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Professional Governance of Intensive Care Medicine

The real improvement will not happen from the inside.

The Covid-19 focused worldwide attention on the ICUs. With ever-greater control over the spread, evaluations of how the pandemic has been addressed will take place everywhere. The functioning of the ICUs will also be examined. The doctors, nurses and support staff have done a fantastic job with great effort and care. More than usual, the strong sense of togetherness and cooperation will receive favourable attention. Although there were many deaths, we know from studies that improved professional collaboration leads to better functioning and better output of the ICs. It leads to fewer deaths. So it could have been much worse.

Suggestions for improving the ICU will aim to maintain solidarity as much as possible, and some actions and practices may need to be adapted. Internal efforts are likely to optimise the existing system in parts.

However, to evaluate the functioning of the ICU as a whole, it is necessary to look remotely and also with non-medical eyes. You should not expect that people who work within a system can assess and change the system as such. External help is needed to get an overview. From experts for the substantive side, but also from administrators, to monitor the context, make decisions and facilitate.

The attached article aims at them.

The studies to which this article refers took place before the pandemic. Therefore, it ignores the control and logistics processes that strongly affected the functioning of the ICUs during this period. They were essential to the coordination and collaboration processes between ICUs during the Covid19 outbreak.

This article focuses on improving ICUs as an organizational unit. It highlights two crucial points for improvements in ICUs: their organization and operation and the need to investigate underlying physiological patterns in severe conditions.

The Legacy Paper of Professor Reis Miranda aims to make the ICUs even more effective and efficient and to increase job satisfaction.

Drs. Gertjan Nooij Human Performance BV

Groningen, june 2020

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Professional Governance of Intensive Care Medicine

Legacy Paper

Dinis dos Reis Miranda, MD, PhD, FCCM*

May 2020

Summary

Intensive Care Medicine (ICM) has substantially increased along time its impact on the care of patients in the hospital. Clinical expertise and intervention capability improved. However, two limitations hinder further progression:

1. the development of the organisation has lagged. Which means the contribution of the diverse pro- fessionals can not be supported optimal and efficiently;

2. critical scientific developments did not reach the daily medical reasoning yet.

Ad 1. A unique international collaboration between dozens of ICU’s and research centres in Europe, repre-senting different medical and non-medical disciplines** addresses these organisational insufficiencies. It is known as the EURICUS-studies. A 10-year programme of three separate studies developed and implement-ed as Concerted Actions of the BIOMED Research Programmes of the European Union.

Notable outcomes of these studies include:

1. Non-medical factors influence mortality rate. In randomised controlled trials (RCT’s), variables of non-medical disciplines correlate with mortality odds ratios. ‘Process awareness’ ‘professional com- munication’ ‘mutual respect’ ‘budgeting and budget control’ prove to be vital.

2. Non-systematic variation of organisation variables in the ICUs is seen among countries and within each country.

For example, periodically, the media of all countries report a shortage of ICU-nurses. Irrespectively significant variation of nurses per bed in the ICU, which goes from 2,4 in Belgium up to 10 in Nor- way.

3. After controlling for severity of illness, the outcomes of patient care in ICUs of university hospitals do not differ significantly from those of non-university hospitals. In other words, a higher provision of resources, human and other, does not mount to make the expected difference.

4. A system for permanent professional improvement and control of the nursing work is not in place. The fundamental condition of professional accountability in the hospital setting is, therefore, not yet met for the nursing staff in the ICU.

Ad. 2. Besides the organisation insufficiencies, the immense potential of care available seems to have unveiled our knowledge regarding the physiologic changes occurring during critical illness. In the ICU, critical illness refers to the malfunction of organs and systems. These dysfunction(s), at admission, may be followed by the additional failure of another organ or organs or systems. These ‘secondary’ malfunctions are usually seen as complications of the primary illness condition. The plan of care of the critically ill is mainly focussed on the recovery of each dysfunction, frequently implying the external (often mechanical) control of those functions.

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Growing evidence suggests these multiple malfunctions may be the clinical expressions of “deeper” and ongoing physiologic deregulation. The failures are eventual clinical markers of a complex course of illness, not explicitly addressed by the plan of care. A reconsideration is necessary.

Outline

After summarising the results of the EURICUS-studies, the present work is divided into four parts address-ing the areas of governance needing urgent modernisation:

1. Structure of the teamwork. Integrate the professional efforts of physicians and nurses in a systematic manner. To improve the organisation of cooperative-work in the ICU to an up to date level the application of five well known ‘tried-and-true’ methods is obvious: the general system theory; the standardisation of the processes of care; quantified management; professional accountability; and the definition of governance objectives. The ICU-professionals will accomplish the analysis and standardisation of the process of care, carefully guided and supported by a work-psychologist and a job-analysts.

2. The primary management structures. Focus on matching course of illness and plan of care. Does the bedside monitoring of the timelines of course of illness (previous and actual profiles) match with those of the ongoing plan of care? Improve the decision latitude of the nursing staff; install systematic nursing supervision, ensuring compliance with and adequacy of the plan of care.

Audit regularly the match of requirements and resources of care.

3. Investigate the course of illness. Advocate a new approach to the understanding of the course of critical illness. Re-assess the information available to intensivists (e.g. reviewing monitoring), as well as integrate insights from research from other sciences (e.g. MIT). Encourage the need for fundamental research to the patterns of physiologic derangement underlying critical illness. The goal is the definition of meaningful and mutually exclusive profiles of illness, which could iden- tify and characterise different stages of the ongoing physiologic deregulation in the course of the dis- ease until recovery or dead ensues.

4. Closing remarks. Five topics highlighted:

a. Updating the approach to illness may imply essential updates in the curriculum of the Medical Schools.

Those who take care of the critically ill are still missing the understanding of the ‘transversal’ in- teractive deregulation of individual physiologic systems.

b. Continued professional education of intensivists has to ensure to meet the organisational require- ments of the hospital.

Until the traditional sources of continuous professional education will systematic and comprehen- sively cover the non-medical issues regarding the governance of care, the hospitals have to take this as their duty. c. Standardisation of the ways of working is a ‘must-have’. d. ‘Intensive Care’ shall entail the maximal utilisation of the time available to control and revert the course of illness. e. ICM requires the necessary support of non-medical disciplines.

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Keywords: Intensive Care Unit (ICU), Organisation & Management, Processes of Care, Team-Work, Accountabili-ty, Monitoring, EURICUS-studies, Nursing Activities Score (NAS).___ *Emeritus Professor Intensive Care, University of Groningen, the Netherlands – dreismiranda@gmail.com**An intense collaboration of Intensivists, Nurses, Directors of IC, Management & Organisation Experts, Economists, Organ-isational & Social Psychologists, Financial Experts, Health Services Research, Medical Technology Assessment, Statisticians and Methodologists, representing 120 ICUs, 10 Universities, and 17 Research Centres from 13 countries: Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Spain, United Kingdom. ______________________

Introduction Ignorance is complementary to knowledge

Decisions and performance do reflect both. drm

During the second half of the last century, the clinical practice in the ICU has been influenced by the outstanding work of W. Knaus regarding the pre-diction of the outcome of illness (the APACHE-re-search program), based on a set of clinical variables [1]. The APACHE scoring system was developed to assess the performance of care in each ICU, for the first time, by comparing the observed mortality vs. the standard mortality ratio (SMR, derived from the outcome of all ICUs in the study). Besides, his work

anchored the call for ‘quantification’ in medical prac-tice. It has, however, to be noted that the APACHE score, is unable of linking the estimated performance with the governance of the activities of care.At about the same time, the new Health Services

Research (HSR) discipline approached the study of health care based on the general system theory in which professionals (from diverse disciplines) should focus on the analysis and standardisation of the ways of working: aiming at achieving controlla-ble and reproducible performance.Both these methodologies are essential but not al-

ternative options to appraise performance in the ICU.

In the ICU, the physicians are today qualified with a specialist degree in Intensive Care Medicine (ICM). Their professional education did not include issues of the organisation and management of care in team-work. Although the ICU is a rather complex organi-sational environment, the intensivists have not been told about the manner of effectively incorporating their activities in the local organisation. The liability is not felt as such by the professionals, intuitively focussed in the classic patient-physician relationship as the compass for action.The nurses are also increasingly becoming qualified

with a degree in ICM. However, they are restricted in their professional decision latitude for reasons that will be discussed. As a consequence, their potential contribution to the care of the critically ill is not fully ensured.

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ICM has known exceptional scientific and techno-logic progress in the last decades. The gradual im-provements occurred primarily under the auspices of a few well-established medical specialities in the hospital. Their traditional approach to illness and care was therefore transmitted to the neophyte spe-ciality. The ICU is potentially prepared, in the view of the

resources at hand, to execute any stated plan of care and to react timely to any change in the course of illness. However, opposite to the course of illness in the general ward, clearly tending to recover more fre-quently along time, the critically ill in the ICU gets quite often worse. In the actual clinical knowledge, the ‘course of getting ill, and worse’ is not easily understood as describing one and the same process, particularly beyond a particular stage of severity.

