Rui P. MorenoAndrew RhodesYoel Donchin

Patient safety in intensive caremedicine: the Declarationof Vienna

Received: 9 August 2009Accepted: 9 August 2009

Copyright jointly hold by Springer andESICM 2009

A declaration by the Executive Committeeof the European Society of Intensive CareMedicine.

On behalf of the Executive Committee.

ESICM Executive CommitteeMembers Rui Moreno, Andrew Rhodes,Charles Sprung, Herwig Gerlach,Jean Daniel Chiche, Hans Flaaten, Danielde Backer, Ruth Endacott, ChristianPutensen, Massimo Antonelli, MarcoRanieri, and Paolo Biban.

Patient safety in intensive caremedicine

Improving the outcome of criticallyill patients remains an ideal that everypracticing Intensivist strives toachieve. Every year there are manyhundreds of research paperspublished that help us to betterunderstand the physiology and path-ophysiology of our patients and alsohow our treatment strategies interactand eventually alter a patientscourse. Many of these papers focus ondiscrete parts of the therapeuticregimes that we are able to deliver;however, few have had a significantimpact on overall outcome measuresthat are relevant to patients them-selves. One area of medicine that isoften overlooked, but can impactsignificantly on relevant patient

outcomes, is the process of care. Theway we practice, the culture we workin, the climate that our professionaldemeanor creates can all dramaticallyimpact on outcome measures. Unfor-tunately, these topics are often noteasy to explain, difficult to study anddo not attract research funding thatstimulates scientific minds to addressthe problem. This paper describeshow the European Society of Inten-sive Care Medicine (ESICM) aims toraise patient safety to the top of thescientific agenda with the hope ofultimately increasing the quality ofcare delivered to our patients andimproving their outcomes.

The Institute of Medicine (IOM)published in 1999 their seminal reportentitled To err is human: building asafer health system [1]. This paperdescribed quality as the degree towhich health services for individualsand populations increase the likeli-hood of desired health outcomes andare consistent with current profes-sional knowledge. Safety was definedas the absence of clinical error, eitherby commission (unintentionally doingthe wrong thing) or omission (unin-tentionally not doing the right thing)[2], and error as the failure of aplanned action to be completed asintended or the use of a wrong plan toachieve an aim. The accumulation oferrors results in accidents. Theauthors delineated just how commonfailure to provide quality care is, withbetween 44,000 and 98,000 patientsdying each year in the USA as a resultof a clinical error. This makes medi-cal error the eighth leading cause ofdeath, more frequent than motorvehicle accidents (43,458), breastcancer (42,458) and AIDS (16,516).Despite the awareness of patientsafety and quality of care issuesincreasing in both patient and politi-cal arenas, this has not translatedthrough to groundbreaking researchstudies that have ignited thetopic with significant outcomebenefits [3, 4].

To improve the profile of thesesubjects, the ESICM in 2009 haslaunched a major initiative that willbring together the representatives ofCritical Care Societies from aroundthe world (national and international)with the aim of pledging their effortsand resources towards improving thecare of our patients. Together with thesocieties signing this Declaration ofVienna (Appendix 1) will be seniorrepresentatives from the politicalworld, our partners in industry and ofcourse patient representatives them-selves. The meeting will assessproblems and solutions from aroundthe world irrespective of geographi-cal, political or economic factors.This unique partnership will allowcollaborations to be fostered and forpartnerships to develop. We hope tobe able to use this group to raise theprofile of the patient safety agendaand therefore change the way wepractice everyday with resultant ben-efits for all.

From efficacy to effectiveness

Patient safety in intensive care med-icine is best evaluated in terms of twodimensions:

at the individual patient level, bydoing good and not doing harm toany individual patient;

at the collective level by doinggood and not doing harm to groupsof patients, by increasing the safetyand the effectiveness of our inter-ventions or in other words, thecostbenefit ratio.

