Children’s HospitalInformatics Program

HarvardMedical School

INDIVO as a Personally-Controlled Research Platform for Chronic Disease Registries Research

Marc D. Natter, MDProject Manager, CARRAnet Informatics Development CoreFellow, Intelligent Health Lab

Kenneth D. Mandl, MD MPHPI & Director, CARRAnet Informatics Development CoreDirector, Intelligent Health Lab

Intelligent Health Lab & Children’s Hospital Informatics Program, Children’s Hospital BostonCenter for Biomedical Informatics, Harvard Medical School

June 18, 2012

Going ‘Retro’:

Translating Research into Improved Care through Registries• Cystic Fibrosis Foundation

– LeRoy Matthews, Warren Warwick, Don Berwick, and others

Left: Gawande A, The Bell Curve. New Yorker Magazine 12/2004Right: http://www.nytimes.com/2009/12/22/health/22cyst.html

The Pediatric Oncology Story:Protocol-Based Care, 1981-1991

Sources: 1. Wagner HP, et al. Childhood NHL in Switzerland: incidence and survival of 120 study and 42 non-study patients. Med Pediatr Oncol. 1995 May; 24(5):279-80.2. Sharon Murphy, Pediatric Oncology Group, personal communication

• Patients enrolled on SPOG/POG Protocol: Survival = 76%, N=120• Patients not enrolled in study: Survival = 52%, N = 42

NCI; $801.4

NCCDPHP; $707.9

NIA; $378.9

NHLBI; $243.3

NIMH; $202.4

NIDDK; $188.0

NIAMS; $157.1

NIAAA; $139.6

NIAID; $82.0

NINDS; $81.7

NIDA; $29.8

NCBDD; $28.3NCRR; $24.9

NIDCD; $19.3 NIDCR; $16.4 ATSDR; $16.0 NICHD; $12.7 NIEHS; $9.9NIGMS; $9.3

NIOSH; $7.5NCPDCID; $2.1

NIBIB; $1.6NEI; $1.2

NLM; $0.5

FIC; $0.1

NIH & CDC Registry-related Project Funding:FY 2009 active projects by Institute or Center(cumulative since 1992, in millions, FY 2008

CPI-adjusted dollars)

*NIH grants & contracts: FY 1992-2009; CDC grants & contracts: FY 1995-2009

ATSDR: Agency for Toxic Substances & Dis-ease RegistryFIC: Fogarty International CenterNCBBB: Nat'l Center on Birth Defects & De-velopmental DisabilitiesNCCDPDP: Nat'l Center for Chronic Disease Prevention & Health PromotionNCI: National Cancer InstituteNCPDCID: Nat'l Center for Preparedness, Detection, & Control of Infectious DiseasesNCRR: Nat'l Center for Research ResourcesNEI: National Eye InstituteNHLBI: Nat'l Heart, Lung, & Blood InstituteNIA: National Institute on AgingNIAAA: Nat'l Inst on Alcohol Abuse & Alco-holismNIAID: Nat'l Institute of Allergy & Infectious DiseasesNIAMS: Nat'l Institute of Arthritis & Muscu-loskeletal & Skin DiseasesNIBIB: Nat'l Institute of Biomedical Imaging & BioengineeringNICHD: Nat'l Institute of Child Health & Hu-man DevelopmentNIDA: Nat'l Institute on Drug AbuseNIDCD: Nat'l Institute on Deafness & Other Communication DisordersNIDCR: Nat'l Institute of Dental & Craniofa-cial ResearchNIDDK: Nat'l Institute of Diabetes & Digestive & Kidney DisesesNIEHS: Nat'l Institute of Environmental Health SciencesNIGMS: Nat'l Institute of General Medical SciencesNIMH: Nat'l Institute of Mental HealthNINDS: Nat'l Institute of Neurological Disor-ders & StrokeNIOSH: Nat'l Institute for Occupational Safety & HealthNLM: National Library of Medicine

Grand Total: $3.162 Billion

Registries and Reasons: Juvenile Idiopathic Arthritis & Risk for Eye Disease

CARRAnet Grand Opportunities Grant National Registry

NIAMS RC2AR058934, Sites=56, Current Enrollment>7,000 (Target 20K)

CARRAnet: Building ‘Grass Roots’ Access to Subspecialty Research Data

Common Data Set

Enhanced Data Set

Study BStudy A

Study CModular Data Sets,Shared Ontologies

Software as a Service model: server farm provides a SHRINE self-scaling, connected, but private i2b2 ‘cloud’

Data In InForm electronic data capture using standardized forms (for

now) InForm using custom forms (add-on studies) – near future Import study data (raw data files plus data mappings –

spreadsheets, databases, etc) – on the horizon

CARRAnet Researcher Portal

Children’s HospitalInformatics Program

HarvardMedical School

Still in Search of a System that is:

–Convenient for data input: • Patients and research subjects, not just for investigators• Online consenting for studies

–Manages personal health information for research

–Returns data to research subjects and consented 3rd parties

Children’s HospitalInformatics Program

HarvardMedical School

Incorporating Patient-Reported Outcomes(NLM R01 – Mandl, Weitzman, Natter)

10

Children’s HospitalInformatics Program

HarvardMedical School

Contact and Personally-identifying Information Management

– Provides a Unique Identifier for all subjects across all CARRA/CARRAnet studies

– Data under site control– Web-based, centrally hosted– Based on INDIVO

• Fine-grained permissions for patient, guardians, family members, care providers, etc

• Subjects can directly enter and update their own data• SMArt, ‘research app’ based approach

Children’s HospitalInformatics Program

HarvardMedical School

Use Cases:Juvenile Arthritis + Eye Disease Registries Collaboration

• Inception cohort of 650 children with JIA followed for 5 years

• Technical aims:– Subjects enter and manage contact info– Match subjects across two different

registries without exchanging contact or personally identifying info

– Data exchange between registries– Introduce ‘low-cost’ consent process

New Registry Applications,under Development

• M-CM Network: Patient-advocate initiated registry for an especially rare disease

• FDA Reporting App: 3rd party reporting from patient registries

• Ad-hoc Adverse Events Reporting: Post-marketing surveillance studies

• Consensus Treatment Plan Adherence Tool: Collaborative patient-physician views