Transcript The StarNet Case Control Study: Role of the Study Coordinator

The StarNet Case Control
Study and the Role of the
Study Coordinator
Sofia Husain
and
Sarah Ruuska, MPH
Study Coordinators
UW Center for Clinical Genomics
Overview
Research question
 Study design
 Study protocol
 Role of study coordinator
 Progress to date
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Research Question
Do genetic and environmental factors
influence whether a person becomes a
persistent smoker or not?
Study Design
 Case-control design
 Cases: current daily smokers
 Controls: current non-smokers but who
have smoked between 11 and 100
cigarettes in their lifetime
 Compare cases and controls to see if
there are any differences in
environmental exposures or genetics
between the two groups
General Eligibility Criteria
 Participants:
 Men
and women, ages 25-54
 All races/ethnicities
 Live in greater Seattle area
 English-speaking
 Plan to recruit at least 400 subjects
by August 2009
Data Collection: Questionnaire
 Collect information on:
 smoking or non-smoking behaviors
 environmental exposures that may
influence the decision to start or stop
smoking such as family and peer
attitudes, public policies, health
messages, etc.
Data Collection: Questionnaire
 Question examples:
 How old were you when you first tried a
cigarette, even a single puff?
 During your experimental smoking phase, did
you think that smoking was “cool”?
 While you were growing up, how many of your
parents/guardians smoked at all?
 When you were in school, were you taught
about the dangers of smoking (for example,
lung cancer, heart disease, fire hazards)?
Data Collection: Blood Draw
 Blood sample for DNA
 2 teaspoons of blood
How do we conduct the study?
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How do we find the subjects we need?
How do we determine if these subjects meet
the study definition of case/control?
How will we get subjects to participate?
How will we gather the data we need?
How do we make sure subjects understand
what they are agreeing to do for the study?
How do we find subjects?
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Advertise via study fliers posted in Seattle
area: coffee shops, community centers,
churches, etc.
Advertise in local newspapers: The
Seattle Weekly, The Stranger,
neighborhood papers
Advertise on the internet: UW Research
Studies website, Craigslist
Study Flier
How do we determine if the
subjects we find meet the
study definitions?
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Subjects respond to the study ad by calling the
study coordinator to express interest or request
more information
Study coordinator gives a short survey over the
phone to make sure subjects are within the age
range of 25 to 54 years old, determine if their
smoking behavior fits either the case or control
definition
How do we get subjects to
participate?
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Contribute to scientific knowledge
Help society
Help teach high school students about
science
Reimbursement for parking fees
Thank-you gift
 $30 Safeway gift card after completing
study
How will we gather the
data we need?
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Subjects will come to the UW General Clinical
Research Center (GCRC) to:
 Fill out the study questionnaire
 Blood draw
How do we make sure subjects
understand what they are
agreeing to do for the study?
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Be careful to state clearly what is being
asked of the subject both verbally and in
writing
Give the subject opportunity to ask
questions, inform them of their rights as a
research subject
Process of informed consent
Informed Consent
Crucial elements:
 Participation in research is voluntary
 Ability to withdraw from study at any time
without penalty (financial, health
insurance, health care, etc.)
 Privacy and confidentiality
 Clearly state study procedures, what
subject will be asked to do, and the time it
will take
Informed Consent
Crucial elements (continued):
 State risks
 Sensitive questions, slight pain and bruising
from blood draw
 State benefits
 No direct benefit to the subject
 Better understanding of factors that
contribute to smoking behavior
Approval to Conduct Study
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Institutional Review Board Review
 Reviews
all research on human subjects
BEFORE study begins to ensure:
 No
coercion of study subjects
 Benefits of research outweigh the risks
 No one group is being singled out or
studied too much
 Consent form and all study materials are
understandable
Role of a Study Coordinator
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Assists with study design and protocol
development
Prepares study materials
Helps get approval to conduct the study
Coordinates day-to-day study operations
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Interacts with study subjects, schedules appointments
Collects data (questionnaires, interviews, biologic
samples)
Role of a Study Coordinator
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Administrative aspects:
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Budget preparation, purchasing, hiring study staff,
supervision of interviewers, technicians, etc.
Works directly with the Principal Investigator
and other study investigators
Educational background: nursing, public
health, health sciences
Role of StarNet Study Coordinator:
Setting Up the Study
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Apply to UW IRB for approval to conduct the study
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Develop study documents
Newspaper ad, study flier
 Consent form
 Subject contact materials (letter, reminder call script,
directions to UW, etc.)
 Phone screening survey
 Written questionnaire
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Develop study protocol and logistics (where to post
ads, how do we reimburse subjects for parking?)
Role of StarNet Study Coordinator:
Conducting the Study
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Place ads in newspapers
Answer study phone line when subjects
respond to study ad, describe the study
and give the screening survey
Schedule the study appointment
Mail study packet to study participants to
review before their appointment
Role of StarNet Study Coordinator:
Conducting the Study
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Meet subjects for their study appointment at the
UW General Clinical Research Center
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Go over consent form
Give the questionnaire
Coordinate the blood draw
Available to answer questions throughout study
visit
Give out thank-you gift
After the visit:
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Transport blood samples to the lab
Check samples in for processing
Results so Far
Jan
Feb
Mar
Apr
May
Jun
Jul
Total
Total inquiries
88
69
27
79
46
82
46
437
Total interviews
48
79
27
72
43
58
52
379
Total eligible
8
22
2
15
10
15
14
86
Total eligible cases
4
15
1
10
6
3
7
46
Total eligible controls
4
7
1
5
4
12
7
40
Total eligible females
4
13
1
9
6
7
9
49
Total eligible males
4
9
1
6
4
8
5
37
Total GCRC visits
5
15
5
7
12
8
16
68
Challenges
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Getting a good response to the newspaper ads &
fliers
Being able get in touch with everyone who calls
(13% unable to get in touch with)
Finding people who fit the case/control definitions
(23% eligible)
Getting people to show up for their study
appointment (17% no-show rate)