Governance is the way rules, normsand actions are

structured, sustained,regulated and held

accountable

The intermittently identified new developments are often seen as disconnected events from or complica-tions of the original illness. Our persisting ignorance of the detailed sequence of physiology derangement explaining the process of illness impairs the possi-bility of mastering the process. These limitations, somehow uncovered by the overwhelming capacity of intervention available, are perhaps best evidenced by the predominantly ‘follow-the-events’ therapeu-tic policies practised in the ICU. Surprisingly, these issues do not yet figure in the to-do research list of intensivists. The majority of the published papers merely meet academic purposes; very few do report on the performance of health care; organisation and/or management topics are rarely addressed in a sys-tematic manner, and about never in a HSR context.

When I became the director of one starting ICU, some 50 years ago, the activities there were main-ly dependent on one or two major specialities. The related organisational difficulties were several, par-ticularly related to the allocation and functioning of staff and regarding the medical responsibility of the care provided.I was therefore motivated to follow courses on the

OM of the Profit- and the “non-Profit Organisations” administered at my University. After completion, I knew that the effective solution of the existing obsta-cles could only be found in the expertise and support of other, non-medical disciplines.

The Foundation for Research on Intensive Care in Europe (FRICE) designed a large research project to study the effectiveness and the efficiency of Health Care Departments, from an HSR perspective. It is

known as EURICUS (European ICU studies): A 10-year programme of three separate studies developed and implemented as Concerted Actions of the BI-OMED Research Programmes of the European Un-ion.

The first study explored in detail the organisation of the ICUs in Europe, with a particular focus on the non-medical variables of the organisation and man-agement of work regarding patient care. The study confirmed a non-systematic variation of these varia-bles, among countries and within each country. Also, the odds of dying in one or other Unit could vary up to 6 times, after controlling for severity of illness.

Subsequently, the research programme demon-strated in two randomised control trials that simple managerial interventions: a) The harmonisation and standardisation of collaborative practice; and b) The implementation of guidelines for budget control and cost calculation – had a significant and positive im-pact upon the intermediate and final outcomes of pa-tient care in the ICU’s.

The lessons from the EURICUS-studies are as actual and compelling today as they were twenty five years ago. A summary of this research programme can be found in Appendix 1, page 24.

The chapters that follow, address the very elementa-ry framework of good governance, aimed at reaching out to the younger generations of professionals and researchers eager to improve the outcomes of care in the hospital.

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1 - Structured team-work

The ICU is a well-suited place where a group of people work together to achieve jointed results. For attaining the shared purposes efficiently, the resourc-es need to be organised most effective. The EURICUS-studies have shown that the OM

(Organisation and Management) of the ICUs can im-prove significantly.This is made clear based on five basic OM concepts:

the general system theory, the work-processes, quan-tified management, professional accountability and purposeful governance.

1.1 - General System Theory

A system is an organised collection of elements or parts that are highly integrated to accomplish an overall goal [6]. The way those elements interact is constant and predictable and can, therefore, be an-alysed. The basic elements are the input of the sys-tem, the mutual interaction between the elements the throughput, and the output the results of the system.The complexity of each system may vary, as systems

may be interconnected giving rise to more elaborated and systematic entities. The connectivity of systems implies that the output of one system belongs to the input of another. The interactions may be so tight that a system failure can be devastating, or loose enough that the system can adjust to it (through feedback) and continue to function. Complex systems usually interact with their environment, being therefore open systems.

These universal principles of organisation are wide-ly accepted by a large number of sciences such as physics, chemistry, biology, and sociology.

In Medicine, the basic notion of systems is derived from the concept of tissue that is made up of cells working together to perform a specific function. Any disorder in cells will have adverse effects on the tis-sue and consequently elsewhere in the human body. The human biology system takes inputs such as air, light and food from the surrounding environment. The human body is, therefore, not a fixed structure but an organised collection of systems.Expectedly, the use of the general system theory in

the approach to the critically ill will be beneficial. However, it will require much more detailed knowl-edge of the processes of illness, as discussed in

Chapter 3.3.

Also to optimise teamwork in the ICU, insights from the GST can be used. Hereafter it is done from an organisational perspective.

1.2 - Processes of care

The hospital is composed of a group of departments or units. Each of these accomplishes a particular and specialised kind of work. The work started within one Unit is usually continued by a set of tasks per-formed within another unit. It is a functional cascade of systems and sub-systems of care, in which, from admission through the discharge of each patient, the output of one system becomes the input of the next. For example: Emergency room > ICU > Medium Care Unit > General Ward (figure 1.1).

A system is a collection of interrelated work processes,

activities, and tasks, such that the collection and the interrelationships

together avoid disorder

Figure 1.1 – System and sub-systems of care

The general system theory is essential for standard-ising the work in the ICU. The definition of goals guides the performance of care. The focus in the outcomes of illness (morbidity and mortality), very important in the past, is shifting today towards the outcomes of action (figure 1.2) This brings physio-logic derangement, the elementary source of about all illnesses, closer to the action of care.

A process of care (also to be seen as a system) is a collection of interrelated work activities, and tasks, such that the collection and the interrelationships to-

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Figure 1.2 – Changing focus of outcome

gether avoid disorder [7]. Any complex process of care is decomposed into different subprocesses, which are partitioned into specific parts that tackle particular problems. In the ICU, nearly all processes of care are the result of a multidisciplinary contribu-tion of intensivists, nurses and other staff. The contribution of the involved professionals has

to be organised into a recognisable structure to be effective and controllable. The use of the system ap-proach is vital to the standardisation of the activities. Therefore, we first need to ‘map’ all the processes

of care and determine exactly their content and im-portance. The analysis of each process will evaluate and describe 1. the activities involved and their sequence in time; 2. who is responsible; 3. the interaction between professionals (overlap-

ping interactions to be described in protocols); 4. control of outcomes and reporting.

After the complete inventory of processes, a distinc-tion is necessary for ‘key’ and ‘standard’ processes of care. In the ICU, the key-processes are those related to the functioning of vital organs and systems, such as respiratory, cardiovascular, renal, metabolic, etc. All the other, such as monitoring, hygiene, mobilisa-tion, etc., are standard processes. Each key-process will be composed of tasks which can be described “systematically”. The distinction between these cru-cial and standard processes brings the key-processes to the foreground, emphasising the specific role of the ICU in the hospital system of care.

The recurrent cycle of inventory, review and opti-misation of work-processes: • allows for the systematic and controlled improve-

ment of quality of care;• is reported to result in cost savings of 30-40%

while improving performance;• increases staff engagement and productivity, as

a result of role clarity, consistency, training and accountability. •The combination of these outcomes creates a sig-

nificant return on the investment in the mapping process [8].

The maturation of a clear work-organisation will enhance the professional sense of accountability.The analysis of the processes of care cannot be done

professionally and independently by the ICU staff alone. It is, therefore, necessary that this work is ex-plained and supervised by a work-psychologist and carefully guided by job-analysts.When the inventory and description of the activities

are complete, the re-definition of jobs and tasks in the ICU may probably follow.

Culture follows Structure

1.3 - Quantified management

The Nursing Activities Score (NAS) -NAS [11] is the first scoring system devised to the

quantified management of the nursing staff in the ICU.It is used worldwide, replacing all other scoring

systems in use such as the Therapeutic Intervention Scoring System (TISS) [12] aiming at assessing ‘nursing workload’ in the ICU. The development of NAS concentrated on the con-

sumption of nursing time in the ICU. The invento-ry of all nursing interventions and activities in the ICU makes using a Delphi methodology. Then, ex-cept a few typically ICU tasks, all these professional activities are translated into elementary work activ-ities such as ‘watching’, ‘dressing’, ‘lifting’, ‘posi-tioning’, ‘hygiene’ etc. NAS measures, therefore, working time independently of the professional in-terventions performed. The mean working time spent is attributed using ‘work-sampling’ in a large and diverse group of international ICUs [11]. 100 NAS-points equals the 24hs-fulltime dedicated-work of one nurse (usually during three shifts).

In a considerable amount of NAS studies published, the tool is consistently confirmed as complete and reliable.

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Summarising, NAS attributes a time-score to the performance of each nursing activity in the ICU. The knowledge of the nursing-time consumed with pa-tient care enables a significant improvement in the management of the nursing staff:

1. the number of patients that can be cared by one nurse (P/N ratio) is easily computed at the patient level and is also useful to determine, for example, the consumption of nursing time by stratified groups of patients. Because the annual volume and characteristics of the ad-missions in each ICU are somewhat constant, the detailed knowledge of the annual P/N ratios can be instrumental in the planning of the nurs-ing resource; 2. the inventory of the variation in P/N ra-

tios along the daily shifts may improve the nurs- ing staffing of these; 3. the cost of nursing care is easily calculat-

ed after determining the hourly cost of nursing work. This will allow, for example, the compar-ison of nursing work cost of two or more equal-ly effective procedures of care aiming at achiev-ing the same goal.

