RegisPt: registry of registries in Portugal: design, data model, and functionalities

Resea ch A icle Po J Public Heal h 2017;35:126–131 RegisP : Regis y o Regis ies in Po ugal – Design, Da a Model, and Func ionali ies Ped o Lai es a Vi o Ba os b a Cen o de In es igação em Saúde Pública, Escola Nacional de Saúde Pública, Lisbon, Po ugal; b Me ck Sha p & Dohme – Ou comes Resea ch, Lisbon, Po ugal Recei ed: No embe 15, 2016 Accep ed: July 6, 2017 Published online: Decembe 18, 2017 D . Ped o A. Lai es Facul y o Medical Sciences, Lisbon Academic Medical Cen e A . Pad e C uz PT–1600-560 Lisbon (Po ugal) E-Mail lai es.ped o @ gmail.com © 2017 The Au ho (s). Published by S. Ka ge AG, Basel on behal o NOVA Na ional School o Public Heal h E-Mail ka ge @ka ge .com www.ka ge .com/pjp DOI: 10.1159/000479778 Keywo ds Pa ien egis ies · Da abases · Epidemiologic s udies · Heal h echnology assessmen Abs ac In oduc ion: The numbe and quali y o exis ing pa ien egis ies a e no known in Po ugal. In o de o imp o e he knowledge ega ding his issue, an in e ac i e ool (RegisP ) was de eloped o iden i y and cha ac e ize all a ailable pa- ien egis ies in ou coun y. This a icle aims o desc ibe he RegisP design, da a model, and due unc ionali ies. Me hods: RegisP was de eloped in Mic oso O ice Access 2010 and all a iables de ini ions we e done acco ding o s anda dized in e na ional classi ica ions. A e iew o he a ailable li e a u e and web esou ces was pe o med in o - de o iden i y all ele an pa ien egis ies. Resul s: The RegisP pla o m is di ided in o 5 co e modules con aining comp ehensi e in o ma ion om each pa ien egis y (gen- e al da a, egis y design, cha ac e iza ion, e ec i eness, and publica ions). E ec i eness is o u mos impo ance o heal h echnology assessmen and is di ided in o 2 sec ions: he exposu e (heal h ca e se ice, pha maceu ical d ugs, and medical de ices) and he ou comes (sa e y, clinical, and eco- nomic). The RegisP pla o m allows adding and edi ing eg- is ies as well as consul ing all a ailable egis ies in an in e - ac i e and use - iendly way, using a p e e ed que y (e.g., egis y name, ins i u ion, and he apeu ic a ea). Abou 50 pa ien egis ies we e iden i ied and cha ac e ized in Po u- gal in acco dance wi h he pa ien egis y de ini ion o he In e na ional Socie y o Pha macoeconomics and Ou - comes Resea ch (ISPOR). Discussion: The RegisP is a i s s ep o be e unde s and and use he a ailable esou ces o heal h esea ch in Po ugal. RegisP can p omo e collabo a- ion be ween esea che s and egis y owne s and encou - age he e icien use o esou ces and may imp o e he ac- cess o egis ies. This p ojec may also be use ul o iden i y he apeu ic a eas s ill lacking pa ien egis ies and o op i- mize exis ing ones in he coun y, by compa ing egis y de- sign, quali y, and unc ional s a egies. In he u u e, his aluable pla o m may be pa icula ly ele an o esea ch- e s and au ho i ies aiming o ca y ou heal h echnology assessmen . © 2017 The Au ho (s). Published by S. Ka ge AG, Basel on behal o NOVA Na ional School o Public Heal h RegisP : egis o de egis os em Po ugal: desenho, modelo de dados e espe i as uncionalidades Pala as cha e Regis o de doen es · Bases de dados · Es udos epidemiológicos · A aliação de ecnologias da saúde This a icle is licensed unde he C ea i e Commons A ibu ion- NonComme cial-NoDe i a i es 4.0 In e na ional License (CC BY- NC-ND) (h p://www.ka ge .com/Se ices/OpenAccessLicense). Usage and dis ibu ion o comme cial pu poses as well as any dis- ibu ion o modi ied ma e ial equi es w i en pe mission. RegisP : Regis y o Regis ies in Po ugal 127 Po J Public Heal h 2017;35:126–131 DOI: 10.1159/000479778 Resumo In odução: O núme o e a qualidade dos egis os de doen es