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Tilburg University

Diabetes Attitudes Wishes and Needs 2 (DAWN2)

Peyrot, M.; Burns, K.K.; Davies, M.M.; Forbes, A.; Hermanns, N.; Holt, R.I.G.; Kalra, S.;

Nicolucci, A.; Pouwer, F.; Wens, J.; Willaing, I.; Skovlund, S.E.

Published in:

Diabetes Research and Clinical Practice

DOI:

10.1016/j.diabres.2012.11.016

Publication date:

2013

Document Version

Publisher's PDF, also known as Version of record

Link to publication in Tilburg University Research Portal

Citation for published version (APA):

Peyrot, M., Burns, K. K., Davies, M. M., Forbes, A., Hermanns, N., Holt, R. I. G., Kalra, S., Nicolucci, A., Pouwer,

F., Wens, J., Willaing, I., & Skovlund, S. E. (2013). Diabetes Attitudes Wishes and Needs 2 (DAWN2): A

multinational, multi-stakeholder study of psychosocial issues in diabetes and person-centred diabetes care.

Diabetes Research and Clinical Practice, 99(2), 174-184. https://doi.org/10.1016/j.diabres.2012.11.016

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Diabetes

Attitudes

Wishes

and

Needs

2

(DAWN2):

A

multinational,

multi-stakeholder

study

of

psychosocial

issues

in

diabetes

and

person-centred

diabetes

care

Mark

Peyrot

a,1,

*

,

Katharina

Kovacs

Burns

b,1

,

Melanie

Davies

c,1

,

Angus

Forbes

d,1

,

Norbert

Hermanns

e,1

,

Richard

Holt

f,1

,

Sanjay

Kalra

g,1

,

Antonio

Nicolucci

h,1

,

Frans

Pouwer

i,1

,

Johan

Wens

j,1

,

Ingrid

Willaing

k,1

,

Søren

E.

Skovlund

l,1

aDepartmentofSociology,LoyolaUniversityMaryland,4501NorthCharlesStreet,Baltimore,MD21210,USA

bInterdisciplinaryHealthResearchAcademy,EdmontonClinicHealthAcademy,UniversityofAlberta,Edmonton,Canada cDiabetesResearch,DepartmentofCardiovascularSciences,UniversityofLeicester,LeicesterLE15WW,UK

dDepartmentofPrimaryandIntermediateCare,FlorenceNightingaleSchoolofNursingandMidwifery,King’sCollegeLondon,London,UK e

ResearchInstituteoftheDiabetesAcademyMergentheim(FIDAM),BadMergentheim,Germany

fHumanDevelopmentandHealthAcademicUnit,FacultyofMedicine,UniversityofSouthampton,Southampton,UK gBhartiHospital&B.R.I.D.E.,Karnal132001,Haryana,India

hDepartmentofClinicalPharmacologyandEpidemiology,ConsorzioMarioNegriSud,S.MariaImbaro,Chieti,Italy iDepartmentofMedicalandClinicalPsychology,TilburgUniversity,Tilburg,TheNetherlands

j

DepartmentofMedicineandHealthSciences,PrimaryandInterdisciplinaryCareAntwerp,UniversityofAntwerp,Antwerp,Belgium

k

StenoHealthPromotionCenter,StenoDiabetesCenter,DK-2820Gentofte,Denmark

lPatientResearch,Advocacy&Support,NovoNordiskA/S,Copenhagen,Denmark

a

r

t

i

c

l

e

i

n

f

o

Articlehistory:

Received22November2012 Accepted22November2012 Publishedonline27December2012 Keywords:

Peoplewithdiabetes Familymembers Healthcareproviders Survey Person-centredcare Psychosocial Self-management

a

b

s

t

r

a

c

t

Aims:TheDiabetesAttitudesWishesandNeeds2(DAWN2)studyaimstoprovideaholistic assessmentofdiabetescareandmanagementamongpeoplewithdiabetes(PWD),family members(FM),andhealthcareprofessionals(HCPs)andexplorespotentialdriversleadingto activemanagement.

Methods: DAWN2surveyover16,000individuals(9000PWD,2000FMofPWD,and5000 HCPs)in17countriesacross4continents.Respondentscompleteagroup-specific question-naire;itemsaredesignedtoallowcross-groupcomparisonsoncommontopics.The ques-tionnaires comprise elements from the original DAWN study (2001), as well as psychometricallyvalidatedinstrumentsandnovelquestionsdevelopedforthisstudyto assessself-management,attitudes/beliefs,disease impact/burden,psychosocialdistress, health-relatedqualityoflife,healthcareprovision/receipt,socialsupportandprioritiesfor improvementinthefuture.Thequestionnairesarecompletedpredominantlyonlineorby telephoneinterview,supplementedbyface-to-faceinterviewsincountrieswithlow inter-netaccess.Ineachcountry,recruitmentensuresrepresentationofthediabetespopulation intermsofgeographicaldistribution,age,gender,educationanddiseasestatus.

Discussion: DAWN2aimstobuildontheoriginalDAWNstudytoidentifynewavenuesfor improvingdiabetescare.Thispaperdescribesthestudyrationale,goalsandmethodology.

#2012ElsevierIrelandLtd.

*Correspondingauthor.Tel.:+14106175140;fax:+14106172215. E-mailaddress:mpeyrot@loyola.edu(M.Peyrot).

