2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Research Methods: Introduction to Epidemiology

Operational Studies in Tuberculosis
Michael Lauzardo, MD
Principal Investigator, Southeastern National Tuberculosis Center
Center
Assistant Professor, Division of Pulmonary and Critical Care Medicine,
Medicine,
University of Florida College of Medicine
Deputy Health Officer for TB – State of Florida

Epidemiology The Public Health Cycle

y Is the process to study the distribution and determinants of disease

frequency
Measure/Evaluate
Epidemiology
y Is a discipline which approaches problems systematically and
quantitatively
Intervene Analyze
y Is the basic science of public health Epidemiology

Communicate

Epidemiology History of Epidemiology

y Disease frequency (descriptive):
y Quantifies the occurrence of disease
y Original focus was infectious disease epidemics
[How many?]
many?] y Current epidemiology is much broader
– Acute and chronic diseases
y Disease distribution (descriptive):
– Health events
y Who gets the disease? Where is the disease occurring? When is the
disease occurring? – Conditions
– Behaviors
y Disease determinants (analytic):
y Combination of first two (Why?
(Why?))

PAGE 1
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Populations The Epidemiologist’

Epidemiologist’s Toolbox

y Unit of observation is groups rather than individuals y Experimental Studies

– Investigators allocate the exposure
y Clinical observations and basic science inform epidemiology, but
epidemiology also informs clinical practice
y Observational Studies
– Understanding disease trends helps clinical providers with – Investigators observe natural course of events
their diagnoses

A Typical Epidemiological Approach (1) A Typical Epidemiological Approach (2)

y Assess validity of any observed association
y Determine the existence and magnitude of a problem – Exclude possible alternative explanations
y Chance
y Describe who has the problem:
y Bias - systematic data collection/interpretation error
– Person, place, and time y Confounding - other variables cause the observed association

y Develop hypotheses about why the problem occurs y Make judgement if a true cause-
cause-effect relationship exists between factor and
outcome
y Test these hypotheses using appropriate analytic study designs and
and
statistical techniques y Based on the findings, develop interventions

y Evaluate intervention effectiveness

Important Definitions

y Risk:
Risk: the statistical chance of being ill if one is exposed to some
factor

y Exposure:
Exposure: being in contact with, or having, a factor which may or
may not be the cause of illness Ratios, Proportions, and Rates
[other term used = risk factor]
factor]

PAGE 2
 2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Ratios Proportions
y Proportion = a ratio in which the numerator is included in denominator,
y Express the relationship of two quantities. These quantities often expressed as %
may be related or totally independent – e.g. 4/100 homeless individuals have TB = 4%
– x / (x+y) or x / y
y Prevalence = proportion of individuals in a population who have the disease
disease
(event)
y Example: A hospital sees 4000 male TB patients and 2000
female TB patients. – Point prevalence: # with disease / total # in population at a given point
in time
– The ratio of male to female TB patients = 4000 / 2000 =
2 / 1 = 2 to 1 – Period prevalence: # with disease any time during a given interval /
total # in population at mid-
mid-interval

Rates Comparison of Incidence and Prevalence

y A ratio with a distinct relationship between the numerator &
denominator, and time is an intrinsic part of the denominator y Prevalence =
y Incidence = quantifies the # of new events or cases of disease that Incidence X Duration of illness
develop in a population at risk during a specified time interval
y Prevalence is the product of incidence and disease duration
– Example:
South Africa had 346 new TB cases per 100,000 population in 2000

Incidence Rates Other Important Rates

y Cumulative incidence rate = # new cases during specified time period / y Morbidity: measure rate of illness/ time
total pop at risk at mid-
mid-interval
[note: assumes everyone in study for whole time period] y Mortality: measure rate of death/ time
– Crude mortality rate:
rate: the mortality rate from all causes of death for a specified
y Incidence density rate = # new cases during specified time period / total population
person-
person-time at-
at-risk – Cause-
Cause-specific mortality rate:
rate: the mortality rate from a specified cause for a
[note: accounts for different amounts of time in study] specified population

– Age-
Age-specific mortality rate:
rate: a mortality rate which limits both the numerator
and denominator to a particular age or age group

