Epidemiology overview

Dr Lesline A Davis DDS MSc DPH

 How tall is the human race?

What is meant by being short?
Walking down the street one will see people of
various heights and a degree of variation exists
Some are shorter than others but when is
someone abnormally short?
How is it possible to make this judgement?

 By recording the height of everyone

Distribution of heights - minimum, maximum,
mean
The science used to collect and examine data in
this way is known as epidemiology

epidemiology
The orderly study of diseases and conditions
where the group and not the individual is the
unit of interest
Concerned with the frequencies of illnesses
and injuries in groups of people as well as
the factors that influence their distribution

 By investigating differences between subgroups of the

population and their exposure to certain factors it is
possible to identify causal factors and consequently to
develop programmes to alleviate the problems
Knowledge is gained by studying patterns in groups and
not concentrating on an individual

Epidemiology in dentistry
1. Measurement of dental disease in order to understand
factors that influence the distribution
2. Evaluation of effectiveness of new materials and
treatment in clinical trials and assessment of needs
and requirements for dental services within the
community

 Why is it important to know if different

sections of the community have different
disease patterns?

 A series of standards and procedures

Measures must be made to an agreed common
standard, in a methodological manner, and, when
necessary using an appropriate random sample
Using height, a basketball team or a kindergarten class
as a sample would give misleading data as to the
inferred heights of the population in general

Epidemiology vs screening
Epidemiology is the scientific method of
studying diseases in populations
Different from both clinical examination and
from screening

Epidemiological study the protocol

To describe the thinking behind the proposed study and the exact
methodology
To ensure the study is well thought through and adequately planned
To allow the study to be evaluated for scientific and ethical factors prior to
starting
To ensure that the investigators complete the study as planned
To allow others to complete the study for the original investigator, if
necessary
To enable others to repeat the study

background
What previous work has been done in the general
area?
What was learned?
What mistakes were made?
What was done well? What was done badly?
Should then be possible to formulate questions that
can become aims and objectives

aims
Questions that are being answered
Extremely important
Should be clear
Should not attempt to answer too much

objectives
Steps necessary to answer the questions of
the aim(s).

hypothesis
In descriptive studies, aims and objectives are
often sufficient
In analytical studies, it is usually necessary to also
formulate a hypothesis
Eg A clinical trial that has the aim of comparing
the caries-preventive effectiveness of two
toothpastes

 Objectives would be to measure and

compare the caries increment in two groups
of children aged, eg, 12 years, over a given
time period, eg 36 months
Hypothesis
Null hypothesis

hypothesis
There is a difference in caries preventive
effectiveness between the two toothpastes

Null hypothesis
There is no difference in caries-preventive effectiveness
between the two toothpastes
The null hypothesis is used because it is impossible to
prove something, one can only disprove an accepted
hypothesis
Statistical tests are used to identify the chance of the
observed results occurring

Study design and sampling

Choose an appropriate study type

Decide which population would be appropriate for the study
Consider whether and how a sample should be drawn
May be appropriate to include the whole population but usually a
subgroup is selected
The key principle of sampling is that it must be representative of
the population from which it is drawn

 Achieved by randomly sampling all the people in the

eligible group in such a way that every individual has an
equal chance of being selected
Analyses on a random sample can then be used to
describe the population with appropriate statistical
limitations being placed upon the interpretation

stratification
To get a random sample of 5 year old children from
schools
A simple way is to sample in stages
First sample the schools
And then the children within the schools
It may be necessary to weight schools to ensure that all
children have an equal chance of being selected

Quota sample
Identifying people who meet predetermined criteria and
asking them to participate
Used in market research and also in some qualitative research
Problem there may be some characteristics in common
between the people who are prepared to take part in the
research that influence the results
Important to acknowledge that this may be so when the data
is being analysed

Sample size
Critical!
A statistician should be consulted to ensure that sufficient
subjects are included for any proposed study where
comparisons are to be made
If too few people are selected, its possible that a real
difference which exists may not be identified
On the other hand, costs may increase for no real benefit if
too many subjects are used

Data collection
The aims, choice of study design and the population (sample)
will provide information on both the type of data and the
frequency with which they need to be collected
With previous eg, where two toothpastes are to be compared
in a clinical trial
Data has to be gathered on at least two occasions (baseline
and end of study) on two groups (one for each toothpaste)

Type of data
Have to decide what is to be measured
In previous eg, a clinical examination will be
required to evaluate caries status
Extra information gained with bitewings
Acceptability of the toothpaste to clients can be
measured by a questionnaire or interview

