Quality indicators in intensive care medicine: why? Use or burden for the intensivist.

In order to improve quality (of therapy), one has to know, evaluate and make transparent, one's own daily processes. This process of reflection can be supported by the presentation of key data or indicators, in which the real as-is state can be represented. Quality indicators are required in order to depict the as-is state.Quality indicators reflect adherence to specific quality measures. Continuing registration of an indicator is useless once it becomes irrelevant or adherence is 100%. In the field of intensive care medicine, studies of quality indicators have been performed in some countries. Quality indicators relevant for medical quality and outcome in critically ill patients have been identified by following standardized approaches.Different German societies of intensive care medicine have finally agreed on 10 core quality indicators that will be valid for two years and are currently recommended in German intensive care units (ICUs).

Quality indicators in medicine: the search for meaning

The legal requirement of hospitals (Pursuant to §137, Volume V of the German Social Security Code) to engage with Quality Management, is frequently perceived to be a tedious duty. This is due to Quality Management frequently appearing to be bureaucratic and removed from routine practice. This complicates daily clinical practice with additional paperwork and certification formalities. Quality Management in this form is being incorrectly implemented because the starting point is not routine practice but practice-distant constructions. Vagts, Bauer and Martin [1] have explicitly described this in their article on the meaning of certification. In order to improve quality (of therapy), one has to know, evaluate and make transparent, one’s own daily processes. That is the real driving force behind quality management. The target outcome quality depends on structure and process quality. These are the three interacting dimensions of quality management, as described by Donabedian [2]. The first challenge in quality management is to define which resources are necessary for the required outcome quality. The formation of clinical processes belongs to the core of medical practice and is at the same time the second challenge. This is especially true for such a process intense and interface rich area as intensive care medicine. There is hardly any other area where processes have such direct vital consequences, where information hand over and failure causes such immediate implications, as in intensive care medicine.

All the problems of quality management in medicine can be reduced to two questions each of theory and practice.

Theory:

Are their therapy standards and individualized therapy concepts?

Are the principles of therapy/therapy standards evidence based, i.e. is there a guideline compliant therapy model?

Practice:

Is the clinical routine so organized that errors are minimized?

Does the patient normally receive what we would like to believe they receive or what we are trying to achieve?

In order to be able to answer these questions one requires transparency regarding one’s own actions. This process of reflection can be supported by the presentation of key data or indicators, in which the real as-is state can be represented. Quality indicators are required in order to depict the as-is state.

Quality indicators are measurements, whose value helps to distinguish between good and bad structural processes and outcome quality. Quality is not measured directly this way; rather the indicators represent surrogate markers that indirectly but numerically map quality. Quality indicators should be based on the best available evidence/be derived from the scientific literature or should at least, in the case of absence of empiric evidence, be based on expert consensus. That also means that quality indicators can and must be evaluated on the basis of the evidence supporting them [3].

The classification of quality indicators is according to the quality dimension at which the indicator is aimed. Analogous to the classification of quality dimensions by Donabedian [4], quality indicators correspond to structure-, process- and outcome quality. Structure or process indicators can only be valid indicators if it is possible to demonstrate a positive effect on outcome. A quality indicator can simultaneously reflect structure- and process-quality or process- and outcome-quality.

Quality indicators are control systems in the context of medical quality management, serve to improve quality and are a tool to for mapping or evaluating daily actions. They are not an end in themselves. Indicators should have been accepted by all members of the ICU team and their measurement should be objective. In order that the quality indicators are accepted, they should be compliant with the RUMBA-rule. According to the RUMBA rule, the requirements of indicators are as follows:

Relevant to the problem

Understandable

Measurable (with high dependability and validity)

Behaviourable (changeable through behavior)

Achievable and feasible

These requirements are necessary, in order to be able to have any influence at all on the daily routine of the relevant stakeholders in the ICU [5]. The relevance for patients must be clear to medical personnel, in order that necessary changes in process really are implemented. Nursing staff especially, as those who carry out most of the bedside processes, must be involved in the design and development of patient-near processes, in order that the bridge in quality management between theory and practice can be crossed. For nurses, it is self-evident that they take on the role of the “patient advocate” and this should be used productively regarding quality improving measures, in that awareness of the relevance of the quality indicators is conveyed [6]. If it is not conveyed, that a certain measure is of benefit to patients, there will be problems with the implementation of this measure in routine practice. The indicators should not require any additional documentation, rather it should ideally be possible to collate them using routine documentation. Additional burdens of work lead to errors in data collection. An electronic patient data management system (PDMS) has been described by some authors as being very advantageous [7].