1 OnbehalfoftheGlobalDAWN2StudyGroup.

ContentsavailableatSciverseScienceDirect

Diabetes

Research

and

Clinical

Practice

j o u r n a lh o m e p a g e :w w w . e l s e v i e r . c o m / l o c a t e / d i a b r e s

0168-8227#2012ElsevierIrelandLtd.

http://dx.doi.org/10.1016/j.diabres.2012.11.016

Open access under CC BY-NC-ND license.

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1.

Introduction

In2001,theDiabetes, Attitudes,WishesandNeeds(DAWN) studyshowedthatself-managementofdiabeteswas consid-ered poor by people with diabetes (PWD) and healthcare professionals(HCPs).Diabetes-relateddistresswas common amongst PWD and hampered efforts to self-manage their condition, but few received psychological treatment [1]. Although recognition by HCPs of emotional problems and diabetes-specificdistressamongstPWDwaslow,HCPsdesired abetterunderstandingofsuchissues[2].Collaborationamong diabetescareproviderswasidentifiedasanimportantfactorfor improvingdiabetesoutcomes,butinterdisciplinaryteamcare wasuncommon[2],andtherewassomeresistancebyPWDand HCPstothetimelyinitiationofeffectivetherapies[3].

FollowingDAWN,patientrepresentativesandan interdis-ciplinarygroupofdiabetescareexperts discussed howthe DAWNfindings couldbetranslatedinto improved diabetes care[4].Theresulting‘DAWNCalltoAction’[5]encouraged multiplestakeholders(HCPs,PWDandtheirfamilymembers [FMs]/carers,payers, policy makers, industry and non-gov-ernmentorganisations)toimplementperson-centred diabe-tescare,andactivelyinvolvePWDinself-managementwith supportfromaninterdisciplinaryteamofHCPs[2].

TheDAWNfindingssupportaparadigmshiftfromanacute care model to a person-centred, integrated chronic care model, such as the WHO Innovative Care for Chronic Conditionsframework to diabetes[6]. Thismodel involves careatthreelevels:micro,mesoandmacro,whichreferto individual, healthcare organisation/community, and policy levels,respectively[6].Optimaldiabetescareisbestachieved bycollaborationbetweenPWD,FM,communitypartnersand healthcareteamsthatareinformed,motivated,prepared,and able towork together. This collaboration issupportedand influenced by the broader healthcare organisations and communities,and by the policy environment [6]. Scientific evidenceprovidesthefoundationfortheapproachestocare

[6], but the PWDperspective is important in informing all levelsofhealthcare[7].PWDhavetherighttobeinformedand educated,tohaveaccesstoproperdiabetescareandoptimal medicine,andnottobediscriminatedagainstbecauseoftheir condition[8].

ItisadecadesincetheDAWNstudyhighlightedtheneed for collaborative action across countries to improve self-management and psychosocial support. Despite major advancesincollaborativecaremanyPWDstilldonotachieve desirabletreatmentoutcomes.Thegrowingburdenof diabe-tescallsforstrongerandbroaderglobally-coordinatedefforts. As more countries recognise the effect of diabetes on populationhealth,andtheeconomicandpersonalburdens, wemustexpandourknowledgetoincludethediversesocial institutionsandculturesofthesecountries.Asourknowledge hasadvanced,wehaveidentifiedgapsinourknowledgeofthe roleofsupportfromfamilyandcommunityinlivingwithand caringforPWD.Acrossnations,thereisapressingneedfora newglobaltranslationalresearchinitiativethatcanformthe foundation formeasurement-guided multi-stakeholder col-laborationfor theadvancement ofperson-centred diabetes careworld-wide.Thus,itistimeforanewDAWN.

TheDAWN2studyinitiative,undertakenbyNovoNordisk in partnership with the International Diabetes Federation (IDF), the International Alliance of Patient Organisations (IAPO), the Steno Diabetes Center, and a range of other national,regionalandglobalpartners,aimsto(a)improveour understandingofthe unmetneedsofPWDandtheir care-takers,(b)facilitatedialogueandcollaborationamongallkey stakeholderstostrengthenpatientinvolvementandimprove self-managementand(c)establishacross-culturally validat-ed multi-national survey framework for assessing and benchmarking psychosocial and educational aspects of diabetescaredelivery.Theoverallaimistoidentifyavenues forimprovementatallthreelevelsofcare–atthemesoand macro-levelsfor diabetescare fundingandcareprovision, andatthemicrolevelfordeliveryofcare.Thestudyexplores how PWD, FMs and HCPs perceive diabetes care and investigatesthevalueofaperson-centredmodelofdiabetes care that emphasises the needs of the individual in the contextofcurrentchroniccare,self-managementeducation and psychosocialsupport. This paper describes the study methodology.

2.

Materials

and

methods

2.1. Studyobjectives

Within anationaland internationalsetting, thepredefined objectivesoftheDAWN2studyare:

Primaryobjective:

 Toassesspotentialbarrierstoandfacilitatorsofactiveand successfulmanagementofdiabetesamongPWD,FMs,and HCPs.

Secondaryobjectives:

 Toestablishnationalbenchmarksforhealthstatus,quality oflife(QoL),accesstoself-managementeducationandto self-careindiabetes.

 Toassesstheaccessto,anduseandbenefitof,supportfrom healthcare teams, family and friends, communities and society.

 Toexploreandpinpointthemostimportantfacilitatorsand barrierstoperson-centredchroniccareforeachstakeholder group.

