LifeGene. An example of efficient use of e-tools in large prospective cohort studies with biobanking. Nancy Pedersen, Scientific Director, LifeGene
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1 LifeGene An example of efficient use of e-tools in large prospective cohort studies with biobanking Nancy Pedersen, Scientific Director, LifeGene
2 Sweden: a goldmine for biomedical research National health care system, universally available Personal registration number State of the art Biobanking Well characterized patient materials Continuously updated population and health care registers Scientifically motivated population Support from our research council for biobanking and -omics research
3 Swedish Health Registries across the lifespan LIFE SPAN REGISTRIES EARLY LIFE Cancer Hospital Discharge LATE LIFE Medical Birth Registry Congenital EARLY Malformations LIFE Clinical Quality Registries Conscription Registry Register LIFE SPAN of prescribed REGISTRIES drug sales Cause of Death LATE LIFE LIFESPAN GENETICALLY INFORMATIVE Total Population Multiple Generation Twin Registry Migration
4 A variety of sources and responsibilities 22 counties 6 regions 8 univ with univ hospitals Univ Med Centers National Health Registries: Nat l Board of Health and Welfare (EpC) Quality Registries Varying coverage, regional Biobanking County councils, univ. Insurance board Sick listings Statistics Sweden Everything else
5 Sweden has registers and biobanks: What is missing? Information on primary care Information on lifestyle and exposures Sample collections that can be used for full scale omics Studies that bridge basic research to clinical applications >> Especially population based Opportunity to study co-morbidity
6 What more is missing? Disorders with early onset: in adolescence and young adulthood Disorders that cost society >> Due to sick leave, etc Disorders which lead to chronic diseases late in life such as cardiovascular disease Psychiatric disorders, e.g., spectrum disorders, stress related diseases and gambling Infections, e.g., susceptibility to influenza Inflammation related disorders Musculoskeletal diseases, e.g., back pain, chronic pain Obesity Lack of primary care data and info on exposures
7 Exposure /Events Children Teenagers Adults Example areas of interest Allergies Infections Behavior Neuropsychiatry Infections Behavior Neuropsychiatry Muscle pain Pregnancies Obesity Collection of data & samples over time Sampling Blood Physical data Questionnaires Blood Urine Clinical chemistry Physical data Questionnaires Blood Urine Clinical chemistry Physical data Questionnaires
8 LifeGene s Concept National prospective cohort with biobanking Over 200,000 participants: 0-50 years at baseline Including children and born into cohort Household based ascertainment Information collected at several occasions Including biobanking Including event driven collection Using modern E-epidemiology Follows changes in lifestyle and symptoms A resource for all scientific disciplines, nationally and internationally
9 Processes in LifeGene Recruitment Registration Questionnaire Test data Test Center Physical measures Biosampling Clinical Chemistry Biobanking Research Web activities Biosamples ILI-E
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13 All participants respond to a baseline questionnaire Theme Socio-demography Lifestyle Menstruation and reproduction Tobacco, alcohol and drugs Self-care Medical history Inflammation and allergy Injuries Mental health # questions Modules General, Occupation, Working environment General, Diet, Physical activity, Sexual behavior, Wireless devices Menstruation, Reproduction, Menopause, Diseases, Osteoporosis Smoking, Snus, Alcohol, Illicit drugs Medication Over The Counter, Complementary and Alternative Medicine Dental, Diseases, Infections, Eating disorder, Reflux/IBS, Sleep, Headache, Hearing General exposures, Asthma & COPD, Allergy and chronic sinusitis One module Personality test, Screener, Depression, Panic disorder, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, Social phobia
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15 LifeGene participants perform physical measures Physical measures Audiometry Height, Weight Hip & Waist circumference Bio-impedance Spirometry Blood pressure Heart rate
16 Sampling in LifeGene allows state of the art omics Tube Volume (ml) Spun down Chilled Processed by: EDTA 4 X KI Biobank EDTA 4 X KUL LiHep gel 4 X X KUL PPT gel 8.5 X X KI Biobank PPTgel 8.5 X X KI Biobank Citrat 3.8% 4.5 X X KI Biobank PST gel 8 X X KI Biobank Trace Metals 6 X X KI Biobank Urine 4 X KI Biobank
17 Max 30h från provtagning till frys