Recent studies do indicate that NAS can be used in the online calculation of the total cost of care at the patient level [13].Finally, NAS will allow the audit of the use of hu-

man resources in the ICU, by comparing the total nursing-time available in the Unit with the nurs-ing-time consumed during the same period, or the ‘Work Utilisation Ratio’ (WUR, see also 2.2.2) [14].

On the side of the nursing activities, NAS has deter-mined that only 30% of the nursing time is consumed with activities related to specific ICU-technology and -interventions. Consequently, it allows for job differentiation of the nursing activities:

1. a professional ICU-nursing career and

2. decentralisation to the other hospital-wards of the skills and expertise developed in the ICU.

As explained in 2.2.1, NAS will support the effi-cient use of resources in the hospital, particularly re-garding the transfer of patients between the various facilities.The itemised nursing activities in NAS will expect-

edly play an essential role in the analysis and de-scription of the processes of care in the ICU.

1.4 - Professional accountability

Professional accountability is generally defined as one is responsible for his/her judgement, actions and omissions during the performance of his/her profes-sional duties.Along with many generations, the notion of ac-

countability in the care of patients has known several interpretations, to a large extent due to the customary philanthropic character of patient care.Nowadays, the concept of professional accounta-

bility in Health Care is quite well established. The application of liability, however, remains a particular problem, particularly concerning the nursing profes-sion. The primary reason derives from the persisting ambiguities around the function and responsibilities of the nursing staff.In the ICU, for example, the professional core of

care is composed of intensivists and intensive care(ic) nurses. The hierarchy of professional duties and ac-countability in the physician’s group, from trainees up to the ICU-director, is well understood and often written down. The professional checks of the ongo-ing medical care frequently occur during the daily exchange of views with multiple colleagues. On the side of the ic-nurses, this is not the case.The organisation of the nursing staff is extremely

flat. At the work-floor, the team of working nurses is usually equally credentialed. The professional hierar-chy only knows ‘ic-nurses’ and the ICU ‘head-nurse’ (in few countries an additional group of less qualified nurses may be attributed to specific standard tasks). Usually, the head-nurse does not have clinical duties. Consequently, the ‘double-checking’ of the nursing work is only to a certain extent done by the physi-cians, mainly when both activities of care do over-lap, and occasionally by a nursing colleague. Sys-tematic control of the nursing work is not in place. The fundamental condition for the establishment of professional accountability in the hospital setting is therefore not yet met for the nursing staff in the ICU.The ambiguities existing in the organisation of the

nursing profession are now addressed by the nursing leadership [15]. They envisage the introduction of a ‘clinical supervisory’ function in the organisation to oversee the activities of the nursing staff.

I will come later to the importance of nursing ac-countability. The decision latitude of the nurses, de-pending on existing responsibility, is a significant variable regarding both professional performance

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The systematic controlof performance is the very basic conditionbefore professional

accountability is possible

and nursing well-being.

1.5 – Purposeful governance matters

The EURICUS-II studied the effect of an organi-sation based managerial intervention on the perfor-mance of ICUs (see Appendix 1, page 24). 37 ICU’s participated in the study, of which 19 were randomly allocated to the experimental group [16].The intervention comprised a set of managerial

changes, applied during a period of six months, aim-ing at increasing:

1. the collaborative practice between physicians and nurses;

2. the nurse’s awareness of the work process, with a focus on the level of their skill discretion and their participation in decision-making.

A team of experienced psychologists introduced the collaborative practice to the staff of the ICUs in the intervention group, by means of presentations (dealing with issues such as communication, con-versation technique and cooperation) and training de participants in staged interactive conditions going from regular feedback up to hefty disagreement. The content of the training was also addressed in an ex-tensive manual, with illustrations and examples. The brief training was sustained by the use of two proto-cols during the intervention, addressing:

1. Process awareness. Hourly, after the regu-lar monitoring check and the eventual registration of abnormal values the nurse, using a specific deci-sion-tree should consider whether interaction with the physician was necessary.

2. Stimulating communication and mutual re-spect. During the major daily ward-round, the nurse of each patient should administer, together with the physician, a questionnaire addressing three issues not necessarily dependent of professional expertise, concerning: families, sedation and decision to dis-charge.

3. Besides, each staff member received a flyer with the essentials of each chapter and a ‘credit-card’ with tips and reminders.

A set of Questionnaires, concerning human re-

source outcomes, were administered on two occa-sions to the staff in the course of the field research, covering nurse-physician collaboration and work and well-being.

The ICU-performance was monitored before, during and after the intervention, in terms of mortali-ty and the occurrence of out-of-range-measurements (ORMs; see ‘Chapter 3.1 - Monitoring Revisited’). Data were statistically analysed by logistic regres-sion with random effects due to ICUs.

The overall ICU and hospital mortalities were 14% and 20%; the incidence of BP-, HR-, SaO2- and Diur-ORMs were respectively 46%, 38%, 28% and 48%. After adjusting for SAPS II, admission type and age, the regression analyses revealed a positive effect of the intervention for all the six outcome variables. The summary of the results is depicted in table 1.

OutcomeVariable

OR*Control Intervent.

Ratio of OR’s ¥

Int./Contr. 95% CIP-value

ICU death 1.35 0.97 0.72 0.55--0.95 .020

Hp death 1.37 1.04 0.76 0.60-0.95 .018

BP ORM 1.09 0.87 0.80 0.66-0.96 0.18

HR ORM 1.08 0.78 0.72 0.60-0.87 .001

SatO2 ORM 1.39 0.98 0.76 0.62-0.94 .010

Diur ORM 1.28 0.92 0.72 0.59-0.87 .001

Table 1 - Comparison of Outcomes in the Control and Interven-tion Groups. *- Postintervention period versus pre-intervention period. ¥ - “Intervention OR” divided by “Control OR”. BP- Blood Pressure; HR- Heart Rate; SaO2- Arterial Saturation of O2; Diur- Diuresis. ORM- Out of range measurement.

All 6 outcomes are in the left column; the follow-ing two columns present the odds ratio of the sec-ond research period (post-intervention) versus the first period (pre-intervention). Concerning the ICU death, for example, the odds ratio of mortality af-ter to before the intervention was 1.35 in the control group and lower (0.97) in the intervention group. The third column presents the ratio of the OR’s of the intervention group to the control group: the mor-tality in the ICU, the odds ratio was 0.72 times lower in.the intervention group than in the control group (p< .020).

This study shows that a rather modest but struc-tured managerial intervention can have a positive and significant impact upon the outcomes of care.

The results of the questionnaires concerning col-laborative practice and work and well-being are published somewhere else [17].

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Besides the improvement of collaborative practice, the positive results caused by the intervention can also be explained by the increased focus of the staff on the outcomes of the process of care. During theEURICUS-I study we found that the ICUs with a ‘re-sults-oriented’ culture perform better than those with a ‘process-oriented’ culture*.

The ICU performance is also significantly influ-enced by organisation commitment, decision latitude of nurses and the predictability of workflow. The pre-dictability of workflow (six categorical variables re-

presenting lack of ‘communication’ and lack of ‘work planning’) is significantly and inversely relat-ed to the incidence of ‘burnout’._________

(*) – ‘In the process-oriented cultures people perceive themselves as avoiding risks and as devoting only a limit-ed amount of effort to their jobs; each day is pretty much the same. In results-oriented cultures, people perceive themselves as being comfortable in unfamiliar situations and as applying a maximum amount of effort; each day is felt to bring new challenges’ (G.Sanders – EURICUS, Culture sub-study)

2 – Basic management structure

The ICU is usually the place in the hospital where all critically ill patients convene and also where the more significant number of highly specialised physi-cians and nurses work around the clock.

Part of the Euricus studies, and in addition to ob-servations, there was an in-depth interview with the leaders of staff, during a one-day visit to all partici-pating ICUs. The professionals involved belonged to two wholly separated organisations. The single-sub-ject collecting the most negative remarks was the collaboration between physicians and nurses. The description of what we found was perhaps best sum-marised by one head-nurse: “We are not a team. We work together”.

2.1 - Mastering the plan of care

Primum non nocere (‘First, do no harm!’) is the an-cient advice that physicians should always keep in mind when the choice lays between ‘action’ with an uncertain result, and ‘wait’ for a more clear clinical picture in the course of illness before undertaking a targeted intervention. The more clear picture usual-ly corresponds to a clinical diagnose, summarising a predefined set of signs and symptoms. Although everybody agrees that the advice of caution should always apply, the point is that the score of success of any therapeutic intervention upon the course of illness appears to be time-dependent: the longer it is withheld, the more critical the physiologic deregula-tion can be.

The conclusion to retain is that the principle ‘prim-um non nocere’ is also inevitably linked to our broad ignorance concerning the courses of illness, often

impairing that timely action takes place. The limited knowledge of the factual progression of each critical disease reflects clearly in the rather general nature of many of the arrangements of care, and in the at-mosphere of just routine activities predominating in a large number of ICUs.