 To identify successes, wishes, needs, preferences and prioritiesforchangeamongallkeystakeholdersindiabetes. 2.2. Studydesign

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Diabetes,andmultipleotherorganisationsinvolvedin person-centreddiabetescare.FieldworkbeganinMarch2012. 2.3. Ethicalconsiderations

Ineachcountry,thestudyisbeingconductedinaccordance with the relevant ethicalrequirements, followingregional/ national/local guidelines relating to the conduct of non-interventionalstudiesandusesguidelinesoftheInternational Chamber of Commerce/European Society for Opinion and Marketing Research [9], the Council of American Survey ResearchOrganizations[10]andGoodPharmacoepidemiology Practices[11]asaminimumstandard.

2.4. Studyparticipants

DAWN2isbeingconductedin17countries:Algeria,Canada, China,Denmark,France,Germany,India,Italy,Japan,Mexico, The Netherlands, Poland, Russia, Spain, Turkey, United Kingdom (UK) and United States of America (USA). Brazil was originally included inthe study plan, howeverdue to timingissues,theDAWN2studyinBrazilwillbeconducted separately.

The participating countries represent 4 continents – Europe,Asia, NorthAmerica,andAfrica.Countries volun-teered for participation in DAWN2, including providing studyfunding,mainlytoidentifywaystoenhancediabetes careandthelivesofPWDandtheirFM.Othercountriesare currentlyapplyingorplanningtoapplycomponentsofthe DAWN2studydesignaspartofthewiderDAWNnetwork; however, these research activities are not part of the 17-country DAWN2 study. Overall, the study population comprises 16,100 participants:9040 PWD, 2160 FMs and 4900 HCPs. Inclusion/exclusion criteria are presented in

Table 1. Each country’s sample is a minimum of 900 participants:500 PWD,120FMs and280HCPs (seeFig. 1). IntheUSA,anadditionalsampleof540PWDand120FMsof African-American,HispanicandAsianethnicoriginand140 HCPswhotreatminoritypopulationsisincludedtoobtain adequate numbers for subgroup analyses. In general, the threeparticipantgroupsareindependent(e.g.,participants in PWD sample are not treated by participants in HCP sample). However, for the FM sample, some of the 120 participants dolive inthe samehouseholdas individuals who participated in the PWD survey. The data for these participants enables linkage between this subset of PWD andtheirFMs.

TheHCPsamplecomprisesspecialistphysicians (endocri-nologists and diabetologists), primary care (PC) providers, generalpractitioners(GPs)andinternalmedicinephysicians (with a sub-speciality in diabetes) and other HCPs (e.g., diabetes nurses, dietitians, diabetes educators, counsellors orphysician’sassistants,whovarybycountry).Thesampleof PWD predominantly comprises those withtype 2 diabetes (with quotas for different treatment regimens), but also includesparticipantswithtype1diabetes.

The global study sample (and subsample) sizes are sufficienttoachievemorethan80%powerfora‘small’effect size(e.g.,Cohen’sd=0.2).NationalsamplesofPWDandHCP weredesignedtoachieve80%powerfora‘medium’effectsize

(e.g.,Cohen’sd=0.5).Minimumnationalsamplesizewas120 toachieve80%powertodetectadifferenceinproportionsof 10%. Minimum national subsample size was 80 to permit effectiveweighting(especiallyimportantwhenproportional samplingwouldgenerateasmallersubsamplethatwouldnot yieldareliablesubsampleestimate).

2.5. Recruitmentmethodology 2.5.1. HCPs

Inallcountries,potentialparticipantsareidentified primar-ily from online panels and databases. When necessary, other sources such as telephone lists and physician directories are used for recruitment. All potential partici-pants areinvitedtotakepart viaemailor phone.Aswith otherDAWN2surveygroups,allparticipantsreceivea web-link to a secure server to enable them to complete the surveyonline.

2.5.2. PWDandFMs

Web, telephone and in-person methods relevant to each country’s situation were applied while trying tomaximise comparability of methodologies and survey populations acrosscountries.

Table1–Inclusionandexclusioncriteria.

Inclusioncriteria

Allparticipants:Internetaccessathomeorconvenient locationorabletoattendaface-to-faceortelephone interview;informedconsentbeforethestartofany study-relatedactivities

PWD:Adultsaged18yearsdiagnosedwithdiabetesbyan HCPatleast12monthsago(type1ortype2;notonlyduring pregnancy)

FM:Adultsaged18yearswhoarenotdiagnosedwith diabetes,liveinthesamehouseholdwithanadult (18years)withdiabetes(type1ortype2;notonly duringpregnancy)andareinvolvedinhis/hercare HCP:GPs,PCphysiciansandinternalmedicinephysicians

whohavebeeninpracticefor1yearandwhopersonally treat5adults(18years)withdiabetespermonthand initiateoralmedication

HCP:Diabetesspecialists(endocrinologists/diabetologists orGP/PCphysicians/internalmedicinephysicianswith sub-specialityindiabetes)whohavebeeninpracticefor 1year,personallytreat50adults(18years)with diabetespermonthandprescribeinsulin(mayalso prescribeoralmedicationorotherinjectablediabetes medications).Thresholdmaybeadjustedaccording tocountry-specificrequirements

HCP:OtherHCPs(diabetesnurses/dietitians/otherHCPs) whohavebeenintheirrespectiveprofessionsfor 1yearandprovidecarefor5adults(18years)with diabetespermonth

