Exploring the applicability of the pregnancy and childbirth outcome set: A mixed methods study

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Exploring

the

applicability

of

the

pregnancy

and

childbirth

outcome

set:

A

mixed

methods

study

Lyzette

T. Laureij

a,

*,

Jasper

V. Been

a,b,c

,

Marjolein

Lugtenberg

c

,

Hiske

E. Ernst-Smelt

a

,

Arie

Franx

a

,

Jan.

A. Hazelzet

c

,

on

behalf

of

the

PCB

outcome

set

study

group

Collaborative

authors

a

DepartmentofObstetricsandGynecology,ErasmusMC–SophiaChildren’sHospital,UniversityMedicalCenterRotterdam,theNetherlands

b

DepartmentofPediatrics,DivisionofNeonatology,ErasmusMC–SophiaChildren’sHospital,UniversityMedicalCenterRotterdam,theNetherlands

c_Department_of_Public_Health,_Erasmus_MC,_University_Medical_Center_Rotterdam,_Rotterdam,_the_Netherlands

ARTICLE INFO Articlehistory: Received9July2019

Receivedinrevisedform20September2019 Accepted23September2019 Keywords: Value-basedhealthcare Obstetrics Perinatalcare Patient-reportedoutcomes Shareddecisionmaking Qualitativeresearch Quantitativeresearch Mixedmethods

ABSTRACT

Objective:TheInternationalConsortiumforHealthOutcomesMeasurementdevelopedthePregnancy andChildbirth(PCB)outcomesettoimprovevalue-basedperinatalcare.Thissetcontains clinician-reportedoutcomesandpatient-reportedoutcomes.WevalidatedthesetforuseintheNetherlandsby exploringitsapplicabilityamongallend-userspriortoimplementation.

Methods:Amixed-methodsdesignwasapplied.Asurveywasperformedtoassesspatients(n= 142), professionals(n=134)andadministrators(n=35)viewsonthePCBset.Tofurtherexploreapplicability, separatefocusgroupswereheldwithrepresentativesofeachofthesegroups.

Results: The majorityof surveyparticipants agreedthat thePCB setcontains themost important outcomes. Patient-reported experience measures were considered relevant by the majority of participants. Perceivedrelevance ofpatient-reported outcomemeasures varied.Mainthemes from the focus groups were content of the set, data collection timing, implementation (also IT and transparency),andquality-basedgovernance.

Conclusion:ThisstudysupportssuitabilityofthePCBoutcomesetforimplementation,evaluationof qualityofcareandshareddecisionmakinginperinatalcare.

PracticeImplications:ImplementationofthePCBsetmaychangeexistingcarepathwaysofperinatalcare. Focusontransparencyofoutcomesisrequiredinordertoachievequality-basedgovernancewithproper ITsolutions.

1.Introduction

Traditionally in healthcare, professionals document clinical findingsandhealthoutcomes,whichmaybeincludedinquality registries. These registriescommonly containcondition-specific processindicatorsandoutcomesthatprimarilyfocusonmorbidity andmortality.Analysesofdatafromtheseregistriesmayprovide insightintoforexampleetiology,treatmenteffectsandtemporal trends in healthcare. Supplemented with process indicators, e.g.thetime betweena patient’sfirstappointment andstart of treatment, registriesmayprovidefeedback ontheperformance and quality of the delivered care. However, when focusing on recording of traditional outcomes alone, other outcomes that mattertopatients’health-relatedqualityoflifeareundervaluedin theevaluationandimprovementofqualityofcare.Fromapatient perspectivenotonlytheoccurrenceofadiseaseisimportantbut alsotheimpactofthediseaseanditstreatmentonthepatient’s

Pieter-KeesdeGrootd ,OdileFrauenfelderd ,DaciaHenriqueze ,MarijeLamain-de Ruiterf , Elise Neppelenbroekg

, Sebastiaan W.A. Nij Bijvankh

, Timme Schaapf

, Murielle Schagend

, Marieke Veenhof, Jolanda H. Vermoleni

; d

Department of Obstetrics,SpaarneGasthuis,Haarlem,theNetherlands,j_Department_of_Pediatrics,

DivisionofNeonatology,ErasmusMC –SophiaChildren’sHospital,University MedicalCenterRotterdam,theNetherlands. e

DepartmentofObstetrics,Leiden UniversityMedicalCenter,Leiden,theNetherlands.f

DepartmentofObstetricsand Gynecology, University Medical Center Utrecht, Utrecht, the Netherlands.

g

MidwiferypracticeVerloskundigenBakerraad,Zwolle,theNetherlands.h

Depart-ment of Obstetrics, Isala Clinics, Zwolle, the Netherlands. i

Maternity care organizationDeWaarden,Schoonhoven,theNetherlands.

* Correspondingauthorat:DepartmentofObstetricsandGynecology,Erasmus MC–SophiaChildren’sHospital,UniversityMedicalCenterRotterdam,roomEe 2130,Wytemaweg80,3015CNRotterdam,theNetherlands.

E-mailaddress:l.laureij@erasmusmc.nl(L.T. Laureij). https://doi.org/10.1016/j.pec.2019.09.022

ContentslistsavailableatScienceDirect

Patient

Education

and

Counseling

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abilitytoparticipateinnormaldailyactivities.Suchoutcomesare best reported by patients themselves rather than by health professionals,henceforthreferredtoas‘professionals’[1–5].

Patient-reported outcomes (PROs) may be deﬁned as any informationstemmingdirectlyfrompatientsrelatedtotheimpact oftheirconditionoritstreatmentontheirhealth,functioningand symptoms[3,6].PROscanbeusedatanindividualpatientlevelto providepatientand professionals information abouta patient’s current health status or treatment response and any relevant temporalchangesthereof.WhenPROsareusedcomplementaryto professional-reporteddataonan aggregatelevel, theycanalso provideusefulinformationonperformanceandqualityofcare,at theleveloftheprofessional,institutionoroverarchinghealthcare systemandbeusedforimprovementactivities[4,5].

Healthcare outcomes, including PROs and professional-reportedoutcomes,needtobebalancedagainstthecostsneeded toachievethoseoutcomesinordertocreatevalueforpatients,a principle known as value-based healthcare (VBHC) [7]. The International Consortium for Health Outcome Measurement (ICHOM)developsoutcome setsforspeciﬁc(groupsof)medical conditionsaimedatstandardizingqualityassessmentaccordingto the VBHC principle [8]. These outcome sets contain both professional- and patient-reported outcomes as well as initial patientconditionswhicharedesignedtocoverthefullcycleofcare per condition, i.e. including short- and long-term outcomes, insteadofoutcomesperspecialtyorcareepisode.Thisallowsall professionalstojointlybeaccountablefortheoutcomesandthe perceivedvalueforthepatient[7–9].

Upuntil2019,ICHOMhasdeveloped26outcomesetswhich togethercover54%oftheglobaldiseaseburden[10–13].Countries maydifferincultureandhealthservicesystems.Forthisreason, implementationofthese outcomesets requirestailoring tothe localsituation,involvingrelevantstakeholdersincludingpatients, professionalsandadministrators.UsingsuchanapproachICHOM outcome sets have been implemented into routine practice in varioussettings[14–16].

