Indivo as a Personally-Controlled Research Platform for Chronic Disease Registries Research
•Download as PPTX, PDF•
1 like•564 views
Lightning talk at the Indivo X 2012 User's Conference: embedding Indivo in the CARRAnet registry provides personal control and patient engagement in research systems. By Marc Natter, MD, Fellow at the Intelligent Health Lab, Children's Hospital Informatics Program.
Recommended
More Related Content
Similar to Indivo as a Personally-Controlled Research Platform for Chronic Disease Registries Research
Similar to Indivo as a Personally-Controlled Research Platform for Chronic Disease Registries Research (20)
Recently uploaded
Recently uploaded (20)
Indivo as a Personally-Controlled Research Platform for Chronic Disease Registries Research
- 1. INDIVO as a Personally-Controlled Research Platform for Chronic Disease Registries Research Marc D. Natter, MD Project Manager, CARRAnet Informatics Development Core Fellow, Intelligent Health Lab Kenneth D. Mandl, MD MPH PI & Director, CARRAnet Informatics Development Core Director, Intelligent Health Lab Intelligent Health Lab & Children’s Hospital Informatics Program, Children’s Hospital Boston Center for Biomedical Informatics, Harvard Medical School June 18, 2012 Harvard Children’s Hospital Medical School Informatics Program
- 2. 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 12/2004 Right: http://www.nytimes.com/2009/12/22/health/22cyst.html
- 3. The Pediatric Oncology Story: Protocol-Based Care, 1981-1991 • Patients enrolled on SPOG/POG Protocol: Survival = 76%, N=120 • Patients not enrolled in study: Survival = 52%, N = 42 Sources: 1. Wagner HP, et al. Childhood NHL in Switzerland: incidence and survival of 120 study and 42 non-study patients. Med PediatrOncol. 1995 May; 24(5):279-80. 2. Sharon Murphy, Pediatric Oncology Group, personal communication
- 4. ATSDR: Agency for Toxic Substances & Disease Registry FIC: Fogarty International Center NIH & CDC Registry-related Project Funding: NCBBB: Nat'l Center on Birth Defects & FY 2009 active projects by Institute or Center Developmental Disabilities NCCDPDP: Nat'l Center for Chronic Disease (cumulative since 1992, in millions, FY 2008 CPI-adjusted dollars) Prevention & Health Promotion NCI: National Cancer Institute NIDDK, $188.0 NCPDCID: Nat'l Center for NIAMS, $157.1 Preparedness, Detection, & Control of NIMH, $202.4 Infectious Diseases NIAAA, $139.6 NCRR: Nat'l Center for Research Resources NEI: National Eye Institute NIAID, $82.0 NHLBI: Nat'l Heart, Lung, & Blood Institute NIA: National Institute on Aging NHLBI, $243.3 NIAAA: Nat'l Inst on Alcohol Abuse & NINDS, $81.7 NIDA, $29.8 Alcoholism NIAID: Nat'l Institute of Allergy & Infectious NCBDD, $28.3 Diseases NCRR, $24.9 NIAMS: Nat'l Institute of Arthritis & NIDCD, $19.3 Musculoskeletal & Skin Diseases NIA, $378.9 NIDCR, $16.4 NIBIB: Nat'l Institute of Biomedical Imaging & Bioengineering ATSDR, $16.0 NICHD: Nat'l Institute of Child Health & Other, $179.6 NICHD, $12.7 Human Development NIEHS, $9.9 NIDA: Nat'l Institute on Drug Abuse NIGMS, $9.3 NIDCD: Nat'l Institute on Deafness & Other Communication Disorders NIOSH, $7.5 NCCDPHP, $707.9 NIDCR: Nat'l Institute of Dental & NCPDCID, $2.1 Craniofacial Research NIBIB, $1.6 NIDDK: Nat'l Institute of Diabetes & NCI, $801.4 NEI, $1.2 Digestive & Kidney Diseses NIEHS: Nat'l Institute of Environmental NLM, $0.5 Health Sciences FIC, $0.1 NIGMS: Nat'l Institute of General Medical Sciences NIMH: Nat'l Institute of Mental Health NINDS: Nat'l Institute of Neurological Grand Total: $3.162 Billion Disorders & Stroke NIOSH: Nat'l Institute for Occupational *NIH grants & contracts: FY 1992-2009; Safety & Health CDC grants & contracts: FY 1995-2009 NLM: National Library of Medicine
- 5. Registries and Reasons: Juvenile Idiopathic Arthritis & Risk for Eye Disease
- 6. CARRAnet Grand Opportunities Grant National Registry NIAMS RC2AR058934, Sites=56, Current Enrollment>7,000 (Target 20K)
- 7. CARRAnet: Building ‘Grass Roots’ Access to Subspecialty Research Data 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 Study C Modular Study A Study B Data Sets, Enhanced Data Set Shared Ontologies Common Data Set
- 9. 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 Harvard Children’s Hospital Medical School Informatics Program
- 10. Incorporating Patient-Reported Outcomes (NLM R01 – Mandl, Weitzman, Natter) Harvard Children’s Hospital Medical School Informatics Program 10
- 11. 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 Harvard Children’s Hospital Medical School Informatics Program
- 12. 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 Harvard Children’s Hospital Medical School Informatics Program
- 13. 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
Editor's Notes
- One small field in medicine has been far ahead of most others in measuring the performance of its practitioners: cystic-fibrosis care. For forty years, the Cystic Fibrosis Foundation has gathered detailed data from the country's cystic-fibrosis treatment centers. It did not begin doing so because it was more enlightened than everyone else. It did so because, in the nineteen-sixties, a pediatrician from Cleveland named LeRoy Matthews was driving people in the field crazy. Matthews had started a cystic-fibrosis treatment program as a young pulmonary specialist at Babies and Children's Hospital, in Cleveland, in 1957, and within a few years was claiming to have an annual mortality rate that was less than two per cent. To anyone treating CF at the time, it was a preposterous assertion. National mortality rates for the disease were estimated to be higher than twenty per cent a year, and the average patient died by the age of three. Yet here was Matthews saying that he and his colleagues could stop the disease from doing serious harm for years. "How long [our patients] will five remains to be seen, but I expect most of them to come to my funeral," he told one conference of physicians. In 1964, the Cystic Fibrosis Foundation gave a University of Minnesota pediatrician named Warren Warwick a budget of ten thousand dollars to collect reports on every patient treated at the thirty-one CF centers in the United States that year--data that would test Matthews's claim. Several months later, he had the results: the median estimated age at death for patients in Matthews's center was twenty-one years, seven times the age of patients treated elsewhere. He had not had a single death among patients younger than six in at least five years. Unlike pediatricians elsewhere, Matthews viewed CF as a cumulative disease and provided aggressive treatment long before his patients became sick. He made his patients sleep each night in a plastic tent filled with a continuous, aerosolized water mist so dense you could barely see through it. This thinned the tenacious mucus that clogged their airways and enabled them to cough it up. Like British pediatricians, he also had family members clap on the children's chests daily to help loosen the mucus. After Warwick's report came out, Matthews's treatment quickly became the standard in this count. The American Thoracic Society endorsed his approach, and Warwick's data registry on treatment centers proved to be so useful that the Cystic Fibrosis Foundation has continued it ever since.