Exclusioncriteria

Allparticipants:Inabilitytounderstandandcomplywith writtenandverbalinstructions

PWD:Individualsaged<18yearsand/ordiagnosedwith diabeteslessthan12monthsagoand/ordiagnosedwith diabetesonlyduringpregnancy

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2.5.3. Hybridonlineandtelephonemethodology

In11DAWN2countrieswithhighinternetpenetration(USA, Canada, UK, France, Germany, Italy, Spain, Denmark, Netherlands, Poland, Japan) ahybrid online and telephone methodologyisusedtorecruitPWDandFMs.Inthesegroups, participantsareenrolledusingweb-basedrecruitmentorby telephone. This recruitment methodology is intended to ensure the study population in these countries is as representativeaspossibleofthewiderdiabetescommunity andtoaddressconcernsregardingpotentialbiasiftheentire samplewereobtainedthroughweb-basedrecruitment.

Fortheonlinesample,potentialparticipantsareidentified from multiple online panels and databases per country. Individuals identified from these sourcesare contacted by email and invited to participate in the study. Participants recruited bytelephone maycomplete the survey either by telephoneoronline.Dependingontheirpreference, partici-pantsareeithersenta web-linkviaemail tocompletethe surveyonlineorareinterviewedbytelephone.

For the telephone sample, potential participants are identifiedfromavarietyofsources(generaltelephonelists, proprietary databases, lists from past research, patient association lists). They are contacted by telephone and, if eligible,invitedtoparticipateinthestudy.Proceduraldetails for non-web-based recruitment are country-specific and complywithlocallogisticsandethicalregulations.

2.5.4. Face-to-face-methodology

Intheremaining sixDAWN2countrieswithlowerinternet access (Algeria, China, India, Mexico, Russia and Turkey) participantsarerecruitedbytelephoneorface-to-faceusing telephone lists, patient association lists, proprietary data-bases, and hospital and physician directories. Participants completethequestionnaireviaaface-to-faceinterview.

2.6. Questionnaires

Themulti-dimensional scientificsurveydesign forDAWN2 wasdevelopedbytheGlobalDAWN2SurveyWorkingGroup accordingtoaperson-centredmodelforchronicillnesscare withinputfrommulti-national,multi-disciplinarymeetings involvingrepresentativesofallthecountriesparticipatingin DAWN2,andpatientadvocacyandscientificexpertsfromthe collaboratingorganisations.A summaryofthe main topics and subtopicscoveredbythePWD,FM,and HCP question-naires is presented in Table 2. The questionnaires were designed to permit comparison across respondent types wherepossible.

Thequestionnairesincorporateseveralelements, includ-ing: items from the original DAWN study (to enable evaluationoftrendsindiabetescareoverthepastdecade); newly developed questions (to investigate areas such as discrimination and the needs and preferences for better education and support); and open-ended questions (to capture the individual stories of the respondents). Some new questions were developed with inspiration from, or adapted/modified from existing validated instruments, as relevant in each case with the originators of the ques-tionnaires, including the Diabetes Empowerment Scale-short form (DES-SF) [12,13]; Diabetes Family Behavior Checklist(DFBC)[14]andtheHealthCareClimate Question-naire (HCC) [15]. In addition, several standardised instru-mentswereincorporatedintothequestionnairesinoriginal or shortened forms, including: the Problem Areas in Diabetes-short form (PAID-5) [12–20]; Patient Assessment ofChronicIllnessCare(PACIC)[16,17];SummaryofDiabetes Self-Care Activities Measure (SDSCA) [21]; WHOQOL-BREF

[22]; EuroQol (EQ-5D)[23]; andthe WHO Well-Being Index (WHO-5)[24].

HCPs (n=280)

Nurses/dietitians and other HCPs (n=80)

*In the USA, additional 540 PWD and 120 FMs recruited to better represent African-American, Hispanic and Asian ethnic groups, plus 140 HCPs who work with minority populations.

Some of the 120 FMs live with PWDs, allowing linkage between this subset of PWD and

their FMs.

FM: family members; GPs: general practitioners; HCP: healthcare professional; PWD: people with diabetes

Endocrinologists/ diabetologists (n=80) GPs (n=120) PWDs (n=500) FMs (n=120)† Type 2 - insulin treated (n=150) - non-insulin medication (n=170) - diet/exercise only (n=100) Type 1 (n=80)

Participants per country (n=900)*

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Table2–SummaryofmaintopicsandsubtopicscoveredbythePWD,FM,andHCPquestionnaires.

Topic Subtopic

PWD FM HCP

Sociodemographics Age;gender;height;weight; ethnicorigin; country-specificeducationand income;country-specific socioeconomicquestions; worksituation;geographical location;country-specific regionquestions

Age;gender;ethnicorigin; country-specificeducation andincome;country-specific socioeconomicquestions; worksituation;geographical location;country-specific regionquestions

Age;gender;geographical location;yearsinpractice/ profession;areaofspeciality/ subspecialty

Diabetesprofile Diagnosis;timeofdiagnosis; typeoftreatmentreceivedat diagnosisandcurrently; medication/treatmentstatus (currentdiabetestreatment, typesofpills,modeof insulinadministration, numberofinsulin injections);hypoglycaemia (self-treated,severe, hypoglycaemiaawareness); existingcomorbidities/ complications

