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

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. Re e ences [1] S. N. G ie , “Uppe espi a o y in ec ions,” P ima y Ca e, ol. 40, no. 3, pp. 757–770, 2013. [2] A. S. Mon o, E. R. B yan, and S. 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