Risk-adjustment model in health outcomes evaluation: a contribution to strengthen assessment towards quality improvement in interventional cardiology

Risk-adjus men model in heal h ou comes e alua ion: a con ibu ion o s eng hen assessmen owa ds quali y imp o emen in in e en ional ca diology PAULO SOUSA1,2, ANTO ´NIO SOUSA UVA1AND FAUSTO PINTO3ON BEHALF OF THE INVESTIGATORS OF PCI REGISTRY OF PORTUGUESE SOCIETY OF CARDIOLOGY 1 Na ional School o Public Heal h, New Uni e si y o Lisbon, Lisbon, Po ugal, 2 School o Heal h Technologies o Lisbon, Lisbon, Po ugal, and 3 Facul y o Medicine, Uni e si y o Lisbon, Lisbon, Po ugal Abs ac Objec i e. The aim o his s udy was o de elop a isk adjus men model o majo ad e se ca diac and ce eb o ascula e en s ollowing pe cu aneous co ona y in e en ion (PCI), using da a om a na ional egis y, and o highligh he use o he isk adjus men when we e alua e he quali y o ca e in in e en ional ca diology. Design. The s udy design was based on a Coo e s udy. Bi a ia e and mul i a ia e logis ic eg ession models we e used o iden i y independen isk ac o s o hese majo ad e se e en s. Se ing. A o al o 19 hospi als om he Po uguese Na ional Regis y o In e en ional Ca diology. Pa icipan s. Da a om 10.641 consecu i es p ocedu es collec ed be ween June 30, 2003 and June 30, 2006. In e en ion. Build a isk adjus men model o hese majo ad e se e en s, ollowing pe cu aneous co ona y in e en ion. Main Ou come Measu e. Fac o s ha we e associa ed wi h majo ad e se ca diac and ce eb o ascula e en s ollowing pe cu aneous co ona y in e en ion. Resul s. The a e o in-hospi al majo ad e se ca diac and ce eb o ascula e en s was 1.9%. Fac o s associa ed wi h majo ad e se ca diac and ce eb o ascula e en s included, among o he s: age .80 yea s (adjus ed odds a io ¼3.91); emale gende (1.72); and ca diogenic shock (6.05). O e all, a good disc imina ion was achie ed wi h ecei e ope a ing cha ac e is ics cu e ¼0.84 and Hosme -Lemeshow goodness o fi s a is ic ac oss g oups o isk was no significan (P¼0.18) indica ing li le depa u e om a pe ec fi . Conclusions. These findings will ep esen an impo an con ibu ion o quali y and sa e y imp o emen and should help d i ing new esea ch and inno a i e app oaches o di e en subg oups o pa ien s who ha e highe chances o ha ing an ad e se e en o poo e ou comes ollowing his in e en ion. Keywo ds: isk adjus men , PCI, quali y imp o emen , sa e y, ou comes esea ch In oduc ion The g owing emphasis and in e es in Quali y a e ela i ely ecen phenomena in heal h sys ems. In ac , i is a cu en heme ha has become pa icula ly impo an in he agendas and he policies o many coun ies all o e he wo ld [1, 2]. The concep o quali y in heal h is nowadays seen om di e en iewpoin s and is defined in di e en ways. The e a e se e al models o assess quali y o ca e, each one wi h di e en dimensions and app oaches. The mos ly used wo ld- wide is he model defined, some yea s ago, by Donabedian, based on h ee dimensions: s uc u e, p ocess and ou comes [3]. In he las yea s, pa icula ly in he Uni ed S a es o Ame ica, Canada, Aus alia, and some Eu opean coun ies, he emphasis is inc easingly on ou comes e alua ion [4, 5]. The es ablishmen o quali y s anda ds based on pa ien ou come da a is a a ional means o di e en ia ing he quali y o heal h ca e in he ma ke place. Howe e , a ia ion in pa ien ’s Add ess ep in eques s o: Paulo Sousa, School o Heal h Technologies o Lisbon, Lisbon, Po ugal. Tel: þ351 8980423; Fax: þ351 7221392; E-mail: [email p o ec ed] In e na ional Jou nal o Quali y in Heal h Ca e ol. 20 no. 5 #The Au ho 2008. Published by Ox o d Uni e si y P ess in associa ion wi h he In e na ional Socie y o Quali y in Heal h Ca e; all igh s ese ed 324 In e na ional Jou nal o Quali y in Heal h Ca e 2008; Volume 20, Numbe 5: pp. 324–330 10.1093/in qhc/mzn029 Ad ance Access Publica ion: 11 July 2008 Downloaded om h ps://academic.oup.com/in qhc/a icle-abs ac /20/5/324/1795212 by gues on 14 No embe 2018 baseline clinical isks p ecludes he di ec compa ison o ou - comes ac oss ope a o s, ins i u ions and heal h ca e plans. Mo eo e , acco ding o Iezzoni [6], meaning ul compa ison wi hin he heal h ca e sys em, gene ally equi es isk adjus men – accoun ing o pa ien associa ed ac o s be o e compa ing ou comes ac oss di e en pa ien s, ea men s, p o ide s, heal h plans, o popula ions. The a ionale is ob ious; on an a e age highe - isk pa ien s ypically gene a e la ge cos s, and pe sons wi h complex illnesses, mul iple coexis ing diseases, o o he significan isk ac o s, gene ally de elop mo e complica ions and ha e poo e ou comes, e en wi h excellen ca e. The e ha e been se e al a emp s, in ecen yea s, pa icula ly in he Uni ed S a es o Ame ica and Eu ope, o inco po a e isk-adjus men me hodology in he e alua ion o pe cu aneous co ona y in e en ion (PCI) ou comes [7–10]. These a emp s ha e been limi ed by small sample sizes, pa ien samples ha do no eflec con empo a y PCI, limi ed geog aphic ep esen- a ion, inconsis en defini ions and coding o he a iables, poo quali y o he da a used o build hese models, and conse- quen ly, by he lack o applied da a s anda ds. In 2002, he Po uguese Socie y o Ca diology launched he na ional egis y on in e en ional ca diology, no a man- da o y egis y like in Sweden, wi h he aim o ob ain know- ledge abou he p ofile o he pa ien , pa e ns o disease and ea men s a egies; o assess adhe ence o guidelines o ca dio ascula disease in clinical p ac ice; and o s imula e clinical esea ch in his impo an a ea [11]. Since 2005, he Po uguese egis y uses he Eu o Hea Su ey on PCI pla o m, which ein o ce mo e he quali y o da a [since i uses he Ca diology Audi and Regis a ion Da a S anda ds sys em (CARDS)] and ha e opened a window o u u e compa isons among Eu opean coun ies, which used simila da a [12]. Me hods S udy popula ion Re ospec i e analysis o p ospec i e collec ed da a om 10 641 consecu i e pa ien s who unde wen PCI, in a o al o 19 Po uguese cen es who pa icipa ed in he Po uguese PCI egis y, be ween June 30, 2003 and June 30, 2006. As a majo ad e se e en , o he pu pose o his s udy, we conside ed a composi e a iable comp ising, dea h, acu e myoca dial in a c ion, need o a new e ascula iza ion by u gen co ona y a e y bypass g a , and s oke. We conside ed as independen a iables hose ha cha ac- e ize he indi iduals and ea men aspec s, namely demo- g aphic (e.g. age, gende ); clinical aspec s (e.g. diabe es, hype ension, pe iphe al disease) and echnical and unc ional aspec s (e.g. numbe o essels diseased, lesion ype, ejec ion ac ion, defined as no mal .50%; sligh ly educed 41–50%; mode a ely educed 31–40%; se e ely educed ,30%). Da a collec ion The da a we e collec ed om he PCI da abase o he na ional cen e o da a collec ion in