PAGE 3
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Estimated Annual Incidence of TB in High Burden

Countries, 1999 Examples

Population Cases
Country Rate x105 (thousands) (thousands)

1. India 185 998,056 1,847

2. China 103 1,266,838 1,300
7. Philippines 314 74,454 234
8. S. Africa 495 39,900 197
10. Viet Nam 189 78,705 149
13. Brazil 70 167,988 118
15. Kenya 417 29,549 123

All Roads Lead to Ratios Risk Ratio or Relative Risk

y The ratio of two ratios
y Proportions, such as PREVALENCE,
PREVALENCE, and Rates, such as y A way to compare risks in those exposed versus those not exposed
INCIDENCE,
INCIDENCE, are both specific types of ratios – If 4 in 100 people who are homeless develop TB (exposure=homeless),
(exposure=homeless),
then risk=4/100 = 0.04 =4%

y RELATIVE RISKS and ODDS RATIOS (to be discussed more – If 1 in 100 who are not homeless develop TB, then risk = 1/100 = 0.01 =
1%
later…
later…) are ratios of ratios
– Then the risk ratio is 4/100 divided by 1/100 = 4/1
– Homeless people are 4 times more likely to get TB as non-
non-homeless

Conclusion
y Epidemiology
– Is a basic tool for public health action
– Provides data for decision-
decision-makers
– Increasingly emphasizes development and evaluation of
control measures Study Design
y Application of findings to improve health

PAGE 4
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Questions for Study Design Study Types

y What is the purpose?
y Descriptive studies
y What information is needed to intervene?

y When is it needed? y Analytical studies

y What kind of study provides the answers? – Experimental
– Observational

Descriptive Studies Descriptive Studies: Person (1)

y Describes patterns of disease y Question: Who is getting the disease/event?

– person, place, time y Characteristics of person must include age and sex
y Provides data for program planning y Other characteristics
– high risk behaviors: alcohol use, smoking
y Provides data for resource allocation
– Homelessness, incarceration, income level, occupation, or others
y Generates hypotheses

Descriptive Studies: Person (2) Descriptive Studies: Person (2)

Death Rates per 100,000 from coronary disease in the Death Rates per 100,000 from coronary disease in the
US, 1981, by age and sex US, 1981, by age and sex
Age Men Women Age Men Women
0-4 2.2 2.0 0-4 2.2 2.0
5-14 0.9 0.8 5-14 0.9 0.8
15-
15-24 2.6 1.6 15-
15-24 2.6 1.6
25-
25-34 9.4 4.2 25-
25-34 9.4 4.2
35-
35-44 60.6 16.2 35-
35-44 60.6 16.2
45-
45-54 265.6 71.2 45-
45-54 265.6 71.2
55-
55-64 708.7 243.7 55-
55-64 708.7 243.7
65-
65-74 1669.9 769.4 65-
65-74 1669.9 769.4
75+ 5696.0 4215.1 75+ 5696.0 4215.1

PAGE 5
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Descriptive Studies: Place (1) Estimated Percent of New Cases that

are MDR-TB, 2000
y Question: Where are the rates of the disease highest and lowest? Where
do resources need to be targeted?
y Geographic characteristics can provide insights into disease etiology
etiology
y Geographic comparisons of disease frequency can be made
0 - 0.9
y Data can be efficiently presented in a pictorial manner 1 - 2.9
3 - 4.9
5 - 6.9
7 or more
No Estimate

Descriptive Studies: Time (1) Tuberculosis Morbidity in Russia

per 100,000 population

80
y Question: When does the disease (event) occur? Is the disease
frequency different now compared to the past? 70
y Changes in disease rates over time can signal an epidemic or 60
introduction of the causal agent
y Cyclic changes, such as seasonal patterns, are very valuable 50

40

30

20

10

0
70
72
74
76
78
80
82
84
86
88
90
92
94
96
98
19
19
19
19
19
19
19
19
19
19
19
19
19
19
19

