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Self-Care Practices for Common Colds by Primary Care Patients: Study Protocol of a European Multicenter Survey—The COCO Study

Abstract

Background. Self-care for common colds is frequent, yet little is known about the spectrum, regional differences, and potential risks of self-care practices in patients from various European regions. Methods/Design. We describe the study protocol for a cross-sectional survey in 27 primary care centers from 14 European countries. At all sites, 120 consecutive adult patients, who visit their general practitioner for any reason, filled in a self-administered 27-item questionnaire. This addresses patients' self-care practices for common colds. Separately, the subjective level of discomfort when having a common cold, knowing about the diseases' self-limited nature, and medical and sociodemographic data are requested. Additionally, physicians are surveyed on their use of and recommendations for self-care practices. We are interested in investigating which self-care practices for common colds are used, whether the number of self-care practices used is influenced by knowledge about the self-limited nature of the disease, and the subjective level of discomfort when having a cold and to identify potential adverse interactions with chronic physician-prescribed medications. Further factors that will be considered are, for example, demographic characteristics, chronic conditions, and sources of information for self-care practices. All descriptive and analytical statistics will be performed on the pooled dataset and stratified by country and site. Discussion. To our knowledge, COCO is the first European survey on the use of self-care practices for common colds. The study will provide new insight into patients' and general practitioners' self-care measures for common colds across Europe.

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Self-Care Practices for Common Colds by Primary Care Patients: Study Protocol of a European Multicenter Survey—The COCO Study

Author: Weltermann, Birgitta M.,Gerasimovska-Kitanovska, Biljana,Thielman, Anika,Koskela, Tuomas
Year: 2015
Source: https://trepo.tuni.fi/bitstream/10024/99570/1/self-care_practices_for_common_2015.pdf
Resea ch A icle
Sel -Ca e P ac ices o Common Colds by P ima y
Ca e Pa ien s: S udy P o ocol o a Eu opean Mul icen e
Su ey—The COCO S udy
Bi gi a M. Wel e mann,1Biljana Ge asimo ska-Ki ano ska,2
Anika Thielmann,1Julie e Chambe,3Heid un Lingne ,4Enzo Pi o a,5
K zysz o Buczkowski,6Selda Tekine ,7Slawomi Czachowski,6Tame Edi ne,8
And zej Zielinski,9Hülya Yikilkan,10 Tuomas Koskela,11 Fe dinando Pe azzuoli,12
Robe D. Ho man,13 Ma ija Pe ek Š e ,14 Cla a Guede Fe nández,15 AyGegül UludaL,16
Ka h yn Ho mann,17 Vildan Me sim,18 and Sanda K ei maye Pes ic19
1Ins i u e o Gene al Medicine, Essen Uni e si y Hospi al, Uni e si y o Duisbu g-Essen, Hu elands aße 55,
45147 Essen, Ge many
2Depa men o Family Medicine and Depa men o Neph ology, Ss. Cy il and Me hodius Uni e si y o Skopje,
Vodnjanska S ee 17, Skopje, Macedonia
3Depa men o Gene al P ac ice, Uni e si y o S asbou g, 2a ue de B an ˆ
ome, 67100 S asbou g, F ance
4Cen e o Public Heal h and Heal hca e, Hanno e Medical School, Ca l-Neube g-S aße 1, 30625 Hanno e , Ge many
5SNAMID, I alian Socie y o Gene al P ac i ione s and ASL Roma B, Via Tuscolana, 859 Rome, I aly
6Depa men o Family Medicine, Nicolaus Cope nicus Uni e si y, Skłodowskiej-Cu ie 9, 85-094 Bydgoszcz, Poland
7Depa men o Family Medicine, Ibni Sina Hospi al, Anka a Uni e si y School o Medicine, Samanpaza ı,
06100 Anka a, Tu key
