Clinical Decision Making and Outcome in Routine Care for People with Severe Mental Illness (CEDAR): study protocol

STUDY PROTOCOL Open Access Clinical Decision Making and Ou come in Rou ine Ca e o People wi h Se e e Men al Illness (CEDAR): S udy p o ocol Be nd Puschne 1* , Sabine S e en 1 , Mike Slade 2 , Helena Kaliniecka 2 , Ma io Maj 3 , And ea Fio illo 3 , Po l Munk-Jø gensen 4 , Jens I a La sen 4 , Anikó Ége házi 5 , Zol an Nemes 5 , Wul Rössle 6 , Wol am Kawohl 6 , Thomas Becke 1 Abs ac Backg ound: A conside able amoun o esea ch has been conduc ed on clinical decision making (CDM) in sho - e m physical condi ions. Howe e , he e is a lack o knowledge on CDM and i s ou come in long- e m illnesses, especially in ca e o people wi h se e e men al illness. Me hods/Design: The s udy en i led “Clinical decision making and ou come in ou ine ca e o people wi h se e e men al illness”(CEDAR) is ca ied ou in six Eu opean coun ies (Denma k, Ge many, Hunga y, I aly, Swi ze land and UK). Fi s , CEDAR es ablishes a me hodology o assess CDM in people wi h se e e men al illness. Speci ic ins umen s a e de eloped (and psychome ic p ope ies es ablished) o measu e CDM s yle, key elemen s o CDM in ou ine ca e, as well as CDM in ol emen and sa is ac ion om pa ien and he apis pe spec i es. Second, hese ins umen s a e being pu o use in a mul i-na ional p ospec i e obse a ional s udy (bimon hly assessmen s du ing a one-yea obse a ion pe iod; N = 560). This s udy in es iga es he immedia e, sho - and long- e m e ec o CDM on c ucial dimensions o clinical ou come (symp om le el, quali y o li e, needs) by aking in o accoun signi ican a iables mode a ing he ela ionship be ween CDM and ou come. Discussion: The esul s o his s udy will make possible o delinea e quali y indica o s o CDM, as well as o speci y p ime a eas o u he imp o emen . Ing edien s o bes p ac ice in CDM in he ou ine ca e o people wi h se e e men al illness will be ex ac ed and ecommenda ions o mula ed. Wi h i s explici ocus on he pa ien ole in CDM, CEDAR will also con ibu e o s eng hening he se ice use pe spec i e. This p ojec will subs an ially add o imp o ing he p ac ice o CDM in men al heal h ca e ac oss Eu ope. T ial egis e : ISRCTN75841675. Backg ound Se e e men al illness (SMI) subs an ially con ibu es o disabili y and global bu deno disease.In hegene al popula ion in Eu ope o adul age, he p e alence a e (12 mon hs) o se e e men al illness is abou 2.2% [1] indica ing ha abou 11 million people in he Eu opean Union a e a ec ed by clinically and socially disabling condi ions wi h a high need o in ensi e and long- e m p o essional ea men . While people wi h SMI in Eu ope ecei e p o essional heal h ca e in di e en ea men se ings wi h he majo i y being ca ed o by communi y-based se ices, he e is a lack o knowledge on clinical decision making (CDM) and i s ou come in ou ine ca e. This is espe- cially dis u bing since du ing he las decades, men al heal h esea ch has esul ed in a la ge numbe o in e - en ions wi h p o en e icacy whose implemen a ion equi es communica ion be ween pa ien and clinician as well as ac ions ollowing hei in e ac ions. I is unknownwhe he , owhichex en ,andhowposi i e pa ien ou come ollowing such in e en ions depends upon pa ien -clinician in e ac ion o CDM. We a gue * Co espondence: be nd.puschne @bkh-guenzbu g.de 1 Depa men o Psychia y and Psycho he apy II, Ulm Uni e si y, Ludwig- Heilmeye -S . 2, 89312 Günzbu g, Ge many Full lis o au ho in o ma ion is a ailable a he end o he a icle Puschne e al.BMC Psychia y 2010, 10:90 h p://www.biomedcen al.com/1471-244X/10/90 © 2010 Puschne e al; licensee BioMed Cen al L d. This is an Open Access a icle dis ibu ed unde he e ms o he C ea i e Commons A ibu ion License (h p://c ea i ecommons.o g/licenses/by/2.0), which pe mi s un es ic ed use, dis ibu ion, and ep oduc ion in any medium, p o ided he o iginal wo k is p ope ly ci ed. ha he majo eason o his lack o knowledge is ha esea ch on CDM in heal h ca e has p ima ily ocused upon well-de ined si ua ions in physical condi ions, while he e a e only e y ew s udies on CDM in ou ine ca e o people wi h SMI wi h i s high demands on pa ien engagemen , ensu ing con inui y o ca e and es ablishing s able he apeu ic ela ionships. Con ex ualising clinical decision making Gi en a gene al inc ease in in e es in pa ien -cen e ed [2] o pa ien - ocused [3] app oaches, i has been sug- ges ed ha esea ch on clinical decision making should become a p io i y. E.g. he NIMH B idging Science and P ac ice Repo [4] speci ically ecommended o encou- age “ he de elopmen o me hods o s udy and inco po- a e clinician and pa ien /consume decision making p ocesses in o in e en ion esea ch”( ecommenda ion #24), as well as “ he imp o emen o me hods o bo h e alua ing clinician implemen a ion and pa ien /consu- me adhe ence o ea men ecommenda ions and es i- ma ing he consequences o hese a ia ionson he e ec i eness o ea men ”( ecommenda ion #26). Since he 1960s, concep s de eloped wi hin he ame- wo k o decision heo y ha e been applied o heal h ca e esea ch. Resea ch on CDM has d awn upon se - e al concep ual app oaches