The whole purpose of the indicators is to determine whether in specific areas problems with the implementation of specific therapy forms exist, and whether after successful measurement and presentation of the results an about-turn towards improvement follows. Quality indicators are suitable for showing a team weakness and potential for improvement and for making successes visible. At the beginning of the introduction of quality indicators, regular measurement and presentation of the results have to take place. On the other hand, the requirement for regular measurement of an indicator lapses when uptake reaches 100%. This also arises out of the fact that the indicators have a limited life span and must, after a defined period of use, be reevaluated with respect to their efficacy and validity. If one cannot achieve any (positive) development by using a quality indicator, the observation of this indicator should be viewed as a waste of time, and one should examine whether there are indicators better suited to the support of positive development [8].

Deming and Shewart's PDCA-cycle (Figure 1 (Fig. 1)) aids regular evaluation [9]. Regular working through of the cycle supports the desired continuous improvement process and helps the team to implement the desired quality improving measures more quickly and effectively and to lead to an enduring improvement in quality.

Figure 1

PDCA-cycle

The principal possible applications of quality indicators are in internal and external control of medical care as well as as tools for continuous improvement. The use of quality indicators serves:

the measurement of the current degree of implementation (evaluation)

the description of changes in the degree of implementation over time (monitoring)

identifies situations that require intervention (alarm function)

The monitoring of individual quality development is in this way to be seen as much more important than the possibility of comparing oneself to others (bench marking). The use of external bench marking is contentious, because due to differing structures between hospitals the outcomes of interest are not 100% comparable. Nevertheless trends in different hospitals or the rate of change in an area of interest and not the absolute values are used as a benchmark, in order to achieve comparability.

Development of quality indicators in intensive care medicine

The development of quality indicators for intensive medicine has already a significant history. The first programmatic impulse came from the department of anesthesiology and intensive care medicine at Johns Hopkins University in Baltimore. In a large study, that was carried out in a total of 13 conservative and operative intensive care units, the steps in the development of quality indicators, which had a local/regional validity, were described [10]:

a thorough literature review with the question: what improves outcome in intensive care units?

evaluation of various outcome parameters

selection of pilot indicators in order to investigate in the field the feasibility of data collection and the evidence with respect to the process to be influenced and outcome

definition of the data collection process: who, what, when, how. This was based on the experience collected in the field studies

examination of the validity and reliability on the basis of the field studies, i.e are the collected data plausible or are the variations in the results too high for conclusions to be made

the real pilot study of the developed indicators

The results of the literature review were assessed by an expert panel and in a Delphi process the indicators that on the basis of the above listed prerequisites should be further researched in the pilot test, were filtered out. On the basis of this very labor intensive and exemplary method, the authors developed the first quality indicators, that were used on many intensive care units [5]. The authors were, on the basis of their comprehensive data collection, in the position to research the effects on the indicators on outcome parameters and economics. For the involved ICUs, the following quality indicators were identified:

6 outcome criteria: mortality on the ICU, duration of stay over 7 days, mean duration of stay on the ICU, mean duration of mechanical ventilation, sub-optimal pain therapy, patient and relatives satisfaction.

6 process criteria: rate of effective pain measurement, standards compliant transfusion of blood products, prevention of ventilation associated pneumonia, adequate sedation according to standards, adequate stress ulcer prophylaxis and adequate prophylaxis of deep vein thrombosis.