exis en es em Po ugal não são in ei amen e conhecidos. Com o obje i o de melho a o conhecimen o nes a á ea, oi desen ol ida uma e amen a in e a i a (RegisP ) pa a iden i ica e ca ac e iza odos os egis os de doen es disponí eis no nosso país. Es e a igo de- sc e e a es u u a e o desenho do RegisP , o modelo de dados ecolhidos e as espe i as uncionalidades. Mé o- dos: O RegisP oi desen ol ido em Mic oso O ice Ac- cess 2010 e odas as de inições de a iá eis basea am-se em classi icações in e nacionais. Foi ealizada uma e- isão de li e a u a pa a iden i ica e ca ac e iza odos os egis os de doen es ele an es. Resul ados: A pla a o ma RegisP es á di idida em cinco módulos p incipais que con êm in o mações ab angen es de cada egis o de doen es (Dados Ge ais, Desenho do Regis o, Ca ac e iza- ção, E e i idade e Publicações). Em pa icula , o módulo de E e i idade é de ex ema impo ância pa a a A aliação de Tecnologias em Saúde e es á di idido em duas seções p incipais: Exposição (Se iço de Saúde, Medicamen os e Disposi i os Médicos) e Resul ados (Segu ança, Ou - comes Clínicos e Económicos). A pla a o ma RegisP pe - mi e adiciona e edi a egis os, bem como consul a o- dos os egis os disponí eis de o ma simples e in e a i a, a a és de pesquisas especí icas (po exemplo, nome do egis o, ins i uição e á ea e apêu ica). Ce ca de 50 egis- os de doen es o am iden i icados e ca ac e izados de aco do com a de inição ado ada pela In e na ional Soci- e y o Pha macoeconomics and Ou comes Resea ch (ISPOR). Discussão: O RegisP é um p imei o passo pa a melho en ende e u iliza os ecu sos disponí eis pa a in- es igação em saúde ealizada em Po ugal. O RegisP pode á p omo e a colabo ação en e in es igado es e esponsá eis de egis os, bem como incen i a a u iliza- ção e icien e de ecu sos e melho a o acesso aos egis os já exis en es. Es e p oje o pode á ainda se ú il pa a iden- i ica á eas e apêu icas com lacuna de egis os de doen- es e pa a o imiza aqueles já exis en es. No u u o, es a pla a o ma pode á se pa icula men e ele an e pa a in- es igado es e Au o idades pa a a e icien e implemen a- ção da A aliação de Tecnologias em Saúde em Po ugal. © 2017 The Au ho (s). Published by S. Ka ge AG, Basel on behal o NOVA Na ional School o Public Heal h In oduc ion The Po uguese Na ional Heal h Se ice (NHS) is cu - en ly unde high p essu e o become mo e e icien , by ea ing be e wi h ewe esou ces. This eali y in luenc- es policy make s, esea che s, and heal hca e p o ession- als. I a ec s he whole decision-making p ocess in he heal hca e a ea and all due alloca ion o needed esou ces. Good quali y knowledge abou disease pa e ns and po- en ial in e en ions, such as heal hca e echnologies, is needed in o de o help decide s making easoned and sus ainable decisions abou he u u e o he NHS. Al- hough clinical guidelines and suppo o decision-mak- ing mainly comes om clinical ials and e idence om ab oad, he need o knowing ou own eali y, namely he epidemiologic pa e ns, and he e ec i eness o a ailable policies and in e en ions is inc easing. Mo eo e , a con- sensus exis s on he gene al need o g ea e a ailabili y o eal wo ld da a (RWD) [1]. Regis ies ep esen one o he main sou ces o RWD. The use o egis ies was ini ia ed in he 1930s in he UK and USA as a means o sys ema ically collec da a on can- ce pa ien s [2]. In 1949, he e m “ egis y” was de ined as a “sys em o eco ding equen ly used in he gene al ield o public heal h which se es as a de ice o he ad- minis a ion o p og ams conce ned wi h he long- e m ca e, ollow-up o obse a ion o indi idual cases” [3]. O e he las decades, se e al de ini ions ha e been p o- posed by he Wo ld Heal h O ganiza ion and US Na ion- al Commi ee on Vi al and Heal h S a is ics