such as in o ma ion p oces- sing, social judgemen heo y, and expec ed u ili y heo y. Un il he 1980s, his esea ch almos solely ocused on clinician decision making [5]. The e is con- side able deba e on wha cons i u es a “good”clinical decision. In a well-de ined one- ime clinical decision scena io, an ideal decision is concep ualised as being he sole esponsibili y o he physician who decides ia a a ional p ocess aking in o accoun scien i ic e idence and clinical expe ience. In his scena io i is assumed ha pa ien s would make he same decision i p o ided wi h he same in o ma ion [6]. In o ma ion would be communica ed o he pa ien , bu he con ex o deci- sion making is a he unimpo an in such a scena io [7]. CDM iewed his way is a a ional and linea p o- cess lending i sel eadily o sys ema ic analysis [8]. Howe e , since CDM a ely akes place in such clea - cu si ua ions, less decon ex ualised models o decision making ha e been de eloped. En wis le e al. [9] p oposed a con ex ualised sequence o ac i i ies in decision making consis ing o : (a) ecog- ni ion and cla i ica ion o a p oblem; (b) iden i ica ion o po en ial solu ions; (c) app aisal o po en ial solu ions; (d) selec ion o cou se o ac ion; (e) implemen a ion o he chosen cou se o ac ion; and ( ) e alua ion o he solu ion adop ed. Simila ly, Ro he e al. [10] de eloped a gene al amewo k (see Figu e 1) which concep ualises he decision making p ocess om he pa ien ’s pe spec- i e, and shows how - ia he p ocess o decision making - indi idual-le el a iables migh be ela ed o indi idual- and se ice-le el ou comes. This amewo k sugges s ha e ec i e decision mak- ing depends on accu a e in o ma ion ega ding he isks and bene i s as well as he likelihoods o ele an ou - comes and an unde s anding o he alues ele an o he decision. Decisions a e made a e p e e ences ha e been o mula ed by combining in o ma ion and alues and in u n a ec pa ien beha iou s (e.g. ea men adhe ence) and ou comes. In o ma ion e e s o deci- sion- ele an da a, e.g. isks and bene i s associa ed wi h a gi en ea men , which should be easily accessible and comp ehensible. Values ep esen he indi idual a ac- i eness o heal h s a es aking in o accoun a gi en ea men ’s nega i e aspec s, e.g. unwan ed side e ec s. The con ex o decision making e e s o a ious aspec s o a pe son’s e e yday li e including s uc u e and acces- sibili y o he heal hca e sys em as well as na u e, du a- ion and se e i y o he illness. P e e ences indica e g ea e liking o one ea men op ion compa ed o ano he and a e concep ualised as an in e ac ion be ween in o ma ion and alues. Ou comes as he esul o pa ien beha iou include pa ien heal h s a us o cos s o ca e [5]. Types o clinical decision making Fu he mo e, inc easing a en ion has been gi en o pa ien in ol emen in CDM. Cha les e al. [11] p o- posed h ee gene al ypes o ea men decision making (see Table 1) in which h ee main ac i i ies (in o ma ion ans e , delibe a ion, and deciding abou implemen ing ea men ) a e being conside ed. Analogue ypes aking in o accoun desi e o in o ma ion and o ea men choice ha e been sugges ed [12]: (a) P o essional choice: The clinician decides and he pa ien consen s; (b) Sha ed decision making: In o ma ion is sha ed and bo h decide oge he ; (c) Consume choice: The clinician in o ms and he pa ien makes he decision. Coul e [12] a gues ha di e en models may be app op ia e a di e en imes. While sha ed decision making has been ad oca ed as a p omising app oach in o de o imp o e ma ching o ea men s o pa ien s, pa ien sa is ac ion, and ou come, he ex en o decision making in ol emen ha is necessa y o a sha ed deci- sion making p ocess is unde deba e. E.g. he e is con- sis en e idence o a high (and o en unme ) need o ea men in o ma ion by pa ien s, bu i has also been ound ha in some ins ances, pa ien s do no wan o be esponsible o making ea men decisions. Thus, in high-s ake decisions such as eme gency and li e- h ea ening si ua ions, a pa e nalis ic app oach migh be mo e easonable while in si ua ions whe e ea men decisions a e mo e con o e sial, he sha ed decision making o e en he consume choice model Puschne e al.BMC Psychia y 2010, 10:90 h p://www.biomedcen al.com/1471-244X/10/90 Page 2 o 11 migh be p e e able [13]. The e is no e idence on which app oach is o be p e e ed in CDM si ua ions ega ding he ca e o people wi h SMI. Clinical decision making in ch onic illness Much o he li e a u e on CDM has ocused on acu e and se ious medical condi ions. In immedia e and high- isk acu e ca e si ua ions, he clinician is o en seen as he p ima y sou ce o medical knowledge and as he sole au ho i y o deciding on ea men op ions, which is mos o en es ic ed on whe he o no o comply wi h his o he ecommenda ion [8]. Howe e , decision making in ch onic condi ions such as SMI di e s om decision making in acu e ca e in se e al aspec s. Wa [8] in oduced a amewo k o unde s anding decision making in ch onic condi ions which can also be applied o SMI. The au ho delinea ed se e al ac o s impac ing di e en ly upon decision making in acu e s. ch onic ill- ness (see Table 2). Acco ding o his amewo k, CDM in pe sis en