ca diology, he s uc u e o he Po uguese Socie y o Ca diology, which is esponsible o he Po uguese egis y. The Po uguese da abase is based on he Eu o Hea Su ey o he Eu opean Socie y o Ca diology. Da a collec ion me hods and defini ion o he a iables ollow he policy o CARDS sys em o Eu opean Socie y o Ca diology. The o m, o each p ocedu e, is filled in a web pla o m and he quali y con ol o he da a and audi is done by Eu opean Socie y o Ca diology. A e ha , he da a a e sen o he Po uguese na ional cen e and hen dis ibu ed o each pa icipan cen es. Da a a e also a ailable in he webpage o he Eu opean Socie y o Ca diology. S a is ical analysis Fi s ly, we ha e s a ed wi h a desc ip i e analysis wi h he aim o ge knowledge abou he popula ion pa e ns wi h espec o each a iable. Subsequen ly, a bi a ia e analysis was done c ossing he independen ( hose who cha ac e ize he indi iduals and ea men aspec s) wi h he dependen a iable, wi h he aim o iden i ying hose ha ha e he s onges s a is ical associ- a ion wi h majo ad e se ca diac and ce eb o ascula e en s. To build he model, and o iden i y independen isk ac o s o majo ad e se ca diac and ce eb o ascula e en s, a mul i a ia e logis ic eg ession analysis was unde aken, using he s epwise o wa d echnique, which includes all a iables ha showed, in he bi a ia e analysis, an odds a io .1 (which indica es a posi i e associa ion o he occu ence o majo ad e se ca diac and ce eb o ascula e en s), and we e s a is ically significan (wi h P- alue ,0.05). To assess he pe o mance and calib a ion o he model, he a ea unde he ecei e ope a ing cha ac e is ics (ROC) cu e and he Hosme –Lemeshow goodness o fi s a is ic we e calcula ed. All s a is ical analysis we e conduc ed using he S a is ical p og amwSPSS 14, o a le el o significance o 0.05 (P¼0.05) and a confidence in e al (CI) o 95%. The associa ion measu e used was he odds a io. Resul s In he 10 641 pa ien s who unde wen PCI, and we e included in he egis e , he p ima y success a e was 98.1% and he a e o in-hospi al majo ad e se ca diac and ce e- b o ascula e en s was 1.9%. In hese, 1.4% was dea h; 0.4% de eloped an acu e myoca dial in a c ion; 0.2% had a s oke; and 0.1% eme gency co ona y a e y bypass g a . These a es a e no mu ually exclusi e, which means ha in some pa ien s occu ed mo e han one majo ad e se e en . The fi s s ep o he model de elopmen was o examine he bi a ia e ela ionship be ween majo ad e se ca diac and ce eb o ascula e en s and each p e-p ocedu al isk ac o (Table 1). In he mul i a ia e logis ic eg ession model we included all he a iables ha showed, in he bi a ia e analy- sis, an odds a io .1 and we e s a is ically significan (wi h P- alue ,0.05), such as age, gende , acu e myoca dial in a c- ion, ca diogenic shock, conges i e hea ailu e, diabe es, pe iphe al disease, enal ailu e (c ea inine .2.0 mg/dl), Risk-adjus men model in heal h ou comes e alua ion 325 Downloaded om h ps://academic.oup.com/in qhc/a icle-abs ac /20/5/324/1795212 by gues on 14 No embe 2018 ............................................................................................................................................................................. Table 1 Uni a ia e and bi a ia e analysis be ween dependen and independen a iables Va iable % o pa ien s (n¼10 641) % o majo ad e se e en s Odds a io (95% CI) P- alue Age ,50 yea s 13.7 1.0 Re e ence