among o he en i ies [4]. Despi e a ia ions in de ini ion, i is clea ha a egis y in ol es a long- e m, sys ema ic, and o ganized p ocess o collec ing da a, which is d i en by speci ic, p e- de ined aims [1]. Nowadays, he US Agency o Heal h- ca e Resea ch and Quali y (AHRQ) de ines “pa ien eg- is y” as “an o ganized sys em ha uses obse a ional s udy me hods o collec uni o m da a (clinical and o he ) o e alua e speci ied ou comes o a popula ion de ined by a pa icula disease, condi ion, o exposu e, and ha se es one o mo e p ede e mined scien i ic, clinical, o policy pu poses” [4]. In line wi h his de ini ion, he In- e na ional Socie y o Pha macoeconomics and Ou - comes Resea ch (ISPOR) also has i s own de ini ion o “pa ien egis y” [5]. As a di ec esponse o he objec i e se in A icle 14(2) b o he heal hca e Di ec i e 2011/24/EU, he Membe S a es and he Eu opean Commission c ea ed he “PAR- ENT Join Ac ion”, c oss-bo de PA ien REgis ies iNiTia i e o imp o e seconda y use o da a om pa ien egis ies in a c oss-bo de se ing o bo h public heal h Lai es/Ba os Po J Public Heal h 2017;35:126–131 128 DOI: 10.1159/000479778 and esea ch needs. To achie e one o hei objec i es, he PARENT launched an online ool “Regis y o Regis ies (RoR)” a ailable a h p://www.pa en - o .eu wi h he aim o mapping pa ien egis ies in he Eu opean Union wi h he pu pose o suppo ing sea ch and iden i ica ion o a ailable da a sou ces, and exchanging in o ma ion abou na ional bes p ac ices and lessons lea n on pa ien egis ies [1]. O he ini ia i es a e also known, including Regis y o Pa ien Regis ies (RoPR) in he USA. In addi ion, he e a e also se e al o he examples such as DoCDa – Di ec- o y o clinical da abases in he UK [6], Monash Clinical Regis ies in Aus alia [7], Heal h In o ma ion and Qual- i y Au ho i y (HIQA) in I eland, and Sweden Quali y Regis ies in Sweden. Al hough hese in e na ional o ga- niza ions con ain comp ehensi e lis s o pa ien egis- ies, he le el o egis y cha ac e iza ion a ies signi i- can ly ac oss he se e al lis s o pa ien egis ies. In Po ugal, despi e he g owing need o RWD, we s ill do no know exac ly he cu en si ua ion in ou coun y when i comes o pa ien egis ies, namely ega ding he numbe , he quali y, and he clinical a eas al eady co - e ed. The exis ence o a sea chable public websi e (o da- abase) designed speci ically o p o ide in o ma ion abou pa ien egis ies in Po ugal would esul in a sig- ni ican esou ce o imp o ing he e iciency o ou NHS. Essen ially, such a da abase would p e en unnec- essa y duplica ion o egis ies, educe edundancies, iden i y gaps in esea ch and epidemiologic da a, enable esea che s o unde s and he quali y o da a wi hin eg- is ies, suppo esea ch collabo a ions, encou age he e - icien use o esou ces, and imp o e quali y and ans- pa ency in obse a ional esea ch. Thus, in an a emp o imp o e he knowledge o exis ing pa ien egis ies in Po ugal, we de eloped an in e ac i e ool (RegisP ) ha iden i ies and cha ac e izes all a ailable pa ien egis ies in Po ugal. Ul ima ely, a egis y o egis ies may be a majo con ibu ion o boos e idence-based decisions in ou heal hca e sec o . This a icle aims o desc ibe he RegisP design, da a model, and due unc ionali ies. Me hods The RegisP was de eloped in se e al phases. Phase I Iden i ica ion o a iables o be included in RegisP using 2 main guiding documen s: “Regis ies o E alua ing Pa ien Ou - comes: A Use ’s Guide” [4] and “ISPOR Taxonomy o Pa ien Reg- is ies: Classi ica ion, Cha ac e is ics and Te ms” [5]. Phase II Fi e co e modules we e buil in o de o g oup all he p e i- ously selec ed a iables: Gene al Da a This module includes he desc ip ion o he egis y, ele an adminis a i e in o ma ion (e.g., owne ship, main scien i ic