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

2. Competency to be gained from this lecture Write a protocol for an epidemiological investigation

3. Key areas Concept paper First draft of the protocol Review

4. The seven steps of a successful protocol 1.Identify topic, question and objectives 2.Outline a one-page concept paper 3.Prepare dummy tables 4.Write draft protocol 5.Prepare instruments and annexes 6.Submit to peer review 7.Seek ethical committee clearance

5. The seven steps of a successful protocol 1.Identify topic, question and objectives 2.Outline a one-page concept paper 3.Prepare dummy tables 4.Write draft protocol 5.Prepare instruments and annexes 6.Submit to peer review 7.Seek ethical committee clearance

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. First step, in practice Write a short presentation: 1.Summarize the background 2.Start from a problem statement 3.Document the importance of the problem 4.Analyze causes and consequences 5.Summarize what is being done to address it so far 6.Make an inventory of the known and the unknown 7.Write the research question 8.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

13. The seven steps of a successful protocol 1.Identify topic, question and objectives 2.Outline a one-page concept paper 3.Prepare dummy tables 4.Write draft protocol 5.Prepare instruments and annexes 6.Submit to peer review 7.Seek ethical committee clearance

14. 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

15. Outline of the one-page, bullet-style, concept paper Background and justification Objectives Methods Expected benefits Budget Concept paper

16. 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 Objectives Methods Expected benefits Budget Concept paper

17. 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

18. 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

19. 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

20. 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

21. Outline of the methods Study design Study population Operational definitions Sampling procedure Sample size Data collection Analysis plan Human subjects protection Concept paper

22. 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

23. 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

24. 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

25. 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

26. Outline of the one-page, bullet-style, concept paper Background and justification Objectives Methods Expected benefits  What action will be taken following results  Future operational research agenda Budget Concept paper

27. 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

28. Outline of the one-page, bullet-style, concept paper 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

29. Budget: Example Per diem  USD 1500 Travel  USD 1500 Supplies  Laboratory reagents, drugs, stationary)  USD 2000 Total  USD 5000 Concept paper

30. The seven steps of a successful protocol 1.Identify topic, question and objectives 2.Outline a one-page concept paper 3.Prepare dummy tables 4.Write draft protocol 5.Prepare instruments and annexes 6.Submit to peer review 7.Seek ethical committee clearance

31. Dummy table for iodine deficiency study (Analytical stage) Prevalence Prevalence ratio (95% confidence interval) ExposuresExposedUnexposed Female sexXX/XX (XX%) XX (XX-XX) MuslimXX/XX (XX%) XX (XX-XX) Age > 30XX/XX (XX%) XX (XX-XX) Below poverty lineXX/XX (XX%) XX (XX-XX) Schedule casteXX/XX (XX%) XX (XX-XX)

32. The seven steps of a successful protocol 1.Identify topic, question and objectives 2.Outline a one-page concept paper 3.Prepare dummy tables 4.Write draft protocol 5.Prepare instruments and annexes 6.Submit to peer review 7.Seek ethical committee clearance

33. 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

34. The outline of the protocol is identical to the outline of the concept paper Background and justification Objectives Methods Expected benefits Budget First draft

35. Outline of the protocol Background and justification Objectives Methods Expected benefits Budget Take from concept paper First draft

36. Outline of the protocol Background and justification Objectives Methods Expected benefits Budget Expansion of the concept paper with full sentences and few additional details First draft

37. Outline of the protocol Background and justification Objectives Methods  Require many more additional details Expected benefits Budget First draft

38. 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

39. 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

40. 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

41. 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

42. Operational definitions paragraph Spells out and justifies:  Key outcomes  Key exposures Clarity and specificity essential References if applicable First draft

43. 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

44. 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

45. 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

46. The analysis plan paragraph Data entry Software used Recoding stage Descriptive stage  Prevalence, incidence Analytical stage  Univariate  Stratified  Multivariate analysis First draft

47. 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

48. 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

49. The seven steps of a successful protocol 1.Identify topic, question and objectives 2.Outline a one-page concept paper 3.Write the first draft of the protocol 4.Prepare instruments and annexes 5.Submit to peer review 6.Propose to ethical committee 7.Finalize First draft

50. Data collection instruments Present all data collection instruments  Questionnaires  Abstraction forms  Structured observation guides Drafts may evolve as the protocol evolves First draft

51. Annexes Procedures Training framework for field workers Patient recruitment material Adverse event management form Consent forms First draft

52. The seven steps of a successful protocol 1.Identify topic, question and objectives 2.Outline a one-page concept paper 3.Prepare dummy tables 4.Write draft protocol 5.Prepare instruments and annexes 6.Submit to peer review 7.Seek ethical committee clearance

53. Rationale of peer review Obtain feedback Ensure quality Facilitate ethical committee approval Review

54. 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

55. The seven steps of a successful protocol 1.Identify topic, question and objectives 2.Outline a one-page concept paper 3.Prepare dummy tables 4.Write draft protocol 5.Prepare instruments and annexes 6.Submit to peer review 7.Seek ethical committee clearance

56. Rationale of ethical committee Protect human subjects Document conformity to principles Ensure quality Review

57. 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

58. Ethical committee approval Obtain guidance Prepare protocol and annexes Write cover letter Obtain feedback Follow directions and include requested changes Review

59. Finalizing a protocol Disseminate Keep and use for reference Use for report writing Archive Review

60. Take home messages Always start with a concept paper Unfold the protocol logically from the objectives Revise, revise and revise

61. 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