Although at the level of the indi-vidual patient there is little difficultyin explaining what is meant by theconcept of safe practice, at a collec-tive level this is far more complex.Partly this is because often the con-cepts are more easily addressed bycomplex statistical approaches when

Intensive Care MedDOI 10.1007/s00134-009-1621-2 ESICM STATEMENT

addressing groups of patients andthe fact that they relate to the twopillars of quality, efficacy and effec-tiveness [5]. This differencebetween efficacy and effectivenessis very important to understand [6].Efficacy relates to the capacity of anintervention to produce an effect,for instance in a research trial,effectiveness relates to how wellthis translates to improved outcomesin real-life pragmatic situations. Thestandards for the evaluation andreporting of the efficacy of an inter-vention are now reasonably wellestablished, despite several concernssurrounding methodological pitfalls[7]. These standards have beendescribed both for the individuallevel situation [8] and also wherethe evidence is arising from a vari-ety of different sources [9]. Whenwe move from efficacy to effective-ness, the picture is not so clear.

These problems are usually seenwhen trying to translate researchscenarios into everyday clinicalpractice, or when trying to developor assess clinical practice recom-mendations or guidelines. Thedefinitive answer about the risk-ben-efit balance of any intervention canonly be made when the balancebetween the expected benefits andthe expected risks is assessed in thereal world, outside of the experi-mental setting. To move from what isknown about the benefits, the risksand the limitations of a certainintervention when applied in a verystrict usually non-generalizablecohort of patients to everyday prac-tice is very difficult. This often relatesto patient case mix differences,severity of illness differences and theeffects of multiple interventionsimpacting on each other that were notfully assessed in the original trial.If we take clinical practice guidelines,there are many examples of recom-mendations that have beensuggested following single trialsthat have been subsequently refutedwhen more data became available[10, 11]. For these reasons, and dueto an innate bias between the

appraisal of evidence and cliniciansown past experience and beliefs [12],orthodox medicine is often not evi-dence based [13], and anecdote isoften used as to determine treatmentplans [14].

Why now: the changingdemographics of intensive caremedicine?

Recent years have witnessed greatchanges in the topology of the humanpopulation. We are now greater innumber and older in age. We aresicker and more dependent on pro-phylactic and preventive therapies.Resources are becoming scarcer andare increasingly becoming moreunevenly distributed. Diseases arebecoming more global. Technologicaladvancements have allowed, andbeen the stimulus for, the develop-ment of our specialty, intensive caremedicine. This specialty cares for andtreats patients with acute life-threat-ening illnesses. The prevention, careand/or cure of these patients are nowa global challenge, needing multiplelocal solutions.

Contrary to previous times,where almost all of the health chal-lenges could be addressed by singleinterventions, such as vaccines,antibiotics or nutritional supple-ments, or eventually by smallpackages of interventions (washingof hands before interventionalchildbirth, surgery with anesthesia,prophylactic antibiotics before sur-gery), critical illness is unique inseveral respects:

in its dimensions: it is a situation inwhich every organ and many of theinter-related systems may beaffected, either as a primary orsecondary phenomena;

in its time-dependence: most of thediagnostic and therapeutic inter-ventions must be performedexceptionally quickly in order to begiven a chance to work;

in its challenges: the acceptabilityof the practice of intensive caremedicine is crucially dependent onthe application of the strictest eth-ical standards. These have to bemaintained with the utmost respectfor the patient (and their familys)wishes and in accordance withsocietys values and expectations.These may change with time andcertainly change with cultural,religious and geographicdemographics;

in its consequences: the increasingprevalence of residual disabilitypost-critical illness, with the con-sequent burden on the patient, theirfamilies and on society as a whole,has an impact for many years afterthe acute illness.

The current pandemic of criticalillness will spare few and will be partof the dying process of millions ofhuman beings in the forthcomingdecades, with an increasing numberof patients requiring intensive care aspart of their therapeutic plans or endof life care. Given the narrow thera-peutic margins for a significantnumber of the interventions belong-ing to our field, it is probable that asignificant number of patients will beinjured and will suffer from theunattended consequences of medicalpractice. An important dimension ofthis problem, which can either becaused by errors of action or by errorsof omission in the process of caredelivery, are the educational andtraining standards of all professionalsinvolved. We have to recognize thatthe safety of our patients and also ourhealth-care teams is of the utmostimportance. However, despite recentreports on the increasing disparitybetween the supply and demand ofintensive care [15] and on the proveneffectiveness of the intervention ofintensive care specialists on patientcare, both physicians [16, 17] andnurses [18], this problem remainshidden and unaddressed by plannersof health-care systems and thoseresponsible for the planning ofmedical education. Consequently, we

can expect to see an increase in theimpact of these phenomena.