Age 50–59 yea s 23.4 1.4 1.44 (0.75–2.75) 0.21 Age 60–69 yea s 30.8 1.4 1.51 (0.81–2.81) 0.20 Age 70–79 yea s 26.5 2.4 2.53 (1.39–4.61) 0.002 Age .80 yea s 5.6 7.1 7.85 (4.16–14.82) ,0.001 Gende Male 24.9 1.6 1.79 (1.32–2.41) ,0.001 Female 75.1 2.9 Acu e myoca dial in a c ion No 82.0 0.9 7.39 (5.50–9.91) ,0.001 Yes 18.0 6.6 Ca diogenic shock No 99.1 1.5 62.46 (39.40–97.79) ,0.001 Yes 0.9 48.9 Myoca dial in a c ion an eceden s No 65.4 2.0 0.81 (0.59–1.11) 0.19 Yes 34.6 1.7 Conges i e hea ailu e No 95.1 1.8 7.39 (5.50–9.91) ,0.001 Yes 4.9 3.8 P io co ona y a e y bypass g a No 95.2 1.9 1.23 (0.67–2.29) 0.51 Yes 4.8 2.3 P io pe cu aneous co ona y in e en ion No 84.6 1.9 0.87 (0.58–1.33) 0.53 Yes 15.4 1.7 P io ce eb o ascula disease No 97.1 1.9 1.70 (0.86–3.36) 0.12 Yes 2.9 3.1 Hype ension No 36.2 1.8 1.07 (0.79–1.44) 0.68 Yes 63.8 1.9 Diabe es No 74.7 1.7 1.42 (1.04–1.93) 0.03 Yes 25.3 2.4 Pe iphe al disease No 97.1 1.8 2.96 (1.72–5.08) ,0.001 Yes 2.9 5.2 Renal ailu e No 98.0 1.8 3.86 (2.16–6.91) ,0.001 Yes 2.0 6.6 Ejec ion ac ion (no mal) 71.9 1.0 Re e ence Ejec ion ac ion sligh ly educed 18.2 1.5 1.55 (0.98–2.47) 0.06 Ejec ion ac ion mode a ely educed 6.2 2.7 2.78 (1.57–4.90) ,0.001 Ejec ion ac ion se e ely educed 3.7 10.1 11.43 (7.43–17.61) ,0.001 One essel disease 50.6 1.3 Re e ence Two essels disease 31.3 1.9 1.40 (0.98–2.01) 0.06 Th ee o mo e essels diseases 18.1 3.8 2.91 (2.06–4.11) ,0.001 In a-ao ic balloon pump No 99.3 1.7 42.39 (25.18–71.24) ,0.001 Yes 0.7 42.2 (con inued ) P. Sousa e al. 326 Downloaded om h ps://academic.oup.com/in qhc/a icle-abs ac /20/5/324/1795212 by gues on 14 No embe 2018 ejec ion ac ion, numbe o diseased essels, in a-ao ic balloon pump, ype o lesion, non-s en ing, p io i y o p o- cedu e and le main ea ed. In Table 2 we can see he a iables ha esul ed om he mul i a ia e logis ic eg ession analysis, using he s epwise o wa d echnique, wi h hei espec i e coe ficien , odds a io, significance alue and CI. O e all, a good disc imina ion was achie ed wi h ROC cu e ¼0.84 (Fig. 1), and a Hosme –Lemeshow goodness o fi s a is ic ac oss g oups o isk was no significan (P¼0.18), indica ing li le depa u e om a pe ec fi . Discussion In oday’s wo ld, he apid sp ead o in o ma ion, g owing le el o knowledge and g ea e equi emen s o pa ien s, s ong financial cons ain s, inc easing call o accoun abili y, and he need o in oduce c i e ia and quali y indica o s in he heal h ca e p o ided, ha e con ibu ed o some change in he dynamics o heal h ins i u ions [13, 14] These dynamics ha e e ol ed in he di ec ion o gi ing g ea e alue o he collec ion and ea men o c edible s an- da dized da a which makes possible he e alua ion and moni o o se ices ega ding he olume o ac i i y and he quali y o esul s achie ed [15]. The final goal o isk adjus men is o accoun o pe i- nen pa ien cha ac e is ics be o e making in e ence abou he e ec i eness o ca e. In he ecen pas we ha e seen g ea p og ess in PCI ha has led o a widening ange o si ua ions wi h well- es ablished clinical and angiog aphic indica ions [16–18]. Howe e , PCI s ill ca ies significan isk, especially in subg oups in which a mo e complex clinical condi ion may lead o highe ad e se e en a es. In Po ugal, he numbe o p ocedu es and cen es whe e PCI is pe o med has exponen ially inc eased in he pas decade, om 3017 in e en ions (302 pe million inhabi an s) in 12 cen