Anaesthesia, Pain, Intensive Care and Emergency - Part 7 ppt

Today we are confronted with more than local routines: We are invited to readand to follow international or national guidelines, clinical pathways, recommen-dations or disease management

PERIOPERATIVE MEDICINE

Standards of care in operating theatres

F GRÜNE, T OTTENS, M KLIMEK

Most clinicians develop “routines”, “protocols”, “standards” or “configurations”for the evaluation and management of diseases they frequently encounter Espe-cially in anaesthesiology, doctors and nurses are used to working with thosestandards, dealing with such matters as venous access, spinal anaesthesia andairway management

Where do these standards come from? In many cases, their first drafts weregenerated by postgraduate trainees and result from “updates” of the advice of theirrespected teachers, commands received from their consultants and informationgleaned from books and congresses Later, as these trainees gained the ability andfreedom to operate in searching and appraising modes, these standards werecontinuously modified and developed on the basis of the highest level of evidencethe operators could find Furthermore, such evidence is modified by the valuesaccepted by our patients and by our local hospital conditions For years we haveaccepted these local routines or standards or configurations The process of manag-ing our standards costs us a lot of effort, but we consider the time and energy wellspent

Today we are confronted with more than local routines: We are invited to readand to follow international or national guidelines, clinical pathways, recommen-dations or disease management programmes—and have the feeling that if we fail

to do so this might have bad consequences Are all of them valid? And what is therole of the “good old standard operating procedure” (SOP)?

This article will give an overview of the “jungle” of phrases, definitions andterms concerning standards In addition, we will describe how SOP can be devel-oped and implemented

Definitions/terminology

Every routine, protocol, standard, configuration or pathway for the evaluation andmanagement of illness is based on three questions:

1 What is the best therapy for me (efficacy)? (patient’s view)

2 Which therapy has the best evidence and

efficiency for him/her? (physician’s view)

3 Which therapy is most effective/efficient? (hospital economic view)Every health care professional will consider these questions, with the aim of

developing the best medical and organisational pathways possible in the conditionspertaining locally.

Increasing shortages of resources in hospitals demand an enhanced economicperformance of clinical procedures This should be achieved by optimising all thework processes involved in the provision of healthcare Healthcare providers areoften confused by the terms used in the field of medical quality improvement Insome countries such terms as “SOP”, “guidelines” and “pathways” are defined bymedical societies (Table 1) [1–6]

Table 1 Definition of terms

Medical

recommendations

Are descriptions of diagnostic procedures or therapeuticintervention Adherence is not legally mandatory, but wellreasonable Are not systematically developed

Standard operating

procedures (SOP)

SOP can be seen as more specific than guidelines, defined ingreater detail Protocols provide “a comprehensive set of rigidcriteria outlining the management steps for a single clinicalcondition or aspects of organisation”

Clinical guidelines

Are “systematically developed statements to assist practitionersand patient decisions about appropriate health care for specificcircumstances” [19, 20] They are sometimes published byinternational and national medical societies

Clinical pathways

Are care paths or managed plans that display goals for patientsand provide the sequence and timing of actions necessary toachieve these goals with optimal efficiency [21]

Differences between guidelines and SOPs

When we consider the definitions of SOPs and guidelines we have two distinctcomponents (Table 2): first the evidence summary and secondly the detailed in-structions for applying that evidence to our patients [6] International or nationalguidelines must be rigorously developed and should pass through an appraisalprocess using evidence-based medicine criteria Some authors use the terms SOPand local hospital guideline as synonyms For the common hospital nurse orphysician, nationally produced guidelines still require local adaptation to suit localcircumstances and to achieve a feeling of “ownership” in local clinicians, which is

a major factor in uptake and use [7]

In their local form, guidelines or SOPs should have three components: a simplealgorithm that gives a practical sequence of steps to follow for each patient; anexplanation of the content of the algorithm; and a detailed summary of the evidencethat supports such advice (Fig 1)

Table 2 The two distinct components of any guideline

Evidence component Detailed instructional component Bottom line “Here is the typical effect of this

diagnostic/therapeutic/preventative

intervention on the typical patient”

“Here is exactly what to do / not

do with this patient!”

Human biology, clinical sciences,

consumerism, database searching,

clinical epidemiology, biostatistics

Clinical practice; local patients’values; local current practice; localgeography; local economics; localsociology; local politics; localtradition

Site where this

Form of output Level of evidence Grades of recommendation and

detailed instructions, flowcharts

Fig 1 What is a Standard Operation Procedure (SOP)?

