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

SLIDE 1

O p e n s

u

r c e t

l

s f

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

k

Š t

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

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 1 3

SLIDE 2

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

SLIDE 3

D i f f e r e n t I T p r

b

l e ms i n c l i n i c a l d i a b e t

l
g

y

S

t a n d a r d i s a t i

n
f

E l e c t r

n

i c M e d i c a l R e c

r

d ( s t i l l a l

t
f

w

r

k t

d
)
H
s

p i t a l a n d a m b u l a t

r

y i n f

r

m a t i

n

s y s t e m s ( m

s

t l y p r

p

r i e t a r y a n d c l

s

e d s

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

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
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

SLIDE 4

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

f

E n d

c

r i n

l
g

y , D i a b e t e s a n d Me t a b

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

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

s
K

V M v i r t u a l i s a t i

n
A

p a c h e / T

m

c a t i n d i f f e r e n t V M ' s

SLIDE 5

 D

i f f e r e n t d a t a s

u

r c e s

 l

a b

r

a t

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

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

n

s



C

m

p l e x r e s e a r c h p r

t
c
l

s



M

n

i t

r

i n g

f

r e s e a r c h p r

g

r e s s



L

n

g t e r m a r c h i v i n g

f

d a t a

C l i n i c a l d a t a f

r

r e s e a r c h

SLIDE 6

SLIDE 7

+ 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)

Simple electronic forms (.xls, .mdb, ..)

SLIDE 8

+ 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 ...)

„Tailored“ - custom made applications

SLIDE 9

SLIDE 10

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

SLIDE 11

Trends

SLIDE 12

CRF (clinical research form) editor

SLIDE 13

CRF – clinical research form

SLIDE 14

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

Additional features

SLIDE 15

SLIDE 16

Data export

SLIDE 17

SLIDE 18

+

 Excelent stabillity  Very good support/very active community  Low cost of ownership

 ?

Conclusions

SLIDE 19

" E U r

p

e a n B e s t I n f

r

m a t i

n

t h r

u

g h R e g i

n

a l O u t c

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

j

e c t i n t h e f i e l d

f

d i a b e t e s s p

n

s

r

e d b y t h e E u r

p

e a n U n i

n

G

a

l : t

c

r e a t e e x t e n s i v e r e p

r

t

n

s e v e r a l r e g i

n

s i n E u r

p

e i n d i a b e t e s c a r e

SLIDE 20

BIRO Core EU Dataset

1. ID Patient
2. ID Centre
3. Type of Diabetes
4. Sex
5. Date of Birth
6. Date of Diagnosis
7. Episode Date
8. Smoking Status
9. N.Cigarettes (x day)
10. Alcohol Intake (g/x day)
11. Weight
12. Height
13. BMI
14. Systolic Blood Pressure
15. Dyastolic Blood Pressure
16. HbA1c
17. Creatinine
18. Microalbumin
19. Total Cholesterol
20. HDL
21. Tryglicerides
22. Eye Examination
23. Retinopathy Status
24. Maculopathy Status

N=48

25. Foot Examination
26. Foot Pulses
27. Foot vibration
28. End Stage Renal Failure
29. Renal Dyalisis
30. Renal Transplant
31. Stroke
32. Foot Ulceration
33. Acute Myocardial Infarction
34. Laser
35. Hypertension
36. Blindness
37. Amputation
38. Antihypertensive Medication
39. Hypoglicemic Drug Therapy
40. Oral Drug Therapy
41. Pump Therapy
42. Nasal Therapy
43. Average Injections (x day)
44. Self monitoring
45. Diabetes Specific Education
46. Lipid Lowering Therapy
47. Anti-platelet Therapy
48. Patient enrollment in DMP for diabetes

SLIDE 21

1. step: Discard Heterogenity from primary sources

Diabetes clinic/region/country Mapping to standard Standardized database

SLIDE 22

2. step: Local statistical analysis

BIRO Standard Statistical Analysis Local Report

Local report: Web page and PDF

SLIDE 23

SLIDE 24

SLIDE 25

SLIDE 26

The complete BIRO model www.biro-project.eu

Clinic 1 Local Report Statistical Analysis

Aggregate Tables

BIRO Standard Mapping Local Global

Global Report

Transmission

Clinic 2

SLIDE 27

R e p

r

t 2 1 : C e n t r e s f r

m

1 9 e u r

p

e a n c

u

n t r i e s N = 1 9 9 , 9 2 p a t i e n t s

SLIDE 28

SLIDE 29

 S

l

v e s p r

b

l e m

f

s

f

t w a r e d i s t r i b u t i

n

a n d u p g r a d e s

 V

i r t u a l B

x

L i n u x a p p l i a n c e – b a s e d

n

U b u n t u

 U

p g r a d e s

f

s

f

t w a r e t h r

u

g h r e p

s

i t

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

x

– J a v a d e s k t

p

C l i e n t

 P

r e c

n

f i g u r e d p

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

c

u m e n t a t i

n

 S

m

e a d d i t i

n

a l t

l

s

B I R O X L i n u x

SLIDE 30

Me d i a wi k i : d i s t r i b u t i

n
f

E H R d a t a m

d

e l p r

p
s

a l d

t

C MS (

p

e n s

u

r c e j a v a C M S ) :

d

i s t r i b u t i

n
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

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

r

m a t i

n

s i t e Mo

d

l e : e d u c a t i

n

C

l

l a b

r

a t i

n

A l f r e s c

:

p a p e r f

r

m s r e p

s

i t

r

y

SLIDE 31

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

n

s a n d c u s t

m

i z a t i

n

f

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

f

p a t i e n t d a t a m a n i p u l a t i

n
f

r e e a s i n b e e r (

t

h e r v i s e

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

r

d a b l e t

s

m a l l d e p a r t m e n t s )

O p e n s

u

r c e d e v e l

p

m e n t m

d

e l

SLIDE 32

Q u e s t i

n