8Depa men o Family Medicine, Uni e si y o Pamukkale, PAU Tip Fakul esi, Aile Hekimligi AD, Kinikli Kampus,
Denizli, Tu key
9Blekinge Cen e o Compe ence and Lyckeby P ima y Heal h Ca e Cen e, K¨
alle ¨
agen 12, 37162 Lyckeby, Sweden
10Family Medicine Depa men , Dıs¸kapı Yıldı ım Beyazı T aining and Resea ch Hospi al, I an Basbug Caddesi, Dıs¸kapı,
06110 Anka a, Tu key
11 Depa men o Gene al P ac ice, Uni e si y o Tampe e, L¨
a¨
ak¨
a ika u 1, 33014 Tampe e, Finland
12Depa men o Clinical Sciences in Malm¨
o, Cen e o P ima y Heal h Ca e Resea ch, Lund Uni e si y, Malm¨
o, Sweden
13Depa men so FamilyMedicineandMedicalEduca ion,Sakla MedicalSchool,TelA i Uni e si y,8Go donS ee ,
76291 Reho o , Is ael
14Depa men o Family Medicine, Uni e si y o Ljubljana, Poljanski Nasip 58, SI-1000 Ljubljana, Slo enia
15EOXI Vigo, Uni e si y o Vigo, Calle Za agoza, Vigo, 36203 Pon e ed a, Spain
16Depa men o Family Medicine, Facul y o Medicine, C¸anakkale Onsekiz Ma Uni e si y, Te zio˘
glu Campus,
17100 C¸anakkale,Tu key
17Depa men o Gene al P ac ice and Family Medicine, Cen e o Public Heal h, Medical Uni e si y o Vienna,
Kinde spi algasse 15, 1s Floo , 1090 Vienna, Aus ia
18Depa men o Family Medicine, Dokuz Eyl¨
ul Uni e si y Facul y o Medicine, Izmi , Tu key
19Medical Facul y Tuzla, Family Medicine Depa men and Heal h Cen e Tuzla, Depa men o Gene al/Family Medicine,
Ma salaTi a199,75000Tuzla,BosniaandHe zego ina
Co espondence should be add essed o Bi gi a M. Wel e mann; bi gi a.wel e [email p o ec ed]
Recei ed 29 May 2015; Accep ed 26 July 2015
Academic Edi o : Wa is Qidwai
Copy igh © 2015 Bi gi a M. Wel e mann e al. This is an open access a icle dis ibu ed unde he C ea i e Commons A ibu ion
License, which pe mi s un es ic ed use, dis ibu ion, and ep oduc ion in any medium, p o ided he o iginal wo k is p ope ly ci ed.
Hindawi Publishing Co po a ion
E idence-Based Complemen a y and Al e na i e Medicine
Volume 2015, A icle ID 272189, 6 pages
h p://dx.doi.o g/10.1155/2015/272189
2 E idence-Based Complemen a y and Al e na i e Medicine
Backg ound. Sel -ca e o common colds is equen , ye li le is known abou he spec um, egional di e ences, and po en ial
isks o sel -ca e p ac ices in pa ien s om a ious Eu opean egions. Me hods/Design. We desc ibe he s udy p o ocol o a c oss-
sec ional su ey in 27 p ima y ca e cen e s om 14 Eu opean coun ies. A all si es, 120 consecu i e adul pa ien s, who isi hei
gene al p ac i ione o any eason, illed in a sel -adminis e ed 27-i em ques ionnai e. This add esses pa ien s’ sel -ca e p ac ices
o common colds. Sepa a ely, he subjec i e le el o discom o when ha ing a common cold, knowing abou he diseases’ sel -
limi ed na u e, and medical and sociodemog aphic da a a e eques ed. Addi ionally, physicians a e su eyed on hei use o and
ecommenda ions o sel -ca e p ac ices. We a e in e es ed in in es iga ing which sel -ca e p ac ices o common colds a e used,
whe he he numbe o sel -ca e p ac ices used is in luenced by knowledge abou he sel -limi ed na u e o he disease, and he
subjec i e le el o discom o when ha ing a cold and o iden i y po en ial ad e se in e ac ions wi h ch onic physician-p esc ibed
medica ions. Fu he ac o s ha will be conside ed a e, o example, demog aphic cha ac e is ics, ch onic condi ions, and sou ces
o in o ma ion o sel -ca e p ac ices. All desc ip i e and analy ical s a is ics will be pe o med on he pooled da ase and s a i ied
by coun y and si e. Discussion. To ou knowledge, COCO is he i s Eu opean su ey on he use o sel -ca e p ac ices o common
colds. The s udy will p o ide new insigh in o pa ien s’ and gene al p ac i ione s’ sel -ca e measu es o common colds ac oss
Eu ope.
