ACADEMIC EMERGENCY MEDICINE • January 1999, Volume 6, Number 1
Research Fundamentals: IV. Choosing a
Research Design
KENT N. HALL, MD, RASHMI U. KOTHARI, MD
Abstract. Once a research question or hypothesis
has been derived, the investigator must determine
which research methodology can best answer his or
her question. Prospective, randomized, controlled tri-
als are often considered the sine qua non of research
design. However, this study design is not always fea-
sible, and often an alternate design will adequately
answer the question at significantly less cost. All re-
search designs have potential advantages and limi-
tations. The decision of which study design to use is
often a compromise between science and resources.
BASIC RESEARCH PARADIGMS (TABLE 1)
Most medical research is performed 1) to establish
the frequency of a disease or characteristic, 2) to
compare two groups, or 3) to establish causation
between a therapy or agent and an endpoint or
outcome. The research design chosen to fulfill
these goals must be able to answer the question
posed by the researcher. Study designs can be cat-
egorized as observational or interventional. Obser-
vational studies, in which the investigator ob-
serves events without attempting to influence
them, are done to answer the first two types of
questions. Following a population over a period of
time, and then analyzing the differences between
those who do and do not get a specific disease, is
an example of an observational study. Observa-
tional studies can identify an association between
two variables. However, they cannot establish a
causal link. For example, the result of an obser-
vational study may be that hypertension and
stroke are associated with each other, but the
statement cannot be accurately made that hyper-
tension causes stroke, based on the result of an
observational study alone.
From the Department of Emergency Medicine, University of
Cincinnati, Cincinnati, OH (KNH, RUK).
Series editor: Roger J. Lewis, MD, PhD, Department of Emer-
gency Medicine, Harbor – UCLA Medical Center, Torrance, CA.
Accepted September 11, 1998.
Address for correspondence and reprints: Rashmi U. Kothari,
MD, University of Cincinnati Medical Center, Department of
Emergency Medicine, 231 Bethesda Avenue, Cincinnati, OH
45267-0769. Fax: 513-558-5791; e-mail: rashmi.kothari@uc.edu
67
This article was prepared by members of the SAEM
Research Committee to describe the fundamental re-
search concepts of research design. This paper defines
different research methodologies and discusses their
different uses, strengths, and weaknesses. It also de-
scribes the process of randomization and blinding. Fi-
nally, the concept of bias and its remedies is deline-
ated. Key words: clinical trial methods; prospective;
retrospective; cohorts; case – control; interventional
study designs; bias; research. ACADEMIC EMER-
GENCY MEDICINE 1999; 6:67 – 74
Interventional studies, also known as clinical or
experimental trials, are used to address the ques-
tion of causation. In this study type the investi-
gator intervenes in the events being studied by
manipulating a specific variable, and observing the
effect of this manipulation on a specified outcome.
For example, a clinical trial might be designed to
investigate the effects of a new drug on outcome
after ischemic stroke. In such a trial, the investi-
gators would intervene in the management of the
patients by the delivery of the drug or an appro-
priate placebo in order to establish whether the
use of the drug would result in an improved neu-
rologic outcome.
Observational studies can be subdivided into
retrospective and prospective studies. The primary
difference between these subdivisions is the timing
of the measurement of the outcome variable (Table
1). In retrospective studies, the event of interest
has already occurred. The investigator divides the
study population into subjects and controls based
on whether they do or do not have the outcome
variable. Comparisons are then made between
these two groups. For example, if an investigator
wanted to retrospectively determine whether there
is an association between smoking and myocardial
infarction (MI), he or she would look at groups of
patients with and without MI. The prevalence of
smoking in both of these samples would then be
determined.
In a prospective study, the outcome variable has
not yet occurred; the investigator will measure it
in the future. The investigator follows the popu-
lation over time, looking for the presence of the
outcome variable. He or she then compares those

