1. Intensive Care Med
DOI 10.1007/s00134-009-1621-2 ESICM STATEMENT
Rui P. Moreno outcomes, is the process of care. The To improve the profile of these
Andrew Rhodes way we practice, the culture we work subjects, the ESICM in 2009 has
Yoel Donchin in, the climate that our professional launched a major initiative that will
demeanor creates can all dramatically bring together the representatives of
impact on outcome measures. Unfor- Critical Care Societies from around
Patient safety in intensive care tunately, these topics are often not the world (national and international)
easy to explain, difficult to study and with the aim of pledging their efforts
medicine: the Declaration do not attract research funding that and resources towards improving the
of Vienna stimulates scientific minds to address care of our patients. Together with the
the problem. This paper describes societies signing this Declaration of
how the European Society of Inten- Vienna (Appendix 1) will be senior
Received: 9 August 2009 sive Care Medicine (ESICM) aims to representatives from the political
Accepted: 9 August 2009 raise patient safety to the top of the world, our partners in industry and of
scientific agenda with the hope of course patient representatives them-
Ó Copyright jointly hold by Springer and ultimately increasing the quality of selves. The meeting will assess
ESICM 2009
care delivered to our patients and problems and solutions from around
A declaration by the Executive Committee improving their outcomes. the world irrespective of geographi-
of the European Society of Intensive Care The Institute of Medicine (IOM) cal, political or economic factors.
Medicine. published in 1999 their seminal report This unique partnership will allow
On behalf of the Executive Committee. entitled ‘To err is human: building a collaborations to be fostered and for
safer health system’ [1]. This paper partnerships to develop. We hope to
ESICM Executive Committee described quality as the degree to be able to use this group to raise the
Members Rui Moreno, Andrew Rhodes, which health services for individuals profile of the patient safety agenda
Charles Sprung, Herwig Gerlach,
Jean Daniel Chiche, Hans Flaaten, Daniel and populations increase the likeli- and therefore change the way we
de Backer, Ruth Endacott, Christian hood of desired health outcomes and practice everyday with resultant ben-
Putensen, Massimo Antonelli, Marco are consistent with current profes- efits for all.
Ranieri, and Paolo Biban. sional knowledge. Safety was defined
as the absence of clinical error, either
by commission (unintentionally doing
the wrong thing) or omission (unin-
tentionally not doing the right thing)
From efficacy to effectiveness
Patient safety in intensive care [2], and error as the failure of a
Patient safety in intensive care med-
medicine planned action to be completed as
icine is best evaluated in terms of two
intended or the use of a wrong plan to
dimensions:
Improving the outcome of critically achieve an aim. The accumulation of
ill patients remains an ideal that every errors results in accidents. The
• at the individual patient level, by
practicing Intensivist strives to authors delineated just how common
doing good and not doing harm to
achieve. Every year there are many failure to provide quality care is, with
any individual patient;
hundreds of research papers between 44,000 and 98,000 patients
• at the collective level by doing
published that help us to better dying each year in the USA as a result
good and not doing harm to groups
understand the physiology and path- of a clinical error. This makes medi-
of patients, by increasing the safety
ophysiology of our patients and also cal error the eighth leading cause of
and the effectiveness of our inter-
how our treatment strategies interact death, more frequent than motor
ventions or in other words, the
and eventually alter a patient’s vehicle accidents (43,458), breast
cost–benefit ratio.
course. Many of these papers focus on cancer (42,458) and AIDS (16,516).
discrete parts of the therapeutic Despite the awareness of patient Although at the level of the indi-
regimes that we are able to deliver; safety and quality of care issues vidual patient there is little difficulty
however, few have had a significant increasing in both patient and politi- in explaining what is meant by the
impact on overall outcome measures cal arenas, this has not translated concept of safe practice, at a collec-
that are relevant to patients them- through to groundbreaking research tive level this is far more complex.
selves. One area of medicine that is studies that have ignited the Partly this is because often the con-
often overlooked, but can impact topic with significant outcome cepts are more easily addressed by
significantly on relevant patient benefits [3, 4]. complex statistical approaches when

2. addressing groups of patients and appraisal of evidence and clinicians • in its challenges: the acceptability
the fact that they relate to the two own past experience and beliefs [12], of the practice of intensive care
pillars of quality, efficacy and effec- orthodox medicine is often not evi- medicine is crucially dependent on
tiveness [5]. This difference dence based [13], and anecdote is the application of the strictest eth-
between efficacy and effectiveness often used as to determine treatment ical standards. These have to be
is very important to understand [6]. plans [14]. maintained with the utmost respect
Efficacy relates to the capacity of an for the patient (and their family’s)
intervention to produce an effect, wishes and in accordance with
for instance in a research trial, society’s values and expectations.