ICHOM developed the Pregnancy and Childbirth (PCB) outcomesetin2016(seeTable1).Useof thisPCBoutcomeset may help standardize assessment of important outcomes in perinatal care and accordingly optimize targeting of quality

improvements of the care process [17]. The PCB outcome set containstwovariantsofPROs,namelypatient-reportedoutcome measures (PROMs) and patient-reported experience measures (PREMs).PREMscanprovideinsightinpatientexperienceduring thecare,forexampleintheﬁeldofcommunication[17,18],andas suchthePCBoutcomesetcanbeusedtosupportshareddecision making(SDM).

Perinatalcareisaparticularlychallengingﬁeldfor implemen-tation of outcomesetsbecausea widevariety ofprofessionals isinvolved,outcomesarerelevantforatleasttwopatient-levels (i.e.themotherand herbaby/babies) andsubstantialcostsare involvedatthepopulationlevelinthecarearoundmotherand herbaby.Weareunawareofanystudieshavingformallyassessed therequirementsfor implementationandlocal tailoringof the PCBoutcomeset.WeaimedtoexploretheapplicabilityofthePCB outcomesetin theNetherlands,a midwife-ledand multidisci-plinary perinatal care system (see Box 1), involving key stakeholders(i.e.patients,professionals,administrators)inorder togeneratetransferrablelessonsforimplementationbothlocally andelsewhere.

2.Methods 2.1.Theproject

Perinatal care is network care with multiple patients, professionals and administrators involved.As such, we focused onassessingtheapplicability ofthePCB outcomesetfor these three user groups. Our study was conducted in ﬁve obstetric collaborativenetworks(OCNs)intheNetherlandsfromFebruary 2017untilMay2018(seeBox1fordetaileddescriptionofDutch perinatal care system). The study group, consisting of professionals, researchers and policy makers of the ﬁve OCNs, led a survey to assess patient, professional, and administrator views onthecontentof thePCB outcomeset. Wefurthermore explored theapplicabilityof thePCB outcome setduringfocus groups. Questionnairesweretranslatedand we exploredwhich existingroutineprofessional-reporteddatamaybeusedasinput for the PCB outcome set, to minimize registration burden for professionals.

Table1

ContentoftheoutcomesinthePregnancyandChildbirthoutcomeset[17].

Category Item Description

Survival Maternalmortality Deathofawomanduringpregnancy,childbirthorintheﬁrst42dayspostpartum Stillbirthandneonataldeath Pregnancylossafter28weeksofgestation,deathofalivebornneonateupto28daysafter

childbirth

Morbidity Severematernalmorbidity CombinationofICUadmission,lengthofhospitalstay,postpartumhemorrhage,readmissionand bloodtransfusionofawoman

Neonatalmorbidity Combinationoflengthofhospitalstay,oxygendependenceandbirthinjuryofaneonate Pre-termbirth Livebirthbefore37+0weeksofgestation,distinctionbetweenspontaneousandiatrogenic

pre-termbirth Patient-reportedoutcome

measures

Healthrelatedqualityoflife Perceivedqualityoflife,trackedviaPROMISGlobal

Postpartumdepression Depressionduringpregnancyorpostpartum,screeningviaPHQ-2,optionalfurtherassessment viaEPDS

Maternalconﬁdenceandsuccesswith breastfeeding

Breastfeeding,combinationofdurationofbreastfeedingandconﬁdencewithbreastfeeding trackedwiththeBSES-SF

Pelvicpainanddysfunction Combinationofincontinence(bothfecalandurine)andpainwithintercourse,trackedviaICIQ-SF and/orWexnerandPROMISSFFAC102

Mother-infantattachment Feelingsofawomanforherchildinthefirstfewweeks,trackedviatheMIBS Confidenceinroleasamother Confidenceofawomanregardinglookingafterherbaby

Patient-reported experiencemeasures

Satisfactionwiththeresultsofcare Degreeofsatisfactionofawomanwithresultsofreceivedcare Shareddecisionmakingandconﬁdence

incareproviders

Conﬁdenceofawomanasanactiveparticipantindecisionsandperceivedconﬁdencein healthcareprofessionals

Birthexperience Assessmentofawoman'sbirthexperience,trackedviaBSS_R

Note:ICU:intensivecareunitPROMIS:PatientReportedOutcomesMeasurementSystemPHQ-2:PatientHealthQuestionnaire-2EPDS:EdinburghPostnatalDepressionScale BSES-SF:BreastfeedingSelf-EfﬁcacyScale-ShortFormICIQ-SF:InternationalConsultationonIncontinenceQuestionnaire-ShortFormPROMISSFFAC102:PatientReported OutcomesMeasurementInformationSystemSexualFunctionandSatisfactionMIBS:Mother-InfantBondingScaleBSS_R:BirthSatisfactionScale-Revised.

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2.2.Survey

2.2.1.Thequestionnaire

Our survey was based on the ICHOM consumer validation survey [17], which was originally conducted with respondents mainlyfromtheUSandAustralia(93.3%),and5.7%fromEurope (nonefromtheNetherlands).Thissurveyaimedtoevaluatethe perceivedrelevance of theprofessional-reported outcomes and PROs(onaninepointscale),andtheperceivedcomprehensiveness ofthePCBoutcomeset(dichotomousquestion).Respondentswho didnot agreeonthecomprehensivenesswereaskedtosuggest outcomeswhichtheyfeltweremissing.Wetranslatedthesurvey intoDutchandansweroptionswerereducedtoathree-pointscale (important,neutralandnotimportant).

ThePCBoutcomesetsuggestscollectingdataatﬁvetimepoints duringpregnancy and thesubsequent months (see Fig.1).Our surveyassessedtheacceptabilityofthedatacollectiontimingvia anextraquestion.

Becausetheitem‘birthexperience’wasaddedtotheoriginal PCBoutcomesetaftertheirvalidationsurvey,wedidnotassess thisiteminoursurvey.

The survey was made available online via LimeSurvey, an opensourcesurveytool[21].Weblinkstothesurveyweresentby e-mail.

2.2.2.Participants

Thesurveywasconductedamongpatients,andamonghealth careadministratorsandprofessionalswithslightmodiﬁcations.

ParticipantswererecruitedduringOctober2017untilJanuary 2018intheﬁveOCNs.Detailsofhowthesurveywasconductedare suppliedinthesupplement(SupplementaryﬁleA).

2.2.3.Analyses

Quantitative data were analyzed using descriptive statistics, withSPSSversion24.0(IBMCorp.,Armonk,N.Y.,USA).Freetext answerswerethemed.

Box1.PerinatalcareintheNetherlands,acollaborativesystem. Policystructure

Perinatalcareisorganizedthroughlocalobstetriccollaborativenetworks(OCNs).AnOCNconsistsofseveralmidwiferypractices andmaternitycareorganizationsattheprimarycarelevelandofatleastonehospital(generalortertiary).AnOCNdevelopslocal protocolsandworkingarrangementsforoptimalperinatalcare.BenchmarkingonoutcomesispossibleatOCNlevel.

Patient-care

TheorganizationanddeliveryofperinatalcareintheNetherlandsisbasedonriskstrati_ﬁcationandaccordingly,allocationof pregnantwomentothreestrataofcare(primary,secondaryandtertiary).