con- di ions such as SMI - as opposed o well-de ined acu e ca e si ua ions - has o ake in o accoun ha : (a) ea - men ocus is on long- e m disease managemen ; (b) a high numbe o decisions ha e o be a i ed a e- quen ly, o en oge he wi h mo e han one se ice p o- ide and/o ca e s; and (c) pa ien s in gene al a e highly knowledgeable abou hei illness. Due o inc eased accessibili y o ea men - ele an in o ma ion e.g. ia in e ne o sel -help sou ces, pa ien s migh e en ha e mo e ecen and be e in o ma ion han hei se - ice p o ide s. Resea ch on clinical decision making in gene al Resea ch on CDM has ocused on a ange o physical condi ions, p edominan ly in well-de ined sho - e m li e- h ea ening e en s (hea a ack, s oke), bu has also looked a p olonged s a es o ill heal h, e.g. cance and ib omyalgia. The esea ch ocus has been p ima ily on o mal decision analysis in high isk- isk acu e ea - men s such as one- ime acu e ea men choices in su - ge y ia hypo he ical scena ios/ igne es. These app oaches ha e been c i icised o being o e ly cogni- i e and decon exualised, and also o lack o gene alisa- bili y o esul s [5]. F om his ype o esea ch, decision ees and decision aids ha e been gene a ed. While he numbe o decision suppo applica ions has been inc easing apidly du ing he las yea s, he e is s ill a ange o open ques ions ega ding hei use, con en , and o ma [14]. Wi h he excep ion o a decision aid o dep ession medica ion, he e is cu en ly no publicly a ailable decision aid o men al illness [5]. In o ma ion o pa ien decision mak- ing a ies widely in i s quali y and comp ehensibili y and is no always adequa ely accessible o pa ien s o be use ul o decision making [15]. Some posi i e e ec s o decision aids ha e been iden i ied, e.g. on pa ien s’ knowledge and unde s anding o hei condi ion, ea - men op ions, and ou come p obabili ies, as well as on ag eemen be ween pa ien p e e ences and subsequen ea men decisions [16]. Howe e , a e iew o 200 deci- sion aids has also shown decision aids ailed o imp o e sa is ac ion wi h decision making, anxie y, and heal h ou comes [17]. Resea ch on clinical decision making in men al heal h I is doub ul whe he he gene al concep s o CDM desc ibed abo e ca y o e well o men al heal h ca e p o ision. On one hand, men al heal h is unique o medicine in ha some pa ien s a e being ea ed agains hei will [13]. The e o e, gene ic indings on CDM may no be applicable in ce ain ins ances, e.g. among people who ha e expe ienced in olun a y men al heal h ea - men [18]. Also, he e migh be pa ien s who ail o pe - cei e pe sonal con ol o choices as a eali y [5]. On he o he hand, pa ien s a e inc easingly ecognised as key Figu e 1 A simpli ied model o decision making (adap ed om Wills e al. [5]). Table 1 Models o ea men decision making Pa e nalis ic model Sha ed decision making model In o med (pa ien ) model In o ma ion ans e One-way (doc o o pa ien ) ans e o minimum medical in o ma ion necessa y o in o med consen Two way: doc o p o ides all medical in o ma ion needed o decision making. Pa ien p o ides in o ma ion abou p e e ences One way (doc o o pa ien ) ans e o all medical in o ma ion needed o decision making Delibe a ion Doc o alone, o wi h o he doc o s Doc o and pa ien (possibly wi h o he s) Pa ien (possibly wi h o he s) Decision abou implemen ing ea men Doc o Doc o and pa ien Pa ien No e. Adap ed om En wis le e al. [9]. Puschne e al.BMC Psychia y 2010, 10:90 h p://www.biomedcen al.com/1471-244X/10/90 Page 3 o 11 decision make s in men al heal h ca e, and i has gene - ally been shown ha choice is impo an o pa ien s and imp o es engagemen wi h se ices [13]. Some ecen s udies epo ha peoplewi hmen al illness wan a say in hei ca e. Hamann e al. [19] ound ha in pa ien s wi h schizoph enia he desi e o decision making was sligh ly s onge han among pa ien s in p ima y ca e [7]. Simila esul s ha e been epo ed o communi y men al heal h pa ien s in Eng- land [20]. The au ho s also showed ha he e was a g ea a ia ion in he ex en o which pa ien s wan ed o be in ol ed in decisions ega ding hei ca e. Fu he mo e, low le els o pa ien in ol emen in medical decisions we e obse ed in p ima y ca e con- sul a ions o dep essi e pa ien s [21] while e ec s o he decision p ocess on pa ien sa is ac ion and ea - men ou come we e no assessed. A ecen RCT ound ha sha ing medical decisions wi h acu ely ill people wi h schizoph enia is easible. Howe e , e ec s o a sha ed decision in e en ion we e only shown wi h ega d o he le el o knowledge abou he illness (which was highe ) and pe cei ed in ol emen in med- ical decisions (which was inc eased), bu no o symp- om le el [22]. A ew s udies on gi ing pa ien s a choice in selec ing be ween a limi ed numbe o (mos ly wo) di e en b oad ea men op ions (e.g. psycho he apy s. medica- ion) ha e been conduc ed. While some posi i e e ec s ha e been shown o ea men adhe ence (lowe d op- ou a es o pa icipan s who we e gi en a choice) in people wi h dep ession [23,24], esul s ega ding clinical ou come a e mixed. No clea e ec s o pa ien p e e - ence on ou come we e e ealed in s udies wi h cocaine abuse s [25] and wi h people wi h