con- ac , websi e, and ins i u ional add ess), egis y classi ica ion (i.e., disease, heal h echnology, heal h managemen /heal h se ices), and due clinical and he apeu ic a ea. Addi ionally, his module desc ibes he ype o in es iga o s (e.g., physicians, pha macis s, and o he heal hca e p o essionals), he ype and numbe o si es in ol ed in he egis y, he numbe o en olled pa ien s, and el- e an miles ones, such as he yea when he egis y s a ed. Regis y Design This module iden i ies he da a sou ces used o collec da a in he egis y (e.g., clinician- and/o pa ien - epo ed da a), he main pu pose (e.g., e ec i eness and sa e y moni o ing), and he pa ien s’ eligibili y c i e ia. This module also con ains in o ma ion abou he equency and desc ip ion o he assessmen s and he ype o ou comes ha a e collec ed in he egis y and iden i ies he po en ial esea ch ou pu s ha may be achie ed using i s da a (e.g., pe sis ence s udies, bu den o illness, and cos -e ec i eness analy- sis). Cha ac e iza ion This module is di ided in o 6 sec ions. The i s sec ion aims o lis he socio-demog aphic a iables collec ed by he egis y. The ollowing sec ions agg ega e a iables ela ed wi h quali y o li e and unc ional measu es, occupa ional da a, li es yle, heal hca e access, and clinical da a. All a iables may be cha ac e ized in ac- co dance wi h he momen o da a collec ion (i.e., baseline and ollow-up). E ec i eness This module is di ided in o 2 sec ions. The exposu e sec ion aims o cha ac e ize he a iables ela ed wi h he heal hca e in e - en ion (i.e., heal hca e se ice, pha maceu ical d ugs, and medi- cal de ices). Pha maceu ical d ugs and medical de ices may be selec ed om p ede ined lis s impo ed om INFARMED’s da a- bases (h ps://www.in a med.p /in omed/inicio.php and h ps:// app.in a med.p /dec_hosp/pages/cdmpublic.aspx), which con ain ele an in o ma ion al eady illed in line wi h s anda dized clas- si ica ions (e.g., d ug subs ance, b and name, dosage o m, s eng h, ma ke ing au ho iza ion holde , medical de ice code, and manu ac u e ). The ou comes sec ion aims o cha ac e ize he a iables ela ed wi h he po en ial ou comes ha migh be ana- lyzed ollowing an in e en ion collec ed in a gi en egis y, en- compassing sa e y, e ec i eness (e.g., su oga e ma ke s and p e- speci ied ha d clinical endpoin s), and economic ou comes (e.g., heal hca e esou ce u iliza ion and p oduc i i y losses). Publica ions This module aims o lis all scien i ic publica ions ela ed wi h in o ma ion e ie ed om he egis y. Phase III De elopmen and es ing o he RegisP IT pla o m using Mi- c oso O ice Access 2010. RegisP : Regis y o Regis ies in Po ugal 129 Po J Public Heal h 2017;35:126–131 DOI: 10.1159/000479778 Phase IV Iden i ica ion and cha ac e iza ion o all a ailable Po uguese pa ien egis ies. A e iew o a ailable li e a u e and web esou c- es was pe o med in o de o iden i y and cha ac e ize all pa ien egis ies aking in o conside a ion he a iables selec ed in RegisP . The adop ed c i e ia used o he inclusion o egis ies in he RegisP was he pa ien egis y de ini ion o ISPOR, which de ines a “pa ien egis y” as “a p ospec i e obse a ional s udy o pa ien s, sha ing some common cha ac e is ics o e ime, which collec s ongoing and suppo ing da a on well-de ined ou comes o in e es o analysis and epo ing” [5]. The e we e no u he c i- e ia applied in he selec ion o pa ien egis ies. Phase V In o de o ga he sus ainable suppo om o he ele an en i- ies, impo an pa ne ships we e c ea ed wi h he ollowing ins i- u ions: Fundação Calous e Gulbenkian, Escola Nacional de Saúde Pública, Ins i u o Nacional Rica do Jo ge and Capí ulo Po uguês do ISPOR. A Scien i ic Commi ee was es ablished wi h ep esen- a i es o each pa ne , which will be