From a research question to study objectives

Key areas

• Levels in fundamental or applied research

• Working with policymakers to understand their data needs

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

Fundamental and applied epidemiological projects

Type of projects Objective of the investigations

Relevance to field epidemiology

Fundamental researchTheoretical rationale

-

Applied research Efficacy +

Prevention research Effectiveness ++

Assessment, monitoring and evaluation

Implementation +++

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

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

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

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

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

Pertussis cases per 100,000 inhabitants by year, 1985-2009,

Poland

0

2

4

6

8

10

1985 1990 1995 2000 2005

Year

Noti

fica

tions

/ 100,0

00

Source: NIPH, Poland

Pertussis cases, by age group, 1985-2008, Poland

0 %

20 %

40 %

60 %

80 %

100 %

1985 1989 1993 1997 2001 2005

Year

Pro

port

ion o

f noti

fied c

ase

s

0-4 5-9 10-14 >15 Source: NIPH, Poland

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

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

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”

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

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

1 1Health

problem

Determinants

Direct contributing

factors

Indirect contributing

factors

Consequences: -1 -2 -3

2

3

2

<Specify>

<Specify>

<Specify>

Determinants and contribution factors diagram for a public health

problem

Possible intervention 1

Possible intervention 2

Possible intervention 3

Pertussis

Exposure

Health problem

Determinants

Direct contributing

factors

Identifi-cation ofcandidate

strains

Treatment

Ineffectivevaccine?

(coverage 95%)

HCWs

Teachers /Police

An analysis of the problem:Pertussis in Poland

Immuni-zation

boosterdoses

travel

Strainreplacement

Young children:- death- disability

Adults:- Loss of productivity

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

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

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

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

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

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

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

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.

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

Framing the research question

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

Objectives of the study

• To measure incidence of pertussis among adults with prolonged cough

• To compare obtained estimates with notification rates

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?

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 publichealth questions is:– Useful

– Gratifying

The life cycle of epidemiological investigations: The never ending

storyIdentifying 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

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