Primarycareisdeliveredbycommunitymidwives.Foreachpregnantwoman,thecommunitymidwifedetermineswhetherthe womancanreceivecarefromthemidwifeorwhethersheshouldbereferredtothegynecologistusingthenationallyimplemented ‘List of Obstetric Indications’ [19]. When medical and obstetric history and pregnancy, childbirth and puerperium are uncomplicated,thewomanmayremainundersupervisionofthecommunitymidwifeandmaydeliverandreceivematernitycare athomeorataprimarycarebirthcenter[20].Amaternitycareassistantusuallyassiststhenewfamilyathomeforuptoeightdays, undersupervisionofthecommunitymidwife.

Secondarycareisprovidedbygeneralhospitals.Ifthepregnancy,childbirthorpuerperiumisconsideredasmedium-risk,the womanisreferredtothegynecologistinageneralhospital(secondarycare).Childbirththentakesplaceatthehospital,supervised byaclinicalmidwifeorgynecologist.Ifthepostpartumperiodisuncomplicated,motherandbabymaythengoontoreceive maternitycareathome.

TertiarycareisdeliveredbyoneoftenDutchtertiaryperinatalcenters,whichhandlespeciﬁcproblemsduringpregnancyor childbirthwhichmaynotbehandledinageneralhospital,e.g.impendingpretermdeliverypriorto32weeksgestation[20]. Aftertheﬁrsteightdaysofthepostpartumperiod,careforthenewbornistransferredtothepreventivechildhealthcare(PCHC) service.PCHCmonitorsdevelopmentofthechildonregularbasisuntiltheageof18years.Thewomanusuallyremainsunder supervisionofthemidwifeorgynecologistuntilsixweekspostpartum.

Fig.1.DatacollectiontimepointsandperinatalprofessionalsintheNetherlands.

Thebluedotsindicatethedatacollectiontimepointsduringpregnancyandpostpartum.(Forinterpretationofthereferencestocolourinthisﬁgurelegend,thereaderis referredtothewebversionofthisarticle.)

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According to ICHOM ’sapproachintheirinitialsurvey,professional-reportedoutcomesandPROswereconsideredrelevantifatleast70% of the participants scored them as ‘important’. We additionally assessedrespondents’opinionson comprehensivenessofthe PCB outcomeset andtiming ofdata collection, which we considered appropriateif75%ofparticipantsagreed.Ifthesethresholdswerenot achieved,theconcerningitemswere usedasinputforthefocusgroups anddiscussedintheprojectteamtodeterminewhetheradjustments tothePCBoutcomesetshouldbemade.

2.3.Focusgroups

2.3.1.Aim,designandsetting

To furtherexplore the applicabilityof thePCB outcome set including theﬁndings derived from the survey, separate focus groupswereheldwitheachusergroup:i.e.patients,professionals andadministrators.

2.3.2.Selectionofparticipants

Forthepatientfocusgroups,aclientpanelandnationalpatient representation platform for obstetric patients were invited. Criteria for selecting participants were: (a) currently pregnant ormotherofachild,(b)age eighteenyears,and(c)sufﬁcient commandoftheDutchlanguage.Patientswereofferedatwenty eurogiftvoucherforparticipation.

Administrators and professionals working in perinatal care wereinvitedbyprojectteammembersviae-mailorinperson.

Oneweekpriortothefocusgroupsaninformationﬁleincluding informationonthePCBoutcomesetandthemainresultsofthe surveywassenttoallparticipants.

2.3.3.Datacollection

Thefocusgroups,ledbyanexperiencedfacilitator(JHorLL),were heldbetweenJanuaryandMay2018.Priortothestartofeachfocus group, participants completed a questionnaire on demographic characteristics and the facilitator explained the purpose and structure of the meeting. Conﬁdentiality was reassured and participantswereencouragedtospeakfreely.Predeﬁnedtopiclists basedonresultsofthesurveyanddiscussionsbetweenprojectteam members(seeSupplementarytableB.1)wereusedtostructurethe discussion.Results of thefocus groupswith administrators and professionalsthatalsoappliedtopatientswereusedasadditional inputforthepatientfocusgroup.Allfocusgroupswereaudio-taped. 2.3.4.Dataanalysis

Thefocusgroupsweretranscribedverbatim.Theverbatimwas sent back to participants who had indicated to be willing to performamembercheck.

Thematicinductivecontentanalysiswasapplied[22]usingthe qualitativesoftwareprogramNVivo11(QSRInternationalPtyLtd., 2015).Tworesearchers(LLandHE)independentlycodedthethree transcriptsandcomparedthecodingtoreachconsensus,resulting inacodingschemeforeachfocusgroup.Codeswerecomparedand therelationshipbetweencodeswasexploredtodetectemerging themesforeachgroup.Finally,theresultsofthethreefocusgroups wereintegratedinanoverviewofthemesandsubthemesforall users,yetstilldemonstratingthedifferencesbetweenusergroups. This process was executed by two authors (LL and HE) and supervisedbyathirdauthor(ML).

Reporting followed the Consolidated criteria for reporting qualitativeresearch(COREQ)[23].

2.4.Ethicalapproval

The Medical Ethics CommitteeErasmus MC(MEC-2017-477) declaredthattheruleslaiddownintheMedicalResearchInvolving

HumanSubjectsAct(alsoknownbyitsDutchabbreviationWMO) donotapplytoeitherthesurveyorthefocusgroups.Assuch,the study was exemptfrom formal medical ethicalassessment. All patientsin thesurvey and all participantsin thefocus groups signedwrittenordigitalinformedconsent.

3.Results 3.1.Survey

3.1.1.Studypopulation

142patients(39%ofthoseapproached)completedthesurvey (Fig.2).

Meanageofpatientparticipantswas33yearsandthemajority wereof Western origin(Table 2).Fifty-two patientshad a low socio-economicstatusbeneaththe20th_percentile._The_majority_of

participants were multiparous and had their pregnancy or childbirthsupervisedbyaclinicalmidwifeorgynecologist,with somevariationbetweentimepoints.

Fig.2.Surveyﬂowchartparticipatingpatients.

Table2

Surveybaselinecharacteristicsofparticipants:patients.

Patientsacross alltimepoints (n= 142)N(%)

Age(years) 33IQR30-36

Westernoriginᵃ 113(83) Socio-economicstatusa Low(<20thpercentile) 52(37) Middle(20-80thpercentile) 69(49) High(>80thpercentile) 21(15) Parity Primiparous 61(45) Mulitparous 75(55)

Pregnancyand/orchildbirthsupervisedby

Communitymidwife(primarycare) 58(43)

Clinicalmidwifeorgynecologist(generalortertiary hospital)

78(57) Complicationsinindexpregnancyduringb

Pregnancy 33(24)

Childbirth 26(34)

Puerperium 7(15)

a

Socio-economicstatusisbasedonazipcodeproxybytheNetherlandsInstitute forSocialResearch(SCP,www.scp.nl)overtheyear2016.

b

Complicationscouldoccurduringpregnancy,childbirthand/orpuerperium, multipleanswerswerepossible.