esponsible o he o e all s a egy, o e sigh , and go e nance o he RegisP . Phase VI Sys ema ic con ac , alida ion, and u he da a inpu by he espec i e egis ies’ owne s in o de o comple e and alida e he RegisP da abase ( his phase is s ill ongoing). Resul s O e 50 pa ien egis ies we e iden i ied in Po ugal acco ding wi h he abo e-men ioned de ini ion o ISPOR. Fu he mo e, du ing he de elopmen and ea ly imple- men a ion o RegisP , abou 60 o he epidemiological da- abases we e ound, which ell ou side his de ini ion. These da abases we e also lis ed and cha ac e ized in hei own eposi o y, labeled “o he da abases” de ined as “o he eco ds/da abases no ul illing he pa ien egis y de ini ion o ISPOR.” The RegisP pla o m allows he addi ion o new eg- is ies and he edi ion o any al eady lis ed, wi hou any access o speci ic pa ien ’s da a. I also allows an in e ac- i e and use - iendly sea ch, using a p e e ed que y (e.g., egis y name, ins i u ion, and he apeu ic a ea). Na iga ion h ough each o he selec ed egis ies is sim- ple and s aigh o wa d. Edi ing o he RegisP pla o m is es ic ed o egis e use s wi h due p i ileges p e i- ously g an ed by he RegisP Scien i ic Commi ee. The sys em is p epa ed o se di e en le els o use p i ileges ( om ead-only o adminis a o igh s). All addi ion o edi ing ac ions done in he RegisP pla o m a e subjec o p io app o al and a e au oma ically no i ied o he Scien i ic Commi ee h ough an e-mail wi h he de ails o pe o med addi ions/edi s. This Commi ee is espon- sible o app o ing o declining any p oposed addi ion/ edi ing done in he sys em. RegisP has a ack eco d sys em in place allowing he Scien i ic Commi ee and he sys em’s adminis a o s o ha e access o he da abase adminis a ion module, whe e hey can iew all pas edi ing pe o med in he RegisP and all decisions ha we e pe o med since he beginning o he RegisP (see online suppl. Fig. 1; see www. ka ge .com/doi/10.1159/000479778 o all online suppl. ma e ial). Discussion The numbe o exis ing pa ien egis ies and hei a ea o in e en ion a e no known in Po ugal. RegisP con- sis in an in e ac i e pla o m ha aims o iden i y and cha ac e ize all a ailable pa ien egis ies in he coun y. This ini ia i e is an ongoing p ojec and un il now, we ha e iden i ied and cha ac e ized abou 50 pa ien egis- ies and 60 o he da abases. RegisP may p omo e collabo a ion be ween esea ch- e s and egis y owne s, encou age he e icien use o e- sou ces, educe edundancy, imp o e he anspa ency in egis y-based esea ch, and acili a e he access o in o - ma ion abou egis ies as well as he o e all quali y o clinical eco ds in Po ugal. This p ojec may also be use- ul o iden i y he apeu ic a eas s ill lacking pa ien egis- ies, o discou age ini ia i es aiming o collec e idence al eady co e ed by o he egis ies, and o op imize exis - ing ones, while making a c i ical con ibu ion in making be e decisions in public heal h. The impo ance o p ojec s like RegisP and o he s a he Eu opean le el ha e al eady been ecognized by e- sea che s, policy make s, and o he s akeholde s, namely o suppo heal h echnology assessmen (HTA) [1, 8]. HTA and pa icula ly heal h economic e alua ions can be use ul ools o help p io i izing new in e en ions, be- cause hey illus a e he cos s and heal h ou comes associ- a ed wi h he di e en in e en ions [9]. In a ime o eco- nomic cons ain s, no all new in e en ions ha a e e - ec i e may be in oduced and/o main ained in he heal hca e sys ems. The e o e, eliable ools ha help his so o analy ical me hods and decisions a e o pa amoun impo ance. T adi ionally, he HTA depends on da a gene a ed by andomized con olled ials and li e a u e e iews on he subjec . Al hough hey a e conside ed as a “gold s an- da d” in clinical e icacy, hese