This document discusses patient diaries which are used in clinical trials to record patients' experiences and health status over time. It defines what patient diaries are, who writes in them, and different types including paper-based diaries, electronic diaries using handheld devices, PDAs, mini computers, and IVR systems. The benefits of electronic diaries over paper diaries are outlined, such as improved data quality and compliance. Guidelines are provided on when diaries can be started and how they support clinical research objectives.

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

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

41. THANK YOU