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A minority of participants had experienced a complication duringpregnancy,childbirthorpuerperium.

134professionalsand35administratorscompletedthesurvey. All relevant groups of professionals and administrators were represented(Table3).

3.1.2.Participants’opinionsonTimingoftheﬁvetimepoints Thevastmajorityofpatientsandprofessionals,andtwo-thirds oftheadministratorsfeltthattimingofthedatacollectionwas appropriate(Table4).

3.1.3.Perceivedrelevanceoftheprofessional-reportedoutcomesand PROs

Overall, the professional-reported outcomes in the PCB outcomesetwereconsideredrelevantbytheparticipants(Table5). WithregardtothePROs(Table6),thetwoPREMs(satisfactionwith care,andhealthcareresponsiveness)werejudgedasrelevantby thevastmajorityofallparticipants.RegardingthePROMsabout breastfeeding (conﬁdence and success), three-quarters of the professionals and administrators perceived these outcomes as relevant. Just over half of the patientsconsidered these items relevant,althoughofthemajorityofpatientsattimepoint four (i.e.thepostpartumperiod)felttheseoutcomeswereimportant (datanotshown).Painwithsexwasconsideredimportantbythe majority of the administrators and professionals, while this

outcome was considered important by less than half of the patients.Thevastmajorityoftheadministratorsandprofessionals indicatedincontinence (bothurinaryand fecal)asanimportant outcome,whereasonlytwo-thirdsofthepatientsdid.

3.1.4.PerceivedcomprehensivenessofthePCBoutcomeset

Themajorityofthepatients,administrators,andprofessionals agreed that the PCBoutcome setcontains the most important outcomes(Table4).

Whenaskedforitemsthatwereconsideredmissingfromthe PCBoutcomeset,thefollowingtopicsweresuggested:relatedto the role of the partner, physical recovery after childbirth, preferences regarding childbirth and continuity of care across timeandstrataofcare.

3.2.Focusgroups 3.2.1.Studypopulation

Characteristics of participants of the three focus groups are displayedinSupplementarytableC.1,C.2andC.3.

3.2.2.PerceivedapplicabilityofthePCBoutcomeset

Fourmainthemesemergedfromthefocusgroupswithregard totheapplicabilityofthePCBoutcomeset:valueandcontentof

Table3

Surveybaselinecharacteristicsofparticipants:professionalsandadministrators. Professionals (n= 134)N(%) Administrators (n= 35)N(%) Profession Gynecologista 17(13) – Neonatologista 17(13) – Physicianassistant 4(3) – Clinicalmidwife 11(8) – Communitymidwife 27(20) – Nursepractitioner 15(11) – Nurse 16(12) –

Maternitycareassistant 27(20) –

Hospitalboardmember – 8(24)

CEOofadepartment – 10(29)

Headofdepartmentinhospital – 9(27)

ChairmanofOCN – 4(12)

Chairmanofﬁrsttiercooperation – 3(9)

missing 1 Workexperience 0–5year 17(13) 15(43) 5–10years 29(22) 13(37) >10years 88(66) 7(20) Organization

Hospital(generalandtertiary) 86(64) 14(40)

Primarycarebirthcenter 13(10) –

OCN – 1(3)

Primarycarecooperation – 5(14)

Maternitycareorganization 19(14) 15(43)

Midwiferypractice 16(12) –

Note:OCN:obstetriccollaborativenetwork.

a

Specialistsandresidentsintraining.

Table4

SurveydescriptivestatisticsofquestionsoncapturingmostimportantoutcomeswiththisPCBoutcomesetandonthetimingoftheﬁvetimepoints.

Patients Professionals Administrators

N(%) N(%) N(%)

Aretheﬁvetimepointsadequate? 142 126 31

yes 133(94) 102(78) 20(64)

no 9(6) 29(22) 11(36)

Arethemostimportantoutcomescaptured? 126 122 27

yes 113(90) 96(79) 18(67)

no 13(10) 26(21) 9(33)

Table5

Surveyparticipant’sratingsperoutcome:professional-reportedoutcomes. Patients Professionals Administrators Total N(%) N(%) N(%) Maternalmortality 132 126 29 important 101(77) 116(92) 27(93) neutral 26(20) 8(6) 2(7) notimportant 5(4) 2(2) 0(0) Stillbirth 132 126 29 important 113(86) 122(97) 28(97) neutral 16(12) 3(2) 1(3) notimportant 3(2) 1(1) 0(0) Neonataldeath 132 126 29 important 113(86) 121(96) 28(97) neutral 15(11) 4(3) 1(3) notimportant 4(3) 1(1) 0(0) Maternalmorbidity 132 126 29 important 110(83) 123(98) 29(100) neutral 18(14) 2(2) 0(0) notimportant 4(3) 1(1) 0(0) Neonatalmorbidity 132 126 29 important 110(83) 121(96) 28(97) neutral 18(14) 4(3) 1(3) notimportant 4(3) 1(1) 0(0) Pretermbirth 131 126 29 important 115(88) 118(94) 28(97) neutral 13(10) 7(6) 1(3) notimportant 3(2) 1(1) 0(0) Birthinjury 131 126 29 important 114(87) 123(98) 29(100) neutral 14(11) 2(2) 0(0) notimportant 3(2) 1(1) 0(0) xxx–xxx

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thePCBoutcomeset,timepointsofdatacollection, implementa-tion of PCB outcome set and quality based governance. These themesandsubthemes(Fig.3)aredescribedindetailbelow,with illustrativequotesinBox2–5.

3.2.3.ValueandcontentofthePCBoutcomeset

The majorityof participants in all groups felt that the PCB outcomesetisofgreatvalueandcontainsacomplete representa-tionofimportantoutcomeswithinperinatalcare,andthatitwould beausefuladditiontoperinatalcare.Allgroupsconsideredthe outcomes,beit professional-reportedorpatient-reported, tobe complementaryandinterrelated.Nonetheless,someprofessionals feltthattheoutcomescouldalsobeindependentofeachotherand canbeinterpretedindependently.

With regard to PROMs, both patients and administrators reported a taboo on some of these outcomes, e.g. pelvic dysfunction,and a lack ofknowledge regarding theprevalence and treatmentpossibilities. Patients mentioned that this taboo maybereducedbyﬁllinginquestionnairesregardingthePROMsin the PCB outcome set multiple times (i.e. during the ﬁve time points)and discussing the resultswitha professional.Patients emphasized that it is the task of their professional to discuss PROMs, especiallythe ‘taboo PROMs’ and that discussingthese outcomesshouldbeintegratedintoregularcare.

All groups viewed PREMs as important outcomes.However, patients reported to feel dependent on their professional and

mentioned a high risk of providing social desirable answers if responsesarelinkedtotheindividualpatient.Patientssuggested completing PREMs anonymously, yet professionals noted that anonymousPREMsaredifﬁculttointerpret.

