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PRESENTED BY:
DR GAYATRI MEHROTRA
 What is research
 Types of research
 Requisites of good research
 Concept in epidemiology
 Epidemiologic studies
 Literature search
 Protocol designing
 Ethical issues
 Dissertation writing
 Research paper writing
 Reviewing a research paper
 RESEARCH = ‘Re’ + ‘Search’
- Means ‘to search again’
 or
- To search for new facts
 or
- To modify older ones
 Obvious function of research is to add
new knowledge
 Oral health research refers to laboratory, clinical
and field investigations that lead to improvement
in the control of oral diseases and health care
delivery.
 The ultimate goal is to improve the quality of life
for the population.
 Basic and applied research
 Empirical and theoretical research
 Quantitative (numeric )or qualitative (non-
numeric)
 Conceptual and Empirical research
 To promote oral health of the public.
 Contribute new knowledge or reevaluate current
knowledge.
 To improve the techniques and practices of
identifying, preventing and treating oral disease.
 To develop and test theories related to oral health
care and oral disease process.
 To identify and solve problems indigenous to
advancement, decision making and change in oral
health care delivery.
 FOCUS: area of interest/expertise
:meaningful progress
 RATIONALE: clinically relevant
: proof of concept
: challenge/change current treatment
methods
 VALIDITY: will the results be useful and to whom
 FEASIBILITY: time
: study population/sample
: infrastructure
: skill/aptitude
 ETHICS: do unto other what you would do unto
you
 BUDGET: materials
: manpower
: equipment
 Epidemiology is derived from the word epidemic
(epi=among; demos=people; logos=study) which
is a very old word dating back to the 3rd Century
B.C.
 Epidemiology has been defined as “ The study of
the distribution and determinants of health related
states or events in specified populations, and the
application of this study to the control of health
problems.”
 “I keep six honest serving men ; they taught
me all I know. Their names are :-
What , When, Where ,Who, How and Why”
- Rudyard kipling
Observational
studies
Experimental studies
Descriptive
study
Analytical
study
Randomised
controlled trial
Field trials
Community trials
Ecological
study Cross-
sectional
study
Case-
control
study Cohort
study
 These studies are concerned with observing the
distribution of disease or health-related
characteristics in human population and identifying
the characteristics with which the disease in
question seems to be associated.
I. Defining the population to be studied
II. Defining the disease under study
III. Describing the disease under study
 Time distribution
Short term
fluctuation
Periodic
fluctuation
Long term
fluctuation
 Place distribution
 Person distribution
International
variation
National
variation
Rural-
urban
differences
Local
distribution
Age
Gender
Bimodality
Ethnicity
Marital status
Occupation
Social class
Behavior
IV. Measurement of disease
V. Comparing with known indices
VI. Formulation of a hypothesis
Cross-sectional
study Longitudinal study
 “Smoking 40-50 bidids per day, will
result in leukoplakia among 4% of
beedi smokers after 10 yrs”
Population-
beedi
smokers
dose response
relationship-
40-50 bidis
per day
expected
effect- disease
that is
leukoplakia
Time response
relationship
– 10 yrs
cause-
smoking
 Provides data with regard to disease problem.
 Provides information about etiology of disease.
 Provides background data for planning, organizing
and evaluating preventive and curative services.
 Describing variations in disease occurrence by
time,place and person.
 In contrast to descriptive studies that look at entire
population, in analytical studies, the subject of
interest is the individual within the population.
 Comprises of : 1) case control study
2) cohort study
 From each of the study design, one can determine:
1) Whether or not association exists between a
disease and factor
2) If one exists, the strength of the association
Population
Cases
Controls
Exposed
Not exposed
Exposed
Not
exposed
 3 distinct features:
Both exposure and outcome have occurred before
the start of the study.
The study proceeds backwards from effect to cause.
It uses a control or comparison group to support or
refute an inference.
I. Selection of cases and controls
 Case : Diagnostic criteria
 : Eligibility criteria
 Sources of case: hospitals
 : general population
 Sources of control: hospitals control
 : relatives
 : neighbourhood controls
 : general population
Specifications
II. Matching:
 It is defined as the process by which we select
controls in such a way that they are similar to
cases with regard to certain pertinent selected
variables (eg age) which are known to influence
the outcome of disease and which, if not
adequately matched for comparability could
distort or confound the results.
