The way things are going to be
Writing a protocol for an
epidemiological study
FETP India
Competency to be gained
from this lecture
Write a protocol for an
epidemiological investigation
Key areas
• Concept paper
• First draft of the protocol
• Review
The seven steps of a successful protocol
1.
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6.
7.
Identify topic, question and objectives
Outline a one-page concept paper
Prepare dummy tables
Write draft protocol
Prepare instruments and annexes
Submit to peer review
Seek ethical committee clearance
The seven steps of a successful protocol
1.
2.
3.
4.
5.
6.
7.
Identify topic, question and objectives
Outline a one-page concept paper
Prepare dummy tables
Write draft protocol
Prepare instruments and annexes
Submit to peer review
Seek ethical committee clearance
The life cycle of an epidemiological
investigation
Identifying
data needs
Involving the
programme
Spelling out the
research question
Formulating
recommendations
Formulating the
study objectives
Drawing conclusions
Planning the
analysis
Analysing data
Preparing data
collection instruments
Collecting data
Working with public health managers to
identify data needs
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Identify public health problems
Estimate public health importance
Analyze problems
Review what is being already done
Identify the information needed to improve
Concept paper
The research question
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Frames the problem in public health terms
Focuses on one issue
Is written in everyday language
Can use more than one verb
Is general
Should link the question to the potential
action that would be taken once the
question is answered
Concept paper
The research question:
Example
• We would like to understand why some
tuberculosis patients do not complete their
DOTs treatment so that we could address
these issues and improve completion rate
Concept paper
The study objectives
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Frame the problem in epidemiological terms
Take the question in a few limited axis
Is written using epidemiological language
Make use of no more than one verb each
May be sorted out as primary and secondary
Should be clear about whether:
 They call for testing a hypothesis
 They call for measuring a quantity
Concept paper
Study objective:
Example
• Compare defaulters and non defaulters in
terms of a number of characteristics that
may be associated with observance among
tuberculosis patients treated with Directly
Observed Therapy (DOTs)
Concept paper
First step, in practice
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Write a short presentation:
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Summarize the background
Start from a problem statement
Document the importance of the problem
Analyze causes and consequences
Summarize what is being done to address it so far
Make an inventory of the known and the unknown
Write the research question
Specify the study objective
Anticipate what would be done with results in hands
Share with public health managers, mentors
Revise, revise and revise
Concept paper
The seven steps of a successful protocol
1.
2.
3.
4.
5.
6.
7.
Identify topic, question and objectives
Outline a one-page concept paper
Prepare dummy tables
Write draft protocol
Prepare instruments and annexes
Submit to peer review
Seek ethical committee clearance
Rationale for using a
one-page concept paper
• Time is precious
 For you
 For your supervisor
• Brevity forces focus
• Many concept papers are not developed
 Save time for an idea that may abort
Concept paper
Outline of the one-page, bullet-style,
concept paper
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Background and justification
Objectives
Methods
Expected benefits
Budget
Concept paper
Outline of the one-page, bullet-style,
concept paper
• Background and justification
 Importance of the problem
 What is being done to address it
 The information that is missing to prevent/
control more effectively
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Objectives
Methods
Expected benefits
Budget
Concept paper
Background and justification:
Example
• In India, anemia is common among
adolescent girls, particularly tribes
• The Government of India supplements
adolescent girls with iron and folic acid in
several states, but not in Madhya Pradesh
• It is unclear whether it is feasible to
supplement tribal adolescent girls with iron
and folic acid in Madhya Pradesh
Concept paper
Outline of the one-page, bullet-style,
concept paper
• Background and justification
• Objectives
 2-3 objectives
 Can be general and specific
 Can be primary and secondary
• Methods
• Expected benefits
• Budget
Concept paper
Objectives: Example
1. To estimate the prevalence of iron
deficiency anemia among adolescent girls
before and after a pilot supplementation
intervention
2. To identify the factors associated with
coverage
Concept paper
Outline of the one-page, bullet-style,
concept paper
• Background and justification
• Objectives
• Methods
 Outline of the methods
 One bullet per point
• Expected benefits
• Budget
Concept paper
Outline of the methods
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Study design
