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768 A P P E N D I X A W O R L D F E D E R AT I O N O F C R I T I C A L C A R E N U R S E S P O S I T I O N S TAT E M E N T S

APPENDIX A4 together the representatives of Critical Care Societies
DECLARATION OF VIENNA: PATIENT from around the world (national and international) with
the aim of pledging their efforts and resources towards
SAFETY IN INTENSIVE CARE MEDICINE improving the care of our patients. Together with the
societies signing this Declaration of Vienna (Appendix 1)
PATIENT SAFETY IN INTENSIVE CARE will be senior representatives from the political world,
MEDICINE: THE DECLARATION OF VIENNA our partners in industry and of course patient representa-
A declaration by the Executive Committee tives themselves. The meeting will assess problems and
of the European Society of Intensive solutions from around the world irrespective of geo-
graphical, political or economic factors. This unique part-
Care Medicine nership will allow collaborations to be fostered and for
Patient safety in intensive care medicine partnerships to develop. We hope to be able to use this
group to raise the profile of the patient safety agenda and
Improving the outcome of critically ill patients remains therefore change the way we practice everyday with resul-
an ideal that every practicing Intensivist strives to achieve. tant benefits for all.
Every year there are many hundreds of research papers
published that help us to better understand the physio-
logy and pathophysiology of our patients and also how From efficacy to effectiveness
our treatment strategies interact and eventually alter a Patient safety in intensive care medicine is best evaluated
patient’s course. Many of these papers focus on discrete in terms of two dimensions:
parts of the therapeutic regimes that we are able to deliver;
however, few have had a significant impact on overall • at the individual patient level, by doing good and not
outcome measures that are relevant to patients them- doing harm to any individual patient;
selves. One area of medicine that is often overlooked, but • at the collective level by doing good and not doing
can impact significantly on relevant patient outcomes, is harm to groups of patients, by increasing the safety
the process of care. The way we practice, the culture we and the effectiveness of our interventions or in other
work in, the climate that our professional demeanor words, the cost–benefit ratio.
creates can all dramatically impact on outcome measures. Although at the level of the individual patient there is
Unfortunately, these topics are often not easy to explain, little difficulty in explaining what is meant by the concept
difficult to study and do not attract research funding that of safe practice, at a collective level this is far more
stimulates scientific minds to address the problem. This complex. Partly this is because often the concepts are
paper describes how the European Society of Intensive more easily addressed by complex statistical approaches
Care Medicine (ESICM) aims to raise patient safety to the when addressing groups of patients and the fact that they
top of the scientific agenda with the hope of ultimately relate to the two pillars of quality, efficacy and effective-
increasing the quality of care delivered to our patients ness. This difference between efficacy and effectiveness
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and improving their outcomes. is very important to understand. Efficacy relates to the
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The Institute of Medicine (IOM) published in 1999 their capacity of an intervention to produce an effect, for
seminal report entitled ‘To err is human: building a safer instance in a research trial, effectiveness relates to how
health system’. This paper described quality as the degree well this translates to improved outcomes in real-life
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to which health services for individuals and populations pragmatic situations. The standards for the evaluation
increase the likelihood of desired health outcomes and and reporting of the efficacy of an intervention are now
are consistent with current professional knowledge. Safety reasonably well established, despite several concerns sur-
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was defined as the absence of clinical error, either by rounding methodological pitfalls. These standards have
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commission (unintentionally doing the wrong thing) or been described both for the individual level situation
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omission (unintentionally not doing the right thing) , and also where the evidence is arising from a variety of
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and error as the failure of a planned action to be com- different sources. When we move from efficacy to effec-
pleted as intended or the use of a wrong plan to achieve tiveness, the picture is not so clear. These problems are
an aim. The accumulation of errors results in accidents. usually seen when trying to translate research scenarios
The authors delineated just how common failure to into everyday clinical practice, or when trying to develop
provide quality care is, with between 44,000 and 98,000 or assess clinical practice recommendations or guidelines.
patients dying each year in the USA as a result of a clinical The definitive answer about the risk–benefit balance of
error. This makes medical error the eighth leading cause any intervention can only be made when the balance
of death, more frequent than motor vehicle accidents between the expected benefits and the expected risks is
(43,458), breast cancer (42,458) and AIDS (16,516). assessed in the real world, outside of the experimental
Despite the awareness of patient safety and quality of care setting. To move from what is known about the benefits,
issues increasing in both patient and political arenas, this the risks and the limitations of a certain intervention
has not translated through to groundbreaking research when applied in a very strict usually non-generalizable
studies that have ignited the topic with significant cohort of patients to everyday practice is very difficult.
outcome benefits. 3,4 This often relates to patient case mix differences, severity
of illness differences and the effects of multiple interven-
To improve the profile of these subjects, the ESICM in tions impacting on each other that were not fully assessed
2009 has launched a major initiative that will bring in the original trial.