dep ession in p ima y ca e [26], whe eas e ec s ha e been shown in people wi h alcohol abuse [27] and wi h phobia [28]. I has also been shown ia con e sa ion analysis ha pa ien s wi h SMI no only wan a say in hei ca e bu a e ac i ely in ol ed in nego ia ing ca e [29]. Assessmen o clinical decision making and o ea men ou come in men al heal h In o de o sc u inise he ela ion be ween quali y o CDM and ou come in he ca e o people wi h SMI, ea- sible measu es wi h good psychome ic p ope ies including sensi i i y o change a e necessa y o cap u e i al elemen s o CDM and ea men ou come. While some ins umen s o measu ing he quali y o decision making in gene al heal h ca e ha e been pu o h [7,30], ins umen de elopmen o assessing he quali y o decision making in men al heal h condi ions has begun only ecen ly [31]. Ins umen s p edominan ly ocus on pa ien s’app aisal o hei in ol emen in ea men decisions o on pa ien au onomy. Howe e , he e is a lack o ins umen s cap u ing c ucial basic ea- u es o CDM in men al heal h ca e including: (a) cha - ac e is ics o clinical decisions; (b) pa ien (and clinician) sa is ac ion wi h clinical decisions; and (c) ac ual ( s. p e e ed) pa ien in ol emen in making clinical decisions. On he o he hand, du ing he las yea s signi ican p og ess has been made in measu ing men al heal h ou comes. Fi s , s anda dised e sions in se e al Eu - opean languages o ins umen s measu ing key ou come domains in he ea men o people wi h se e e men al illness ha e been p esen ed [32]. Second, i has been shown ha con inuous assessmen o ea men ou - come ia s anda dised ins umen s is easible in people wi h men al illness [3,33]. Fu he mo e, ecen e idence indica es ha people wi h men al illness a e well equipped and able o use mode n communica ion ech- nologies o ou come assessmen [34-36], and ha eli- able and alid ou come a ings can be ob ained ia he in e ne [37]. Resea ch need While subs an ial e idence has been accumula ed ia a he e ined and heo y-based me hods o CDM in physical condi ions, esea ch on CDM in men al illness Table 2 Fac o s in clinical decision making in acu e s. ch onic illness Fac o s Acu e illness Ch onic illness Na u e o illness Disc e e; ime-limi ed; ea able Pe asi e; long- e m; manageable Decisions Cu e ocused Con ol ocused Na u e Deal wi h cause; minimal side e ec s Symp om educ ion; sequellae p e en ion; side e ec s ade-o Numbe Single Mul iple; epe i i e E idence used Focused on illness Focused on illness plus li es yle; li le on mul iple ch onic condi ions and hei in e ac ion Decision making ela ionship Pa ien and ea men ocused; Pe mission o p o ide o ac Consume and symp om ocused; Pe mission o consume o ac Decision making en i onmen Tempo a y dis up ion un il pa ien is well Pe manen ly al e ed o accommoda e symp oms and managemen No e. Adap ed om Wa [8]. Puschne e al.BMC Psychia y 2010, 10:90 h p://www.biomedcen al.com/1471-244X/10/90 Page 4 o 11 is s ill a an ea ly s age. By inco po a ing mul iple me h- ods, esea ch on CDM should go beyond he labo a o y se ing which is also consis en wi h calls o s udy men- al heal h phenomena and in e en ions unde less han con olled eal-wo ld condi ions [38]. Resea ch has ocused ei he on how o help pa ien s make decisions, o on how o unde s and he deg ee o in ol emen in decision making desi ed by he pa ien , bu no on he na u e (kind, numbe ) o CDM in e e y- day li e. Key esea ch challenges in CDM in he ca e o people wi h SMI include [5,8]: •Desc ip i e esea ch and ins umen de elopmen ocussing on how decisions a e ac ually made in ou ine ca e, and how he p ocess o decision making ela es o e e yday beha iou s and ou comes; •Imp o emen o measu es o cha ac e ising decision making p ocesses ha a e ma ched o s udy popula ions, complexi y, and ype o decision making, especially in people wi h se e e and long-s anding men al diso de who a e obliged o make mul iple and epe i i e ea - men decisions, o en in coope a ion wi h mo e han one ea men p o ide ; •In o ma ion abou he psychological impac o pa ien pa icipa ion in making complex and s ess ul decisions; •Decision making s yles o bo h pa ien s and o p o i- de s and how hese s yles a e enac ed in a a ie y o CDM encoun e s; •How decision making esul s in cong uen o con- lic ing ou comes and how all pa icipan s e alua e such ou comes. Fu he mo e, quali y o CDM in he ca e o people wi h SMI has ye o be s udied om an in e na ional pe spec- i e which would yield insigh s in o commonali ies and di e ences o CDM be ween di e en coun ies and men- al heal h se ice sys ems. The mos impo an app oach (i.e. bo h clinically ele an and c ucial o clinical go e n- ance) would be a ocus on wha le el o pa icipa ion a pa ien wan s in hei ca e, and whe he a good ma ch be ween desi ed and expe ienced le el o pa icipa ion has any impac on ei he sa is ac ion o ou come. Resea ch ques ion Main objec i e o his s udy is o de elop a me hodology o assess he scope and quali y o clinical decisions in he ca e o people wi h SMI om bo h he pa ien and clinician pe spec i e, and o speci y how and o wha deg ee CDM in ou ine ca e a ec s pa ien beha iou and sho - and