The detailed understanding of the physiologic dis-order involved in the course of each illness will pro-vide a time-frame to its description enabling the use of more specific methods of care at an earlier phase of the disease.

Let’s give an example:

Around 1980, the use of selective decontamination of the digestive tract (SDD) of patients aiming at the reduction of infections was introduced in a Dutch ICU. The study of the incidence of infections in a ‘historic group’ of trauma-patients, before the inter-vention, was much higher (85%) than the incidence of infections in a comparable group of patients af-ter starting the intervention (16%). Accordingly, the mortality between the two groups was also re-markably reduced [18]. The impact of these results among professional intensivists was immense. The significant beneficial effects of SDD were since then worldwide confirmed in many randomised con-trolled trials. However, the extraordinary difference in outcomes was never replicated. Most likely, the explanation is that the intensivist responsible for the original research had a profound knowledge of the course of infections: together with a very motivated group of nurses, the activities of care for combating infections were creative, vigorous and much more frequent than any fixed time-schedule could ever predict.

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This example calls the attention inevitably to the usual planning of repetitive actions of care, the fre-quency of which is commonly associated to the daily number of nursing duty shifts (two, three times/day). Here again, the organisation of the actions of care seems to be subsidiary to general working directives. These matters require appropriate investigation.Per definition, the course of illness occurs chrono-

logically from start to end. During this time, the clin-ical diagnoses are often ascertained when the course of illness gets closer to the end. It is therefore im-perative that fundamental research is developed for understanding and describing the possible courses of illness so that they can be recognised before the standard set of clinical variables (allowing diagno-ses), becomes apparent. As indicated in Chapter 3.3, the use of data-mining, and particularly of artificial intelligence will be decisive in the detailed under-standing of the physiologic derangement intrinsic to illness. Of foremost importance is the identification of specific profiles of disorder to serve as meaningful markers of change in the course of the disease. The description of these markers is indispensable for the pertinent mastery of the processes of care. One can expect the research of these matters will substantiate why the underlying systemic pathophysiologic dis-order should be the primary focus of care. Diagno-ses, vital as they may be, become relevant markers in the course of illness.

Diagnoses, importantas they may be,

become markers in the course of illness

Decision latitude - Other than the lack of in-formation regarding the detailed progression of an illness, a significant part of the rather unspecific arrangements of care in the ICU is due to the very restricted decision latitude of the nursing staff. Deci-sion latitude is dependent on structured accountabil-ity. And accountability, as discussed above, requires to have in place a system for the effective control of professional performance.From a human resources point of view, the nursing

staff is the most critical asset of the ICU: the number of nursing FTE’s is 10 to 20 times the number of physicians; the vast majority of the nurses is special-ised in intensive care; it corresponds (between 30%

and 50% of total cost) to the single highest costs in the ICU.

The absence of decision latitude of the nursing staff (or the extent to which the nurses can make decisions and exercise full control over their work) establish-es that the capabilities of this professional group are mostly underutilised. It is a major cause of profes-sional dissatisfaction, an essential waste of resources and, it precludes the maximisation of the adequacy of care.

The formal establishment of accountability of the nursing staff is, therefore, mandatory and crit-ical. It implies recognition of job differentiation in ICU-nursing as well as the creation of a system over-seeing the performance of care. The control structure ensures the accountability of the nurses, empowered to full commitment and responsibility. Together, con-trol structure, accountability and decision latitude will improve situation awareness and reduce waiting time in the system, enabling the thorough compli-ance with a more specific plan of care.

Monitoring is the single activity most practised in the ICU (figure 2.1). The anaesthesiology was the first speciality to take care of critically ill patients in the hospital. For understandable reasons, the anaes-thetists felt more comfortable with creating a moni-toring environment similar to what they used in the operating theatre.

Figure 2.1 – Typical monitoring in the ICU

The continuous monitoring of a few vital signs (blood pressure, heart rate, peripheral oxygen sat-uration and diuresis), is necessary for anaesthesia procedures, during which the patient undergoes all kinds of external and sudden aggressions.

In the ICU, however, the change in vital signs does not always provide a clear insight into the course of illness, being often the belated warning of the ongo-ing physiologic derangement.

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The classical monitoring is therefore manifestly in-sufficient for the comprehensive exploring and un-derstanding of the course of illness, upon which the plan of care is controlled and reviewed. In the ICU, the monitoring MUST change as it should provide appropriate and timely information regarding the tasks of care, including at least:

1. The course of illness (Figure 2.2)

1) Updated summary of illness highlighting

clinical issues of interest 2 All observational, biological, biochemical

and physiologic data, etc., are automatically summarised into predefined profiles of phys- iologic derangement, visualising the pro- gress of illness along time: at admission, relevant progress markers, today’s profile(s), etc.

3) Relevant laboratory and other results, for matching with those belonging to the targets of care.

2. The plan of care (Figure 2.3)

1) Objectives of care at short and medium term

2) specific processes of care – What (1,2,3,…) -When-Objective//Result

3) standard processes of care – What (1,2,3,..) When//Remarks

4) assessment of planned actions of care vs. those performed

5) results vs. objectives assessment

Figure 2.2 – Monitoring the course of illness

Figure 2.3 – Monitoring the plan of care

The supervisors oversee the nurse’s performance as such, concerning the plan of care and to the oc-currence of clinical changes, deciding whether and when the nurse needs to be contacted (Figure 2.4). This supervisory function is extensively studied in the research of Cummings et al. described in Chap-ter 3.2.

Figure 2.4 – Nursing supervision, adapted from Cum-mings et al [26]

2.2 - Matching requirements and resources

About 5% of all patients admitted in the hospital have a temporary admission in the ICU. Yet, the cost of the ICU is estimated to represent between 10%-20% of the total costs of the hospital. One day in the ICU costs easily >10 times more than one day in the general ward. In other words, the exceptional con-centration of resources makes the ICU, working full-time around the clock, the most expensive Unit in the hospital. The governance of the ICU has, therefore, the responsibility of supervising the usefulness and the coherent use of the available resources, along with the basic principles of organisation discussed in Chapter 1.

2.2.1 - The facilitiesThe beds of the ICU of one hospital are beds at the temporary service of patients (to be) admitted to oth-er departments of the same hospital. The number and the type of the patients admitted to the ICU is there-fore greatly dependent on the activities of care in the other units in the hospital. When fully organised:

a) the ICU has a fixed number of beds, and the nurs-ing staff a fixed number of full-time equivalents;

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b) the Unit admits a rather constant number of pa-tients per year, composed of rather consistent groups of case-mix;

c) annually, the mean severity of illness at admission, as well as the first day NAS-score remain similar; d) after entry, the clinical condition improves in a rather constant percentage of patients, and the amount of nursing care decreases so that they can return to the general ward.

The constant changes in the amount of nursing care required (i.e. the individual P/N ratio of care measured by NAS) will determine, to a large extent, the availability of care in the Unit. The research group of Iapichino has published interesting work detailing the appropriate use of the nursing work-force in the ICU [19, 20].

The transfer of critically ill patients between the so-called step down/up units is only justified if those units are differently staffed (do have a different #Beds/Nurse ratio). Today, the transfer of patients in the hospital is not adequately processed in the ma-jority of the countries. The cause of this insufficien-cy lays in a fundamental misconception: these units are frequently used as a stratification of categories of professional competence, instead of stratification in the availability of provision of care (different P/N ratios). The types of ‘professional competence’ are coined in the attributed names (Medium Care, High Dependency Care, etc.), and functionally precise by indicating the interventions of care allowed in each of them. Besides not cost-effective, this approach is entirely unjustified as each of these units is/(should be) certified in Intensive Care Medicine.

The most dramatic inadequacy of the ‘competence approach’ is that the decisions to transfer along the step-down system are principally based upon the reduction of the specific ICU-care interventions re-quired (which together represent 30% of the nursing activities in the ICU [11]). This modus operandi has significant consequences: the admitting ‘step down unit’ will often not be able to provide the amount of care still required (the expected NAS score). This will be reflected in the outcomes, such as the incidence of re-admissions to the ICU. To cope with these in-sufficiencies, the amount of nursing work delivered to these patients at the admitting Unit is often not significantly different from that scored in the ICU

[21]. Therefore, the step-down/up unit system does not usually function as such, and the loss of resources regarding both beds and workforce will be sizeable.

2.2.2 – Auditing the use of the resourcesThe audit to the use of all ICU resources shall be done at least once per year. The use of the resources may then be set against the classic benchmarks such as patients, clinical aspects, outcomes, etc. Let us focus only on the use of beds and nursing staff.

The Work Utilisation Ratio (WUR). The planning and use of the nursing staff is a sig-

nificant factor of loss of resources observed in the EURICUS-studies. WUR determines the relation be-tween the total nursing work produced (sum of all NAS-points scored) and the total NAS-points that can be provided by the nursing staff (FTE’s), during a meaningful period (usually one year). A significant part of the loss of resources is caused by a relatively low occupancy rate.

