist of the
prevalence or incidence of disease in
the population.
Significance Tests
• Used to decide whether to reject or fail to reject
a null hypothesis.
• Involves computation of a test statistic, which is
compared with a critical value obtained from
statistical tables.
• The critical value is set by the significance level
of the test.
• The significance level is the chance of rejecting
the null hypothesis when, in fact, it is true.
The P Value
• Indicates the probability that the
findings observed could have
occurred by
chance alone.
• However, a nonsignificant difference
is not necessarily attributable to
chance alone.
The P Value (cont’d)
• Possible meaning of nonsignificant
differences: For studies with a small
sample size the sampling error may
be large, which can lead to a
nonsignificant test even if the
observed difference is caused by a
real effect.
Confidence Interval (CI)
• A computed interval of values that, with a
given probability, contains the true value
of the population parameter.
• The degree of confidence is usually stated
as a percentage; commonly the 95% CI is
used.
• Influenced by variability of the data and
sample size.
Clinical vs. Statistical
Significance
• While small differences in disease frequency or
low magnitudes of relative risk (RR) may be
significant, they may have no clinical
significance.
• Conversely, with small sample sizes, large
differences or measures of effect may be
clinically important and worthy of additional
study.
Statistical Power
• The ability of a study to demonstrate
an association if one exists.
• Determined by:
– Frequency of the condition under study.
– Magnitude of the effect.
– Study design.
– Sample size.
Evaluating Epidemiologic
Associations
• Five key questions to be asked:
– Could the association have been observed by
chance?
• Determined through the use of statistical tests.
– Could the association be due to bias?
• Bias refers to systematic errors, i.e., how samples
were selected or how data was analyzed.
Evaluating Epidemiologic
Associations (cont’d)
• Could other confounding variables have
accounted for the observed relationship?
• To whom does this association apply?
– Representativeness of sample
– Participation rates
• Does the association represent a cause-
and-effect relationship?
– Considers criteria of causality.
Types of Associations between
Factors and Outcomes
• Not statistically associated
(independent)
• Statistically associated
Statistical Association
• When a factor and outcome are
statistically associated, the
relationship can be:
– Non-causal
– Causal
• Indirect
• Direct
Multiple Causality
• Also referred to as multifactorial
etiology.
• “…requirement that more than one
factor be present for disease to
develop…”
Models of Multiple Causality
• Epidemiologic triangle
• Web of causation, e.g., in avian
influenza
• Wheel model, e.g., childhood lead
poisoning
• Pie model, e.g., lung cancer
Chapter 10
Data Interpretation Issues
Learning Objectives
• Distinguish between random and
systematic errors
• State and describe sources of bias
• Identify techniques to reduce bias at the
design and analysis phases of a study
• Define what is meant by the term
confounding and provide three examples
• Describe methods to control confounding
Validity of Study Designs
• The degree to which the inference drawn
from a study, is warranted when account it
taken of the study, methods, the
representativeness of the study sample,
and the nature of the population from
which it is drawn.
Validity of Study Designs
• Two components of validity:
– Internal validity
– External validity
Internal Validity
• A study is said to have internal validity
when there have been proper selection of
study groups and a lack of error in
measurement.
• Concerned with the appropriate
measurement of exposure, outcome, and
association between exposure and
disease.
External Validity
• External validity implies the ability to
generalize beyond a set of observations to
some universal statement.
• A study is externally valid, or
generalizable, if it allows unbiased
inferences regarding some other target
population beyond the subjects in the
study.
Sources of Error in
Epidemiologic Research
• Random errors
• Systematic errors (bias)
Random Errors
• Reflect fluctuations around a true value of
a parameter because of sampling
variability.
Factors That Contribute to
Random Error
• Poor precision
• Sampling error
• Variability in measurement
Poor Precision
• Occurs when the factor being measured is
not measured sharply.
• Analogous to aiming a rifle at a target that
is not in focus.
• Precision can be increased by increasing
sample size or the number of
measurements.
• Example: Bogalusa Heart Study
Sampling Error
• Arises when obtained sample values
(statistics) differ from the values
(parameters) of the parent population.
• Although there is no way to prevent a
non-representative sample from
occurring, increasing the sample size
can reduce the likelihood of its
happening.
Variability in Measurement
• The lack of agreement in results from
time to time reflects random error
inherent in the type of measurement
procedure employed.
Bias (Systematic Errors)
• “Deviation of results or inferences
from the truth, or processes leading to
such deviation. Any trend in the
collection, analysis, interpretation,
publication, or review of data that can
lead to conclusions that are
systematically different from the
truth.”
Factors That Contribute to
Systematic Errors
• Selection bias
• Information bias
• Confounding
Selection Bias
• Refers to distortions that result from procedures
used to select subjects and from factors that
influence participation in the study.
• Arises when the relation between exposure and
disease is different for those who participate and
those who theoretically would be eligible for study
but do not participate.
• Example: Respondents to the Iowa Women’s
Health Study were younger, weighed less, and were
more likely to live in rural, less affluent counties than
nonrespondents.
Information Bias
• Can be introduced as a result of
measurement error in assessment of
both exposure and disease.
• Types of information bias:
– Recall bias: better recall among cases
than among controls.