4 admission/discharge criteria: rate of delayed admission to the ICU, rate of delayed discharge from the ICU, rate of canceled operations due to lack of ICU beds, emergency admission delays due to lack of ICU beds

3 complications criteria: rate of unplanned re-admissions on the ICU within 48 hours, rate of catheter associated sepsis per 1000-CVC-days. Rate of new infections with multi-resistant organisms

Quality indicators (QIs), that are a part of the quality management (QM) system on a local level and that should contribute to the optimization of patient care, have been described in the literature on many occasions. Kastrup and colleagues [7] could show that the target orientated treatment processes that were created by experts on the basis of literature reviews, lead in routine clinical practice to patients having significantly shorter durations of stay on the ICU and probably also a better medium term outcome. These processes are displayed in the patients' electronic charts together with target parameters that were captured form the PDMS. The authors called the desired target parameters “key performance indicators” (KPIs), i.e. indicators that reflect key processes in ICU medicine. The KPIs were worked into themed bundles: analgosedation aims, cardiovascular aims, ventilation aims, infection therapy aims and nutrition aims. It is not surprising, that a few of the indicators are appear simultaneously by different authors as factors, that are associated with better patient outcome. The processes described by Kastrup at the Charité correspond to a great extent to those indicators described at Johns Hopkins University, such as for example lung protective measures such as the use of low tidal volumes, low ventilation pressures and use of elevated upper body.

National institutions in several countries have been busying themselves trying to help the spread of evidence based and outcome relevant procedures in ICU medicine to widespread use. In the Netherlands, a feasibility study was carried out by the National Institute for Public Health and Environment in cooperation with the OLVG Hospital that examined QIs and their use on ICUs [8]. For this 50 indicators were identified through a comprehensive literature search (among them the literature from the Johns Hopkins working group) and 12 additional factors were produced by an expert group. The in total 62 factors were put through a strict scientific selection procedure by a multidisciplinary expert group of the Dutch Intensive Care Medicine Society. 12 indicators met all the selection criteria and were more closely examined in a field study. ICUs from 18 hospitals took part in this study, that were selected from 97 hospitals so that all levels of care were evenly represented. The Dutch working group divided the evaluated indicators strictly according to character: structure, process and outcome:

outcome indicators: standardized mortality rate (SMR) according to APACHE II, pressure sore rate, accidental extubations

process indicators: duration of ICU stay, duration of ventilation, full bed occupancy, normoglycemia

structural indicators: availability of ICU doctors, nurse to patient ratio, risk management, patient/relative satisfaction

Health care policy and hospital specific basic conditions differ profoundly between nations. QIs for ICU medicine developed in other countries cannot be transferred unchanged to Germany. For instance the round the clock availability of experienced medical and nursing staff is a prerequisite for health care provider compensation [11]. Duration of ventilation and duration of stay are in the context of the allocation of health care funds in Germany (G-DRG) relevant to how departments are financed, mortality and unplanned re-admissions to the ICU are elements of the core data set for ICU medicine in Germany [12], the communication of the pressure sore rate is a compulsory part of quality assurance for all German hospitals, the measurement of patient satisfaction and the presence of error management are in the context of current certification procedures regularly required by hospitals and the bed occupancy rates are regularly sent to insurers and the institutions responsible for hospital planning.