es, in 1997 [19] o an es ima ion o abou 11 500 (1150 pe million inhabi an s) in 24 cen es, in 2006. Wi h his apid inc ease in he numbe o p ocedu es and cen es which pe o m PCI in Po ugal, which is simila o he end o o he Eu opean coun ies, and since he e is a na ional con inuous egis y, i would be impo an o build a isk-adjus men model. This could g ea ly help o do eliable compa isons o esul s among ins i u ions, egions o popu- la ions, con ibu ing o he de elopmen o mul icen e s udies, and es ablishing c edible and igo ous benchma king alues in he coun y. In o ma ion ob ained om egis ies is inc easingly being used o assess he p ocess o ca e and pa ien ou comes, sup- po ed by he pa adigm ha he u u e o heal hca e is inc easingly in he hands o hose who a e e ec i e use s o clinical da a [20]. Mo eo e , his b ings up ano he impo an ques ion ha Po ugal and all Eu opean coun ies mus ace in he sho e m – which is he need o eliable and s anda dized da a sys ems o collec , sys ema ize and analyse da a which could help o moni o he heal h ca e sys em ei he , pa ially o as a whole. Fo hese ha e concu ed di e en easons such as: (i) s ong mo emen s o accoun abili y and p essing o ou come da a, due o he ac ha he consume s o oday a e mo e in o med and demanding han e e , and call o a desc ip ion o he ecommended ea men and i s ad an- ages and isks [21]; (ii) legal ques ions, he example o Uni ed Kingdom, since he in oduc ion o eedom o ............................................................................................................................................................................. Table 1 Con inued Va iable % o pa ien s (n¼10 641) % o majo ad e se e en s Odds a io (95% CI) P- alue Lesion ype A (Ame ican College o Ca diology classifica ion) 7.7 0.9 Re e ence Lesion ype B 60.0 1.4 1.45 (0.67–3.16) 0.35 Lesion ype C 32.3 3.2 3.55 (1.64–7.67) ,0.001 Non-s en ing No 94.0 1.6 4.43 (3.09–6.34) ,0.001 Yes 6.0 6.7 Le main ea ed No 99 1.8 6.00 (3.07–11.73) ,0.001 Yes 1.0 10.1 PCI in g a lesions No 98.6 1.9 1.15 (0.36–3.63) 0.75 Yes 1.4 2.2 P io i y o p ocedu e (u gen /eme gen ) No 72.0 0.8 6.70 (4.89–9.19) ,0.001 Yes 28.0 5.0 Risk-adjus men model in heal h ou comes e alua ion 327 Downloaded om h ps://academic.oup.com/in qhc/a icle-abs ac /20/5/324/1795212 by gues on 14 No embe 2018 in o ma ion ac , ha became manda o y he indi idual dis- closu e in o ma ion abou he su geons esul s, in di e en a eas [9]. We belie e ha any a emp o p oduce unadjus ed ou come analysis and compa isons, by named ope a o , o ins i u ions, may be misleading and will he e o e encou age ad e se selec ion p ac ices, and will jeopa dize he ela ion- ship be ween pa ien s and heal h ca e p o essionals; (iii) economic implica ions, which poin ou no only he impo - ance o e ec i eness bu also he e ficiency o he heal h ca e deli e ed [22]. I is well known ha he absence o guidelines o da a collec ion and clea defini ions o da a i ems a e e y impo - an causes o da a e o s in medical egis ies, making i di ficul o de elop mul icen e s udies and also hampe ing he compa isons o esul s be ween di e en egions and coun ies [12, 15]. By de eloping and using da a s anda ds, based on he CARDS sys em, he Eu o Hea Su ey and all egis ies ha use hei pla o m, a e hese ques ions and ha e g ea ly expanded he pool o pa ien s and geog aphical a ea in which da a ou comes can be analysed and compa ed [12]. Fu he mo e his emphasizes he impo ance o heal h ou come analysis, based on c edible, s anda dized and audi ed da a, as a cen al poin in a quali y assu ance p o- g amme and also as a key pa hway in he di ec ion o edu- cing he bu den o ca dio ascula disease in Eu ope.