Diagnosis;timeofdiagnosis; typeoftreatmentreceivedat diagnosisandcurrently; medication/treatmentstatus (currentdiabetestreatment, typesofpills,modeof insulinadministration, numberofinsulin injections);hypoglycaemia (self-treated,severe,number oftimesreceivedmedical assistance,awareness);type ofdiabetes

Patients(%)withtype1/type 2diabetes;medication/ treatmentstatus(current diabetestreatment,typesof pills,modeofinsulin administration,numberof insulininjections)

HealthandQoL QoL(WHOQOL-BREF);health status(EQ-5Dmobility, self-care,usualactivities,pain/ discomfort,anxiety depression,VASScale); emotionalwell-being/mental health(WHO-5);BMI;weight

QoL(self–WHOQOL-BREF); emotionalwell-being/mental health(self–WHO-5);weight

Patients(%)withclinical depression

Diabetesimpact andburden

Diabetesdistress(PAID); overallimpact;impacton physicalhealth;personal relationships;financial impact;productivity/work/ leisureactivities;impacton emotionalwell-being; depressionrelatedto diabetes;dietaryrestrictions

Diabetesdistress(PAID FamilyVersions);overall impact;physicalhealth; impactonpersonal relationships;financial impact;productivity/work/ leisureactivities;impacton emotionalwell-being; depressionrelatedto diabetes;dietaryrestrictions; burdenofcaring

Needforimprovementin dealingwithemotions arounddiabetes;societal burdenofdiabetes

Diabetescontrol Perceivedcontrol; improvementsneededin HbA1c;bloodpressure;lipid profile/cholesterol;weight

Perceivedcontrol; improvementsneededin HbA1c;weight

HbA1clevels;improvements neededinweight

Diabetesmanagement Self-management

behaviours(SDSCAincluding diet,exercise,bloodsugar testing,feetchecking,taking medication,smoking); improvementsneeded

Self-management behaviours(improvements neededindiet,exercise, bloodsugartesting/control, takingmedication,dealing withemotionsaround diabetes,weight)

Self-management behaviours(improvements neededin:diet,exercise, bloodsugartesting,taking medication,dealingwith emotionsarounddiabetes, weight,takingresponsibility) Familyandsocial

support

Non-HCPsupportbehaviours (modifiedDFBC);non-HCP involvement;reasonsfor non-involvement;living situation;familyconflict; overallsocialsupport

Non-HCPsupportbehaviours (modifiedDFBC);non-HCP involvement;reasonsfor non-involvement;living situation;familyconflict; splitofresponsibilities; overallsocialsupport; assistancewith hypoglycaemia

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Table2 (Continued)

Topic Subtopic

PWD FM HCP

Healthcaresupport Person-CentredChronic IllnessCare:(modified PACIC/HCC:askingabout QoLandmedication problems,patientactivation, listening,goal-setting, problem-solving,giving confidence,planning on-goingfamily/community support,group

interventions,pro-active follow-up,careorganisation) Accesstomedicalcare/ medicalsupplies; accessibility;HCP assessments(HbA1c,blood pressure,lipidprofile/ cholesterol,weight,feet, anxiety/depression,diet, exercise);earlydiagnosis

Accessingmedicalcare; discussion/improvementof preventionactivities;early diagnosis

Person-CentredChronic IllnessCare(HCPPACIC items/HCCversion:asking aboutQoLandmedication problems,patientactivation, listening,goal-setting, problem-solving,giving confidence,planning on-goingfamilyandcommunity support,group

interventions,pro-active follow-up,overallcare organisation);teamcare Accesstomedicalcare/ medicalsupplies; accessibility;HCP assessments(HbA1c,blood pressure,lipidprofile/ cholesterol,weight,feet, depression,eyes) Practice/provisionaround: screening/earlydetection, diabetesprevention,HbA1c labtests,emotionaldistress, structurededucation Clinicresourcesfor:Carefor vulnerablegroups,individual counselling,IT-systemsfor qualitymonitoring/ improvementand coordinatedcare, involvementofpatientsto improvelocalcare; healthcareremuneration system

Roleofdietitians/educators Educationandinformation Educationattendedand

helpfulness;education, informationandsupport reliedon,desired; understandingof medications

Educationattendedand helpfulness;education, informationandsupport reliedon,desired

Educationattended, resourcesandreferral optionsforHCPs;desired futuretraining;roleof educatorsanddietitians; informationandsupport methods

Workplace,community andwiderenvironment

Community/societal improvements(acceptance healthyeating,exercising, workplaces,earlydiagnosis andtreatment) Discrimination;community support/activities;virtual support Community/societal improvements(acceptance healthyeating,exercising, workplaces,earlydiagnosis andtreatment,public awareness,prevention,good medicalcare)

Discrimination;community support/activities;virtual support;tolerance;diabetes inthemedia

Community/societal improvements(acceptance healthyeating,exercising, workplaces,earlydiagnosis andtreatment,public awareness,prevention) Discrimination;Community support,collaboration, preventionprogrammes; virtualsupport; reimbursement Attitudesandbeliefs Illnessandtreatmentbeliefs

andattitudes,activationand empowerment;intentionsto improveself-management; medicationbeliefs;insulin beliefs;willingnesstostart medication;fearof hypoglycaemia;dietand exercisebeliefs

Illnessandtreatmentbeliefs andattitudes,activationand empowerment,intentionsto improveself-management; fearofhypoglycaemia; confidenceindealingwith hypoglycaemia;inspiration fromPWD;understandingof diabetes

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All surveyswere reviewed andapproved inthe original English version by leading experts from all participating countries. Thethree surveyquestionnaires inEnglishwere testedfurtherwith16participants(7PWD,3FMsand6HCPs) fromIndia,Canada,USA,andtheUK,toassesswhetherthe questionnairecontentwasunambiguousandunderstandable andtoensurefacevalidityandacceptability.Questionnaires weresubjectedtoadditionalwrittenreviewsbypeoplewith type1andtype2diabetespriortofinalisation.

