• Dr. Legiran, M.

Kes
 Research Question
Is the regular consumption of Red Bull
associated with improved academic
performance among FK Unsri medical students?
 Rationale
• “functional drink” designed for periods of mental
and physical exertion.
– performance, concentration, memory, reaction time,
vigilance, and emotional balance

• Taurine + glucuronolactone + caffeine

 Background
• Alford C, Cox H, Wescott R. The effects of red bull energy drink on human
performance and mood. Amino Acids. 2001;21(2):139-50.

• Warburton DM, Bersellini E, Sweeney E. An evaluation of a caffeinated taurine

drink on mood, memory and information processing in healthy volunteers without
caffeine abstinence. Psychopharmacology (Berl). 2001 Nov;158(3):322-8.

• Seidl R, Peyrl A, Nicham R, Hauser E. A taurine and caffeine-containing drink

stimulates cognitive performance and well-being. Amino Acids. 2000;19(3-
4):635-42.

• Horne JA, Reyner LA. Beneficial effects of an "energy drink" given to sleepy
drivers. Amino Acids. 2001;20(1):83-9.

• Kennedy DO, Scholey AB. A glucose-caffeine 'energy drink' ameliorates

subjective and performancedeficits during prolonged cognitive demand. Appetite.
2004 Jun;42(3):331-3.
Great idea, but how do you get
started….

• Interesting, novel, and relevant, but…

• You only have 2 million rupiahs to start

investigating this question.

• What is feasible?
 Study Design
• Cross-sectional study of FK Unsri medical students
taking written test

• Questionnaire administered when registering for written

test
– Primary predictor: self-report of >3 cans Red Bull per week
for the previous year
– Covariates: Age, sex, undergraduate university, place of birth

• Outcome: Score on written test

Cross-sectional study: structure

Red Bull consumption

Written test Score

time
 Cross-sectional Study:
• Descriptive value:
– How many FK Unsri medical students drink Red Bull?
– What is the age and sex distribution of FK Unsri medical students
who drink Red Bull?
• Analytic value:
– Is there an association between regular Red Bull consumption and
test scores among FK Unsri med students?
• Univariate
• Multivariate (controlling for “confounders”)
• Other cross-sectional surveys:
– AAMC
– California Health Interview Survey (NHIS, CHIS)
– National Health and Nutrition Exam Survey (NHANES)
 Cross-sectional Study: Pluses
+ Prevalence (not incidence)

+ Fast/Inexpensive - no waiting!

+ No loss to follow up

+ Associations can be studied

 Measures of association
Risk ratio
Disease (relative risk)

Yes No A
A+B
C
C+D
Yes A B
Risk
Factor
No C D
Cross-sectional study: minuses
- Cannot determine causality

Red Bull consumption

Written test Score

time
Cross-sectional study: minuses
- Cannot determine causality

•ACE inhibitor use and hospitalization rates

among those with heart failure

•Heart failure patients with a documented DNR

(do not resuscitate) status and mortality

time
Cross-sectional study: minuses

- Cannot determine causality

- Cannot study rare outcomes

 Hierarchy of Study Types

Descriptive Analytic
•Case report
•Case series
•Survey Observational Experimental
•Cross sectional •Randomized
•Case-control controlled trials
•Cohort studies

Strength of evidence for causality between a risk factor and outcome

 Observational Study

• “A nonexperimental analytic study in

which the investigator monitors, but
does not influence, the exposure status
of individual subjects and their
subsequent disease status”.
 Hierarchy of Study Types

Descriptive Analytic
•Case report
•Case series
•Survey Observational Experimental
•Cross sectional •Randomized
•Case-control controlled trials
•Cohort studies

Strength of evidence for causality between a risk factor and outcome

 Experimental Study

• A study in which the investigator influences the

exposure status of individual subjects (independent
variable) and then monitors the subjects outcome
(dependent variable).
 Levels of Evidence
• Level 1: Randomized Clinical Trials
• Level 2: Head to Head Trial or
Systematic Review of Cohort Studies
• Level 3: Case-Control Studies
• Level 4: Case-series
• Level 5: Expert Opinion
 Levels of Evidence
• Level 1: Highest:
• Level 2:
• Level 3:
• Level 4:
• Level 5: Lowest—but still evidence
 Cross sectional studies
• Measurements are made on a population at one
point in time
– For example, a survey done in a village to identify the
number of individuals with hypertension.
– Here the villagers are screened with blood pressure
measurement at one point in time.
– The frequency of hypertension is then examined in
relation to age sex, socioeconomic status, and other risk
factors for hypertension.
–
 Cross sectional studies
• Cross sectional studies measure the prevalence of
disease and are also called prevalence studies.
• Since there is no longitudinal component, cross
sectional surveys cannot possibly measure
incidence of any disease.
• Cross sectional studies are easy to do and tend to
be economical since repeated data collection is
not done.
 Cross-sectional studies
Disease Status
Yes No Total

Exposure Yes a b a +b
Status
No c d c +d

a +c b +d N
Cross-Sectional Study: Definition
• Conducted at a single point in time or over a
short period of time. No Follow-up.
• Exposure status and disease status are
measured at one point in time or over a
period.
• Prevalence studies. Comparison of
prevalence among exposed and non-exp.
 Cross-Sectional Studies

 “Snapshot” (point in time) picture of

population.

 Designed to provide a general idea of the

prevalence of disease or risk factor
(descriptive), or the relationship
between prevalent disease and risk
factor status (analytical).
 Cross-Sectional Studies

 Exposure and disease outcome are usually

measured simultaneously.

 Need to be as thorough as possible in ascertaining

primary and secondary exposure variables and
disease outcomes.

 Self-report vs. clinical measured variables.

