Introduction to research methods.ppt

7/28/2019 Introduction to research methods.ppt

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Introduction to

Health Research & Methods


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Research


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Research what is it all about?

Central to the scientific enquiry.

Seeing what others see and findingwhat others dont.

Purpose:to add to knowledge

that will better the lives of people


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Research - Definition

Research is a quest for knowledge through

diligent search or investigation orexperimentation aimed at the discovery and

interpretation of new knowledge WHO


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Research is a scientific

process

There is a need to demystify the scientific process.

Scientific Inquiry is basically a potentiation of commonsense ,which is one of the most equitably distributed

human gifts.

As Einstein said The whole of science is nothing morethan a refinement of everyday thinking.

In a sense ,most of us conduct some research in ourdaily life.(e.g) ,if we want to buy a car in a proper way, wecollect information about the models anddealers,analyse it then try to reach the scientific

conclusion on which one to buy.


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Health Research

Health most vital part of human life

Health research & Medical research

Cornerstone of all the advancements

Health for all or Millennium

Development Goals only through proper

research


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Health Research

what is it all about ?

Increase understanding of causal association

both etiologic agents and risk factors to disease.

To improve methods of diagnosis

To optimize therapy and management of the

sick.


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Research provides the reliableevidence


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Good research & Bad research

There is only one type of research - goodresearch .

Bad research does not deserve the name -Research

Badly done research is utter waste of time ,money and effort; it is unethical as it exposesresearch subjects to the inherent risk ofexperimentation with no reward to them ,to

others or communities


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Is Health Research a luxury?

Should Countries with scarce resources doresearch ?Yes

Because we are a poor country , wecannot afford not to do research .

(Jawaharlal Nehru) India cannot wait indefinitely for

development of new technologies for

health that are urgently required fortackling various diseases effecting thepeople of country Gulam Nabi Azad

Health research A vital investment


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Health research in India

Since more than 2000 years 1911 to 2011 (IRFA to ICMR)

DHR 2007

National Health Research Policy

Health research in India is poor: TheLancet *

Research to achieve healthcare for all in India

0.4% in 1988 to 1.8% in 2008*The Hindu, 04.04.2011

96% from 9 medical colleges only!


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Types of health research

Basic and applied

Empirical and theoretical

Qualitative and quantitative

Health research triangle

Biomedical

Behavioral

Health research


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Tools for health research

Epidemiology

Measures of disease frequency

Causations & Associations

Validity & reliability

Study designs etc.,

Biostatistics

Descriptive statistics

Sample size

Tests of significance etc.,


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Anatomy and physiology of

Research methods


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The anatomy

What it is made of?


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Anatomy of research

What questions to address?

Why are these questions important?

How is the study structured? Who are the subjects and how will they be

selected?

What measurements will be made? How large is the study and how will it be

analysed?


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Anatomy of research

What questions to address? Research question(s) / topic

Why are these questions important? Background and significance

How is the study structured? Epidemiologic approach Who are the subjects and how will they be selected?

Selection criteria; sampling

What measurements will be made?

Exposure; Outcome; Confounding variables

How large is the study and how will it be analysed? Hypotheses; sample size; analysis plan


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Research question

Translates into the objective(s) of the study Begins with general uncertainty about a health

issue

Narrows down to a concrete, researchable issue Research topic should be FINER*

Feasible

Interesting

Novel Ethical

Relevant*Hulley et al, 2001


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Example: Research question

General

Should people eat more fish?

Specific components

How often people eat?

Does eating fish lower risk of cardiovascular disease?

Is there a risk of mercurial toxicity from increasing fishintake in older adults?

Do fish oil supplements have the same effect oncardiovascular disease as dietary fish?

Which fish oil supplements do not smell like fish?


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Background and significance

Provide the context and rationale

What is known about the topic?

Why is the research question important?

What kind of answers will the study provide?


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Example: Significance

Regular consumption of fish in some

communities

Reports of reduced risk from eating fish

Certain communities do not like or eat fish

No evidence on the benefits of fish oil

supplements over eating fish


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Study designs

1. Different questions require different

types of Study Designs.