1. In oduc ion
Wo ldwide, common colds a e he mos equen ly encoun-
e edhumandisease[1].Commoncoldisacon en ional e m
o a he e ogeneous g oup o mild uppe espi a o y illnesses
caused by mo e han 100 i uses such as hino i uses, RSVs,
in luenza A i uses, adeno i uses, and pa ain luenza ype 3
i uses [2, 3]. The incidence o common colds is known o
be age-speci ic [4], wi h a yea ly a e age o 6–8 episodes in
younge child en dec easing o 2–4 episodes in adul hood
[5, 6]. Acco ding o a US Ame ican s udy (2015) wi h 3333
pa icipan s, 85% o he popula ion abo e 18 yea s o age will
de elop a leas 1 common cold pe yea , las ing be ween 3 and
7 days [7]. To ou knowledge, no Eu opean da a a e a ailable.
The incidence o he Eu opean egion is likely compa able.
The socioeconomic cos s caused by common colds a e a
bu den o socie y, especially cos s due o sick lea es [8].
The e idence o common cold ea men s is poo wi h
only ew medica ions p o en e ec i e in elie ing symp oms
o in educing he du a ion o he disease, o example,
nons e oidal an i-in lamma o y d ug [9], o al an ihis amine-
deconges an -analgesic combina ions [10], nasal deconges-
an s [11], and zinc (lozenges o sy up) [8]. Despi e poo
e idence, sys ema ic and unsys ema ic obse a ions show
ha pa ien s use a wide a ie y o sel -ca e p ac ices o his
sel -limi ed disease [12–16].
Following he de ini ion o he WHO [17], his s udy
unde s ands sel -ca e as “(...) heabili yo indi iduals,
amilies and communi ies o p omo e heal h, p e en disease,
and main ain heal h and o cope wi h illness and disabili y
(...). I is a b oad concep encompassing (...)nu i ion
(...), li es yle (...) (and) sel -medica ion.” Thus, sel -ca e
p ac ices in ol e all pa ien d i en heal h ac ions, including
he dimensions: sel -medica ion, complemen a y medicine,
and he so-called home emedies [16].
Un ilnow,nos udyexis s ha compa essel -ca ep ac-
ices o common colds in di e en Eu opean coun ies.
The opic is o in e es o se e al easons: (1) he spec um
o sel -ca e p ac ices used o common colds is unknown;
(2) po en ial medica ion in e ac ions in pa ien s on ch onic,
physician-p esc ibed medica ions ha e no been e alua ed;
(3) ac o s which in luence he use o sel -ca e p ac ices
a e poo ly unde s ood. Ye , i may be impo an o be e
unde s and hese opics because he same ac o s may d i e
he high demand and o e p esc ip ion o an ibio ics o
common colds, despi e public campaigns in o ming abou
he benign and sel -limi ed disease cou se. The Eu opean
wo king g oup on sel -ca e was o med o add ess hese
issues. The g oup consis s o membe s o he Eu opean
Gene al P ac ice Resea ch Ne wo k (www.egp n.o g).
2. Me hods and Ma e ials
The p ima y aim o his s udy is o de e mine which sel -
ca e p ac ices o common colds a e used by p ima y ca e
pa ien s om di e en Eu opean coun ies and o iden i y
ac o s in luencing sel -ca e p ac ices. To in es iga e sel -ca e
p ac ices o common colds, we a e conduc ing a mul icen e
c oss-sec ional su ey in 14 Eu opean coun ies.
2.1. Hypo heses. The s udy will in es iga e he ollowing
speci ic hypo heses:
(1) The e a e di e ences in he use o sel -ca e p ac ices
o common colds be ween coun ies (Pu chasing
Powe S anda d, egion) and wi hin coun ies ( u al/
u ban a eas).
(2) The e a e di e ences in he use o sel -ca e p ac ices
acco ding o pa ien s’ socioeconomic ac o s (age,
gende , mig a ion backg ound, heal h insu ance s a-
us,andnumbe o schoolyea s(includinghighe
educa ion)), knowing abou he sel -limi ed na u e o
common colds, subjec i e le el o discom o when
ha ing a common cold, li es yle ac o s (smoking),
ch onic condi ions, numbe o able s aken daily, and
sou ces o in o ma ion.
