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The MURDOCK StudyData and Population Assets

Social Sciences Challenge Round 2

L. Kristin Newby, MD, MHSProfessor of MedicineDivision of Cardiology

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What is the MURDOCK Study?Measurement to Understand the Reclassification of Disease Of

Cabarrus / Kannapolis

A longitudinal health study to characterize health and the development, progression and outcomes of major chronic diseases and disorders

Centered in Kannapolis/Cabarrus County, NC

Support from the David H. Murdock Institute for Business and Culture and the Duke Translational Medicine Institute CTSA grant (UL1TR001117)

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Design: Organized as Horizons

H o r i z o n 1• Generated molecular

biosignatures using legacy samples, mined associated clinical data

• Generated hypotheses to reclassify diseases: Liver disease, CV disease, Osteoarthritis, Obesity

H o r i z o n 2• Prospective cohort

studies• Multiple sclerosis• Alzheimer’s

disease• Physical functioning• Severe acne• Centenarians

• Drawing from subjects accessible via Horizon 1.5 registry

H o r i z o n 3 +• New waves of

molecular data from diverse patient populations

• New cohort studies• Data meta-analyses• Multi-institutional and

multi-national collaborations

• Measurement of public health impact

H o r i z o n 1 . 5

• Building a Community Registry and Biorepository (Informatics and Sample Management)

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Local Duke study operations here

*Goal: Enroll 50,000 local residents

• 11,469 enrolled• 20 Zip code catchment area

MURDOCK Study

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Locally based, Duke-employed clinical research team with an average of 7 years’ experience

• 26 full-time personnel based in Kannapolis• Certified clinical research coordinators, clinical trials

assistants, project managers, regulatory staff, and data technicians

• Spanish-speaking coordinators with translation capabilities• On-the-ground recruiters engaged with local community

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Participant Recruitment: Hybrid Strategy

Open enrollment of self-selected volunteers: ongoing Site network enrollment across region Mass enrollment approach proven successful – bringing

enrollment opportunities to large groups Use of churches, workplaces, schools as enrollment venues

Representative sample planned: design methodology outlined and expert advisory board of internationally recognized epidemiologists convened

Pilots performed to assess processes, marketing, other tools Operations will be evaluated for implementation of full random

sampling (n=15,000)

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Inclusion criteria* Age 18 or older** Resides in qualifying zip code OR Male healthcare worker in catchment area regardless of residence *Study-specific waiver available**12 and older in specific cohort recruitment

Participants consent to: Health and demographic questionnaire Ongoing access to medical record Brief exam (HR, BP, waist circumference) Geospatial mapping Blood and urine samples for approved research investigations Annual follow-up and re-contact up to 4x yearly for additional research studies Participation indefinite or until consent withdrawn

Participation in the MURDOCK Registry

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Self-Reported Data CollectionBaseline Questionnaire • Demographics, weight, height• Socioeconomic

– Income– Education– Housing and living arrangements

• Environmental exposures • Medications • Lifestyle and habits

– Activity (work and leisure time activity) – Smoking– Alcohol

• Diet survey• Patient-reported outcomes (PROMIS®)• Geospatial mapping

Follow-up Questionnaire (yearly)• Demographics review, weight, height• Medications• Lifestyle and habits

– Smoking– Alcohol

• Patient-reported outcomes (PROMIS®)• Procedures• Hospitalizations

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Heart Metabolic NeurologicalCoronary artery disease Diabetes Alzheimer’s diseaseAtrial fibrillation High cholesterol DepressionHeart attack or angina Thyroid disease Other mental illnessCongestive heart failure High blood pressure StrokeICD or pacemaker placement Obesity Multiple sclerosisCancer Lung/Respiratory Gastrointestinal/RenalBreast cancer Asthma Crohn’s disease/ulcerative colitisColon cancer Emphysema or “COPD” Liver diseaseLung cancer Bone/Joint Kidney diseaseProstate cancer Osteoarthritis  Cervical cancer Rheumatoid arthritis  Melanoma Other autoimmune disease  Skin cancer, not melanoma Osteoporosis/Osteopenia  Oral cancer Gout  Other type of cancer    

