Research 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 is the continual search for truth using the scientific method. It is the pursuit of the truth with the help of study, investigation, observation, comparison and/or

definitions

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 discussed and proved. A discussion to maintain and prove a thesis especially written or delivered by a candidate for university degree- Ph.D

Dissertation:

Dissertation means to discuss. It is an academic activity laid down by the partial fulfillment of MDS degree. university for the

It is an exercise to train a PG student to plan, execute, evaluate, write and report a scientific project. It is an in-depth study of a particular topic which contributes new information and knowledge in the field A formal, often lengthy treatise (a book or writing of some particular subject, one containing a methodical discussion or exposition of principles of subject) or discourse, especially one

It is a pre-requisite or academic activity for acquiring a masters degree or doctorial. To find out the truth which is hidden and which has not been discovered yet. To contribute new knowledge to the existing one as the scientific knowledge develops in increments. As a profession to conduct research in various aspects. To solve an existing health problem.

Categories of research

1.

Empirical research and theoretical research Basic research and Applied research

Empirical

Observational research

Experimental research

Basic or pure research

It is usually considered to involve the search for knowledge without a defined goal of utility or specific purpose. Eg. The microbiologist, whose expertise is the identification of pathogenic micro organisms may conduct research in-vitro, in a laboratory on bacterial reproduction, growth and endotoxin production without any direct application to clinical dentistry. Probably, the researcher is interested in monitoring endotoxins produced over the life cycle of bacteria to determine a pathogenecity.

Applied research

It is problem oriented and is directed towards a defined and purposeful end.

Eg. An oral health researcher investigating the relationship between periodontal disease and myocardial infarction may use the findings of the microbiologist as a theoretical framework to test the relationship between bacterial endotoxins, periodontal disease and myocardial infarction in animal and then in human subjects

Research methods

methods/ techniques that are used for conducting research are termed as research methods or research techniques. They fall into 3 groups
1. Those concerned with collection of data 2. Those statistical techniques which are used for establishing relationship between the data and the unknown

1. 2.

3.

Research methodology

It is a way to systematically solve the research problem. It is necessary for the researcher to design his methodology for his problem, as the same may differ from problem to problem i.e.
1.

2. Why a research study has been undertaken 3. 4. How the research problem has been defined 5. 6. In what way and why the hypothesis has been formed

4. 5.

4. What data has been collected 5. What particular method has been adopted for collection of data 6. Why a particular technique of data collection has been used

And a host of similar questions are usually answered when we talk of research methodology, so that research results are capable of being evaluated either by the researcher himself or by others

Procedural steps in research

Selection of problem for investigation-further exploration Inexperienced-seek opinion senior Constructing essential starting point

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 collaborationreviews 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
Selection

of a research strategy is the core of a research design and is probably the single most Important decision the investigator has to make, i.e. whether to undertake a descriptive, an analytical or an experimental study.

Classification of Epidemiologic studies

Decscriptive study

Concerned with observing the distribution of disease or health related characteristics in human population Eg. Surveys. Defining population:denominator Defining the disease:operational definition. Describing disease-time,place and person Time: Short term fluctuation:
1. Common source epidemics-single,continuous 2. Propagated epidemics-person to person transmission of infectious agent---epidemics of hepatitis A and poliomyelitis

Periodic fluctuations: Seasonal communicable diseases like measles,varicella,malaria Eg:upper Resp tract infections inc during winter and GI inf in summer Cyclic trends-measles-incidence every 2-3 yrs Influenza occurs at intervals of 7-10 yrs Long term fluctuation Changes occur over long period of time,change in frequency encompassing sev decades Eg:CHD,diabetes,lung cancer shows upward trend in 50 decades and TB, typhoid downward

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

Surveys are methods of scientific or systematic collection of data, compiling, presenting in order (useful manner), analysing and evaluating them

The focus of attention must be on the following a) Formulating the objective of the study-obj describing what is to be measured,resources

b) d)
f)

c) Designing the method of data collection eg. Questionnaires, interviewing, examination of records or observations
e) Selecting the sample

a)

Collection of data through questionnaires

Questionnaire is considered as the heart of survey operation. 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

1. 2. 3. 4. 5.

Conducting examination: Obtaining approval from authorities Budgeting Scheduling Emergency care and refferal (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

Case study: it is an intensive investigation of a person, a family, a group, a social institution or an entire community in a natural setting

Correlational study: it is a descriptive research technique utilized to identify consistent relationship among variables

Analytical study
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

study

Design of a case-control 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
The criteria for inclusion in the study must be clearly specified. Sources of cases:

Hospitals 1.