TABLE 1. Characteristics of Observational and Interventional Research Designs
Name Types Characteristics
Observational
Case – control Prospective Select sample from popula-
tion at risk with disease.
Select sample from popula-
tion at risk without disease.
Measure predictor variables
to see if they occur.
Retrospective Select sample from popula-
tion at risk with disease.
Select sample from popula-
tion at risk without disease.
Measure predictor variables
that have already occurred.
Cohort Prospective Select sample from popula-
tion.
Predictor variables measured.
Sample followed.
Outcome variable(s) mea-
sured.
Comparison between cohorts
with and without out-
come(s) compared.
Retrospective Identify cohort previously as-
sembled.
Measure variables that oc-
curred in past.
Follow-up cohort.
Measure outcome variables
(now or past).
Comparison between cohorts
with and without out-
come(s) measured.
Uses
Study rare conditions.
Gives odds ratio.
Study rare conditions.
Gives odds ratio.
Study several outcomes.
Gives incidence, relative risk,
excess risk.
Study several outcomes.
Gives incidence, relative risk,
excess risk.
Strengths
Short duration.
Relatively inexpensive.
Relatively small.
Short duration.
Relatively inexpensive.
Relatively small.
Avoids measuring predictors
and survival bias.
Number of outcome events in-
creases over time.
More control over subject se-
lection and measurements.
Avoids measuring predictors
and survival bias.
Number of outcome events in-
creases over time.
Less expensive.
Shorter.
68
Weaknesses
RESEARCH DESIGNS
Bias from sampling two popu-
lations.
No sequence of events estab-
lished.
Biases: predictor measure-
ments; survivor bias.
Only one outcome variable.
No information on preva-
lence, incidence, or excess
risk.
Bias from sampling two popu-
lations.
No sequence of events estab-
lished.
Biases: predictor measure-
ments; survivor bias.
Only one outcome variable.
No information on preva-
lence, incidence, or excess
risk.
Often requires large sample
sizes.
Not useful in rare conditions.
Can be expensive.
Lasts longer.
Hall, Kothari • RESEARCH DESIGNS
Often requires large sample
sizes.
Not useful in rare conditions.
Less control over subject se-
lection and measurements.
ACADEMIC EMERGENCY MEDICINE • January 1999, Volume 6, Number 1 69

Some questions unsuitable for

Bias: predictor measurements

cal barriers or outcomes too

Answer very limited question

Not useful in rare conditions.
subjects who develop the outcome variable with

No information on incidence

experimental design (ethi-

Frequency of events not es-

Standardized interventions
Often expensive and time-
those who do not. Applying a prospective design to

different from common

the above example, the investigator might identify
or true relative risk. a study population, and divide it into two groups
based on the smoking status of each individual. He
and survivor.

or she would then follow the entire population over

consuming.
tablished.

time and record the incidence of MI in smokers and

practice.
nonsmokers. Types of observational studies in-

rare).

only.
clude case – control, cohort, and cross-sectional. All
experimental (i.e., interventional) studies are pro-
spective.
Produce strongest evidence of
Control over subject selection

expensive answer than ob-

Sometimes gives faster, less
Establishing the Frequency of a Condition.
Establishing the frequency of a condition is best
and measurements.

done using an observational study design, specifi-

cally a cross-sectional study. For example, we may
Short duration.

servational.

want to assess the frequency of acute myocardial

causation.

infarctions (AMIs) in smokers in our ED popula-

tion. In a cross-sectional study, the study sample
is selected (e.g., the ED population), and the out-
come variable (e.g., AMI) and the predictor varia-
ble (smoking) are measured simultaneously. Be-
cause the data are collected at one point in time,
Gives prevalence, and rela-
Exploratory before cohort

the investigator has no control over extraneous fac-

Study several outcomes.

tors. In contrast to a cohort study (which is dis-

cussed later), there is no follow-up period in a
Suggest causation.
tive prevalence.

cross-sectional study.
Cross-sectional studies are effective in deter-
mining the prevalence of a disease (the proportion
study.

of the population that has a disease at a particular

point in time) and the coexistence of associated
variables. They do not give us information about
disease incidence (the proportion of the population
Measure outcome variable(s).
Measure baseline variables.

that gets an illness over a specified period of time).

Measure predictor and out-
Select sample from popula-

Select sample from popula-

Cross-sectional studies can usually be done quickly

and avoid the problem of losing patients to follow-
Apply interventions.

up (which can introduce bias in the results). Cross-

come variables.

sectional studies are often preludes to prospective

Follow cohorts.

cohort or experimental studies because they are

Randomize.

usually quick and relatively inexpensive. They pro-

tion.

tion.