III. Measurement of exposure
IV. Analysis and interpretation
 Exposure rate
 Estimation of disease risk associated with
exposure (odds ratio)
 Exposure rate-cases: a/(a+c) =33/35 =94.2%
 controls: b/(b+d) = 55/82= 67%
Cases ( with oral
cancer)
Controls (without
oral cancer)
Tobacco
chewers(atleast 5
times a day)
( a) 33 (b) 55
Non tobacco
chewers
(c ) 2 (d) 27
Total (a+c) 35 (b+d) 82
 Odds ratio= ad/bc
=33*27 / 55*2
=8.1
 This implies that the risk of oral cancer was 8.1
times greater in individuals who chewed tobacco
than in those who did not chew tobacco.
 Bias is any systemic error in the determination of
the association between the exposure and disease.
Bias due to confounding
Memory or recall bias
Selection bias
Berkesonian bias
Interviewer bias
1) Easy to carry
2) Rapid and inexpensive
3) Investigate rare disease
4) No risk to subjects
5) Allows study of several
different etiological
factors
6) Do not require follow up
7) Ethical prob minimal
8) Rational prevention and
control programmes
1) Problem of bias
2) Selection of appropriate
control grp not possible
3) Cannot measure
incidence
4) Not suited to evaluation of
therapy or prophylaxis of
disease
 It is usually undertaken to obtain additional
evidence to refute or support the existence of an
association between suspected cause and disease.
 Prospective study, longitudinal study, incidence
study, forward looking study
 Distinguishing features are:
Cohorts are identified prior to the appearance of the
disease
Study grp are observed over a period of time to
determine the frequency of disease among them.
The study proceeds from cause to effect.
 The term cohort is defined as a group of people who
share a common characteristic or experience within
a defined time period.
TIME
DIRECTION OF
ENQUIRY
COHORT STUDY
TIME
DIRECTION OF
ENQUIRY
CASE CONTROL
STUDY
Population
Free Of
Condition
S
A
M
P
L
E
With
Characteristic
Without
Characteristic
Develop
Disease
Do Not
develop
Disease
Develop
disease
Do not develop
disease
I. Selection of study subjects:
 General population
 Special groups
II. Obtaining data on exposure
 Cohort members
 Review of records
 Special tests
 Environmental survey
III. Selection of comparison groups
IV. Followup
V. Analysis
 Incidence rate
 Estimation of risk
Relative risk
Attributable risk
Tobacco
chewing
Developed oral
cancer
Did not
develop oral
cancer
Total
Yes 45 (a) 9955 (b) 10000 (a+b)
No 5 (c) 9955 (d) 10000 (c+d)
 Incidence rate among tobacco chewers = a/(a+b)=
45/10000= 4.5 per 1000
 among non tobacco chewers = c/(c+d)=
5/10000= 0.5 per 1000
 RR= incidence of disease among exposed
incidence of disease among non-exposed
= 4.5/0.5= 9
 AR= incidence of disease among exposed-
incidence of disease among non-exposed
incidence rate among exposed
=(4.5-0.5)/4.5 * 100
= 88.9%
1) Incidence can be
calculated
2) Several possible
outcomes can be
studied
3) Estimate of relative risk
4) Dose-response ratio can
be calculated
5) Bias can be minimized
1) Involve large no. of
people
2) Long time to complete
the study
3) Expensive
4) Ethical problems
5) Administrative
problems
6) Changes in diagnostic
criteria over prolonged
followup
7) May alter peoples
behaviour
 2 types: a) Randomized controlled trials
b) Non-randomized or “non-experimental”
trials
 For new programmes or new therapies, the RCT is
the No.1 method of evaluation.
Select suitable population
Select suitable
sample
Make necessary
exclusions
RANDOMISE
Experimental
grp
Control grp
Manipulation
& follow up
Assessment
Those not
eligible
Those who do
not wish to give
consent
Design of
a RCT
I. Drawing up a protocol
II. Selecting reference and experimental population
III. Randomization
IV. Manipulation or intervention
V. Follow up
VI. Assessment of outcome
 Blinding can be done in 3 ways:
 Single blind trial- participant is not aware
 Double blind trial- neither doctor nor participant is
aware
 Triple blind trial- neither investigator, participant
and person analysing data are all “blind”.
Patients
Exposed to
specific R
Unexposed to
specific R
COMPARE
OUTCOME
Concurrent Parallel Study Design
Random
assignment
Observation
TIME
Patients
Random
assignment Exposed to
specific R
Unexposed to
specific R
Observation
COMPARE
OUTCOME
EXPOSED
AND
UNEXPOSED
TO R
TIME
Cross Over Type Of Study Design
Systematic review
Randomized controlled trial
Non- RCT
Cohort study
Case control study
Cross sectional
study
Case series
Isolated
case
report
Hierarchy of
evidence
 Taste alteration and impact on quality of life
after head and neck radiotherapy.