General population

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 (a)

55 controls (b) 27 (d) 82 (b+d)

non Smokers 2 (c) Total 35 (a+c)

Exposure rate among cases= (a/a+c)100 = (33/35) 100 = 94.2 % Exposure rate among controls= (b/b+d)100 = (55/82) 100 = 67 %

2.Estimation of risk
Relative risk (RR) or Risk ratio Relative risk = Incidence among exposed Incidence among non exposed Cases Smokers Non smokers Total 33 (a) 2 (c) 35 (a+c) Controls 55 (b) 27 (d) 82 (b+d) = a/(a+b)

c/(c+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 Disease under investigation is a rare one Cases are representative of those with disease Controls are representative of those without disease

smokers Non smokers total

cases 33 (a) 2 (c) 35 (a+c)

55 (b) 27 (d) 82 (b+d)

controls

Odds ratio = ad/bc = 33 X27/ 55X2 = 8.1

Smokers have a risk of having lung cancer 8.1 times that of non smokers

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. Interviewers 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

Usually undertaken to obtain additional evidence to

Cohort studies

refute or support the existence of an association

between suspected cause and disease Other names

Incidence study Forward looking study Longitudinal study Prospective study

distinguishing Features of

Cohorts are identified prior to the appearance of the disease under investigation

Study groups are observed over a period of time to determine the frequency of disease

The study proceeds from cause to effect

Cohort is defined as a group of people who share a common characteristic or experience within a defined time period

Eg, birth cohort,age cohorts, occupational cohorts, exposure to a drug cohorts, marriage cohort etc.

The comparison group may be

the general population from which the cohort is

drawn

Indications for

When there is a good evidence of an association between exposure and disease

When the exposure is rare but the incidence of disease is high among exposed

When the attrition can be minimised When ample funds are available

of a cohort study
Time Direction of enquiry

Screening to exclude those with the condition With the characteristi c Time

Develop Disease

Population free of condition

S A M P L E

Do not develop disease

Without the characteristi c

Develop Disease

Do not

Considerations for selecting cohorts

Cohorts must be free from the disease under study both the groups should be equally susceptible to disease under study Both the groups should be comparable in respect of all possible variables, except the assumed risk factors Diagnostic and eligibility criteria of the disease must be defined beforehand. Inclusion and exclusion criteria should be clearly stated before the commencement

Steps in

Selection of study subjects Obtaining data on exposure Selection of comparison groups Follow up Analysis

Selection of study subjects

Cohorts can be selected from

General population

Special groups
Select groups (eg. Doctors, lawyers, teachers, etc.) Exposure groups

Obtaining data on exposure

Information can be obtained from

Cohorts Review of records Medical examination or special tests Environmental surveys

Information about exposure should facilitate classification of cohort members

According to whether or not they were exposed According to the degree of exposure

Selection of comparison groups

Internal comparisons: no outside comparision group is required External comparisons: when degree of exposure is not available,ext cohort .eg:smokers and non smokers,radiologists and opthamologists.

Comparison with general population:mortality experience of exposure group is compared with mortality experience of general populationin same geographic area

Follow up

Periodic medical examination of each member Reviewing physician and hospital records Routine surveillence of morbidity and mortality records

Mailed questionnaires, telephone interviews, periodic home visits

Analysis

Data is analysed interms of

i. Incidence rates of outcome among exposed and nonexposed

ii. Estimation of risk

Relative risk Attributable risk

Incidence rates

Incidence can be measured directly

Cigarett Lung No lung Total e cancer cancer smoking

Incidence rate among smokers = 70/7000 Yes = 10 per thousand

No

70 a 3 c

6930 b 2997 d

7000 a+b 3000 c+d

Incidence rate among non-smokers= 3/3000 = 1 per 1000

Relative risk
Relative risThe ratio of incidence among exposed and incidence among non-exposed In cid ecalledmrisk ratio se d = Also n ce a o n g e x p o

Cigarett Lung No lung Total e cancer cancer smoking Yes No 70 a 3 c 6930 b 2997 d 7000 a+b 3000 c+d

In cid e n ce a m o n g n o n - e x p o se d

10 / 1 = 10

RR= RR is the direct measure of strength of association

RR-i= no assossiation RR > 1= positive assossiation

Attributable risk

The difference in incidence rates between exposed and non-exposed groups Also called risk difference

Incident rate among exposed incidence rate among non-exposedX 100 Incident rate among exposed

(10-1/10) X 100 = 90%

It indicates to what extent disease can be attributed to the exposure Suggests the amount of disease that might be

of lung cancer was due to their smoking

Relative risk X Attributable risk

Relative risk Etiological enquiries Larger the RR, stronger the association between risk factor and outcome Does not reflect the potential public health importance

Attributable risk Gives a better idea of the impact of a successful intervention might have in reducing the problem

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 Because the presence or absence of the risk factor is recorded before the disease occurs, there is no chance of bias

Cohort studies are capable of identifying other diseases that may be related to the same risk factor.