 Principle aim of data collection is to

ensure that valid, reliable and unbiased
data are collected

valid

Means that the data measures

something that truly exists accurately

reliable

Means that if measurements are

taken on a different occasion the
same answer is obtained

unbiased

Neither the subject nor the examiner

influences the finding

bias
PRE-TRIAL BIAS

Study design bias

Selection bias
Channeling bias
Gender bias
Qualitative study bias
Quantitative study bias

Bias during trial

Interviewer or observer bias

Recall bias
Chronology bias
Transfer bias
Performance bias
Misclassification of exposure or outcome bias

Bias after trial

Citation/publication bias
Confounding

http://www.medicalbiostatistics.com/Types%20of%20bias.pdf
Concept bias
Definition bias
Bias due to concomitant medication or concurrent disease
Instruction bias
Length bias
Bias in detection of cases
Lead-time bias
Contamination in controls
Berksons bias
Bias in ascertainment or assessment
Instrument bias

Hawthorne effect
Response bias
Repeat testing bias
Mid-course bias
Self-improvement effect
Digit preference
Bias due to nonresponse
Attrition bias
Bias in handling outliers
Recording bias
Bias in analysis
Bias due to lack of power

 Interpretation bias
Reporting bias
Bias in presentation of results

Minimising bias
Develop an unbiased scientific temperament by realising that you are
in the occupation of relentless search for truth.
Specify the problem to the minutest detail.
Assess the validity of the identified target population, and the groups
to be included in the study in the context of objectives and the
methodology.
Assess the validity of antecedents and outcomes for providing correct
answer to your questions. Beware of uncertainties arising from
limitation of knowledge.

 Evaluate the reliability and validity of the measurements required to

assess the antecedents and outcomes, as also of the other tools you
plan to deploy.
Carry out a pilot study and pretest the tools. Make changes as needed.
Identify all possible confounding factors and other sources of bias, and
develop an appropriate design that can take care of most of these
biases if not all.
Choose a representative sample, preferably by random method.

 Choose an adequate size of sample in each group.

Train yourself and coworkers in making correct assessments.
Use matching, blinding, masking, and random allocation as
needed.
Monitor each stage of research, including periodic check of
the data.
Minimise nonresponse and partial response.
Double check the data and cleanse it of errors in recording,
entries, etc.

 Analyse the data with proper statistical methods. Use standardised or

adjusted rates where needed, do the stratified analysis, or use
mathematical models such as regression to take care of biases that
could not be ruled out by design.
Interpret the results in an objective manner based on evidence.
Report only the evidence based the results enthusiastically but
dispassionately.
Exercise extreme care in drafting the report and keep comments or
opinions separate from the results.

blinding
Subject isnt aware whether they are test or
control group

Double blinding
Neither the subject or the assessor is aware of
who is in the test or the control group

 Comparing two toothpastes trial vs

Comparing amalgam and composite
restorations

Training and calibration

Calibration checking against known standards
Standardisation ensuring uniformity
Need to keep inter-examiner variability and intra-examiner variability to a
minimum
Monitored by re-examining a percentage of subjects or administering
questionnaires on a second occasion to measure reproducibility
Pilot study
Standard system for recording data needs to be agreed and training given as
errors are possible

Data analysis
Plan the data analysis before the start of the study
Utilise a statistician
The investigator needs to explain the types of data being
collected and the reasons for doing so
Statistician can advise on the correct analyses and any
limitations
Data from a pilot study can be analysed for problems

conclusions

Not described in detail in the protocol as they are unknown

Conclusions should relate back to aims and objectives
Previous eg
Impossible to conclude that as there was no difference
between the toothpastes, so a sealant programme should be
implemented.
The study never evaluated sealants

dissemination
Final stage
Even if only negative results were found it is
important that these are communicated to the
scientific community

Ethical approval
Required for any study involving the collection of data on
human subjects
Ensures that the study is scientifically sound and ethical
Ethics committees are composed of medical researchers and
lay people
Lay representation is very important in ensuring the projects
acceptability to potential subjects

Factors examined by ethics committee

Satisfactory scientific design
That the information given to the subject is adequate and
comprehensible
That the proposed subjects are competent to give consent
That the consent is voluntary
That the risks and benefits of participating in the study are fully
explained
That issues of confidentiality and data protection are adequately
handled

references
Essential Dental Public Health (Daly et al) (2003)