vide a ‘‘snapshot’’ of baseline demographics and

clinical characteristics, and can sometimes reveal
associations that will allow refinements in the
planning of more detailed studies.
Cohort studies can also be used to establish the
frequency of a disease or event. A cohort is a group
of patients with a specific characteristic (e.g., pa-
tients with asthma). An investigator may want to
answer the question, ‘‘Do patients with asthma
have concurrent upper respiratory infections
(URIs) more often than patients who do not have
asthma?’’ Using a retrospective cohort study design,
Cross-sectional

the investigator might look at all ED records of the

Interventional

cohort of patients with asthma (the outcome vari-

able), and match these records with the cohort of
patients without asthma. The investigator can
then review the records to see how often the pres-
ence of a URI (the predictor variable) was docu-
70 RESEARCH DESIGNS
mented in these two cohorts. The retrospective na-
ture of this study design means the investigator is
dependent on documentation of a URI (and an
asthma exacerbation) to properly classify patients.
If the same question is answered using a pro-
spective cohort study, the same data are obtained.
However, rather than reviewing past cases, the co-
horts are defined (e.g., patients with asthma, pa-
tients without asthma who are otherwise similar),
the parameter of interest (e.g., presence of URI) is
established, and the information is collected pro-
spectively. The prospective format is superior to
the retrospective design because the investigator
is more likely to capture all eligible cases of inter-
est (e.g., the investigator can define exactly what
he or she considers an ‘‘asthmatic’’ and then ensure
that all cases match this definition). In addition,
prospective data collection is more likely to be com-
plete, and the data set is less subject to interpre-
tation. However, a prospective cohort study takes
longer and costs more than a retrospective study
because the investigator must wait for the cases to
present. When studying a rare disease or infre-
quent clinical condition, a prospective cohort de-
sign may be prohibitively expensive and logisti-
cally not feasible.
Cohort studies are particularly effective at de-
scribing the incidence of disease and analyzing as-
sociations between risk factors and outcomes.
Though a cohort study may show a temporal link
between a predictive factor (e.g., URI) and an end-
point (e.g., asthma exacerbation), it cannot ‘‘prove’’
that the observed factor was the cause of the end-
point. This is an error of interpretation commonly
made in the lay press.
Comparing Groups. Sometimes investigators
want to compare different patient groups to deter-
mine better ways of medical management. For ex-
ample, we may wish to determine whether the af-
filiation with a primary care physician has an
effect on an asthmatic patient’s ability to use a me-
tered dose inhaler (MDI). If we find that patients
without a primary care physician are less able to
appropriately use a MDI, we could then institute
an educational program for these patients when
they present to the ED. The best study design to
make this comparison is a prospective cohort
study. Alternative design choices would be a ret-
rospective cohort study or a case – control study.
Using this example, a prospective cohort study
design could be used to compare ED asthma pa-
tients who have a primary care physician with
those who do not. Patients with asthma would be
identified using predefined criteria for inclusion
into the study. These patients would then be di-
vided into two cohorts, those with and without a
primary care physician. The ability to use a MDI
Hall, Kothari • RESEARCH DESIGNS
would be determined prospectively, and analysis
comparing these two cohorts performed. Because
the data points are decided beforehand, and a data
collection instrument is specifically developed to
prospectively collect the necessary information, the
data should be complete. The prospective nature of
the study requires a significant investment of time,
effort, and dollars.
The same study could be done in a retrospective
time frame. In this circumstance, patients would
be identified based on their ED discharge diagnosis
(asthma) and whether they reported having a pri-
mary care physician. Their medical records would
be reviewed to assess their ability to use a MDI.
Because the data are being collected from previ-
ously accrued information, they are subject to bias.
For example, if the patient had a primary care
physician, but did not declare this on ED admis-
sion, he or she would be included in the wrong co-
hort. Similarly, if the documentation of the pa-
tient’s ability to use a MDI is not included in the
medical record (which is often true), then the out-
come for this patient is unknown. The meaning of
these missing data must interpreted by the re-
searcher. Is it because the patient obviously knew
how to use the MDI, or because the provider did
not evaluate the patient’s ability to use it?
This study could also be performed using a
case – control design. However, the case-control de-
sign is best suited for instances when the disease
of interest is unusual. In case– control studies in-
dividuals with (cases) and without (controls) a dis-
ease or outcome are identified. The investigator
then reviews records or interviews the cases and
controls to determine what factor(s) of interest are
present in each of these groups. For example, a
prospective study comparing asthma patients with
patients suffering from nocturnal asthma only,
might take an inordinately long time to accumu-
late a meaningful number of patients with noctur-
nal asthma. With a case – control design, the re-
searcher would define the type of case of interest
(e.g., patients with nocturnal asthma), identify
those cases, and match them to controls (e.g., other
asthmatics) on all important variables (e.g., age,
sex, years with asthma symptoms). Because of the
retrospective nature of this study, the data are
more likely to be inaccurate or incomplete. Fur-
ther, some of the variables would be open to inter-
pretation because no predefined parameters ex-
isted when the data were collected. For example,
if the medical record indicates a patient has noc-
turnal asthma, the question must be asked ‘‘What
criteria were used to make this diagnosis?’’
Establishing Causation. Thus far, the research
methods discussed have centered on establishing
associations between groups. In many circum-
ACADEMIC EMERGENCY MEDICINE • January 1999, Volume 6, Number 1 71