Questionnairesforthethreesurveysweretranslatedinto theprimarylanguage(s) ofeachparticipatingcountrybyat leasttwoindependentlocalprofessionaltranslatorswhowere nativespeakersintherelevantlocallanguage.These transla-tions were reviewed by national diabetes experts in each countrytoconfirmtheaccuracy andcross-cultural equiva-lenceofthetranslations.Asubsetofselected psychometri-cally validated scales and items intended for scientific benchmarkingwithinandacrosscountrieswereback trans-lated into English by a third independent professional translator and a review and harmonisation process was undertaken.Thisinvolvedtheapprovalbyacademicexperts andoriginatorsoftheoriginalscientificscales,aswellasPWD, where feasible. This process also involved multi-national harmonisation of previously published local language ver-sions of scientific instruments, including the PAID-5, the WHO-5,theWHOQOL-BrefandtheSDSCA.

2.7. Researchquestions

TheDAWN2surveys weredesigned toprovide data-driven guidancerelevantforallstakeholdersindiabetesandchronic illness management regarding how diabetes care may be optimisedlocally,nationallyorinternationallyatthemicro, mesoormacrolevelwithinaholisticperson-centredchronic careframework.Keyresearchquestionsinclude:

1. Howdothe participatingcountriescompare interms of healthcareprocessesandoutcomesbasedonthemeasures

that are proposed as suitable for benchmarking (e.g., establishedvalidityandreliabilityofsourcemeasures)? 2. What are the determinants of QoL and psychosocial

adaptationofPWD?

3. Whatarethedeterminantsofself-managementbehaviour byPWD?

4. What are the determinants of HCP delivery of person-centred diabetescare/support (especially those forms of care/support that arefound to have a majorimpact on patientoutcomes)?

5. WhatarethedeterminantsofburdenforFMsandfamily supportforPWD,especiallythoseformsofsupportthatare foundtohaveamajorimpactonpatientoutcomes? 6. Whatisthecurrentlevelofaccesstodiabeteseducation,

howisitprovided,andwhatarethebenefitstoPWD?What aretherolesofnurses,dietitiansandotherHCPproviders? 7. What are the determinants of medication initiation,

adherence,persistenceandintensification?

8. WhatchangeshaveoccurredintheperiodbetweenDAWN andDAWN2?

9. Whatarethekeyeventsthathavecreatedturning-pointsin howpeoplelivewithandmanagediabetes?What individ-ualandsocietalchangesdosurveyrespondentswant?

Numerousadditionaltopics willbeaddressed,but afull listingofquestionsisbeyondthescopeofthispaper. 2.8. Supplementaryresearch

Inparallelwiththethreemainsurveys,aseparatesituational assessment isbeingperformedineachcountry,comprising literature research on national guidelines, policies and activitiesrelatedtoperson-centreddiabetescare, supplemen-ted byinterviews with arange ofdifferent national stake-holders.Thesearedesignedtoprovideanassessmentofthe existingdiabetesandchroniccaredeliverysystemsineach country,againstwhichtheperceptionsofsurveyrespondents can be compared. Representatives of patient associations,

Table2 (Continued)

Topic Subtopic

PWD FM HCP

Wishesandfuture needs

Desiredfuturefamilyand socialsupport;improvement areasincountry/region; improvementsin self-management

Desiredfuturefamilyand socialsupport;improvement areasincountry/region

Desiredfuturefamilyand socialsupport;desired improvementsof medications;improvement areasincountry/region; improvementsneededin medicalcareand psychosocialsupport Personalexperiences Open-endedquestions

(impactfulstoryabouthow tomanagediabetes, challenges,successes, wishes)

Open-endedquestions (impactfulstoryaboutliving withsomeonewithdiabetes/ involvementindiabetescare ofPWD,challenges, successes,wishes)

Open-endedquestions (challenges,successes, wishes)

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policy-makersand thoughtleadersineachcountryarekey contributorstothisstudycomponent.Thesituational assess-mentallowseachcountrytobenchmarkitselfrelativetoother countriesinrelationtohealthpolicies,guidelines,healthcare infrastructures,nationalprogrammes,andcommunity struc-turesrelatedtoperson-centred chronic illnesscare,and to identify concrete opportunities for national improvement fromtheDAWN2surveyresults.

2.9. Analysis

SurveydataareprovidedtothePrincipalInvestigatorsofeach country’s national advisory or survey group as descriptive statisticsforallvariablesforeachparticipantgroup.Topermit generalisationfromthesampletolargerpopulations, individ-ual weights are provided. These weights are based on populationproportionsforeachcountry,asprovidedbyeach country’s survey advisorygroup, and on publicly available epidemiologicaldata.

