1. Patient Diaries
Abhina a Sa hu
nd n nd
Fa ulty a C
c t linic l Re e rc Ins
a s a h titute
a hi_g
b ill@ ya o o
ho .c .in
2. Objective
W t a P tie d irie ?
ha re a nt a s
W ta P
ha re ROs ?
Ne dfo p tie d rie
e r a nt ia s
W w sin thed ry?
ho rite ia
Typ so d rie
e f ia s
C m a o o p p r a e c nicd rie
o p ris n f a e nd le tro ia s
C a n o d rie
re tio f ia s
Sub c p fe nc s
je t re re e
3. What are Patient Dairy?
Patient Diary is a to l us d d
o e uring a
clinic l tria o a d e s tre tm nt to
a l r is a e a e
m a uretre tm nt c m lia e
es a e o p nc
P tie s Dia a o p vid s w a
a nt’ ry ls ro e ith
s le ha y p c to d c e he lth
ing , nd la e o um nt a
ins nc p lic info a n, d c r’
ura e o y rm tio o to s
vis , p s rip ns a q s ns fo
its re c tio , nd ue tio r
yo ur d c rs
o to , p rm c t a
ha a is nd
ins nc c m a
ura e o p ny
4. What are PROs
P tie
a nt-re o d o o e (P
p rte utc m s RO)
ha lo b e e s ntia s urc s o
ve ng e n s e l o e f
d ta
a in b p rm c utic l
io ha a e a
c ma sc
o p nie ' linic l re e rc
a sa h
A PRO is a m a ure e o a
e s m nt f ny
a p c o a p tie s he lth s tus
s et f a nt’ a ta
tha c m s d c fro thep tie
t o e ire tly m a nt
(i.e w ut the inte re tio o
., itho rp ta n f
the p tie s re p ns s b a
a nt’ so e y
p ic n o a nee e
hys ia r nyo ls )