Study population
Operational definitions
Sampling procedure
Sample size
Data collection
Analysis plan
Human subjects protection
Concept paper
Methods: Example (1)
• Study design
 Pilot intervention with pre and post cross
sectional studies
• Study population
 Adolescent tribal girls aged 12-19 years, Mandla
district, MP, India
• Operational definitions
 Use of WHO criteria to define anemia
Concept paper
Methods: Example (2)
• Sampling procedure
 Cluster sample of the study population
• Sample size
 Considering 95% confidence interval, 20%  error,
allowing 20% dropout, expecting a difference of
1g% of hemoglobin level, a total of 168
adolescent girls will be required
Concept paper
Methods: Example (3)
• Data collection
 Field worker will collect data under supervision
from primary investigator
 Baseline and post intervention estimation of Hb
using cyanmethaemoglobin method
 Collection of data using semi-structure
questionnaire on demographic characteristics,
knowledge and socio-cultural practices after the
intervention
Concept paper
Methods: Example (4)
• Analysis plan
 Descriptive and multivariate analysis of data to:
• Estimate the prevalence of anemia before and after
• Identify factors associated with (a) tablet consumption
and (b) anemia in the post intervention phase
• Human subjects protection
 Confidentiality protection
 Written informed consent will be obtained from
adolescent girls and their guardians
 Protocol submitted for ethical clearance
Concept paper
Outline of the one-page, bullet-style,
concept paper
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Background and justification
Objectives
Methods
Expected benefits
 What action will be taken following results
 Future operational research agenda
• Budget
Concept paper
Expected benefits: Example
• Output
 Documented report shared with local health
authorities
• Outcome
 Enable local authorities to implement the
programme on a larger scale after taking
cognizance of compliance issues identified
through the study
Concept paper
Outline of the one-page, bullet-style,
concept paper
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Background and justification
Objectives
Methods
Expected benefits
Budget
 4-5 lines
 No detailed justification
 Divided in salaries/per diem, travel, equipment
& supply and miscellaneous
Concept paper
Budget: Example
• Per diem
 USD 1500
• Travel
 USD 1500
• Supplies
 Laboratory reagents, drugs, stationary)
 USD 2000
• Total
 USD 5000
Concept paper
The seven steps of a successful protocol
1.
2.
3.
4.
5.
6.
7.
Identify topic, question and objectives
Outline a one-page concept paper
Prepare dummy tables
Write draft protocol
Prepare instruments and annexes
Submit to peer review
Seek ethical committee clearance
Dummy table for iodine deficiency study
(Analytical stage)
Prevalence
Exposures
Exposed
Unexposed
Prevalence ratio
(95% confidence
interval)
Female sex
XX/XX (XX%)
XX/XX (XX%)
XX (XX-XX)
Muslim
XX/XX (XX%)
XX/XX (XX%)
XX (XX-XX)
Age > 30
XX/XX (XX%)
XX/XX (XX%)
XX (XX-XX)
Below poverty line
XX/XX (XX%)
XX/XX (XX%)
XX (XX-XX)
Schedule caste
XX/XX (XX%)
XX/XX (XX%)
XX (XX-XX)
The seven steps of a successful protocol
1.
2.
3.
4.
5.
6.
7.
Identify topic, question and objectives
Outline a one-page concept paper
Prepare dummy tables
Write draft protocol
Prepare instruments and annexes
Submit to peer review
Seek ethical committee clearance
The first draft of the protocol
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Thought as it is written
Uses the concept paper outline
Keeps concept paper as summary
Does not exceed 2000 words
 Introduction < 20% of length
• Contains 5 – 10 key references
First draft
The outline of the protocol is identical to
the outline of the concept paper
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Background and justification
Objectives
Methods
Expected benefits
Budget
First draft
Outline of the protocol
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Background and justification
Objectives
Take from concept paper
Methods
Expected benefits
Budget
First draft
Outline of the protocol
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Background and justification
Objectives
Methods
Expected benefits
Budget
Expansion of the
concept paper
with full sentences
and few additional
details
First draft
Outline of the protocol
• Background and justification
• Objectives
• Methods
 Require many more additional details
• Expected benefits
• Budget
First draft
Outline of the methods
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Study design
Description of the interventions
Study population
Operational definitions
Sampling procedure
Sample size
Data collection
The analysis plan
Quality assurance
Human subjects protection
First draft
Study design paragraph
• Explains how the objectives lead to
indicators and to the study design
• Describes the type of study
 Cohort
 Case control
 Cross sectional
• Describes logistical arrangements
 Prospective
 Retrospective
First draft
Description of the interventions
• Applicable if an intervention is planned
 Clinical trial
 Community intervention
• Describes the “treatment” applied to the
intervention and control group
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Who?