• Example: Family recall bias
Information Bias (cont’d)
– Interviewer/abstractor bias–occurs
when interviewers probe more
thoroughly for an exposure in a case
than in a control.
– Prevarication (lying) bias–occurs when
participants have ulterior motives for
answering a question and thus may
underestimate or exaggerate an
exposure.
Confounding
• The distortion of the estimate of the
effect of an exposure of interest
because it is mixed with the effect of
an extraneous factor.
• Occurs when the crude and
adjusted measures of effect are not
equal (difference of at least 10%).
• Can be controlled for in the data
analysis.
Criteria of Confounders
• To be a confounder, an extraneous
factor must satisfy the following
criteria:
– Be a risk factor for the disease.
– Be associated with the exposure.
– Not be an intermediate step in the
causal path between exposure and
disease.
Simpson’s Paradox as an
Example of Confounding
• Simpson’s paradox means that an
association in observed subgroups of a
population may be reversed in the entire
population.
• Illustrated by examining the data (% of
black and gray hats) first according to two
individual tables and then by combining all
the hats on a single table.
Simpson’s Paradox (cont’d)
• When the hats are on separate tables, a
greater proportion of black hats than gray
hats on each table fit.
– On table 1:
• 90% of black hats fit
• 85% of gray hats fit
– On table 2:
• 15% of black hats fit
• 10% of gray hats fit
Simpson’s Paradox (cont’d)
Simpson’s Paradox (cont’d)
• When the man returns the next day
and all of the hats are on one table:
– 60% of gray hats fit (18 of 30)
– 40% of black hats fit (12 of 30)
Note that combining all of the hats on
one table is analogous to
confounding.
Examples of Confounding
• Air pollution and bronchitis are positively
associated. Both are influenced by
crowding, a confounding variable.
• The association between high altitude and
lower heart disease mortality also may be
linked to the ethnic composition of the
people in these regions.
Techniques to Reduce
Selection Bias
• Develop an explicit (objective) case
definition.
• Enroll all cases in a defined time and
region.
• Strive for high participation rates.
• Take precautions to ensure
representativeness.
Reducing Selection Bias Among
Cases
• Ensure that all medical facilities are thoroughly
canvassed.
• Develop an effective system for case
ascertainment.
• Consider whether all cases require medical
attention; consider possible strategies to
identify where else the cases might be
ascertained.
Reducing Selection Bias
Among Controls
• Compare the prevalence of the exposure
with other sources to evaluate credibility.
• Attempt to draw controls from a variety of
sources.
Techniques to Reduce
Information Bias
• Use memory aids; validate exposures.
• Blind interviewers as to subjects’ study status.
• Provide standardized training sessions and
protocols.
• Use standardized data collection forms.
• Blind participants as to study goals and
classification status.
• Try to ensure that questions are clearly
understood through careful wording and
pretesting.
Methods to Control
Confounding
• Prevention strategies–attempt to control confounding
through the study design itself.
• Three types of prevention strategies:
–
Randomization
–
Restriction
– Matching
• Two types of analysis strategies:
– Stratification
– Multivariate techniques
Randomization
• Attempts to ensure equal distributions of the
confounding variable in each exposure
category.
• Advantages:
– Convenient, inexpensive; permits straightforward
data analysis.
• Disadvantages:
– Need control over the exposure and the ability to
assign subjects to study groups.
– Need large sample sizes.
Restriction
• May prohibit variation of the confounder in the
study groups.
– For example, restricting participants to a
narrow age category can eliminate age as a
confounder.
• Provides complete control of known
confounders.
• Unlike randomization, cannot control for
unknown confounders.
Matching
• Matches subjects in the study groups according
to the value of the suspected or known
confounding variable to ensure equal
distributions.
• Frequency matching–the number of cases with
particular match characteristics is tabulated.
• Individual matching–the pairing of one or more
controls to each case based on similarity in sex,
race, or other variables.
Matching (cont’d)
• Advantages:
– Fewer subjects are required than in
unmatched studies of the same hypothesis.
– May enhance the validity of a follow-up study.
• Disadvantages:
– Costly because extensive searching and
recordkeeping are required to find matches.
Two Analysis Strategies to
Control Confounding
• Stratification–analyses performed to evaluate
the effect of an exposure within strata (levels) of
the confounder.
• Multivariate techniques–use computers to
construct mathematical models that describe
simultaneously the influence of exposure and
other factors that may be confounding the
effect.
Advantages of Stratification
• Performing analyses within strata is a
direct and logical strategy.
• Minimum assumptions must be
satisfied for the analysis to be
appropriate.
• The computational procedure is
straightforward.
Disadvantages of Stratification
• Small numbers of observations in some
strata.
• A variety of ways to form strata with
continuous variables.
• Difficulty in interpretation when several
confounding factors must be evaluated.
• Categorization results in loss of
information.
Multivariate Techniques
• Advantages:
– Continuous variables do not need to be
converted to categorical variables.
– Allow for simultaneous control of several
exposure variables in a single analysis.
• Disadvantages:
– Potential for misuse.
Publication Bias
• Occurs because of the influence of
study results on the chance of
publication.
– Studies with positive results are more
likely to be published than studies with
negative results.
Publication Bias (cont’d)
• May result in a preponderance of
false-positive results in the
literature.
• Bias is compounded when
published studies are subjected to
meta-analysis.