1. Developing a Research Question and Writing a Proposal GH531/ Epi539 2016

2. Defining a research question Clarify what you are planning to do –For yourself –For potential funders General objective (Broad Goals) –Ideas: more conceptual –Some reference to setting/population but need not be specific Specific study questions (Specific Aims) –Exactly what you will be doing –Be specific! Should explicitly state (or strongly suggest) study methodology that will be detailed later

3. Study questions – example 1 You are a researcher interested in studying the prevalence of malnutrition among Bolivian children General objective To determine the most important factors related to malnutrition in Bolivian children Specific study questions:

4. Study questions – example 1 You are a researcher interested in studying the prevalence of malnutrition among Bolivian children General objective To determine the most important factors related to malnutrition in Bolivian children Specific study questions: What is the prevalence of wasting (Wt/Ht < 2z) among Bolivian children, ages 12-24 months, attending 20 randomly selected immunization clinics in Cochabamba Department, Bolivia? Is there a significant difference in potential factors associated with malnutrition (e.g., mother’s education completion level, age, reported family income) between children diagnosed as wasted vs. those who are not?

5. Study questions – example 2 General objective: To define the health and economic burden from injury in a developing country and to define the major mechanisms of injury contributing to this burden. Specific study questions:

6. Study questions – example 2 General objective: To define the health and economic burden from injury in a developing country and to define the major mechanisms of injury contributing to this burden. Specific study questions: To obtain population based estimates of the incidence of injury in the city of Kumasi and the Berekum District in Ghana; To estimate the morbidity costs due to injury, by estimating time lost from work or school; To estimate the direct costs of medical care for injury; To estimate all of the above overall and by mechanism; To estimate the overall incidence of injury related mortality.

7. Study questions – example 3 You are a researcher interested in knowing if activists can improve ART utilization among pregnant women in pMTCT programs General objective To determine the impact of using activists for improving utilization of ART among pregnant women attending pMTCT programs

8. Study questions – example 3 You are a researcher interested in knowing if activists can improve ART utilization among pregnant women in pMTCT programs General objective To determine the impact of using activists for improving utilization of ART among pregnant women attending pMTCT programs Specific study questions: Among 10 health facilities in central Mozambique, is the proportion of ART-eligible women who are started on ART within 30 days of initial HIV testing significantly greater in 5 clinics with activists compared to 5 clinics without activists?

9. Model Proposal for 531/539 Should be 2000 words (8 pages double spaced); but can include additional brief material in appendix (such as a questionnaire, if applicable).

10. FOR 2016 (38 points total) TITLE PROBLEM AND RATIONALE (“Introduction”) 4 –Include LITERATURE REVIEW, but be brief in this assignment. Fit the questions you will be asking into context of existing information. Show importance of your study question. FOR THIS COURSE, LIMIT THIS SECTION TO ONLY 1 – 2 PARAGRAPHS, The emphasis should be on the study methods, rather than the background. GENERAL OBJECTIVES (with potential policy impact) 2 SPECIFIC STUDY QUESTIONS / AIMS 2 METHODOLOGY (24 total) –Study type (descriptive, case-control, cohort, etc.) 1 –Study/target population and universe 1 –Sampling strategy and recruitment 2 –Indicators (of what, measure) 2 –Data collection strategy & study instruments (e.g., questionnaire, test) 6 Examples of questions and specifics of measurement Reliability and validity If full QA available, include as appendix. –Basic analysis plan 4 Dependent and independent variables, numerator and denominator (if applicable) Statistical measures of description and association (if applicable) Dummy tables (if applicable) –Sample size and Power 2 (NB: This is different from sampling strategy) –Ethical issues, consent, and authorization / approval (government, IRBs, etc). 2 What letters of support would need to be included with the proposal. –Limitations of study design 4 To what extent does the study design address the question? Representativeness of the sample to the target population Misclassification and measurement error Comparability of groups (if analytical study) Generalizability CHRONOLOGY 1 BUDGET AND PERSONNEL 1 –Personnel, material, transport, food, lodging required –Indicate other resources available DISSEMINATION / POLICY IMPACT PLAN 2 READABILITY, PRESENTATION, FORMATTING 2

11. Chronology: Gantt chart

12. BUDGET ITEMUNIT COSTTOTAL PERSONNEL Study Nurse$150 / month x 18 months$2700 Data entry$0.20 / record x 2400 records $480 SUPPLIES AND EQUIPMENT Forms$500 TRANSPORTATION AND TRAVEL Transport costs for nurses$3 / day x 18 months$1620 Airfare for PI to visit site$1000 / trip x 2 trips$2000 SERVICES Training Course$130 per medic x 23$2990 MISCELLANEOUS Telecommunications$710 Total Direct Costs$11,000 Indirect Costs (10% of direct)$1,100 TOTAL$12,100

13. FOR 2016 (38 points total) TITLE PROBLEM AND RATIONALE (“Introduction”) 4 –Include LITERATURE REVIEW, but be brief in this assignment. Fit the questions you will be asking into context of existing information. Show importance of your study question. FOR THIS COURSE, LIMIT THIS SECTION TO ONLY 1 – 2 PARAGRAPHS, The emphasis should be on the study methods, rather than the background. GENERAL OBJECTIVES (with potential policy impact) 2 SPECIFIC STUDY QUESTIONS / AIMS 2 METHODOLOGY (24 total) –Study type (descriptive, case-control, cohort, etc.) 1 –Study/target population and universe 1 –Sampling strategy and recruitment 2 –Indicators (of what, measure) 2 –Data collection strategy & study instruments (e.g., questionnaire, test) 6 Examples of questions and specifics of measurement Reliability and validity If full QA available, include as appendix. –Basic analysis plan 4 Dependent and independent variables, numerator and denominator (if applicable) Statistical measures of description and association (if applicable) Dummy tables (if applicable) –Sample size and Power 2 (NB: This is different from sampling strategy) –Ethical issues, consent, and authorization / approval (government, IRBs, etc). 2 What letters of support would need to be included with the proposal. –Limitations of study design 4 To what extent does the study design address the question? Representativeness of the sample to the target population Misclassification and measurement error Comparability of groups (if analytical study) Generalizability CHRONOLOGY 1 BUDGET AND PERSONNEL 1 –Personnel, material, transport, food, lodging required –Indicate other resources available DISSEMINATION / POLICY IMPACT PLAN 2 READABILITY, PRESENTATION, FORMATTING 2

14. DISSEMINATION / POLICY IMPACT PLAN Discuss impact you think study finds will have. –Influence future research –Change medical practice –Change health practices of the public –Change policy Discuss plan to disseminate the findings: –E.g. report to ministry –Scientific publication (what journals) –Scientific presentation (what meetings).