 Measures of clinical and/or subclinical disease.

 Cross-Sectional: Uses
• Very useful for public health planning
(number of beds in a hospital).
• Disease etiology. Conduct this by obtaining
data on risk factors for a disease.
• Hypothesis generating
 Cross-sectional:
Diseases/Outcomes
• Diseases of slow on-set and long duration.
• Care not sought for until later advanced
stage (e.g. chronic bronchitis or
osteoarthritis, mental illness).
• Diseases of short duration.
• Many outcomes can be assessed using
cross-sectional studies.
 Cross-Sectional Study

Study Population

Gather Data on Exposure and Disease

Exposed: Exposed: Not Exposed:

Not
Has Does Not Does Not Have
Exposed:
Disease Have Disease Disease
Has Disease
 Cross-Sectional Studies

Exposure
Status Disease Status Total
Yes No

Yes a b (a + b)

No c d (c + d)

(a + c) (b + d) n
 Cross-Sectional Studies

Statistical Analyses

• Prevalence of disease = (a + c) / n

• Prevalence of risk factor = (a + b) / n

• Assessment of risk
– Prevalence of disease among exposed vs. unexposed
a / (a + b) vs. c / (c + d)
– Prevalence of exposure among diseased vs. non-
diseased
a / (a + c) vs. b / (b + d)
 Cross-Sectional Studies

Statistical analyses

 Types of data: Continuous, Dichotomous, Ordinal, …

 Descriptive statistics (means  standard deviation,

percentages, median, …)

 Differences between groups according to disease risk

factor status.

 T-test/Analysis of Variance, Chi-square, regression

analysis…
Advantages of Cross-Sectional Studies

• Generally fast
– Don’t have to wait for disease to occur

• Generally inexpensive
– No intervention
– No follow-up visits

• Allows you to estimate the population prevalence of

a disease or risk factor.
Advantages
•A cross sectional study is short term,
easy and economical to conduct

•A cross sectional study starts with a

reference population and is generalisable

•Causal inference can be made from cross

sectional data, provided it is known that the
exposure preceded the effect or disease
 Cross-sectional: Advantages
• Usually use population-based samples,
instead of convenient samples.
Generalizability.
• Conducted over short period of time
• Relatively inexpensive
Disadvantages of Cross-Sectional Studies

• Difficulty in establishing causal association.

– Temporal sequencing – “Did disease precede or

proceed risk factor exposure?”

• Difficulty for studying rare diseases – would need too

many people to get an adequate number of people
with the disease.

• For generalization, selected sample must adequately

reflect the population at large.
Disadvantages
•It is not possible to determine in some
cases whether the exposure preceded the
condition or disease
•Not suitable for investigation of rare diseases
or those with long latent periods

•Generally requires large number of subjects

•The problem of selective survival may

be an issue
Disadvantages of Cross-Sectional Studies

• Can measure prevalence of disease, but can only

measure incidence if you specify a time period of
diagnosis (i.e., if a respondent has disease, how
long have they had the disease)

• “Healthy participant” effect – only healthy,

accessible population may participate in study
(i.e., have to have a telephone to participate in a
telephone survey)
PURPOSE: Women with chronic medical conditions are at
increased risk for adverse pregnancy outcomes, yet
contraceptive use by these women has not been well
described. The purpose of this study was to describe
contraceptive use by diabetic and overweight/obese
women compared with women without these
conditions.
METHODS: Using cross-sectional data from the 11 states
participating in the optional Family Planning Module of the
Behavioral Risk Factor Surveillance System in 2000, we
analyzed contraceptive use among 7,943 sexually active women
of reproductive age (18-44) who were not trying to conceive.
Using logistic regression techniques, we modeled the effect of
diabetes and overweight/obesity on contraceptive nonuse,
controlling for age, race/ethnicity, marital status, education,
income, and health insurance coverage.
 MAIN FINDINGS: Contraceptive nonuse was reported by
1,500 (18.9%) of the total sample, 31 (25.8%) diabetic
women, 371 (20.0%) overweight women, and 385
(23.4%) obese women. In the multivariable model,
obesity was significantly associated with contraceptive
nonuse (adjusted odds ratio [OR] 1.34, 95% confidence
interval [CI] 1.16-1.55), but there were no significant
differences in contraceptive nonuse for diabetic women
(adjusted OR 1.23, 95% CI 0.80-1.87) or overweight
women (adjusted OR 1.14, 95% CI 0.99-1.31). Older,
Black, Hispanic, married, less educated, and women
without health insurance were more likely to report
contraceptive nonuse.
CONCLUSION: Among women with need for
contraception, obese women were more likely to
report contraceptive nonuse than normal weight
women. Because women with chronic conditions like
obesity are at higher risk of pregnancy-related
complications and adverse pregnancy outcomes, proper
contraceptive use and unintended pregnancy avoidance is
a priority.
.
.
.
.
.
.
 Cross-sectional: Disadvantages
• Difficult to separate cause from effect,
because measurement of exposure and
disease is conducted at the same time.
• A persons exposure status at the time of the
study may have little to do with their
exposure status at the time the disease
began.
• Neyman Bias. Longer-lasting cases.
Large Cross-Sectional Studies
 Which Design is Best?
• 1st Case-control study
• 2nd Cohort study
• 3rd Cross-sectional study
• 4th Trial
 Which is Fastest?
• 1st Cross-sectional study
• 2nd Case-control study
• 3rd Cohort study
• 4th Trial
 Which is Most Expensive?
• 1st Cross-sectional study
• 2nd Case-control study
• 3rd Cohort study
• 4th Trial
 Most Accurate Exposure
Measurement?
• 1st Trial
• 2nd Cohort study
• 3rd Case-control study
• 4th Cross-sectional study