3. Goals of Science /
Scientific Community
Reduce uncertainty about phenomena in the Universe
Describe a phenomenon of interest
Explain what causes it
Predict what it causes
Cause and effect relationships are learned by human
beings based on their interaction with the natural
environment.
Astute scientists observe patterns, describe them,
analyse harms & benefits and contribute to betterment
of mankind
4. The Scientific Method
A logical system used to evaluate data derived from systematic observation.
◦ Inductive – first data, then theory
◦ Deductive – first theory, then evaluation
Inductive Model Deductive Model
5. Creative and Systematic work
undertaken to increase the stock of
knowledge.
Collection, organization and analysis
of information to increase
understanding of a topic
Most if not all research is an
expansion on past work in the field
We stand on the shoulders of giants!
What is Research?
6. The general
Epidemiologic
( scientific )
Approach
1. Identify a PROBLEM: i.) clinical suspicion; ii.) case series; or
iii.) review of medical literature, etc.
2. Formulate a HYPOTHESIS (asking the right question)
~ good hypotheses are: Specific, Measurable, & Plausible
3. TEST that hypothesis ( assumptions vs. type of data )
4. Use: appropriate samples, most efficient study design, &
correct test
5. Always Question the VALIDITY of the result(s):
Is the explanation due to i.) Chance ii.) Bias or iii.) a truly “Causal”
association ?
12. Refining ‘ideas’ into research questions
Begins with general uncertainty about a health
issue
Narrows down to a concrete, researchable
issue
Research question sets out what the
investigator wants to know
13. Research Question
addresses uncertainty…..
•‘Uncertainty’ about something in the population
that the investigator wants to resolve by making
measurements in the study population
•Uncertainty = ‘data needs’
•Clear question facilitates - Choosing the most
optimal design
•Identify who should be included, what the
outcomes should be, and when the outcomes
need to be measured
14. Types of research questions
• Involve observations to measure quantity
• No comparison groups / interventions
1. Descriptive questions
• Involve comparisons / interventions to test a hypothesis
2. Analytical questions
15. Translating uncertainty to research question
Frame the problem in specific terms (clinical/public health/…)
•Focus on one issue
•Formulate in everyday language
•Can use more than one operational verb, if needed
•Link the question to the potential action that would be taken once the question is
answered
•State as a question!
16. Sources of
research
questions
1. Mastering the published literature
Continue review of work of others in the area
of interest
2. Being alert to new ideas and techniques
•Attending research meetings / conferences
•Having a skeptical attitude about prevailing
beliefs
•Applying new technologies to old issues
3. Staying alert to data needs
•Careful observation; teaching, tenacity
4. Choosing a guide/mentor
17. Framing a good research question
Do a good review of literature
Identify uncertainty and think how it can be addressed
Consult peers and mentors whether it is worth investigating
Formulate a question
Refine the question by specifying details about the population and measurable outcomes
18. Good research question
should pass the ‘so what?’ test
•Feasible
–Adequate number of participants, technical expertise & resources
•Interesting
•Novel
–Confirms, refutes or extends previous findings
–Provides new information
•Ethical
–Amenable to a study that ethics committee will approve
•Relevant
–Advance scientific knowledge, improve practice, influence policy
19. Comment on
the following
research
questions
Relationship between depression &
health
Does eating red meat cause cancer?
Does lowering serum cholesterol
prevent heart disease?
Can relaxation exercise decrease anxiety
associated with mammography?
Do contraceptive vaginal sponges
prevent HIV infection?
21. Research question
The protocol should start with a clear and precise formulation of
the research question. It is good practice to write this in the form
of a question, not a statement
Example:
Why do more children in Delhi have asthma than in rest of India?
22. Title
Title makes clear the main area of research.
If your title is ‘scientific’ it is also a good idea to re-state the title in layman’s
language.
E.g. –
i) A study of factors associated with childhood asthma in Delhi NCR
ii) Role of inhaled corticosteroids in preventing airway remodeling in pediatric asthma
23. Background
It justifies the need to undertake the proposed research.
This is essentially your literature review.
The background should show you have a critical understanding of relevant literature
and research around the area you are hoping to investigate and above all justifies you
undertaking the research.
24. Aims & Objectives
The Aims are the main goals that you have set for yourself which
include a referral to the study design
◦ “To conduct an epidemiological study of asthma among children in Delhi.”
◦ “To conduct a randomised double-blind trial to assess the performance of two laxative agents in
preparing the large bowel for barium enema examinations.”
25. Objectives
•Even a precise study question is often too broad for one
study to answer
• You must therefore break down the question into several
objectives.
Example:
The objectives of this study are:
i) to determine the prevalence of asthma in Delhi
ii) its relation to socioeconomic status and / or air pollution.