In the planning of the ICU, the permanent avail-ability of intensive care beds is logically secured re-garding unexpected admissions. The overestimated number of ICU-beds can be avoided, by pooling all critical care-beds in the hospital or the region, in a ‘bed-availability management centre’. With a suffi-cient volume of beds in the pool, all ICUs associat-ed may increase their occupancy rates to above 95%, while a free bed will always be available [14]. Sub-sequently, the number of beds in each ICU can be substantially reduced.

P/N ratio’s overall in the hospital In the developmental research of NAS, the nursing

activities in the ICU were first thoroughly invento-ried and described in a mutually exclusive manner. The weights of each activity were then allocated in a work-sampling study [11]. The activities itemised in NAS accounted for 98% of all nursing activities and 100% of their work-time in the ICU. Since then, the completeness of the set of items included in NAS has been confirmed in numerous studies.

Today, the use of NAS increases exponentially worldwide, replacing the other commonly used in-struments (mainly TISS-28 [12] and NEMS [22]).

Moreover, NAS increased from 40% to 100%, the identification of the time consumed by the nurses.

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The 40% time explained by the previous instruments corresponds mostly to the nursing activities linked to the ‘key processes of care’ (Chapter 1.2), consuming only 30% of the nursing time in the ICU [11]. The additional 60% time identification of nursing time does correspond mainly to the inclusion in the score of the ‘standard processes of care’ in the ICU.

The ‘standard processes of care’ included in NAS–items 1 (monitoring and titration), item 4 (hygiene procedures), item 6 (mobilisation and positioning), item7 (support of patients and relatives) and item 8 (administrative and managerial tasks) – do represent the core of the general nursing activities in the hos-pital. The complexity and the duration of the time consumed with each of these activities will vary ac-cording to the requirements of care. During the field research of NAS, to accommodate this variation, the complexity of each process was linked to the expect-ed duration of time involved with the procedure, di-

vided into standard, more and much more. The an-alyse of the data produced three clear and mutual-ly exclusive periods regarding the mean duration of each of these processes of care [11]. The differenti-ation in the duration of time between ‘standard’ and ‘more’ is very important as it allows to measure the time consumed with nursing care in other hospital units, such as the general ward, in which the duration of the executed activities of care will more frequent-ly belong to the category ‘standard’.The published literature reported already the suc-

cessful use of NAS in about all types of critical care units [21, 23]. Following the reasoning above, I do expect that NAS is suitable to quantify all nursing activities in the hospital, including in the general wards. Research has to be done, to test the hypothe-sis that NAS can determine the P/N ratios of all lo-cations of care in the hospital. Such capability will improve significantly the outcomes of care and the use of resources as well.

3 – Investigate the course of illness

The outcomes of care can be much improved if we deepen our understanding of the pathophysiology of the illness.In this chapter, the ICU professionals are encour-

aged to investigate the course of illness by:

3.1 reappraise the clinical information they get and how they use it;

3.2 actively learn from the research of other sciences; 3.3 feel uncomfortable with the poor knowl-

edge of about every course of illness, and be open-minded for a radical change of ap- proach to diseases.

3.1 - Monitoring Revisited

The monitoring of vital signs is a routine task in the ICU. At least four physiologic parameters are usu-ally monitored online: systolic blood pressure (BP), heart rate (HR), oxygen saturation (SatO2) and urine output (Diur). The conformance of the value of these parameters with normality is verified at least hourly. The EURICUS-II studied the effect of collaborative

practice among the ICU staff on the results of care (see 1.5 above) [16]. Besides mortality, we were also interested in the effect of collaborative practice upon intermediate outcomes. To this end, the values of the four physiologic parameters were separately record-ed: whether the respective value was out of normal range, and for how long the abnormality did last. A panel of experts defined an Event as a short-timed de-rangement between 10min-1hr, and a ‘Critical Event’ as a longer-lasting derangement of 1 hr or more (ta-ble 3.1). Because the urine output is often not meas-ured online, the time intervals were adapted.

Suggested Range

Events Critical events

SPB mmHg 90-180 > 10 min > 60 min

Sat O2> 90% > 10 min > 60 min

HR 60-120bpm > 10 min > 60 min

Diur >30ml/hr > 1 hr > 2 hrs

Table 3.1 – Adopted range of ‘normality’ of the four parame-ters monitored

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Table 3.2 displays the number of Events and Criti-cal Events registered. In all variables, the incidence of Events is about three times higher than that of Critical Events.

Ev CrEv Total

BP 66,583 23,826 90,409

HR 50,993 17,582 68,575

SatO2 26,506 8,284 34,790

Diur 72,935 28,175 101,110

Total 217,017 77,867 294,884

Table 3.2 – Incidence of all adverse events in about 2 million measurements

The incidence of Events in the group of non-survi-vors was at least three times higher than in the group of survivors. Taking the example of BP, the patients who survived had in average one Event every second day, whereas those who died had almost 2 BP Events every day. The mean duration of each Critical Event was also significantly longer in the group of non-sur-vivors.

Duration Mortality Odds RatioEvent Crit.Event Event Crit.Event

BP

No 4,6 4,8 1 10-1 hr 17,3 20,6 1,5 1,71-4 hrs 33,4 40,2 1,9 2,9>4 hrs 53,9 65,5 2,5 4,9

HR

No 6.1 6.8 1 10-1 hr 23.3 26.0 1.8 1.41-4 hrs 32.1 36.3 2.1 1.7>4hrs 43.2 49.7 2.1 2.3

SatO2

No 7.7 8.1 1 10-1 hr 25.6 33.4 1.3 1.71-4 hrs 40.8 56.8 1.7 3.6>4 hrs 57.1 72.6 2.0 4.0

Diur

No 6.9 6.9 1 10-1 hr 19.0 11.6 0.8 1.41-4 hrs 23.9 29.1 0.7 3.0>4 hrs 44.7 62.8 0.8 8.6

Table 3.3 – Mean duration of Events and Critical Events and ICU mortality (%) Out of Range Measurements: BP- blood pressure; HR- heart rate; Sat02 – arterial saturation Oxygen; Diur- diuresis.

Table 3.3 shows the incidence of mortality rate and respective odds ratio of de cumulative duration of Events in comparison with that of Critical Events. The cumulative duration is aggregated in four peri-ods of time: NO (non existing); 1 hour or less; be-tween 1 and 4 hours; more than 4 hours.

For each patient, the duration of (critical)events was included in one of four categories (from NO to >4hrs) after summing up the length of events regis-tered during their stay in the ICU:

• For each variable, the cumulative duration of time in out-of-range is consistently and significantly associated with mortality and the increased chance (OR) of dying. This is particularly true concerning ‘systolic blood pressure’ and ‘Saturation of O2’.

• For each period-of-time category, the dura-tion of the individual events is more important than the number of events registered (the mortality of ‘one critical event’ of 4hrs is higher than that of 4 events of 1hr each).

• The Event-Mortality correlation also remains when controlled for SAPS. In the survivors’ group (SAPS> 43), the mean incidence and duration were

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fessions are entirely different, the tasks of the vehicle operators are quite similar to some of the tasks of ICU-nurses.

In the Ministry of Defense of the USA, ‘The Net-work Centric Operation (NOC)’ is a concept of op-erations envisioned to increase warfare performance. In the NOC, a team of operators is responsible for the supervisory control of crewless vehicles (UVs). The major supervisory activities consist of monitor-ing the functioning of UVs, repairing malfunction, taking over the actions of a vehicle, and (re)pro-gramming new tasks for it.Therefore, the interaction of the operator with each

robot consists of sets of electronic signals (informa-tion and feedback), in both directions.Like all humans, the operators are multi-task ori-

ented. However, they can only solve a single com-plex task at a time. Consequently, the information arriving at the NOC will not always be immediately attended, and therefore wait time will build.

In the MIT, the research group of M.L. Cummings introduced a new ‘discrete-event simulation model’ (DES), for evaluating the functioning of these oper-ators, including a quantitative relationship between workload and performance. In DES, the operation of a system is represented as

a chronological sequence of events (each at a time) [26].The DES model includes two sub-models (figure

3.1): 1. the vehicle team model, concerning the

generation of endogenous (vehicle-gener- ated or operator-induced) and exogenous events (resulting from unexpected condi- tions);

2. the human operator model, recognising and understanding the raised events and inter- acting appropriately.

The relation between them uses the queuing theory for analyses.

In the human operator model considers three vari-ables:1. attention allocation strategies, for handling prior-

ities (e.g., first in first out, high attribute first, last in last out, etc.) through the queuing policy. The meth-od by which operators allocate their attention to the different vehicles/tasks is likely to affect system per-formance.2. Interaction times, or the average time it takes for

lower than in the non-survivors group (SAPS <18). A more detailed analysis of the non-survivors, in com-parison to the group of survivors, has shown that the duration of the events increases first. The increase in incidence comes later (particularly true in the ‘low SAPS group’). For the ‘higher SAPS group’, there was an earlier increase in both incidence and dura-tion in those who died.