(3) The use o sel -ca e p ac ices in he subg oup o
pa ien s on ch onic physician-p esc ibed medica ions
bea s he isk o po en ial ad e se e ec s due o
in e ac ions be ween sel -ca e p ac ices and medica-
ions. This isk e alua ion will be pe o med using a
pha macological e iew on in e ac ions be ween, o
example, wa a in, coumadin, ASA/aspi in, and o al
con acep i es/“ he pill” (e.g., wa a in and lico ice,
E idence-Based Complemen a y and Al e na i e Medicine 3
ibup o en and willow, con acep i es, and an idep es-
san ssuchasami ip ylineandSSRIwi hS .John’s
wo ) [18].
In addi ion o hese speci ic hypo heses, he s udy will explo e
sel -ca e p ac ices o pa icipa ing gene al p ac i ione s:
which sel -ca e p ac ices do hey apply hemsel es and which
do hey ecommend o hei pa ien s?
2.2. Coo dina ion and Pa icipa ing Si es o he COCO S udy.
This c oss-sec ional s udy was ini ia ed by p ima y ca e
physician esea che s om h ee Eu opean coun ies (Ge -
many, Macedonia, and Bosnia and He zego ina) du ing
a con e ence o he Eu opean Gene al P ac ice Resea ch
Ne wo k (EGPRN) in Oc obe 2012. The s ee ing commi ee
used subsequen EGPRN mee ings in 2013 o ec ui addi-
ional academic p ima y ca e physicians om he EGPRN
aswo kingg ouppa ne s.The inalwo kingg oupconsis s
o 25 EGPRN membe s om 14 Eu opean and associa ed
coun ies: Aus ia, Bosnia and He zego ina, Finland, F ance,
Ge many, Is ael, I aly, Macedonia, Poland, Romania, Slo e-
nia, Spain, Sweden, and Tu key. A each si e, he coo dina o s
a e esponsible o he ansla ion o he English ques ion-
nai e in o he si e language, i s dis ibu ion o pa ien s, he
back- ansla ion o pa ien ’s answe s o open ques ions in o
English, and ei he he ans e o he ques ionnai e o da a
en y a he s udy cen e in Essen, Ge many, o he da a en y
on-si e wi h subsequen ansmission o he da ase o he
s udy cen e .
The coo dina o s a each si e signed a consen o m o he
ou line o he s udy plan and de ails on expec ed pa icipa ion
equi emen s, ha is, he ansla ion o he ques ionnai e, he
sampling p ocess, and he da a handling. Coo dina o s a e
esponsible o ollowing he s udy plan.
The i s e hical app o al was ob ained om he E hics
Commi ee o he Uni e si y o Duisbu g-Essen, Ge many
(13-5495-BO). This e hical app o al was p o ided o he
coo dina o s o all pa icipa ing si es who ob ained any
app o als equi ed, including, i necessa y, an addi ional
e hical app o al acco ding o local laws and guidelines.
2.3. S udy Ins umen s and Ques ionnai e Design P ocess. The
ques ionnai e was de eloped based on a p eceding su ey in
10 p ima y ca e physicians om se en Eu opean coun ies
and one associa ed coun y (Aus ia, Bosnia and He zego -
ina, Ge many, Is ael, I aly, Macedonia, Poland, and Tu key).
Physicians we e asked o name ypical sel -ca e i ems used by
hei pa ien s o common cold [19]. The physicians’ answe s
we e g ouped o cons uc he su ey ins umen . The inal
ques ionnai e consis s o 27 ques ions wi h a o al o 94
sel -ca e i ems in 11 ca ego ies: o e - he-coun e medica ion
(11 i ems), speci ic ood o d inks (11 i ems), he bal ea (18
i ems), alcoholic d ink (3 i ems), sel -p epa ed special ecipe
(7 i ems), pas illes o d ops (10 i ems), some hing o he nose
(4 i ems), inhala ion (8 i ems), ga gle o sp ay o he h oa
(4 i ems), some hing ex e nal (5 i ems), and ex as a home
(13 i ems). Fo each ca ego y, an addi ional ee- ex op ion
is p o ided. The ques ionnai e app oach o a combina ion o
closed and open ques ions was chosen because pa icipan s
a emo elikely o ecall ea men swhenclosedo semiclosed
p oduc -speci ic ques ions a e p o ided a he han a single
open ques ion only [20].
