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Practices of end-of-life decisions in 66 southern French
ICUs 4years after an official legal framework: A 1-day
audit
Claire Roger, Jérôme Morel, Nicolas Molinari, Jean Christophe Orban, Boris
Jung, Emmanuel Futier, Olivier Desebbe, Arnaud Friggeri, Stein Silva, Pierre
Bouzat, et al.
To cite this version:
Claire Roger, Jérôme Morel, Nicolas Molinari, Jean Christophe Orban, Boris Jung, et al.. Practices
of end-of-life decisions in 66 southern French ICUs 4years after an official legal framework: A
1-day audit. Anaesthesia Critical Care & Pain Medicine, Elsevier Masson, 2015, 34 (2), pp.73 - 77.
�10.1016/j.accpm.2014.10.001�. �hal-01759479�
Practices
of
end-of-life
decisions
in
66
southern
French
ICUs
4
years
after
an
official
legal
framework:
A
1-day
audit
Claire
Roger
a,*
,
Je´
rome
Morel
b,
Nicolas
Molinari
c,
Jean
Christophe
Orban
d,
Boris
Jung
e,f,
Emmanuel
Futier
g,
Olivier
Desebbe
h,
Arnaud
Friggeri
i,
Stein
Silva
j,
Pierre
Bouzat
k,
Benoit
Ragonnet
l,
Bernard
Allaouchiche
m,
Jean-Michel
Constantin
g,
Carole
Ichai
d,
Samir
Jaber
e,f,
Marc
Leone
l,
Jean-Yves
Lefrant
a,
Thomas
Rimmele´
m,
for
the
AzuRea
Group
a
PoˆleAnesthe´sieRe´animationDouleurUrgences,CHUdeNıˆmes,placeduPr-Debre´,30029Nıˆmes,France b
Serviced’Anesthe´sieRe´animation,HoˆpitalNord,42055Saint-E´tienneCedex2,France c
UMR729,ServiceDIM,CHRUdeMontpellier,HoˆpitallaColombie`re,39,avenueCharles-Flahaut,34091MontpellierCedex5,France d
Re´animationMe´dico-Chirurgicale,HoˆpitalSaint-Roch,CHUdeNice,5,ruePierre-De´voluy,06001Nicecedex1,France
e De´partementd’Anesthe´sieRe´animation,HoˆpitalSaint-Eloi,CHUdeMontpellier,80,avenueAugustin-Fliche,34295MontpellierCedex5,France f InsermU-1046,Universite´ MontpellierI,Universite´ MontpellierII,34295Montpelliercedex5,France
g
De´partementd’Anesthe´sieRe´animation,HoˆpitalEstaing,CHUdeClermont-Ferrand,1,placeLucie-Aubrac,63003Clermont-FerrandCedex1,France h Hospices CivilsdeLyon,GroupementHospitalierest,De´partementd’Anesthe´sieRe´animation,HoˆpitalLouis-Pradel,Universite´ Claude-BernardLyon1,59, boulevardPinel, 69677Bron,France
i
HospicesCivilsdeLyon,HoˆpitalLyonSud,De´partementd’Anesthe´sieRe´animation,165,cheminduGrand-Revoyet,69495PierreBe´nite,France j Serviced’Anesthe´sieRe´animation,HoˆpitalPurpan,placeduDocteur-Baylac,31059Toulouse,France
k PoˆleAnesthe´sieRe´animation,CHUdeGrenoble,38700LaTronche,Grenoble,France l
Serviced’Anesthe´sieetdeRe´animation,AP–HM,HoˆpitalNord,AixMarseilleUniversite´,13915Marseillecedex20,France m
Serviced’Anesthe´sieRe´animation,GroupementHospitalierE´douard-Herriot,69003Lyon,France
Keywords: End-of-life Withholding Withdrawing Familycommunication ABSTRACT
Objective:SincetheimplementationoftwoFrenchlawsin2002and2005andtheimplementationof guidelinesaboutEnd-of-Life(EoL)decisions,fewstudiesconcerningEoLpracticesinFrenchintensive care units (ICUs) have been reported. This study was aimed at assessing compliance with recommendationsandcurrentlegislationconcerningEoLdecisions.