Self-Reported Medical Illnesses• Surveyed for data on 34 prevalent illnesses at

baseline• Yearly follow up for incident disease

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Average number of specimens obtained per participant: ~35 aliquotsTotal N >400,000 aliquots banked at LabCorp®-Kannapolis Biorepository

Sample Type Aliquots/volunteer

Plasma 16 x 500 µL

Buffy coat From 2 EDTA tubes

Serum 10 x 500 µL

Whole blood 3 x 2 mL

Environmental (Serum)

1 x 3 mL

PaxGene RNA 3 tubes

Urine 4 x 10 mL

Locally stored samples, CAP-accredited, long-term storage facility for Duke efforts

Sample Inventory

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Age15 30 58 59 600

MURDOCK Study Enrollment

AsthmaDepression

High Blood PressureHeart Attack

Characterizing Health Over Time

bl f/u f/u

= baseline = follow-up

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Snapshot of MURDOCK Study Cohort - DemographicsN=11,469

AgeRange N % of Cohort

12-19 241 2.2

20-29 904 8.1

30-39 1541 13.8

40-49 2233 20.0

50-59 2389 21.4

60-69 2279 20.4

70-79 1158 10.4

80-89 362 3.2

90 49 0.4

% MURDOCK1 % Region2

Female 66.0 51.3

African American

13.7 25.3

Asian 0.9 3.5

Hispanic 12.4 10.9

Age (median)

52 --

Rural -- 12.5

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Snapshot of MURDOCK Study Cohort - SocioecomomicN=11,469

Employment Status N % of Cohort

Working full time 4102 36.2

Working part time 1340 11.8

Unemployed 940 8.3

Stay at home 826 7.3

Retired 2691 23.8

Temporary lay off/sick or maternity leave

97 0.9

Permanently disabled 759 6.7

Student 260 2.3

Other 310 2.7

HighestEducation N % of Cohort

<High school 1118 9.8

High school 2444 21.3

Some college/ Associates

4086 35.7

Bachelors 2326 20.3

Masters degree or higher

1481 12.9

*also available for mother and father

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Snapshot of MURDOCK Study Cohort - SocioecomomicN=11,469

Household Income N % of Cohort

<10,000 738 6.5

10,000-29,999 1930 17.1

30,000-49,999 1916 17.0

50,000-69,999 1602 14.2

70,000-89,900 1219 10.8

>90,000 2381 21.1

Don’t know 1493 13.2

Housing N % of Cohort

Where

Single family detached 9412 82.2

Single family attached 521 4.6

Apartment 892 7.8

Other 620 5.4

Payment

Mortgage 5445 47.6

Rent 2351 20.6

Own outright 2191 19.2

Live with others 882 7.7

Other 562 4.9

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Lifestyle Habits: Activity, Past Year

Leisure Time ActivityVery little 35%Heavy activity, 3x/week 10%Moderate, 3x/week 28%Regular program, daily 6%Some activity, weekdays, weekends 21%

On-the-job ActivityHard physical labor 1%Lifting, carrying, moving 4%Not applicable 42%Sitting or standing 37%Walking or moderate exertion 16%

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Lifestyle Habits: Diet, Past Year

Sugar sweetened beverages (#)1 46%2 23%3 11%4 5%5 2%6 1%6-10 1%11-20 0%21-40 0%Don't know 9%

Servings, fruit & veggies (#)1 1%2 21%3 27%4 17%5 10%6 5%6-10 3%11-20 0%21-40 0%Don't know 14%

Read nutrition labelsAlways 16%Very often 30%Sometimes 29%Rarely 13%Never 10%

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MURDOCK Study PROMIS Domains

• Overall health perceptions• Pain• Physical performance

– Abilities/limitations– Activity level– Fatigue

• Emotional state– Anxiety– Anger– Mood/depression

MURDOCK

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At Baseline (N=11,469)

