Comparison of volar-flexion, ulnar-deviation and functional position cast immobilization in the non-operative treatment of distal radius fracture in elderly patients : a pragmatic randomized controlled trial study protocol
Abstract
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Compa ison o ola - lexion, ulna -de ia ion
and unc ional posi ion cas immobiliza ion
in he non-ope a i e ea men o dis al
adius ac u e in elde ly pa ien s:
a p agma ic andomized con olled
ial s udy p o ocol
Lau i Rai io
1*
, An i Launonen
2
, Teemu He onko pi
1
, Toni Luokkala
3
, Juha Kukkonen
4
, Aleksi Rei o
3
, Baki Sum ein
2
,
Minna Lai inen
2
and Ville M. Ma ila
1,2
Abs ac
Backg ound: Dis al adius ac u es (DRFs) a e he second mos common ac u es, a e hip ac u es, seen in
clinical p ac ice. The high incidence o low-ene gy auma DRFs in elde ly pa ien s aises ques ions abou he bes
ea men me hod in e ms o unc ion, pain, and quali y o li e. Al hough he majo i y o hese ac u es a e ea ed
non-ope a i ely wi h cas immobiliza ion, alid scien i ic e idence o he op imal cas immobiliza ion is lacking. In
addi ion, se e al publica ions, including Coch ane e iew ha e ou lined he need o mo e e idence o de e mine
he mos app op ia e me hod o cas immobiliza ion.
Me hods: This s udy is a p agma ic, p ospec i e, andomized, mul i-cen e ial. The ial is designed o
compa e wo widely used cas posi ions ( ola lexion-ulna de ia ion posi ion and unc ional posi ion) o
he non-ope a i e ea men o DRF in pa ien s o e 64 yea s o age. The main hypo hesis o he ial is ha
unc ion posi ion yields co esponding unc ional ou come, pain elie and quali y o li e when compa ed o
he ola lexion-ulna de ia ion posi ion. The p ima y ou come measu e is Pa ien Ra ed W is E alua ion
(PRWE) sco e and he seconda y ou come measu es will be he Disabili ies o he A m, Shoulde and Hand
(DASH) sco e, Visual Analogue Scale (VAS), 15-dimensional (15D) alue and a e o su gical in e en ions. The
esul s o he ial will be analysed a e 1 and 2-yea s.
Discussion: This publica ion p esen s a p ospec i e, p agma ic, andomized, na ional mul i-cen e ial s udy
p o ocol. I p o ides de ails o pa ien low, andomiza ion, ollow-up and me hods o analysis o he ma e ial
as well as publica ion plan.
T ial egis a ion: ClinicalT ials.go iden i ie : NCT02894983 22 Augus 2016.
Keywo ds: Colles’ ac u e, Rehabili a ion, Conse a i e ea men , T ea men ou come, P ospec i e s udies,
Pain, Clinical p o ocols
* Co espondence: [email p o ec ed]
1
Uni e si y o Tampe e, School o Medicine, 33014 Tampe e, Finland
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Rai io e al. BMC Musculoskele al Diso de s (2017) 18:401
DOI 10.1186/s12891-017-1759-y
Backg ound
Dis al adius ac u es (DRFs) a e p e alen in he gen-
e al popula ion, and in pa ien s o e 60 yea s o age hey
a e he second mos common ac u es a e hip ac-
u es. [1]. In elde ly pa ien s, DRFs a e ypically caused
by a all om a s anding heigh o e an ou s e ched hand,
whe eas in younge pa ien s he ac u e is mainly
caused by high-ene gy auma such as mo o ehicle
collisions [2, 3]. The popula ion-based ac u e inci-
dence a ies be ween na ions. In No he n Eu ope, he
o e all incidence is 200–320/100,000 pe son yea s and
550/100,000 pe son yea s in pa ien s o e 60 yea s o
age [4–7]. The o e all ac u e incidence o DRFs in he
No dic coun ies seems o ha e le elled o in he las
wo decades [8].
The majo i y o DRFs a e ea ed wi h cas
immobiliza ion. The heo e ical pu pose o he cas is o
s abilize he ac u e, and hus o allow he bone o heal.
