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Development framework for a patient-centered record
John Puentes, Michèle Roux, Julien Montagner, Laurent Lecornu
To cite this version:
John Puentes, Michèle Roux, Julien Montagner, Laurent Lecornu. Development framework for a
patient-centered record. Computer Methods and Programs in Biomedicine, Elsevier, 2012, 108,
pp.1036 - 1051. �10.1016/j.cmpb.2012.06.007�. �hal-01162673�
Development framework for a patient-centered record
John Puentes
a,∗, Michèle Roux
b, Julien Montagner
a, Laurent Lecornu
aaInstitutMines-Telecom,TelecomBretagne,DépartementImageetTraitementdel’Information,Brest,France
bLaboratoireInformationCoordinationIncitations,UniversitédeBretagneOccidentale,Brest,France
Keywords:
Patient-centeredrecord Userrequirements Medicalworkflow Complementarypatient information
Developmentmethodology Conceptualdatamodel
Patientrecordshavebeendevelopedtosupportthephysician-orientedmedicalactivity scheme.Onerecommendedyetrarelystudiedalternative,expectedtoimprovehealthcare, isthepatient-centeredrecord.Weproposeadevelopmentframeworkforsuchrecord,which includesdomain-specificdatabasemodelsattheconceptuallevel,analyzingthefundamen- talroleofcomplementaryinformationdestinedtoensureproperpatientunderstandingof relatedclinicalsituations.Apatient-centeredawarenessfieldstudyofuserrequirements andmedicalworkflowwascarriedoutinthreemedicalservicesandtwotechnicalunitsto identifythemostrelevantelementsoftheframework,andcomparedtothedefinitionsofa theoreticalapproach.Threecoredatamodels–centeredonthepatient,medicalpersonnel, andcomplementarypatientinformation,correspondingtothedeterminedsetofentities, informationexchangesandactorsroles,constitutethetechnicalrecommendationsofthe developmentframework.Anopensourceproofofconceptprototypewasdevelopedtoshow themodelfeasibility.Theresultingpatient-centeredrecorddevelopmentframeworkimplies particularmedicalpersonnelcontributionstosupplycomplementaryinformation.
1. Introduction
Physicians practice relies on a particular combination of essential skills: clinical assessmentbased on interviewing, historytaking,andexamination,inadditiontohighlydevel- opedvisualandexplicitmemory,combinedwiththeuseof averylargespecializedterminology.Thesecompetencesare supportedbya strong professionalculture basedon paper patientrecords,oftenhandledinaclinicalworkflowonwhich thepatientmovesfromonesteptothenextofthehealth- careprocess,asapassivesubjectundertheresponsibilityof aphysicianoracareteam.Analternativetothisphysician oriented scheme is the so-called patient-centered care, on whichsignificantimportanceisgiventothepatient’sunder- standingofthe pathology,itsdiagnosis,treatment,andthe waytocopewithit,bymeansofcomplementaryinformation
∗ Correspondingauthorat:TelecomBretagne,ImageandInformationProcessing,CS83818,29238BrestCedex3,Finistere,France.
Tel.:+33229001339.
E-mail address:John.Puentes@telecom-bretagne.eu(J. Puentes).
that should be associated to the record. Notwithstanding the complexity of defining the patient-centered character ofamedicalinteraction,essential elements toconceptual- ize it have been theoretically studied byMead and Bower [1].Thisapproachreliesonfivedimensions:theexplanation of an illness taking into account biomedical, psychologi- cal,and social factors;understanding the personaldisease experienceofeachpatient;anegalitarianphysician–patient relationshipincludinginformationavailabilityandcommon decision making; a shared comprehension of the thera- peuticobjectives;and physicianawarenessofthe potential impactofpersonalqualitiesandsubjectivityontherelation withthepatient.Mostofthesedimensionsrequireselected complementary medical and legal information, as well as relatedlifestyleadvice,noteasilyavailableintheinforma- tion systems used by the conventional physician-centered approach.
Despite the fact that patient-centeredness iseminently a medical practice notion, adapted applications based on informationtechnologyare still requiredin order tofacili- tateitstransfertomedicalactivitysupportsystems[2].Even so,thecurrent usesofinformationtechnologytofunction- allyimprovethephysician-centeredschemeevolveslowly,are somewhatlimited,andfacemultiplechallenges[3].Oneofthe coreissuesisrelatedtoelectronicpatientrecordstructureand content,whichhasbeenthesubjectofmultipleproposalsfor morethan35years[4–9].Nevertheless,noconsensushasbeen reachedbetweenuser requirements and system designers’
initiatives.Furthermore,thepatientrecordstructureproblem hasbeen frequentlyunsuitablyformulatedinterms ofnew availableproprietarytechnologies,instead ofconcentrating theeffort onuser requirementsunderstanding andsystem compatibilitywithmedicalpractice.
Currently,theelectronichealthrecord(EHR)isgenerated assemblingdatafromdifferentproprietarycomponentsofthe hospitalinformationsystems(HIS), creatingaconsiderable EHRarchitecturevariabilitybetweenhealthcareinstitutions, aswellasmultipleinteroperabilityissues.EHRmodelshave beenstudied indetail accordingtofunctionality, structure, servicesaccessibility,mediasupport,andsecurity[10];defin- ing how EHR architectures are significantly shaped bythe medical specialty [11,12]; and with a particular focus on architecturesusingstandardizedcommunicationsofhealth databycombiningreferencemodelsandarchetypes[13],like openEHR[14]andISOEN13606[15].EveniftheglobalopenEHR archetypesarchitecturehasbeenintegratedbyISOEN13606 andHL7commonclinicaldocumentsarchitecture[16],with theobjectiveofseamlessinteroperability,thearchetypesoft- wareentitiesremaincomplextodevelop[11].Othermodels, liketheAmericanSocietyforTestingandMaterialsStandard ASTME1384[17,18],includeintheEHRbasichealthinfor- mationlikepatientidentification,clinicalhistory,laboratory tests results, diagnosis reports, drugs and treatments pre- scriptions, amongothers, in the formofdata elements or documentstransferabletocompatiblesystems.Noneofthese EHRmodelshasbeenconceivedtostructuretherequiredcom- plementaryinformationofthepatient-centeredapproach,or tosupportdirectpatientaccesstoit.Ontheotherhand,ini- tiativesasthepersonalhealthrecord(PHR) mainlyconcern systemsthathandlemanuallyorautomaticallyentereddata, collectedandmanagedbythepatient,havingeventualaccess toselectedcontentoftheEHR,butwithoutspecificationofthe toolsnecessarytounderstandthesepersonaldataandacton theinformationcontainedintherecord[19].Otherwise,the patient-centeredrecordhasbeendefinedasapatient-owned andpatientmanagedpersonalrecord,representingthehealth informationimportanttopatientsinwaystheyprefertorep- resentit [20],which issomewhat similartothe PHR. Also, thepatient-centeredrecordshouldcontain,besidestheEHR information,adescriptionoftheassessmentandplan,aswell asattendingnotesonteachingservices,inordertoaddress thepatient’sperspective,beyondthedisease[21].Nonethe- less,aspecificcomputermodelor developmentframework hasnotbeenproposedtoimplementsuchpatient-centered recordapproaches.
Inthiswork,apatient-centeredrecordisasystemdesigned toprovidecomplementaryinformation,directlyassociatedto
themedicaldatarequiredbyclinicalpractice.Suchcomple- mentaryinformationisdynamicallyadaptedtothepatient evolvingsituation,tosupportthepatient’sunderstandingand participationinthemedicaldecisionprocess.Inthatsense, it can encompass, but differ from the so-called consumer healthinformation,conceivedforpatientsalreadytakingcare oftheirowncondition,withaparticularinterestinpreven- tionand wellness.Collectedcomplementaryinformationis intendedtoenablepatientstocompletelyandeasilyunder- standtheirmedicalconditionsandhealthcareprocess,andbe usedmostlybythepatientandfamilymembers.Therefore, itisnotaPHRbecausethereisneitherpersonallycollected datanorpatientmanagement ofthe complementaryinfor- mation,eventhough the proposed patient-centered record canbeinterconnectedtotheEHR.Inaddition,HIShavebeen traditionallydesignedforthemostparttosupportadministra- tivetasksand,inaslighterdegree,healthcareprofessionals’
activity[22].Beyondthiswell knownfunctionalprofile,HIS advancementisexpectedtoalsoincludeapatient-centered record[23],addingundoubtedlytothecomplexityofhowto developadaptedpatientrecords.Ourworkfocusestherefore onthequestionofhowtoconceivearealisticandextensi- blepatient-centeredrecord,adaptedtopatientrequirements andthecorrespondingmedicalpractice,capableofproviding dynamicallythenecessarycomplementarypatientinforma- tion(CPI).
