Dr Staffan Lindblad: clinical development utilizing registers in novel ways in clinical arthritis
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Dr Staffan Lindblad: clinical development utilizing registers in novel ways in clinical arthritis
- 1. Clinical development Utilizing Registers in novel ways in chronic arthritis Staffan Lindblad M.D. Medical Management Centrum, Karolinska Institutet and Department of Rheumatology, Karolinska University hospital The C.U.R. project
- 2. Crossing the quality chasm Safe Timely Effective Efficient Equitable Patient oriented IOM; Crossing the Quality Chasm: A New Health System for the 21st Century, 2001.
- 3. ”The future is bright…” I feel secure despite risks of my drugs Safe I can see when I need a new drug Timely I can monitor the effect of my drug Effective I can manage myself much more Efficient I compare my measures with others Equitable I work together with my doctor now Patient oriented
- 4. The empowered care provider Safe Side effects can be reported at the visit Timely Patient needs based clinics Effective National outcome measures for all Efficient Costs are reduced, results are better Equitable Benchmarking in national quality registers Patient oriented Patients share the work – task shifting
- 5. This is spreading all over Sweden Staffan.Lindblad@ki.se
- 6. This is spreading all over Sweden Staffan.Lindblad@ki.se
- 7. Clinical registers Rheumatology We use the unique Swedish advantage of national quality registers describing regular clinical practice – what characterizes each patient – which treatments are given – the health outcomes generated Staffan.Lindblad@ki.se
- 8. Clinical development Utilizing Registers C.U.R. project Patient engagement Care quality Clinical trials improvement and studies Clinical registers Surveillance Information drugs generator Rheumatology Rheuma medtech Law and Industry ethics bridge Translational Health research economy Clinical research Staffan.Lindblad@ki.se
- 9. Swedish national mandatory registers can be linked to national quality registers analyzing co-morbidity Register linkages Swedish Biologics Quality Register Swedish Rheumatoid Arthritis (RA) Register Inpatient Register RA General population controls
- 10. Increase of tuberculosis inRA patients with TNF blocker Relative Risk 9 General Population RA, no TNF-antagonist 2 RA with TNF antagonist 1 9 No increase of lymphoma in RA patients with TNF blocker - 2 1
- 11. The C.U.R. Patient project engagement Care quality Clinical trials improvement and studies Clinical registers Surveillance Information drugs generator Rheumatology Rheuma medtech Law and Industry ethics bridge Translational Health research economy Clinical research Staffan.Lindblad@ki.se
- 12. Clinical development Utilizing Registers – the CUR platform for care, research and industrial innovation Patient engagement Care quality Clinical trials improvement and studies Clinical Kliniska registers Surveillance Information Kliniska register drugs generator Rheumatology Rheuma Kliniska register medtech Neurology Neuro Kliniska register Pediatrics Law and register Primary Care Surgery Industry ethics Primary Care Surgery bridge etc… Translational Health research economy Clinical research Staffan.Lindblad@ki.se
- 13. Patient engagement Care quality improvement Clinical Information registers generator Rheumatology Rheuma Staffan.Lindblad@ki.se
- 16. Project background • Treatment guidelines of the Swedish Society for Rheumatology are based on evidence from meta-analysis of clinical drug trials • These guidelines are linked to the rheumatology register’s comprehensive patient overview visualising disease course and effects of treatments prescribed Staffan.Lindblad@ki.se
- 18. Guidelines Staffan.Lindblad@ki.se
- 20. Medelvärde av CRP 10 15 20 25 30 35 40 45 0 5 2000 Jan Mar Maj Jul Sep Nov 2001 Jan Mar Maj Jul Sep Nov 2002 Jan Mar Maj Jul Sep Nov 2003 Jan Mar Maj Jul Sep Staffan.Lindblad@ki.se Nov Medel CRP, Falun (N=8 405) 2004 Jan Mar Maj Jul Sep Nov 2005 Jan Mar Maj Jul Sep Nov 2006 Jan Mar Maj Jul Sep Nov 2007 Jan Mar Medel CRP, Riket-Falun (N=155 521) Maj arthritis seen as decreasing Jul Sep Nov 2008 Jan Mar Maj Improving health in rheumatoid Jul Sep Nov 2009 Jan Mar Maj inflammation (CRP) over 10 years
