The way things are going to be Writing a protocol for an epidemiological study FETP India.

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. Identify topic, question and objectives 2. Outline a one-page concept paper3. Prepare dummy tables4. Write draft protocol5. Prepare instruments and annexes 6. Submit to peer review7. Seek ethical committee clearance

The life cycle of an epidemiological investigation

Identifying data needs

Spelling out the research question

Formulating the study objectives

Planning the analysis

Preparing data collection instruments

Analysing data

Drawing conclusions

Formulating recommendations

Involving the programme

Collecting data

Working with public health managers to identify data needs

• 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

• 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

• 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

• Write a short presentation:1. Summarize the background2. Start from a problem statement3. Document the importance of the problem4. Analyze causes and consequences5. Summarize what is being done to address it so far6. Make an inventory of the known and the unknown7. Write the research question8. Specify the study objective 9. Anticipate what would be done with results in hands

• Share with public health managers, mentors • Revise, revise and revise

Concept paper

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

• Background and justification• Objectives• Methods• Expected benefits • Budget

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

• Objectives• Methods• Expected benefits • Budget

Concept paper

Background and justification:Example

Concept paper

• 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


• 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

Concept paper

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


• Background and justification• Objectives• Methods

Outline of the methods One bullet per point

• Expected benefits • Budget

Concept paper

Outline of the methods

• 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


• 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


• 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


• 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


• 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



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

Dummy table for iodine deficiency study

(Analytical stage)

Prevalence Prevalence ratio (95% confidence

interval)Exposures Exposed Unexposed

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 first draft of the protocol

• 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• Background and justification• Objectives• Methods• Expected benefits • Budget

First draft

Outline of the protocol


Take from concept paper

First draft



Expansion of the concept paper with full sentences and few additional details

First draft


• Background and justification• Objectives• Methods

Require many more additional details

• Expected benefits • Budget

First draft

Outline of the methods

• 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 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 :

• 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

• 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: 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: Minimization of risks (Confidentiality) Maximization of benefits Compensations (without undue incentive) Informed consent Approval procedures (Ethical committee)

First draft


1. Identify topic, question and objectives 2. Outline a one-page concept paper3. Write the first draft of the protocol4. Prepare instruments and annexes 5. Submit to peer review6. Propose to ethical committee7. 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

• Procedures• Training framework for field workers• Patient recruitment material• Adverse event management form• Consent forms

First draft

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

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

• Obtain guidance• Prepare protocol and annexes• Write cover letter• Obtain feedback• Follow directions and include requested

changes

Review

Finalizing a protocol

• 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

The way things are going to be Writing a protocol for an epidemiological study FETP India.

Documents

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