5. Emergence of Psychometrics
P rha s the m s im o nt d ve p e ha b e
e p o t p rta e lo m nt s e n
g a r a ntio to p yc m tric , the s ie e o
re te tte n s ho e s c nc f
a s s ingp tie e e nc
ses a nt xp rie e
Qua tive w rk is inc a ing to e ure tha the
lita o re s ly ns t
inte e m a ure ta s the full ra e o p tie
nd d e s p ng f a nt
e e nc s a q s nna s a s je te to
xp rie e nd ue tio ire re ub c d
rig ro q ntita s tis a te ts
o us ua tive ta tic l s
6. Need of Diaries in Clinical Trials
So etreatment effects a known only to the patient
m re
To know the patient perspective a o the e c ne s
b ut ffe tive s
o atre tm nt
f a e
Sys m tic a s s m nt o the patient’s perspective may
te a ses e f
provide valuable information tha c n b lo t w n tha
t a e s he t
p rs e tive is filte d thro h a c
e pc re ug linic n’ e lua n o
ia s va tio f
thep tie sre p ns toc
a nt’ s o e linic l inte wq s ns
a rvie ue tio
7. PROs Objectives
Thefo us o P
c f RO m a ure is s
e s s hifting fro b a
m ro d
q lity o life a s s m nts to measures of signs
ua f ses e
and symptoms, w h m y b d e s s e ific
hic a e is a e p c
Tre tm nt-re te changes in quality of life
a e la d
Direct consequences of disease and treatment,
the ha m reo n s rve a p a e p ints
y ve o fte e d s rim ry nd o
in clinic l tria
a ls
8. When can the Diary be started
In clinic l tria , d iry iss re p r tous o
a ls a ta d rio e f
inve tig tio l a e
s a na g nt
In inte ivec re d rie a us lly s rte o the
ns a , ia s re ua ta d n
p tie sthirdd y b c us p tie w s y
a nt’ a e a e a nts ho ta
lo e us lly e e nc m rem m ry g p
ng r ua xp rie e o e o as
9. Who writes in the Diary ?
P tie him e re o stheo s rva ns
a nt s lf c rd b e tio
A d ry ke t b nurs s w n in the
ia p y e , ritte
IC d
U uring p rio s o c a illne s
e d f ritic l s,
w h isha e o r to thep tie w n
hic nd d ve a nts he
the a c ns e d a le to re e it in
y re o id re b c ive
c s o inte ivec re
ae f ns a
In c s o c re e r the p re o
a e f hild n, ithe a nts r
c re und r thes e io o p re
hild n e up rvis n f a nts
10. Types of Patient Diaries
Paper Based
Electronic Handheld device diaries
Personal data assistants (PDAs)
Mini computers
IVR systems
11. Paper Diary
P tie
a nts ke p a d ily p p r d ry
e a ae ia
thro ho
ug ut the s y a
tud nd re o
c rd
s p m w n the e e nc dthe
ym to s he y xp rie e m
P p r p tie d rie c nno b tra ke fo
a e a nt ia s a t e c d r
a he nc tothere o
d re e p rtings he ule
c d
If thep tie fo e to c m le thed ry
a nt rg ts o p te ia
o the d te the s p m o c d the
n a ym to c urre , y
c n c m le the d ry la r, inc a ing
a o p te ia te re s
thelike o tha d taw h ise re is
liho d t a hic nte d
ina c te
c ura
12. Paper Diaries
The d ta re o
a p rting s ture
truc
s und p p r d rie is s w a
urro ing a e ia s lo nd
cs
o tly
By the tim the a e tio
e b rra ns are
d c ve d the p tie c n no lo e
is o re , a nt a ng r
re e b r the c rre t re p ns a
mm e o c s o e nd
im o nt d ta is lo t w h c n
p rta a s hic a
im a t theo o eo thes y
pc utc m f tud
13. Paper Diaries
The a ila ility o re va d ta
va b f le nt a
o re uire tim is q
n q d e uite
c m lic te a d ult
o p a d nd iffic
Re e rc r
s a he ha s to s a h
e rc
m nua
a lly fo re o
r p rts in the
e us
xha tive file a b the tim
s nd y e
he find the s e ific d ry he
s pc ia
m y s the p int he w nts to
a kip o a
put
14. PROs go Electronic
Clinic l re e rc rs ha
a s a he ve us d p p r
e ae
d rie fo tha p o e s e the 19 0 ,
ia s r t urp s inc 4s
b in a a m t to o rc m s je t
ut n tte p ve o e ub c
no o p nc a d ta ua p b m
nc m lia e nd a -q lity ro le s
a s c te w p p r d rie , the no
s o ia d ith a e ia s y w
o n us EDs
fte e
Re e s ie ha s w tha p tie
c nt tud s s ho n t a nt
c m lia e in va us c
o p nc rio linic l tria
a ls
inc a e totrip w theus o e ia s
re s s le ith e f -d rie
15. Rationale for Developing EDs
The a p a n o EDs ha its ro ts in the e
p lic tio f s o s
p rs te p b m a s c te w
e is nt ro le s s o ia d ith p p r
ae
d rie
ia s
P o d taq lity
o r a ua
Lo d la to d talo k
ng e ys a c
P o s je t c m lia e
o r ub c o p nc
Theris p te l fo lo s d m g
ks o ntia r s , a a e
Ina c c
c ura y
16. Electronic based Patient Diaries
Ele tro
c nic d ry m tho s fo c lle ting d ta fro
ia e d r o c a m
p tie in c
a nts linic l tria w sd ve p d in 19 7
a ls a e lo e 8
An Electronic Patient Diary re is rs thed ry in a
g te ia
s ra ed vic a a w fo m nito
to g e e nd llo s r o ringthetim the
e
m d a n w s ta n, a s p m o Qua o
e ic tio a ke nd ym to s r lity f
Lifed tare o e
a c rd d
Sp ns rs s uld e ta lis a ‘ o
o o ho s b h to lkit’o p fe d
f re rre
te hno g a a a o
c lo y nd n lg rithm b w h the c n
y hic y a
d c e w h te hno g to a p to a p rtic r
e id hic c lo y p ly a ula
s y
tud
17. Handheld Device diaries
De e c n b c nfig d to b e o fla h to re ind the
vic s a e o ure le p r s m
p tie o as he ule d ry e
a nt f c d d ia ntry
The in-built s re n fa ilita s the e
c e c te ntry o fre te a
f e xt nd
vis l a lo ue s a d ta a c n a o b us d to p s nt
ua na g c le a , nd a ls e e re e
o c e d
n-s re n uringd ry c m le n
ia o p tio
The m in lim tio c ntre a und the e s o us , the
ir a ita ns e ro ir a e f e
re uire e to d p y a
q m nt e lo nd m inta ha w re a
a in rd a , nd
c nne tivity is ue
o c s
18.