Du ing cas immobiliza ion, he s abilized ac u e main-
ains alignmen . Howe e , a signi ican p opo ion o
ac u es will lose alignmen du ing cas immobiliza ion,
>especially in olde pa ien s wi h os eopo o ic bone. The
alignmen o hese uns able ac u es is o en accep able
a e closed educ ion and a he beginning o cas
immobiliza ion, bu is los du ing he pe iod he cas is
wo n [9].
Se e al di e en immobiliza ion me hods o he non-
ope a i e ea men o DRFs ha e been desc ibed [10–15].
These me hods o immobiliza ion include unc ional b a-
cing, he immobiliza ion o he w is in neu al and
sligh ly ex ended posi ion o in p ona ion o in supina ion.
The o iginal educ ion in o ola lexion- was i s de-
sc ibed by F ede ic J. Co on in 1910 [16]. The sligh
lexion-ulna de ia ion- posi ion was popula ized by
Cha nley in his seminal wo k [17]. I has been hough
ha a sligh lexion-ulna de ia ion posi ion would induce
so issue a ound he ac u e and he pull p oduced by
adioca pal ligamen s (i.e. ligamen o axis) would esis he
disloca ing o ces gene a ed o e he ac u e line [18, 19].
In clinical p ac ice, he lexion-ulna de ia ion pos-
i ion can cause he common ex enso endons o
igh en and p oduce inapp op ia e inge lexion du -
ing ea men . Thus, he posi ion en ails p oblems wi h
degene a i e join s ha a e ulne able o he s i ness
p oduced by immobiliza ion, which is a common p ob-
lem in elde ly people. In addi ion, a ise in ca pal un-
nel p essu e om 18 mmHg o neu al posi ion o
47 mmHg o lexion posi ion has been de ec ed, [20]
median ne e comp ession being he mos common
complica ion o DRF [21, 22].
E alua ion o ea men
T ea men ou comes o DRFs can be measu ed wi h a
a ie y o ools. Pa ien - epo ed ou come measu es
(PROMs) desc ibe a pa ien ’s iew o hei symp oms
combined wi h unc ional s a us. The ools used in he
e alua ion measu e he mobili y and usabili y o he
o ea m and w is and include he Pa ien Ra ed W is
E alua ion (PRWE) ques ionnai e, he Disabili ies o
he A m, Shoulde and Hand (DASH) ques ionnai e,
he Ga land-We ley ques ionnai e and he Visual
Analogue Scale (VAS). A commonly used objec i e
measu e is g ip s eng h. In addi ion, he 15D ques ion-
nai emeasu es hepa ien ’s gene al quali y o li e
h ough di e en ques ions and akes in o accoun di-
e sea easo li e[23].Theou comesa eindexedand
compa able wi h a e e ence popula ion and he pa-
ien ’s own esul s a di e en s ages o he ea men
[24]. In addi ion o PROM’s, pa ien cha ac e is ics
ha e been shown o be associa ed wi h ea men ou -
come [25]. The se e i y o acu e pain, ca as ophic
hinking and auma- ela ed anxie y expe ienced by he
pa ien a e measu ed using he pain ca as ophizing
scale (PCS) [26]. The scale has been shown o be asso-
cia ed wi h inge s i ness a e DRF [27], and i is one
o he mos commonly used ools o measu ing he
ca as ophic hinking ela ed o pain [26].
P e ious s udies
The li e a u e on he non-ope a i e ea men o DRFs is
ex ensi e. Howe e , p e ious s udies ha ha e examined
he mos alid me hod o cas immobiliza ion ha e been
mainly case s udies wi hou con ol g oups. The exis ing
compa a i e ials lack uni o m and pa ien - a ed ou -
come measu es, and su e om inadequa e andomizing
and sho ollow-up pe iods [10–13]. In e es ingly, he e
ha e been no p e ious s udies ha ha e compa ed he
lexion-ulna de ia ion posi ion wi h he unc ional cas
posi ion in elde ly pa ien s. Consequen ly, he Coch ane
e iew has concluded he e is no enough e idence
based on andomized con olled ials o conclude which
me hod o cas immobiliza ion is he bes o he com-
mon ypes o DRFs in he elde ly [28].