18 Participants receive feedback after consent From Blood Feedback Physical tests Feedback B-Hemoglobin X Height X B-HbA1c X Waist X P-CRP, sensitive X Hip X P-Cholesterol X Waist/Hip X P-Triglycerides Weight X P-Apolipoprotein A1 X BMI X P-Apolipoprotein B X Body fat in % X P-ApoB/P-ApoA1 X Bioimpedance X B-LPK Blood pressure X B-Diff Pulse X P-ALAT Audiometry X P-Creatinine Spirometry X
19 Use of e-tools Registration / recruitment CRM Including spontaneous self-recruitment Invite a friend Personalized home page Follow progress Feedback on results Web-based questionnaires LIMS (Laboratory Information Management System) Facebook, Twitter, blogg
20 Progress thus far Over 20,000 participants Three sites 14 successful applications for use of LifeGene material Infrastructure used by other cohorts EpiHealth Born into Cohort, Pregnancy study
21 All was well in Camelot Working groups with representation internationally identified the scientific questions and best design for LifeGene The former prime minister of Sweden, Ingvar Carlsson led our steering group A policy document on Ethics was drafted, Potential participants involved in discussions regarding LifeGene Two reasons for participating To contribute to science For one s own sake
22 All was well in Camelot Applications were submitted to the regional ethics board (for the pilot) And approved Appropriate informed consents were obtained from all subjects The Data Inspection Board was informed A pilot of 5,000 participants was performed
23 Something went wrong The regional ethical review board approved the main study But not for sampling those under 6 years of age LifeGene appealed to the Central Ethical Review Board Because this is an infrastructure and the purposes are broad it is not relevant for review by an ethical review board However, any future research based on the data should be reviewed by an ethical review board
24 Enter Swedish Data Inspection Authority (Sensitive) personal data must be reviewed by an ethical review board participants must be informed of the use of their data The purpose of the use of the data must be defined LifeGene was deemed illegal because the the purpose of the research was considered too broad. LifeGene s consent included future research that would be reviewed by an ethical review board Some 20,000 individuals have provided informed consent to participate in LifeGene and allow their data to be used for future research Are they to be considered incompetent of making their own decisions??!! Minister of Education and Research New law for LifeGene and similar studies effective Oct. 1, 2013
25 A Scientific Balancing Act Prospective, population based studies are the core of cutting edge (Swedish) research Prospective studies with broad purposes to study genetic and environmental factors for health and disease should be allowed (according to the Minister of Higher Education) Conflicting legislation (ethics, data inspection, biobanks) need resolution. Need for an understanding of the infrastructure required for prospective/longitudinal studies React to the proposed European General Data Protection Regulation!!
26 Representatives from six Swedish medical faculties participate in LifeGene National Scientific Board 26
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The menopausal transition usually has three parts: Perimenopause begins several years before a woman s last menstrual period, when the ovaries gradually produce less estrogen. In the last 1-2 years of
Health care reform update
Preventive services coverage Kaiser Foundation Health Plan of the Northwest has always offered broad, affordable coverage options that encourage members to seek care before a health condition becomes serious.
Personal Injury Questionnaire
Personal Injury Questionnaire Patient Information Date Date of Birth Health Insurance Do you have a Flex Spending (FSA) or Health Savings (HSA) Account? Y N Patient Name First M Last What do you prefer
REFERRAL INFORMATION CHILD, YOUTH AND FAMILY PROGRAM
Please Note the following information: WE DO NOT OFFER EMERGENCY OR CRISIS SERVICE Please print clearly and ensure contact information is correct. Complete all forms. We will contact the family to set
Workman s Compensation
Workman s Compensation Name: Sex: Phone Number: Age: Address (Street/City/State/Zip) Name of Employer: Phone: Address of Employer (Street/City/State/Zip) Date and time of accident?: Where were you taken
MVA Accident Questionnaire
MVA Accident Questionnaire Name Date Date of Accident Time of Accident Road conditions at time of accident Were you the driver? Were you the passenger? Where were you seated in the vehicle? FRONT BACK
Preventive Services for Pregnancy SERVICE WHAT IS COVERED INTERVALS OF COVERAGE Anemia Screening Screening Annual screening for pregnant women
Preventive Services for Pregnancy SERVICE WHAT IS COVERED INTERVALS OF COVERAGE Anemia Annual screening for pregnant women Bacteriuria For pregnant women at 12-16 weeks gestation or first prenatal visit