Although Mead and Bower approach seems adapted to evaluate physicians’ self-perceived degree of patient- centeredness [24], it was not defined to take account of patient-centeredrecord’srole, andneither didother works thatprecededit[25–27].Yet,itprovidesasubstantialreference todetermineonwhichofitsdimensionsapatient-centered recordislikelytobeessential(Section2).Wecomparedthose elementsto themainrelated informationexchanges iden- tifiedbymeansofapatient-centered awarenessfield work, and the corresponding user requirements, to understand thisworkflowcompatibilitywithapatient-centeredpractice (Section3).ConsideringthatCPIintendstoprovidedetailed explanations of pathology diagnosis, main and alternative treatments, recommended changes oflifestyle, as well as personalandlegaladvice,dataofthepatient-centeredrecord werethenmodeledtocopewithidentifieduserrequirements.
Domain-specificdatabase schemas defined at the concep- tuallevelwereused,matchingtherelatedpatient-centered workflowandthreeparticularentities:patient,medicalper- sonnel,andCPI. These schemasare presentedasessential designanddevelopmentrecommendations,inthecontextof apatient-centeredrecordproofofconceptsystem(Section4).
Thediscussionfocusesontheresultingdevelopmentframe- workforapatient-centeredrecord,aswell asthedatabase schemasconceptualizationissues(Section5),beforeoutlin- ingthelearnedlessons(Section6)andfutureplans(Section 7).
2. Background
Whilepatient-centeredcareappearsasanintelligiblemedi- calpracticeorientednotion,itislesssoforapatient-centered electronicrecord.Fromamedicalinformaticspointofview,
“patient-centeredness” remains a concept that needs real meaning[28]. However,suchdefinition isnotlikelyto rely onestablishedclinicaldocumentationpractices,whichdonot provideoptimalandintegratedinformationnecessarytobuild apatient-centeredrecord[29].Ontheotherhand,effortsto associatepatient-centeredcareandrelatedtechnologyhave concentratedonmakingexistingpatientinformationacces- sible, for instance facilitating the use of a PHR [30–32], or identifyingpatientinformationaccesspreferences[33].Nev- ertheless, an explicit patient-centered record development frameworkhasnotbeenformulated.
Consideringthatthemaininterestofthepatient-centered record is toenhance patient understanding and participa- tioninthehealthcareprocess,wefirstexaminedMeadand Bowertheoreticalanalysis,beforeconfrontingittoapatient- centeredawarenessfieldstudy,inordertoformulatethebasic elementsoftheproposeddevelopmentframework.
2.1. Theoreticalpatient-centeredness
AmongthefivedimensionsofMeadandBowerapproach[1], threerelystronglyoninformationexchange,evidencingthe importantrolethatapatient-centeredrecordcouldachieve:
- Theexplanationofanillnessaccordingtobiomedical,psy- chological,andsocialfactors.
- An egalitarian physician–patient relationship based on informationavailabilityandcommondecisionmaking.
- Asharedcomprehensionofthetherapeuticobjectives.
Explaininganillnessfromdifferentprofessionalperspec- tives–biomedical,butalsopsychological,andsocial–requires an exchange of selected information, in agreement with patients’ questions and beyond essential points discussed withthephysicianduringconsultation.Suchancillaryinfor- mationshouldbeprovidedtothepatientand/orrelatives,to ensurethem afine understanding ofthe patient’smedical situation.Thiselementseems essentialtoenablecommon decision making, even though it is not straightforward to determinehowmuchinformationwouldcompensatetheevi- dentknowledge unbalancebetween the physicianand the patient. That is also the case offundamental information to facilitate proper comprehension of defined therapeutic objectives.Regardlessofthisimplicitcontentvariability,our worksearchedtodefineacoherentdevelopmentframework ofa patient-centered record givingaccess to such kind of information, taking into account the previously identified threedimensionsoftheMeadandBowermodelasstarting premises,tobeconfrontedwithafieldstudycarriedoutat medicalservicesandunits.
2.2. Prospectivepatient-centerednessaccordingto informationexchange
To study system requirements in detail, three hospital medical services (general medicine, gastroenterology, and pneumology)andtwotechnicalunits(orthopedicsurgeryand nuclear medicine), were visited during 2days by two ana- lysts,toexamineprospectivepatient-centeredrecordusers’
needs, following daily service personnel (specialist, nurse,
Fig.1–Schematicrepresentationofthemain patient-centeredworkflowactors.
secretaries)activities,anddefiningtheresultingworkflowsin ahypotheticalpatient-centeredscenario.Ontheotherhand, 12volunteerpatients(atleast2perserviceorunit)wereasked tostatewhattheirpatient-centeredrecordcouldcontain.Even thoughtoanswersuchopenquestionallpatientsreferredto understandableandaccessibleinformationaboutdiagnosis, treatment,expectedresultsandmedicationsecondaryeffects, only5addeddetailslikeadviceonalternativetreatments,life styleandlegaladvice.
Considering the lack of systemic analysis to develop patient-centered records, users’needs were analyzed with respect to observed daily activities, investigating which changeswouldbenecessarytoestablishapatient-centered recordinformationflow.Theinteractioncontext insideand betweenmedicalservicesandtechnicalunitswasidentified asthereferenceworkflowscenario,giventhatthoseinterac- tionsencompassmostofthesystemrequirements,detailed inthenextsection.Thischoicerestrictsbothinvolvedperson- nelandinformationstreams,permittingtoexaminepossible variationsoftheconventionalmedicalserviceandtechnical unitworkflow,whenapatient-centeredperspectiveisapplied.
Besidesthepatient,sevenhospitalstaffmemberswereidenti- fiedasthemainpatient-centeredworkflowactors(Fig.1),with highpotentialofhavinganactiverolerelatedtothepatient- centeredrecord.
These actors’ activitiesare stronglyinterrelated,mostly basedoninformationexchanges(Fig.2),complyingwiththe threeunderlineddimensionsofMeadand Bower model. A visittothefamilyphysicianstartstheexchanges,leadingafter consultationto referthe patient tothe hospital physician, indicatinginalettertheobjectofthevisit,andrequestingan appointmenttothemedicalsecretary.Meanwhilethepatient mayhavebeenaidedbyparamedics,whotransmitelements abouttheirintervention,beforecontactingthe medicaland administrativesecretariestofulfilltheadministrativepartof thepatientadmission.
The hospital physician examines the patient, although otherhospitalspecialistscouldalsobecalled(forinstance, in this case, a surgery team). Considering the elements prescribed bythe physician, nurses completemedical acts execution,andasthemedicalsecretary,hospitalphysiciansor
Fig.2–Identifiedinformationexchangesina patient-centeredscenario.
otherspecialists,mayconsultpeerstoaccomplishtheirtasks.
Reportsofcodedactivitiesaretransmittedperiodicallybythe medicalsecretary to the hospital information department.
Thepatientand/orfamilymembersareconstantlyinformed ofthecareprogress:medicalexamination,requestedexams, pathologydiagnosis,treatmentdecision,andhowtohandle it.OralexplanationsandCPIsourcesaresuppliedregarding thoseitemsatthedifferentstagesofthecareprogress.Note thatthepatientorfamilymembersareexpectedtoeasilyand permanentlyaccessCPI.