long- e m ea men ou come. Thus, he main s udy hypo heses a e: (1) P ima y (a) The quali y o CDM can be adequa ely desc ibed by aking in o accoun decision making s yles, sa is ac ion wi h decision making, and ype o decision making ("pa e nalis ic” s. “sha ed” s. “in o med”) om bo h pa ien and clinician pe spec- i e as well as hei cong uence o incong uence. (b) The ype and quali y o CDM is posi i ely ela ed o ea men ou come in he ou ine ca e o people wi h SMI. (c) Ac ual CDM in ou ine ca e depends on con ex a iables, i.e. a ies o di e en ypes o decision and is suscep ible o change o e ime. (2) Seconda y (a) The ela ion be ween quali y o CDM and ou - come is a ec ed by a numbe o co a ia es a he le el o (i) he pa ien (sociodemog aphic s a us, clinical cha ac e is ics, symp om se e i y), (ii) he clinician (expe ience, expe ise), (iii) hei in e ac ion, (i ) he quali y o hei he apeu ic ela ionship, ( ) he cong uence o incong uence o CDM p ocess om pa ien and clinician pe spec i e, ( i) he se ice sys em (a ailabili y o and access o ea men ). (b) The quali y o CDM is ela ed o se ice use, i.e. mo e adequa e se ice use is o be ound in people wi h a high quali y o CDM. Me hods/Design The s udy “Clinical decision making and ou come in ou ineca e o peoplewi hse e emen alillness” (CEDAR) will es a model o CDM in people wi h SMI as shown in Figu e 2. This model shows ha he ocus o CDM is he in e - ac ion be ween pa ien and clinician who a e cha ac- e ised by a numbe o a ibu es including decision making s yle and o m a he apeu ic alliance o a ce ain quali y. Bo h pa ien and clinician as well as hei alli- ance a e a ec ed by aspec s o he se ice sys em, e.g. whe he a gi en in e en ion is a ailable o a o dable. This builds he con ex o clinical decisions which du - ing a gi en pe iod di e in kind (e.g. ela ed o pha ma- cological o psychosocial ea men s) and numbe , as well as in ex en o which hey con ain elemen s o “sha ed decision making”. In e media e consequences o decision making a e sa is ac ion wi h decision making om he pe spec i e o bo h pa ien and clinician and pa ien beha iou (adhe ence). The esul o CDM is clinical ou come which should cap u e di e en domains (symp oms, quali y o li e, needs) and be obse ed om di e en pe spec i es (pa ien , clinician, and indepen- den a e ). The e a e a numbe o possible eedback Puschne e al.BMC Psychia y 2010, 10:90 h p://www.biomedcen al.com/1471-244X/10/90 Page 5 o 11 loops. The mos ob ious is an ou come-o ien ed adap a- ion o clinical decisions ollowing e alua ion o adhe - ence o and ou come o he p e ious decision. Speci ically, as de i ed om his model, he ela ion- ships be ween he ollowing a iables will be in es iga ed in a p ospec i e mul i-cen e s udy: (a) Pa ien desi e o and expe ience o in ol emen in CDM; (b) Cong uence o pe cep ion o CDM (CDM ype, sa is ac ion) be ween pa ien and clinician; (c) Quali y o he he apeu ic ela ionship; (d) Pa ien sa is ac ion wi h hei in ol emen ( he hypo hesis being ha a high ma ch be ween desi ed and expe ienced in ol emen will be associa ed wi h highe sa is ac ion); (e) T ea men adhe ence (wi h he same hypo hesis); ( ) Ou come (needs, quali y o li e, symp oms). Design and ec ui men CEDAR is a na u alis ic p ospec i e longi udinal obse - a ional s udy wi h bimon hly assessmen s du ing a 12-mon h obse a ion pe iod (T0-T6). Pa icipan s a e being ec ui ed om caseloads o ou pa ien /commu- ni y men al heal h se ices a six cen es h oughou Eu ope: Depa men o Psychia y II, Ulm Uni e si y, Ge many (coo dina ing cen e); Sec ion o Reco e y a Ins i u e o Psychia y, London, U.K.; he Depa men o Psychia y a Second Uni e si y o Naples, I aly; he Depa men o Psychia y a Deb ecen Uni e si y, Hunga y; he Uni o Psychia ic Resea ch a Aalbo g Psychia ic Hospi al, Denma k; and he Depa men o Gene al and Social Psychia y a Uni e si y o Zu ich, Swi ze land. Be o e he s a o ec ui men in No embe 2009, he s udy p o ocol has been app o ed by all cen es’e hics commi ees. Only subjec s will be included who p o- ided alid in o med consen . Each po en ial pa icipan in his esea ch p ojec , p io o consen , will be clea ly in o med o i s goals, i s possible ad e se e en s and he possibili y o e use o pa icipa e o o wi hd aw con- sen wi hou any ad e se consequences. In o med con- sen will be asked only o pe sons able o eely unde s and and ques ion. Inclusion and exclusion c i e ia Sc eening o inclusion and exclusion c i e ia is ca ied ou by quali ied esea ch wo ke s in close con ac wi h clinical s a . Inclusion c i e ia •Adul age (18-60 yea s) a in ake; •Men al diso de o any kind as main diagnosis es ab- lished by case no es o s a communica ion using SCID c i e ia; •P esence o se e e men al illness (Th eshold Assessmen G id ≥5 poin s and illness du a ion ≥2 yea s); Figu e 2 Model o clinical decision making in he ca e o people wi h se e e men al illness o be es ed in CEDAR. Puschne e al.BMC Psychia y 2010, 10:90 h p://www.biomedcen al.com/1471-244X/10/90 Page 6 o 11 •Expec ed con ac wi h men al heal h se ices (excluding inpa ien se ices) du ing he ime o s udy pa icipa ion; •Su icien command o he hos coun y’s