Method:Prospectiveobservationalstudybasedon1-dayauditconductedfromJanuarytoMay2009in 66southernFrenchICUs.
Results:Sixhundredandtwenty-fivepatientswereincluded(medianage:63[52–76]years,median SAPSII:46[34–58]).Thewrittendesignationofasurrogatedecision-makerwasreportedfor87(15%) patients.Advancedirectiveswerecompletedforonly4%ofpatients.TheEoLdecision-makingprocess consistedinamultidisciplinaryapproachfor99(47%)patientsandwasrecordedinthemedicalchartfor 63(64%)cases.Familieswereinformedaboutmedicaldecisionsin58%ofcases.Thisproportionwas higher (87%) if adecision to foregolife-sustaining therapy was made. EoL decisions consisted of withholdingtreatmentsfor72(94%)patientsandwithdrawaloftreatmentsfor5(6%)patients.Inthe multivariatestepwiselogisticregression,fourvariableswereindependentlyassociatedwithadecision toforegolifesupport:preexistingdependenceonothers(P<0.0001),advancedirectives(P=0.01),age (P=0.008)andtheSAPS2score(P=0.009).
Conclusion:Themajorfindingofthepresentstudyistheexistenceofagapbetweenthewidelyapproved EoLrecommendationsmadebyscientificsocietiesandthedailypracticeofsouthernFrenchICUs.Evenif EoLdecisionsaremostlysharedwithrelatives,theirwrittendocumentationinmedicalchartsremains insufficient.ConcerningEoLpractices,thewithdrawaloftreatmentremainsanuncommondecision.
Abbreviations:EoL,end-of-life;ICU,intensivecareunit;SAPS,simplifiedacutephysiologyscore;SD,standarddeviation;OR,oddsratios. * Correspondingauthor.Tel.:+33466683050.
1. Introduction
The overall mortality rate in intensive care units (ICUs) is around20%withalargepartofdeathsoccurringafterdecisionsto withholdorwithdrawlife-sustainingtherapy[1–4].Thequalityof dyingpatientcarehasbeenafocusofincreasingresearchoverthe last decade. It is considered an indicator of ICU quality [5– 7].Nevertheless,a greatdealofvariationexistsinEoLpractices betweenandwithincountries[8–13].InFrance,recommendations byscientificsocietiesandtwolawshaveclarifiedtheethicaland legalaspects ofEoL decisions [14]. In2002, lawsrequired that patients were informed about their diagnosis, the associated potentialoutcomesandtheoptiontodesignateasurrogate(onan officialwrittenform), especially for decision-making in case of incompetence [15]. In 2005, a law concerning patient EoL promoted the patient’s right to make her/his own decisions, including the right to refuse unwanted therapies [16]. This strengthens the possibility for establishing advance directives anddesignatingasurrogatedecision-maker[17].Forincompetent patients, decisions to forego life-sustaining therapy should be madeaftera multidisciplinarystaff meetingand theprocedure shouldbereportedin themedical chart[18].However, recom-mendations are difficult to implement. Moreover, a great variability has been reported concerning practices relating to patient information and decisions concerning EoL care
[2,8,9,13]. In 2009,an auditfocusingon theimplementation of 13recommendationswasperformedin66FrenchICUs[19].Two of these recommendations detailed patient information and ethical decision procedures. Therefore, the aim of the present studywastoevaluatecompliancewiththesetwo recommenda-tionsandwithcurrentlegislationconcerningEoLdecisions4years aftertheirimplementation.
2. Methods
A1-dayauditwasperformedinordertoverifythe implementa-tionof13recommendationsin66FrenchICUs[19].Becausethis studywasobservational,theneedforinformedconsentwaswaived inaccordancewithFrenchlaw.Allpatientsortheirrelativeswere informedaboutthestudybytheICUphysiciansandcouldrefuse participation.ThestudywasapprovedbytheInstitutionalReview BoardoftheNıˆmesUniversityHospital(IRB09/04/03).