I has been shown ha he unc ional ou come o DRF
in elde ly people (o e 64 yea s) is poo ly co ela ed o
he adiog aphic ou come [29–35]. Mo eo e , i has been
sugges ed ha unc ional ou come a e DRFs in elde ly
pa ien s may be a ec ed by mo e han ac u e-speci ic
ac o s. Pain ca as ophizing hough s and a ea o using
he inju ed limb a e ela ed o disabili y, inc eased pain
and muscle weakness in all uppe ex emi y aumas in-
cluding DRF pa ien s [36–39]. Pain ca as ophizing as a
p edic o o unc ional ou come has been mos ly s udied
among pa ien s diagnosed wi h ch onic musculoskele al
pain such as os eoa h i is, lowe back pain o acu e
whiplash inju ies [40–42]. Pain ca as ophizing has no ,
howe e , been p e iously s udied in elde ly pa ien s wi h
non-ope a i ely ea ed DRF.
Rai io e al. BMC Musculoskele al Diso de s (2017) 18:401 Page 2 o 7
The aim o his p agma ic, andomized con olled
s udy is o compa e unc ional ou come measu ed wi h
PRWE sco e a e DRF ea ed wi h ola lexion-ulna
de ia ion cas immobiliza ion o unc ional cas
immobiliza ion in elde ly pa ien s o e 64 yea s o age.
Fu he , we aim o assess whe he PCS and unc ional
ou come a e DRFs a e associa ed.
Me hods and design
The p esen s udy is a p agma ic, p ospec i e, andom-
ized con olled, mul i-cen e ial. The ial cen es a e
Tampe e Uni e si y Hospi al, Cen al Finland Cen al
Hospi al and Sa akun a Cen al Hospi al. The s udy aims
o compa e wo di e en cas immobiliza ion posi ions.
The wo cas posi ions compa ed a e sligh ola
lexion-ulna de ia ion immobiliza ion (widely used glo-
bally) and unc ional immobiliza ion (also commonly
used in se e al coun ies). See Addi ional iles 1, 2, 3
and 4 o he pic u es o he cas posi ions.
The p ima y ou come in his s udy is he PRWE sco e
measu ed a e one and 2 yea s. The seconda y ou -
comes measu ed a e Quick-DASH sco e, pain in isual
analogue scale (VAS), quali y o li e (15D), g ip s eng h,
complica ions and numbe o su gical in e en ions and
cas changes. Subg oup analysis will be pe o med o
iden i y pa ien -speci ic ea u es indica ing good o poo
ou comes and he associa ion o he ea u es wi h PCS.
F ac u es will be classi ied wi h AO-classi ica ion.
Hypo heses
Ou p ima y hypo heses in he s udy a e as ollows:
(i) The ola - lexion, ulna de ia ion cas and he
unc ional cas ea men s will yield simila
unc ional ou comes measu ed wi h PRWE
(ii)The ola - lexion, ulna de ia ion cas and he unc-
ional cas ea men s will esul in co esponding
ou comes wi h ega d o quali y o li e and g ip
s eng h. Func ional cas ea men will esul in
lowe a es o complica ions and numbe o cas
changes.
(iii)High PCS will be associa ed wi h poo unc ional
ou come on he PRWE scale despi e he
adiog aphic pa ame e s.
(i )The high g ip s eng h o he uninju ed limb
(ie. pa ien gene al physiological s eng h) will no
p edic he poo unc ional ou come on he PRWE
despi e he adiog aphic pa ame e s.
Pa ien selec ion and me hods
The eligible s udy popula ion comp ises conse a i ely
ea ed elde ly pa ien s (o e 64 yea s o age) wi h a DRF
iden i ied in he public o e e al eme gency depa -
men s (ER) o pa icipa ing hospi als.
The ollowing c i e ia we e used in pa ien selec ion:
Inclusion c i e ia
low ene gy in a- o ex a-a icula do sal p ima ily
s able, educible DRF wi hin 3 cm o he adioca pal
join diagnosed wi h la e al and pos e io -an e io
adiog aphs in ER
physician on-call (gene al p ac i ione , acu e phys-
ician, o hopaedic esiden , o hopaedic consul an )
hinks pa ien would be sui able o non-ope a i e
ea men
Exclusion c i e ia
Ope a i e ea men
Re used o pa icipa e in he s udy
Open ac u e mo e han Gus ilo 1 g adus
Unde 65 yea s o age
Chau eu e’s o Ba on’s ac u e
Smi h’s ac u e ( ola angula ion o he ac u e)
Does no unde s and w i en and spoken guidance
in local languages
Pa hological ac u e o p e ious ac u e in he
same w is , o ea m o elbow
Randomiza ion
All pa ien s will be andomized a e diagnosis, bu be-
o e ea men , o ei he unc ional cas o ola lexion-
ulna de ia ion cas using a andom numbe ma ix in
block alloca ion ashion. The blocks will be dependen
on age, cen e and in a-ex a a icula ac u e because,
based on he li e a u e, unc ional ou come is a ec ed
by age and p esence o in a-a icula ac u e [43, 44].