SOPs are a modular instrument of clinical pathways

Clinical pathways should only be defined by departments that are responsible fororganising and providing healthcare services for the patient from the point ofhospital admission to discharge They must be developed in a multidisciplinaryapproach and with close cooperation between the different specialties and profes-sions involved The SOP is an instrument that is included as one module in a clinicalpathway (Fig 2) [8, 9]

Legal and political consideration of SOPs

When they read SOPs or national guidelines, physicians and nurses are oftenconcerned about their legal status

1 Are guidelines advisory or mandatory?

2 Do doctors who deviate from guidelines place themselves at increased risk ofbeing found liable for negligence if patients suffer injury as a result?

3 Can compliance with guidelines protect healthcare workers from liability insuch circumstances?

4 What legal responsibility do the developers and issuers of guidelines have iftheir guidance is found to be faulty?

Fig 2 SOP as a modular instrument of clinical pathways

In a case of medical malpractice, judges and lawyers are looking at medical andorganisational aspects of wrong diagnostic or therapeutic procedures Courts have

to assess the applicable standard of care, the causation (the connection between thealleged wrongful conduct and the harm suffered by the plaintiff) and the damage,which often involves a medical prognosis

Medical expert testimony helps the court to ascertain what is accepted “state ofthe art” and proper practice in a particular case The definition of state of the art isbased on medical textbooks, and the expert should be a graduate in a medicalspecialty

International experience shows that guidelines or SOPs are regarded as “justanother form of expert evidence” [10]

For consideration of the state of the art in medicine in the future, printedmedical textbooks will be replaced by internet-based knowledge resources Medicalsocieties are asked to develop guidelines based on the best evidence When theorganisational aspects of medical malpractice are considered, hospital boards will

be asked to define their clinical pathways so as to reduce the frequency of adverseevents consequent on negligence

For example: A young doctor fails in an attempt to intubate a patient Hypoxialeads to cardiac arrest and death In this situation the medical expert would be able

to explain to the court the state of the art in difficult airway management andresuscitation, basing this explanation on the guidelines of the American Society ofAnesthesiologists or the European Resuscitation Council The defendant doctorwould explain why a specific action was taken, or why one was not If clinicalguidelines are meant to enhance the quality of clinical care, then the courts mightenquire why such guidelines were not followed and whether adecision not to followthem was reasonable But the judge would also ask the hospital board about theorganisation of resuscitation officers and the level of education among youngdoctors and the support available to them, and whether SOPs were in place in thehospital concerned

Effectiveness of SOPs

In contrast to the relatively limited data and review of clinical pathways, there hasbeen more careful appraisal of clinical protocols and SOPs in the medical literature.When we consider the steps in a patient’s journey through the operating depart-ment, it is obvious that SOPs are aimed at improving the process quality and patientoutcomes (Table 3)

The product of an operation theatre—the surgical procedure performed on apatient successfully, time-efficiently and without complications—is based on threerelevant processes:

1 Technical process (instruments, equipment, rooms)

2 Organisational process (workflow, time, methods of work)

3 Social process (knowledge, skills, attitude, motivation, level of cooperation)

On the basis of these processes, the operating theatre management team canand should produce:

1 SOP for the process (steps in induction of anaesthesia, steps in surgicalpreparation)

2 SOP for the organisation (set of surgical instruments, operation room ment, teamwork)

equip-3 SOP for calculation the costs (cost of hospital staff, instruments, medicine).This means the clinical pathway–SOP system has the following advantages inoperating theatres [11]:

1 Optimised process

2 Implemented best evidence-based medicine

3 Cost-effectiveness

4 Improved education

5 Improved induction of new hospital staff

6 Integrated quality control

7 Transparency

8 Protection from malpractice

Table 3 Patient’s path through a surgical department and the role of SOP

1 Risk evaluation SOP for cardiac evaluation, preoperative

beta blockade

2 Preparation prior to the surgical

procedure

SOP for preoperative antibiotic prophylaxis

3 Admission to the operating theatre SOP for preparation prior to operation

4 Induction of anaesthesia SOP for anaesthetic technique

5 Surgical procedure SOP for instruments, disinfection,

technique

6 Postoperative care SOP for pain therapy, PONV

7 Discharge from the operating theatre SOP for report

Local guidelines or SOPs lead for example to a significant improvement inpreoperative antibiotic prophylaxis Wolters et al demonstrated that the percentage