effectiveness relates to how well These may change with time and
this translates to improved outcomes Why now: the changing certainly change with cultural,
in real-life pragmatic situations. The demographics of intensive care religious and geographic
standards for the evaluation and medicine? demographics;
reporting of the efficacy of an inter- • in its consequences: the increasing
vention are now reasonably well Recent years have witnessed great prevalence of residual disability
established, despite several concerns changes in the topology of the human post-critical illness, with the con-
surrounding methodological pitfalls population. We are now greater in sequent burden on the patient, their
[7]. These standards have been number and older in age. We are families and on society as a whole,
described both for the individual sicker and more dependent on pro- has an impact for many years after
level situation [8] and also where phylactic and preventive therapies. the acute illness.
the evidence is arising from a vari- Resources are becoming scarcer and
are increasingly becoming more The current pandemic of critical
ety of different sources [9]. When
unevenly distributed. Diseases are illness will spare few and will be part
we move from efficacy to effective-
ness, the picture is not so clear. becoming more global. Technological of the dying process of millions of
advancements have allowed, and human beings in the forthcoming
These problems are usually seen
been the stimulus for, the develop- decades, with an increasing number
when trying to translate research
scenarios into everyday clinical ment of our specialty, intensive care of patients requiring intensive care as
practice, or when trying to develop medicine. This specialty cares for and part of their therapeutic plans or end
or assess clinical practice recom- treats patients with acute life-threat- of life care. Given the narrow thera-
mendations or guidelines. The ening illnesses. The prevention, care peutic margins for a significant
definitive answer about the risk-ben- and/or cure of these patients are now number of the interventions belong-
efit balance of any intervention can a global challenge, needing multiple ing to our field, it is probable that a
local solutions. significant number of patients will be
only be made when the balance
Contrary to previous times, injured and will suffer from the
between the expected benefits and
the expected risks is assessed in the where almost all of the health chal- unattended consequences of medical
real world, outside of the experi- lenges could be addressed by single practice. An important dimension of
interventions, such as vaccines, this problem, which can either be
mental setting. To move from what is
antibiotics or nutritional supple- caused by errors of action or by errors
known about the benefits, the risks
ments, or eventually by small of omission in the process of care
and the limitations of a certain
intervention when applied in a very packages of interventions (washing delivery, are the educational and
of hands before interventional training standards of all professionals
strict usually non-generalizable
cohort of patients to everyday prac- childbirth, surgery with anesthesia, involved. We have to recognize that
tice is very difficult. This often relates prophylactic antibiotics before sur- the safety of our patient’s and also our
gery), critical illness is unique in health-care teams is of the utmost
to patient case mix differences,
several respects: importance. However, despite recent
severity of illness differences and the
reports on the increasing disparity
effects of multiple interventions
impacting on each other that were not • in its dimensions: it is a situation in between the supply and demand of
fully assessed in the original trial. which every organ and many of the intensive care [15] and on the proven
inter-related systems may be effectiveness of the intervention of
If we take clinical practice guidelines,
affected, either as a primary or intensive care specialists on patient
there are many examples of recom-
secondary phenomena; care, both physicians [16, 17] and
mendations that have been
suggested following single trials • in its time-dependence: most of the nurses [18], this problem remains
diagnostic and therapeutic inter- hidden and unaddressed by planners
that have been subsequently refuted
ventions must be performed of health-care systems and those
when more data became available
[10, 11]. For these reasons, and due exceptionally quickly in order to be responsible for the planning of
given a chance to work; medical education. Consequently, we
to an innate bias between the

3. can expect to see an increase in the checks at nurses’ shift change and an quality in the hospital [27]. These
impact of these phenomena. increased ratio of patient turnover to works lead many authors to conclude
the size of the unit. that a high-acuity nurse-patient ratio
Although these above examples is cost-effective [28], and that it is
all relate to individual patients, a crucial to have ICUs adequately
Error in intensive care bigger and less reported problem is staffed [29].