2.1. Studydesign
Asdescribedinapreviousstudy,theAzuReagroupisanetwork including 66 ICUs (33 in academic hospitals and 33 in non-academichospitals),representing710beds[20].FromJanuaryto May2009,a1-dayauditwasconductedafterobtaininginformed consentfromeachICUdepartmenthead.Sixty-fourresidentswere inchargeofthestudy.Theywererequiredtobeinthelast2years of their educative process and should have spent6-months as residentsintheICUinordertohaveknowledgeofitsorganization. Ineachuniversitysystem,aseniorinvestigatortrainedagroupof residentsbeforetheauditday.
2.2. Datacollection
Asdescribedpreviously,theresidentshadtofillacase-report form(20sheets)including[19]:
patientcharacteristicsatadmission; pastmedicalhistory;
informationconcerningclosestpatientrelativesand surrogate decision-makers;
theidentificationofthegeneralpractitioner;
the patient goals of care comprising treatment and EoL care planning;
information concerning ethicaldiscussions and EoL decisions werecollected:
multiprofessionalapproach, documentationofthedecisions, informationsharedwithfamilies,
withholding or withdrawing life-sustaining therapies (me-chanicalventilation,vasopressors,renalreplacementtherapy, artificialnutrition);
theexistenceofadvancewrittendirectives.
Thetypeofhospital(academicornon-academic),thenumberof ICUbeds,theratioofnursestopatientsandthenumberofdoctors presentontheauditdaywerecollected.Themortalityratewas measured28daysaftertheauditdaybycontactingeachICU. 2.3. Statisticalanalysis
Because this observational study was part of an audit concerning13recommendations,thespecificnumberofsubjects neededwasnotcalculatedforthepresentpartofthestudy.The quantitativevariablesareexpressedasmeans[standarddeviation (SD)]ormedians[firstquartile(Q1),thirdquartile(Q3)]according to variabledistributions. Qualitative variables are expressed as percentages.
Aunivariate analysiswasfirst performedusingChi2 testsor
Fisherexacttestswhennecessaryforqualitativefactorsandusing analysisofvariance orMann-Whitneytestswhen necessaryfor quantitative factors. Then, we used unconditional multivariate logisticregressiontoestimatetheadjustedoddsratios(ORs)and 95%confidenceintervals(CIs)fortheassociationbetweenselected factors and foregoing life-sustaining treatments. For model building, we applied forwardstepwise introduction of selected variables from univariate analysis (P=0.20). Model fit was assessed by the Hosmer-Lemeshow test. All analyses were performed usingSAS version9.2 (SASInstituteInc,Cary,North Carolina) using a two-sided type 1 error rate of 0.05 as the thresholdforstatisticalsignificance.
3. Results
3.1. Studypopulation
The characteristicsof the studypopulation aredescribed in
Table1.
3.1.1. Relationshipwithrelatives
UponICUadmission, contactwithrelativeswasreportedfor 582(93%)patients(Table2).Inthe43(7%)remainingpatients,no relatives were clearly reported. An official surrogate decision-maker designatedin a writtensheetwasreported for87 (15%) patients,withnodifferencesobservedbetweenpatientsadmitted fromtheemergencydepartmentorfromhome(n=36.41%),the otherhospitalwards(n=47,54%),andlong-termfacilities(n=3, 3%),(P=0.25,missingdata=1).Theidentificationofthepatient’s generalpractitionerwasreportedfor392(63%)patients.Therate ofgeneralpractitioneridentificationwassimilarinpatientswith an ICU stay<2days (16/28, 57%) and those with an ICU stay2days(375/596,63%)(P=0.55).
3.1.2. Ethicaldiscussionsandend-of-lifedecisions
Ethicaldiscussionsoccurredin411(66%)patients.Theseethical considerationswereeitherrecordedonthemedicalchartfor166 (40%) patients ororallydiscussed byphysicians and/ornursing stafffor245(60%)patients.