Furthermore, the subset of FMs who live in the same householdasindividualswhocompletethePWDquestionnaire arelinkedtooneanotherforanalysis.Thisenablescomparison oftheperceptionsofprovisionofpracticalandemotionalcare andsupportfrombothmembersofthedyadandassessmentof theassociationbetweenthebehaviourofsupportgiversandthe impactonsupportrecipients.Fornon-linkedsamples, concor-dancebetweenrespondentscanbeassessedstatisticallyfor itemsthatareidentical,butotheritemscanonlybecompared numerically(e.g.,thepercentageofPWDwhoreportengagingin a behaviour and the percentage of PWD that physicians estimatetoengageinthatbehaviour).

Publicationswillusetheappropriatestatisticaltestsfora particular hypothesis and type of data. These include nonparametric bivariate statistics (e.g., chi-squared test, Kendall correlation coefficient, Mann–Whitney test, Krus-kal–Wallistest),parametricbivariatestatistics(e.g.,analysisof variance, Pearson correlation) and multivariate tests (e.g., logisticregression,ordinaryleastsquaresregression,analysis ofcovariance).

Inaddition, psychometricvalidationofmulti-item mea-sures in eachcountrywill beperformed to confirm cross-culturalvalidityandsuitabilityforclinicalandbenchmarking purposes.

3.

Discussion

The‘DAWNCalltoAction’[5]identifiedstrategicareasforthe improvementofdiabetescarebyfocusingonthepsychosocial issues attached to living with diabetes [2,5]. Strategies for nationalactiontoimproveaccesstoperson-centreddiabetes care,asguidedbythefirstDAWNstudy,included:(1)raising awarenessofthePWDperspective,(2)empowermentofPWD throughinformationandeducation,(3)trainingofHCPs,(4) developmentofinnovativetoolstodeliverPWDsupport,(5) improvementofguidelines/policiesforperson-centredcare, and(6)translationalresearchintodeliveryofperson-centred diabetescare.

Evidencesuggeststhatsubstantialprogresshasbeenmade within these areas, but there is a need for continued

implementation of these strategies, including training of HCPsinperson-centredchronicillnesscare[25,26],newtools and interventionstrategies forimproving the psychosocial careofPWD[2,27],revisionofguidelinestoincludesectionson the self-management and psychosocialaspects ofdiabetes care[28–39],andresearchonpsychosocialandperson-centred diabetescare[40].

DAWN2buildsuponadecadeofmulti-nationally coordi-nated actions and efforts to improve person-centred care. FollowingDAWN,otherdiabetessurveyshavebeeninitiated toexplorepsychosocialissuesindiabetes,butpredominantly in relation to medical therapy and not addressing FM, community,orpatientorganisationperspectives.

The scope of DAWN2 is broad and should further our understandingofissuesindiabetesandperson-centredcare, overandabovethatprovidedbyotherdiabetessurveys.By surveying the attitudes, wishes and needs of over 16,000 peoplefromthethreestakeholdergroupsinvolvedin day-to-daylivingwithandmanagementofdiabetes,DAWN2aimsto provideaunique,comprehensive,systematicperspectiveon the facilitators and barriers to achieving optimal person-centreddiabetescare.

Thedesign ofthe DAWN2questionnairesshouldenable identificationofdiscrepanciesbetweenthe‘feltneeds’ofPWD andtheir‘perceivedneeds’byFMsandHCPs.Comparisonsof the resultsacross countries,within thecontextofdiffering nationalguidelines, policiesandcaredeliverymodels,may identifyoptimalandsub-optimalnationalandlocalmodelsof care,educationandcommunitysupport.Throughthe cross-cultural validation of the multiple scientific measurement instruments incorporated into the DAWN2 survey, each country can incorporate mini-DAWN2 surveys into clinic, local,andregionalqualityimprovementprogrammes,toallow forwithin-countrybenchmarking.

ComparisonofDAWN2datawiththosefromDAWNallows for the determination of temporal trends in the profile of diabetes care and, possibly, whether differences between thesedataincountriesthatparticipatedinbothstudiesreflect a growingrecognition and acceptance of the psychosocial aspectsofdiabetescareinthepast10years.

3.1. Studylimitations

ManychallengesareassociatedwithconductingDAWN2,the largestmulti-nationalstudyofitskindindiabetes,including how to represent the population within each country accurately.SinceDAWN2aimstostudyvariationsinaccess toandconsequencesofdiabetescare,communitysupportand educationwithinandbetweencountries,samplesneededto be geographically and socio-demographically dispersed in eachcountry.Therefore,recruitingthroughalimitednumber of centresor clinics,as oftendone indiabetes surveysfor practical reasons,would notbe appropriate forDAWN2as resultswouldbebiasedtowardswell-resourcedclinics.

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proportionsshouldhelpminimisesuchbiases.However,in somecountries,telephonepenetrationispoor.Whiletheuse offace-to-facerecruitmentandinterviewingintheDAWN2 studyhelpsovercomethisbarriertorepresentativeness,the expenseassociatedwithoutreachtoruralareasincountries withbroadgeographicdispersionmakessamplingofallareas of the country infeasible. In addition, some countries and regionsarenotrepresented,e.g.,Indonesia,Thailand,theArab countries, sub-Saharan Africa and South America. Thus, resultscannotbegeneralisedtotheentireglobalpopulation ofthethreekeydiabetesstakeholdergroups.

4.