The ea men alloca ions om he ma ix will be sealed
in en elopes and si ua ed in he eme gency oom.
A e pa ien en olmen has been con i med and in-
o med consen ob ained, he pa ien will be asked o ill
in he PCS ques ionnai e and a medical o de ly will
open he andomiza ion en elope. The physician on-call
will be esponsible o he educ ion, i needed. The
medical o de lies esponsible o he cas ing will no
pa icipa e in he s udy in any o he way. The esea ch
coo dina o moni o s he s udy low and an independen
moni o ing commi ee will be es ablished o he s udy.
In e en ion
I he ac u e is well aligned, closed educ ion will no
be pe o med. The ea ing physician will pe o m
closed educ ion when necessa y, bu speci ic h esh-
olds (sho ening, do sal angula ion, adial inclina ion)
is no se . Closed educ ion akes place unde local an-
aes hesia by means o a local in il a ion commonly
used in Finland. The echnique o closed educ ion is
Rai io e al. BMC Musculoskele al Diso de s (2017) 18:401 Page 3 o 7
no limi ed o some speci ic echnique. Fluo oscopy
may be used i i is a ailable in he pa icipa ing cen e.
Since DRFs a e usually ea ed by heal hca e cen e
physicians, expe ienced acu e physicians and auma
su geons, we do no see any eason o limi he numbe ,
educa ion o expe ience o he on-call physicians in his
p agma ic ial.
The bookle showing cas posi ion examples will be
deli e ed o he pa icipa ing cen es and adequa e ain-
ing will be gi en o ensu e a uni o m posi ion o cas ing
in he s udy. The ini ial ma e ial o he cas is plas e .
A e educ ion, a se o adiog aphs will be aken o
e i y he posi ion o he ac u e. Should he physician
on-call accep ha he ac u e will be ea ed non-
ope a i ely, he cas alloca ed will be used o 5 weeks.
Follow-up
Follow-up isi s in his s udy will be conduc ed in p i-
ma y heal hca e cen es, as seen necessa y by he phys-
ician on-call. We expec ha ollow-ups will be a anged
acco ding o egional guidelines, no mally a e 1 and
2 weeks wi h adiog aphs. Due o he p agma ic na u e
o he ial, we will no se any angula ion deg ees o
sho ening limi s o indica e ope a i e ea men . In case
seconda y displacemen o he ac u e occu s du ing
he ollow-up, he ea ing physicians will use hei dis-
c e ion o consul a local o hopaedic su geon o hand
su geon who will pe o m he necessa y ope a i e ea -
men . Since pa ien s will be andomized in blocks by he
hospi al, we assume ha andomiza ion will ake ca e o
any possible di e ences be ween cen es.
Figu e 1 cas immobiliza ion ime is es ima ed o be
5 weeks, acco ding o cu en guidelines in Finland. The
inal isi o a gene al p ac i ione (GP) will be a he
ime o cas emo al. All pa ien s will unde go an x- ay
p io o cas emo al. The decision o e e pa ien s o a
physio he apis a e cas emo al will be le o he dis-
c e ion o he ea ing GP.
The i s esea ch isi will occu a e 3 mon hs a he
o hopaedic ou pa ien clinic in he hospi al whe e he
ea men was ini ially s a ed. This isi is speci ically
pa o he s udy p o ocol. Du ing his isi , di ec la e al
and an e opos e io adiog aphs will be aken. PRWE,
PCS, Quick-DASH, 15D, pain in VAS and g ip s eng h
(bo h hands) will all be assessed. In o ma ion on he
numbe o cas changes du ing ea men will be
acqui ed om he pa ien .
P ima y ou come, PRWE a 1- and 2-yea ollow-up
will be measu ed by using an In e ne -based sys em.