Eighteen patients (4%) formulated advance directives.These patients had directly communicated these directives to the medical staff. Thesedirectives werewritten for 2 patients and orallygivenfor16patients.For2patients,thegeneralpractitioner wasinvolvedinthetransmissionoftheiradvancedirectivestothe ICUstaff.AnEoLdecision-makingprocesshadbeenimplemented for210(34%)patientsontheauditday.In41(20%)patients,this decision-makingwasmadeuponICUadmission. Thediscussion wasconductedusingamultiprofessionalapproach(physiciansand nurses)for99(47%)patients.Itwaswritteninthemedicalchartfor 63(64%)cases(Table3).Among210patientswithEoL decision-making processes, 122 relatives (58%) were informed of the medical decisionsinvolved. For 77 patients (12% of theoverall studypopulation),a decision toforego life-sustainingtherapies wasmade.ThemediannumberofEoLdecisions(withholdingor withdrawing)was1EoL decisionperunit and19 unitsdidnot reportEoL decisions on the audit day. Decisions to forego life support consisted in withholding therapies for 72/77 (94%) patients(includingthewithholdingofcardiopulmonary resusci-tation(CPR)inthecaseofcardiacarrestfor23(30%)patients)and inwithdrawaltherapies for5/77(6%) patients(Table4). Ofthe 77patientswithadecisiontoforegolife-sustainingtherapy,35 (45%)patientsdied.WhenthisdecisionwasrestrictedtolimitCPR incaseofcardiacarrest,themortalityratewaslowerthanaftera moreextensivewithholdingorwithdrawaldecision(7/23(30%) versus28/54(52%)patients,P=0.03).Amongpatientsforwhom deliberations abouta decision toforego life-sustaining therapy occurred, relatives were informed in 67/77 (87%) of cases, as comparedto55/133(41%)oftherelativesinthegroupofpatients
forwhomnodecisiontoforegolife-sustainingtherapywasmade (P<0.0001).Fourparameterswereindependentlyassociatedwith adecisiontoforegolifesupport,namely:
reportedpreviouspoorqualityoflife; age;
patient severity assessed via the simplified acute physiology score(SAPS2);
availableadvancedirectives(Table5). 4. Discussion
The present 1-day audit carried out in 66 southern French ICUs evaluated compliance with recommendations and legal
Table3
EoLdecision-makingpractices.
EoLdecision-makingprocess n % EoLdiscussion
Yes 210 34
No 415 66
Timingofthediscussion(n=210)
ICUadmission 41 20
DuringICUstay 91 43
Undocumented 78 37
Multidisciplinarydiscussion(n=210)
Yes 99 47
No 111 53
Documentationofthediscussion(n=99)
Writteninthemedicalchart 63 64
Undocumented 31 31
Missingdata 5 5
EoL:End-of-Life;ICU:intensivecareunit. Table4
Characteristicsofdecisionstoforegolife-sustainingtherapies(DFLST)(n=77).
DFLST n %
NoCPRincaseofcardiacarrest 23 30 Withholdingtreatment 49 64 Withdrawaloftreatment 5 6 Withholdingand/orwithdrawal(n=54)
Renalreplacementtherapy 36 67
Vasopressors 31 57
Mechanicalventilation 23 43
Transfusions 19 35
Nutrition 9 16
CPR: cardiopulmonaryresuscitation;DFLST: decisionsto foregolife-sustaining therapies.
Table5
ResultsofmultivariatestepwiselogisticregressiononDFLST. Variable Oddsratios 95%confidence
interval
P Previouspoorqualityoflife
Yes 1
No 8.11 3.16–20.81 <0.0001 Advancedirectives
Yes 1
No 5.12 1.48–17.73 0.01 Ageincrease(peryear) 1.03 1.008–1.053 0.008 SAPS2increase(perpoint) 1.02 1.006–1.043 0.009 SAPS:simplifiedacutephysiologyscore.Thefollowingvariableswereenteredinthe multivariatestepwise logisticregression:causeofadmission, typeofhospital (academic,non-academic),age,SAPS2score,MacCabescore,advancedirectives andpreviouspoorqualityoflife.P(Hosmer-Lemeshow)=0.5312.
Table1
Characteristicsofthestudypopulation(n=625).