s udies ha e some limi a- ions. Typically, hey a e conduc ed du ing a sho pe i- Lai es/Ba os Po J Public Heal h 2017;35:126–131 130 DOI: 10.1159/000479778 od o ime, in a well-de ined popula ion wi h he aim o es ablishing clinical e icacy and sa e y, wi h speci ic in- clusion and exclusion c i e ia, and unde almos “labo a- o y-like” condi ions [10]. Due o hese me hodological cha ac e is ics, hei esul s canno be ex apola ed o uncon olled en i onmen s as he eal clinical p ac ice [10]. In HTA, da a om egis ies may se e as a sou ce o eal-wo ld e idence abou he “e ec i eness” o ea - men s. Hence, i is clea ha da a om pa ien egis ies can supplemen he da a om andomized con olled ials, because i allows ha ing a mo e ealis ic iew o he ue impac o a gi en ea men in he popula ion (i.e., eal-wo ld ea men e ec ) [10]. The use o pa ien eg- is ies has se e al po en iali ies, such as o obse e he clinical cou se o a disease, o illus a e p ac ice pa e ns and a ia ions o hem, o de e mine clinical e ec i e- ness and/o cos -e ec i eness, o assess sa e y o ha m, o explo e humanis ic ou comes, including heal h- ela - ed quali y o li e and o he pa ien - epo ed ou comes, and o ack economic da a, namely esou ce u iliza ion [8]. Po ugal is no excep ion o he global esou ces sca - ci y scena io and he ein o ced need o ake in o accoun he sus ainabili y o he NHS. This si ua ion has led o he new HTA sys em implemen ed in ou coun y, called “Sis ema Nacional de A aliação de Tecnologias de Saúde” (SiNATS), which in oduced subs an ial changes in he p e ious model o echnology assessmen in heal h. The SiNATS main objec i es a e o maximize heal h gains and he quali y o li e o he ci izens, o con ibu e o sus ain- abili y o he NHS, o gua an ee e icien use o public esou ces in heal h, o moni o he use and echnologies, o educe was e and ine iciencies, o p omo e and ewa d ele an inno a ion de elopmen , and o p omo e equi- able access o echnologies [11]. Among se e al impo an changes o he old model, his new sys em in oduces a eassessmen o echnolo- gies (ex pos e alua ion), based on e ec i eness moni o - ing on pa ien egis ies, showing a pa adigm change in he HTA se ing in Po ugal. Wi hin his new sys em, an in o ma ion sys em o HTA (SiATS – Sis ema de In o - mação pa a a A aliação das Tecnologias de Saúde) was ini ia ed ha aims o moni o all da a sou ces and exis ing pa ien egis ies ha may suppo he assessmen s o new p oduc s in he u u e. SiATS will p io i ize he ollowing pa ien egis ies a a na ional le el: (1) oncology (na ion- al oncologic egis y), (2) HIV/AIDS, (3) a e diseases/ o phan p oduc s, (4) medical de ices (ca diology), and (5) hepa i is C (al eady in use) [11]. In Po ugal, he cu en si ua ion abou exis ing pa- ien egis ies is unknown. Wi hin he amewo k o his new na ional HTA sys em and aking in o accoun he need o pa ien egis ies as da a sou ce o eassessmen o new echnologies in he ma ke , he RegisP can be iewed as an use ul ool o he ac i i y o SiNATS and be used as a s a ing poin o he much needed discussion ega ding he a ailabili y o da a sou ces o he execu ion o hei aims. A guably, RegisP migh be a aluable e- sou ce o SiNATS. O e all, by inc easing he public knowledge o pa ien egis ies, RegisP may con ibu e o accele a ing he mos needed e idence-based decisions in ou heal hca e sec o . Fu u e Pe spec i es Despi e he po en ial bene i s o pa ien egis ies, he e a e some limi a ions ha need o be highligh ed, which in u n in luence i s u iliza ion as a p ima y da a sou ce o eassessmen o echnologies, clinical esea ch, clinical audi , o planning and managemen o clinical se ices. The use o egis ies is no only condi ioned by he lack o knowledge abou hei exis ence/a ailabili y and by he co e age hey