TABLE 2. Glossary of Terms Used in Study Design

Bias A systematic error in study design that results in variation that distorts the study findings
in one direction.

Blinding A method to decrease bias in which the subject or investigator (single blinding) or both (double
blinding) are unaware of the subject’s assignment to interventional or control samples.

Cohort design Individuals are separated into groups (cohorts) based on specific characteristics. Prospective
cohort design involves enrolling subjects and measuring predictor variables before the
outcome variable has occurred. In retrospective cohort design, the investigator measures
predictor variables after the outcome variable has occurred.

Confounding When a third variable is a cause of both the predictor and outcome variables.

Cross-sectional Similar to cohort study design, except that outcome and design predictor variables are mea-
sured at the same time.

Incidence The number of new cases of a disease over a period of time divided by the number of people
at risk over the same time period.

Interventional A special type of cohort study in which the investigator manipulates a predictor variable,
and measures the effect of this manipulation on a specific outcome variable.

Odds ratio An approximation of the relative risk obtained, using a case – control study design. The odds
ratio is calculated as follows:

Disease No Disease

Risk factor present a b

Risk factor absent c d

Odds ratio = a ⭈ d/b ⭈ c.

Outcome variable That endpoint variable identified by the investigator as the measurement of interest used
to assess study results.

Prospective A study design in which predictor variables are selected and measured before the design
outcome of interest occurs.

Prevalence The number of people who have a disease at one point in time divided by the number of
people at risk at that point.

Randomization Technique where all study subjects have equal probabilities of being chosen.

Retrospective A study design in which the sample is defined and data are collected after the outcome has
occurred.

Validity The degree to which a variable actually represents what it is supposed to be representing.
External validity is the degree to which a finding in a study represents the population as
a whole. Internal validity is the degree to which a finding from a single experimental
study represents the study population within that clinical environment.