19. Personal Data Assistants (PDAs)
The e d vic s ha
s e e ve a s a s re n to d p y
m ll c e is la
q s ns a
ue tio , nd a num e o b ns to c ntro
b r f utto o l
na a n thro h q s ns a to a s n a re p ns
vig tio ug ue tio nd s ig so e
toaq s n
ue tio
Da c lle te o the P
ta o c d n DA is tra m d b the
ns itte y
s je t,
ub c thro h
ug w le s
ire s o r a lo
na g
te c m unic tio , to a c ntra s rve ho te b the
le o m a ns e l e r s d y
e RO s lutio p vid r
P o n ro e
The PDAs c n b p g m e to he p tie
a e ro ra m d lp a nts
re e b r tore o the d ta
mm e c rd ir a
20. IVR systems
IVR s te s a a c s e b the p tie w
ys m re c e s d y a nt ho
te p ne into a c ntra c m ute s te via a to
le ho s e l o p r ys m ll-
fre num e
e br
P -re o e m s a e c m ris the d ry q s ns
re c rd d e s g s o p e ia ue tio ,
a re p ns s a m d us
nd s o e re a e ing the ke o the
ys f
te p neke a
le ho yp d
21. IVR systems
IVRS re o s the info a n in vo e fo a a
c rd rm tio ic rm t nd
tha c nve it intofilefo a
n o rt rm t
Da a e re d c
ta re nte d ire tly onto the c ntra IVR
e l
d ta a e e ina
a b s , lim ting d w a a
o nlo d nd c nne tivity
o c
is ue a m king a d ry d ta a ila le fo re w
s s nd a ll ia a va b r vie
in re l-tim
a e
IVR d rie us the te p ne ke a to e r d ta
ia s e le ho yp d nte a ,
m king it id a fo c lle tio o num ric b ry,
a el r o c n f e , ina
o ina s a , a c te o a ultip -c ic
rd l c le nd a g ric l/m le ho e
22. IVR Systems
Ea h p tie e
c a nt ntry is tim s m e w the p tie s
e ta p d ith a nt’
lo a tim d c e
cl e o um ntinge c w n thec ll ism d
xa tly he a ae
The IVR s te d fine a w o o tim d
ys m e s ind w f e uring
w h the p tie re o s p m tha the a
hic a nt p rts ym to s t y re
e e nc
xp rie ing a the m m nt o w
t o e r ithin the p vio
re us
12 4ho
-2 urs
Re o
p rting p ra e rs a s t d p nd w re o the
a m te re e e e ing he n
g b thep tie re id s
lo e a nt s e
23. IVR Systems
P g m e to g ne tea a rt w n d taise re
ro ra m d e ra n le he a nte d
w h isinva o o id a c p dra e
hic lid r uts e c e te ng s
Re p nd nts a im e ia ly p m te to re nte
so e re m d te ro p d -e r
d ta
a
Thus c nflic a re o dre o ly a ins ntly
, o ts re s lve m te nd ta
24. IVR Patie nt Diary
Patient diary call
Daily / weekly symptoms data
Update eCRFs
Record
diary IVR Non-compliance EDC
data alerts
System System
Query
cycle
Update IVR Patient enrolment
database - Screening number
- Initials
- Date of birth
- IVR user-envelope number
Withdrawal event
Adapted from Presentation EDC-IVR Integration, David M. Fishbach
25. Adapted from Electronic Diary Solutions: Enhanced Collection of Patient Reported Outcomes Data by
Dr Bill Byrom
26. Use of Electronic Diary
Ele tro p tie d rie he m ke s lf-re o d
c nic a nt ia s lp a e p rte
p tie d tam h m rere b fo c m a s
a nt a uc o lia le r o p nie
e RO re o c n b s nt to thes y te min re l
P p rts a e e tud a a
tim ,e
Elim te theris o lo s sin tra it
ina s k f se ns
P vid ss s ntia m red c tio a p c
ro e ub ta lly o is re n nd riva y
fo thep tie
r a nt
27. Limitations of Paper Based Diary
The c m o is ue ra e w n c lle ting d ta fro
o m n s s is d he o c a m
p p r-b s d ins
a e ae trum ntsa tha o le ib
e re t f g ility a hum n
nd a
e r w n inte re
rro he rp tingha w n a w rs
nd ritte ns e
All m nne o a c e
a r f c id nts c n ha p n, le d
a pe a ing to the
p p r b ingd m g d o e n lo t b fo e ingup b c
ae e a a e r ve s e re nd ak
in theha so thes y m na e e te m
nd f tud a g m nt a
Fa ric tio o thed ta
b a n f a
28. Limitations of Paper Based Diary
Sp llingc n a oa c thea c c o thed ta a this