Fu he mo e, he ques ionnai e elici s he ollowing
pa ien cha ac e is ics: age, gende , place o bi h, o igin
o amily,heal hinsu ances a us,numbe o schoolyea s,
numbe o pills aken daily, egula in ake o speci ic medi-
ca ions (i.e., an icoagulan s, bi h con ol, and aspi in) daily
smoking, money spen o he las common cold, sou ce o
in o ma ion o sel -ca e p ac ices, whe he sel -ca e p ac-
ices we e ecommended o o he s, and ha ing one o he
ollowing ch onic condi ions: dep ession, ch onic kidney
disease, ch onic pain/a h i is, as hma/ch onic b onchi is,
high blood p essu e, hea disease, and diabe es. Following
he Common Sense Sel -Regula ion Model (CS-SRM) [21],
hesubjec i ele elo discom o ismeasu edaskingwhe he
one “ eels e y bad when ha ing a common cold” (answe
op ions: “yes,” “no,” and “do no know”). The pe cep ion
ega ding con ol and cu e is measu ed ocusing on he sel -
limi edness o he disease “i a common cold goes away by
i sel ” (answe op ions: “yes,” “no,” and “do no know”).
Ra he han p o iding a de ailed de ini ion o common
colds, we elied on he pa icipan s’ in ui i e unde s anding
as laymen o wha is mean by common colds. The comple e
pa ien ques ionnai e is displayed in addi ional ile 1 in
Supplemen a y Ma e ial a ailable online a h p://dx.doi.o g/
10.1155/2015/272189.
A e a p e es in 10 p ima y ca e pa ien s each in Macedo-
niaandGe manyaswellasawo kingg oupdiscussiona he
all EGRPN mee ing in Kus¸adası, Tu key, he ques ionnai e
was inalized. The o iginal ques ionnai e was de eloped in
English. Each s udy si e coo dina o is esponsible o i s
ansla ion in o he na i e languages and i s e iew by a
second physician.
Fo da a analysis, he ca ego ies a e eclassi ied acco ding
o hemodeo applica ion oa oido e lapbe weeng oups:
o al applica ion, in anasal applica ion, inhala ion, opical
use in h oa , ex e nal use on he body, and ex as a
home. Foods u s a e ea ed as a sepa a e ca ego y, al hough
o mally hey would belong o he o al applica ion g oup.
All indus y-p epa ed i ems om he pha macy/d ug s o e
which equi e no p esc ip ion a e g ouped as o e - he-
coun e (OTC) medica ions.
A all si es, a sho ques ionnai e collec s cha ac e is ics o
he pa icipa ing p ac ices and physicians: numbe o physi-
cians in p ac ice, o al numbe o pa ien s in he p e ious
yea , a e age pa ien con ac s pe day by he physician, age
dis ibu ion o pa ien s in he p e ious yea , pe cen age o
pa ien s wi h mig a ion backg ound, and whe he he p ac-
ice is loca ed in an u ban o u al a ea. Fo all pa icipa ing
physicians, he numbe o yea s wo king in he p ac ice,
he h ee ypical sel -applied measu es o colds, and he
h ee mos equen ly ecommended measu es o pa ien s
a e ob ained (see addi ional ile 2).
2.4. Da a Collec ion and Managemen
2.4.1. SamplingP ocedu e. Each si e coo dina o was ins uc ed
how o pe o m he s anda dized ques ionnai e ansla ion
4 E idence-Based Complemen a y and Al e na i e Medicine
and he da a collec ion in he selec ed p ima y ca e p ac-
ice(s) o cen e (s). To ensu e a andom sample, ques ion-
nai es a e dis ibu ed o consecu i e pa ien s ul illing he
inclusion c i e ia, independen o hei eason o he p ac ice
isi . The inclusion c i e ia a e age abo e 18 yea s and su -
icien language capabili ies o answe he sel -adminis e ed
ques ionnai e o being in a endance o someone able o
p o ide assis ance (in eading, ansla ing, o o he suppo ).
The si e coo dina o o ganizes he dis ibu ion o he ques-
ionnai es a he ecep ion desk o be comple ed by he pa ien
in he wai ing oom. In g oup p ac ices o cen e s wi h se e al
physicians, ques ionnai es will be dis ibu ed o consecu i e
pa ien s, ega dless o he physician in cha ge o he pa ien .
To calcula e p ac ice esponse a es, e used o un illed
ques ionnai es a e collec ed oge he wi h he comple ed
ques ionnai es. De ails abou he sampling p ocess in each
pa icipa ing si e (e.g., esponse a e pe si e) will be included
in hemainpublica ion.