Professional and patients both felt that the complete setof outcomescanfacilitateprofessionalstobetterguidecarefortheir patients. Professionalsalso considereddiscussing theoutcomes with their patients as an extra form of care. According to professionals, it allows patients tobe better prepared because completingthequestionnairesforcesthemtooverthinkthevisit andaddresscertainproblemsduringthevisit.Patientsmentioned the same bene_fits of discussing the outcomes with healthcare professionals. Patients and professionals endorsed that by collectinganddiscussingimportantoutcomesSDMissupported. Patientsstatedthatconfidenceinprofessionalsisveryimportant whendiscussingoutcomesduringalltimepoints,butespecially duringtimepointthreeandfive.Withrespecttorestrictionsofthe current set, both patients and professionals underlined the importance of involving the partnerin perinatalcare, an item which is currently not covered by the PCB outcome set. Also professionalsandpatientsunderlinedthelackof(dis)continuityof careoutcomesinthePCBoutcomeset.

3.2.4.Timepointsofdatacollection

Whereas professionals and administrators stated that data collection at ﬁvetime pointsmight be tootaxing for patients, patientsgenerallyindicatedthat theywould notmindtoﬁllin questionnaires multiple times. Patients reported that their complianceislikelytobemaximizedifsafety,i.e.bothregarding privacyandIT,isensured.Toincreasetheircompliance,theyalso stated that questionnaires should contain relevant questions, outcomes should be discussed with their professional and an explanationonthePROsshouldbeprovided.

With respect to time point three both professionals and patients indicated that this is an important moment for interventionsif problemsoccur. However,theymentioned that theinterpretationofthesePROsreliesheavilyonthetimingand thedesignatedprofessionaldiscussingtheseoutcomes.

Allgroupsconsideredtimepointﬁveasavaluablemomentto revisit the perinatalcare professional. Sucha visit is currently lackinginperinatalcareintheNetherlands.Thegroupsagreedon theaddedvalueofdiscussingtheoutcomesandevaluatingcareat this time point, but differed in their views on which type of professional should discuss the outcomes. Whereas patients generally preferred the community midwife and felt that preventivechildhealthcare(PCHC)professionalswerelesssuitable to discuss outcomes at this time point, professionals and administratorsconsideredthistobeanimportanttaskforPCHC professionals. They indicated that this could strengthen the connectionbetweenperinatalcareandPCHC.

3.2.5.ImplementationofthePCBoutcomeset

Arecurrentthemeinallfocusgroupswastheimplementation ofthePCBoutcomeset.

Bothpatientsandadministratorssuggestedthatregistrationof theoutcomesinthePCBoutcomesetshouldbeobligatory,inorder to make implementation successful.According toprofessionals andadministrators,directaccesstooutcomesderivedfromPROsin anadequateITsystemwasconsideredessentialfordeliveringgood care. Proper IT-arrangementswere alsoconsidered essential to prevent excessive and duplicate registration, which would also beneﬁtimplementation.

Adequate education and information was formulated as a preconditionforsuccessfulimplementationbyadministratorsand patients. Both for professionals, in order to effectively discuss outcomeswiththeirpatients,andforpatientsandprofessionalsto

Table6

Surveyparticipant’sratingsperoutcome:patient-reportedoutcomes. Patients Professionals Administrators Total

N(%) N(%) N(%)

Health-relatedqualityoflife 127 124 28

important 91(72) 87(70) 21(75)

neutral 32(25) 35(28) 7(25)

notimportant 4(3) 2(2) 0(0)

Conﬁdencewithbreastfeeding 127 124 28

important 75(59) 91(73) 21(75)

neutral 44(35) 31(25) 5(18)

Successwithbreastfeeding 127 124 28

important 70(55) 92(74) 21(75) neutral 48(38) 27(22) 7(25) notimportant 9(7) 5(4) 0(0) Incontinence 127 124 28 important 81(64) 89(72) 26(93) neutral 39(31) 29(23) 2(7) notimportant 7(6) 6(5) 0(0)

Painwithsex 127 124 27

important 57(45) 70(57) 22(82) neutral 48(38) 46(37) 3(11) notimportant 22(17) 8(7) 2(7) Postpartumdepression 127 124 27 important 101(80) 117(94) 26(96) neutral 25(20) 6(5) 1(4) notimportant 1(1) 1(1) 0(0) Conﬁdenceinrole 127 124 27 important 78(61) 92(74) 22(82) neutral 45(35) 30(24) 5(19) notimportant 4(3) 2(2) 0(0) Mother-infantattachment 127 124 27 important 94(74) 109(88) 26(96) neutral 29(23) 12(11) 1(4) notimportant 4(3) 2(2) 0(0)

Satisfactionwithcare 127 124 27

important 104(82) 115(93) 27(100)

neutral 23(18) 9(7) 0(0)

Healthcareresponsiveness 127 124 27

important 98(77) 112(90) 27(100)

neutral 29(23) 12(10) 0(0)

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underline the importance of measuring outcomes and the importanceof these outcomes. Bothpatientsand professionals indicated that information and education would be helpful to reducetheriskofsocialdesirabilityandtaboooncertainoutcomes. All groups felt that exposure of the outcomes to patients, professionalsandadministrators,isnecessaryforimplementation.

They indicated that SDM and improving outcomes require transparency. However, administrators worried about the consequences oftransparencyof theoutcomes;wrongful inter-pretationofoutcomesbypatientsandhealth-insurers,e.g.when publishedonawebsitewithoutadditionalinformation,wasseen asarisk.Also,severalprofessionalsandadministratorsmentioned

Fig.3.MainthemesandtheirsubthemesontheapplicabilityofthePCBoutcomesetderivedfromthefocusgroups.

Box2.IllustrativequotesonvalueandcontentofthePCBoutcomeset.

SubthemevalueofthePCBoutcomeset:“... butIthinkthatthisisallveryimportantandverygood... Sofortheresultsherein [thePCBSet],Ithinkitisextremelygoodthattheexperiencesofthewomenthemselvesarecaptured[intheSet].”(Focusgroup patients,currentlypregnantwoman)

Subthemetaboo:_“AndIalsothinkthatthemorepeoplequestionanddiscussthis[outcomeintheSet],theless-_”(pregnant woman)“-highthethresholdis.”(otherpregnantwoman)(Focusgrouppatients)

SubthemerestrictionsofthePCBoutcomeset:“Especiallythefather,Ibelieve.Heexperiencesalotofthingsdifferentlycompared tothemother;heisstandingnexttoitandnotinthemiddleofit.”(Focusgroupprofessionals,maternitycareassistant) Subthemediscussingoutcomeswithprofessionals:“ButIthinkitdoesmakeadifferencewhetheryoufeelateasewithsomeone whetheryouwanttotalkaboutit.Andthenitmaynotevenmattertoyouifsomeoneelsereadsit,however,totalkaboutit,Ibelieve thatyouwouldprefertodothiswithsomeoneyouknow.”(Focusgrouppatients,currentlypregnantwoman)

Box3.Illustrativequotesonthetimepointsofdatacollection.

Subthemedatacollectionat_fivetimepoints:_{“Personally,}Ireallywouldnotmind[to_fillin5questionnaires]._”(pregnantwoman). “Meneither,Iwouldbewillingtofillthemin.”(severalparticipants)(focusgrouppatients)

Subthemetimepoint5:“Wealwaysofferthepostpartumcheck-upsixweeksafterdelivery,butyounoticethatitisreallytooearly totalkaboutit[childbirth]forsomewomen.Itwouldthenbeverynicetomeasurethisbecauseitisveryeasytoselectthese women.[...]Andonewouldthinkthatyoucanﬁlterthatduringtimepointﬁve.”(Focusgroupadministrators,boardmemberof anOCN)

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theroleofthehealth-insurerasapossiblebarrierto implementa-tion. They were hesitant about quality-based payment and interpretationofoutcomesbyhealth-insurers.Bothprofessionals and administratorsstressed thatthe PCBoutcome set mustbe implementedstepbystep.