Descriptive Studies:
Descriptive Studies: Types Correlational (Ecological)
y Correlational studies y Determines the relationship of disease and exposure in a population
population
y Case Reports and Case Series – Different groups, same time period
y Cross-
Cross-sectional Surveys – Same group, different time period
y Cannot link an exposure to the occurrence of disease in the individual
individual

PAGE 6
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Primary MDR TB in US-

US-born versus Foreign-
Foreign-born Descriptive Studies:
Persons, 1993-
1993-2001 Case Reports and Case Series

y Careful, detailed report(s)

report(s) by one or more clinicians
y No denominator
% new
TB
cases

Descriptive Studies Summary:

Cross-
Cross-sectional Study Descriptive Studies
y Both exposure and disease outcome is measured y Characterize disease by person, place, time
simultaneously y Three types: Correlational,
Correlational, case reports or case series, cross-
cross-sectional
y Generally used to determine association between disease and y Assist in generating hypothesis, but not used to test hypothesis
exposure
y Usually cannot establish if exposure came before or after

Study Types Analytic Studies (1)

y Descriptive studies
y Used to test epidemiologic hypotheses
y Identify risk factors
y Analytical studies
y Compare groups
– Observational
– Experimental or Intervention

PAGE 7
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Analytic Studies (2) Analytic Studies:

y Observational Studies
Case-
Case-Control Study
– Investigators observe natural course of events y Subjects are selected on basis of outcome status
– Two types – Case: Subject with outcome of interest
y Case-
Case-Control Study – Control: Subject without outcome of interest in the same
y Cohort Study population
y Experimental Studies y Exposure for two groups is determined
– Investigators control the exposure

EXPOSURE OUTCOME

Basic Analytical Approach in a Basic Analytical Approach in a

Case-Control Study Case-Control Study
Total population Total population

Exposed
Cases Cases
Non-Exposed

Exposed
Controls Controls
Non-Exposed

Basic Analytical Approach in a Basic Analytical Approach in a

Case-Control Study Case-Control Study
Total population Total population

Exposed Exposed
Odds Cases Odds Cases
Non-Exposed Non-Exposed

Odds Ratio

Exposed Exposed
Odds Controls Odds Controls
Non-Exposed Non-Exposed

PAGE 8
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Advantages and Disadvantages(1):

Example: Case-
Case-Control Study Case-
Case-Control

y “Smoking and mortality from TB and other diseases in India: y Advantages

retrospective study of 43,000 adult male deaths and 35,000 – Best design for rare outcome
controls,”
controls,” Gajalakshmi et al
– Can identify more than one exposure
– Cases: men who died of disease
– Relatively quick and inexpensive
– Controls: living men
– Exposure: Smoking

Advantages and Disadvantages(2): Analytic Studies:

Case-
Case-Control Cohort Study
y Disadvantages y Subjects are chosen on the basis of the presence or absence
– Not useful for rare exposures of exposure
– Not population-
population-based, cannot calculate incidence rates of disease y Subjects are followed for a specified period of time to
– Time relationship between exposure and disease may be difficult determine the development of outcome
to establish
– Prone to selection and recall bias
– Hard to ascertain exposure accurately

EXPOSURE OUTCOME

Analytic Studies: Analytic Studies:

Cohort Study Timing Cohort Study Timing
y Prospective: Subjects followed from time of exposure (present) y Retrospective: Exposure and outcome occurred in the past
to outcome (future)

Exposure Outcome Exposure Outcome

Past Present Future Past Present Future

(initiation of study) (initiation of study)
Timeline Timeline

PAGE 9
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Basic Analytical Approach in a Basic Analytical Approach in a

Cohort Study Cohort Study
Total population Total population

Outcome
Exposed Exposed
No Outcome

Outcome
Non-Exposed Non-Exposed
No outcome

Basic Analytical Approach in a Basic Analytical Approach in a

Cohort Study Cohort Study
Total population Total population

Outcome Outcome
Exposed Incidence Exposed Incidence
No Outcome No Outcome

Relative Risk

Outcome Outcome
Incidence Incidence
Non-Exposed Non-Exposed
No outcome No outcome

Advantages and Disadvantages:

Example: Cohort Study Cohort (1)

y “Effect of Highly Active Antir

ntiretroviral Therapy (HAART) on incidence of y Advantages
tuberculosis in South Africa: a cohort study,”
study,” Badri et al – Best design for studying common diseases or rare exposures
– Exposed: HIV patients receiving HAART – Can examine multiple outcomes
– Unexposed: HIV patients without HAART
– Can determine time relationship between exposure and outcome
– Outcome: active TB
– Can measure incidence of outcome

PAGE 10
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Advantages and Disadvantages: Analytic Studies Experimental/Intervention Study

Cohort (2)
y Disadvantages
y Type of cohort (ex: clinical trial)
– Is inefficient for rare diseases
y Exposure status is determined by the investigator
– Can be expensive and time-
time-consuming y Provides the most reliable evidence from epidemiologic
– Validity of the results can be seriously affected by losses to research
follow-
follow-up – randomization used to determine exposure status
– Requires the availability of adequate records if retrospective y Ethical issues
y Expensive

Design Choice Conclusion

y The choice of study design to use for a particular exposure-

exposure- y Descriptive studies describe patterns of disease occurrence
outcome relationship depends upon and allow the formulation of hypotheses
– The nature of the outcome under investigation y Analytic studies generally test epidemiologic hypotheses
– The type of exposure y For most epidemiologic hypotheses, it is necessary and
– The available resources desirable to employ both descriptive and analytic design
strategies

Steps in the research process

y Generate a research question
y Organize a team
y Draft a proposal/protocol
y Get TB Program and ethics approval

Writing a Research Proposal y

y
Test on a small scale (pilot) and revise proposal
Do study and analyze data
y Make conclusions for report and manuscript
y Disseminate information and plan action

PAGE 11
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

A good proposal…
proposal…
Why write a proposal?
y Focuses on a clear and specific research question
y To organize your own thinking and plans
y Uses a structured format
y To share your ideas
y Is easy to read and understand
– Why,
Why, what,
what, and how you want to do something
y Is detailed enough so any reader can understand
y To ask for funds
y Anticipates most questions and problems
y To obtain ethical clearance

A good proposal
A proposal starts with an important
idea
y Allows planning
y Helps secure support from supervisors and funders y A problem
y Makes doing the activity easy
y Makes doing the analysis easier
y A question
y Makes drawing conclusions easier
y Makes writing the report easier
y A hypothesis
– Cause => Effect

Examples of TB research questions Components of a proposal

1. Background/Rationale
y Why do patients interrupt TB treatment? 2. Objectives and hypothesis
y Why do TB drug shortages occur at district clinics? 3. Methods
y Does treatment failure predict MDR TB? 4. Ethics/Protection of human subjects
5. Timeline
y What kind of stigma is attached to TB? 6. Budget
y Is clinic-
clinic-based DOT more cost-
cost-effective than home-
home-based 7. Investigators and responsibilities
DOT? 8. Results dissemination
9. Appendices

PAGE 12
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Background: Components

y General background of issue

y Literature review and previous data
1. BACKGROUND/ RATIONALE – Has anyone studied this question before?
– If yes, are the answers relevant?
y Is it ethical to do it again? (Use of resources)
y Is it essential to do it again? (Justification)
=> Why is it important to do this study? – What will THIS study contribute?
y What is the funding source?
y What is the intended use of the findings?

Sources of information
y Peer-
Peer-reviewed books and articles, official statistics (best)
– Lancet, New England Journal of Medicine, JAMA, WHO
Bulletin, PanAmerican Journal of Public Health, International
2. OBJECTIVES AND HYPOTHESIS
Journal of TB and Lung Disease, etc.

y Health services reports (good)

=> What is the purpose of this study?

y Personal communications/anecdotal evidence (fair)

Objectives and hypothesis Objectives: Examples

y Objectives
– Statement of what you will do, short and clear – Measure body mass changes in children on TB treatment
in district X in 2004
– May be primary and secondary objectives – Identify the barriers to clinic access by TB patients in rural
– Must be specific and attainable areas in 2004
y Hypothesis:
– Compare the treatment outcomes of male and female
patients at health centre Y during 2003
– Cause => Effect – Determine whether previous TB treatment is a risk factor
– Concise, clear, specific for anti-
anti-TB drug resistance
– Compare the cost to society of home-
home-based and clinic-
clinic-
based DOT in province Z

