Professional Documents
Culture Documents
methodology
contents
Introduction to research
Definitions
Research
Thesis
Dissertation
Why to do a research
Categories of research
Research methods & research methodology
Procedural steps in research
Research strategy
epidemiologic studies
Introduction
Investigation using scientific procedures, by
searching again and again to find out the
truth
Research (WHO Health research methodology, 1992, a
guide for training in research methods):
Research is a quest for knowledge through diligent search
or investigation or experimentation aimed at the discovery
and interpretation of new knowledge. Scientific method is a
systematic body of procedures and techniques applied in
carrying out investigation or experimentation targeted at
obtaining new knowledge. Here research and scientific
methods may be considered a course of critical enquiry
leading to discovery of facts or information which increases
Thesis
(according to Oxford English dictionary)
A proposition laid down as a theme to be
Empirical research and theoretical research
1.
Basic research and Applied research
Empirical
Observational research
Experimental research
Basic or pure research
Review literature
Modern electronic research
Abstract collection held on CD-ROMS-enables –key words
Medline and psyclit database
Role of systemic review grown recently-cochrane collaboration-
reviews from volunteer researchers internationally adds
them to a bank,which is open for inspection by interesting
parties.
Specifying study design
Selection of measures: many measure ,assessments
Eg:self report rating scales for dental
anxiety,observations,interviews,stand questionnaires
simple rating scale can be given a no.1-strongly agree
2-agree
3-undecided
4-disagree
5-strongly disgree
May not exist for the study ,this may necessiate the
development of new scale.
should possess Reliability and validity
Selection of sample:
Sampling techniques-inorder to provide information ,can be generalised
to cover the whole population.
Writing a protocol: aims &
objectives,method,materials,sample ,procedure
Ethical approval
Pilot work
Main study
Analysis of results
Report writing
publication
Research strategies
Place distribution:
Interanational-
National-endemic disease like goitre,flourosis
Rural-urban-lung cancer,cardiovascular accidents-urban
Person distribution:age sex
Measurement of disease :morbidity and mortality indicators
Expressed in terms of incidence and prevalence
Comparing with known indices:comparision b/n different
population and subgroups of same populn-clue to etiology
Formulation of hypothesis:relating to disease etiology
specify-population,sp cause ,expected outcome,dose-response
r/n,time-resp r/n.
Eg:smoking of 30-40 cigarettes/day causes lung cancer in 10% of
smokers after 20 yrs of exposure.
Uses:
1. magnitude and type of disease in community
2. Clues to etiology
3. contributes to research
surveys
a)
Collection of data through questionnaires
a)
b) General form:
It can be either structured or unstructured.
May be either closed or open.
d)
e) Question sequence:
The question sequence should be clear
First few questions are particularly important in seeking
the desired co-operation
Questions related to personal character, wealth or memory
of the respondent should be avoided as opening
questions
Conducting examination:
1. Obtaining approval from authorities
2. Budgeting
3. Scheduling
4. Emergency care and refferal
5. (diagnostic method)Validity and reliabilty of the data
Classification of study types-ADA(1970)
typeI: complete examination
typeII: limited examination
Type III: inspection
Type IV:screening procedures:tongue depressor
d) Analysing the data
e)Drawing the conclusion
f) Publishing the reports
Second major type
Subject of interest –individual with in population
Object –not to formulate but test hypothesis
Can determine:
1.Statistical association between disease and suspected
factors
2.If exists--strength
Case control studies
Design of a case-control
study Time
Direction of enquiry
Exposed
Cases
Not Exposed
Populat
ion
Exposed
Controls
Not Exposed
Defining the cases and
controls:
Case: you have to decide a case before the start of
the study. The case has to fit in to two criteria.
1. Diagnostic criteria.
2.
3. Eligibility criteria.
only newly diagnosed cases within a specified period
of time than old cases
Selection of cases
▪ Hospitals
▪ General population
1.