3.2.6.Quality-basedgovernance

All groups expressed that the PCB outcome set offers possibilitiestofocusonimprovementofqualityofcare.

Bothadministratorsand professionalsindicatedthat quality-basedgovernanceismorewithinreachwiththePCBoutcomeset. However, they emphasized that comparing outcomes within an OCN must be conducted blame-free and within a safe environment.Inaddition,administratorssuggestedthataculture changeisneededinordertocreateanenvironmentinwhichitis normaltoaddresseachotheronoutcomes.

All groups stated that in order to useoutcomes for quality improvement,itshouldbepartoftheOCN’spolicyplan.Patients additionallymentionedthattheoutcomesshouldalsobeusedto improveindividualpatientcare.

Administratorsandprofessionalsreportedmixedviewsonthe use ofbenchmarkingonoutcomes. Professionalssuggested that benchmarkingshouldbeimplementedinsmallsteps,firstatthe leveloftheOCNandwithout(financial)consequences.Professionals indicated that a next step would be clear agreements withthe health-insurersontheconsequencesofbenchmarkingonanationallevel. Both administratorsand professionals emphasized that it is yet unclear whether the casemix in the PCB outcomeset makes a sufficientdistinctionbetweendifferentpatientgroups.

In ordertoincreasequalityofcare,measuringoutcomesand discussing them at an OCN level was considered to have the potentialtostimulatelearningfromeachotherbyadministrators and professionals. Joint responsibility by all health care professionals involved in perinatal care, for both positive and negativeoutcomes,wassetasapreconditionbythesegroups. 4.Discussionandconclusion

4.1.Discussion

In this mixed methods study the applicability of the PCB outcome set was explored among patients, professionals, and administratorsinﬁveOCNs intheNetherlands.Allusergroups recognizedthepotentialvalueinperinatalcareofthePCBoutcome setinwhich theybelieved themost importantoutcomes were represented.Also,thetimingofdatacollectionofthePCBoutcome

set was evaluated as appropriate. Essential preconditions for successfulimplementationmentionedbyallusergroupswere:an adequate IT system, and education and information for both patients and professionals. To use the outcomes of the PCB outcome setfor quality improvement,a culturechangeamong professionals and transparency of outcomes were considered necessary.

Astrengthofthisstudyisthatweusedbothquantitativeand qualitativedatamethods,therebyensuringtriangulation[22].The resultsofthesurveywereusedasinputforthefocusgroupsand theoutcomesofboththesurveyandfocusgroupswerediscussed intheinterdisciplinary workinggroup.Thefocusgroupanalysis generally supported the survey ﬁndings and provided an explanation and in-depth understanding of the arising issues. Furthermore,byinvolvingallstakeholders,includingprofessionals andadministrators,wewereabletogainacompleteoverviewof users’perceivedapplicability,contributingtotherobustnessand generalizabilityoftheresults.

A limitation of our study is its sample size; the intended inclusionof250patientsinthesurveywasnotachieved.Selection bias is another potential limitation. We only included Dutch-speakingparticipantsforboththesurveyandfocusgroups.Their perspectives,especiallyfrompatients,maydifferfromthosewith an immigrant background. On the other hand, both primary, secondaryandtertiarycarepatientswererepresentedand17%of theincludedpatientsin thesurveywas ofnon-Western origin. Therefore,weexpectthatthepotentialinﬂuenceofselectionbias ontheresultswaslimited.

ThecomprehensivenessofthePCBoutcomesetwassupported byallusergroups.Consistentwiththeﬁndings oftheprevious consumervalidationsurveyofthePCBoutcomesetbyNijagaletal. [17],avastmajorityofpatientsagreedthatthePCBoutcomeset covered the most important outcomes. Some PROMs were perceivedaslessrelevantascompared toothers, similartothe consumer validation survey [17]. Possible explanations for this include the perceived taboo on certain outcomes (e.g. pelvic dysfunction) and lack of knowledge about theimportance and incidenceofthesetaboo-relatedoutcomes[24 –28], whichwas alsoreportedbytheparticipants.

PREMswereindicatedasimportant,althoughpatientsinour focusgroupnotedthatthesemayyieldsociallydesirableanswers duetopatients’dependenceontheirprofessional.Thismayrestrict reliabilityofPREMS,andanonymouslycollectedPREMsmaybea usefulsolution[29].

PatientsgenerallyfeltthattimingofdatacollectioninthePCB setwasappropriate.Datacollectionat_ﬁvetimepointswas not Box4.IllustrativequotesonimplementationofthePCBoutcomeset.

Subthemeeducation:_“Yes,Ialsothinkaboutwhydoweneedto_ﬁllinthequestionnairewhenprovidinginformation,whatisdone withtheresultseventually,thenmaybeyouunderstandtheneed... whatisinitforme.”(Focusgrouppatients,mother) Subthemeroleofhealth-insurer:“Iwouldbehesitantifthehealthinsurergetsit[theoutcomes],becauseIamnotconvincedthat theywillinterpretitcorrectly...”(Focusgroupprofessionals,communitymidwife)

Box5.Illustrativequotesonqualitybasedgovernance.

Subthemeblame-free:_“Itisveryusefulthatyouareallowedto,ormay,showvulnerability,youarenottoblame,youknow.Ithink thatisvéryimportant._”(Focusgroupadministrators,boardmemberofanOCN)

SubthememeasuringatOCNlevel:“Yesofcourseitdependsonwhetheryouseeitbothasacommongoal,sotosay.Soifyou onlylookatyourownoutcomeswithinyourownpractice,oratyourownoutcomeswithinthehospital,thereisstillnocommon outcome.SothenyoureallyneedtotackleittogetherasanOCN.”(Focusgroupprofessionals,clinicalmidwife)

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consideredasaburdenbypatients.Itisinterestingtonotethat time point ﬁve (i.e. six months postpartum) was considered a valuabledatacollectionpoint byallusergroups,particularlyas perinatalcareintheNetherlandscurrentlyonlyextendsuptosix weeks postpartum. Patients and professionals both regarded discussingthelong-termoutcomesofpregnancyand childbirth withtheexpertprofessionalofimportance.Whetherworkingwith thePCBoutcomesetactuallybeneﬁtspatientcarerequiresfurther studythroughanimplementationproject.

Providingpatientswithadequateinformation onthe impor-tanceofoutcomesandofmeasuringthemwasmentionedasakey factor. Thefactthat outcomesweregoingtobediscussed with professionalswas consideredtocontributetothemotivationto completequestionnaires.Signalingadeclineinscoresofcertain PROsovertimeoranunfavorablePROatoneofthetimepoints,and discussing them with the patient, will allow institution of appropriateinterventionsin ordertoimproveoutcomes.Inthis way, implementation of the PCB outcome set may enhance individualizedcare via SDM. Follow-up researchduring imple-mentationof thesetis requiredtoassesswhetherthisactually leadstoimprovedmaternalandperinataloutcomes.Completing PROMscanalsoleadtoa betterpatientunderstandingof their conditionand empowerspatientstodiscuss certaintopicswith theirprofessional[30].Thismechanismwasalsoacknowledgedby patientsinourfocusgroups.