- 21. Project background • Treatment guidelines of the Swedish Society for Rheumatology are based on evidence from meta-analysis of clinical drug trials • These guidelines are linked to the rheumatology register’s comprehensive patient overview visualising disease course and effects of treatments prescribed • Trial patients and drug protocols are not typical for the every day clinical situation • Current patient overview in the rheumatology register build on evidence from the single patient only not utilizing the entire medical information available in the register Staffan.Lindblad@ki.se
- 22. Predictive modeling in real time Aim • Identification of the optimal treatment for an individual patient directly during the clinical visit Specific aims • Development of a predictive model based on the rheumatology registry data (45.000 pats, 300.000 visits) • Development of an on-line application supporting both a medical provider and a patient during the visit Staffan.Lindblad@ki.se
- 23. Predictive modeling in real time • A predictive model for treatment decision support has been developed and tested in rheumatoid arthritis • Variables found to be the most influencing are: doctor‘s global evaluation, disease duration, gender, DAS-28, HAQ, and interactions between DAS-28 & combination-of-drugs as well as disease duration & combination-of-drugs. Staffan.Lindblad@ki.se
- 24. The 20 most frequently used combinations of drugs Staffan.Lindblad@ki.se
- 25. Predictive modeling in real time Implementation on the Internet • Probability that a particular patient will reach a significantly lower or at least unchanged DAS-28 value at the next clinical visit if treated with the proposed combination of drugs Staffan.Lindblad@ki.se
- 28. Predictive modeling in real time Tasks to solve – Future potentials • Improve graphical presentation of the modeling results • Find better methods to evaluate probabilities despite incomplete data in the voluntary register • Include effective treatments not yet fully known; a novel drug just approved or one seldom used, which drugs do not appear on the list in the current model • Future use of two graphs of “combinations of drugs” – Most frequently used “combinations of drugs” – Most effective “combinations of drugs” Staffan.Lindblad@ki.se
- 29. Success is a journey, not a goal
- 31. The 3T:s road map The ”3T’s” road map to transform US health care, Dougherty D et al, JAMA 2008, 299, 2319 Staffan.Lindblad@ki.se
- 32. Understanding etiology and pathogenesis of immmune mediated diseases such as rheumatoid arthritis, requires longitudinal studies Chronic destruction Inflammation Diagnosis by physician Diagnosis by patient Unspecific arthritis/arthragia Autoimmunity Normal 30 40 50 60 Time genes Courtesy of Rikard Holmdahl 33
- 33. Understanding etiology and pathogenesis of immmune mediated diseases such as rheumatoid arthritis, requires longitudinal studies Chronic destruction Inflammation Diagnosis by physician Diagnosis by patient Unspecific arthritis/arthragia Autoimmunity Normal 30 40 50 60 Time genes Courtesy of Rikard Holmdahl 34
- 34. Our patients have improved and have a much better life But prevention and cure is still lacking Chronic Initiation of Today´s destruction Inflammation Criterion-defined disease treatment Results of Today´s treatment Chronic treatment 30 40 50 60 genes Courtesy of Rikard Holmdahl 35
- 35. Development of new methods for prevention and treatment is dependent on understanding of etiology and molecular pathogenesis Chronic destruction Inflammation Chronic treatment The treatments we want Prevention & cure Disappearance of symtoms, normalized function Repair Cured 30 40 50 60 genes Courtesy of Rikard Holmdahl
- 36. Rheumatoid arthritis – a prototype for a complex disease influenced by genes, immunity and environment