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Types of study designs:
from descriptive studies to
randomized controlled trials
Kirsten Bibbins-Domingo, PhD, MD Assistant Professor of Medicine and of
Epidemiology and Biostatistics University of California, San Francisco
Objectives To understand the difference between descriptive and analytic
studies To identify the hierarchy of study designs, and the strengths and
weakness of each design To be able to apply different study designs to the same
research question Types of Studies Descriptive Studies Observational Analytic
Studies Cross Sectional studies
Case Control studies
Cohort studies
Experimental Studies Randomized controlled trials Hierarchy of Study Types
Descriptive •Case report
•Case series
•Survey
Analytic Observational •Cross sectional
•Case-control
•Cohort studies
Experimental •Randomized controlled trials Strength of evidence for causality
between a risk factor and outcome Descriptive studies Getting a “lay of the
land” Surveys (NHIS, MCBS) “How many men in the U.S. filled Viagra
prescriptions in 2004?” Describing a novel phenomena Case reports or case
series Viagra-associated serous macular detachment. Sildenafil-associated
nonarteritic anterior ischemic optic neuropathy.
Descriptive studies Cannot establish causal relationships Still play an
important role in describing trends and generating hypotheses about novel
associations The start of HIV/AIDS research Squamous cell carcinoma in sexual
partner of Kaposi sarcoma patient. Lancet. 1982 Jan 30;1(8266):286. New
outbreak of oral tumors, malignancies and infectious
diseases strikes young male homosexuals. CDA J. 1982
Mar;10(3):39-42.
AIDS in the "gay" areas of San Francisco. Lancet. 1983 Apr 23;1(8330):923-4.
Analytic Studies Attempt to establish a causal link between a predictor/risk
factor and an outcome. You are doing an analytic study if you have any of the
following words in your research question: greater than, less than, causes,
leads to,
compared with, more likely than, associated
with, related to, similar to, correlated with
Hierarchy of Study Types Descriptive •Case report
•Case series
•Survey
Analytic Observational •Cross sectional
•Case-control
•Cohort studies
Experimental •Randomized controlled trials Strength of evidence for causality
between a risk factor and outcome
Research Question Is the regular consumption of Red Bull
associated with improved academic
performance among U.S. 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 25,000 dollars to start investigating this question. What
is feasible?
Study Design #1 Cross-sectional study of UCSF medical students taking USMLE
Step 2 Questionnaire administered when registering for USMLE 2 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 USMLE Step 2
Cross-sectional study: structure time USMLE Score Red Bull consumption
Cross-sectional Study: Descriptive value: How many UCSF medical students
drink Red Bull? What is the age and sex distribution of UCSF medical students
who drink Red Bull? Analytic value: Is there an association between regular
Red Bull consumption and test scores among UCSF 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 No Yes Disease D C B A Risk Factor No Yes Risk ratio
(relative risk) A A+B C C+D
 Cross-sectional study: minuses time - Cannot determine causality USMLE Score
Red Bull consumption
Cross-sectional study: minuses time - Cannot determine causality •ACE inhibitor
use and hospitalization rates among those with heart failure •Heart failure
patients with a documented DNR status and mortality
Cross-sectional study: minuses - Cannot determine causality - Cannot study rare
outcomes
What if you are interested in the rare outcome? The association between
regular Red Bull consumption and… A perfect score on the USMLE – Step 2
Graduating top 1% of the medical school class Acceptance into a highly
selective residency ANSWER: A Case-Control study
Study Design #2 A case-control study Cases: 4th year med students accepted to
residency in “highly selective specialty X”. Controls: 4th year med students
who applied but were not accepted. Predictor: self-reported regular Red Bull
consumption Additional covariates (age, sex, medical school, undergraduate
institution)
Case control studies Investigator works “backward” (from outcome to predictor)
Sample chosen on the basis of outcome (cases), plus comparison group (controls)
Case-control study structure time TARGET CASES Medical students accepted to
highly selective residencies ACTUAL CASES 4th year UCSF students
who matched in “highly
selective specialty X”
TARGET CONTROLS
All unsuccessful applicants to highly
selective residency programs
ACTUAL CONTROLS
4th year students who failed
to match in “highly selective
specialty X”
Red Bull consumption YES Red Bull consumption NO present
Case control studies Determines the strength of the association between each
predictor variable and the
presence or absence of disease
Cannot yield estimates of incidence or prevalence of disease in the population
(why?) Odds Ratio is statistics
Case-control Study: pluses + Rare outcome/Long latent period + Inexpensive and
efficient: may be only feasible option
+ Establishes association (Odds ratio)
+ Useful for generating hypotheses
(multiple risk factors can be explored)
Case-control study-minuses - Causality still difficult to establish - Selection
bias (appropriate controls) - Caffeine and Pancreatic cancer in the GI clinic -
Recall bias: sampling (retrospective) - Abortion and risk of breast cancer in
Sweden - Cannot tell about incidence or prevalence - Studies of diagnostic
tests: - Sensitivity, specificity - Positive predictive value, negative
predictive value
Measures of association No Yes Disease D C B A Test No Yes Sensitivity = A/A+C
Specificity = D/B+D PPV = A/A+B NPV = D/C+D
Hierarchy of Study Types Descriptive •Case report
•Case series
•Survey
Analytic Observational •Cross sectional
•Case-control
•Cohort studies
Experimental •Randomized controlled trials Strength of evidence for causality
between a risk factor and outcome
What distinguishes observational studies from experiments? Ability to control
for confounding Predictor Outcome Confounder Examples: sex (men are more likely
to drink red bull and men are more likely to match in neurosurgery)
Undergraduate institution (students from northwest school are more likely to
drink red bull and also more likely to score higher on USMLE)
But we measured all of the potential confounders……. In a prospective cohort
study you can (maybe) measure all potential known confounders, but… You can’t
control for unanticipated or unmeasured confounders
Study design # 4 Randomized controlled trial of daily Red Bull consumption
among entering UCSF medical students Class 2009 Randomized to daily consumption
of Red Bull vs. daily consumption of placebo Outcomes: USMLE Step 1 score,
USMLE Step 2 score, match in first choice residency
Randomized controlled trials Investigator controls the predictor variable
(intervention or treatment) Major advantage over observational studies is
ability to demonstrate causality Randomization controls unmeasured confounding
Only for mature research questions
Basic Trial Design Population Sample Treatment Dx No Dx Control Dx No Dx
Placebo Randomization
Types of Study Designs
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trialsstudy designdescriptive studies(fewer)
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