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GiovanniBoniolo
DepartmentofHealthSciencesUniversityofMilano
&BiomedicalHumanitiesUnit
DepartmentofExperimentalOncologyEuropeanInstituteofOncology(IEO,Milano)
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YourHolyGrail
Justification
no practice shall be carriedout unless its introductionproduces a positive netbenefit
Optimization
allexposuresshallbekeptaslow as reasonablyachievable, economic andsocial factors being takenintoaccount
Limitation
the dose equivalent toindividuals shall not exceedthe limits recommended byICRP
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Otherethicalissues
Malpractice
concerning1) you do not know what
youshouldknow2) youdo(notdo)whatyou
should(not)do
Communicationofrisk
concerning1) known stochastic or
deterministeffects2) unknown stochastic
effects
Conflictofinterests
between practitioners’duties and practitioners’advantages
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from
informedconsentto
participationpact
basedontrustandfurnishingthecontextualizedrelevant
information
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Ethicalcounselling
Ethicalcounsellingisadialogicservicebymeansofwhichanethicalcounsellor
helpsapatient(oroneofhis/herrelatives)toundergoaparticularsolutionofwhat
couldbesaidanethicalanddecisionalparalysisconcerningaparticulardiagnostic
ortherapeuticprocedure.
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Carla,32,ismarriedwith2children.Sheisatthethirdmonthofpregnancyanddecidestogotothedentistfortheusualyearlycontrol.Thedentistfindssomethingstrangeandasksfortestsandforanoncologicalcontrol.Thediagnosisisfrightening:jawsarcoma.
Sheistoldshehastwooptions:thebestdiagnosticandtherapeuticone(afirststagingstepwithCATtotalbodyandPET;asecondtherapeuticstepwithpresurgerychemotherapy,surgeryandpostsurgerychemotherapy)andone“adapted”(nodiagnosticstaging,justsurgery).
Ifshechoosesthefirst,thepregnancyhastobeinterruptedbutshehasgreatpossibilitiesofhavinganormalandlonglife.Ifshechoosesthesecond,shehasthepossibilitytokeeppregnancyon,butthereisnocertaintyaboutherlife.
Carladoesnotknowwhattodo:savingherlifeandlettingthenewchilddie,orsavingthelatterandprobablydie?
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Participationpact&Ethicalcounselling
forareal
patientempowerment
Patientempowermentisaboutdesigninganddeliveringhealthandsocialcare
servicesinawaythatareinclusiveandenablecitizenstotakecontroloftheirhealth
careneeds.Patientempowermentputsthepatientattheheartofservices.
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ACCE…isamodelprocessthatincludescollecting,evaluating,interpreting,andreportingdataaboutDNA(andrelated)testingfordisorderswithageneticcomponentinaformatthatallowspolicymakerstohaveaccesstouptodateandreliableinformationfordecisionmaking.
….
AnimportantbyproductoftheACCEmodelprocessistheidentificationofgapsinknowledgethatwillhelptodefinefutureresearchagendas.
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ACCEforradioprotection
AAnalyticalvalidity.Itconcernsboththeexperimentalaccuracyofthediagnosticortherapeuticinterventionandthescientificqualityoftheequipmentandofthepersonnel.
CClinicalvalidity.Itconcernstheaccuracyandprecisionthatthediagnosticortherapeuticinterventionpredictsortreatsthepathologicalsituation.
CClinicalutility.Itconcernstheclinicalsignificanceforthepatient’sbenifitofthediagnosticortherapeuticintervention.
EEmpowermentofthepatient.Itconcernstoenablepatients/citizenstotakecontroloftheirdiagnosticortherapeuticneedsforashareddecisionmaking.
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ACCEforradioprotection
AAnalyticalvalidity.Itconcernsboththeexperimentalaccuracyofthediagnosticortherapeuticinterventionandthescientificqualityoftheequipmentandofthepersonnel.
• Limitation• Malpractice
CClinicalvalidity.Itconcernstheaccuracyandprecisionthatthediagnosticortherapeuticinterventionpredictsortreatsthepathologicalsituation.
• Optimisation
CClinicalutility.Itconcernstheclinicalsignificanceforthepatient’sbenifitofthediagnosticortherapeuticintervention.
• Justification• Optimisation• Malpractice
EEmpowermentofthepatient.Itconcernstoenablepatients/citizenstotakecontroloftheirdiagnosticortherapeuticneedsforashareddecisionmaking.
• Justification• Optimisation• Malpractice• Communicationofriskandoftherelevantinformation
• Participationpact• Ethicalcounselling
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TheACCEmodelprocessiscomposedofastandardsetof44targetedquestionsthat
addressdisorder,testing,andclinicalscenarios,aswellasanalyticandclinical
validity,clinicalutility,andassociatedethical,legal,andsocialissues.
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ACCE:XXtargetedquestionsconcerningradioprotection
ELEMENT COMPONENT SPECIFICQUESTION
Disorder/Setting AnalyticValidity • Limitation
• Malpractice• Whichisthe“right”patient‐centreddosefortheprocedure?
• Isthepersonellrightlytrained?• Isthelabrightlyequippedandconstructed?
ClinicalValidity • Optimisation • Istheonlypossiblealternative?ClinicalUtility • Justification
• Optimisation• Malpractice
• Isreallyusefulforthepatienttheprocedure?
Empowerment • Justification• Optimisation• Malpractice• Communicationofriskandoftherelevantinformation
• Participationpact• Ethicalcounselling
• Isthepatientproperlyinformedabouttheprocedureandaboutthestochasticanddeterministicpossibleharmufuleffects?
• Hasbeenpatient‐centredtheinformation?• Isthereanyconflictofinterest?• Hasthepatientagreedwiththeparticipationpact?• Istherethenecessityofanethicalcounsellingandhasthisbeenrigtlyinstantied?