stances, the investigator is instead interested in
evaluating a cause – effect relationship between
variables.
Only an interventional (experimental) study
that controls important variables that may other-
wise skew the results (confounders) can establish
causation. If ED patients with an asthma exacer-
bation are treated with magnesium and seem to
improve enough so that they do not require hos-
pital admission, it is tempting to speculate that
magnesium has had a significant effect on their
outcome. However, until an interventional study is
performed, where patients are randomly distrib-
uted to magnesium and no-magnesium protocols,
and confounding variables (such as the severity of
the asthma exacerbation) are equally distributed
between the two groups, causation cannot be es-
tablished.
Interventional (experimental) studies can gen-
erally be considered as either therapeutic or pre-
ventive. Therapeutic trials are conducted on pa-
tients with a particular disease to determine the
ability of an agent or procedure to diminish symp-
toms, prevent recurrence, or decrease morbidity or
mortality from that disease. Preventive interven-
tional trials involve the evaluation of whether an
72 RESEARCH DESIGNS
applied agent or procedure reduces the risk of de-
veloping the disease among individuals without
the disease at the time of study enrollment.
Interventional studies are structured similarly
to cohort studies. The investigator identifies pre-
dictive factors and outcomes of interest. In the
above example of the use of magnesium in asthma,
the predictive variable is the use of magnesium or
placebo as part of a standardized therapeutic reg-
imen. The outcomes of interest might be needed for
hospital admission, total time in the ED, and im-
provement in peak expiratory flow rate (PEFR).
Recording of responses is done prospectively;
therefore, more complete data are collected for
each subject. The major strength of interventional
studies is the ability to control many confounding
factors. In many ways, interventional studies re-
semble the controlled experiments done by basic
scientists and provide the strongest evidence for
cause and effect. In most instances, interventional
studies can be done more quickly than prospective
observational studies.
Although interventional (experimental) trials
offer the strongest support of a causal relationship,
they have numerous limitations. They are often ex-
pensive and time-consuming, especially if the dif-
ference between the treatment and control groups
is small or if the disease of interest is rare. In ad-
dition, ethical considerations may preclude the
evaluation of an exposure or new treatment, and
do preclude the withholding of already proven
therapies. If, for example, we wanted to test the
efficacy of magnesium alone in management of the
patient with an acute asthma exacerbation, we
would have to withhold ␤-agonist therapy. Because
the benefit from magnesium therapy alone is un-
known, while the benefit of ␤-agonist therapy is
well known, this would be unethical.
RANDOMIZATION AND BLINDING
Fundamental to the validity (Table 2) of interven-
tional studies is the establishment of comparable
populations (through random sampling or selection
of appropriate controls) and blinding of the observ-
ers. Randomization is the process of assigning pa-
tients to ‘‘intervention’’ and ‘‘control’’ groups in a
manner not influenced by the investigator. Tech-
niques of randomization include simple, stratified,
and systematic. Simple randomization occurs
when patients are randomized into one of the
treatment groups without consideration of their
clinical situations. By definition, all patients must
have equal chances of being selected into each
study group. Random number tables are often used
to assign patients to particular study groups when
simple randomization is used.
Hall, Kothari • RESEARCH DESIGNS
In stratified randomization, patients are ini-
tially placed into strata (groups) based on their
clinical characteristics. Characteristics that define
these strata may include age, gender, ethnicity, or
duration of disease. A random sample is then se-
lected from each stratum. Using this method, all
known potentially important subgroups can be
represented in the study, and precise estimates of
population parameters are derived.
In systematic sampling, every nth patient from
the potential patient list is selected. This method
of sampling allows for random sampling without
knowing the exact extent of the population to be
studied, and therefore is useful under field condi-
tions. Because of the cyclical nature of this sam-
pling technique, it is not recommended when cy-
clical trends in the variables of interest occur. For
example, if an investigator wanted to document
the prevalence of ED visits for alcohol-related ill-
ness and injury, and used a sampling time frame
that systematically did not include the weekend,
the prevalence of the condition of interest would be
underestimated. Systematic sampling is a common
method of sampling in epidemiologic research.
There are other methods of randomization, and
their descriptions are beyond the scope of this ar-
ticle. It is important to consult an epidemiologist,
research design consultant, statistician, or mentor
early in the study design process to choose the
most relevant randomization strategy for your
study.
Blinding refers to the lack of knowledge regard-
ing aspects of the study from the perspective of the
subject, the investigator, or both. Double blinding
occurs when neither the subject nor the investi-
gator is aware of which treatment group the sub-
ject has been randomized to. Sometimes it is not
possible to completely blind both the investigator
and the subject to the study group assignment. In
such cases, single blinding can be used, where ei-
ther the subject or the investigator is unaware of
group assignment. Blinding is one method of de-
creasing the potential for bias in a study.
BIAS IN STUDY DESIGN
Bias is any systematic error in a study that can
result in distortion of the associations under con-
sideration. There are two major categories of bias:
selection and observation. Selection bias occurs
when the study sample is not representative of the
target population of interest. For example, trauma
patients managed at a Level 1 trauma center prob-
ably do not reflect the population of trauma victims
presenting to community hospitals; they may se-
lectively have more severe injuries and thus a
higher mortality. This selection bias can be avoided
ACADEMIC EMERGENCY MEDICINE • January 1999, Volume 6, Number 1
by rigorous selection criteria defining a study sam-