3. Design considerations based on user requirements
Medicalservicescoverawiderangeofactivitypatternsaimed atenablingproperhealthcareprovision.Fromthiscomplex process,ourfieldstudyconcentratedonthemainfunctionsof whatcanbeconsideredasacommonpatient-centeredwork- flowofthevisitedservicesandtechnicalunits.
3.1. Patient-centeredcareworkflow
Itstartswiththearrivalofadmittedpatients(Fig.3),whomay come,oncestabilizedanddiagnosedfromemergency(Fig.3 step(1)),orambulatoryconsultation(step(2)).Ifthepatient recorddoesnotexist,itiscreated.Whenthepatientcomes fromanothermedicalservice(step(3)),theidentificationnum- bersofexistingHISandspecificmedicalservice(s)record(s)are communicatedtotheconcernedmedicalservice.
Thepatientand/orrelativesareinformedabouttheexis- tenceofthepatient-centeredrecordandhowtouseitduring thecareprocess(steps1,2,and3).Whenthepatiententers, theserviceortechnicalunitisinformedaboutrecentrecord updates(step3).Themedicalsecretarysearchestheservice patientrecord,updatesrequiredfields,andaddsnewletters orreports(step4).Thephysicianstudiesthepatientrecord, examinesthepatient(step5),anddecidesifitisnecessary
toprescribecomplementaryexamsdonebyatechnicalunit (step6),orifexistingresultscanleadtoatherapydecision (step7).Atthispoint,incomplex,rare,ordifficultcasesthe physiciancan ask for a second opinion, search additional informationinspecializeddatabases,interrogatingadecision supportapplicationifit isavailable[34–38],toconfrontthe decisions. Otherwise, diagnosis and treatment are defined, discussed with the patient, and the correspondingpatient recordupdated(step 8),beforeplanningthe corresponding patientcare(step 9),aswellaspreparingandapplyingthe prescribedmedicalprocedures(step10).
Nursescarryoutprescribedphysiologicalexams,admin- ister medication, and collect data to update the patient- centered record, inputting relevant observations and com- ments (step 11). In a surgery context,nurses alsoprepare instruments and document operation room conditions for thesurgeryreport (step11). Theanesthesiologistevaluates thepatientbeforesurgery,plansindividual anesthesiapro- ceduresandpost-operativesupport,notesperiodicallyduring surgerythepatientphysiologicaldatathatwillbeaddedto thesurgeryreport(step11).Attheendofany medicalpro- cedure,thephysiciandictates aprocedure report(step 12), whichiscodedtobesenttocontrolentities(step13)andto thereferringphysician(initiallythefamilyphysician–step 14).Ifnecessarytheupdatedpatientrecordistransferredto anotherclinicalservice(step15).Thereafter,prescriptionsare givenandexplained(step16),andbillingdetailsarecompleted bythe administrativesecretary(step 17).When thepatient leaves,historicdataare stored (step18) and acopy ofthe stayrecordisarchivedbythemedicalinformationdepartment (step19).Oncealegaldeadlineismet,theconcernedrecords aredestroyed(step20).Paramedics,pharmacists,andother medicalpersonnelalsoparticipateatdifferentstepsofthe describedworkflow.Ateachstageofthisscheme,thepatient and/orrelativesareinformedindetailaboutthecareprocess andtheavailableCPI.Theproposedapproachreliesonthis workflowtodefinethedevelopmentframework,focusingon informationexchangesrelatedtopatient-centeredcare.
3.2. Rolesofpatient-centeredworkflowactors
Information exchanges in the described patient-centered workflowtakeplaceaccording towell-definedactors’ roles.
Theserolesaredescribedhereafterinaschematicmanner, outliningthepredominantpatient-centeredinformationpro- cessingrelatedactivities:
- Patient:usesfrequentlythepatient-centeredrecordbefore and after consultation, as well as before, during, and afterhospitalizationtoimprovepersonalunderstandingof the providedcare,diagnosis,evolution ofsymptomsand treatmentresults,medicationsecondaryeffects,suggested lifestylechangesandlegaladvice,alongwithinformation exchangesamonghealthcareactors.
- Administrative secretary: collects administrative patient dataconcerninghealthinsuranceandbilling.Sendsperti- nentinformationtomedicalservicesandtechnicalunits, followingpatientmovementsduringhospitalizationuntilit finishes.Ifnecessary,givesadministrativeproceduressta- tustothepatient.
Fig.3–Mainstepsoftheidentifiedcommonpatient-centeredcareworkflow.
- Medical secretary: assigns a unique patient record iden- tificationnumber (PIN), and inputspatientmedicaldata.
Duringpatientstayattheservice,centralizesinformation formedicalpersonnelaboutappliedhealthcareprotocols, and all related CPI to be attached to the corresponding patient-centeredrecord.Whenthepatientleavestheser- vice,sendstheconsultationand/ortherapyreportstothe HIS and the data storageservice, making it availablefor otherservices,medicalunits,andthepatient.Informsthe patientandrelativesabouttheseactionsandthenatureof theavailableCPI.
- Hospital physician: access, visualizes, and modifies the patient-centeredrecord.Examinesthepatientandprovides allthenecessaryinformationaboutthediagnosedpathol- ogy, the prescribed therapy, other existing therapiesand medicationsecondaryeffects,aswellasparticularlifestyle recommendationsassociatedtothepatient’sclinicalcondi- tion.Decideswiththepatientwhichhealthcareprotocolto applyandinformsmedicalpersonnel.Writesconsultation and/ortherapyreportsdestinedtothereferringphysician, keepingacopyintheserviceandpatientrecords.Exchanges observationsand opinionswithother hospitalphysicians andthereferringphysicianaboutthepatientstatus.Points outallthenecessarykeywordstoenablethesearch,classi- ficationanddeliveryofCPIforthepatient.Answerspatient questionsandfosterscommondecisionmaking.
- Nurse: accesses and visualizes patient records to apply theprescribedhealthcare,updatingthenursingsectionof the record, and informing the patient about given care.
Communicatesconstantlywithmedicalservicepersonnel, physicians,andthepatient.
- Referringphysician:refersthepatienttothemedicalser- vice,providing requestedparts ofthepatient recordand any other useful information. If necessary, manages the
prescribed treatment.Carriesoutmediumand long-term follow-upofthemedicalserviceinterventionsandreceives copiesofconsultationand/ortherapyreports.Isauthorized by the patient to access part or all the patient-centered record. Gives additional information to the patient and makessurethattheexamination,treatments,andfollow- upareproperlyunderstood.
- Paramedics,pharmacists,andothermedicalpersonnel:pro- videemergency medicalcare,and/orperformemergency pre-hospital life support interventions under physician supervision. Provide prescribed medication and devices requiredduringhospitalization,amongothers.Theseper- sonnelneedcriticalinformationlikeallergies, treatments in progress, dietary restrictions (meals distribution), and pathologies, to improve provided care outcome. Explain unclearpointsoftheiractionstothepatient.
- Internalandexternalcontrolentities:exploitmedicalactiv- ity parameters,whilesupervisingandregulating theway thosevaluesaregenerated.Conductedstudiesincludeanal- ysesofpatient-centeredrecordadequacyandutilization.
3.3. Requirementsofpatient-centeredrecordusers
Exceptforparamedics,pharmacists,supportpersonneland control entities, all other described actors appear as core usersofthe patient-centeredrecord.Whilethepatientand thehospitalphysicianproceedcommonlyasindividuals,the membersofmedicalservicesandtechnicalunits(including theconcernedphysicians)workasteamswithcommonneeds.
Forthis reason,themostsignificant userrequirements are listedandexplainedforpatient,hospitalphysician,medical services,andtechnicalunitsasrelatedfunctionalactors,even ifsomerequirementsmaynotbeconsideredasstrictlyrelated tothepatient-centeredrecord.
- Patientrecordcreation:shouldtakeplaceonlyonceatthe HISlevelforeachpatient,avoidingdataredundancies.
