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Observational study
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In fields such as epidemiology, social sciences, psychology and statistics, an observational study
draws inferences from a sample to a population where the independent variable is not under the
control of the researcher because of ethical concerns or logistical constraints. One common
observational study is about the possible effect of a treatment on subjects, where the assignment of
subjects into a treated group versus a control group is outside the control of the investigator.[1][2]
This is in contrast with experiments, such as randomized controlled trials, where each subject is
randomly assigned to a treated group or a control group.

Contents
1 Motivation
2 Types of observational studies
3 Degree of usefulness and reliability
4 Bias and compensating methods
5 See also
6 References
7 Further reading

Motivation
The independent variable may be beyond the control of the investigator for a variety of reasons:

A randomized experiment would violate ethical standards. Suppose one wanted to investigate
the abortion breast cancer hypothesis, which postulates a causal link between induced
abortion and the incidence of breast cancer. In a hypothetical controlled experiment, one
would start with a large subject pool of pregnant women and divide them randomly into a
treatment group (receiving induced abortions) and a control group (not receiving abortions),
and then conduct regular cancer screenings for women from both groups. Needless to say,
such an experiment would run counter to common ethical principles. (It would also suffer
from various confounds and sources of bias, e.g. it would be impossible to conduct it as a
blind experiment.) The published studies investigating the abortionbreast cancer hypothesis
generally start with a group of women who already have received abortions. Membership in
this "treated" group is not controlled by the investigator: the group is formed after the
"treatment" has been assigned.
The investigator may simply lack the requisite influence. Suppose a scientist wants to study
the public health effects of a community-wide ban on smoking in public indoor areas. In a

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controlled experiment, the investigator would randomly pick a set of communities to be in the
treatment group. However, it is typically up to each community and/or its legislature to enact
a smoking ban. The investigator can be expected to lack the political power to cause precisely
those communities in the randomly selected treatment group to pass a smoking ban. In an
observational study, the investigator would typically start with a treatment group consisting of
those communities where a smoking ban is already in effect.
A randomized experiment may be impractical. Suppose a researcher wants to study the
suspected link between a certain medication and a very rare group of symptoms arising as a
side effect. Setting aside any ethical considerations, a randomized experiment would be
impractical because of the rarity of the effect. There may not be a subject pool large enough
for the symptoms to be observed in at least one treated subject. An observational study would
typically start with a group of symptomatic subjects and work backwards to find those who
were given the medication and later developed the symptoms. Thus a subset of the treated
group was determined based on the presence of symptoms, instead of by random assignment.

Types of observational studies

Case-control study: study originally developed in epidemiology, in which two existing groups
differing in outcome are identified and compared on the basis of some supposed causal
attribute.
Cross-sectional study: involves data collection from a population, or a representative subset,
at one specific point in time.
Longitudinal study: correlational research study that involves repeated observations of the
same variables over long periods of time.
Cohort study or Panel study: a particular form of longitudinal study where a group of patients
is closely monitored over a span of time.
Ecological study: an observational study in which at least one variable is measured at the
group level.

Degree of usefulness and reliability

Although observational studies cannot be used as reliable sources to make statements of fact about
the "safety, efficacy, or effectiveness" of a practice,[3] they can still be of use for some other things:

"[T]hey can: 1) provide information on real world use and practice; 2) detect signals about
the benefits and risks of...[the] use [of practices] in the general population; 3) help formulate
hypotheses to be tested in subsequent experiments; 4) provide part of the community-level
data needed to design more informative pragmatic clinical trials; and 5) inform clinical
practice."[3]

Bias and compensating methods

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In all of those cases, if a randomized experiment cannot be carried out, the alternative line of
investigation suffers from the problem that the decision of which subjects receive the treatment is
not entirely random and thus is a potential source of bias. A major challenge in conducting
observational studies is to draw inferences that are acceptably free from influences by overt biases,
as well as to assess the influence of potential hidden biases.

An observer of an uncontrolled experiment (or process) records potential factors and the data
output: the goal is to determine the effects of the factors. Sometimes the recorded factors may not
be directly causing the differences in the output. There may be more important factors which were
not recorded but are, in fact, causal. Also, recorded or unrecorded factors may be correlated which
may yield incorrect conclusions. Finally, as the number of recorded factors increases, the likelihood
increases that at least one of the recorded factors will be highly correlated with the data output
simply by chance.

In lieu of experimental control, multivariate statistical techniques allow the approximation of

experimental control with statistical control, which accounts for the influences of observed factors
that might influence a cause-and-effect relationship. In healthcare and the social sciences,
investigators may use matching to compare units that nonrandomly received the treatment and
control. One common approach is to use propensity score matching in order to reduce
confounding.[4]

A report from the Cochrane Collaboration in 2014 came to the conclusion that observational studies
are very similar in results reported by similarly conducted randomized controlled trials. In other
words, it reported little evidence for significant effect estimate differences between observational
studies and randomized controlled trials, regardless of specific observational study design,
heterogeneity, or inclusion of studies of pharmacological interventions. It therefore recommended
that factors other than study design per se need to be considered when exploring reasons for a lack
of agreement between results of randomized controlled trials and observational studies.[5]

In 2007, several prominent medical researchers issued the Strengthening the reporting of
observational studies in epidemiology (STROBE) statement, in which they called for observational
studies to conform to 22 criteria that would make their conclusions easier to understand and
generalise.[6]

See also
Correlation does not imply causation
Natural experiment
Regression discontinuity
Difference-in-differences
Instrumental variable
Scientific method
Quantitative research

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References
1. "Observational study". Retrieved 2008-06-25.
2. Porta, M., ed. (2008). A Dictionary of Epidemiology (5th ed.). New York: Oxford University Press.
ISBN 9780195314496.
3. "Although observational studies cannot provide definitive evidence of safety, efficacy, or effectiveness,
they can: 1) provide information on "real world" use and practice; 2) detect signals about the benefits
and risks of complementary therapies use in the general population; 3) help formulate hypotheses to be
tested in subsequent experiments; 4) provide part of the community-level data needed to design more
informative pragmatic clinical trials; and 5) inform clinical practice." "Observational Studies and
Secondary Data Analyses To Assess Outcomes in Complementary and Integrative Health Care."
(http://nccih.nih.gov/research/blog/observational-secondary) Richard Nahin, Ph.D., M.P.H., Senior
Advisor for Scientific Coordination and Outreach, National Center for Complementary and Integrative
Health, June 25, 2012
4. Rosenbaum, Paul R. 2009. Design of Observational Studies. New York: Springer.
5. Anglemyer, Andrew; Horvath, Hacsi T; Bero, Lisa; Bero, Lisa (2014). "Healthcare outcomes assessed
with observational study designs compared with those assessed in randomized trials". Cochrane
Database Syst Rev. 4: MR000034. doi:10.1002/14651858.MR000034.pub2. PMID 24782322.
6. von Elm E, Altman DG, Egger M, Pocock SJ, Gtzsche PC, Vandenbroucke JP (2007). "The
Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement:
Guidelines for Reporting Observational Studies". PLoS Med. 4 (10): e296.
doi:10.1371/journal.pmed.0040296. PMC 2020495 . PMID 17941714.

Further reading
Rosenbaum, Paul R. (2002). Observational Studies (2nd ed.). New York: Springer-Verlag.
ISBN 0387989676.
"NIST/SEMATECH Handbook on Engineering Statistics" (http://www.itl.nist.gov/div898
/handbook/) at NIST

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