Controls
they must be as similar to the cases as possible, except for the
absence of the disease,which is under study.
Selection of controls
Crucial step in case-control studies
Controls must be
▪ Be similar to the cases except for the absence of the disease under
study
▪ Equal ratio
Sources of controls
Hospitals:diff illness
Relatives
Matching
Definition:
the process by which we select controls in such a way that
they are similar to cases with regard to certain pertinent
selected variables, which are known to influence the out
come of disease and which, if not adequately matched for
comparability, could distort or confound the results.
Example: age.
Confounding factor
One which is associated both with exposure and disease;
and is distributed unequally in study and control groups
Although associated with ‘exposure’ under investigation, it
Measurement of exposure
Exposure can be measured by
Interviews
Questionnaires
By studying past records
Examinations
Bias/ systematic error should be avoided while
measuring the exposure
Analysis
Involves two steps
1. Exposure rates among cases and controls
2. Estimation of disease risk associated with exposure
(odds ratio)
1. Exposure rates
A case control study of smoking and lung cancer
cases
Smokers 33 controls
55
(a) (b)
non Smokers 2 27
(c) (d)
Total 35 82
(a+c) (b+d)
Cases Controls
Smokers 33 55
(a) (b)
Non smokers 2 27
(c) (d)
Total 35 82
(a+c) (b+d)
Odds
ratio (cross product ratio)
It is a key parameter in the analysis of case control
studies
A measure of the strength of the association
between risk factor and outcome
Derivation of odds ratio is based on 3 assumptions
Odds ratio = ad/bc = 33 X27/ 55X2 = 8.1
Bias in case control study
1. Bias due to confounding
2. Memory bias
3. Selection bias
4. Berksonians bias:different rates of admission to
hosp for people with diff disease
5. Interviewer’s bias
6.
advantages of …
Relatively easy to carry out
Rapid and inexpensive (compared with cohort studies)
Require comparatively few subjects
suitable to investigate rare diseases or diseases
about which little is known.
No risk to subjects
Allows the study of several different aetiological factors (e.g.,
smoking, physical activity and personality characteristics in
myocardial infarction)
No attrition problems, because case control studies do not
require follow-up of individuals into the future
Ethical problems minimal
Disadvantages of …
High chances for bias
Validation of information obtained is difficult or sometimes
impossible
Selection of an appropriate control group may be difficult
We cannot measure incidence, and can only estimate the odds
ratio but not relative risk
Not suited to the evaluation of therapy or prophylaxis of a
disease
Another major concern is the representativeness of cases and
Cohort studies
Usually undertaken to obtain additional evidence to
Other names
Incidence study
Forward looking study
Longitudinal study
Prospective study
distinguishing Features of …
drawn
Indications for …
Direction of enquiry
Screening to
exclude those
with the Develop a
condition Disease
With the
characteristi
c Do not
S develop b
Population A disease
free of M
P Time
condition L
E Develop c
Disease
Without the
characteristi
c
Do not d
Considerations
for selecting cohorts
Cohorts must be free from the disease under study
Follow up
Analysis
Selection of study subjects
Cohorts can be selected from
General population
Special groups
▪ Exposure groups
Obtaining data on exposure
Information can be obtained from
Cohorts
Review of records
Environmental surveys
records
home visits
Analysis
Data is analysed interms of
exposed
▪ Relative risk
▪ Attributable risk
Incidence rates
Incidence can be Cigarett Lung No lung Total
measured directly e cancer cancer
smoking
Incidence rate among
smokers = 70/7000 Yes 70 6930 7000
a b a+b
= 10 per
thousand
No 3 2997 3000
c d c+d
Incidence rate among
non-smokers=
3/3000 =
1 per 1000
Relative risk
Cigarett Lung No lung Total
Relative risThe ratio of e cancer cancer
incidence smoking
among exposed and
incidence among Yes 70 6930 7000
non-exposed a b a+b
InAlso
cid ecalled
n ce a m‘risk
o n g ratio’
e x p o=se d
In cid e n ce a m o n g n o n - e x p o se d No 3 2997 3000
c d c+d
10 / 1 = 10
RR=
Relative risk Attributable risk
Advantages of cohort
studies
Allow the possibility of measuring directly
the relative risk of developing the condition for those
who have the characteristic, compared to those who do
not
Allows for a conclusion of cause-effect relationship
Case control study
cohort study
Proceeds from effect to cause Proceeds from "cause to effect".