- Patient recordaccess: visualizationofasummarizedand comprehensibleversionofthepatientmedicalinformation structuredinadetailedchronologicalmanner,bypathology, orselectedperiodsoftime.Itshouldincludeconsultation, diagnosis, therapy, surgery, laboratory, and paramedical reports,aswellasacquiredmedicaldata.
- Patientrecord update:inputofadditionalinformationon symptoms, reactions tomedications, andpersonal treat- mentfollow-up.
- Structured reporting: predefined report model useful for dataaggregation,exchange,andanalysis.Suchreportmodel is different depending on the concerned users (hospital physician,medicalservice,ortechnicalunit).
- Accessrightsdefinition:decisionmadebythepatient,about whichpartsoftherecordcanbeaccessedbyotherworkflow actors,ornot.
- Informationavailability:thepatient-centeredrecordshould beaccessible 24ha dayand 7days aweek.Suchservice couldbeprovidedbyamedicaldatastorageserviceprovider.
- Externaltransmission: make availableand communicate theEHRtothefamilyphysicianorexpertinanotherhos- pital,aswellasthedatastorageserviceprovider.
- Internaltransmission:makeavailableandcommunicatethe EHRtootherphysiciansorservicesthatarealsotreatingthe patient.
- Confidential information: provided by the patient and unknown to relatives, or supplied by family members or medical personnel, without the patient being aware ofit.
- Complementary information: for the patient, it consists inmakinguseofselectedinformationregardingthediag- nosedpathology,theprescribedtherapyandotherexisting therapies,secondaryeffects,particularlifestylerecommen- dationsassociatedtotheclinicalcondition, andthelegal texts about patient rights. For the physician and medi- cal services it consists in setting up the corresponding information, including the production of relevant docu- ments,organizingthepiecesofinformationavailableasCPI resourcesatthehospitallevel,pointingoutinformationto beattachedtoagivenrecord,andtobeupdatedwithrespect topreviouslydescribedpatientrecordcontent.CPIisindi- viduallycollectedforeachpatientandcontainsbasicparts (commonforgroupsofhospitalsandequivalentpatientcat- egories),combinedwithmorespecificpiecesofinformation tobeaddeddependingonthetreatmentand/orpathology evolution, specific requestsofthe patient, and physician suggestions.
- Patientmovements:follow-upofthepatientconsultations inotherservicesandtechnicalunitsofthesamehospital.
- Appointments: management of patient appointments dynamicscheduling,takingintoaccountpatients’referral, alongwithexpertsandmedicalserviceconstraints.
- System help: thepatient needsacomprehensive, simple andclearhelptoaccessandupdatethepatientrecord,as wellastoaccesstheCPIandappointments.Thephysician, medicalserviceandtechnicalunitmembersrequiresupport toproperlymakeuseofthepatientrecordanditsassociated tools.
Fig.4–Correspondencebetweenthefourexamineduser types–patient,physician,medicalservice,technicalunit– andthepreviouslydescribedrequirements.
Fig. 4represents ina schematic mannerthe four main users’particularrequirements,enablingtoeasilyidentifyon eachcolumntherequirementssubsets,citedbytherespective examinedactor.
This analysis does not pretend to be exhaustive, con- sideringthe complexityofdefininga commonworkflow in thehighlyinterdependentframeworkofapatient-centered record.Thecollectedinformationprovidesneverthelesssig- nificantelementstoformulateourapproach.
Comparatively evaluating the described users’ require- ments allows identifying key functional features of the envisionedpatient-centeredrecorddevelopmentframework.
As it was previously identified in the theoretical patient- centeredness analysis (Section 2.1), the most important requirementis relatedtoCPI, which isproduced byphysi- ciansand medicalservices,tobeaccessed andunderstood bypatientsand/ortheirrelatives.Associateddatashouldbe ascompleteand pertinent aspossible,with respecttothe particularsituationoftheconcernedpatient,inthesenseof carefullyselectingpiecesofinformationincloserelationwith boththegivenpatientrecordcontentandthetemporalevo- lutionanalysisofthepatientcondition,treatmentfollow-up, controlexams,etc.
FocusingonthepracticalnotionofCPI,itsagreementwith thethreeselectedcomponentsoftheMeadandBowermodel reliesstronglyontheirtranslationintokeyfunctionalobjec- tiveslike:
- Providethepatientareliableinformationsourcetosearch fordetailsofinterest(avoidingsearchinginformationfrom unreliablesources,e.g.theInternet).
- Guidethepatienttopreparediscussionswiththephysician:
raiseappropriatequestions,beingabletoexplainspecific pointstobedetailed foracomprehensionofthecurrent situation.
Fig.5–ActorsandtypeofdatainvolvedintheproductionandutilizationofCPI.
As a result, three other roles can beidentified in rela- tionwiththequestionofCPI(Fig.5):informationproducer, informationorganizer and supplier (person who transmits theinformationbetweenthetwoothercategories),andinfor- mation receiver. The main actor likely to produce those informationcontentsisthehospitalphysician.Writingsuch documentationisnotevidentlyacommontaskinthedaily medicalpracticeofthehospitalphysician,butinitiallyitcould beassignedtovolunteerpractitioners,includingspecialistsof agivendomain(e.g.radiologist,stafffrommedicalservices and/ortechnicalunits,lawyers, etc.).However,thehospital physiciankeepstheessentialresponsibilityofcoordinatingall actionsrelatedtoproducingdocumentationdestinedtothe patient.
Afterreferencedocumentsareproduced,CPIbecomespart ofmedicalinformation tobemanaged withinthe patient- centeredrecord.Themedicalsecretaryortheadministrative servicesgatherspecificpiecesofinformationthatcorrespond toeachpatientcaseaccordingtothehospitalphysicianindi- cations,organizeandattachtheconcerned documentsand contenttotherecord,and/ortransmitthatCPIdirectlytothe finaladdressee.Thepatientmustbetoldofthisinformation availability.
Sucha scenarioraises the question ofwho else should beinformedabouttheavailabilityofCPIbesidesthepatient ora family member,to facilitatethe patient’sunderstand- ing ofits content.Amongthe actorslisted above,onlythe nurse seems to be able to take that responsibility during thepatientstay,butthereferringphysiciancanalsohavea significant role duringthe out clinicstage.At afunctional level,oralexplanations givendirectlytothe patientduring adiscussionmightbeforinstancestrengthened bytextual comments, emitted bynurses, hospital physicianor refer- ringphysician,andjoinedtothegeneraldocumentationas awayofpersonalizingCPI.Otherwellestablishedinforma- tionprocessingactivitypatterns,linkedtobudgetexecution, expendinganalysis,healthcarequalityevaluation,andcoding ofmedicalactivities,arealsopartofsomeidentifiedactors’
role,andcouldeventuallyaffectpatientinformationexchange ifinvestedresourcesarediminished.Theyarenotdiscussed herebecauseexceptformedicalactivitiescoding,allofthem takeplaceoutsidemedicalservices.
3.4. Technicalrequirementsforthemanagementof complementaryinformation
Independently of the form given to CPI (e.g. documents, database entries, indexes, etc.), its content consists of
structured and detailed text, diagrams and images, which implyahighworkloadfortheactorswhohavetherespon- sibilitytowriteit.Thischargewillbeverysignificantforthe hospitalphysician,whoaccordingtotheproposedmodelhas acrucialrole ofcoordinatingtheCPI providers.Inaddition to expert knowledge contributed by specialists, this con- ceptiontaskcould alsotake advantageofexisting medical knowledge databases.For instance, establishing automatic linksbetweenidentifiedCPIkeywordsandconceptsusedin theindexationofglobalsourcesofevidence-basedmedicine, likethe systematic reviewsofthe Cochranelibrary [35,36], wouldfacilitateensuringthattheconcerned subjectisfur- therexplored.Nevertheless,documentsextractedfromsuch informationsources,notoriginallyintendedforpatients,can- notbeuseddirectlyasCPI,andatradeoffremainstobefound betweencompleteness of the documentation and required efforttobuildandfeedtheinformationbase.Furthermore,CPI managementisalsoconstrainedbysometechnicalconsidera- tionssuchasstoragevolume,informationresearchefficiency, andservers’traffic,whichhighlyinfluencedatastructuring.