Development of ICU QIs in Germany

The scientific ICU working group of the Germany Society for ICU medicine (DGAI) has, in cooperation with the interdisciplinary working group Quality Assurance in ICU medicine of the German interdisciplinary Association for ICU medicine and Emergency Medicine (DIVI) and the German Society for internal medical ICU medicine (DGII), created a review of the possibilities for the introduction of a German-wide Quality Management system [13]. The scientific working group has in doing this and according to the experience described above, followed the goal of developing a manageable number of practicably applicable Qis, for which outcome relevance has been scientifically demonstrated. The organization of clinical processes in ICU medicine should receive an assistance point of call, in which a framework of key data is available, that serve as an orientation help for all professional groups involved in the process on the ICU. The development of ICU medicine QIs in Germany in closely linked with the development of QIs by the Spanish Society of ICU Medicine. The Spanish intensivists have developed and published a catalog of 120 quality indicators [14]. The Spanish QIs have been excellently drafted and presented in a strict logic. Every indicator is defined by group (efficacy, risk, satisfaction, suitability) an explanation, a mathematical formula, how the indicators are calculated, the details of the population it concerns (ventilated, heart, heart disease, septic etc), bullet point type explanation of the terms, type of indicator (process, structure, result), the data source (patient charts, staff rota, OT plan, quality report), the desired target value and the references as a comment. After translation into German the scientific working group of the DGAI adopted their Spanish colleagues method of presenting the indicators. The list however did not seem to be transferable for German use for the reasons discussed above. Beside clinical process indicators, such as for example target orientated blood sugar therapy or lung protective ventilation, the Spanish list also contained indicators such as the regular changing of warming humidifying systems in ventilated patients or the indication for isolation of patients with multi-resistant bacteria. The later indicators are controlled by infection control guidelines and have no direct connection with process or quality improving measures on the ICU. In the development of QIs we are not concerned with producing parameters that are already managed by existing rules, recommendations or administrative orders. In order to avoid redundancies and in order to correct real profit, initially 36 and finally 10 QIs, with direct influence on the routine daily care on the ICU, were generated by two Delphi rounds of the expert committee. All indicators have a direct influence on improved patient outcome. This first version of the intensive care QIs was signed off by the expert committees of the the DGAI and DIVI with a period of validity of 2 years. The discussion regarding the scientific evidence of each indicator is very important and stimulating, however it should not be forgotten that the existence of every indicator is immediately dependent on the current state of scientific knowledge and every indicator has additionally to prove its own clinical relevance. Further indicators are in development, such as for example an indicator regarding targeted cardiovascular therapy. Should I find an indicator to be irrelevant, it should be removed from the list. Whats more an indicator should be seen to be pointless if its implementation rate is 100% because quality cannot be improved in this case, that is the indicator loses its purpose as a tool.

The first version of the consensus ICU QIs

(see Attachment 1)

QI 1 – upper body elevation

The discussion about the relevance of upper body elevation of ventilated patients for the prevention of nosocomial pneumonia. After studying the original literature, only 45 degree upper body elevation is proven to have an influence on patient outcome [15], [16], [17], [18], [19]. However studies support the significance of this measure. The use of this positioning is on the precondition that there are no contraindications to it.

QI 2 – monitoring of sedation, analgesia and delirium

The meaning of a target orientated sedation and analgesia procedure for ICU patients is excellently described in the current S3-guidelines [20] and the evidence is clearly described. The standardized procedure includes a step by step approach to the diagnosis of postoperative delirium. Rational analgosedation and diagnosis and treatment of delirium on the ICU are a working bundle, that positively influences morbidity, mortality and the duration of stay of patients on the ICU.

QI 3 – lung protective ventilation

Lung protective ventilation of patients in acute pulmonary failure has been demonstrated to be outcome relevant [21], [22], [23], [24], [25], [26], [27], [28]. That the described process is not applicable to all ICU patients, has to be critically taken into consideration. Patients with severe obstructive lung disease/high grade emphysema should not be given this therapy in a blind manner.

QI 4 – weaning protocol and spontaneous breathing trial

The use of weaning protocols in the ICU has a positive influence on patient outcome [27], [29], [30], [31], [32], [33]. There is no universal protocol, a structured approach including a standardized procedure involving daily spontaneous breathing trial shortens the duration of ventilation and improves survival. This bundle is closely associated with the analgosedation bundle, because structured weaning requires co-operative patients.

QI 5 – early and adequate antibiotic therapy

Early antibiotic therapy is an element of modern guideline-compliant sepsis therapy [24], [34], [35], [36], [37], [38]. It is a daily duty of every intensivist to promptly diagnose a systemic infection. Many ICU measure make the diagnosis more difficult, such as catecholamine therapy, hypovolemia and postoperative hypermetabolism. This makes a standardized protocol all the more important. This should make the recognition of sepsis for medical and nursing staff easier during routine practice. The adequate therapy of infection can additionally be supported through the use of an online special program such as the so-called x-Program [39], which is diagnosis orientated and includes current scientific discoveries and in so doing provides a continuously up to date, guidelines compliant and resistance pattern orientated anti-infective therapy for every intensive care unit.

QI 6 – therapeutic hypothermia following cardiac arrest

Controlled hypothermia following cardiac arrest is now a gold standard [40], [41], [42], [43], [44]. Its implementation into routine practice still poses a challenge. Vague statements regarding possible short periods of hypoxia in the course of a resuscitation repeatedly lead to controlled hypothermia not being carried out in routine daily practice. This indicator should serve to optimize the implementation rate.