• The incidence and the duration of events in-creased with age (divided into 10yr intervals). The older group of patients who survived shows signif-icant lower mean values of incidence and duration, and the product of both, then the younger groups of patients who died.

• Rivera-Fernandez et al. [24] have shown that a score constructed with the first-day events can pre-dict mortality with a discrimination power of 0,666. When adding age, provenience, Glasgow coma score, and diagnosis to the score of the first-day Event, the discrimination power of the new score (area under the ROC) increased to 0,818.The study shows that out-of-range measurements

are meaningful proxies of intermediate outcomes of care [25].

These results demonstrate the relation between ab-normal physiologic parameters and mortality. They also point out the consistent link of the duration of time during which the abnormal values persist and the outcome. It brings back the concept of ‘Titrat-ed Therapy’ (coined by Safar and Grenvik some 60 years ago) to the forefront of medical judgement in the care of the critically ill. It emphasises once again, that time is fundamental for life.

the severity of physiologic derangement

is Time Dependent

3.2 - MIT performance researchIt happens from time to time that the management

of one professional activity will benefit from the approach and the results of research concerning a completely different professional business. The su-perb research on the performance of the operators of crewless vehicles developed at the Massachusetts In-stitute of Technology might give an unexpected point of view. Although subjects and objectives of the pro-

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Figure 3.1 - MIT Discrete Event Simulation Model [26]

a human to interact with the robot to ensure that it is working toward mission accomplishment.3. Workload-performance model. This model is the

more scientific version of the ‘arousal-performance’ inverted U relationship labelled by Yerkes-Dodson in 1908 (figure 3.2). Here, arousal is replaced by ‘utilisation’, i.e. the per cent busy time dedicated to the performance of the job/task. In the beginning, the performance is low, and it increases with utilisation time until it reaches 70%, hereafter performance de-creases.

Figure 3.2 - Relating Performance to Workload. Adapted from Cummings and Neheme [26]

The research group has included other variables in the model, such as:

1. interaction wait time. Recorded from the time an operator identified a deteriorated UV to the time a solution he communicates to the UV.

2. Wait time in the queue. Wait time can occur: a) when a vehicle is neglected while the oper-ator is busy with another vehicle; b) when the operator requires re-orientation while switch-ing between vehicles; c) when the vehicle is neglected due to lack of operator’s situation awareness.

3. Situation awareness (SA) wait time. SA is defined as the combination of

a. the perception of elements of the UV and its environment,

b. the comprehension of their meaning, and c. the projection of their status in the future.

The loss of SA effect led to decreased per formance scores.The temporal aspects of a system (wait times, inter-

action times, neglected times) determine the limita-tions of the system.

Loss of performance results in inadequate interactions andunduly increase in Wait Times

Figure 3.3 shows the wait time proportions in low and high utilisation conditions:

1. by far the most important source of wait time,‘situation awareness’ decreased signifi- cantly with the increase of workload;

2. after indication for intervention was identif- ied, wait time in the queue increased with in creasing workload [27].

Figure 3.3- Wait Time Proportions in Low and High workload conditions. i) situation awareness wait time (blue); ii) inter-action wait time including cognitive reorientation (red); iii) wait time in the queue (green). Adapted from Cummings and Mitchel [27]

The wait time resulting from cognitive re-orienta-tion (particularly when supervising more than one UV), and from human interactions remains some-what unchanged. Its apparent reduction in the high workload conditions is due to the proportional in-crease of the other two (situation awareness and wait time in the queue).

(Because of its relevance, the text above respects the

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original description of the research of Cummings et al.)

The study of Cummings & Nehme establishes the undeniable relation between ‘wait time’ and opera-tional performance. Any course of illness is, per defi-nition, related to time. Although we are not yet able to identify how this relation evolves and according to which factors, we can assume that the effectiveness of the process of care is also related to time. We may, therefore, anticipate that the introduction of wait time in the process of care may have some measur-able influence on the outcomes of care (see Chapter 3.1 above).

The understanding of these questions requires the appropriate investigation. In the ICU setting, often pointless policies and questionable decisions pro-longed the wait time. For example,

o the physicians – ‘wait and see’, further diagnosis, inter-collegial conference, ‘first thing tomorrow

morning’, ‘we treat a patient, not a number’, etc.;o the nursing organisation – fixed daily routines of work and pauses, family visits, etc.

ICU-professionals easily recognise the rationale be-hind, and the results of the MIT-research. Although the DES-model is perhaps not readily applicable in the ICU setting, the amount of research work already developed by the MIT-group should be a fertile source of inspiration for those studying professional performance in Health Care.

3.3 - Zooming on critical illness

Nowadays, the principal diagnosis at admission in the ICU is usually related to the malfunctioning of one organ or system, selected from an extensive list of singular and mutually exclusive pathological con-ditions. The designed plan of care is directed to the recovery from the malfunction.Critical illness, as we know it in the ICU, is regu-

larly rather complex, implicating the disease of mul-tiple numbers of organs and systems. Strikingly, the therapeutic plan will be directed to the set of mal-functions, addressing each of them individually. This policy reflects perhaps a significant limitation in the medical understanding of critical illness.

Let us put a few other pieces of information togeth-er:

The APACHE-studies show that a consistent phys-iologic derangement becomes apparent after the age of 45 years: for the same clinical condition (from health through illness), the odds of dying increases with age after the 45 years [28].

We also know today that the malfunctioning of or-gans and systems is related to the amount of dam-aged DNA appearing regularly after cell-replication. In optimal circumstances, the ‘DNA-repair system’ will restore nearly all of these abnormalities. How-ever, the structural and chemical damage to DNA in-creases while the capacity to repair DNA decreases with age leading to the build-up of damaged DNA [29]. The measurable increase of abnormal DNA starts around the 30-40 years of age (personal com-munication from prof. P. Viana Baptista, PharmD, PhD). We may, therefore, assume that the consistent increase of abnormal DNA is a forerunner of physi-ologic derangement that becomes apparent after the 45 years of age.

The condition of illness-proneness resulting from age can present various grades of complexity depend-ing on the number of organs and systems involved and on the severity of their eventual physiologic de-rangement. Expectedly, the manifest malfunction of one organ or system may interact negatively with the functioning of others (figure 3.4).

Applying data-mining to the admission- and dis-charge data on the digital records of 667,000 patients, the research group of Knaus found 120 associations of clinical variables relating significantly to the out-come of the patients. 61% of these associations were well established, 15% were less known, and 24% were unknown in the published literature [30]. The study concludes: ”the initial results from this

study suggest that these approaches have the po-tential to expand research capabilities through the identification of potentially novel clinical disease associations”. The further research of these associa-tions seems of the utmost importance, because a) the interactive derangement is probably not random; b) an identifiable cascade of possible patterns of patho-logical associations along the course of illness may exist.

Besides data mining, the use of artificial intelli-gence (AI) [31] and machine learning [32] seems most appropriate to review and deepen our knowl-edge concerning the ‘course of illness’. The interest in AI in Medicine is not new. Already

in 1970, Jack Myers et al. started a project (the ‘IN-

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Figure 2.4 – Interactive physiologic derangement

TERNIST’) using AI for making multiple and com-plex diagnoses in internal Medicine [33]. Their work illustrates the underdevelopment of the computers of that time, requiring the project to be previously conditioned with several decisions what did limit the scope of the investigation.In the last decade or two, because the computers are

immensely more capable, AI is supporting science and development in a considerable number of areas [34]: analytic, predictive or operational. The latter, concerning the development of machines for replac-ing humans (such as autonomous auto’s, drones, do-mestic tools, etc.) is getting the most attention. In Medicine, predictive tasks were used in the making of scoring systems such as the APACHE-III [28] and the Discharge Readiness Score [35].

A large window of challenging and maybe revo-lutionary research opens before us. I expect that we will soon understand differently much of what we did learn at school.The diagnose of an organ malfunction, in itself,

does not disclose the underlying deregulations at the origin of the dysfunction. Expectedly, the course of illness can be brought down to elementary (and inter-active) physiologic deregulations.

The ‘prediction methodology’ of Knaus may have a predominant contribution to future knowledge-break-

ing research. I feature it as ‘The analysis of a large amount of data composed of physical signs, monitor-ing, laboratory and all other clinical information’, leading to the definition of meaningful and mutually exclusive profiles of illness. These could identify dif-ferent stages of the ongoing physiologic deregulation in the course of diseases until recovery or dead en-sues.