Another keyfactorwastheimportanceofeducating professionals onapplyingVBHC.Thispreconditionhaspreviouslybeen acknowl-edgedbypost-implementationstudiesofotherICHOM outcomesets [15,16].Similartoourwork,thesestudiesalsoidentiﬁedadequateIT asanimportantkeyfactorforsuccessfulimplementation.Theneed foradequateITwasrecognized,particularlytominimizeregistration burdenamongprofessionals.

AccordingtoprofessionalsandadministratorsthePCBoutcome setalsoprovidesopportunitiesforcomparingoutcomestoimprove qualityofcare(i.e.benchmarking).Professionalsemphasizedthata culturechangeisnecessaryinordertosafelyaddresseachotheron outcomes.Consistentwithourresults,bothAroraetal.andPorter andTeisbergstatedthatprofessionalsneedtoleadtheseculture changesandtheprocessofcomparingoutcomes[9,16].

Also, the role of the health-insurer in terms of financial consequenceswashighlighted.Administratorsandprofessionals inourfocusgroupsfearedthefinancialconsequencesofmeasuring outcomesand makingthemtransparenttowardsinsurers.Clear agreements with insurers on the consequences of transparent outcomes and introducing benchmarkingon outcomesstep by steponasmallscaleseempropersolutionswhichweresuggested byparticipantsinthefocusgroups.Implementinganoutcomeset onasmallscalefirstwasalsoadvisedbyAroraetal.[16].Further researchisrequiredintotheeffectsofbenchmarkingonqualityof perinatalcare.

Two outcomes were currently missed by the user groups, namely continuity of care and the role of the partner. Dutch patients,professionalsandadministratorssuggestedtoaddthese subjectstothePCBoutcomeset.Thisshowsthatforassessingand improving quality of care for different settings, some context-speciﬁcoutcomescanbeaddedtothePCBoutcomeset. 4.2.Conclusion

OurstudyshowsthatthePCBoutcomesetisacceptedasan appropriateinstrumentforevaluationofqualityofperinatalcare andSDMbyallpatients,professionalsandadministratorsinthe Dutchperinatalcaresystem.ThePCBoutcomesetwasfoundto contain themost important outcomes as judged by end-users. Minor context-speciﬁc additions were suggested by the user groups.Thesuggestedtimingofthedatacollectionwasalsojudged

as adequate and data collectionwas perceived toadd valueto perinatalcare.ItisessentialthatadequateITsupportiswarranted and that education on the PCB outcome set is provided to professionalsandpatients.Finally,ourmethodologymayserveas anexampleforotherperinatalhealthcaresystemsacrosstheglobe, and otherdiseaseorpatientgroups forwhomICHOMdevelops outcomestandards.

4.3.Practiceimplications

The implementation of the ICHOM PCB outcome set with additional outcomes regarding the role of the partner and continuityofcaremustbecloselymonitoredinan implementa-tionpilot.FurtherresearchshouldfocusonthevalueofthePCB outcome set to patients, professionals and administrators in perinatalcare.

Theadditionalevaluationof patient-reportedoutcomesat six monthspostpartum accordingtothePCBoutcome setwould requireachangeofdailypractice.Thistimepointisseenby end-usersasavaluableadditiontoperinatalcare.Inordertofully utilize the added value of discussing the outcomes, special attention must be paid to make patients feel familiar with professionalsespeciallyatthistimepoint.

The focus of working with the PCB outcome set for both professionalsandadministratorsmustbeontransparencyofthe outcomes, to be able to make progress towards quality improvement. Outcomes must be made transparent to all stakeholdersinvolvedinperinatalcare.

DuringimplementationofthePCBoutcomeset,attentionmust bepaidtothefeasibilityofworkingwiththePCBoutcomesetfor professionals.DevelopmentofITsolutionsfortransferringdata andmergingprofessional-reporteddatawithpatient-reported dataisessentialinordertoreduceregistrationburden,andto support benchmarking. Additionally, adequate data could provide insight in perinatal outcomes. The effect of working withthePCBoutcomesetontheseoutcomescanbeassessed duringimplementation.

Funding

This work was supported by the Netherlands Federation of University Medical Centers (NFU) [grant number 8392010042]. The NFU had no involvement in study design, data collection, analysisandinterpretationofdata,writingthereportanddecision to submit the article for publication. JVB is supported by personalfellowshipsfromErasmusMCandtheNetherlandsLung Foundation.

CRediTauthorshipcontributionstatement

LyzetteT.Laureij:Conceptualization,Methodology,Validation, Formalanalysis,Investigation,Writing-originaldraft,Writing -review&editing,Visualization.JasperV.Been:Conceptualization, Methodology,Validation,Formalanalysis,Writing-originaldraft, Writing-review&editing,Visualization.MarjoleinLugtenberg: Methodology,Validation,Formalanalysis,Writing-originaldraft, Writing-review&editing.HiskeE.Ernst-Smelt: Conceptualiza-tion,Formalanalysis,Investigation,Writing-originaldraft.Arie Franx:Conceptualization,Writing-review&editing,Supervision. Jan. A.Hazelzet:Conceptualization,Methodology,Investigation, Resources,Writing-review&editing,Supervision.Pieter-Keesde Groot:.OdileFrauenfelder:.DaciaHenriquez:.Marije Lamain-deRuiter:.EliseNeppelenbroek:.SebastiaanW.A.NijBijvank:. TimmeSchaap:.MurielleSchagen:.MariekeVeenhof:.Jolanda H.Vermolen:.

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DeclarationofCompetingInterest

AFwaspartoftheICHOMPCBoutcomesetWorkingGroup.The otherauthorshavenoconﬂictsofinteresttoreport.

Acknowledgments

Wethankallparticipatingpatients,professionalsand admin-istrators for their efforts. We acknowledge the NFU for their ﬁnancialsupport.

Iconfirmallpatient/personalidentifiershavebeenremovedor disguisedsothepatient/person(s)describedarenotidenti_fiable andcannotbeidentifiedthroughthedetailsofthestory. AppendixA.Supplementarydata

Supplementarymaterialrelatedtothisarticlecanbefound,inthe onlineversion,atdoi:https://doi.org/10.1016/j.pec.2019.09.022. References

[1]S.Mann,S.Pratt,P.Gluck,Assessingqualityinobstetricalcare:developmentof standardizedmeasures,Comm.J.Qual.PatientSaf.32(2006)497–505. [2]A.Coulter,Measuringwhatmatterstopatients,Br.Med.J.Clin.Res.Ed(Clin.

Res.Ed.)356(2017)j816.

[3]R.E. Gliklich, N.A. Dreyer, M.B. Leavy, Registries for Evaluating Patient Outcomes:AUser’sGuide[Internet],3ed.,(2014).