e a ls ffe t c ura y f a , s
c n le dthete mtom keap s ib s rio
a a a a o s ly e us
m inte re tio
is rp ta n
W thea m tra
ith d inis tiveb e o typ upthe
urd n f ing
ha w n re p ns s
nd ritte s o e
29. Benefits of e-Patient Diary
Re l-tim , 2 /7 a c s
a e 4 c es
P m te p tie c m lia e
ro o s a nt o p nc
P vid sp c s c ns te y
ro e ro e s o is nc
Dra a a re uc shum n e r
m tic lly d e a rro
Im ro sd tare b
p ve a lia ility
Sa stim a m ne
ve e nd o y
He re e rc rs m re e c ly m na e p tie
lp s a he o ffe tive a g a nts
in s ie w re s lf-re o d d ta a a ke
tud s he e p rte a re y
e p int
nd o
30. Adapted from Applied Clinical Trials, Jun 1, 2004: Proving the eDiary Dividend by Sara McKenzie
31. FDA's ALCOA
The FDA's ALCOA (Attributable, Legible,
Contemporaneous, Original, Accurate) criteria
for patient data in labelling claims have helped
to substantiate the argument for using ePRO, as
patient data is far more accurate when collected
electronically
32. Compliance by Paper and Electronic
Subject Diary
Adapted from Applied Clinical Trials, Jun 1, 2004: Proving the eDiary Dividend by Sara McKenzie
33. Compliance by paper and electronic subject
diary
Adapted from Applied Clinical Trials, Jun 1, 2004: Proving the eDiary Dividend by Sara McKenzie
34. Aim of the Patient diary
Atte p to m a ureb th thee c ne s a
mt es o ffe tive s nd
thes ee c o tre tm nt
id ffe ts f a e
Me s
a ure the a ve e c ns q nc s o
d rs o e ue e f
tre tm nt s p ra ly fro the e c ne s o
a e e a te m ffe tive s f
tre tm nt
a e
35. Creation of the Diaries
W n d ve p
he e lo ing a d ry, s o o a e o g d to
ia p ns rs re nc ura e
a s s its a e ua y in the c nte o the fo w
ses dq c o xt f llo ing
d ve p e p c s e
e lo m nt ro e s s
Ge ra n o Ite s
ne tio f m
C ic o theDa C lle tio Me d
ho e f ta o c n tho
C ic o theRe a P rio
ho e f c ll e d
C ic o Re p ns Op ns
ho e f s o e tio
36. Creation of the Diaries
Eva tio o P tie Und rs nd
lua n f a nt e ta ing
De lo m nt
ve p e of Fo a
rm t, Ins tio ,
truc ns and
Training
C nfirm tio o the C nc p l Fra e o a
o a n f o e tua m w rk nd
Fina tio o theDAIRY
liza n f
37. Prior to e Diaries
Training s je ts is a ke
ub c y
e m nt in a e RO s lutio
le e ny P o n
Inve tig to ne d to b a le to
s a rs e e b
he s je ts us the e rie
lp ub c e Dia s
thro ho thes y
ug ut tud
38. A symbol based Patient Diary for children
Most children between 5
and 8 years old have not
yet learned to write full
sentences
Electronic patient diary in
which small children at
age 5-8 could express their
feelings through symbols
and drawings
39. Subjects Preference
The e p a lite ture re c a c a s je t p fe nc
m iric l ra fle ts le r ub c re re e
fo e c nicd rie re tivetop p r d rie
r le tro ia s la a e ia s
Drum o a c lle g s re o d tha 5
m nd nd o a ue p rte t 7% o the
f ir
s je ts w g s inte tina d o e p fe d the
ub c ith a tro s l is rd rs re rre
e c nic a s s m nt, a o 13 p fe d thep p r
le tro s e s e nd nly % re rre ae
ve io ; 3 % e re s dnop fe nc
rs ns 0 xp s e re re e
40. Subjects Preference
Tip d a c lle g s c m a d EDs a p p r d rie in 2
la y nd o a ue o p re nd a e ia s 2
re p to c
s ira ry linic o a nts w s lf-m nito d w
utp tie ho e o re ith b th
o
m tho s fo fo w e ; 5 % e re s d p fe nc fo the ED
e d r ur e ks 9 xp s e re re e r
o r thep p r d ry, 18 p fe d p p r, a 2 % e re s d no
ve a e ia % re rre a e nd 3 xp s e
p fe nc
re re e
Fina J ha s a c lle g s fo
lly, o nne nd o a ue und tha a p xim te 70
t p ro a ly %
o the a m le s m le (n=2 ) p fe d a ED ve us a p p r
f ir ll-fe a a p 3 re rre n rs ae
m ns l d ry
e trua ia