Error in intensive care

Two recent studies performed bythe Health Services Research andOutcomes Section of the ESICMhave helped to bring light to thisissue. In the first study, the sentinelevents evaluation (SEE) study,Valentin [19] performed an observa-tional, 24-h cross-sectional study ofincidents in 205 intensive care unitsaround the world. Thirty-nine seri-ous events were observed forevery 100 patient days. The eventsincluded medication errors (136patients), unplanned dislodgement orinappropriate disconnection of lines,catheters and drains (158), equip-ment failure (112), loss, obstructionor leakage of artificial airway (47)and inappropriate turning-off ofalarms (17). The presence of organfailure, a higher intensity in level ofcare and time of exposure all relatedto these events. In 2009, the samegroup, focusing this time on errors inthe administration of parenteraldrugs, found 74.5 events per 100patient days in the SEE 2 study [20].Interestingly, three quarters of theerrors were classified as errors ofomission; 1% of the study popula-tion experienced permanent harm ordied because of a medication error atthe administration stage. The oddsratios for the occurrence of at leastone parenteral medication error wereraised depending on the number oforgan failures, the use of any intra-venous medication, the number ofparenteral administrations, typicalinterventions in patients in intensivecare, a larger intensive care unit,number of patients per nurse andunit occupancy rate. Odds ratios forthe occurrence of parenteral medica-tion errors were decreased for thepresence of basic monitoring, anexisting critical incident reportingsystem, an established routine of

checks at nurses shift change and anincreased ratio of patient turnover tothe size of the unit.

Although these above examplesall relate to individual patients, abigger and less reported problem isthat of the omission or commission oftherapies for populations of patients.In intensive care practice this mayrelate to the provision of appropri-ately sized tidal volumes duringmechanical ventilation or the timelyuse of antimicrobial therapy in septicshock [21, 22]. In other clinical situ-ations, it may relate to the patientsbeing discharged post-acute myocar-dial infarction being prescribedappropriate doses of beta-blocker andstatin therapies.

What are the causes of an unsafeICU and how can we improve thesafety culture and environmentwithin our intensive care units?

Defining and assessing safety andquality are only one side of the issue.Often in clinical practice the problemis broader than individual errors, andthe whole system is at fault or at theleast predisposes to an unsafe envi-ronment. When assessing an unsafeICU, several factors need to beunderstood, and these fit into two maincategories: problems with the organi-zation and structure of the unit andproblems with the process of care used.

Perhaps the most obvious factorsfrom the organization or structuralpoint of view relate to the volume ofwork performed and outcome. Thistopic remains contentious [23],although there is good evidence tosupport centralization and increasedvolume services in many circum-stances [24, 25] (Nathens, 2001 no.10382). Some authors have describedthe relationship between patient tonurse ratios and nosocomial infectionrates [26], medication errors [20],complications and resource use afteresophagectomy [18] or more broadlyeven all the aspects of safety and

quality in the hospital [27]. Theseworks lead many authors to concludethat a high-acuity nurse-patient ratiois cost-effective [28], and that it iscrucial to have ICUs adequatelystaffed [29].

The process of care relates toissues of teamwork, collaboration andcommunication. These issues are farmore difficult to quantify and areoften obscure and forgotten. Inintensive care medicine they wereperhaps first raised by Pascale leBlanc and Wilmar Schaufeli in theEURICUS studies [30, 31]. Theydemonstrated these variables to beassociated with increasng nosocomialinfection rates [32]. Among theseaspects, the issue of nursephysiciancollaboration in ICUs [3335] seemsto be crucial. Also, the issue of thetransmission of individual informa-tion between professionals is today acritical issue [36], first raised byDonchin in 1995 [37] and later con-firmed in the SEE study [19]. Notwithstanding these issues, it isimportant not to forget the well-beingof intensive care nurses [38] or theeffect of a pharmacists and/or anurses interventions on cost andadverse effects of drug therapy in theICU [3941].