PAGE 13
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

3. METHODS METHODS Components

Design
Intervention
=>“
=>“How are you going to do the study?”
study?” Study population
Study sample
Enrollment procedures
=>“
=>“Who are you studying?”
studying?” Data collection and variables
Data analysis
Limitations
=>“
=>“When will you do the study”
study”
Pilot study
Training

3.1 Design 3.2 Intervention(s)

Intervention(s)

y Descriptive study? y Refers to the intervention received by the study participants

y May have been administered in the past (retrospective study)
y Analytical study? (Asking WHY?)
y Can be more than one per study (describe all)
– Cross-
Cross-sectional y One can be the common standard of care, or no care
– Case-
Case-control y Description must be detailed enough
– Cohort
y Is it testing an intervention?
– Randomized controlled trial
y Prospective or retrospective?

Intervention: Example 3.3 Study Population

“The anti-
anti-TB drug regimens used in Country A and referred to in this y Exactly WHO will be studied
study, are defined as follows:
– Standardized treatment for MDR-
MDR-TB: Three months of PZA,
– Time, place, person
EMB, ethionamide,
ethionamide, kanamycin, and ciprofloxacin, followed with
15 months of PZA, EMB, ethionamide,
ethionamide, and kanamycin.
Treatment is administered daily and under direct observation. y Inclusion & exclusion criteria
– Individualized treatment for MDR-
MDR-TB: A treatment regimen of at – Stated exclusions – eg children, recent arrivals, prisoners,
least 18 months duration that includes at least five drugs, to extrapulmonary TB
which the organism has shown in vitro susceptibility. It is
administered daily under direct observation.”
observation.”

PAGE 14
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

Study Population: Example Inclusion and exclusion: Example

Participants Inclusion Criteria

y Patients who started treatment with second-
second-line drugs between August 1996 and
“The study population is made up of adult TB patients in Country March 2002. Patients with HIV disease, a history of renal insufficiency,
insufficiency, hepatitis, or
diabetes will be analyzed separately due to these medically complicating
complicating factors.
A who began treatment for MDR-
MDR-TB between August 1996 and Participant Exclusion Criteria
March 2002. These patients are distributed throughout Country A, y Children <= 18 years old, pregnant women, and/or those for whom treatment
outcomes cannot be determined with certainty.
however a majority of them are residents of the capital. Justification of Exclusion
y Establishing a culture-
culture-confirmed treatment outcome for children is much more difficult
than for adults. As this evaluation relies on knowing treatment outcomes, children
have been excluded. Lastly, MDR-
MDR-TB treatment and MDR-
MDR-TB treatment outcomes are
more complex for pregnant women, and thus pregnant women have been been excluded
from this evaluation.
Estimated Number of Participants: 2700

3.4 Case Definition Case Definition: Example

y Criteria for classifying subjects as cases or controls
y Does not need to be a TB case (depends on the study question)
y For the purposes of this study, a patient who received
MDR-
MDR-TB treatment is a patient who was enrolled in a
second-
second-line drug regimen for at least 1 day.

3.5 Study Sample

3.6 Participant enrollment
y Describe the sampling frame
– E.g.: clinic’
y How will eligible participants be identified
clinic’s patient registry
y Describe the sampling method y Will study participants be assigned a study ID number?
– Random, systematic, cluster, etc. y Who will talk to the eligible participants to ask them to
participate?
y Stratification?
y Will a form be filled at the time of enrollment?
y Indicate the sample Size (n=xx)
– Computer, table, formula, or statistician
– Based on estimated proportion of what is being measured,
precision and variation required

PAGE 15
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

3.7 Variables Variables : Examples

y List each variable necessary for the analysis y Socio-

Socio-demographic characteristics
– Dependent, independent, control…
control… – Gender, age, etc.
y Describe what it will look like and how it will be created y Culture dates and results
– Type (dummy, index, scale, categorical, etc.) y Treatment outcomes
– Values y Drug expiry dates
– Source of information y Distance between patient’
patient’s house and clinic
– Any recoding, calculations involved, etc. y Number of patients per DOT worker
y Patient’
Patient’s accurate knowledge of TB transmission
y Quality of TB services at clinics

3.8 Data collection Sources of data

y Design questionnaire/data collection forms y Records

y Describe the data collection process – Patient histories, lab registry, personnel roll, etc.
– Who will collect/abstract the data? y Interviews or surveys
– How many data collectors?
y Observations
– Who will supervise the data collection?
y Describe data entry process y Tests/instruments
– Who will enter the data?
– Software used?
– How will the data quality be checked?