26. Hypotheses
To meet the objectives, comparisons may have to be made.
Hypotheses should be formulated, so that they can be refuted
(null hypotheses):
Examples:
1. Asthma prevalence is not different between children from low versus high
socioeconomic groups
2. Asthma prevalence is not increased in children living in homes with increased
air pollution
3. There is no relationship between asthma prevalence and socioeconomic status
of the child
27. Methodology
o Study design
o Study population
o Sample size and statistical power
o Subjects: selection and definitions
o Data collection methods: measurements,
definitions
o Data management and statistical analysis
28. Methodology
Study design
• This should state the selected design of the study.
• Keep in mind that the study design is chosen in relation to study
objectives.
Explain why the particular study design has been chosen in preference to
other possible designs
29. Methodology
Study population
This section outlines the setting for which the research has
relevance
Example:
o Which children in Delhi should we study?
o Can the study results be extrapolated?
o What is the definition of “child”?
30. Methodology
Sample size and statistical power
Specify assumptions and provide tables of sample size and
power calculation
Example:
o How many children will be recruited?
o What proportion of the population is included?
o Will the number of children be sufficient?
32. Methodology
Subjects: selection and definitions
This section should provide:
o Definitions of eligibility, inclusion and exclusion
o Realistic estimates of the number eligible subjects
o Description of recruitment mechanism
o Discussion of recruitment feasibility
33. Methodology
Example:
o Will children with (without) asthma be included?
o Which children will be excluded?
o How will the children be approached?
o What will you do when they decline?
o How many children will be eligible and what percentage do you expect will
actually participate?
34. Methodology
Data collection methods: definitions and measurements
• It is essential to state how the data will be collected to determine
both the health outcomes and the determinants you are planning to
study.
• This means specifying exactly how these will be measured or
defined in the proposed study.
• Quality control procedures should be specified.
•If the procedure is a standard one that has been described before, it
should be referenced.
35. Methodology
Data collection methods: definitions and measurements
This includes:
o Precise definitions of all terms
o Consideration of pilot testing for methods and instruments
o Discussing the limitations of the measurement tools and
definitions proposed
36. Methodology
Example:
o How will the presence of asthma be determined?
o What will happen if someone who doesn’t have asthma is said to
have it?
o What is the definition of indoor pollution?
o Which components of indoor pollution will be evaluated?
o How will socio-economic status be determined?
37. Methodology
Data: management and analysis
o Procedures for coding and data entry
o Measures to ensure completeness and accuracy
o Examples of data presentation and comparisons
o Formal hypothesis testing
38. Strengths and Limitations
Issues
o Compromises have to be made in design
o There is no “perfect protocol”: provide a section discussing areas
open to criticism; provide reasoning for accepting limitations.
39. Ethical Considerations
o How the quality of technical aspects is ensured
o The expected hazards and benefits
o The rational and justification for the research
o The priority of participants’ interest
o Responsibility for liability for injury
o How participants are informed about study
o How participants give consent for enrolment
40. Ethical Considerations
Example:
o Will any child be at risk from a reaction to the allergy skin tests?
o Who will provide consent for the child to participate?
o Who will know about the results of the examinations?
o What will be done if disease is found?
41. Significance (expected impact)
This section restates the justification for the study in terms of the
anticipated results. It will specify:
o The implications of the potential results
o How the results of the study may be used by your own research
team in the future, by other researchers, by policy makers, by the
community
42. Questions that the Study Description must answer
Why? - Sets out the study question and the relevant background information
How?- Describes the study design and the rationale for choosing it
Who?- Defines the target and study populations and sample size
What?- Identifies the variables to be measured, instruments to use and outcomes to be analyzed
So what?- Comments on the expected significance of results and contribution to knowledge
43. Template: Standard Protocol
Title
Background
Aims & objectives
Materials & methods
◦ Study design
◦ Study population
◦ Sample size and statistical power
◦ Subjects: selection and definitions
◦ Data collection methods: measurements, definitions
◦ Data management and statistical analysis
Conclusion
Reference
The research protocol contains all elements except study results and their discussion that will also
provide the backbone of the ultimate research paper
44.
45.
46. What exactly is an ‘Operational Verb?
•Verbs that denote the descriptive or analytical nature of the research question.
• Operational or active verb mean that the verb denotes "measurable or operational
aspect" of the descriptive or analytical nature of the research question.
•Descriptive studies: Estimate, Describe, Measure, Quantify, Explore, Characterize.
• Analytical studies: Determine, Investigate, Examine, Estimate/Measure association,
Identify.
Editor's Notes
Deductive Science
Scientific knowledge accumulated through reason and intuition
Inductive Reasoning
Observations and perceptions of natural phenomena are the ultimate judge of knowledge (Inference by observation)
What we need is a combination
