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Patient Diary by Abhinandan Sandhu
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    Patient Diary by Abhinandan Sandhu Patient Diary by Abhinandan Sandhu Presentation Transcript

    • 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
    • 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
    • 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
    • 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 )
    • 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
    • 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
    • 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
    • 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
    • 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
    • Types of Patient Diaries Paper Based Electronic  Handheld device diaries  Personal data assistants (PDAs)  Mini computers  IVR systems
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • Adapted from Electronic Diary Solutions: Enhanced Collection of Patient Reported Outcomes Data by Dr Bill Byrom
    • 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
    • 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
    • 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
    • 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
    • Adapted from Applied Clinical Trials, Jun 1, 2004: Proving the eDiary Dividend by Sara McKenzie
    • 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
    • Compliance by Paper and Electronic Subject Diary Adapted from Applied Clinical Trials, Jun 1, 2004: Proving the eDiary Dividend by Sara McKenzie
    • Compliance by paper and electronic subject diary Adapted from Applied Clinical Trials, Jun 1, 2004: Proving the eDiary Dividend by Sara McKenzie
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • THANK YOU