During Follow Up (N=8236; 3.0 yrs)

N % of Cohort N

Oncology Breast Colon Lung Prostate

2878537

179

2.50.70.31.6

1394329

104

Coronary artery disease 667 5.8 320

Atrial fibrillation 495 4.3 283

Diabetes 1747 15.3 1068

High Cholesterol 4388 38.3 2400

Osteoarthritis (OA) 1988 17.4 1396

Depression 2833 24.7 1132

Snapshot of Self-Reported Illnesses

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Horizon 2 Studies

Horizon 2 StudiesLead

InvestigatorCurrent N Enrollment

GoalAdditional Data

Multiple Sclerosis Simon Gregory 691 1000 Dx of MS, MS-specific questionnaire

Primary Progressive MS Simon Gregory 10 100 MS-specific questionnaire, serial sampling for 5 years

Memory and Cognitive Health Kathy Welsh-Bohmer 1487 1500 MoCa, CERAD, Trail Making Test, Part B; follow-up testing and sample collection at

3 years

Healthy Aging (Physical performance screener)

Miriam MoreyHarvey Cohen

805 1000 Gait speed, 30-second chair stand, balance test, 6-minute walk test, 7-day accelerometry, MoCA, follow-up at 2

years

Severe Acne Russell Hall(David Goldstein)

121 200 Current or previous dx of severe acne vulgaris and oral isotretinoin; acne-

specific questionnaire

Centenarians Liz Cirulli(David Goldstein)

20 20 None

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MURDOCK-Related StudiesStudy PI Status

Google Baseline Study Kristin Newby Contract pending, Duke, MURDOCK, Stanford sites

Ethical Approaches to Research Use of Clinical Records and Data

Laura Beskow R01 funded by NIH, includes MURDOCK Study participants

Male Fertility Study-Betaine Steve Zeisel, UNC MURDOCK samples transferred to UNC NRI, 2/2015

Takeda-CHS TOMMORROW Study -- Recruitment work on-going for CHS site

NIDA TAPS Tool Litzy WuRecruitment completed, utilizing MURDOCK infrastructure

(e.g. personnel), expected completion 4/2015

Profiling MURDOCK nutrition environmentMatt Harding

(Sanford-BECR)Under review

NIH Precision Medicine CohortMURDOCK Leadership

Submitted to NHGRI for consideration of inclusion

EHR vs. Self-report comparison Meredith Zosus PCORI and R00 funding awarded

Interrogation of novel alternatively spliced genes in race-related aggressive prostate cancer

Jenny Freedman, Steven Patierno

Awarded; jointly funded by GU Oncology and MURDOCK Study

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MURDOCK Integrated Data Repository (MIDR)

BiospecimenData

Electronic Health

Records

MIDR Omics, ImagingMetadata

ConsentData

ClinicalData / CRF

StudyMetadata

Information Retrieval

DiscoveryData mining, disease stratification, predictive algorithms, pathway modeling, systems biology

Metadata queries, cohort selection, administrative reports

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Adding Electronic Health Records to MURDOCK

• McGill Federally Qualified Health Center –available• Novant Health System –in progress• Carolinas Healthcare System –in planning and

negotiation– Shared data space specifically for CHS EHR data and

MURDOCK data on CHS patients– Joint governance– Shared resources and projects

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1. Investigator has a new idea

2. Contact Melissa Cornish for proposal concept formmelissa.cornish@duke.edu required of all interested collaborators

Collaborating is Easy3. Proposal concept form submitted to MURDOCK Leadership with budget for associated costs for samples, data, infrastructure, analyses, and funding targets

4. MURDOCK Leadership reviews proposal concept form, opportunity for interested investigator to present concepts to team

5. Approved proposal submitted with support from MURDOCK Study (e.g. boilerplate, support letters, data, other supporting documentation)

5. Revisions are requested by MURDOCK Leadership and decision is made on how to proceed

6. Once funded, approval memo generated by MURDOCK Study outlining agreement of collaboration

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