Characteristics Measure Age,median[IQ1–IQ3],year 63[52–76] Sex,n(%) Men 391(63) Women 234(37) Physiologicassessment,n(%) MacCabe0 383(61) MacCabe1 181(29) MacCabe2 61(10)
AdmissionSAPSII,median[IQ1–IQ3] 46[34–58] Causeofadmission,n(%)
Medical 393(63)
Surgery
Urgent 169(27)
Non-urgent 63(10)
Auditdayassessment
SOFA,median[Q1–Q3] 3[1–6] SAPS:simplifiedacutephysiologyscore;Q1:firstquartile;Q3:thirdquartile;SOFA: sequentialorganfailureassessment.
Table2
Identityoftheclosestrelatives(n=625).
Identificationofrelatives n % Norelativesidentified 43 7
Spouse/partner 261 42
Children 168 27
Parent 65 10
Otherfamilymember 53 9
Otherrelative 27 4
obligationsconcerning EoLpracticesas determinedbyFrench law and scientific societies [15,16]. The major finding is the observedgapbetweenthewidelypublishedandapprovedEoL recommendations based on legislation and daily practice in FrenchICUs [14,16]. Documentationof EoL practices remains insufficient.
ThepresentstudyidentifiestheaspectsofEoLdecisionsthatare stillproblematic.First,thoughtheICUstaffhadidentifiedrelatives for93% of patients,only 15% ofpatients officially designated a surrogatedecision-maker.TheMAHOandLATAREA2studiesalso reportedless than20%of surrogatedecision-makerdesignation
[21,22].Second,only4%ofthepresentcohortformulatedadvance directivesbefore ICUadmission. These advancedirectives were mostlyreportedbythepatienther-orhimself.This recommenda-tion, as specified by the 2005 French law, was established to protect patient autonomy and to ensure a shared decision
[16]. However, the present findings as previously reported in otherstudies,highlightthatthispracticeremainsexceptionalin Europe(exceptintheNetherlands)[9].
In the literature, contradictory results were reported: in a recent study, elderly Americans were more likely to complete advance directives (67%) and this was associated with better respect of patients’ wishes [23]. However, some studies also reportedfeweffectsofadvancedirectivesonEoLdecision-making
[24,25].Officialsurrogatedecision-makerdesignationandadvance directivesformulationweretwokeypointsof2005legislation,but aredifficulttoapplyindailypractice.
Ethical discussion had occurred in one-third of the study population.Thedeliberationsofthisdiscussionweredisclosedto 58% of families. This finding suggests that French intensivists remainreluctanttosharedecision-makingwithpatientsandtheir relatives. However, in patients with a decision to forego life support, 87%of their relatives wereinformed of EoLdecisions, whichisahigherrateascomparedtotheLATAREA1study(44%)
[4].Explicit,clearandearlyinformationtoICUpatientrelativesis animportantgoalinordertoimprovethesatisfactionofrelatives withEoLcareandtopreparethemforthelossoftheirlovedones
[28–30].Anotherimportantfindingistheincomplete documenta-tion of EoL decisions in the present study (63%), despite its statutoryrequirement[31].Thisfindingisconsistentwithdata from the Ethicus study, (involving 37 ICUs in 17 European countries)reportingthatthedecisiondocumentationfolloweda prevalence gradient from North (88%) and Central (77%) to Southern(34%)Europe[32].ArecentDutchstudyreportedpoor andincompletedocumentationonwithholdingandwithdrawing lifesupport:in32%ofthecases,ICUteammembersinvolvedinthe EoL decisions were not mentioned [33]. Moreover, 36% of EoL decisionswerenotsharedwithpatientrelatives.Nevertheless,the documentation of medical decisions is crucial to preserve the continuityofinpatientcareand toensuretransparencyin such decisions.Discussionsoccurredaftermultidisciplinary collabora-tionfor47%ofpatients.Fewchangeshavetakenplaceconcerning sharedEoLdecisionssincetheLATAREA1study,whichreported thatonly54%ofdecision-makingprocessesinvolvedthenursing staff[4].Previousstudiesdemonstratedawidevariabilityacross countries. In a single ICU study in Lebanon, nurses were not involvedin26%ofEoLdecisions[34].AnItalianstudyinvolving 84ICUs reportedthat decisionswereshared byphysicians and nurses in 24.5% of cases and by a single physician in 18.6%