Unlike case-control studies, cohort studies provide the possibility of estimating attributable risks, thus indicating the absolute magnitude of

Disadvantages of cohort studies

Not always feasible. Relatively inefficient for studying rare conditions. They are very costly in time, personnel, space and patient follow-up. Sample sizes required for cohort studies are extremely large, especially for infrequent conditions; it is usually difficult to find and manage samples of this size.

The most serious problem is that of attrition, which can affect the validity of the conclusion, if it renders the samples less representative, or if the people who become unavailable are different from those actually followed up. The higher the proportion lost (say beyond 10-15%) the more serious the potential bias.

There may also be attrition among investigators who may lose interest, leave for another job, or become involved in another project. Over a long period, many changes may occur in the environment, among individuals or in the type of intervention, and these may confuse the issue of association and attributable risk.

Case control study cohort study

Proceeds from effect to cause Starts with the disease Tests whether the suspected exposure occurs more frequently in those with the disease than among those without the disease. Involves fewer number of subjects Yields relatively quick results Suitable for the study of rare diseases Generally yields only estimate of RR (odds ratio) Cannot yield information about diseases other than that selected for study Relatively inexpensive

Proceeds from "cause to effect". Starts with people exposed to risk factor or suspected cause. Tests whether disease occurs more frequently in those exposed, than in those not similarly exposed. Involves larger number of subjects Long follow-up period often needed, involving delayed results. Inappropriate when the disease or exposure under investigation is rare. Yields incidence rates, RR as well as AR. Can yield information about more than one disease outcome. Expensive.

Experimental studies
Study of epidemics among colonies of experimental animals such as rats and mice . AIMS

To provide scientific proofs of etiological factors To provide a method of measuring the effectiveness and

has all adv and disadv of cohort study and also ethics,cost and feasibility Animal studies: important application Advantages 1. Bred in lab,and can manipulated easily 2. They multiply rapidly Disadvantages: 1. Not all human diseases can be reprodeuced

efficiency of health services

Human studies: To investigate disease etiology and to evaluate the preventive ,therapeutic measures 1747-john lind-scurvy 1796-Edward Jennar-cowpox

1. Ethical and logistic considerations,benefits weighed againsts the risks involved 2. Volunteers made fully aware of the experiment 3. WHO (1980)-strict code of practice

Experimental studies

Randomised controlled trials Non-randomized trials

Randomised controlled trials:

Involves some action,interventionor manipulation such as deliberate application or withdrawl of suspected cause.

1. Drawing up a protocal

2. 4. 6. 8.

3. Selecting reference and experimental population 5. Randomization 7. Blinding 9. Manipulation or intervention

D E s i G N o F a N

Select population (Reference or target population)

Select suitable sample (Experimental or study population)

Selection by defined criteria Potential participants (Meet selection criteria) Invitation to participate Participants Randomization & double blinding Experimental group Control group Manipulation, Follow up & Assessment Non-participants (do not meet selection criteria) Non-participants (do not give consent)

Positive results: benefit of exp measure----reduced incidence or severity of disease or other appropriate outcomes of study. Negative results: severity and frequency of side effects and complications ,if any death

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. Declaration of Helsinki code of ethics on principles of ethical behaviour was established in HELSINKII in 1975. The term clinical research to biomedical research was revised in HELSINKI- II in 1975

institutional ethics committee or institutional review board Institutions undertaking clinical trials have to constitute an Institutional Ethics Committee (IEC) or Institutional Review Board (IRB). It is mandatory that each dissertation research proposal (synopsis) involving humans (irrespective of type of study, including questionnaire based surveys) or animals should be accompanied by a clearance letter from IEC.

ethics and its principles

The science of ideal human character and behavior in situations where distinction must be made between right and wrong, duty must be followed and good inter-personal relations maintained. When considering the ethical aspect of health research the following principles should also be kept in mind. (Helsinki declaration)

Ethical principles
1. Non-malificence 2. Benificience 3. Veracity or truthfulness 4. Autonomy 5. Justice 6. Confidentiality

submitted to the ethics committee in the following manner objectives and rationale for 1. Clear research

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,

undertaking the investigation in human subjects in the light of existing knowledge.

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.

Health research methodology- a guide for training in research methods. WHO 1992

Critical thinking; understanding and evaluating dental research. D.M.Brunette. Quintessence publishing. 1996.

Dentistry, dental practice and community. 5th edition. B.A. Burt & S.A.Eklund. WB Saunders company.

Parks text book of preventive and social medicine. 19th edition. K.Park. Bhanot publishers. 2007.

TH A N K YO U