1. From a research question to study objectives

2. Key areas Levels in fundamental or applied research Working with policymakers to understand their data needs

3. Asking yourself the right question Two ways to deal with a poor or irrelevant research question: –Try to answer it The answer may be of no use of anyone There may be no answer… –Try to reframe it If your research question is wrong: –No matter how much effort you put in your study, it will be irrelevant… If your research question is right: –You have an opportunity to do a good job

4. Fundamental and applied epidemiological projects Type of projects Objective of the investigations Relevance to field epidemiology Fundamental researchTheoretical rationale- Applied researchEfficacy+ Prevention researchEffectiveness++ Assessment, monitoring and evaluation Implementation+++

5. Progressing towards applied research questions: Immunization example Fundamental research –Studies assessing candidate vaccine antigens Applied investigation –Clinical trials Prevention research –Social marketing, cost effectiveness Assessment, monitoring and evaluation –Post implementation evaluation, coverage survey

6. Data needs assessment Identify public health problems Estimate public health importance Analyze problems Review what is being already done Identify information needed for decision making/policy change

7. Data needs assessment Identify public health problems Estimate public health importance Analyze problems Review what is being already done Identify the information needed to improve

8. Identification of a public health problem Any disease, injury, risk factor, environment threat or social condition that can cause death / disability Points that need to be characterized –What Nature / etiology of the condition –How much Magnitude –Who Population at risk –Where Geographic locations –When Time of occurrence / seasonal variations

9. Health problem statement: Example Pertussis rates in Poland, increased from 0.8 to 8 per 100,000 between 1993 and 2004, particularly affecting adolescents and adults, which maintain circulation Specifies: –What –Where –How much –When –Who

10. Pertussis cases per 100,000 inhabitants by year, 1985-2009, Poland Source: NIPH, Poland

11. Pertussis cases, by age group, 1985- 2008, Poland Source: NIPH, Poland

12. Data needs assessment Identify public health problems Estimate public health importance Analyze problems Review what is being already done Identify the information needed to improve

13. Criteria used to assess the public health importance of a problem Burden of disease –Use local, national and international estimates Death Disease Disability Economic losses Recent emergence Availability of effective interventions Cost effectiveness of interventions

14. Public health importance of pertussis in Poland Burden –Pertussis in unvaccinated infants can be fatal –Untreated pertussis in adults: loss of productivity –Estimated 300,000 deaths worldwide (13 million DALYs/year) Possible interventions –Targeted antibiotic decreases complications –Vaccination: immunity ~ 10 years Recommended “cocoon strategy”

15. Data needs assessment Identify public health problems Estimate public health importance Analyze problems Review what is being already done Identify the information needed to improve

16. Analysing a public health problem: Spreading out issues to identify options Identify the problem –E.g., High pertussis rates –Increase of disease transmission among adults Identify causes –Immediate determinants E.g., Waning immunity Surveillance bias –Direct and indirect contributing factors E.g., Changes in pertussis strains Identify consequences –E.g., Increased risk for unvaccinated infants Identify possible solutions –E.g., Implement booster doses in adults –Identify candidate strains for vaccine

17. 1 1 Health problem Determinants Direct contributing factors Indirect contributing factors Consequences: - 1 - 2 - 3 2 3 2 Determinants and contribution factors diagram for a public health problem Possible intervention 1 Possible intervention 2 Possible intervention 3

18.    Pertussis    Exposure Health problem Determinants Direct contributing factors Identifi- cation of candidate strains Treatment Ineffective vaccine? (coverage 95%) HCWs Teachers / Police An analysis of the problem: Pertussis in Poland Immuni- zation booster doses travel Strain replacement Young children: - death - disability Adults: - Loss of productivity

19. Data needs assessment Identify public health problems Estimate public health importance Analyze problems Review what is being already done Identify the information needed to improve

20. Reviewing planned, ongoing or completed interventions Locate the level of the various interventions: –Determinants –Contributing factors Review effectiveness Estimate cost effectiveness Analyze implementation status –Input –Process –Outcome

21. Interventions for pertussis in Poland Treatment of cases –Antibiotics and supportive treatment Immunization –Intervention 3 doses of primary vaccination 2 boosters during the 2nd and 6th year –Implementation Reported coverage: 95% No validation No monitoring of high-risk groups

22. Data needs assessment Identify public health problems Estimate public health importance Analyze problems Review what is being already done Identify the information needed to improve

23. Identifying the information needed to allow better prevention and control Is the problem a consequence of a failure to implement a well validated strategy? –Need of assessment, monitoring and evaluation Is the problem a consequence of difficulty to apply a recommended strategy? –Need of prevention research Is the problem a consequence of a limitation or of a lack of validated strategy (i.e., the recommendations are implemented but they don’t work)? –Applied investigation

24. Making sure you are not re-inventing the wheel Identify what is known (easy) –Guidelines –Recommendations –Reviews –Literature search Identify what is not known (difficult) –Meeting reports –Research agenda –Expert opinion

25. What is known and unknown about pertussis in Poland Established facts –Primary immunization protects small children –Boosters are needed for limiting transmission –Reported vaccine coverage is high –Seroprevalence indicate high circulation among adults Areas of uncertainty: –Vaccine failure? Is the vaccine as effective as it is supposed to be ? –Role of particular adult groups in infant exposure Evidence needed for vaccination of adults

26. Prevalence of anti-Ptx IgG antibodies in the Netherlands, 2006-2007 Source: de Greeff SC, et al. PLoS One. 2010 Dec 1;5(12):e14183.

27. Anticipating what will be done with the information that will be delivered by an applied research project Anticipate the various possible results of the study –Imagine scenarios of various possible answers to the research question Identify the kind of public health action that could be realistically taken for each case scenario

28. Framing the research question To provide evidence for possible introduction of booster pertussis vaccination among adults (prioritize either universal adult vaccination or cocoon strategy).

29. Objectives of the study To measure incidence of pertussis among adults with prolonged cough To compare obtained estimates with notification rates

30. Expected benefit of pertussis study in Poland If the study will identify adult groups with high burden of pertussis –Evidence for strenghtening “cocoon” strategy –Evidence for recommending booster vaccination in adults Potential validation of surveillance figures Possible next question –What is the best strategy to use to increase the coverage of booster among adults?

31. Evolving public health concepts are like onions being peeled Sound answers to good research question allow prevention BUT bring new questions These questions should be framed with the same careful methods Addressing consecutive public health questions is: –Useful –Gratifying

32. The life cycle of epidemiological investigations: The never ending story 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 Here we go again

33. Take home messages Work with public health managers –to understand the public health problem –to apply your results immediately Imagine yourself with your results in hands –Imagine how they would contribute to better health –Determine how the results will guide new prevention / control opportunities