language; •Capable o gi ing in o med consen . Exclusion c i e ia •Main diagnosis o men al e a da ion, demen ia, sub- s ance use o o ganic b ain diso de ; •Cogni i e impai men se e e enough o make i impossible o gi e meaning ul in o ma ion on s udy ins umen s; •T ea men by o ensic psychia ic se ices. Ins umen s and da a collec ion Using in ensi e li e a u e sea ch and ocus g oup me h- odology [39], h ee ins umen s we e de eloped in he cou se o p epa ing he s a o he s udy (Ap il - Oc obe 2009): (1) Clinical Decision Making S yle Scale (CDMS CEDAR) in o de o comp ehensi ely assess na u e (p e- e ences, au onomy, in o ma ion seeking) and s abili y o pa ien s’and clinicians’decision making s yle bo h a baseline and a one-yea ollow-up (21 i ems); (2) Clinical Decision Making in Rou ine Ca e Scale (CDRC CEDAR) in o de o measu e key aspec s o CDM om he pa ien and clinician pe spec i es as hey un old in ou ine ca e (4 i ems plus 3 ollow-up i ems measu ing deg ee o implemen a ion o he decision iden i ied a he las CEDAR assessmen and signi ican li e e en s since hen). (3) Clinical Decision Making In ol emen and Sa is ac- ion Scale (CDIS CEDAR) in o de o assess subjec i e sa is ac ion and in ol emen wi h clinical decision mak- ing (7 i ems). Table 3 lis s he ins umen s used in CEDAR o assess ele an a iables by ime poin s o hei applica ion and a e pe spec i e(s). Uni o analysis o he CDM measu es is always he decision a i ed a du ing he mee ing p io o he cu - en assessmen poin as indica ed by he pa ien . Fu he mo e, adhe ence o he decision indica ed a he p e ious ime poin is sc u inized ia he espec i e i ems in he CDRC ollow-up ("Ha e you implemen ed he decision iden i ied in you las CEDAR assessmen wo mon hs ago?”). All ins umen s used we e made a ailable in all cen- es’languages ia in ensi e o wa d and backwa d ansla ion ollowing common s anda ds [40]. Da a is collec ed ia ques ionnai es ( illed in by he pa ien o his o he key wo ke ) o ia in e iews conduc ed by he CEDAR s udy wo ke . Da a en y modes a e ia compu e o pape -pencil o ms. Sample size Sample size calcula ion was pe o med o he analyses o he p ima y ou come, i.e. whe he needs a ed ia he CANSAS-P a e a ec ed by he quali y o decision making du ing he one-yea obse a ion ime. Following Hedeke e al. [56], assuming a cons an g oup e ec o e ime wi h a andom-e ec s uc u e and au o-co ela ed esi- duals, and es ima ing a panel a i ion o 5% a each mea- su emen poin , a small e ec size (0.2 SD) should be de ec ed wi h a powe o 0.80 a a wo- ailed signi icance le el o 0.05 wi h a g oup sample size o N = 222 o six ime poin s (and o N = 238 o eigh ime poin s). Requi ed sample size o se en ime poin s as in ou design was es ima ed ia in e pola ing he di e ence in N om six o eigh ime poin s wi h all o he elemen s o he equa ion emaining unchanged: N = (222 + 238)/2 = 230. Fo his analyses, pa icipan s will be g ouped in wo ca ego ies o quali y o decision making, esul ing in a o al equi ed g oup size a T0 o N = 460. This means ha baseline sample size o be ec ui ed a each cen e is N = 77 (a e ounding o he nex highe in ege ). Va ia ion be ween cen es will be aken in o accoun by ea ing cen es as clus e s. Acco ding o Donne [57], he a iance in la ion ac o (o design e ec ) is gi en by IF =1+(m-1)* ;whe em= clus e size, and = ICC (in e -clus e co ela ion). Wi h m = 77 and = .003, IF = 1,22, esul ing in an adjus ed sample size o N = 561 (94 pe cen e). P ocedu es Desc ip i e epo sincludeabsolu eand ela i e e- quencies o ca ego ical a iables, and means and s an- da d de ia ions (and minimum, median and maximum as well he 25%- and 75%-pe cen iles whe e applicable) o con inuous a iables. Be ween-cen e di e ences will be explo a i ely es ed by c 2 -Tes s o ac o s and by T- es s o ANOVAs esp. o con inuous a iables. The e ec o he in e en ion on needs, quali y o li e and symp oma ic impai men will be es ed by means o hie a chical linea models [41] wi h he ime a iable (0, 2, 4, 6, 8, 10 and 12 mon hs). Random e ec s will be obse a ions “wi hin”subjec o e ime, and ixed e ec s will e ec s o ime, quali y o clinical decision making and o he co a ia es (see Figu e 2) on he gi en ou - come measu e. All a ailable da a will be used in he da a analysis. Sum scales will be p o a ed in case o missing alues on less han 80% o he single i ems mak- ing up he sco e. Fu he mo e, clus e analyses will be used o a i e a meaning ul ca ego ies o quali y o decision making om he CDM measu es applied, and chain modelling [42] will be used o d aw possible cau- sal in e ences om he panel da a. Puschne e al.BMC Psychia y 2010, 10:90 h p://www.biomedcen al.com/1471-244X/10/90 Page 7 o 11 Discussion Du ing he las decades, almos all EU membe s a es ha e unde gone subs an ial psychia ic e o ms. In addi- ion, men al heal h p ac ice and esea ch has p o ided a la ge numbe o pha macological and psychosocial in e - en ions wi h p o en e icacy and also e ec i eness o imp o ing clinical ou come and quali y o li e among people wi h SMI. S ill, as s a ed in he EC’s ecen G een Pape [43], “men al heal h o he EU popula ion can be conside ably imp o ed”(p. 