Pa ien s no using he In e ne will be con ac ed by
phone o egula mail by a s udy nu se. Complica ions
and he numbe o su gical in e en ions will be eco ded
on he pa ien ’s medical iles a e 1 and 2 yea s (Table 1).
Powe analysis
In his ial, a alida ed w is speci ic PRWE sco e will
be used as he main ou come measu e. The minimal
clinically impo an di e ence (MCID) in PRWE is 11
poin s and s anda d de ia ion (SD) is 14 poin s [45]. In
powe calcula ions, we de e mined he equi ed sample
size pe g oup o be 40 pa ien s wi h 95% con idence
in e al, powe o 0.95 and SD o 14. Thus, in o de o
ha e enough s a is ical powe , 40 pa ien s in bo h g oups
ha e o comple e 1 yea ollow-up. Assuming a d op-ou
a e o 30%, g oup size would be 57 (114 in o al).
Analysis o he ma e ial
All anonymised in o ma ion ga he ed in he s udy will be
s o ed in a s udy cloud- egis y a Tampe e Uni e si y
Hospi al. The egis y is p o ec ed wi h passwo ds and he
da a will be dele ed 15 yea s a e he end o he s udy.
S a is ical analysis
Cha ac e is ics o he pa icipan s will be desc ibed using
mean and s anda d de ia ion, median and qua iles
(con inuous a iables) o p opo ion (ca ego ical a i-
ables). The pa ien s will be analysed acco ding o he
in en ion- o- ea p inciple, i he pa ien changes o a
di e en ea men g oup. G oups a baseline will hen
be compa ed using - es , Mann-Whi ney U o Fishe ’s
exac es . P ima y (PRWE) and seconda y ou comes
(Quick-DASH sco e, VAS, 15D, g ip s eng h, complica-
ions and numbe o su gical in e en ions and cas
changes) will be compa ed be ween he g oups a
12 mon hs and 24 mon hs using he Mann-Whi ney U
es . The esul s a e p esen ed wi h 95% con idence in-
e als. Two-way- ables wi h he chi-squa e es will be
used o dicho omous a iables. In subg oup analysis,
he e ec o age, sex, ac u e g oup, smoking and o he
diseases will be e alua ed agains he sco es and o e all
quali y o li e a e ac u e. Analysis o co a iance will
be used o assess he e ec o PCS on he ou come o
cas ea men . PRWE will be used as a dependen a i-
able, cas as independen and PCS as co a ia e. The e -
ec o cas ea men on he PRWE is also in es iga ed
in mul i a iable analysis by pe o ming linea eg ession
analysis since he dependen a iable, PRWE, is no mally
dis ibu ed. The main explana o y a iables a e belie ed
o be cas , age, sex, ac u e g oup, smoking and o he
diseases. O he au ho s, AR is esponsible o he
s a is ics.
E hics
The ial p o ocol and addi ional pape s, including con-
sen o m, pa ien in o ma ion shee and ques ionnai es
ha e been app o ed by he Regional E hics Commi ee o
Tampe e Uni e si y Hospi al (App o al numbe : R16035).
Rai io e al. BMC Musculoskele al Diso de s (2017) 18:401 Page 4 o 7
Fig. 1 The low cha o he s udy
Table 1 The assessmen s and p ocedu es o he ial
Medical his o y Radiog aph PRWE PCS Pain G ip Quick-DASH 15D ROM
Baseline x x x
1–2 weeks (x) (x)
5–6 weeks (x) x
3 mon hs x x x x x x x x x
1 yea x x x x x x
2 yea s x x x x x x
Rai io e al. BMC Musculoskele al Diso de s (2017) 18:401 Page 5 o 7
Time schedule
The ec ui men o he s udy began in Augus o 2016
and he esul s will be analysed a e he 1 and 2-yea
ollow-up pe iod. The inal epo will be published by
he end o 2019.
Discussion
This publica ion p esen s a p ospec i e, andomized, na-
ional mul i-cen e ial o he non-ope a i e ea men o
DRF. I depic s de ails o he pa ien low, andomiza ion,
in e en ion, ollow-up and analysis o he ma e ial.
