O p e n s o u r c e t o o l s f o r c l i n i - PowerPoint PPT Presentation

O p e n s o u r c e t o o l s f o r c l i n i c a l r e s e a r c h i n a d i a b e t e s c l i n i c I z t o k Š t o t l U n i v e r s i t y M e d i c a l C e n t r e L j u b l j a n a P e t e r B e c k J O A N N E U M R E S E A R C H F o r s c h u n g s g e s e l l s c h a f t m b H B e r l i n 2 0 1 3

Source od data: IDF Diabetes World Atlas; http://www.idf.org/

D i f f e r e n t I T p r o b l e ms i n c l i n i c a l d i a b e t o l o g y - S t a n d a r d i s a t i o n o f E l e c t r o n i c M e d i c a l R e c o r d ( s t i l l a l o t o f w o r k t o d o ) - H o s p i t a l a n d a m b u l a t o r y i n f o r m a t i o n s y s t e m s ( m o s t l y p r o p r i e t a r y a n d c l o s e d s o u r c e ) - T e l e m e d i c i n e , P H R a n d d i f f e r e n t m e d i c a l g a d g e t s ( i n s u l i n p u m p s , s e n s o r s . . . ) - D a t a ma n a g e me n t i n C l i n i c a l r e s e a r c h - C o mp u t e r i s e d d i a b e t e s r e g i s t r i e s

U n i v e r s i t y me d i c a l c e n t r e L j u b l j a n a , D e p a r t me n t o f E n d o c r i n o l o g y , D i a b e t e s a n d Me t a b o l i c D i s e a s e s S ma l l d e p a r t me n t wi t h i n p a t i e n t a n d o u t p a t i e n t d i a b e t e s c l i n i c O w n s e r v e r s : - C e n t o s - K V M v i r t u a l i s a t i o n - A p a c h e / T o m c a t i n d i f f e r e n t V M ' s

C l i n i c a l d a t a f o r r e s e a r c h  D i f f e r e n t d a t a s o u r c e s  l a b o r a t o r i e s  b e d s i d e d a t a  d i f f e r e n t d e p a r t m e n t s  m u l t i c e n t r i c / i n t e r n a t i o n a l r e s e a r c h  S t r i c t r e g u l a t i o n s  C o m p l e x r e s e a r c h p r o t o c o l s  M o n i t o r i n g o f r e s e a r c h p r o g r e s s  L o n g t e r m a r c h i v i n g o f d a t a

Simple electronic forms (.xls, .mdb, ..) + easy to develop + low price - not practical for complex protocols - bad for big research teams, multicentric studies - without tracking changes, not compliant with regulations - not flexibile enough, lack of support for different data formats - archiving not complete (signatures, modifications tracking)

„Tailored“ - custom made applications + web/desktop applications + everything can be customised - time consuming - $$$ - price to high for small research teams - bad reusability - public clouds not an option (privacy, regulations) - propriatary solutions (expensive, lock-in ...)

Vanderbilt University OpenClinica, LLC Standard/LTS Community/Enterprise Available only for non- Lesser General Public License commercial research purposes Apache/PHP/MySql Tomcat/J2EE/Postgres or Oracle Certifikate FDA 21 part 11

Trends

CRF (clinical research form) editor

CRF – clinical research form

Additional features Redcap:  Tablet computers  Data Transfer Service (DTS) – push or pull data  Randomisation module  Very friendly user interface  Surveys Openclinica:  Very good REST/SOAP infrastructure / easy customisation  Discrepancy management (GUI entry and WS)  CDISC ODM

Data export

Conclusions +  Excelent stabillity  Very good support/very active community  Low cost of ownership -  ?