3). We belie e ha an e ec i e way o achie e his is no so much he de elopmen o u he new in e en ions, bu o see o ha exis ing e ec i e ea men a e being o e ed and u ilised ia speci ying bes p ac ices o clinical decision making in he ca e o people wi h se e e men al illness. As desc ibed abo e, du ing he las decades conside - able e idence has been accumula ed on CDM in physi- cal condi ions, especially in well-de ined high- isk si ua ions. Howe e , he e is a sho age o esea ch ind- ings on CDM in he ou ine ca e o people wi h pe sis- en diseases such as se e e men al illness. High-quali y desc ip i e esea ch is needed in o de o gain knowledge on he s uc u e and p ocess o CDM in he ou ine ca e o people wi h SMI. Fu he - mo e, mo e knowledge is needed on he immedia e and long- e m e ec s o CDM on sa is ac ion wi h decision making, pa ien beha iou , and mos impo - an ly on ea men ou come. The igo ous sc u iny o hese issues in a well-designed la ge mul ina ional p o- spec i e obse a ional s udy will yield insigh s in o gene al e ec i e ing edien s o CDM and in o speci ic ing edien s applicable o speci ic men al heal h se ice sys ems a indi idual (pa ien , clinician) and se ice le el, bu also in o ac o s no eadily amenable o change, and hus subs an ially ad ance he s a e-o - he-a in he ield. In he ollowing, CEDAR’sexpec ed impac s will be ou lined in ela ion o he opics o he call (FP7- HEALTH-2007-3.1-4: Imp o ing clinical decision mak- ing, [44] p. 44). De elop and alida e me hodology o measu e he quali y o clinical decisions Ins umen s o cap u e s uc u e, p ocess, and ou come o decision making in he ca eo peoplewi hSMIwillbe de eloped and empi ically alida ed: (a) S uc u e: Clinical decision making s yle and key elemen s o clinical deci- sions; (b) P ocess: Con ibu ion o pa ien and clinician o CDM, pa ien beha iou (immedia e and long- e m); (c) Ou come: Sa is ac ion wi h CDM, and clinical ou come (immedia e and long- e m). Since he e is no cu en gold s anda d o a clinical decision, CEDAR will con ibu e o an ou come-o ien ed concep ualisa ion o CDM quali y: Clinical decisions o a “good quali y”a e hose wi h a s ong associa ion wi h good clinical ou come. Apply me hodology o explain a ia ions o ca e esul ing om clinical decision making Th ough a mul i-cen e p ospec i e obse a ional s udy, a comp ehensi e model o CDM will be es ed in people Table 3 S udy ins umen s by pe spec i e and measu emen poin Va iable Ins umen Pe spec- i e Measu emen poin 0 1- 5 6 Clinical cha ac e is ics (diagnosis, illness du a ion) S uc u ed Clinical In e iew o DSM-IV on he basis o case no es (SCID [45,46]) P R ✓ Sociodemog aphic s a us, se ice use Clien Sociodemog aphic and Se ice Receip In en o y (CSSRI-EU [49]) P R ✓✓ Illness se e i y Th eshold Assessmen G id (TAG [47]) P R ✓✓ CDM S yle Clinical Decision Making S yle Scale (CDMS CEDAR) P/S ✓✓ CDM in Rou ine Ca e Clinical Decision Making in Rou ine Ca e Scale (CDRC CEDAR) P/S ✓✓✓ CDM In ol emen and Sa is ac ion Clinical Decision Making In ol emen and Sa is ac ion Scale (CDIS CEDAR) P/S ✓✓✓ Needs Cambe well Assessmen o Need Sho App aisal Schedule (CANSAS [48,49]) P✓✓✓ Quali y o Li e Manches e Sho Assessmen o Quali y o Li e (MANSA[50]) P ✓✓ The apeu ic ela ionship Helping Alliance Scale (HAS [51]) P/S ✓✓✓ Symp oma ic impai men Ou come Ques ionnai e (OQ-45.2 [52]) P ✓✓ Heal h o he Na ion Ou come Scale (HoNOS [53]) S ✓✓ Func ioning Global Assessmen o Func ioning Scale (GAF [54]) S ✓✓ Reco e y S ages o Reco e y Ins umen (STORI-30 [55]) P ✓✓ No es. CDM: Clinical Decision Making; P: Pa ien ; S: S a ; P/S: Pa ien and S a ; P R : Pa ien , esea che -led, 0: baseline assessmen ; 1- 5: in e media e assessmen s (2, 4, 6, 8, and 10 mon hs); 6: inal assessmen (12 mon hs). Puschne e al.BMC Psychia y 2010, 10:90 h p://www.biomedcen al.com/1471-244X/10/90 Page 8 o 11 wi h se e e men al illness in di e en coun ies wi h di - e en men al heal h se ice sys ems. The objec i e is o ex ac bes p ac ices o CDM, i.e. o iden i y s uc u e and p ocess a iables wi h a subs an ial ela ion o clini- cal ou come. Since quali y o CDM is jus one o many ac o s impac ing upon clinical ou come, possible mod- e a o s and media o s o he CDM-ou come ela ion (e.g. sociodemog aphic cha ac e is ics, clinical a iables, he apeu ic ela ionship, sa is ac ion wi h in ol emen ) will be comp ehensi ely included in he model. People wi h SMI will se e as he popula ion o he es ablish- men o bes CDM p ac ices. In case di e ences ela ed o diagnoses should eme ge, hese p ac ices will be spe- ci ied o di e en se e e men al diso de s (e.g. schizo- ph enia and dep ession), and can se e as a model o be ans e ed o o he pe sis en illnesses. S eng hen he clinical go e nance p ocess o imp o emen s in clinical decision making Fu he mo e, by speci ying he ela ionship be ween CDM and ou come, bes p ac ices o clinical decision making in he ca e o people wi h se e e men al illness will be made a ailable o s akeholde s (pa ien s, clini- cian, heal h ca e unde s) and clinical go e nance will be s eng hened. This will include he ques ion o whe he and o wha ex en clinical e idence and