STATISTICS AND RESEARCH DESIGN
Bias in observational studies
Nikolaos Pandis, Associate Editor of Statistics and Research Design
Bern, Switzerland, and Corfu, Greece
B
ias is an important issue in observational studies,
and it should be carefully considered when inter-
preting the results of such studies. In this article, I
will highlight the main types of bias encountered in
observational studies.
Bias is a systematic error in the design and methods
of the study, leading to an incorrect interpretation. It is
important that bias is considered during the design and
conduct of the study because it cannot be corrected
afterward. Bias should be distinguished from random
error, which is related to the variability in the sampled
population and can be reduced by increasing the
sample size.1
SELECTION BIAS
Selection bias occurs when the selected study partic-
ipants are systematically different in characteristics from
eligible participants who are not selected for the study.
Additionally, when the exposed and unexposed groups
are different in important outcome predictors. the
results might be biased.
If a study is assessing the frequency of visits to the
dentist among participants in wealthy and poor
neighborhoods via a questionnaire, no response
(self-selection), especially by participants less likely
to visit the dentist, will result in biased estimates
caused by a special form of selection bias called
nonresponse bias. It is possible that the nonre-
sponders are less likely to be reached because they
live in a poor neighborhood, or that they are embar-
rassed to respond since they do not visit the dentist
regularly.
Selection bias also arises from what has been
termed the healthy-worker effect, which indicates
that working participants, who are more likely to be
healthy, are compared with less healthy participants,
introducing bias in the results. This is usually an issue
when the general population is selected as the compar-
ison group.
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INFORMATION BIAS
Information bias refers to systematic errors in
measurement (or misclassification) of the exposure or
outcome (Table).
Spencer et al2 examined the association between
exposure to water fluoridation and the increase of dental
caries in 2 Australian states, South Australia (SA) and
Queensland (Qld). “Children were enrolled between
1991 and 1992 (SA: 5-15 yrs old, n 5 9,980; Qld:
5-12 yrs old, n 5 10,695). Follow-up caries status
data for 3 years (6 1/2 year) were available on 8,183
children in SA and 6,711 children in Qld.” The authors
reported that “Baseline data on lifetime exposure to
fluoridated water, use of other fluorides and socio-
economic status (SES) were collected by questionnaire,
and tooth surface caries status by dental examinations
in school dental service clinics.”
In this study, a potential source of bias can be
related to the use of the questionnaire and the possi-
bility that information on exposure is incomplete and
inaccurate (reporting bias or recall bias). If for some
reason the completeness and accuracy of the re-
sponses are associated with the outcome—ie, more ac-
curate among participants with healthier dentitions or
the opposite—then the results of the study might be
biased because of differential misclassification.
Differential misclassification can overestimate or
underestimate the association of interest. If the inac-
curacies are similar among the exposed and the unex-
posed subjects, then we have what we call
nondifferential misclassification, which tends to
underestimate potential associations by making the
groups more similar.
We can also have information bias from biased
recording of the outcome (observer bias): dental exam-
iners might record dental caries incorrectly, especially if
they are not blind to the exposure.
KEY POINTS
 Selection and information bias (report or recall and
observer) are the main types of bias in observational
studies.
 Differential misclassification is less of a problem than
nondifferential misclassification.
Statistics and research design 543

Table. Problems with information bias

Nondifferential misclassification Differential misclassification
Consequences of information bias Reduces the strength of the association Can reduce or increase the strength of the association
(reporting/recall and observer bias)

REFERENCES 2. Spencer AJ, Armfield JM, Slade GD. Exposure to water fluorida-
tion and caries increment. Community Dent Health 2008;25:
1. Gordis L. Epidemiology. 4th ed. Philadelphia: Saunders Elsevier;
12-22.
2009. p. 247-63.

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