ha e, bu also by he quali y o da a included in he egis y. To ou knowledge, he e a e no es ablished guidelines a he in e na ional le el se ing c i e ia and quali y measu es o pa ien egis ies. Ne e - heless, some quali y assessmen checklis s ha e al eady been de eloped, o ins ance in he UK [6], by o he ini- ia i es simila o RegisP based on he app oach used o de elop CONSORT [12], he checklis assessing he qual- i y o andomized ials. Due o he need o high-quali y egis ies, go e nmen al agencies such as he Agency o Heal hca e Resea ch and Quali y [4] o in e na ional so- cie ies such as ISPOR [5] among o he s ha e p epa ed and published dossie s o guide heal hca e o ganiza ions owa ds planning and implemen a ion o new egis ies. On his ega d, he RegisP Scien i ic Commi ee will y o de elop a quali y assessmen checklis based on he a ailable li e a u e and in he expe ience o simila p oj- ec s. This checklis migh hen be applied o all egis ies included in ou da abase. Finally, RegisP will be soon ac- cessible o he scien i ic communi y and he gene al pub- lic h ough a public websi e ha will allow any use o consul all pa ien egis ies iden i ied in Po ugal and o iew all a iables collec ed by each egis y. This may highligh he he apeu ic a eas s ill needing o be co e ed by a pa ien egis y and migh also help o aise he cu - en quali y s anda ds o he ongoing egis ies, no only RegisP : Regis y o Regis ies in Po ugal 131 Po J Public Heal h 2017;35:126–131 DOI: 10.1159/000479778 in e ms o he quali y o da a being collec ed and egis- e ed, bu also ega ding he in e connec i i y wi hin he es ablished egis ies and wi h o he da abases, such as he hospi al and dea h eco ds, which is undoub edly an a ea o imp o e in ou coun y. Acknowledgemen s We would like o acknowledge Paulo Nicola o he c i ical e- ision o his a icle. Re e ences 1 Zale el M, K alj M (eds): Me hodological guidelines and ecommenda ions o e icien and a ional go e nance o pa ien egis ies. Ljubljana: Na ional Ins i u e o Public Heal h; 2015. 2 S o m HH: Cance egis ies in epidemiolog- ic esea ch. Cance Causes Con ol 1996; 7: 299–301. 3 Bellows MT: Case egis e s. Public Heal h Re- po s 1949; 64: 1148–1158. 4 Gliklich R, D eye N, Lea y M (eds): Regis- ies o E alua ing Pa ien Ou comes: A Us- e ’s Guide. 3 d edi ion (In e ne ). Rock ille, MD: Agency o Heal hca e Resea ch and Quali y; 2014. Ci ed 12.10.2016. A ailable om: h p://www.e ec i eheal hca e.ah q. go / egis ies-guide-3.c m. 5 Polygenis D (ed): ISPOR Taxonomy o Pa- ien Regis ies: Classi ica ion, Cha ac e is ics and Te ms. Law ence ille, NJ: In e na ional Socie y o Pha macoeconomics and Ou - comes Resea ch (ISPOR); 2013. 6 Black N, Payne M; on behal o he DoCDa De elopmen G oup: Di ec o y o clinical da- abases: imp o ing and p omo ing hei use. Qual Sa Heal h Ca e 2003; 12: 348–352. 7 Aus alian Commission on Sa e y and Qual- i y in Heal h Ca e. In as uc u e and Techni- cal S anda ds o Aus alian Clinical Quali y Regis ies (In e ne ). Sydney: ACSQHC; 2012. (Ci ed 15.05.2016). A ailable om: h p://www.sa e yandquali y.go .au/wp-con- en /uploads/2012/03/In as uc u e-and- Technical-S anda ds- o -Clinical-Quali y- Regis ies- 1.0-May-2012.pd . 8 C oss-bo de Pa ien Regis ies iNiTia i e (PARENT). Pa ien Regis ies as Suppo Mechanism o C oss-Bo de Heal hca e Di- ec i e implemen a ion and Fu u e Policy Ac- ions. B ussels: Eu opean Commission. PAR- ENT; 2016. (WP6 Final Repo D8). 9 Doupi P, Klemp M, Goe sch W, P is as I: Pa- ien egis ies as ins umen s o HTA ou - comes esea ch: a Eu opean pe spec i e. Val- ue and Ou comes Spo ligh 2016; 2: 12–15. 10 Dang A, Angle VS: U ilizing pa ien egis ies as heal h echnology assessmen (HTA) ool. 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