of cases in which antibiotics were indicated but not administered was reduced from15.5% to 8.4% Compared with the result of the retrospective analysis, the prospectivestudy showed a significantly higher percentage of adequately administered antibio-tics (35.7% vs 63.5%) [12] Even in such difficult situations as weaning from mecha-nical ventilation the use of SOPs was effective [13] Rivers et al provided impressiveevidence of the beneficial effect of early goal-directed therapy for patients in septicshock when emergency department care was carried out according to a predefinedSOP or protocol The in-hospital mortality rate was 38% in the early goal-directed

protocol group and 59% in the standard care group (P=0.009) [14].

Introducing SOPs in your hospital in ten steps

Development of SOPs is a structured process [15] The management team of ananaesthesiology department should ask questions covering matters ranging fromthe choice of topics through authorisation and membership to the form of reports

to be submitted (Table 4)

Table 4 Developing SOPs in 10 steps

1 Choose your topic Which topic is most important and most urgent?

Which are our high-cost diagnoses or procedures?Are our nurses and doctors interested in a solution?

Is the topic measurable?

2 Authorisation Who will give us support?

Every working group needs support an approvalfrom the board of the anaesthesiology department(anaesthesiological topics) or from the board ofhospital directors (multidisciplinary topics) This isespecially needed in the phase of SOP

implementation, in order to break down obstacles

3 Team Should we invite everybody?

It is important to develop a multidisciplinary teamfor development of critical SOP or pathways Thismeans including representatives of all groups thatwould be affected by the pathway (house staff,physiotherapists, dietitians)

4 Moderation Do we expect conflicts among professionals?

How difficult is the topic?

Moderation should be: neutral and goal orientated.For difficult topics external professional moderatorsare advisable

5 The power of the first meeting The first meeting should consider several points:

Introduction to auditingRules of communicationVisions and goals (top-down)Expectations and perceptions (bottom-up)

6 Scheduling When will we reach what?

Workgroups on SOP should work in agoal-orientated manner with predefined period oftimes to reach their goals

7 Set standards What is the best evidence?

Do we have national guidelines?

What are our local conditions?

After developing SOPs the team has to define theperiod of validity (2 years)!

8 Evaluation Measuring what and for how long?

The SOP team has to define indicators These could

be factors of outcome, differences in time or number

of personnel They should follow R.U.M.B.A

principles:

Relevant for the selected problem

Understandable for providers and patients

Measurable with reliability and validity

Behavioural, i.e changeable by behaviour

Achievable and feasible

9 Implementation Which implementation techniques are suitable for

my hospital?

Systematic reviews of rigorous studies provide thebest evidence on the effectiveness of differentstrategies to promote the implementation of researchfindings

Consistently effective interventions are [22]:

Educational outreach visitsReminders (manual or computerised)Multifaceted interventions (a combination thatincludes two or more of the following: audit andfeedback, reminders, local consensus processes, ormarketing)

Interactive educational meetings (participation ofhealthcare providers in workshops that includediscussion or practice)

10 Reports What, when and how?

SOPs could be published on paper or oninternet/intranet It depends on the level ofimplementation

All SOP must be coded The code should include:SOP number, version and period of validity!

The most urgent and important topics for SOP development can be found in riskfactor studies relating to anaesthesia management Arbous et al., in a case-controlstudy, described an incidence of 24-h postoperative death of 8.8 (95% confidenceinterval 8.2–9.5) per 10,000 anaesthetics After multivariate analysis they identifiedequipment check, direct availability of an anaesthesiologist, presence of an anaestheticnurse and no intraoperative changeover of anaesthesiologist as factors associated with

a decreased risk of death [16] Kendall et al showed that 60–82.5% of machines checkedhad at least one fault, and 11–18% of these were deemed serious [17] Montasser citedanother example of identified malpractice Based on the standards of the AmericanSociety of Anesthesiologists (ASA), a spreadsheet was developed for documentingfeatures of pre-, intra- and postanaesthetic care The spreadsheet enabled the re-searcher to document all equipment, supplies and personnel involved from the prea-naesthetic evaluation to discharge Even in developing nations this evaluation ofstructure, processes and outcome of anaesthetic practice has improved the identifica-tion of risk factors leading to perioperative death [18] All these findings support theneed for SOPs used as modules in clinical pathways