[35]. However, in half of the cases, thesedecisions involved a physicianfromanotherunit.Thisproportionishigherthanin2001 (2%) [4]. Multidisciplinary collaborationconcerning EoL care is stronglyencouragedinthe2005Frenchlaw[16].This collabora-tion is associated with increased family satisfaction and can prevent ICU staff burnout [36–38]. Among the 625 patients enrolledinthepresentstudy,decisionstoforegolife-sustaining
therapyoccurredin77(12%)patients,butthisratewascertainly underestimatedby theassociated transversal design (ICUstays were not considered across their entire durations). Our data suggest that theEoL practices in thesouth of France havenot changed since theimplementation of theofficial recommenda-tions.In 2001,theLATAREAstudyreportedthat withholdingor withdrawaldecisionsrepresented11%ofICUadmissions[4].The Ethicus studyshoweda similarrate (10%) inEurope [8].More recently,Azoulayetal.[2]reportedthatthedecisionstoforegolife supportrepresented 8.6% of admissions, whereas theLATAREA 2 study found a similar rate (12%) as in 2001 [2,22]. Previous studiesinNorthAmericareportedmuchhigherrates[13,39]. Al-though many ethicists and critical care societies considerthat thereisnoethicalandlegaldistinctionbetweenwithholdingand withdrawinglife-sustainingtreatments,ourfindingsindicatethat withholding is the most common decision made by French intensivists[40,41].Theseresultsareconsistentwithdatareported fromGreece,LebanonandsouthernEurope[32,34,42]. Heteroge-neity also exists in the practical aspects of withholding or withdrawaloftreatments[43,45].Vasopressorsanddialysiswere the most frequently limited therapies in the present study. Physicians’ reluctance to withdraw mechanical ventilation still persists. Withdrawal of mechanical ventilation, in particular trachealextubation,seemstobeamoredifficultact forFrench intensivists[46].Thepresentstudycannotdetailthispractice.
Certain limitations concerning the present study should be acknowledged.AllthestudiedICUswereconcentratedinthesouth ofFrance.Since previousworkshave demonstrateda North-to-SouthgradientinEoLpracticesinEurope,ourresultsmayhave beenaffectedbyregionalcultures.GiventhatallICUswerelocated insouthernFrance,thepresentfindingscannotbeextrapolatedto thewholecountryortoanothercountry.However,thenumberof participatingICUswaslargeandEoLrecommendationswerenot reviewed before performing the present 1-day audit/study. Therefore,ourfindingsprobablyreflectcurrentdailypracticein FrenchICUs. We didnot investigatethenecessary actionsthat requireimplementationinordertoimproveintensivists’ compli-ancewiththeserecommendations.
5. Conclusion
Inconclusion, effortstoimproveEoLcarearestill neededin French ICUs, despite the existence of guidelines. Even if EoL decisions are mostly shared withrelatives, their written docu-mentationinmedicalchartsremainsinsufficient.ConcerningEoL practices, the withdrawal of treatment remains an uncommon decision. Our findings demonstratethat progressis required at eachstepofthepatientpathway,fromthegeneralpractitionerto theintensivist.Currently,weintendtoplanaprospectivestudy involvingseveralICUsfromthroughoutFrancetoreportupdated dataaboutEoLpracticesinFrance10yearsafterthe implementa-tionofthelegalrecommendations.
Authors’contributions
CR,JM,JCO,EF,OD,TR,BRconceivedanddesignedthestudy. NMperformedstatisticalanalysis.CR,JM,JCO,EF,OD,TR,AF,SS, PB,TR,BRanalyzedthedata.CR,TRwrotethemanuscript.Allother authorsmadecriticalrevisionsofthemanuscriptforintellectual content.
Disclosureofinterest
The authors declare that they have no conflicts of interest concerningthisarticle.
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