guide- lines a e pu in o p ac ice (in he CDM p ocess) in ou- ine ca e o people wi h se e e men al illness. This will also include a ho ough analysis whe he he pa ien / use pe spec i e is ac i ely in eg a ed in he CDM p o- cess in ou ine ca e. Thus, he s udy will con ibu e o ou ine men al heal h ca e being based on an in eg a- ion o p o essional and use pe spec i es. The cen al a ge will be o p o ide a di e en ia ed answe o he ques ion, “Wha amoun o pa ien in ol- emen is mos bene icial (i.e. subs an ially ela ed o pa ien sa is ac ion, pa ien beha iou , and clinical ou - come)inwha kindo clinicaldecision?”This will be done on a gene al le el, bu also ake in o accoun a ia- ions in se ice p o ision be ween he pa icipa ing cen- es in Ge many, UK, I aly, Hunga y, Denma k, and Swi ze land. This will lead o a se o good p ac ice poin s which will gi e guidance on how o imp o e CDM in he se ice p o ision o people wi h SMI. Op imising he deli e y o heal h ca e and ansla ing he esul s o clinical esea ch in o p ac ice Communica ion be ween clinicians and pa ien s builds he con ex o he deli e y o men al heal h ca e in he o m o speci ic ea men s a he pa ien -le el. While being a ec ed by a wide backg ound o sys em le el a iables (i.e. he ex en o which local men al heal h policy and se ice p o ide o ganisa ions adequa ely suppo he p o ision o e idence-based in e en ions), CDM can be ega ded he p ima y means o ansla ing he esul s o clinical esea ch in o p ac ice. The e is a lack o knowledge on he scope and quali y o CDM in he ca e o people wi h ch onic diseases such as SMI. In addi ion, a small numbe o s udies in es iga ing he e ec o in e en ions o imp o e CDM in men al heal h ha e yielded mixed esul s, and pa icula ly ha dly any on clinical ou come. A ho ough examina ion o CDM and i s ou come in his ield ia a mul i-cen e p ospec i e s udy will help o ill his gap. By iden i ying elemen s o bes p ac ice CDM (i.e. aspec s o CDM wi h a subs an ial ela ion o good ea men ou come), CEDAR will p o ide e idence di ec ly con ibu ing o op imising he deli e y o heal h ca e o Eu opean ci izens. Fu he mo e, CEDAR will pa e he way o he de elopmen o a ge ed in e en- ions o imp o e CDM in men al heal h. Lis o abb e ia ions CEDAR: Clinical Decision Making and Ou come in Rou ine Ca e o People wi h Se e e Men al Illness (s udy ac onym); CDIS CEDAR: Clinical Decision Making In ol emen and Sa is ac ion Scale (ins umen ); CDM: Clinical decision making; CDMS CEDAR: Clinical Decision Making S yle Scale (ins umen ); CDRC CEDAR: Clinical Decision Making in Rou ine Ca e Scale (ins umen ); SMI: Se e e men al illness; ANOVA: Analysis o Va iance Acknowledgemen s The CEDAR s udy is unded by a g an om he Se en h F amewo k P og amme (Resea ch A ea HEALTH-2007-3.1-4 Imp o ing clinical decision making) o he Eu opean Union (G an no. 223290). CEDAR is a mul i-cen e collabo a ion be ween he Depa men o Psychia y II, Ulm Uni e si y, Ge many; he Sec ion o Reco e y, Ins i u e o Psychia y, King’s College London, U.K. (in he con ex o he NIHR Specialis Men al Heal h Biomedical Resea ch Cen e a he Ins i u e o Psychia y, King’s College London and he Sou h London and Maudsley NHS Founda ion T us ); he Depa men o Psychia y, Uni e si y o Naples SUN, I aly; he Uni o Psychia ic Resea ch, Aalbo g Psychia ic Hospi al, Aa hus Uni e si y Hospi al, Denma k; he Medical and Heal h Science Cen e , Depa men o Psychia y, Uni e si y o Deb ecen, Hunga y; and he Depa men o Gene al and Social Psychia y, Uni e si y o Zu ich, Swi ze land. The CEDAR g oup includes: Sabine S e en, Pe a Neumann, Ka in A nold, Es a-Sul an A a , Nadja Zen ne (Ulm); Ha ie Jo dan, S ephen Williams (London); Co ado De Rosa, Domenico Giacco (Naples); Zol án Nemes, Tibo I ánka, Agnes Su eges (Deb ecen); Malene F økjæ K ogsgaa d Bo ding, Helle Øs e ma k Sø ensen (Aalbo g); A le e Bä (Zu ich). We a e g a e ul o he membe s o he CEDAR ad iso y boa d: Sue Es o (Depa men o An h opology, Uni e si y o No h Ca olina a Chapel Hill, U.S.A.), Ma ga e a Ös man (Facul y o Heal h and Socie y, Malmö Uni e si y, Sweden), Di k Rich e (Depa men o Heal h, Be n Uni e si y o Applied Sciences, Swi ze land), Is àn Bi e (Depa men o Psychia y and Psycho he apy, Semmelweis Uni e si y, Budapes , Hunga y). We also wish o hank Is àn Deg ell † o ini ia ing he CEDAR coope a ion wi h Deb ecen Uni e si y, Hunga y. Au ho de ails 1 Depa men o Psychia y and Psycho he apy II, Ulm Uni e si y, Ludwig- Heilmeye -S . 2, 89312 Günzbu g, Ge many. 2 King’s College London, Ins i u e o Psychia y, Box P029, De C espigny Pa k, London SE5 8AF, UK. 3 Depa men o Psychia y, Uni e si y o Naples SUN, La go Madonna delle G azie, 80138 Naples, I aly. 4 Uni o Psychia ic Resea ch, Aalbo g Psychia ic Hospi al, Aa hus Uni e si y Hospi al, Møllepa k ej 10, 9000 Aalbo g, Denma k. 5 Medical and Heal h Science Cen e , Depa men o Psychia y, Uni e si y o Deb ecen, Nagye dei k . 98, 4012 Deb ecen, Hunga y. 6 Depa men o Gene al and Social Psychia y, Uni e si y o Zu ich, Mili ä s asse 8, 8021 Zu ich, Swi ze land. Puschne e al.BMC Psychia y 2010, 10:90 h p://www.biomedcen al.com/1471-244X/10/90 Page 9 o 11