What?
When?
How?
First draft
Study population paragraph
• Use time, place and person:
 Inclusion criteria
 Exclusion criteria
• May be added as a separate section but do not differ
conceptually from the inclusion criteria
• Do not confuse the study population and the
study sample
• Ensure that the study population is suitable
to address the objectives
First draft
Operational definitions paragraph
• Spells out and justifies:
 Key outcomes
 Key exposures
• Clarity and specificity essential
• References if applicable
First draft
Sampling procedure paragraph
• Describes and justifies:
 The type of sample used :
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Convenience sample (Avoid if possible)
Random sample
Systematic sample
Cluster sample
 The way the sample will be selected in practice
• Provides references if needed
• Explains randomization if applicable
First draft
Sample size paragraph
• Details all parameters used to estimate the
sample size
• Explains how the estimate was generated
 Software used
 Formula used
• Provides references if needed
First draft
Data collection paragraph
• Lists the data that will be collected
 Headings
 Bullet points
• Specifies how the data will be collected
 Who?
 How?
• Type of instrument to be used
• Type of data collection method
First draft
The analysis plan paragraph
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Data entry
Software used
Recoding stage
Descriptive stage
 Prevalence, incidence
• Analytical stage
 Univariate
 Stratified
 Multivariate analysis
First draft
Quality assurance paragraph
• Details the steps that will be used to ensure
data quality at all stages
• Addresses:
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Protocol writing
Data collection
Data entry
Data analysis
Reporting
First draft
Human subjects protection paragraph
• Explains the steps that will be used to
protect human subjects
• Addresses:
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Minimization of risks (Confidentiality)
Maximization of benefits
Compensations (without undue incentive)
Informed consent
Approval procedures (Ethical committee)
First draft
The seven steps of a successful protocol
1.
2.
3.
4.
5.
6.
7.
Identify topic, question and objectives
Outline a one-page concept paper
Write the first draft of the protocol
Prepare instruments and annexes
Submit to peer review
Propose to ethical committee
Finalize
First draft
Data collection instruments
• Present all data collection instruments
 Questionnaires
 Abstraction forms
 Structured observation guides
• Drafts may evolve as the protocol evolves
First draft
Annexes
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Procedures
Training framework for field workers
Patient recruitment material
Adverse event management form
Consent forms
First draft
The seven steps of a successful protocol
1.
2.
3.
4.
5.
6.
7.
Identify topic, question and objectives
Outline a one-page concept paper
Prepare dummy tables
Write draft protocol
Prepare instruments and annexes
Submit to peer review
Seek ethical committee clearance
Rationale of peer review
• Obtain feedback
• Ensure quality
• Facilitate ethical committee approval
Review
Peer review
• Submit to experts and colleagues
 Methodological experts
 Subject matter experts
• Ask for comments and suggestions
• Document how comments and suggestions
were addressed:
 Inclusion of the suggestions
 Reason for non inclusion
Review
The seven steps of a successful protocol
1.
2.
3.
4.
5.
6.
7.
Identify topic, question and objectives
Outline a one-page concept paper
Prepare dummy tables
Write draft protocol
Prepare instruments and annexes
Submit to peer review
Seek ethical committee clearance
Rationale of ethical committee
• Protect human subjects
• Document conformity to principles
• Ensure quality
Review
What protocol are submitted to the
ethical committee?
• All research protocols
 Even if no intervention
• Evaluation protocols that may expose
participants to risks
• Only the ethical committee can make a
decision of exemption
Review
Ethical committee approval
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Obtain guidance
Prepare protocol and annexes
Write cover letter
Obtain feedback
Follow directions and include requested
changes
Review
Finalizing a protocol
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Disseminate
Keep and use for reference
Use for report writing
Archive
Review
Take home messages
• Always start with a concept paper
• Unfold the protocol logically from the
objectives
• Revise, revise and revise
Additional resources on
protocol writing
• Concept paper:
 Example
 Template
• Case study on protocol writing (Scrub Typhus
in Darjeeling, Volume 2)
• Template protocol
• Guide to common errors in protocols (with
checklist)
• Dummy tables for field epidemiology