[23, 24]. Bea ing in mind ha ca dio ascula disease, including co - ona y a e y disease, a ec s millions o pa ien s wo ldwide, wi h se ious consequences in economic and social weigh , e alua ion o he esul s o PCI using c edible in o ma ion and sys ema ic da abases is c ucial o he achie emen o he g ea e objec i e which is o gua an ee and imp o e he quali y o heal h ca e p o ided [17, 21, 24]. The e o e he use o isk adjus men in ou comes e alua ion o PCI is essen ial o assess di e en quali y dimensions such as e ec- i eness, e ficiency and sa e y [23, 25, 26]. The e a e mul iple a eas whe e he isk-adjus men me hod- ology can be used o con ibu e o s eng hen he quali y assessmen and by his means each he quali y imp o emen , including he ollowing: o de ec po en ial ad e se selec ion (based on he se e i y o he disease); o iden i y and define, in a mo e igo ous way, quali y indica o s; o quali y assessmen pu poses, p o iding a compa ison o ou comes among p o i- de s (hospi als o physicians) a e adjus ing o isk and asses- sing changes in isk-adjus ed ou comes o a single p o ide o e ime; and o help explain and unde s and he impac o p ac ice a ia ions among p o ide s, and hei implica ion in di e en clinical and economic ou comes [6, 27]. The isk-adjus men model de eloped in his s udy, by allowing he iden ifica ion and e alua ion o pa ien isk ac o s ha a e associa ed wi h poo ou comes o ad e se e en s, cons i u es a po en ial con ibu ion o quali y imp o e- men in in e en ional ca diology. Howe e , i needs o be es ed in u u e p ospec i e s udies. Gene ally, he models o isk adjus men a e buil based on clinical da a. Howe e , i will be impo an , in he u u e, o .................................................................................... Table 2 Independen isk ac o s o majo ad e se ca diac and ce eb o ascula e en s Va iable Coe ficien Adjus ed OR (95% CI) P- alue Age ,50 yea s 0.03 1.03 (0.47–2.29) 0.94 Age 50–59 yea s 0.09 1.10 (0.51–2.35) 0.81 Age 60–69 yea s 0.56 1.75 (0.84–3.64) 0.13 Age 70–79 yea s 1.36 3.91 (1.74–8.77) 0.001 Gende ( emale) 0.54 1.72 (1.13–2.61) 0.01 Acu e myoca dial in a c ion 0.99 2.68 (1.46–4.93) 0.001 Ca diogenic shock 1.80 6.05 (2.44–15.01) ,0.001 Renal ailu e 1.09 2.98 (1.28–6.97) 0.01 Ejec ion ac ion sligh ly educed 20.01 0.99 (0.59–1.64) 0.96 Ejec ion ac ion mode a ely educed 0.16 1.17 (0.60–2.27) 0.64 Ejec ion ac ion se e ely impai ed 1.37 3.94 (2.22–7.01) ,0.001 Two essels disease 0.26 1.30 (0.81–2.09) 0.29 Th ee o mo e essels diseases 0.78 2.18 (1.35–3.51) 0.001 Lesion ype B 0.48 1.62 (0.49–5.33) 0.43 Lesion ype C 0.96 2.60 (0.79–8.61) 0.12 In a-ao ic balloon pump 1.44 4.21 (1.53–11.56) 0.005 Non-s en ing 1.07 2.92 (1.72–4.96) ,0.001 P io i y o p ocedu e (u gen /eme gen ) 0.74 2.11 (1.13–3.91) 0.02 Cons an 26.63 – – Figu e 1 A ea unde he ecei e ope a ing cha ac e is ics (ROC) cu e o mul i a ia e p edic ion model P. Sousa e al. 328 Downloaded om h ps://academic.oup.com/in qhc/a icle-abs ac /20/5/324/1795212 by gues on 14 No embe 2018 include also economic da a (cos s pe pa ien and pe p ocedu