Conclusions

TheoriginalDAWNstudyidentifiedamajorgapbetweenthe psychosocialandeducationalsupportneedsofPWD,andthe careandsupport availableindevelopedandlessdeveloped countries.However,despitedevelopmentsinthefieldof self-managementeducationandpsychosocialcareduringthepast decade,toomanyPWDreceiveinadequatecareandsupportto enable them to achieve optimal health and well-being. In response, DAWN2 seeks to identify possible areas for improvementanddeterminethedriversofchangetoachieve optimal person-centred diabetes care. DAWN2 has been designedtofacilitateeasytranslationofthestudyfindings, including involvement of a broad foundation of multiple nationalandinternationaldiabetesstakeholders.

AsthefirstmajorsurveyoftheopinionsofFMsofPWD, DAWN2aimstoachieveabroader humanisticand societal perspectiveontheneedsofPWDandthosecaringforthem. Responding to the IDF declaration on patients’ rights and responsibilities,andincludingallareasoflifewithdiabetes,it ishopedthatDAWN2willpromoteimprovementsin condi-tionsforPWD.Ultimately,DAWN2aspirestoprovideavoice forPWDandthosecaringforthem,whichreflectstheirunmet needs.

TheDAWN2study shouldenable newopportunities for improving diabetes self-management and QoL, and for ascertainingthecriticaldriversofactivemanagementaswell as improvement in person-centred diabetes care. These findingsmayfacilitateinnovativeeffortsbyallstakeholders to improve self-management and psychosocial support in diabetes.

Conflict

of

interest

Melanie Davies has acted as consultant, advisory board member and speaker for Novartis, Novo Nordisk, Sanofi-Aventis,Lilly,MerckSharpandDohme,andRoche,andasa speaker forServier. She hasreceived grants in support of investigator and investigator-initiated trials from Novartis, NovoNordisk,Sanofi-Aventis,Lilly,Pfizer,MerckSharpand Dohme,GlaxoSmithKlineandServier.

RichardHolthasreceivedfundingfortraveland accom-modationtoattend DAWN2InternationalPublication Plan-ningCommitteemeetings,buthasnotreceivedanyfeeforthis workfromNovoNordisk.Hehasactedasanadvisoryboard memberandspeakerforNovoNordisk,andasaspeakerfor

Sanofi-Aventis,EliLilly,OtsukaandBristolMyersSquibb.He hasreceivedgrantsinsupportofinvestigatortrialsfromNovo Nordisk.

Norbert Hermanns is a member of the International DAWN2AdvisoryBoard. Hehasreceivedresearchgrantsin thelastyearfromRoche,BerlinChemie,EliLillyandSanofi Aventis. He also received speaking honoraria from Novo, Germany, Lilly,BerlinChemie, Lifescan,SanofiAventisand MenariniDiagnostics.

AntonioNicoluccihasreceivedresearchgrantsinthelast yearfromNovoNordisk,EliLilly,SanofiAventis,MerckSharp andDohme,BristolMyersSquibb-AstraZenecaandBayer.

MarkPeyrothasrecentlyreceivedresearchgrantsand/or consulting fees from Amylin, Genentech, Lilly, MannKind, Medtronic, and Novo Nordisk. He has received speaking honorariafromNovoNordiskandhasparticipatedinadvisory panelsforNovoNordiskandRoche.Hehasreceivedfinancial supportfromNovoNordiskforhisparticipationasPrincipal InvestigatorfortheDAWN2study.

JohanWenshasactedasanadvisoryboardmemberfor Eli-Lilly,BristolMyersSquibb-AstraZenecaandNovoNordisk.

Søren Skovlund is an employee of Novo Nordisk A/S, Copenhagen,Denmark.

AngusForbes,IngridWillaing,SanjayKalraandKatharina KovacsBurnshavenoconflictsofinteresttodisclose.

Acknowledgements

The DAWN2 Study Group consists of a national lead investigatorfromeachcountryandmembersofthe interna-tionalDAWN2publicationplanningcommittee:RachidMalek, Algeria; Johan Wens, Belgium; Joa˜o Eduardo Salles, Brazil; KatharinaKovacsBurnsandMichaelVallis,Canada;Xiaohui Guo,China;IngridWillaing,Denmark;Ge´rardReach,France; Norbert Hermanns and Bernhard Kulzer, Germany; Sanjay Kalra, India; Antonio Nicolucci and Marco Comaschi, Italy; HitoshiIshii,Japan;MiguelEscalante,Mexico;FransPouwer, The Netherlands; Andrzej Kokoszka, Poland; Alexandre Mayorov, Russia; EdelmiroMenendez, Spain; Ilhan Tarkun, Turkey;MelanieDavies,RichardHolt,AngusForbes,andNeil Munro, United Kingdom; Mark Peyrot, United States of America.

Inadditiontotheauthorsofthismanuscript,theauthors wish toacknowledgesignificantcontributionstothis paper fromChristineMullan-Jensen.Furthermore,theauthorswish tothankMassimoBenedettiforhisreviewofthemanuscript andtoacknowledgethecontributionofWimWientiensofthe International DiabetesFederation,and thenumerous other internationalandnationalexpertsandpatientadvocateswho havecontributeddirectlytothedesignoftheDAWN2study during2010–2012.ThecompletelistofstudyexpertandPWD advisersisavailableatwww.dawnstudy.com.

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StirlingLtd.for providingassistancewith obtainingethical approvalsinseveralcountries.HarrisInteractiveconducted thesurveys, and providedexpertiseindesigning the ques-tionnaires and planning survey implementation, including samplingframesandstrategies,questionnaireadministration strategies,weightingcriteria,etc.

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