2.4.2. Da a Managemen . Da a en y is o ganized using IBM
SPSS S a is ics o Windows, Ve sion 22.0. Pa icipa ing
si es a e ee o choose be ween uploading he da a in o
a cus om-designed SPSS da a ile o ha ing he da a en y
a anged a he s udy cen e in Essen, Ge many. In he la e
case, pa icipa ing si es ei he uploaded scanned anonymous
ques ionnai es o a secu ed uni e si y se e d op box o
mailed he o iginal ques ionnai es using a ce i ied mail
se ice. To ensu e da a quali y, 10% o he da a en e ed in
Essen a e checked h ough double en y by a second pe son.
I e o s a e g ea e han 5%, he comple e ques ionnai e is
double en e ed.
2.4.3. Da a Quali y. Plausibili y checks o con adic o y
answe s a e pe o med. The numbe o pills aken daily is
adjus ed i a pe son ma ks “0” bu answe s ha hey ake,
o example, a con acep i e. F ee- ex answe s a e checked i :
(a) an answe is only gi en as ee- ex hough p o ided in a
mul iple choice o ma (co ec ion: ee- ex answe s dele ed
and mul iple choice ques ion ma ked); (b) he same answe
is gi en as in he mul iple choice ques ion (co ec ion: ee-
ex i em dele ed); (c) answe s a e gi en in he w ong ca ego y
(co ec ion: ea anged). All cu encies a e ans e ed in o
Eu o.
2.5. Sample Size Calcula ion and S a is ical Analysis
2.5.1. Sample Size Calcula ion. The a ge ed sample size
o eachsi ewases ima ed ompowe calcula ionsusing
Ge man da a on nons e oidal analgesic use a es because no
da a we e a ailable on he u iliza ion a e o sel -ca e p ac ices
o all pa icipa ing coun ies. Wi h 62 million packages used
by 80 million people, abou 77% o he popula ion used such
medica ions in 2012 (IMS Pha maScope Na ional by IMS
HEALTH GmbH & Co. OHG). Assuming ha some pa ien s
usemo e hanonepackagepe yea ,wees ima ed ha abou
40% o he adul popula ion ook nons e oidal painkille s
such as ace ylsalicylic acid, ibup o en, o pa ace amol a leas
once a yea .
Aiming a es ima ing he sample size necessa y o ob ain
a ep esen a i e sample o a p ac ice wi h 3,000 pa ien s, a
o al o 94 pa ien s need o be s udied (CI 95%; SE 0.05). In
a p ac ice sample o 1,000 pa ien s wi h all o he pa ame e s
kep equal, a o al o 88 pa ien s would need o be su eyed.
Simila ly, in a p ac ice wi h 10,000 pa ien s, a o al o 96
pa ien s would need o comple e he ques ionnai e. These
es ima es a e based on wo assump ions. (1) The sample o
pa ien s su eyed is andom o he espec i e p ac ice. (2)
The sample size o 100 pa ien s is a adeo be ween s a is ical
powe and p ac icabili y. To accoun o a non esponse a e o
25%, o e sampling by 25% is planned, leading o an adjus ed
sample size o 117.5 (94 + 23.5 pa ien s), ounded o 120
pa ien s pe p ima y ca e p ac ice o cen e .
2.5.2. Response plus Rep esen a i eness. The esponse is cal-
cula ed as pe cen age o he ques ionnai es illed ou in
ela ion o he 120 ques ionnai es dis ibu ed. Due o da a
p o ec ion easons, no cha ac e iza ion o non esponde s
is possible. Analyses o ull and pa ial esponde s will be
pe o med.
The powe calcula ion ocuses on he ep esen a i eness
o he samples on p ac ice le el. In addi ion, we will in es i-
ga e whe he he collec ed da a a e also ep esen a i e on a
coun y le el. To add ess his issue, we a e using ou analy ic
app oaches:
(1) In coun ies wi h ≥2 samples om di e en si es
wi hin one ci y and i s adjacen subu bs, equencies
o sel -ca e i ems will be compa ed be ween he
di e en si es (F ance, Tu key). The eby, di e en
socioeconomic and geog aphical a eas ( u al/u ban)
will be compa ed.
(2) In coun ies wi h ≥2 di e en ci ies, he equencies o
sel -ca e i ems will be compa ed be ween he di e en
ci ies (Ge many, Tu key, and Poland). In one case,
we will compa e a p ac ice sample (𝑛 = 120)wi h
a na ionally ep esen a i e sample ob ained h ough
elephone in e iews conduc ed on he basis o he
COCO ques ionnai e (Aus ia).