QI 7 – early enteral nutrition

There is a certain uncertainty regarding what early enteral nutrition is. This should be judged on a case by case basis. Nevertheless it can be said that an attempt at enteral nutrition is always possible when there are no contraindications. Even gastroesophageal reflux should not stop the intensivist to give nutrition by the natural route. There are no universal gold standards here. Protocols for enteral nutrition are however helpful and support the goal of good nutrition. The clinical and paraclinical monitoring of nutrition should be defined [45], [46], [47], [48]. Enteral nutrition via a tube is an element of the prophylaxis of stress ulcers, as appears in the indicator list of Johns Hopkins University

QI 8 – documentation of relatives meetings

This indicator may not be immediately accessible to all doctors, however according to the literature the significance of this QI for routine practice is clear. Discussions with patients or relatives are frequently not documented, which after several handovers on the ICU, frequently leads to an information deficit regarding the condition of the patient before admission to ICU, limits of therapy and realistic therapy goals. Ignorance of such information leads to slips in routine practice and to a loss of therapy quality. It builds trust with the relatives and helps them to manage grief, if collective discussion and goal setting are documented and therefore transparent [49], [50]. Additionally in Germany, the legal requirement to respect patients will and to follow them when making therapy decisions has been cemented by the Patient Directive Law of 01.09.2009. The evaluation of alleged patient wills can only take place with the help of relatives as long as no written provisions exist. Documented relatives meetings take on a medico-legal character in this way. This QI should help the documented meeting to a higher level of implementation.

QI 9 – hand disinfection solution use

This indicator also seems at first to be unusual, it appears however to be the most effective of all indicators [51], [52], [53], [54], [55], [56]. Contaminated staff hands are the most important vector for infections in the hospital, and especially on ICUs. The generation of multiresistant bacteria is assisted by poor hand disinfection and nosocomial infections are ultimately always induced through contamination (mostly hands). Because per ICU bed per day a calculable number of processes with patient contact occur and because each of these should be associated with hand disinfection, which will require the use of 3 to 5 mls of disinfection solution, the use of hand disinfection solution is not an arbitrary parameter. The data on which the calculations are based are well established in the literature and an element of the WHO's guidelines on hand hygiene. The “clean hands” movement has been very successful in highlighting the problem of hand disinfection in hospitals. The use of disinfection solution is in this way an important indicator of a process with great significance for patients.

QI 10 – 24 hour availability of ICU specialists

The staffing of an ICU with experienced and trained intensivists and nurse specialists has an influence on patient outcome. There is good data supporting this [57], [58], [59]. Not least because the implementation of proven measures requires experienced personnel. This has not yet reached full implementation in Germany. Even the restructuring of ICU compensation based on G-DRG could achieve little to change this. Quality is connected to specific resources. The complex treatment figure serves to “capture” this human resource. The complex treatment figure may only be relevant to a small proportion of ICU patients (usually not more than 10%), but the complex figure in these cases greatly increases the size of the hospital's compensation for the case. For a 12 bed ICU of a moderately sized hospital, we calculated the sum of the annual contribution of the ICU complex figure to be € 500,000. From this the necessary personnel can be financed.

Conclusions

ICU QIs have be developed in several countries in a structured manner, on the basis of best evidence and with the goal of improving the outcome of ICU patients. In this way, structure-, process- and outcome-quality will be systematically further developed. The number of indicators should be manageable and practical.

The effective use of the QIs, from the perspective of the intensivist, lies in the orientation aid that can be provided with respect to routine core procedures on the ICU. QIs should be a tool for bringing best evidence and routine practice into harmony. If a QI is no longer of any benefit regarding the implementation of QM in routine practice, it has been overhauled or has become superfluous.

Notes

Conflicts of interest

The declarations of conflict of interest of all authors can be viewed on request.

Acknowledgements

We are very grateful to Dr. Jeffrey Bierbrauer, Dept. of Anaesthesiology and Surgical Intensive Care Medicine, Campus Virchow-Klinikum und Campus Charité Mitte, Charité – Universitätsmedizin Berlin, and Dr. Martin MacGuill, former colleague in this department and native speaker, for their translation into English.