" E U r o p e a n B e s t I n f o r m a t i o n t h r o u g h R e g i o n a l O u t c o m e s i n D i a b e t e s " ( E U B I R O D ) P u b l i c h e a l t h p r o j e c t i n t h e f i e l d o f d i a b e t e s s p o n s o r e d b y t h e E u r o p e a n U n i o n G o a l : t o c r e a t e e x t e n s i v e r e p o r t o n s e v e r a l r e g i o n s i n E u r o p e i n d i a b e t e s c a r e

BIRO Core EU Dataset 1. ID Patient 25. Foot Examination 2. ID Centre 26. Foot Pulses 3. Type of Diabetes 27. Foot vibration 4. Sex 28. End Stage Renal Failure 5. Date of Birth 29. Renal Dyalisis 6. Date of Diagnosis 30. Renal Transplant 7. Episode Date 31. Stroke 8. Smoking Status 32. Foot Ulceration 9. N.Cigarettes (x day) 33. Acute Myocardial Infarction 10. Alcohol Intake (g/x day) 34. Laser 11. Weight 35. Hypertension N=48 12. Height 36. Blindness 13. BMI 37. Amputation 14. Systolic Blood Pressure 38. Antihypertensive Medication 15. Dyastolic Blood Pressure 39. Hypoglicemic Drug Therapy 16. HbA1c 40. Oral Drug Therapy 17. Creatinine 41. Pump Therapy 18. Microalbumin 42. Nasal Therapy 19. Total Cholesterol 43. Average Injections (x day) 20. HDL 44. Self monitoring 21. Tryglicerides 45. Diabetes Specific Education 22. Eye Examination 46. Lipid Lowering Therapy 23. Retinopathy Status 47. Anti-platelet Therapy 24. Maculopathy Status 48. Patient enrollment in DMP for diabetes

1. step: Discard Heterogenity from primary sources Standardized Diabetes Mapping to database clinic/region/country standard

2. step: Local statistical analysis Local report: Web page and PDF Statistical Local BIRO Analysis Report Standard

The complete BIRO model www.biro-project.eu Local Global Transmission Clinic 1 Mapping BIRO Statistical Standard Local Analysis Global Report Aggregate Report Tables Clinic 2

R e p o r t 2 0 1 0 : C e n t r e s f r o m 1 9 e u r o p e a n c o u n t r i e s N = 1 9 9 , 9 0 2 p a t i e n t s

B I R O X L i n u x  S o l v e s p r o b l e m o f s o f t w a r e d i s t r i b u t i o n a n d u p g r a d e s  V i r t u a l B o x L i n u x a p p l i a n c e – b a s e d o n U b u n t u  U p g r a d e s o f s o f t w a r e t h r o u g h r e p o s i t o r y / s y s t e m u p d a t e  I n c l u d e s :  B I R O B o x – J a v a d e s k t o p C l i e n t  P r e c o n f i g u r e d p o s t g r e s s d a t a b a s e , R , L a T e X , J a v a  D o c u m e n t a t i o n  S o m e a d d i t i o n a l t o o l s

C o l l a b o r a t i o n Me d i a wi k i : d i s t r i b u t i o n o f E H R d a t a m o d e l p r o p o s a l d o t C MS ( o p e n s o u r c e j a v a C M S ) : - d i s t r i b u t i o n o f c l i n i c a l g u i d e l i n e s s - e d u c a t i o n m a t e r i a l s - e v e n t s - p a t i e n t i n f o r m a t i o n s i t e A l f r e s c o : p a p e r f o r m s r e p o s i t o r y Mo o d l e : e d u c a t i o n

O p e n s o u r c e d e v e l o p m e n t m o d e l - e a s i e r d e b u g g i n g - f e a t u r e a d d i t i o n s a n d c u s t o m i z a t i o n f o r s p e c i a l n e e d s - t r a n s p a r e n c y o f p a t i e n t d a t a m a n i p u l a t i o n - f r e e a s i n b e e r ( o t h e r v i s e o f t e n v e r y e x p e n s i v e a n d u n a f f o r d a b l e t o s m a l l d e p a r t m e n t s )

Q u e s t i o n s . . .