In itself, the diagnose of an organ malfunction

does not disclose the underlying deregulations

at the origin ofthe malfunction

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Closing Remarks

Updating the approach to illness

In the interesting paper describing the success sto-ry of the APACHE-programme, and the many and diverse obstacles that were necessary to overcome, W. Knaus points out: “Human anatomy is heavily represented in our medical school curriculums, but offerings emphasising the anatomy of medical in-formation receive minimal emphasis. I am confident that this too will change, and it will take less than 1000 years” [1]. In the medical profession, clinical practice is al-

ways preceded by intensive and purposeful teach-ing and training. In the curriculum of all medical schools, the first year, at least, is focused on the foundation sciences such as Anatomy, Histology Bi-ochemistry and Physiology. Along time this list has been continuously expanded, including other disci-plines such as Genetics, Neuroscience, Endocrinolo-gy, and Immunology among others. The application of this knowledge in the clinical practice comes later in the curriculum. These disciplines, composing the scientific basis of Medicine (starting with Anatomy) do remain logically at the forefront of medical rea-soning and decision making.

The allegory of Knaus (the ‘anatomy of medical information’) also applies to the meaningful integra-tion of the new knowledge continuously emanating from the core disciplines into the clinical practice. At the end of the last century, the ‘Evidence-Based

Medicine (EBM) in Critical Care Group’ introduced a novel line of action in support of good medical practice: “EBM is an approach to practice and teach-ing that is based on knowledge of the evidence upon which practice is based, and the strength of that ev-idence. Although it focuses on the results of clinical reports and human experiments, it acknowledges that trials are built on the pivotal work of laboratory research, and upon preliminary observational studies in animals and humans” [36].

To provide research strength to the method, EBM was designed to be interpreted from a Health Servic-es Research (HSR) perspective: “HSR meets EBM most decisively at the nexus of what is done com-pared to what ought to be done” [37].In the last one or two decades, perhaps a reaction

to these reflections, an increasing number of Medi-cal Schools has changed the teaching curriculum to a more integrative approach of fundamental knowl-edge and clinical practice.

However, although the longitudinal teaching of each discipline is mandatory, the caring of the crit-ically ill is still missing the understanding of the ‘transversal’ interactive deregulation of individual physiologic systems. The proposed EBM approach follows the longitudinal medical reasoning. It is not yet the full compass for good medical practice. “Evidence shows that more active implementation methods are required to change behaviour and en-hance research uptake, such as educational practice guidelines, individual audit and feedback, academic detailing, opinion leaders, administrative interven-tions, or computer decision support systems (origi-nal not underlined)” [37].As contended in Chapter 3, the approach to the

course of illness has to be fundamentally changed. Hopefully, it will take less than 1000 years.

Standardising the ways of working

The organisation of work is a matter of constant analysis and review, mainly when it concerns the production of highly valued outcomes. The creation of any commodity or service will always depend on the interaction of elementary human activities, and the use of specific technologies and equipment. The organisation of work is a science in itself, making use of sophisticated research, and publishing valua-ble literature. The key elements to standardise the organisation of

work are the same, whether the outcomes of work are commodities, goods, or services. Two examples:

1- “The work system itself consists of four ele-ments: the processes and activities, participants, information, and technologies. Five other elements must be included for understanding a work system’s operation, context, and significance: products/servic-es produced, customers, environment, infrastructure, and strategies. Customers may also be participants in a work-system, as it happens when a doctor cares of

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a patient (Figure 4) [38]”.

2- A service system is, therefore “an integrated and interdependent combination of component resources that satisfies service requirements. A service system encompasses everything required for service deliv-ery, including work products, processes, facilities, tools, consumables, and human resources. Note that a service system includes the people necessary to perform the service system’s processes.” Glossary of CMMI (Capability Maturity Model Integration) for Services, version 1.3 (Software Engineering Institute 2010, p. 498) [in 39].

The general system theory and its application in the analysis of work processes are today universally uti-lised in any organisation delivering products or ser-vices: when ‘professional performance’ is the key-word. Otherwise, any attempt of comparison, audit or improvement becomes pointless.

In the hospital, these analyses are not systematical-ly made. However, the Department of Surgery is a remarkable exception. The surgical interventions in human anatomy, delivered at the operating theatre, have been exhaustively analysed and standardised. This because these services depend upon work pro-cesses and activities perfectly-identified from start to the end of each intervention.

Conversely, in the ICU about all processes of care are not standardised. And very few of the key pro-cesses are, perhaps because the physiologic derange-ment during illness, insufficiently explored. Yet, the systematic standardisation of the processes of work in the ICU might be the most appropriate method for identifying and guiding the research to be done.

Figure 4 – Work system framework [38]

Time matters in the course of critical illness

Time is a foundational dimension in life. From a philosophical perspective, in which life is time. But also from a pragmatic perspective in which every somatic condition, from health through illness, pro-gresses along time.In the hospital, the notion that any course of illness

is inevitably bound to time, as in case of an ‘emer-gency’, is not always obvious.In the ICU, the notion of time is present in relation

with particular diagnoses, as long as additional diag-nosis (or ‘complications’) do surface in the course of illness. Generally speaking, when no more organ/sys-tem failure are to diagnose, the notion of time fades out. Yet, the course of illness will progress inevitably.

The importance of time in the course of care is clear-ly presented in this paper. The MIT research of Cum-mings et al. (3.2 above) describes the direct relation-ship between situation awareness and performance waiting time. ‘Monitoring Revised’ (3.1 above) doc-uments the rather quick and significant deterioration of severity of illness directly related to waiting time.

The detrimental effect of waiting time in the course of care seems therefore undisputed. However, the course of physiologic derangement responsible for critical illness is not yet known as discussed in Chap-ter 3.4 . As a result, the planning of specific care can-not take place. In view of the available resources, wait time is therefore equal to unproductive time as purposeful action cannot yet be undertaken.

Specific research is imperative.

ICM is a truly multidisciplinary endeavour

Besides the core disciplines of Medicine and nurs-ing, the adequate performance of Health Care involves the expertise of several other non-medical disciplines such as economics, work-psychology, organisation, etc. The collaboration of all these disciplines is quite usual outside the hospital. Inside the hospital, howev-er, this collaboration is virtually non-existent. Here, the medical disciplines decide usually about all is-sues, even if concerning those over which they do not have specific expertise, under the motto: ‘if we don’t do it, others will do it in our place’. Although it will take perhaps a long time before this conviction

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of distrust is replaced by collaborative eagerness, the change remains urgent.

Important to know, the non-medical disciplines at the Universities are usually willing to assume their contribution to studies for improving health care in the hospital. Besides, this collaboration may moti-vate staff members working in the administration of the hospital and credentialed with the same speciali-ty, to increase their scope of professional application.

Without the support of the non-medical disciplines of the organisation and management of work, ICM compares to a vertebrate without bones.

AcknowledgementThis article, written by an intensivist, unveils the

constructive influence of non-medical disciplines in the way he sees problems and solutions in his own profession. I want to tank immensely Dr. Gertjan Nooij, work- and organisation-psychologist, as he is surely the person to whom this influence can be most credited: due to the inspirational manner he lectured the courses of Organisation and Manage-ment I followed in the 80’s; as Chairman of the sci-entific encounters, he conducted independently and most effectively during 10 years, the meetings of the EURICUS programme when methodologies and multidisciplinary views required to be really coordi-nated; by the many suggestions, advise and revision of this manuscript.

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APPENDIX 1

THE EURICUS PROJECT

The Foundation for Research on Intensive Care in Europe (FRICE) designed a large research project to study methods for improving the effectiveness and the efficiency of Health Care Departments, using In-tensive Care Units (ICUs) as the experimental lab-oratory. In this view, the ICU was approached as a health care sub-system using a methodology based on the “general systems theory” in which the rela-tions between ‘input’, ‘throughput’ and ‘outputs’ of each unit come under analysis. One important implication of the method is that it

focuses in the throughput, or ‘way of working’ in the ICU, assuming that the improvement and standard-isation of policies and work-processes in the ICUs should lead to: 1. the effective functioning of the ICU: 2. the efficient match of demands by the ICUs

with the provision of resources to them.

The project was called EURICUS (European ICU Studies). This program produced, among other things, more than 50 relevant international publica-tions up to 2003 alone.

Given its complexity, EURICUS consists of sepa-rate studies, which were developed and implemented as Concerted Actions (three projects were concluded, with the duration of 3 years each) of the BIOMED Research Programmes of the European Commission. Unique in the project is the true multidisciplinary re-search approach, integrating the contribution of di-verse disciplines, such as economics, management, medicine, nursing, psychology, statistics. These studies paid particular attention to the scientific in-dependence of each of the contributing disciplines.1. After addressing the general hypothesis, e.g.

“better organisation and management will improve patient outcome”; 2. each discipline did define its own hypothesis,

e.g. “collaborative practice has a significant impact upon organisation and management of ICUs”, and sub-hypothesis, e.g. “the use of protocols improve collaborative practice”.3. After defining the set of data to be collected,

the analysis of the data related to each contributing discipline was performed separately by the respec-tive research team (independent of the data, and their

analysis, belonging to the other disciplines). In the end, 4. the general hypothesis was tested using the

best variables defined.