(3) Due o demog aphic he e ogenei y be ween coun-
ies, we will pe o m age and i needed sex s anda d-
iza ion.
(4) S anda diza ion o egional cha ac e is ics (u ban/
u al) will be conside ed as well.
2.5.3. Pooled and Coun y Speci ic Analyses. In p epa a ion
o pooledanalysesac oss14coun ies,po en ialsou ces
o he e ogenei y wi hin he da a will be iden i ied be o e
combining he da ase s.
All desc ip i e s a is ics will be pe o med on he pooled
da ase ands a i iedbycoun yandsi e.Thep e alenceo
i emsusedwillbep esen edasp opo ions.
We will use chi-squa e es s o ca ego ical and ANOVA
o con inuous a iables o iden i y ac o s in luencing sel -
ca e i ems (age, sex, u ban/ u al a ea, numbe o school yea s,
mig a ion backg ound, heal h insu ance s a us, subjec i e
le el o discom o , knowing abou he diseases’ sel -limi ed
E idence-Based Complemen a y and Al e na i e Medicine 5
na u e o common colds, sel -g owing o plan s/he bs, smok-
ing, ch onic condi ions, numbe o able s aken daily, and
di e en sou ces o in o ma ion). Analyses acco ding o he
Pu chasing Powe S anda d [22] will be pe o med on he
basis o he ollowing g oupings: G oup I: Aus ia, Sweden,
Ge many, and Finland; G oup II: F ance, Is ael, I aly, Spain,
and Slo enia; G oup III: Poland, Tu key, Romania, Mace-
donia, and Bosnia and He zego ina. Di e ences be ween
geog aphical egion, u al/u ban a ea, and cul u al back-
g ound will be es ed using he chi-squa e s a is ic. Fo he
compa ison o mo e han wo means (Pu chasing Powe
S anda d), ANOVA will be calcula ed. Logis ic eg ession
analyses will be used o de e mine p edic o s o sel -ca e
p ac ices. All analyses will be pe o med in he o al da ase
and sepa a ely pe si e and coun y and Eu opean egion.
3. Discussion
The COCO s udy aims a desc ibing sel -ca e p ac ices o
common colds used by p ima y ca e pa ien s in di e en
Eu opean coun ies o iden i y he spec um used, o quan i y
sel -ca e p ac ices, o desc ibe di e ences ac oss coun ies
and egions, and o explo e he isk o possible in e ac ions
wi h ch onic physician-p esc ibed medica ions. In e es ingly,
despi e hei high p e alence and hei impac on indi iduals
andsocie ies,commoncoldsandespeciallysel -ca ep ac ices
o hisha mlessdiseaseha eba elybeenasubjec o in e es
o he medical communi y.
In con as o ecen p io s udies on sel -ca e, which
mos ly ocus on single dimensions, ha is, sel -medica ion
o home emedies [12, 23], his s udy explo es sel -ca e o
common colds based on he comp ehensi e WHO de ini ion,
including OTC and nonmedicinal home emedies. This
b oad WHO de ini ion is chosen because o he poo p io
knowledge on he spec um o i ems used in he pa icipa ing
coun ies, cul u al di e ences, and he expec ed di e ences
due oheal hca esys ems.Ino de osu ey helikely
ange o sel -ca e p ac ices used in he pa icipa ing coun ies
and because o he lack o a s anda dized ques ionnai e, he
ques ionnai e design chosen includes closed ques ions and
allows o ee- ex answe s.
This pan-Eu opean mul icen e s udy is conduc ed using
a low budge s a egy, he eby ep esen ing an example o
u u e p ojec s. Ne e heless, he e a e se e al me hodolog-
ical challenges and limi a ions o his s udy: Fi s , al hough
he high numbe o pa icipa ing si es h oughou Eu ope
is a s eng h o he COCO s udy, his p ojec is acing a
majo me hodological challenge wi h ega d o he ep e-
sen a i eness o i s esul s on p ac ice, local, egional, and
na ional le el. This challenge will be add essed by combining
a iousanaly ics a egies:Dependingon henumbe o
indi idual samples wi hin a coun y, equencies o sel -ca e
i ems will be compa ed ei he be ween di e en a eas o he
same ci y o be ween di e en ci ies wi hin one coun y. An
addi ional na ionally ep esen a i e sample ob ained h ough
elephonein e iewson hebasiso heCOCOques ionnai e
allows o a compa ison o single p ima y ca e p ac ices and
a na ional sample. Fu he , age and sex s anda diza ion as
well as s anda diza ion o egional cha ac e is ics will be
conside ed. Second, his c oss-sec ional ques ionnai e su ey
is based on he pa ien s’ ecall o sel -ca e p ac ices du ing
hei las common cold. This may imply a decla a ion and
ecall bias. In o de o limi hose, he ques ionnai e is
dis ibu ed a he end o win e ime du ing he ypical peak
season o common colds. Also, i is unlikely ha pa ien s
comple ely change sel -ca e p ac ices om one common cold
o ano he , hus implying a he s able answe ing beha io .