 A clinicopathological study of 338 dentigerous
cyst.
 A new topical treatment protocol for oral hairy
leukoplakia.
 Genotoxic effects of panoramic radiation by
assessing the frequency of micronuclei
formation in exfoliated buccal epithelium
 Remodeling of the antegonial angle region in
the human mandible: A panoramic
radiographic cross–sectional study
 Role of dermatoglyphics as an indicator of
precancerous and cancerous lesions of the oral
cavity.
 Analgesic efficacy of diazepam and placebo in
patients with temporomandibular disorders: A
double blind randomized clinical trial
Research methodology part 1

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Research methodology part 1

  • 2.  What is research  Types of research  Requisites of good research  Concept in epidemiology  Epidemiologic studies  Literature search  Protocol designing  Ethical issues  Dissertation writing  Research paper writing  Reviewing a research paper
  • 3.  RESEARCH = ‘Re’ + ‘Search’ - Means ‘to search again’  or - To search for new facts  or - To modify older ones  Obvious function of research is to add new knowledge
  • 4.  Oral health research refers to laboratory, clinical and field investigations that lead to improvement in the control of oral diseases and health care delivery.  The ultimate goal is to improve the quality of life for the population.
  • 5.  Basic and applied research  Empirical and theoretical research  Quantitative (numeric )or qualitative (non- numeric)  Conceptual and Empirical research
  • 6.  To promote oral health of the public.  Contribute new knowledge or reevaluate current knowledge.  To improve the techniques and practices of identifying, preventing and treating oral disease.
  • 7.  To develop and test theories related to oral health care and oral disease process.  To identify and solve problems indigenous to advancement, decision making and change in oral health care delivery.
  • 8.  FOCUS: area of interest/expertise :meaningful progress  RATIONALE: clinically relevant : proof of concept : challenge/change current treatment methods  VALIDITY: will the results be useful and to whom
  • 9.  FEASIBILITY: time : study population/sample : infrastructure : skill/aptitude  ETHICS: do unto other what you would do unto you  BUDGET: materials : manpower : equipment
  • 10.  Epidemiology is derived from the word epidemic (epi=among; demos=people; logos=study) which is a very old word dating back to the 3rd Century B.C.  Epidemiology has been defined as “ The study of the distribution and determinants of health related states or events in specified populations, and the application of this study to the control of health problems.”
  • 11.  “I keep six honest serving men ; they taught me all I know. Their names are :- What , When, Where ,Who, How and Why” - Rudyard kipling
  • 12. Observational studies Experimental studies Descriptive study Analytical study Randomised controlled trial Field trials Community trials Ecological study Cross- sectional study Case- control study Cohort study
  • 13.  These studies are concerned with observing the distribution of disease or health-related characteristics in human population and identifying the characteristics with which the disease in question seems to be associated.
  • 14. I. Defining the population to be studied II. Defining the disease under study III. Describing the disease under study  Time distribution Short term fluctuation Periodic fluctuation Long term fluctuation
  • 15.  Place distribution  Person distribution International variation National variation Rural- urban differences Local distribution Age Gender Bimodality Ethnicity Marital status Occupation Social class Behavior
  • 16. IV. Measurement of disease V. Comparing with known indices VI. Formulation of a hypothesis Cross-sectional study Longitudinal study
  • 17.  “Smoking 40-50 bidids per day, will result in leukoplakia among 4% of beedi smokers after 10 yrs” Population- beedi smokers dose response relationship- 40-50 bidis per day expected effect- disease that is leukoplakia Time response relationship – 10 yrs cause- smoking
  • 18.  Provides data with regard to disease problem.  Provides information about etiology of disease.  Provides background data for planning, organizing and evaluating preventive and curative services.  Describing variations in disease occurrence by time,place and person.
  • 19.  In contrast to descriptive studies that look at entire population, in analytical studies, the subject of interest is the individual within the population.  Comprises of : 1) case control study 2) cohort study
  • 20.  From each of the study design, one can determine: 1) Whether or not association exists between a disease and factor 2) If one exists, the strength of the association
  • 22.  3 distinct features: Both exposure and outcome have occurred before the start of the study. The study proceeds backwards from effect to cause. It uses a control or comparison group to support or refute an inference.