Starts with the disease Starts with people exposed to
Tests whether the suspected risk factor or suspected
exposure occurs more frequently cause.
in those with the disease than Tests whether disease occurs
among those without the more frequently in those
disease. exposed, than in those not
Involves fewer number of similarly exposed.
subjects Involves larger number of
Yields relatively quick results subjects
Suitable for the study of rare Long follow-up period often
diseases needed, involving delayed
Generally yields only estimate results.
of RR (odds ratio) Inappropriate when the disease
Cannot yield information about or exposure under
diseases other than that investigation is rare.
selected for study Yields incidence rates, RR as
Relatively inexpensive well as AR.
Can yield information about
more than one disease
outcome.
Expensive.
Experimental studies
1. Drawing up a protocal
2.
3. Selecting reference and experimental population
4.
5. Randomization
6.
7. Blinding
8.
9. Manipulation or intervention
D Select population
(Reference or target population)
E
s
Select suitable sample
i (Experimental or study population)
G Selection by defined criteria
a Randomization &
Experimental group Manipulation,
Follow up
N double blinding
Control group &
Assessment
Positive results: benefit of exp measure----reduced incidence or
severity of disease or other appropriate outcomes of study.
Blinding:
Randomization cannot guard against these sorts of bias nor the size of
the sample.the technique known as blinding is adopted which can be
done in
Single blind trial:
here the participant is not aware whether he belongs to study group or
control group.
Double blind trial;
Here neither the doctor nor the participant is aware of the group
Ethics in research
First important code of ethics was the NURENBURG
CODE of 1947. “No research could proceed in
human subjects without voluntary consent.”
1. Non-malificence
2. Benificience
3. Veracity or truthfulness
4. Autonomy
5. Justice
6. Confidentiality
submitted to the ethics
committee in the following
manner
1. Clear research objectives and rationale for
undertaking the investigation in human subjects in
the light of existing knowledge.
2.
3. Subject recruitment procedures.
4.
5. Inclusion and exclusion criteria for entry of subjects
in the study.
6.
7. Precise description of methodology of the proposed
research, including intended dosage of drugs,
5. A description of plans to withdraw or withhold
standard therapies in the course of research.
6.
7. The plans for statistical analysis of the study.
8.
9. Procedure for seeking and obtaining informed consent
with sample of patient information sheet and
informed consent forms in English and regional
languages.
10.
11.Safety of proposed intervention and any drug or
9. For research carrying more than minimal risk, an account
of plans to provide medical therapy for such risk or
injury or toxicity due to over dosage should be
included.
10.Proposed compensation and reimbursement of incidental
expenses.
11.
12.Storage and maintenance of all data collected during the
trial.
13.
14.Plans for publication of results- positive or negative- while
maintaining the privacy and confidentiality of the
study participants.
Considerations to be kept in
mind while conducting research:
In any research on human beings, each subject must
be adequately informed of the aim, methods,
anticipated benefits and potential hazards of the
study and the discomfort it may entail.
When obtaining informed consent, we should be
cautious if the subject has a dependent relationship
to us. No pressure or threat should be exercised.
In case of legal incompetence informed consent
should be obtained from the legal guardian in
accordance with the existing legislation.
references
Behavioural sciences for dentistry. G.Humphris & M.S.Ling.
Churchill Livingstone.2000.