[4]D.T.Eton,T.J.Beebe,P.T.Hagen,M.Y.Halyard,V.M.Montori,J.M.Naessens, etal.,Harmonizingandconsolidatingthemeasurementofpatient-reported informationathealthcareinstitutions:apositionstatementoftheMayo Clinic,PatientRelat.OutcomeMeas.5(2014)7–15.

[5]E.Basch,X.Jia,G.Heller,A.Barz,L.Sit,M.Fruscione,etal.,Adversesymptom eventreportingbypatientsvsclinicians:relationshipswithclinicaloutcomes, J.Natl.CancerInst.101(2009)1624–1632.

[6]U.S.DepartmentofHealthServicesHumanF.D.A.CenterforDrugEvaluation Research,U.S.DepartmentofHealthHumanServicesF.D.A.Centerfor BiologicsEvaluationResearch,U.S.DepartmentofHealthHumanServicesF.D. A.CenterforDevicesRadiologicalHealth,GuidanceforIndustry: Patient-ReportedOutcomeMeasures:UseinMedicalProductDevelopmenttoSupport LabelingClaims:DraftGuidance.HealthQualLifeOutcomes,4(2006),pp.79. [7]M.E.Porter,E.O.Teisberg,RedeﬁningHealthcare,HarvardBusinessPress,2005. [8]M.E.Porter,S.Larsson,T.H.Lee,Standardizingpatientoutcomesmeasurement,

N.Engl.J.Med.374(2016)504–506.

[9]M.E.Porter,E.O.Teisberg,Howphysicianscanchangethefutureofhealthcare, J.Am.Med.Assoc.297(2007)1103–1111.

[10]A.K.Morgans,A.C.vanBommel,C.Stowell,J.L.Abrahm,E.Basch,J.E.Bekelman, etal.,Developmentofastandardizedsetofpatient-centeredoutcomesfor advancedprostateCancer:aninternationaleffortforauniﬁedapproach,Eur. Urol.68(2015)891–898.

[11]W.L.Ong,M.G.Schouwenburg,A.C.M.vanBommel,C.Stowell,K.H.Allison,K.E. Benn,etal.,Astandardsetofvalue-basedpatient-centeredoutcomesfor breastcancer:theinternationalconsortiumforhealthoutcomes measurement(ICHOM)initiative,JAMAOncol.3(2017)677–685.

[12]A.C.Allori,T.Kelley,J.G.Meara,A.Albert,K.Bonanthaya,K.Chapman,etal.,A standardsetofoutcomemeasuresforthecomprehensiveappraisalofcleft care,CleftPalateCraniofac.J.54(2017)540–554.

[13]J.A.Zerillo,M.G.Schouwenburg,A.C.M.vanBommel,C.Stowell,J.Lippa,D. Bauer,etal.,Aninternationalcollaborativestandardizingacomprehensive patient-centeredoutcomesmeasurementsetforcolorectalcancer,JAMA Oncol.3(2017)686–694.

[14]P.G. Bittar, A.R. Carlson, A. Mabie-DeRuyter, J.R. Marcus, A.C. Allori, Implementationofastandardizeddata-collectionsystemfor

comprehensiveappraisalofcleftcare,CleftPalateCraniofac.J.55(10)(2018) 1382–1390.

[15]I.N.Ackerman,B.Cavka,J.Lippa,A.Bucknill,Thefeasibilityofimplementing theICHOMStandardSetforHipandKneeOsteoarthritis:amixed-methods evaluationinpublicandprivatehospitalsettings,J.PatientRep.Outcomes2 (2017)32.

[16]J.Arora,M.Haj,ImplementingICHOM’sStandardSetsofOutcomes:CleftLip andPalateatErasmusUniversityMedicalCentreintheNetherlands, InternationalConsortiumforHealthOutcomesMeasurement(ICHOM), London,2016.

[17]M.A.Nijagal,S.Wissig,C.Stowell,E.Olson,I.Amer-Wahlin,G.Bonsel,A. Brooks,M.Coleman,S.D.Kralasingam,J.M.N.Duffy,T.Flanagan,S.Gebhardt, M.E.Greene,F.Groenendaal,J.R.R.Jeganathan,T.Kowaliw,Lamain-deRuiter,E. Main,M.Owens,R.Petersen,I.Reiss,C.Sakala,A.M.Speciale,R.Thompson,O. Okunade,A.Franx,Standardizedoutcomemeasuresforpregnancyand childbirth,anICHOMproposal,BMCHealthServ.Res.18(2018)953. [18]A.Mahmud,E. Morris,S.Johnson,K.M. Ismail, Developingcore

patient-reportedoutcomesinmaternity:PRO-maternity,BJOG-Int.J.Obstet.GY121 (2014)15–19.

[19]VerloskundigeIndicatielijst,enVerloskundigVademecum.Eindrapportvande CommissieVerloskundevanhetCollegevoorzorgverzekeringen[FinalReport oftheAdvisoryBoardonObstetricsoftheHealthCareInsuranceBoard] Diemen:CollegevoorZorgverzekeringen,(2003).

[20]M.P.Amelink-Verburg,S.E.Buitendijk, PregnancyandlabourintheDutch maternitycaresystem:whatisnormal?Theroledivisionbetweenmidwives andobstetricians,J.MidwiferyWomensHealth55(2010)216–225. [21]SchmitzC.LimeSurvey, AnOpenSourceSurveyTool,LimeSurvey Project

Hamburg,Germany,2012.

[22]J.Green,N.Thorogood,QualitativeMethodsforHealthResearch,Sage,2018. [23]A.Tong,P.Sainsbury,J.Craig,Consolidatedcriteriaforreportingqualitative research(COREQ):a32-itemchecklistforinterviewsandfocusgroups,Int.J. Qual.HealthCare19(2007)349–357.

[24]L. Mason, S. Glenn, I. Walton, C. Appleton, The experience of stress incontinenceafterchildbirth,Birth26(1999)164–171.

[25]C.Norton,Theeffectsofurinaryincontinenceinwomen,Int.Rehabil.Med.4 (1982)9–14.

[26]K.Holst,P.D.Wilson,Theprevalenceoffemale urinaryincontinenceand reasonsfornotseekingtreatment,N.Z.Med.J.101(1988)756–758. [27]T.Lagro-Janssen,A.Smits,C.VanWeel,Urinaryincontinenceinwomenand

theeffectsontheirlives,Scand.J.Plast.Recons.10(1992)211–216. [28]M.B.R.Buurman,A.L.M.Lagro-Janssen,Women’sperceptionofpostpartum

pelvicﬂoordysfunctionandtheirhelp-seekingbehaviour:aqualitative interviewstudy,Scand.J.CaringSci.27(2013)406–413.

[29]E. Lagha, A. Noble, A. Smith, M.A. Denvir, S.J. Leslie, Patient Reported ExperienceMeasures(PREMs)inchronicheartfailure,J.R.Coll.Physicians Edinb.42(2012)301–305.

[30]J.Greenhalgh,K.Gooding,E.Gibbons,S.Dalkin,J.Wright,J.Valderas,etal., Howdopatientreportedoutcomemeasures(PROMs)support clinician-patientcommunicationandpatientcare?Arealistsynthesis,J. Patient-ReportedOutcomes2(2018)42.