1 Standard operating procedures (SOPs) are a vital component in any qualitymanagement system Written instructions on standardised processes provideguidance to ensure that activities are conducted in a consistent way, leading

to reliable product and service quality SOPs should be prepared in full pliance with guidelines and regulations and must mirror current organisatio-nal practices

com-2 SOPs can and should be used to decrease variation in care, improve guidelinecompliance, and potentially improve overall quality of care

3 Development of SOPs should follow a structured and transparent process

4 Implementation of SOPs should be backed up by a mixture of disseminationtechniques (manuals, intranet, interactive educational meetings)

References

1 National Guideline Clearinghouse™ (NGC), sponsored by the Agency for HealthcareResearch and Quality (AHRQ), U.S Department of Health and Human Services, USA.URL: http://www.guideline.gov/

2 Agency for Quality in Medicine aqumed (Aerztliches Zentrum für Qualität in derMedizin aezq), Berlin, Germany, owned by the German Medical Association (BAEK)and the National Association of Statutory Health Insurance Physicians (KBV), Germa-

ny URL: http://www.aezq.de

3 Programma Nazionale Linee Guida, from Piano nazionale per le linee guida (PNLG),Italy URL: http://www.pnlg.it

4 National Institute for Health and Clinical Excellence (NICE), England, UK URL:http://www.nice.org.uk

5 Guidelines International Network – G.I.N., Scotland, UK URL: http://www.g-i-n.net

6 Sackett DL, Straus ES, Richardson WS et al (2000) Evidence-based Medicine How topractice and teach EBM Churchill Livingstone, London

7 Grimshaw JM, Russell IT (1993) Effect of clinical guidelines on medical practice: asystematic review of rigorous evaluations Lancet 342:1317–1322

8 Martin J, Schleppers A, Kastrup M et al (2003) Development of standard operatingprocedures in anaesthesiology and critical care medicine Anästhesiol Intensivmed44:871–876

9 Every NR, Hochman J, Becker R et al (2000) Critical pathways: a review Circulation101:461–465

10 Pelly JE, Newby L, Tito F et al (1998) Clinical practice guidelines before the law: sword

or shield? Med J Aust 169: 330–333

11 Busse T (1998) OP-Management R v Decker’s Verlag, Hüthig, Heidelberg

12 Wolters U, Schrappe M, Mohrs D et al (2000) Do guidelines bring an improvement inthe preoperative course? A study of preoperative antibiotic prophylaxis Chirurg71:702–706

13 Ely EW, Meade MO, Haponik EF et al (2001) Mechanical ventilator weaning protocolsdriven by nonphysician health-care professionals: evidence-based clinical practiceguidelines Chest 120:454S–463S

14 Rivers E, Nguyen B, Havstad S et al (2001) Early goal-directed therapy in the treatment

of severe sepsis and septic shock N Engl J Med 345:1368–1377

15 Grüne F (2004) Projektgruppenarbeit und Prozessanalyse: eine praxisorientierte führung In: Lauterbach KW, Schrappe M (eds) Gesundheitsökonomie, Qualitätsman-gement und Evidence-based Medicine Schattauer, Stuttgart, pp 388–397

Ein-16 Arbous MS, Meursing AEE, van Kleef JW et al (2005) Impact of anesthesia managementcharacteristics on serve morbidity and mortality Anesthesiology 102:257–268

17 Kendell J Barthram C (1998) Revised checklist for anaesthetic machines Anaesthesia53:887–890

18 Montasser AM (1998) A method for assessment of standards of care of anesthesiaservices in departments with different level of resources J Clin Monit 14:465–470

19 Field MJ, Lohr KN (1990) Clinical practice guidelines National Academy Press, hington DC

Was-20 Field MJ, Lohr KN (1992) Guidelines for clinical practice From development to use.National Academy Press, Washington DC

21 Pearson SD, Goulart-Fisher D, Lee TH (1995) Critical pathways as a strategy forimproving care: problems and potential Ann Intern Med 123:941-948

22 Bero LA, Grilli R, Grimshaw J et al (1998) Closing the gap between research and practice:

an overview of systematic reviews of interventions to promote the implementation ofresearch findings BMJ 317:465-468

M KLIMEK, F GRÜNE

In 1993 the United Kingdom’s National Health Service (NHS) formally introduced

“Clinical Audit” as a quality improvement process The idea was to improve patientcare and outcomes by reviewing (i.e auditing) current performance of, for example, adepartment against explicit criteria and implementing changes where necessary In

simple words, the key component of audit is to ensure that what should be done is

being done; and if not it provides a framework to enable improvements to be made.

