Introduction to

Health Research & Methods

Research

Research what is it all about?

Central to the scientific enquiry.

Seeing what others see and finding what others dont.

Purpose: to add to knowledge that will better the lives of people

Research - Definition

Research is a quest for knowledge through diligent search or investigation or experimentation aimed at the discovery and interpretation of new knowledge WHO

Research is a scientific process

There is a need to demystify the scientific process. Scientific Inquiry is basically a potentiation of common sense ,which is one of the most equitably distributed human gifts. As Einstein said The whole of science is nothing more than a refinement of everyday thinking. In a sense ,most of us conduct some research in our daily life. (e.g) ,if we want to buy a car in a proper way, we collect information about the models and dealers,analyse it then try to reach the scientific conclusion on which one to buy.

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

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.

Research provides the reliable evidence

Good research & Bad research

There is only one type of research - good research . Bad research does not deserve the name Research Badly done research is utter waste of time , money and effort; it is unethical as it exposes research subjects to the inherent risk of experimentation with no reward to them ,to others or communities

Poor medical research is a SCANDAL!*

Due to lack of knowledge or ignorance
Fear of Epidemiology / Biostatistics Unprofessional, unethical & unacceptable Very common *BMJ, 1994;308:283-284

Is Health Research a luxury?

Should Countries with scarce resources do research ?Yes Because we are a poor country , we cannot afford not to do research . (Jawaharlal Nehru) India cannot wait indefinitely for development of new technologies for health that are urgently required for tackling various diseases effecting the people of country Gulam Nabi Azad Health research A vital investment

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: The Lancet *
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!

Types of health research

Basic and applied Empirical and theoretical Qualitative and quantitative Health research triangle
Biomedical Behavioral Health research

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.,

Anatomy and physiology of

Research methods

The anatomy
What it is made of?

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?

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

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

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 fish intake in older adults? Do fish oil supplements have the same effect on cardiovascular disease as dietary fish? Which fish oil supplements do not smell like fish?

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?

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

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

Study designs
Observe the events taking place in the study participants
OR

Apply an intervention and examine its effects on these events

Study designs
Observe the events taking place in the study participants
Observational studies

Apply intervention and examine its effects on these events

Experimental studies

*from International Union Against Tuberculosis and Lung Disease

Examples of study designs

Designs Crosssectional Cohort Example Interview subjects about current and past history of fish intake and relate them with history of CHD Measure fish intake at baseline and periodically examine at follow-up to see if those who eat more fish have fewer CHD events Compare group of CHD patients with those who do not have CHD and ask them about fish intake Assign randomly participants to receive fish oil supplements or placebo, then follow them for several years to observe the incidence of CHD

Casecontrol Clinical trial

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 be chosen to be your study subjects? Will they be randomly selected from a large population or will they be a convenience sample from the attendees of a particular clinic or hospital?

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

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 other dietary

Statistical issues
Hypotheses Sample size Analysis plan

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 require hypothesis and do not involve statistical testing

Sample Size
How many study subjects will you need in order to observe the expected outcome with adequate precision?
Involves assumptions

The physiology
How it works?

Goal of research

Truth in the universe

Infer

Findings in the study

Process of designing & implementing research

Sampling Sample
Sample

Implementation

Target population

Selection Bias

Measurement

Design

Confounding Bias Chance

Conclusions

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?

Internal and external validity

Sampling Sample
Sample

Internal Validity

Population
Selection Bias

Measurement

External Validity

Confounding Bias Chance

Conclusions

Example: Causality
Strength of the association
The stronger the association observed between fish intake and CHD, 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?

Errors in research
Random
Incorrect findings due to chance
Increasing the sample size increases the precision of findings and decreases the likelihood of a random error

Systematic
Incorrect findings due to bias
Reducing the error with which subjects are sampled and measurements are made increases the accuracy of findings

Designing the study

Outline
1 page elements of the study

Protocol
5-25 +pages of details used for planning your study 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

Research cycle

Im quite comfortable with research

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