ple that is similar to the population in which the
treatment will actually be used.
Another example of selection bias may occur
when subjects are not randomly allocated to inter-
vention and control groups in an interventional
study. If, in the example of magnesium for asthma
management, patients in the magnesium treat-
ment group had a higher initial PEFR, the fact
that they had a lower admission rate would not be
surprising. In this case, the difference between the
groups in the outcome variable (hospital admis-
sion) might be because the patients had less severe
asthma exacerbations.
Observation or information bias occurs when
there is a systematic error in the way data are ob-
tained from various study groups. Examples of ob-
servation bias include recall or reporting bias, in-
terviewer bias, and loss of enrolled patients to
follow-up. Recall bias occurs when subjects, or
their surrogates (e.g., family members), recall
events differently because of their experiences. For
example, patients with AMI may have vivid mem-
ories of events surrounding their AMIs. They may,
therefore be more likely to remember what they
were doing immediately preceding their AMIs, and
may erroneously identify a particular action as
‘‘causing’’ the infarction.
Interviewer bias, also called observer bias, oc-
curs when the person collecting data is less than
objective because of his or her previous experi-
ences, preconceived ideas, prejudices, or knowl-
edge of other outcomes in the case. For example,
in performing a retrospective study on risk factors
and liver disease, a researcher may review medical
records more thoroughly for evidence of alcohol use
if the patient is known to have liver disease. Sim-
ilarly, an investigator who believes that the pri-
mary care physician is critical in the successful
treatment of asthma may unconsciously look
harder for evidence that the patient who identifies
a primary care physician understands how to use
a MDI.
Bias due to loss of the patient to follow-up oc-
curs in prospective studies when a subject ‘‘disap-
pears’’ from the study for an unknown reason. The
effect of this bias depends on the number of pa-
tients lost and whether there is a disproportionate
loss from either the case or the control group. An
example of this type of bias occurs when patients
who are being followed for deleterious effects after
being triaged out of an ED without being seen can-
not be located to determine their subsequent
health status. Is the fact they could not be located
an indication of a deleterious effect (e.g., did they
die), is it because they are so healthy they do not
seek other medical care, or does it reflect effects of
other variables, such as socioeconomic factors
73
which make it more difficult for the patient to re-
ceive medical care?
Bias is best controlled through rigorous study
design. Once bias has been introduced, it is possi-
ble to control some of its effects in data analysis.
However, selection bias cannot be mitigated by
analysis, and may completely invalidate an other-
wise excellent study. Design features that mini-
mize bias include appropriate choices of study pop-
ulation and sources of data, blinding of subjects
and/or investigators to the nature of the experi-
mental group in which the subject is enrolled, and
specific features of the data collection process.
Selection of subjects and controls, matched as
closely as possible in all characteristics except that
being studied (treatment, presence of disease, etc.),
greatly reduces the potential for selection bias.
This requires the investigator to thoroughly re-
view, and be familiar with, the relevant patient
characteristics that may be associated with differ-
ent outcomes. For example, in evaluating the effi-
cacy of a neuroprotective agent on long-term sur-
vival from head trauma, choosing subjects and
controls with matched initial Glasgow Coma Scale
scores is essential.
Blinding is an excellent way to decrease obser-
vational bias in experimental studies. Knowledge
of a participant’s treatment status might, con-
sciously or unconsciously, influence the identifica-
tion or reporting of relevant events by either the
patient or the investigator. The likelihood of such
bias is directly related to the degree of subjectivity
of the outcome under study. If the end point being
considered is objective (i.e., death), observation
bias is unlikely. If the end point is more subjective
(i.e., decreased pain), it is more likely to be biased
by a clinician’s or patient’s knowledge of the as-
signed study group.
Appropriate construction of data collection in-
struments and selection and training of study per-
sonnel are important methods to decrease bias.
Data collection instruments, whether question-
naires, interviews, or physical examinations,
should be standardized so that, as nearly as pos-
sible, identical data are collected from all subjects,
regardless of whether they are ‘‘cases’’ or ‘‘controls.’’
In questionnaires and interviewing, closed-ended
objective questions are subject to the least bias.
Open-ended, subjective questions are prone to re-
call bias, as well as bias of interpretation by the
investigator. Similarly, specific aspects of the phys-
ical examination that are important should be in-
cluded on the data collection instrument. The pres-
ence or absence of a finding should be specifically
asked, not just presumed. Similarly, if a grading
system is to be used (e.g., for heart murmurs), then
the definition of the different levels must be clearly
delineated for the clinician who performs the ex-
amination.
74 RESEARCH DESIGNS Hall, Kothari • RESEARCH DESIGNS

CONCLUSION Recommended Reading

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• What is the nature of the question?
• What are the logistic constraints (money, time,
manpower)?
• What ethical issues need to be addressed?
When these questions are answered to the satis-
faction of the researcher, then a proper study de-
sign can be chosen, which will enhance the inves-
tigator’s ability to develop and complete a research
project that is sound in design.
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8. Meinert CL. Clinical Trials: Design, Conduct, and Analysis.
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ton: Little, Brown, 1981.

REFLECTIONS
Prepared for Tornado Aftermath

An emergency medicine resident, donned in universal precautions attire, awaits tornado disaster victims
after Vanderbilt University Medical Center is alerted of 100⫹ casualties when a tornado was an unin-
vited guest at a school picnic on April 16, 1998. Photograph by DONNA JONES BAILEY, Nashville,
Tennessee.