that of the omission or commission of The process of care relates to
Two recent studies performed by therapies for populations of patients. issues of teamwork, collaboration and
the Health Services Research and In intensive care practice this may communication. These issues are far
Outcomes Section of the ESICM relate to the provision of appropri- more difficult to quantify and are
have helped to bring light to this ately sized tidal volumes during often obscure and forgotten. In
issue. In the first study, the sentinel mechanical ventilation or the timely intensive care medicine they were
events evaluation (SEE) study, use of antimicrobial therapy in septic perhaps first raised by Pascale le
Valentin [19] performed an observa- shock [21, 22]. In other clinical situ- Blanc and Wilmar Schaufeli in the
tional, 24-h cross-sectional study of ations, it may relate to the patients EURICUS studies [30, 31]. They
incidents in 205 intensive care units being discharged post-acute myocar- demonstrated these variables to be
around the world. Thirty-nine seri- dial infarction being prescribed associated with increasng nosocomial
ous events were observed for appropriate doses of beta-blocker and infection rates [32]. Among these
every 100 patient days. The events statin therapies. aspects, the issue of nurse–physician
included medication errors (136 collaboration in ICUs [33–35] seems
patients), unplanned dislodgement or to be crucial. Also, the issue of the
inappropriate disconnection of lines, transmission of individual informa-
catheters and drains (158), equip- What are the causes of an unsafe tion between professionals is today a
ment failure (112), loss, obstruction ICU and how can we improve the critical issue [36], first raised by
or leakage of artificial airway (47) safety culture and environment Donchin in 1995 [37] and later con-
and inappropriate turning-off of within our intensive care units? firmed in the SEE study [19]. Not
alarms (17). The presence of organ withstanding these issues, it is
failure, a higher intensity in level of Defining and assessing safety and important not to forget the well-being
care and time of exposure all related quality are only one side of the issue. of intensive care nurses [38] or the
to these events. In 2009, the same Often in clinical practice the problem effect of a pharmacist’s and/or a
group, focusing this time on errors in is broader than individual errors, and nurse’s interventions on cost and
the administration of parenteral the whole system is at fault or at the adverse effects of drug therapy in the
drugs, found 74.5 events per 100 least predisposes to an unsafe envi- ICU [39–41].
patient days in the SEE 2 study [20]. ronment. When assessing an ‘unsafe’ The need for a multidimensional
Interestingly, three quarters of the ICU, several factors need to be approach to the minimization of error
errors were classified as errors of understood, and these fit into two main and the consequent improvement in
omission; 1% of the study popula- categories: problems with the organi- the clinical and economical effec-
tion experienced permanent harm or zation and structure of the unit and tiveness of an ICU is becoming
died because of a medication error at problems with the process of care used. increasingly clear [42]. When com-
the administration stage. The odds Perhaps the most obvious factors paring the ‘‘most efficient’’ with
ratios for the occurrence of at least from the organization or structural ‘‘least efficient’’ ICUs, Rothen and
one parenteral medication error were point of view relate to the volume of co-workers demonstrated that only
raised depending on the number of work performed and outcome. This interprofessional rounds, the presence
organ failures, the use of any intra- topic remains contentious [23], of an emergency department and the
venous medication, the number of although there is good evidence to geographical region of the hospital
parenteral administrations, typical support centralization and increased were significantly associated with
interventions in patients in intensive volume services in many circum- improvement in quality indicators.
care, a larger intensive care unit, stances [24, 25] (Nathens, 2001 no. The adoption of electronic prescrib-
number of patients per nurse and 10382). Some authors have described ing over handwritten prescription has
unit occupancy rate. Odds ratios for the relationship between patient to also been shown to lead to the pre-
the occurrence of parenteral medica- nurse ratios and nosocomial infection scriptions being more readable and
tion errors were decreased for the rates [26], medication errors [20], complete, with fewer errors. This
presence of basic monitoring, an complications and resource use after should result in improved prescribing
existing critical incident reporting esophagectomy [18] or more broadly and a safer environment for the giving
system, an established routine of even all the aspects of safety and of drugs to our patients.

4. In conclusion, a significant num- of intensive care medicine, met in • Further our ability to translate
ber of dangerous human errors occur Vienna on 11 October 2009. the knowledge of safety into
in the ICU. Many of these errors can Together with the representatives improving the quality of care
be attributed to problems of commu- of the main institutions and that can be provided to our
nication between the physicians and stakeholders who speak up for patients.
nurses. Applying human factor engi- patient safety, we declare:
By acting together to fulfill these
neering concepts to the study of the 2. We recognize that patient safety
and clinical team safety are of pledges we will improve the safety of
weak points of a specific ICU may
paramount importance to every intensive care practice and thereby
help to reduce the number of errors.
practicing health professional and increase the quality of care.
Errors should not be considered as an
incurable disease, but rather as pre- represents one of the major chal- 6. Through the design and promotion
ventable phenomena, if systems were lenges in modern day medicine. of safer and even more efficient
designed to cope and to minimize the This affects the lives of women, devices and drugs, we acknowl-
effects and the consequences of these men, and children in every coun- edge that industrial partners have a
errors [43]. try. Without a safe environment it pivotal role to play in improving
is not possible to provide the patient safety. With the signature
quality of care that we all aspire of this declaration, manufacturers
to. This is especially true in of biomedical, pharmaceutical and
The challenges for the future intensive care medicine, given the biotechnology companies pledge
very fragile nature of the patients to:
Medicine in the last 200 years has we care for, often in the extremes
changed dramatically. The nature of of age, unconscious and with • Engage in efforts to improve the
health and disease has altered irrevo- minimal margins for error imposed safety profile of their products.
cably, pain has been conquered with by their deranged physiology. This • Provide resources to facilitate
anesthesia, and infectious diseases global problem requires a global the safe use of their products.
have been fought through a combi- solution. • Release, as soon as they become
nation of drugs and better public 3. We believe that improving levels available, any information
health systems. At the same time our of safety for critically ill patients is related to safety concerns of
understanding of the pathophysiolog- achievable in all units and in all their products to health-care
ical process underpinning these countries, irrespective of the professionals and regulatory
changes has improved exponentially. available resources. If the safety of agencies.