1. The projects

1.1. EURICUS-I: The effect of organisation and management on the effectiveness and efficiency of intensive care units (ICUs) in the countries of the Eu-ropean Community (BMH1-CT93-1340). Four months survey in 89 ICUs of 12 European

countries, involving 2,200 nurses, 750 physicians, 16,000 patients and 76,000 nursing days. The study consisted of five sub-studies: patients and facilities; personnel; organisation and management; culture; finances. Real-time observations and interviews were made

during a ‘one day’ site visit to each ICU.

In this survey, we included the prospective collec-tion of five sets of variables defined by the research groups of the discipline involved in each sub-study. After data collection, each sub-study selected the two most relevant variables to be included as the in-dependent variables in multivariate linear regression analysis: patients and facilities (size, and an index of the wealth of the unit); personnel (emotional exhaus-tion, and organisational commitment); organisation (centralisation, and elementary organisational frame-work); culture (process-oriented vs. results-oriented, and open vs. closed system); finances (budget flexi-bility, and perceived appropriateness of budget).

1.2. EURICUS-II: The effect of harmonising and standardising the nursing tasks on the intensive care units in the countries of the European Community (BMH4-CT96-0817).Randomized Controlled Trial (RCT): the use of an

organisation based managerial intervention aimed at studying the effect of collaborative practise (CP) be-tween doctors and nurses of 41 ICUs of 10 European countries. The general hypothesis assumed that the

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improvement of CP (controlling for case-mix) reduc-es the incidence of adverse events in the ICU and, consequently, reduces the rate of mortality (also read 1.5 above). The ten month’s study of adverse events (shock, arrhythmias, hypoxia, oliguria/anuria) used the most commonly (hourly) measured physiologic parameters: systolic blood pressure, heart rate, oxy-gen saturation and diuresis. The study involved 1,200 nurses, 450 physicians, 20,000 patients and 100,000 nursing days. A team of psychologists trained CP to nurses and physicians in the intervention group. Two protocols were used daily:a) for increasing work-process awareness – at the

hourly check of the physiologic parameters, the nurse used a pre-defined decision tree and determine whether i) the value is within the range of accept-ance; ii) if not, do I have a prescription to follow, or should I call the intensivist;b) for building up mutual respect – during the daily

ward round for controlling and discussing policies of care, the nurse of each patient should take, with the physicians, a pre-defined questionnaire inquiring over non-usual clinical conditions such as comfort and pain of the patient and situations related to fam-ily and visits on which the nurses would have much more information than the physician.

Clinical measures included patient case-mix and outcomes. The collaborative practice was accessed three times during the study. The variables studied were: trust, equality, participation, giving opinion, role clarification. Other scales, such as quality of communication (perceived openness, accuracy, time-liness), problem-solving, satisfaction with communi-cation, job demands and decision latitude were also included in the study. Besides, there were site-visits.

1.3. EURICUS-III: The Implementation of guide-lines for budget control and cost calculation and their effect on the quality of management of intensive care units in the countries of the European Union (BMH4-CT98-3461).RCT performed in 45 ICUs of 10 European coun-

tries. The field research, with the duration of 10 months, involved 89 ICU leaders, 9,300 patients and 54,000 nursing days. Simple to use budgeting and costing software was developed. The software allowed for ‘annual budgeting/costing calculations’ (or any other period), and for the ‘management of resource scenarios’ as well (e.g. the accommodation of a couple of new ventilators in the annual budget). The intervention consisted of one-day training in-volving: budgeting and costing principles and pro-cedures; building up the yearly budget (protocol); direct costing procedures at patient level (protocol);

the use of the software. Managerial skills of the ICU leaders were evaluated (self-assessment question-naires covering: motivation to manage, orientation towards finances, behaviour evaluation). In a satel-lite study, determinants of responsiveness to training were analysed in the context of the economic envi-ronment of ICU managers.

2. Major results

2.1. Use of resourcesThe overriding conclusion was the average loss of

about 30% of the invested resources (both concern-ing beds and nursing personnel).2.1.1. The facilitiesIt became clear that about 60% of the beds were

used for immediate postoperative care.a) In 75% of the hospitals, the recovery room was

not open 24 hours per day. Therefore, patients requir-ing intensive care after closing time were transferred to the ICU.b) Many surgical specialities bypassed the recovery

room and wanted their postoperative cases were ad-mitted directly to the ICU. c) Besides the inappropriate use of resources, the

practice also implied an essential waste of resourc-es. The beds allocated to admit these patients were kept empty for several hours in the morning, await-ing the end of the surgical procedures; the beds were occupied with full recovered patients for several hours in the night before discharge to the ward did take place in the morning. The costly and demanding procedures of admission/discharge of these patients took about 15-20% of the nursing working time in the ICU.

Only 25% of the hospitals made use of ‘step-down units’ (SDUs, e.g. medium care, high dependency units, etc.). The use of SDUs (with lower nursing FTEs per bed) is meant to improve the match be-tween use and demand of resources (when the clinical condition in the ICU improves, less care is required). The EURICUS-studies have shown, however, in Eu-rope, there is no sufficient definition of ICU/SDU. The facilities are rather indistinctly named as one or the other. In the EURICUS database, we took a Patient/Nurse ratio of 1.5 to be the cut-off point between ICU (<) and SDU (>); 66 units are classi-fied as ICUs and 48 as SDUs. However, there are no significant differences in input and output char-acteristics between either group. Nevertheless, the consumption of resources was significantly higher in the ICU group. This result reinforces the findings of mismatch between provision and use of resources; at the same time, it recommends the comprehensive

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definition of intensive care (ICU/SDU) facilities.

2.1.2. Human resourcesThe number of nurses staffing the units was based

on traditional formulas (supported, when existing, by not well-founded national guidelines). In all coun-tries, there were reports of a shortage of nurses, with the same unwanted consequences: beds were closed; admission stops; unnecessary death of patients. However, the number of nurses (FTE’s or full-time equivalents) staffing one ICU-bed did vary widely, e.g., 2.4 FTEs in Belgium, 2.6 in France, 3.2 in Italy, 3.4 in Spain, 4.1 in the Netherlands, 5 in the United Kingdom and 8-10 FTEs per bed in Norway. Given the similarity of the reports, these profoundly differ-ent figures suggest that the problem experienced in Belgium cannot be solved by the simple adoption of the Norwegian model of staffing.Another striking result was that the outcomes of

patient care in ICUs of university hospitals did not differ significantly from those of non-university hos-pitals. In other words, a higher provision of resourc-es, human and other, did not mount to make the ex-pected difference.

Nurses’ burnout levels were not only related to their perceived workload but also their objective work-load. However, burnout and job-dissatisfaction were more dependent on work uncertainty and less of workload. It was found that lack of communication (within the unit, and with its environment) and lack of work-planning were essential causes of work un-predictability.

Only 30% of the nursing time is used in direct rela-tion to the high technology in the unit. The other 70% of the time is dedicated to ‘regular’ nursing care, in the context of the clinical activities in the unit.

2.2. Organisation and managementIn this study, we found a non-systematic variation

of the organisation-variables of the ICUs among countries and within each country.The European ICUs lack elementary organisation

and management (OM) tools, such as the written definition of objectives of the unit and admission and discharge policies.

In each unit, the way the work is organised depends on local views. The existing processes of care have never been comprehensively surveyed and analysed. Therefore, the ICUs lack the most elementary tools for improving the effectiveness and efficiency of care.

ICU performance, both concerning patient outcome (complications of care, and mortality) and human resources outcome (e.g. burnout), was significantly influenced by organisation commitment; results-ori-ented culture; decision latitude of nurses; predictabil-ity of work-flow; structured organisation framework.

In the RCT-studies, rather simple managerial inter-ventions were implemented. The results have shown that these interventions did improve patient out-come, increase collaborative practice, and stimulate the motivation to manage.

2.3. PerformanceIt became clear that a wide variety of clinical per-

formance among the ICUs exists. After controlling for case-mix, the chance of dying could vary up to a factor 6. Differences in OM-variables were found to be significantly associated with differences in perfor-mance (paragraph above).

The occurrence of adverse events in the daily clin-ical practice was studied in EURICUS-II. Besides being associated with the clinical condition of the patients, the severity of illness and the outcome of ad-verse events were significantly associated with their duration. The results also suggest that the quicker the correction of physiologic derangement (adverse event), the better the outcomes were. In the study, the shorter duration of physiologic derangement was as-sociated with the improvement of collaborative prac-tice observed in the intervention group (also read 2.1 above). These results will be published somewhere else.

2.4. CostBudgeting and costing procedures are systematical-

ly lacking or underdeveloped. Notwithstanding, at least 50% of the costs correspond to activities of care that are registered daily for clinical purposes.The same medical intervention may cost signifi-

cantly different across ICUs, with the same clinical outcome.Most ICU-directors do not have control over: 1. the factors that influence the total budget al-

located to their unit;2. the allocation of resources within their unit

(between equipment /personnel/consumables). The control over financial issues is significantly as-

sociated with ‘motivation to manage’.