Fu he mo e, he ques ionnai e was only wo pages long
and included p oduc -speci ic ques ions. This ques ionnai e
design has been p o en o o e come he ecall bias o
ea men s [20].
4. Conclusion
The COCO s udy will p o ide insigh in o pa ien s’ sel -
ca e beha io s o common colds. The esul s no only will
be in e es ing om a desc ip i e pe spec i e wi h ega d o
egional di e ences wi hin Eu ope, bu will also help o guide
esea ch on educa ional in e en ions on he ha mlessness
o common colds and app op ia e sel -ca e p ac ices. Also,
he esul s will help o de elop s a egies o be e p o ec
pa ien s on ch onic medica ions om ad e se medica ion
in e ac ions due o sel -ca e p ac ices o common colds.
Abb e ia ions
COCO: Common Cold s udy
WHO: Wo ld Heal h O ganiza ion.
T ial S a us
Pa icipan s’ ec ui men inished in Ap il 2014.
Con lic o In e es s
The au ho s decla e ha he e is no con lic o in e es s
ega ding he publica ion o his pape .
Au ho s’ Con ibu ion
Bi gi a M. Wel e mann and Biljana Ge asimo ska-
Ki ano ska de eloped he s udy idea. Bi gi a M. Wel e mann
and Biljana Ge asimo ska-Ki ano ska con en ionalized he
s udy and de eloped he ques ionnai e d a . The membe s
o he EGPRN wo king g oup on sel -ca e e ised he
ques ionnai e d a . Bi gi a M. Wel e mann and Biljana
Ge asimo ska-Ki ano ska secu ed i s unding. Bi gi a M.
Wel e mann and Anika Thielmann d a ed he i s e sion
o he pape . Anika Thielmann, Bi gi a M. Wel e mann,
Julie e Chambe, and Enzo Pi o a de ailed he discussion.
All o he au ho s (Julie e Chambe, Heid un Lingne ,
K zysz o Buczkowski, Slawomi Czachowski, Selda Tekine ,
Tame Edi ne, And zej Zielinski, H¨
ulya Yikilkan, Tuomas
Koskela, Fe dinando Pe azzuoli, Robe D. Ho man, Ma ija
Pe ek ˇ
S e , Cla a Guede Fe n´
andez, Ays¸eg¨
ul Uluda˘
g, Ka h yn
Ho mann, Vildan Me sim, and Sanda K ei maye Pes ic)
c i ically e iewed he di e en pape e sions and p o ided
eedback on i . Bi gi a M. Wel e mann, Anika Thielmann,
and Biljana Ge asimo ska-Ki ano ska inalized he pape .
All au ho s ead and app o ed he inal pape .

6 E idence-Based Complemen a y and Al e na i e Medicine
Acknowledgmen s
The s udy ecei ed unding om he Eu opean Gene al
P ac ice Resea ch Ne wo k. All au ho s we e suppo ed by
hei a ilia ed ins i u ions. The au ho s wish o hank Melida
Hasanagic o he help in de eloping he s udy idea and
g an applica ion. The au ho s also hank Anja Viehmann
(Ins i u e o Gene al Medicine, Uni e si y o Duisbu g-
Essen, Essen) and P o esso D . Ka l-Heinz J¨
ockel (Ins i u e
o Medical In o ma ics, Biome y and Epidemiology, Uni-
e si y o Duisbu g-Essen, Essen) o hei s a is ical ad ice
and Ch is ine Ke s ing o he c i ical e iew o he pape .
Special hanks go o he pa icipa ing physicians, p ac ices,
and pa ien s o hei ime and con ibu ions.
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