Dependingonimplementationresourcesandexistinginfras- tructure,thosesystemdesigndecisionscanbecriticalbecause justfewstorage,researchandtrafficmodelswouldbeadapted toeachparticularcase.
Consequently,takingaccountoftheserequirementsinthe propositionofatechnicalframeworkformanagingCPIalso dependsonanswerstothefollowingquestions:
- Howbasicdocumentationshouldbegenerated,whichfor- mats should be used, for which storage modalities, and accordingtowhichinformationresearchmodalities?
- HowtomanagethedifferentaspectsoftheCPIinorderto findacompromisebetweeninformationcompletenessand datavolume?
Theconsidereddirectionstoanswerabovequestionsrely onthenotionofpatientcategories.Althoughpreviousrequire- ments concerning CPI are fully compatible with the three identifieddimensionsoftheMeadandBowermodel,aspe- cificconceptualizationassociatedtoeachdimensiondepends on multiple patient preferences that change according to the healthcare scenario. When asked about their specific requirementsregardingpatient-centeredrecord content,all 12interviewedvolunteerpatientshadtheideaofaccessing information,forexample,abouttheirpathology,thetherapeu- ticprocedurerisks,alternativetherapies,secondaryeffectsof medication,lifestylechanges,palliativecare,orlegalrights incase ofmedicalerror, amongothers. While the relative
Fig.6–Attributionprocesstodetermineapatientcategory.
Atstepsingray(patientconsultation,conclusion),the patientcategoryhastobeinitializedand/orupdatedwith thecorrespondinglinkeddocumentation.
importanceofeachitemdiffersfromonepatienttoanother, theexpectedamountofinformationmayalsochangedepend- ingonthepathologytypeandseverity.Suchvariabilitywas alsoidentified in another context,with previously defined specific categorization of information preferences, related toinformationitemsandparticipationinmedicaldecision- making [33]. Our work takes account ofthat variability by including concepts and attributes destined toexpress this categorization of patients’ requirements in the resulting patient-centeredrecord.Technically,themanagementofCPI isthusfacilitated,withrespecttoabovecriteria,byabstractly associatingnecessarycontentsattheintersectionofinforma- tionclasses(e.g.pathologydescription,medication,laboratory exams, prescribed treatment, etc.) and patient categories, definedwithrespecttothepatientevolvingsituation.
However, the definition ofspecific patient categories is notconsideredinthiswork,becauseofthemultiplelinksto contextualdecisionstakeninthissensebythehospitalphysi- cian.Therefore,ourpatient-centeredrecordmodelremains generic,havingthepossibilityofbeingadaptedtopatientcat- egorytypes,dependingonmedical(typeofpathology,severity, evolutionstage,sex,age,degreeofautonomy,etc.)ortemporal elements(partialoutcomeofthetherapeuticprotocol),other patientindicators(computerliteracyandeducation),ormore subjectivecriteriainrelationwiththephysician’sexperience (forinstance thephysician’s perceptionofpatientcapabili- tiesorpost-treatmentevolutionpotential,butalsodegreeof interestinCPIandactualestimatedcapacitytomakeuseof CPI).
Inatypicalscenarioofpatient-centered recordcreation (Fig. 6), no categoryis assigned to the patient until afirst interviewwiththehospitalphysicianhastakenplace.After initialization,thecategoryassignedtoapatientcanberevised dependingonthegeneratedconsultationreports,whenmedi- calactsanddiagnosedpathologiesareencoded.Theassigned
category then depends on both the current state of the patient-centered record and the history of coded medical acts,determiningthedetaillevelofCPItobeattachedtothe patient-centeredrecord.
Otherwise, the task of structuring CPI to facilitate its research in large databases relies on keywords extraction and indexation mechanisms. Besides, the abilityto search forpieces ofinformation linkedto a givensubject will be usefulforthe patient, aswell as forthemedical secretary whoassumestheroleofattachingrelevantdocumentstothe patient-centeredrecorddependingonthemedicalcondition.
Tosupportdocumentselection,themostadvancedformof informationmanagementthatcanbeconsideredisthefull automationofinformationattachment.Otherwise,interme- diateinformationprocessingmechanismscanbeimagined to guide medical secretaries, relying as well on matching betweenavailabledocumentson the CPIdatabase and the patientrecordcontents.Medicalactscodingcouldplayakey functiontothis end,giventhatcodesrepresentdirectly an indexedversionoftheconcernedmedicalinformation[34].
4. Patient-centered record development framework
Inthissection,weproposeadevelopmentframeworkaimedat supportingtheimplementationofapatient-centeredrecord.
This technical analysis was focused on data structuring, examininghowfunctionalrequirementsexpressedbyinter- viewed users determine the record database design. The recommended data structures were conceptually defined, usingaconventionalentity-relationship(E-R)formalism,well adaptedtomodeldatadestinedtobestoredintorelational databases,widelyusedinthedomainofmedicalinformation.
ThissectionpresentstheE-Rschemasemployedtostructure datainthe prototype that was implementedas aproof of concept.
4.1. Mainentitiesofthemodel
Theresultingdatamodelsformamultifacetedsetofrelated entities,organizedin5maincomponentsaccordingtousers’
requirementsandtheidentifieddataconnections.Fig.7shows thecorecomponentsofthepatient-centeredrecord:Person, Patient,Professional,MedicalPersonnel,andHospitalization.
Person isthe basicmodeltocreate, byinheritance,both PatientandProfessionalentities; aPatientundergoes aHospi- talizationthatistakeninchargebyMedicalPersonnel.Hence, thecorepartsofthemodelrepresentinganindividuals’data, shareanentityabstraction, destinedtorepresentcommon aspectsofthemainactorsidentifiedintheworkflow,butalso toallowacoherentmanagementoftheirnumerouscommon requirements(Section3).ThePersonentitycorrespondstoa separatedatamodel(notpicturedinFig.7),whichstoresiden- tification,localization,and record accessdata, usedbythe Professionaland Patiententities. The Professional entitygen- eralizesthe concept ofhealth professionals, either Medical Personnelassociated to medical Service or Unit entities, or PrivatePhysician(notpictured)takingpartintheconcerned patienthealthcareinterventions, extendingthequestion of
Fig.7–Exampleofthepatient-centeredrecordcore components.
inheritanceandtheresultingdatamodelcitedabovetoahier- archyofdatatypes.
Theneedforcoherentmanagementofcommonrequire- mentsalsoreliesonthenotionofusergroups,forinstance adaptedtostructuringdatarelatedto amedicalserviceor unit. Otherapplications ofthatnotionare: anaturalman- agementofthelistofprofessionalsconsultedbythepatient outside the hospital, intended to be regularly updated to ensuretheirabilitytorefertotherecorddataandtoupdate patient’s follow up and treatment information, according tothe “patient record access” and “patient record update”
requirements;asupporttothemanagementofcorrespond- ingaccessrightsatdatalevel,and relatedactionsondata, especiallyassociated tothe requirements of “access rights definition”andmodificationduring“patientmovements”and record“internal/externaltransmission”(e.g. grantingaccess toacompleteservice,ortotheroleofmedicalpersonnelat once).
4.2. Patientdatamodel
ThePatientdatamodellinksconventionaldatacomponents likespecificmedicaldata,personalhistory,pathologytypes, treatments,consultations,andacts(Fig.8).Apatientcango throughambulatoryconsultationthatproducesarecord,be hospitalized, follow atreatment, go through an additional examinationoramedicalactdescribedbytherespectivecon- ditions,patientpreparation,andknownrisks.Thesedataare likelytobestoredindistributedserversinsideandoutsidethe mainreferencehospital.
