The StarNet Case Control Study and the Part of the Study Facilitator.

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Category: Medical / Health
Review. Research questionStudy designStudy protocolRole of study coordinatorProgress to date. Exploration Question. Do hereditary and ecological elements impact whether a man turns into a tenacious smoker or not?. Study Design. Case-control designCases: current every day smokersControls: current non-smokers yet who have smoked somewhere around 11 and 100 cigarettes in their lifetimeCompare cases and controls
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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

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Overview Research question Study plan Study convention Role of study facilitator Progress to date

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Research Question Do hereditary and ecological variables impact whether a man turns into a constant smoker or not?

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Study Design Case-control outline Cases: ebb and flow day by day smokers Controls: momentum non-smokers however who have smoked somewhere around 11 and 100 cigarettes in their lifetime Compare cases and controls to check whether there are any distinctions in natural exposures or hereditary qualities between the two gatherings

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General Eligibility Criteria Participants: Men and ladies, ages 25-54 All races/ethnicities Live in more prominent Seattle territory English-speaking Plan to enroll no less than 400 subjects by August 2009

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Data Collection: Questionnaire Collect data on: smoking or non-smoking practices ecological exposures that may impact the choice to begin or quit smoking, for example, family and companion mentalities, open approaches, wellbeing messages, and so on

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Data Collection: Questionnaire Question illustrations: How old would you say you were the point at which you initially attempted a cigarette, even a solitary puff? Amid your trial smoking stage, did you feel that smoking was "cool"? While you were growing up, what number of your folks/watchmen smoked by any stretch of the imagination? When you were in school, would you say you were instructed about the threats of smoking (for instance, lung tumor, coronary illness, fire risks)?

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Data Collection: Blood Draw Blood test for DNA 2 teaspoons of blood

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How would we lead the study? How would we discover the subjects we require? How would we figure out whether these subjects meet the study meaning of case/control? In what manner will we inspire subjects to take part? By what method will we accumulate the information we require? How would we ensure subjects comprehend what they are consenting to accomplish for the study?

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How would we discover subjects? Publicize by means of study pamphlets posted in Seattle zone: bistros, group focuses, places of worship, and so forth. Publicize in nearby daily papers: The Seattle Weekly, The Stranger, neighborhood papers Advertise on the web: UW Research Studies site, Craigslist

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Study Flier

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How would we figure out whether the subjects we discover meet the study definitions? Subjects react to the concentrate advertisement by calling the study facilitator to express intrigue or demand more data Study organizer gives a short overview via telephone to ensure subjects are inside the age scope of 25 to 54 years of age, figure out whether their smoking conduct fits either the case or control definition

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How would we motivate subjects to take an interest? Add to logical information Help society Help show secondary school understudies about science Reimbursement for stopping charges Thank-you blessing $30 Safeway blessing card in the wake of finishing study

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How will we accumulate the information we require? Subjects will go to the UW General Clinical Research Center (GCRC) to: Fill out the study poll Blood draw

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How would we ensure subjects comprehend what they are consenting to accomplish for the study? Be mindful so as to state obviously what is being asked of the subject both verbally and in composing Give the subject chance to make inquiries, educate them of their rights as an examination subject Process of educated assent

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Informed Consent Crucial components: Participation in exploration is intentional Ability to pull back from learn whenever without punishment (budgetary, medical coverage, medicinal services, and so forth.) Privacy and secrecy Clearly state study systems, what subject will be requested that do, and the time it will take

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Informed Consent Crucial components (proceeded with): State dangers Sensitive inquiries, slight agony and wounding from blood draw State benefits No immediate advantage to the subject Better comprehension of variables that add to smoking conduct

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Approval to Conduct Study Institutional Review Board Review Reviews all examination on human subjects BEFORE study starts to guarantee: No intimidation of study subjects Benefits of examination exceed the dangers No one gathering is being singled out or concentrated a lot of Consent structure and all study materials are justifiable

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Role of a Study Coordinator Assists with study outline and convention improvement Prepares study materials Helps motivate endorsement to direct the study Coordinates everyday study operations Interacts with study subjects, plans arrangements Collects information (surveys, interviews, biologic examples)

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Role of a Study Coordinator Administrative perspectives: Budget readiness, acquiring, contracting study staff, supervision of questioners, experts, and so forth. Works specifically with the Principal Investigator and other study agents Educational foundation: nursing, general wellbeing, wellbeing sciences

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Role of StarNet Study Coordinator: Setting Up the Study Apply to UW IRB for endorsement to lead the study Develop study archives Newspaper promotion, study pamphlet Consent structure Subject contact materials (letter, update call script, headings to UW, and so forth.) Phone screening overview Written poll Develop study convention and logistics (where to post advertisements, how would we repay subjects for stopping?)

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Role of StarNet Study Coordinator: Conducting the Study Place promotions in daily papers Answer study telephone line when subjects react to concentrate advertisement, portray the study and give the screening study Schedule the study arrangement Mail study parcel to study members to audit before their arrangement

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Role of StarNet Study Coordinator: Conducting the Study Meet subjects for their study arrangement at the UW General Clinical Research Center Go over assent structure Give the survey Coordinate the blood attract Available to answer questions all through study visit Give out thank-you blessing After the visit: Transport blood tests to the lab Check tests in for preparing

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Results in this way

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Challenges Getting a decent reaction to the daily paper advertisements & pamphlets Being capable reach everybody who calls (13% not able to reach) Finding individuals who fit the case/control definitions (23% qualified) Getting individuals to appear for their study arrangement (17% no-show rate)

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