  • 23. I. Selection of cases and controls  Case : Diagnostic criteria  : Eligibility criteria  Sources of case: hospitals  : general population  Sources of control: hospitals control  : relatives  : neighbourhood controls  : general population Specifications
  • 24. II. Matching:  It is defined as the process by which we select controls in such a way that they are similar to cases with regard to certain pertinent selected variables (eg age) which are known to influence the outcome of disease and which, if not adequately matched for comparability could distort or confound the results.
  • 25. III. Measurement of exposure IV. Analysis and interpretation  Exposure rate  Estimation of disease risk associated with exposure (odds ratio)
  • 26.  Exposure rate-cases: a/(a+c) =33/35 =94.2%  controls: b/(b+d) = 55/82= 67% Cases ( with oral cancer) Controls (without oral cancer) Tobacco chewers(atleast 5 times a day) ( a) 33 (b) 55 Non tobacco chewers (c ) 2 (d) 27 Total (a+c) 35 (b+d) 82
  • 27.  Odds ratio= ad/bc =33*27 / 55*2 =8.1  This implies that the risk of oral cancer was 8.1 times greater in individuals who chewed tobacco than in those who did not chew tobacco.
  • 28.  Bias is any systemic error in the determination of the association between the exposure and disease. Bias due to confounding Memory or recall bias Selection bias Berkesonian bias Interviewer bias
  • 29. 1) Easy to carry 2) Rapid and inexpensive 3) Investigate rare disease 4) No risk to subjects 5) Allows study of several different etiological factors 6) Do not require follow up 7) Ethical prob minimal 8) Rational prevention and control programmes 1) Problem of bias 2) Selection of appropriate control grp not possible 3) Cannot measure incidence 4) Not suited to evaluation of therapy or prophylaxis of disease
  • 30.  It is usually undertaken to obtain additional evidence to refute or support the existence of an association between suspected cause and disease.  Prospective study, longitudinal study, incidence study, forward looking study
  • 31.  Distinguishing features are: Cohorts are identified prior to the appearance of the disease Study grp are observed over a period of time to determine the frequency of disease among them. The study proceeds from cause to effect.
  • 32.  The term cohort is defined as a group of people who share a common characteristic or experience within a defined time period. TIME DIRECTION OF ENQUIRY COHORT STUDY TIME DIRECTION OF ENQUIRY CASE CONTROL STUDY
  • 34. I. Selection of study subjects:  General population  Special groups II. Obtaining data on exposure  Cohort members  Review of records  Special tests  Environmental survey III. Selection of comparison groups
  • 35. IV. Followup V. Analysis  Incidence rate  Estimation of risk Relative risk Attributable risk
  • 36. Tobacco chewing Developed oral cancer Did not develop oral cancer Total Yes 45 (a) 9955 (b) 10000 (a+b) No 5 (c) 9955 (d) 10000 (c+d)  Incidence rate among tobacco chewers = a/(a+b)= 45/10000= 4.5 per 1000  among non tobacco chewers = c/(c+d)= 5/10000= 0.5 per 1000
  • 37.  RR= incidence of disease among exposed incidence of disease among non-exposed = 4.5/0.5= 9  AR= incidence of disease among exposed- incidence of disease among non-exposed incidence rate among exposed =(4.5-0.5)/4.5 * 100 = 88.9%
  • 38. 1) Incidence can be calculated 2) Several possible outcomes can be studied 3) Estimate of relative risk 4) Dose-response ratio can be calculated 5) Bias can be minimized 1) Involve large no. of people 2) Long time to complete the study 3) Expensive 4) Ethical problems 5) Administrative problems 6) Changes in diagnostic criteria over prolonged followup 7) May alter peoples behaviour
  • 39.  2 types: a) Randomized controlled trials b) Non-randomized or “non-experimental” trials  For new programmes or new therapies, the RCT is the No.1 method of evaluation.
  • 40. Select suitable population Select suitable sample Make necessary exclusions RANDOMISE Experimental grp Control grp Manipulation & follow up Assessment Those not eligible Those who do not wish to give consent Design of a RCT
  • 41. I. Drawing up a protocol II. Selecting reference and experimental population III. Randomization IV. Manipulation or intervention V. Follow up VI. Assessment of outcome
  • 42.  Blinding can be done in 3 ways:  Single blind trial- participant is not aware  Double blind trial- neither doctor nor participant is aware  Triple blind trial- neither investigator, participant and person analysing data are all “blind”.