Therequirementof“patientrecordaccess”expressesthe needforbothpatientsandhealthprofessionaltoaccessnot onlycurrentrecorddata,butalsodatathatreflectthemedical historyofthepatientinachronologicalmanner,implyingthe managementofatemporaldimensionintherelationaldata ofthe patient-centered record. Historytables like Personal
Historyanswerthatrequirement,withtheadditionalbene- fitsofprovidinganaudittrailofrecordupdates,theabilityto extractusefulaggregatenumbers,andthepossibilityofrecov- eringpastrecordstatesorretrospectivepathologysearch,if necessary[39].
4.3. MedicalPersonneldatamodel
MedicalPersonnelalsohaveacomplementarysetofparticular associateddataentities(Fig.9),inrelationwithpatienthos- pitalization.Duringhospitalization,amedicalinterventionis carriedoutwithinatemporalframe.Eachinterventioncorre- spondstoasetofacts,describedinitiallyusingfreetext,to belatercodedbymeansoftabularcodes.Dependingoninter- ventionresultsandpatientevolution,anydecisionandfact aboutatreatment(includingunwantedeffects)andmedica- tion,isdocumentedindetail.CPIislabeledusingkeywords pointedoutinthetextpartofthedecision,referringtothe informationresourcesneededtofulfillthepatient-centered systemrequirements.
During hospitalization and when it ends, conclusions reports are generated by the responsible medical person- nel.Thesereportsalsocontainrelevantpost-hospitalization keywordspointing to CPI documentsconsidered necessary within the patient-centered scheme, and a given degree ofconfidence.According tothe requirementof“structured reporting”,piecesofinformationcontainedinthesereports arearrangedundertheformofaconclusionssummary,which can take the form ofa conclusion typecode and descrip- tionlist. Noparticularimplementationisspecifiedherefor conclusion, decision and pathology type codes, to allow using different coding standards. Both decisions and con- clusionsgenerateletterssenttothereferringphysician(not pictured).
The temporal dimension linked to the requirement of
“Patient record access” also induces the history of all requested and completed exams to be recorded in his- torytables(not pictured),asforpatient’smedicaldata,and requiresconstraintsontemporaldatatoensure,forinstance, the coherence between related temporal frames and their compatibilitywithdatesofhospitalization.
4.4. Complementaryinformationdatamodeland technicalspecifications
Tocomply withthe patient-centeredrecord users’require- ments specifications defined in Section 3, CPI Elements (Fig. 10) have relations with medical data (not pic- tured) that translate the nature of CPI, summarized as follows:
- Selectedinformationdynamicallyfittedtothepatientevolv- ing situation and degree of interest, to improve patient understandingofbiomedicalillnessfactors(associatedto thePathologyTypeentity):symptoms, pathologydescrip- tionanddiagnosisprocedure.
- Categorizedinformationabouttherapiesandsurgicalpro- cedures,properlyadaptedtopatientconditions,andpatient questions, in order to facilitate decision making and
Fig.8–ConceptualPatientdatamodel.
comprehensionoftherapeuticobjectives(associatedtothe Actentity):treatmentorsurgicalproceduresdescriptions, alternatives,hospitalizationanddischargeconditions.
- Treatmentapplicationdescription(associatedtotheTreat- mententity):detailedexplanationoftheselectedtreatment procedure, precautions during treatment, possible side effects,andlifestyleadvice.
- Post-treatment informationand requestedpatient partic- ipation(relatedinadistributed mannertothePathology,
Act, and Treatment entities): once a decision has been taken,providesupportforpersonalinformationacquisition, storage, and handling to enable personalized longitudi- nalfollow-up, besidesthephysicianand/ormedicalteam follow-up, includingrecommendationsabout information delivery,post-treatment prevention,self-managementfor chronic illness, and palliative care conditions in case it wouldbenecessarytotreatpain, relieffrom suffering,or otherdistressingsymptoms.
Fig.9–ConceptualMedicalPersonneldatamodel.
Fig.10–Entitiesrelatedtothepatient-centeredrecordCPImodel,centeredontheE-Rschemeproposedtomanage informationmodularity(boundedinlightgray).
Socialand psychologicalfactors did notemergeas part ofthemedicalservicesandtechnicalunitspatient-centered careawarenessstudy,eventhoughtheirinclusion couldbe importantinsomecases.Yet,thosefactorswillbemuchbet- terhandledbyaspecialistincontactwiththepatientthanby asystemautomaticallyretrievinginformationfromaspecific database.
Basic generic documentation concerning points cited abovecanthen beenrichedandpersonalizedbythehospi- talphysicianor nursesinchargeofthepatient,or through follow-upbyprivatephysicians,viatheadditionoffreetext comments to information documents, concerning aspects linkedtomedicalfacts(e.g.relationsbetweenthepatientlife styleandprescribedtreatments).Fortraceabilitypurposes,the identityofanycommentsauthoriskept.
Whenreferringtocomplementarypatientinformation,the term “information” designates informational contents like piecesoftextsandspecificideastheyconvey,whichhaveto bedistinguishedfromdocuments,databaseentries,ordigital files,usedasmediatostorethem.Weassumethatthenature ofsuchinformationmakespossibletoexploitseveralsupport typesandtransmititfrominformationproducerstoinforma- tionconsumers.Theproposedpatient-centeredrecordmodel isbasedonthe assumptionthat CPIabout agiventopic is writteninanelectronictextfile(e.g.inPDFformat)thatcan besplit into several parts or completed in anincremental way,depending onthe targetpatientcategory.Suchformat willprobablybemorenaturalforinformationproducers,and appropriate for patients to read. In addition, the require- mentofCPImanagementmakesnecessarytojointothese standarddocuments,freetextasasupportforbothperson- alizedinformationandexplanationaboutCPIcontents,and database entriesthat facilitateindexation and information research.
ThedatamodelonFig.10alsotakescareoftwotechnical requirementstoexamine:modularityinrelationtothecom- posednatureofthe CPIandthe abilitytoadd dynamically newinformationentities.Thislastrequirementcorresponds toanother inheritancesituation(sub-typesofCPIElements inrelation,ascitedabove,withpathology types,acts,etc.).
Thequestionofmodularityreferstothereductionofcoupling betweenpartsoftheinformation,toallowaseparateevolution of,e.g.informationdocumentsandcommentstothepatient, bothin terms ofcontents and form.We proposea simple data-structuringmodeltomanagedatamodularity(Fig.10), composedofthefollowingentities:CPIElement,Information Document,andComment.Theseparateevolutionofeachpart isillustratedbythefactthatversionsandcontentsofInfor- mationDocumentsandCommentsareadapted,respectively, tothepatientcategoryandspecificity.
Whenevertherecordismodified(particularlywhencon- clusionsarerecordedasshowninFig.6),attachedCPIhasto beupdated,andinformationelementsdocumentedinrela- tionwithitemsdetailedabove,areretrievedinthedatabase systembybrowsingrelationshipsconnectedtothepatientsit- uation(recordhistory,demographicsdata,andcurrentclinical data)andtherapeuticstatus(treatments,undergonemedical interventions,decisionsofthehospitalphysicianandrespec- tiveconclusions).Hence,thosemedicalfactsidentifiedinthe patient-centeredrecordprovideCPI,whichisthendeclined into adapteddocuments, with respect tothe patient cate- gory(orcategories oflowerranksifthis conceptdenotesa temporalevolution,justifyingpreviousversionsofinforma- tiontobekeptinthepatient-centeredrecord).Acertainlevel ofautomationcanalsobeconsideredtohelpthephysician identifyingkeyconceptsandCPIindexationkeywords,rely- ingforinstanceonclinicaltoolsusedintheevidence-based medicineapproachtoemitalertsandremindersfrominput
Fig.11–Patient-centeredrecordclient–serversystemarchitecture.
medicalrecords[37,38],andinrelationwithmedicalcoding systems[40].
4.5. Systemarchitecture
Diversearchitecturemodelslikemultitier,web-services,and client–server could be utilized to develop the proposed patient-centeredrecord.Aclient–serverarchitecture,integrat- ingdatamanagementandapplicationprocessing,waschosen accordingtoanopensourcesoftwareapproach.Itdidnotcon- siderhowevertheissueofusingdifferentpatientidentifier approaches,namelythelackofPINuniqueness.Inthepar- ticularcaseofFrenchhospitals,onwhichourstudyisbased, theissueofpatientidentification hasbeen partiallysolved throughmultipleseparatelocalandregionalinitiatives[41].