The need for a multidimensionalapproach to the minimization of errorand the consequent improvement inthe clinical and economical effec-tiveness of an ICU is becomingincreasingly clear [42]. When com-paring the most efficient withleast efficient ICUs, Rothen andco-workers demonstrated that onlyinterprofessional rounds, the presenceof an emergency department and thegeographical region of the hospitalwere significantly associated withimprovement in quality indicators.The adoption of electronic prescrib-ing over handwritten prescription hasalso been shown to lead to the pre-scriptions being more readable andcomplete, with fewer errors. Thisshould result in improved prescribingand a safer environment for the givingof drugs to our patients.

In conclusion, a significant num-ber of dangerous human errors occurin the ICU. Many of these errors canbe attributed to problems of commu-nication between the physicians andnurses. Applying human factor engi-neering concepts to the study of theweak points of a specific ICU mayhelp to reduce the number of errors.Errors should not be considered as anincurable disease, but rather as pre-ventable phenomena, if systems weredesigned to cope and to minimize theeffects and the consequences of theseerrors [43].

The challenges for the future

Medicine in the last 200 years haschanged dramatically. The nature ofhealth and disease has altered irrevo-cably, pain has been conquered withanesthesia, and infectious diseaseshave been fought through a combi-nation of drugs and better publichealth systems. At the same time ourunderstanding of the pathophysiolog-ical process underpinning thesechanges has improved exponentially.Despite these advancements, ourknowledge as to how health-caresystems interact and influence thedelivery of safe and quality care arepoor. The recent discovery of theepidemic of medical error as animportant cause of morbidity andmortality should not be a surprise.The first step to overcome this pre-ventable epidemic is by therecognition of its existence. For thisreason the ESICM is promoting aninitiative to bring together all thestakeholders who relate to our spe-cialty in a process aimed at not onlyraising the profile of patient safety,but to actually improve the outcomeof our patients.

Appendix 1

1. We, the Leaders of the Societiesrepresenting the medical specialty

of intensive care medicine, met inVienna on 11 October 2009.Together with the representativesof the main institutions andstakeholders who speak up forpatient safety, we declare:

2. We recognize that patient safetyand clinical team safety are ofparamount importance to everypracticing health professional andrepresents one of the major chal-lenges in modern day medicine.This affects the lives of women,men, and children in every coun-try. Without a safe environment itis not possible to provide thequality of care that we all aspireto. This is especially true inintensive care medicine, given thevery fragile nature of the patientswe care for, often in the extremesof age, unconscious and withminimal margins for error imposedby their deranged physiology. Thisglobal problem requires a globalsolution.

3. We believe that improving levelsof safety for critically ill patients isachievable in all units and in allcountries, irrespective of theavailable resources. If the safety ofour patients is increased, then thequality of care that we can providewill improve.

4. We strongly believe that increas-ing patient safety is as crucial tothe development of medical prac-tice as the increase in theeffectiveness of our interventions.

5. We have today therefore pledgedto do whatever is necessary to:

Increase the knowledge of thecauses and reasons for failuresto provide a safe environment inthe intensive care unit.

Improve our understanding ofthe consequences of failure toprovide a safe environment forcritically ill adult and childrenand the health-care profession-als caring for these patients.

Develop and promote criteriathat can assess safety in theintensive care unit.

Further our ability to translatethe knowledge of safety intoimproving the quality of carethat can be provided to ourpatients.

By acting together to fulfill thesepledges we will improve the safety ofintensive care practice and therebyincrease the quality of care.

6. Through the design and promotionof safer and even more efficientdevices and drugs, we acknowl-edge that industrial partners have apivotal role to play in improvingpatient safety. With the signatureof this declaration, manufacturersof biomedical, pharmaceutical andbiotechnology companies pledgeto:

Engage in efforts to improve thesafety profile of their products.

Provide resources to facilitatethe safe use of their products.

Release, as soon as they becomeavailable, any informationrelated to safety concerns oftheir products to health-careprofessionals and regulatoryagencies.