3.9 Data analysis plan 3.10 Limitations

y Software used y Description of bias you might expect
y Statistical approach – Self-
Self-report bias
– Univariate – frequencies – Recall bias
– Bivariate – x by y tables – Lag-
Lag-time bias
– Multivariate (regression)
– Selection bias
y Planned tables and figures y Limitations in design that you cannot fix
y Can you estimate true cause -> effect?
Refer to objectives
and research question!

PAGE 16
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

3.11 Pilot Study 3.12 Training

y Purpose of training
y Purpose: to check study procedures:
– Understanding (survey questions) y Who will be trained, by whom
– Acceptability y What you will train them to do
– Feasibility y When training will occur
– Time, distances
– Further training needs
y Where training will take place

y Describe where, when and how pilot testing will occur

4. HUMAN SUBJECTS PROTECTION Informed consent

y Describe all measures taken to protect study participants from y Needed for research with human subjects
harm
y Must follow three principles
– Describe possible harm – pain, risks, embarrassment, costs,
costs & risks to health services – Participation is voluntary
– (How) will informed consent be obtained? – Participant must be able to understand the purpose of
the research, in language that is understandable
– How will confidentiality/privacy be protected
– Participation must NOT be coerced
– What will be done if a problem arises

Consent Form: Essential Components Examples of protective measures

y Describe nature of research and procedures
y Describe nature and duration of participation
y Risk & benefits (physical, psychological, social)
y Stress that participation is voluntary
y Must state that the participant can stop taking part at any time
y Describe how you will protect confidentiality
y Name of contact who can answer questions about the study
y Writing consent forms in simple language
y Translate consent forms into participants’
participants’ native language
y Not writing patients’
patients’ name on data collection forms
y Keeping filled forms in locked cabinets
y Destroy pages containing identifiers once data is entered
y Training data collectors to maintain confidentiality

PAGE 17
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

5. TIMELINE TIMELINE Continued

y Data collection Month 6-
6-8
y Work back from deadline
y Data entry & cleaning Month 8, 9
y Proposal writing Month 1-
1-2
y Analysis Month 9, 10
y Recruiting, training of field
y Report writing Month 11
workers & piloting Month 3
y Deadline for report Month 12
y Finalizing interview format Month 3
y Community meetings Month 12-
12-14
y Permission, ethical
y Conference presentation Month 12-
12-14
clearance, funding Month 5
y Data collection Month 6-
6-8

6. BUDGET BUDGET Continued

y What resources will be needed to conduct the study? y Stationary, photocopies, printing
y Salaries: Different personnel categories y Telephones, faxes, couriers, postage
– (Amount) x (duration) = Total y Report dissemination
y Training (equipment, space, refreshments, etc.) y Written
y Travel (airfare, bus fare, hotel, per-
per-diem) y Conference attendance
y Office accommodation and furniture y Community meetings – hire of hall, refreshments
y Equipment (computer, printer, software) y Administrative charges

8. RESULTS DISSEMINATION
7. INVESTIGATORS and RESPONSIBILITIES

y Name, title, affiliation • To whom will results be reported?

y Contact information for each • Unethical NOT to report research (whatever the results)
– Address, phone, fax, e-
e-mail • Variety of forums
y Describe in detail who will do what • conference, publication, report, community meeting

PAGE 18
2008 HEALTH RESEARCH IN THE AMERICAS IV: HIV/TB MODULE 1: RESEARCH METHODS

9. APPENDICES

y Information sheet and consent form

y Data collection instrument(s)
instrument(s)
y Other relevant documents
Conclusion

PAGE 19