WeassumenonethelessthatthereisauniquePIN,usedby allmedicalservicesand technicalunitsofagivenhospital, capableofassuringpatientanonymity.Userattributeswere handledbyaprofilesdatabase.Alightweightdirectoryaccess protocol (LDAP) was defined for this purpose, considering its effectiveness to embody hierarchical entries represent- ingindividuals,groups, and systems, aswellas toprevent unauthorizedaccesstothesystem.Patient-centeredrecords were structured applying the previously described data model.
4.5.1. Clientandserver
Ontheclientsideitisonlynecessarytorunawebnaviga- toronapersonalcomputerconnectedtoanetwork,without allowinganylocalstorageoftheconsultedinformation.Con- tentwasencapsulatedforpresentation,usingdynamicPHP pagesandJavaapplets,whichcanbehandledbyanynaviga- tor,permittingtoincludesupplementarysecurityrestrictions andcontrols.
Severalcomponentswererequiredontheserverside:web server,contenthandlingandpresentationscripts,databases,
anddatabasemanagementsystem(DBMS).AnApacheweb server,aPHPscriptprocessortocreatedynamicwebpages, a Tomcat-Cocoon based XML-XSLT content manager, and a MySQL relational DBMS, were the implemented compo- nents.Thedatabasewasdesignedtohandleincreasingdata volumeandmultiplekindsofdataformats,includingrefer- encestomultimediaobjects(documentedimagesandimages sequences).
4.5.2. Modulesconnection
The patient-centered record architecture was designed to beopen,modular,flexibleenoughtofacilitatechanges,and basedon various standards. Itsmainobjective isto easily permittheaddition ofother databases and functionalities, without havingtoredefine significant parts ofthe system.
Our implementation proceeded in this direction making useofwidelyaccepted,developed,andutilized informatics standards.Fig. 11 illustratesthe mainsystem architecture componentsontheserverandclientsides.Thecommontrait ofmostuserrequirementsisthepatient-centeredrecorduti- lization,whichmaytakedifferentformsdependingonhow itisexploited.Selectedpartsofthepatient-centeredrecord orallavailableinformationaredisplayeddependingonuser rights,whentherespectiveapplicationuserinterfaceisacti- vated.Systemadministrationfunctionswerealsoanessential partofthepatient-centereddesign,eventhoughtheywerenot beenexplicitlyaddressedintheprevioussections.
5. Discussion
Thiswork exploresacomputerized patient-centeredrecord developmentframeworkforscenariosonwhichitisnecessary tomanipulateinformationunitsformedbyspecificCPIand patientdata,whichcanbeindependently stored,transmit- ted,accessed,andvisualized.Accordingtothisprinciple,the proposedpatient-centeredrecordmodellooksforthemanner
tobuildanarticulatedsystem,usinginformationmoduleson datarepositories, enabling transversal informationstreams exchanges between medical services and technical units, avoidingredundantinformation.Itsimplifiestheintegration ofotherdatatypesandapplicationstothedefinedarchitec- ture,inthecaseoffurthersystemdevelopment.
From atechnical point ofview,future implementations ofapatient-centeredmedicalrecordbasedontheproposed frameworkwillhavetostructuredataandrelatedprocedures accordingtousers’requirementsandtothetechnicalanaly- sisthatwasmadeoftheseuserneeds(Section4).Relational schemasproposedaspracticalsolutionstothesefunctional requirements are domain-specific, but some key concepts identifiedfromtheworkflowanditsanalysiscanbeabstracted to commonly occurring data-structuring problems, leading todefineand applymoregeneraldatabase designpatterns.
Databasedesignhasbeenexperimenteddirectlytransposing conceptsofsoftwaredesignpatterns,knowntofacilitatecap- italizingonaccumulatedknowledgeandexperiencetoensure extensibilityandmaintainability features [42,43], aimingat definingdatamodelsattheconceptual,logical,andphysical levels[44].Originalrelationaldatabasepatternshavealsobeen proposed,mostlyformalizedbyE-Rschemas,fortheformal expressionofconceptionrules[45].Inadditiontoadvanced databasepatterns aimingatimplementing properly inheri- tance inrelational data, thefollowing keydata-structuring concepts identified from users’requirements can be asso- ciated to structuring patterns: extension of the notion of inheritancetoahierarchyofdatatypes(“Hierarchy”pattern), associatedtoa generic management ofthe notionofuser groups(“Composite”pattern);thislastpatternisalsoadapted tostructuringdataassociatedwithpredefinedreportmod- els,possiblydifferentforeachkindofmedicalactor,forthe purposeofgenericprocessing.Inthatcase,therequiredsepa- rationbetweendatainterfaceandimplementationcanalso rely on advanced solutionsto manage ina modular man- nerCPIentities(“Materialization”pattern,inspiredfromthe principle of the “Bridge” software pattern). Also, adding a specialistfromahealthprofessionnotyetregisteredinthe record,oranewkindofCPIelement,canjustifythecreation ofadditionalrelationaldatafieldswhencharacterizedbyspe- cificattributes(“Pivoting”pattern).Finally,themanagement oftemporalframesforentitiessuchasInterventionandAct requiresthedesignofcorrespondingdatastorageandman- agementstrategies[39].
Besides those technical questions, we assumed that patient-centeredcarecanseamlesslymakeuseofapatient- centeredrecord,althoughseveralquestionsneedtobefurther examinedindetail.Prospectivemedicalpersonnelviewswere takenasreferencetoguidesystemdevelopment,giventhat undertheproposedframeworktheyareexpectedtoidentify andcollectalltheneededCPItobestoredanddisplayedby the patient-centeredrecord application. Asa consequence, apatient-centeredrecorddemandsmorephysicianinvolve- menttoprepare,select,anddefineCPIattributionaccording todiagnosis,therapy,andclinicalcondition.Isitreasonable to add that task to physicians’ responsibilities? Moreover, other professionalsparticipationwillalsobenecessary, for instancetoprovidepatients’legalrights,lifestylechanges,or psychologicalinformation.Ontheotherhand,theprovision
ofselectedCPIimpliessignificantinvestmentfrommedical institutions,whichwouldbeexpectedtosupportCPIcreation andutilization,insteadoflettingthepatientstrugglealoneto eventuallyfindit.Willhospitalsbeinapositiontoefficiently developandhandlethoseinformationservices?Anincreas- ing number of hospitals have been proposing simplified informationaboutmedicalexamsdescriptionsontheirweb sites.Thenextsteptowardanelementarypatient-centered recordapproachcouldbetoconvenientlylinkthatinforma- tiontospecificpatientaccounts,accordingtodiagnosesand therapies.
Sincepatienteducationlevelisnotuniform,whatinforma- tiondoesthepatientneedtobuild-upproperunderstanding?
Answers to this question are fundamental to pre-select the type of CPI that should be provided according to the patientcondition, as well as todetermine iftargeted edu- cational efforts can reduce patient lack of understanding.
Shouldthe patientbeauthorized toaccessall the patient- centered record information? Some physicians suggested that it must rather be a summary, eventually containing severalimages.Nevertheless,asummaryrepresentsredun- dantwork,unlessitwouldbeautomaticallyextractedfrom the patient record. This fact raises additional questions about whichkind oflanguage would beemployed, how to structuretheoriginaldocuments, andhow detailedshould summaries be. The question about access rights is even morecomplex giventhatundercertain circumstances,and despite patient decisions, information should be disclosed if it can ameliorate an intervention result, for instance in emergencies.