  • 43. Patients Exposed to specific R Unexposed to specific R COMPARE OUTCOME Concurrent Parallel Study Design Random assignment Observation TIME
  • 44. Patients Random assignment Exposed to specific R Unexposed to specific R Observation COMPARE OUTCOME EXPOSED AND UNEXPOSED TO R TIME Cross Over Type Of Study Design
  • 45. Systematic review Randomized controlled trial Non- RCT Cohort study Case control study Cross sectional study Case series Isolated case report Hierarchy of evidence
  • 46.  Taste alteration and impact on quality of life after head and neck radiotherapy.  A clinicopathological study of 338 dentigerous cyst.  A new topical treatment protocol for oral hairy leukoplakia.
  • 47.  Genotoxic effects of panoramic radiation by assessing the frequency of micronuclei formation in exfoliated buccal epithelium  Remodeling of the antegonial angle region in the human mandible: A panoramic radiographic cross–sectional study
  • 48.  Role of dermatoglyphics as an indicator of precancerous and cancerous lesions of the oral cavity.  Analgesic efficacy of diazepam and placebo in patients with temporomandibular disorders: A double blind randomized clinical trial

Hinweis der Redaktion

  1. 1) Basic research is search for knowledge without any specific purpose. Applied research is problem oriented- finding solu to an existing prob 2) Empirical means that it is based on observation an dexperience more than upon theory and abstraction.
  2. What is the purpose of health research? 1) by improving education, service, practice & delivery. 2) To improve all phases of oral health care 3) in individuals and in grps
  3. Indigenous- occuring naturally in a particular place
  4. Rationale – set of reasons
  5. Feasibility means smethng which can be easily done. Infrastructure means facilities.
  6. Ecological or corelational ; cross sectional study or prevalence; case control or case reference; cohort or followup. Decriptive study is limited to description of a disease in apopulation i.e pattern of occurrence of disease. Analytical study goes by analysing the relationship between health status and other variables.
  7. Meticulous observations made in africa by Burkitt led to the eventual incrimination of Epstein barr virus as the etiological factor of the type of cancer known as Burkitts lymphoma. It was the epidemiological study in New Guinea of “kuru” , a herediatary neurological disorder that led to the discovery of slow virus infections as the cause of chronic degenerative neurological disorders in human beings.
  8. Define the population not only in terms of total number but also its composition in terms of age, sex, occupation. Helps to determine pop at risk.Once the population has been defined, one needs to define the disease to be investigated. It should be both valid nd precise to enable to identify those who have d disease from those who do not hve d disease. The primary objective of descriptive epidemiology is to describe the distribution of disease by time,place nd person & identifying those characteristics associated with presence or absence of disease in individuals.
  9. Measurement of disease in terms of mortility and morbidity…cross sectional or prevalence study cross sectional- both exposure nd outcme at sme time. Longitudinal is cross sectional study done for a longer duration. Comparision is done to find out which population is at risk.
  10. Analytical studies are the second majot type of epidemiological study
  11. Also known as retrospective study
  12. Control must be free form the disease. They must be as similar to cases as possible, except for the absence of disease under study. hospital controli sbias bcoz may be dey hve sme disease which is influenced by factor under study. Eg oral cancer nd smoking. Nd lung cancer
  13. Confounding factor is one which is associated with both exposure and disease and is distributed unequally in study and control grp. Example of age
  14. Measurement of exposure by interview, questionnaire, past record , clinical or laboratory investigation
  15. Relative risk
  16. Berkesonian bias is termed after Dr Joseph Berkson who recognize this problem. Occurs in hospital based studies.
  17. Cohort must be free from the disease under study.
  18. Relative risk implies 9 times higher risk of development of oral cancer in tobacco chewers compared to non-chewers. RR of 1 indicates no association, >1 indicates positive association .. AA- out of the total risk of development of cancer in chewers, 88.9% is attributed to tobacco chewing.
  19. Protocol specifies the aims and objectives of the study, criteria for the selection of study and control grps, sample size, allocation of study subjects into study and control grp.treatment to be apllied and upto the stage evaluation. Assessment of outcme- positive and negative results
  20. 2 sources of bias- on part of participants- feel bttr when they cme to know they receivng sme new treatment. Observer bias- investigatir may be influenced if he knows beforehand the particular therapy to which pt is subjected.
  21. The hierarchy of evidence that is generated from various studies is shown in following figure
  22. 1) – COHORT 2) CASE CONTROL 3) RCT
  23. 1) COHORT 2) CROSS SECTIONAL
  24. 1) CROSS SECTIONAL 2) RCT