2. It is essential to understand the

structure of different Study Designs

3. Choosing the correct study design is

crucial to the success of the Research


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Study designs

Observe the events taking place in the

study participantsOR

Apply an intervention and examine its

effects on these events


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Study designs

Observe the events taking place in the

study participants

Observational studies

Apply intervention and examine its effects

on these events

Experimental studies


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*from International Union Against Tuberculosis and Lung Disease


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Examples of study designs

Designs Example

Cross-

sectional

Interview subjects about current and past

history of fish intake and relate them with

history of CHD

Cohort Measure fish intake at baseline and periodicallyexamine at follow-up to see if those who eat

more fish have fewer CHD events

Case-

control

Compare group of CHD patients with those who

do not have CHD and ask them about fish

intake

Clinical

trial

Assign randomly participants to receive fish oil

supplements or placebo, then follow them for

several years to observe the incidence of CHD


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Study participants

Selection criteria How are you defining your study population?

Inclusion criteria

Exclusion criteria

Sampling How are you selecting your study subjects?

What subgroup of your overall study population will bechosen to be your study subjects?

Will they be randomly selected from a large populationor will they be a convenience sample from theattendees of a particular clinic or hospital?


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Measurements

Which characteristics of the study subjects

are you going to measure?

Exposure variables

Outcome variable(s)

Confounding variables

variables that can confuse interpretation of

outcome


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Example: Measurements

Exposure variables

Age, race, gender; smoking

Types of fish; portion size; fried or baked; any

supplementation Outcome variable(s)

Heart attacks, strokes, quality of life;

Confounding variables Intake of red meat; income level; any otherdietary


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Statistical issues

Hypotheses

Sample size

Analysis plan


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Hypothesis

Re-phrase your study question so that it

provides the basis for testing the statistical

significance of findings

e.g., 50-69 year old women with CHD who

take fish oil supplements will have a lower risk

of myocardial infarction than those who do not

Purely descriptive studies do not requirehypothesis and do not involve statistical

testing


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Sample Size

How many study subjects will you need in

order to observe the expected outcome

with adequate precision?

Involves assumptions


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The physiology

How it works?


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Goal of research

Truth in theuniverse

Findings in

the study

Infer

Process of designing &


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Process of designing &implementing research

Sample

Target

population

Sampling Implementation

Sample

Selection Bias

Measurement

Confounding

Bias

Chance

Conclusions

Design


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Inferences

Internal validity

How well do your conclusions correctly describe

what actually happened in your study?

External validity How well do your conclusions generalize to the

population outside of your study sample?

Causality How well does your measurement(s) explain a

cause and effect relationship with the outcome?


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Internal and external validity

Sample

Population

Sampling InternalValidity

Sample

Selection Bias

Measurement

Confounding

Bias

Chance

Conclusions

ExternalValidity


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Example: Causality Strength of the association

The stronger the association observed between fish intake andCHD, the less likely it is due to error

Dose-response effect

Does the risk of myocardial infarction reduce with dose/duration

of intake of fish intake?

Lack of temporal ambiguity

Does exposure to fish intake precede the occurrence of CHD?

Consistency of findings

Are your findings similar to those of other studies?

Biological plausibility

Does it make sense in the context of current biological

knowledge?

Specificity of the association

Does fish intake reduces risk of other diseases?


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Errors in research

Random

Incorrect findings due to chance

Increasing the sample size increases the precision

of findings and decreases the likelihood of arandom error

Systematic

Incorrect findings due to bias Reducing the error with which subjects aresampled and measurements are made increases

the accuracy of findings


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Designing the study

Outline 1 page elements of the study

Protocol

5-25 +pages of details used for planning yourstudy and grant application

Operations manual Collection of procedural instructions,

questionnaires, and other materials Ensures uniform and standardized approach to

conduct the study with good quality control


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Research cycle


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Im quitecomfortable

with research


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References & Acknowledgment

Designing Clinical Research, 3rd ed. SB

Hulley et al. Lippincott Williams & Wilkins

2007

Epidemiologic Research. DG Kleinbaum et

al. John Wiley and Sons 1982

Thanks to Dr.P.Manickam, NIE

Documents

Introduction to research methods.ppt