e, o c oss-da a om diagnos ic- ela ed g oups, o ins ance) wi h he aim o close he gap be ween e ec i eness and e ficacy and, a he same ime, o ob ain a global and in eg a ed pe spec i e o he quali y o heal h ca e deli e ed [26, 28]. The cu en s udy has con ibu ed o demons a e he po en ial alue o using a con inuous na ional da abase, wi h imely da a analysis, o de eloping a isk-adjus men model o majo ad e se ca diac and ce eb o ascula e en s. Pe haps he mos significan limi a ion o he cu en s udy is he lack o a sys ema ic app oach o audi ing he da a. In ou opinion, one o he bigge challenges o he u u e is he need o submi all da abases o a alid and objec i e audi p ocess, in o de o gua an ee he quali y o he da a. Wi h he p oli e a ion o e o s o epo publicly he ou - comes o heal hca e p o ide s and ins i u ions, mos o hem using isk-adjus men models, he e was a g owing need o define s anda ds o he me hods ha a e being employed. Acco ding o his, he in e disciplina y w i ing g oup o quali y o ca e and ou comes esea ch o he Ame ican Hea Associa ion iden ified, ecen ly, se en p e e ed a ibu es o s a is ical models used [20]. I is ou belie ha his s udy includes all o he se en a ibu es, namely, clea and explici defini ion o an app o- p ia e pa ien sample; clinical cohe ence o he model a i- ables; su ficien ly high-quali y and imely da a; designa ion o an app op ia e e e ence ime be o e which co a ia es a e de i ed and a e which ou comes a e measu ed; use o an adequa e ou come and s anda dized pe iod o ou come assessmen ; applica ion o an analy ical app oach ha akes in o accoun he mul ile el o ganiza ion o da a; and disclos- u e o he me hods used o compa e ou comes, including disclosu e o pe o mance o he isk-adjus men me hod- ology in de i a ion and alida ion samples. Ne e heless, he a iables ha we e gene a ed om ou model a e consis en wi h a numbe o o he s udies ecen ly published [8, 9, 18, 29]. Conclusions The isk-adjus men model de eloped in his s udy, by allow- ing he iden ifica ion and e alua ion o pa ien isk ac o s ha a e associa ed wi h poo ou comes o ad e se e en s ep esen a po en ial con ibu ion o imp o e quali y o ca e h ough a mo e igo ous assessmen o ou comes. The a iables ha we e gene a ed om ou model a e consis en wi h a numbe o o he s udies ecen ly published. These findings will likely ep esen a po en ial con ibu ion o imp o e quali y and should help d i ing new esea ch and inno a i e app oaches o di e en subg oups o pa ien s who ha e highe chances o ha ing an ad e se e en o poo e ou comes ollowing PCI. Despi e he exis ence o models al eady desc ibed in he li e a u e, o ou knowledge he e is none based on da a om Eu o Hea Su ey da abase. This could be seen as an e o o imp o e quali y in a e y ele an public heal h bu den disease, such as co ona y a e y disease. In ou opinion, his issue will be in ensified in he yea s ahead and should be s udied mo e deeply because, on an a e age, he occu ence o ad e se e en s o poo esul s is linked wi h an inc ease in financial and social cos s. De eloping isk-adjus men models o majo ad e se ca diac and ce eb o ascula e en s ollowing PCI is an impo an pa o he quali y and sa e y imp o emen p ocess o ca diac e ascula iza ion p ocedu es, and o es ablishing c edible and igo ous benchma king alues. Acknowledgemen s We hank P o . 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