Thequestionregardingthenecessityofincludingmultime- diadatainthepatient-centeredrecordisdebatable.Legaland medicalreasonsrequirearchivingduringpre-definedtimes, diagnosticdatalikemedicalimagesandsignals,aswellaslab- oratoryresultsandmedicalprescriptions.However,oncethe diagnosishasbeencompleted,thephysicianrarelyexamines againthecompletemultimediadataset,exceptfortheconsul- tationreportsandthepatienthistory.Also,itisnotclearhow importantwillmultimediacontentbeforthepatient.Alterna- tively,patient-centeredcareleadstotheinteractionofseveral actorsordetailed patient follow-up, makingmedicalactiv- itypartiallydependantontheavailabilityofmultimediadata, sharedinadistributedinfrastructure.Theproposedplatform copeswiththisfunctionality.
Anotheressentialquestionthus remainsconcerningthe issueofgeneratingcomplementarydocumentation,underthe constraintofproducingreusabledocumentsandinformation toreducetheworkload associatedwiththistask. Whether suchinformationisstructuredasfieldsofadatabaseorsimply compiledintofiles,assupposedinthedefinedarchitecture, reusingitshouldbeeasierthanexchangingpatientinforma- tion,sinceCPIisnotsubmittedtoconfidentialityconstraints orequivalent restrictions.However,accesstorawinforma- tionshouldberestrictedtoprofessionaluse,giventhatinthe contextofthepatient-centeredrecord,reliableCPIisofkey importance.ACPIdocumentrepositoryshouldbebuiltthere- forewithstandardwebsitearchitecture.Theonlycondition tobefulfilledforanefficientsharingofcontentwillbethe existenceofcommonpreviouslydefinedpatientcategories, havingasemanticmeaningshared bydifferentspecialists,
whosesensitivitieswithrespecttothepatientclassification problemmaydiffer.
Itisalsoimportanttoconsider theabilitytobrowseCPI associated to a given record. Whether this information is storedunderarelationalformorispresentedasasetofref- erenceddocuments,indexingcanbeusedtolinkkeywords extractedfromthepatientrecordwithrelevantinformation.
Therefore,someusesoftheindexingmechanismcouldbe:
- Automatically associate (fully/partially) referenced docu- mentstotherecord.
- Search particularinformation withinthecomplementary documentation.
- Createinternallinksbetweenpartsofdocumentationasso- ciated to a given record,allowing the patient to browse information, and increasing the flexibility of relations betweenreferenceddocumentsandpatientcategories.
- Dynamiccreationofalternativereading pathswithinthe addedCPI,dependingforinstanceonthedegreeofdetail, orparticularmedicalaspect.
Wealsonotetheimportanceofusingstandardizedkey- words and concepts for information indexation, possibly common with existing medical knowledge and evidence- based medicine databases (e.g. Cochrane library, EBMeDS), potentiallysimplifying the conceptionofsharedCPI repos- itories cited above, and possibly facilitating the use of semi-automaticCPIgenerationtools.
Thereareothertechnicalunitsystems,likepharmacovig- ilance(preventionofshortandlongtermadversesideeffects ofmedications),vigilanceofhumanparts(organs,tissues,and cells)utilizationasmedicaltreatments,andvigilanceofnoso- comialinfections(developedafterpatient admissionatthe hospital),whichhavenotbeenconsideredinthisstudy,but thatcouldalsobepartofpatient-centeredrecorddesign.
6. Lessons learned
Despitetheexistenceofmultiplepatientrecordstypes[46], theseareessentiallyphysician-centeredormedicalservice- centered,and as a consequencedo notenable patients to completelyand easilyunderstand theirmedical conditions andhealthcareprocess.Ifsuchunderstandingcouldbefacil- itated by means of a patient-centered record, it implies a mandatorytransferofthepatient-centerednessnotionfrom medical practice to medical practice support systems, by developingadaptedinformationtechnologyapplications,tai- lored to medical workflow. On the other hand, previous patient-centeredrecordstudiesdocumentedintheliterature, basicallyrepresentedthedimensionofpatients’accesstopart oftheirpersonallygeneratedmedicaldata,accordingtoindi- vidualchoices.Inthis context,partialviews oftheoriginal physician-centeredor medicalservice-centered records are extractedandvisualized,withoutmakinguse ofassociated CPI.
Ourworkidentifiedmostnecessaryelementstodefinethe requirementsofapatient-centeredrecordthroughinterviews, fielddatacollectionandanalysisofpatient-centeredaware- ness,leadingtotheconceptionofadevelopmentframework,
tocollectandselectadaptedcomplementarypatient-centered information.Inthis sense, therequirements studyfocused onpatient-centerednessawarenessbyexploringitsinterre- lated dimensions(information exchanges, patient-centered careworkflow,rolesofmainactors,userrequirements,type ofpatient-centeredrecordandtechnicalrequirementsforthe managementofCPI),oftenneglectedbecauseofthepreviously mentionedpredominanceofphysician-centeredness.
One ofthe maininsightsfrom this studyis theindica- tionthatapatient-centeredrecordmainlycontainsCPI,which mustbedynamicallyadaptedtothe patientevolvingsitua- tion,dependingonabstractcategoriesintendedtolinkrelated documentation.Multiplequestionsrelatedtothewayofpro- ducingandhandlingappropriateCPIresultfromthisanalysis.
Giventhatallpatientsareexpectedtomakeuseofapersonal- izedpatient-centeredrecord,compatiblewiththeirpastand currentmedicalstatus,alongwithwhatcouldbeconsidered anarbitrarilyassignedcapabilitytoproduce(formedicalper- sonnel)andtohandle(forpatients)theprovidedinformation, theautomatedtreatmentofthewholeprocessislikelytobe complex.
Asaconsequence,improvementofhowthepatientunder- standsandfollowshis/herownhealthcareprocessrequires additional specialized medical and non-medical person- nel contributions, further system developments, and more detaileduserrequirementsanalysis,beyondthebasicscheme presentedinthispaper.Moreover,patientsdonotknowyet whattoexpectfromapatient-centeredrecord,otherthanbe abletoconsultpartoftheirmedicalinformation,decidewho mayhaveaccesstoit,andexaminetheirrespectiveCPI.
7. Future work
Patient-centerednessisawell-knownmedicalpracticecon- ceptthatrequiresspecificuser requirementsand workflow analysistobeintegratedinmedicalinformationsystems.The proposedpatient-centered record isbased on hospitalper- sonnel/patientprospective interactions likely totake place duringhospitalizationorconsultation,conceptualizingaset ofcoherent abstractions that share embedded patient ori- ented information, to complete the patient-centered care process.
Furtherworkinthisdirectionneedsfirsttoexaminethe efficacyofthedevelopeddatamodels,particularlytheenti- tiesrelatedtoCPI,inordertofindoutuptowhatpointdata obtainedfrom historic, consultationand treatmentfollow- up records,allowidentifying the correct reference phrases togenerate the associated CPI. Otherwise, versions of the implemented architecture using existing components and definitions from medical informatics standards should be examinedinordertoaddresstheproposedframeworkade- quacyintermsofconstrainedfunctionality.Thenextstepwill betoinvestigateautomaticprocedurestocollectCPIinforma- tionaccordingtokeywordsidentifiedinEHR,andhowthose procedurescopewithinfrastructurerestrictions.
Itwillalsobeimportanttomeasurethenecessaryeffort asked to physicians and other professionals to generate thereferenceand morespecializedCPI,whichundoubtedly resultsinaworkloadincreasefortheconcernedpersonnel.
Furthermore, availability of such CPI implies that patient accesstoselectedinformationmustbedynamicallyconfig- uredbythe system, dependingon thecorrelation between specificpatientrequestsandkeywordsmarkedbyphysicians’
on the reports or automatically identified. Finally, regard- lessofthe dataincreasecomparedtoconventional patient recordmodels,thepatient-centeredrecordcouldimprovenot onlyhow the patient understands the healthcare process, butalsoenablephysicianstostimulatepatientsinthepro- cessofbecomingmoreactiveactorsoftheirownhealth.The endeavorofmeasuringthisimpactwillconductprobablyto reformulatepartsoftheinitialpatient-centeredrecordprin- ciples.
Conflict of interest statement
Authors declare not having any personal, financial, or additionalsourceofrelationshipswithotherpeopleororga- nizationsthatcouldinappropriatelyinfluencetheirwork.
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