The limi a ions o his s udy a e he lack o pa ien ’s
blinding o ea men and he exclusion o pa ien s wi h
o he han do sally displaced DRFs. The blinding o
ea men is no easible o p ac ical easons and by
excluding all pa ien s o he han do sally displaced DRF
pa ien s om he s udy enables us o compa e ou
esul s o o he ials.
The s eng hs o he s udy a e he p agma ic na u e o
he s udy, he comp ehensi eness o Finnish egis e s
wi h pe sonal iden i ica ion numbe and he excellen
co e age o ou s udy hospi als. The p agma ic na u e o
he s udy, including no p e-se h esholds o su gical
ea men in case o seconda y displacemen , e eals he
eal impac o he ea men o DRFs in he elde ly
popula ion. The egis e s allow us o ollow-up pa ien s
du ing he s udy, and he e o e educes he p obabili y
o pa ien s being los in ollow-up. All su gical in e en-
ions, o example, a e eco ded o egis e s ega dless o
he hospi al. O he s eng hs o he s udy a e he ali-
da ed p ima y ou come measu e (PRWE) and he aking
in o accoun o pain ca as ophizing endency in
explaining he esul s o he ea men .
Addi ional iles
Addi ional ile 1: Figu e S1. The i s pic u e o lexion-ulna de ia ion
cas . (TIFF 35156 kb)
Addi ional ile 2: Figu e S2. The second pic u e o lexion-ulna
de ia ion cas . (TIFF 35156 kb)
Addi ional ile 3: Figu e S3. The i s pic u e o unc ional cas .
(TIFF 35156 kb)
Addi ional ile 4: Figu e S4. The second pic u e o unc ional cas .
(TIFF 35156 kb)
Abb e ia ions
15-D: 15 dimensional heal h- ela ed quali y o li e indica o ; DRF: dis al adius
ac u e; GP: gene al p ac i ione ; PA: pos e io -an e io ; PCS: Pain Ca as ophizing
Scale; PRWE: Pa ien Ra ed W is E alua ion; Quick-Dash: Quick Disabili y o A m,
Shoulde and Hand; VAS: isual analog scale
Acknowledgemen s
The au ho s o NITEP g oup a e Lau i Rai io
1
, An i Launonen
2
, Teemu
He onko pi
1
, Toni Luokkala
3
, Juha Kukkonen
4
, Aleksi Rei o
3
, Baki Sum ein
2
,
Minna Lai inen
2
, Ville M. Ma ila
1,2
.
Funding
No ex e nal unding.
A ailabili y o da a and ma e ials
No applicable.
Au ho s’con ibu ions
AL, TL, JK and VM a e esponsible o de eloping he ial. AL, TL, JK, VM, AR,
TH, LR and ML d a ed he p o ocol. AL will moni o and ad ise on he
me hodological aspec s o he ial. AL pe o med he powe calcula ions
and he de e mina ion o s udy g oup size. LR will pe o m he s a is ical
analyses and be a majo con ibu o in w i ing he manusc ip . All au ho s
ha e ead and app o ed he inal manusc ip .
Au ho s’in o ma ion
No applicable.
E hics app o al and consen o pa icipa e
The Regional E hics Commi ee o Tampe e Uni e si y Hospi al has app o ed
he p o ocol o he ial and addi ional pape s, including consen o m, pa ien
in o ma ion shee and ques ionnai es. (App o al numbe : R16035). The pa ien s
ha e o gi e hei in o med consen in o de o pa icipa e o he s udy.
Consen o publica ion
No applicable.
Compe ing in e es s
The au ho s decla e ha hey ha e no compe ing in e es s.
Publishe ’sNo e
Sp inge Na u e emains neu al wi h ega d o ju isdic ional claims in
published maps and ins i u ional a ilia ions.
Au ho de ails
1
Uni e si y o Tampe e, School o Medicine, 33014 Tampe e, Finland.
2
Depa men o O hopaedics, Uni o Musculoskele al Su ge y, Tampe e
Uni e si y Hospi al, Teiskon ie 35, PL2000, 33521 Tampe e, Finland.
3
Cen al
Finland Cen al Hospi al, Keskussai aalan ie 19, 40620 Jy äskylä, Finland.
4
Sa akun a Cen al Hospi al, Sai aalan ie 3, 28500 Po i, Finland.
Recei ed: 10 Feb ua y 2017 Accep ed: 11 Sep embe 2017
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