7. The agreements reached today willenable us to develop safety criteriathat can be used by intensive careunits around the world to improvetheir safe practices and increasethe quality of care provided to thebenefit of all of our patients.

Appendix 2

Critical care societies who areparticipating in the initiative

Associacao de Medicina IntensivaBrasileira (AMIB)

Asia-Pacific Association of Criti-cal Care Medicine

Australian and New ZealandIntensive Care Society

Austrian Society of Medical andGeneral Intensive Care Medicine

Bahrain

Belgian Society of Intensive CareMedicine

Canadian Critical Care SocietyChinese Society of Critical Care

MedicineCroatian Society of Intensive Care

MedicineCzech Society of Intensive Care

MedicineDeutsche Gesellschaft fur Anas-

thesiologie und IntensivmedizinDeutsche Interdisziplinare Veren-

igung fur Intensiv- undNotfallmedizin

EBA PresidentEgyptian Society of Critical Care

and Emergency MedicineEmirates Intensive Care SocietyESPNICEstonian Society of

AnaesthesiologistsEuropean Federation of Critical

Care Nursing AssociationsEuropean Society of

AnaesthesiologistsFinnish Society of Intensive CareGeorgian Society of Anesthesiol-

ogy and Critical Care Medicine

German Sepsis Society

Hungarian Society of Anaesthesiolo-gy and Intensive Care Therapy

Indian Society of Critical CareMedicine

Indonesian Society of IntensiveCare Medicine

Intensive Care SocietyInternational Pan-Arab Society of

Intensive Care MedicineIsrael Society of Critical Care

MedicineKorean Society of Critical Care

MedicineKuwaitLithuanian Society of Anaesthe-

siology and Intensive CareMacedonia Society of Anaesthesia

and Intensive CareMalaysian Society of

AnaesthetistsNederlandse Verenigning voor

Intensive CareOsterreichische Gesellschaft fur

Anaesthesiologie, Reanimation undIntensivmedizin

Romanian Society of Anaesthesiaand Intensive Care

Scandinavian Society of Anaes-thesiology and Intensive Care

Scottish Intensive Care Society

Serbian Society of Intensive CareMedicine

Slovak Society of Anaesthesiolo-gy and Intensive Care

Sociedad Espanola de Anestesio-logia, Reanimacion y Terapeutica delDolor

Sociedade Portuguesa de Cuida-dos Intensivos

Sociedad Espanola de MedicinaIntensiva, Crtica y UnidadesCoronarias

Societa` Italiana Di AnestesiaAnalgesia Rianimazione E TerapiaIntensiva

Socie`te` de Re`animation de Lan-gue Francaise

Socie`te` Francaise dAnesthe`sie etde Re`animation

Society of Anaesthesiologists andReanimatologists of Central Russia

Society of Critical Care Medicine

SudanSwedish Society of Anaesthesiol-

ogy and Intensive Care MedicineSwiss Society of Intensive Care

MedicineTunisiaUEMS

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R. P. Moreno ())Unidade de Cuidados IntensivosPolivalente, Hospital de Santo Antonio dosCapuchos, Alameda de Santo Antonio dosCapuchos, 1169-050 Lisbon, Portugale-mail: r.moreno@mail.telepac.ptTel.: ?351-213153784Fax: ?351-213153784

A. RhodesDepartment of Intensive Care Medicine,St Georges Healthcare NHS Trust,London, UK

Y. DonchinPatient Safety Unit, Hadassah HebrewUniversity Medical Center, Jerusalem,Israel

Y. DonchinCenter for Safety at Work and HumanFactors Engineering Technion,Haifa, Israel

Patient safety in intensive care medicine: the Declaration of ViennaPatient safety in intensive care medicineFrom efficacy to effectivenessWhy now: the changing demographics of intensive care medicine?Error in intensive careWhat are the causes of an unsafe ICU and how can we improve the safety culture and environment within our intensive care units?The challenges for the futureAppendix 1Appendix 2Critical care societies who are participating in the initiativeGerman Sepsis SocietySociety of Critical Care Medicine

References

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