Despite these advancements, our our patients is increased, then the
knowledge as to how health-care quality of care that we can provide 7. The agreements reached today will
systems interact and influence the will improve. enable us to develop safety criteria
delivery of safe and quality care are 4. We strongly believe that increas- that can be used by intensive care
poor. The recent ‘‘discovery’’ of the ing patient safety is as crucial to units around the world to improve
epidemic of ‘‘medical error’’ as an the development of medical prac- their safe practices and increase
important cause of morbidity and tice as the increase in the the quality of care provided to the
mortality should not be a surprise. effectiveness of our interventions. benefit of all of our patients.
The first step to overcome this pre- 5. We have today therefore pledged
ventable epidemic is by the to do whatever is necessary to:
recognition of its existence. For this
reason the ESICM is promoting an • Increase the knowledge of the Appendix 2
initiative to bring together all the causes and reasons for failures Critical care societies who are
stakeholders who relate to our spe- to provide a safe environment in participating in the initiative
cialty in a process aimed at not only the intensive care unit.
raising the profile of patient safety, • Improve our understanding of ¸˜
Associacao de Medicina Intensiva
but to actually improve the outcome the consequences of failure to Brasileira (AMIB)
of our patients. provide a safe environment for Asia-Pacific Association of Criti-
critically ill adult and children cal Care Medicine
and the health-care profession- Australian and New Zealand
als caring for these patients. Intensive Care Society
Appendix 1 • Develop and promote criteria Austrian Society of Medical and
1. We, the Leaders of the Societies that can assess safety in the General Intensive Care Medicine
representing the medical specialty intensive care unit. Bahrain

5. Belgian Society of Intensive Care German Sepsis Society Serbian Society of Intensive Care
Medicine Medicine
Canadian Critical Care Society Hungarian Society of Anaesthesiolo- Slovak Society of Anaesthesiolo-
Chinese Society of Critical Care gy and Intensive Care Therapy gy and Intensive Care
Medicine Indian Society of Critical Care Sociedad Espanola de Anestesio-
Croatian Society of Intensive Care Medicine logia, Reanimacion y Terapeutica del
Medicine Indonesian Society of Intensive Dolor
Czech Society of Intensive Care Care Medicine Sociedade Portuguesa de Cuida-
Medicine Intensive Care Society dos Intensivos
Deutsche Gesellschaft fur Anas- International Pan-Arab Society of ˜
Sociedad Espanola de Medicina
thesiologie und Intensivmedizin Intensive Care Medicine ´
Intensiva, Crıtica y Unidades
Deutsche Interdisziplinare Veren- Israel Society of Critical Care Coronarias
igung fur Intensiv- und Medicine `
Societa Italiana Di Anestesia
Notfallmedizin Korean Society of Critical Care Analgesia Rianimazione E Terapia
EBA President Medicine Intensiva
Egyptian Society of Critical Care Kuwait `` `
Societe de Reanimation de Lan-
and Emergency Medicine Lithuanian Society of Anaesthe- gue Francaise
¸
Emirates Intensive Care Society siology and Intensive Care `` `
Societe Francaise d’Anesthesie et
ESPNIC `
Macedonia Society of Anaesthesia de Reanimation
Estonian Society of and Intensive Care Society of Anaesthesiologists and
Anaesthesiologists Malaysian Society of Reanimatologists of Central Russia
European Federation of Critical Anaesthetists
Care Nursing Associations Nederlandse Verenigning voor
European Society of Intensive Care Society of Critical Care Medicine
Anaesthesiologists Osterreichische Gesellschaft fur
Finnish Society of Intensive Care Anaesthesiologie, Reanimation und Sudan
Georgian Society of Anesthesiol- Intensivmedizin Swedish Society of Anaesthesiol-
ogy and Critical Care Medicine Romanian Society of Anaesthesia ogy and Intensive Care Medicine
and Intensive Care Swiss Society of Intensive Care
Scandinavian Society of Anaes- Medicine
thesiology and Intensive Care Tunisia
Scottish Intensive Care Society UEMS
5. Donabedian A (1990) The seven 9. GRADE working group (2004)
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