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.
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