During the Crimean War of 1853–1855 Florence Nightingale performed one ofthe first clinical audits ever, when—shocked by the high mortality among theyoung soldiers—she applied strict sanitary routines and standards of hygiene tothe equipment, leading to a decrease in mortality from 40% to 2% among herpatients, which she carefully documented Based on these numbers, she finallysucceeded in convincing the British government to make sanitary routines man-datory for the care of the wounded patient

In the paper “Principles for Best Practice in Clinical Audit” the NationalInstitute for Health and Clinical Excellence (NICE) defines clinical audit as “aquality improvement process that seeks to improve patient care and outcomesthrough systematic review of care against explicit criteria and the implementation

of change Aspects of the structure, processes, and outcomes of care are selectedand systematically evaluated against explicit criteria Where indicated, changes areimplemented at an individual, team, or service level and further monitoring is used

to confirm improvement in healthcare delivery” [1]

In the United Kingdom’s healthcare system, clinical audit is one part of the

“Clinical Governance” project, a project intended to improve the standards ofclinical practice in all fields of care Other aspects of Clinical Governance are clinicaleffectiveness, research and development, openness, risk management and educa-tion and training

Audit and research—what audit is, and what it isn’t

– Clinical audit is all about the quality of care given to patients [2] It involvesasking questions such as:

– Did we give the best available treatment? What are we trying to achieve?– Did we deliver that treatment in the best possible way? Are we achieving it?Why are we not achieving it?

– Did our treatment benefit or harm patients? Did we make things better?Clinical audit is not the same as research; neither is it just about counting things.Clinical audit and research are closely related but distinct disciplines Research isabout creating new knowledge about whether treatments work or whether onetreatment works better than another Clinical audit is about making sure that thisknowledge is being used to best effect Clinical audit and research can both look atthe outcomes of treatment, but for different reasons: Research might observeoutcomes to find out whether a treatment works whereas clinical audit mightmonitor outcomes to ensure that best practice is producing the results we know(from research) that it should The process of conducting clinical audit sometimesidentifies areas where new research is needed It may be expected for the futurethat multi-professional team-working between researchers and health care practi-tioners undertaking audit will represent an important step in establishing thenecessary synergy needed between audit and research [3] In short: “Research isconcerned with discovering the right thing to do; audit with ensuring that it is doneright [4]” (Table 1).

Table 1 Differences between clinical audit and research [5]

Clinical audit Research

Based on facts (standards) Based on hypotheses; creates new

knowledgeEach patient receives the same care May involve randomisation into different

treatment groups, including placebogroup/s

Informed consent might be required Informed consent always required

Results usually apply to the local

population

Results are often generalisable, that is, theymay influence widespread clinical practiceMethodology is less stringent than in

research

Rigorous methodology and extensivestatistical analysis

Typically do not require ethics approval,

but should abide by an ethical framework

Always require ethical approval from thelocal or national ethics committee

Auditing structure, processes and outcomes

When auditing, say, an anaesthesia department, we can look at different aspects of care:

Structure is defined as the resources that are available Examples of these are

the ventilators and monitors in the operating room (OR), but also the staff membersworking in the department, their level of training and experience, the existence of

a recovery room and its staffing and much more

Processes are the pathways followed, the procedures performed, such as the way

epidural catheters are inserted, the level of supervision of the residents (which can

be limited by a structural shortage of staff members) or the use of a checklist fordischarge from the recovery room

Results can be measured in different ways, such as by the number of procedures

performed, the amount of resources used to perform this number, the frequency

of dental damage during intubation, the percentage of failing brachial plexus blocks

or the percentage of central venous catheter infections on day 3 after insertion.All these examples (and many more!) can be addressed by an audit, which—ifperformed in different hospitals and departments—makes benchmarking betweenthe departments possible, which might be threatening to some However,benchmarking is considered to be one of the most important criteria used byhealthcare insurances (which want their members to be treated in the best possibleway) and the government (which has national responsibility for the quality ofhealthcare) when deciding about investing in a certain department or hospital

The effects of auditing

Auditing is one possible starting point for a change-management process: a lem is addressed and identified, and the people who have to deal with this problemget concerned about it This will result in the intention to solve this problem bymeans of intervention This intervention will influence daily routines, which finallywill have a great influence on behaviour, attitude and culture in hospital staff Adiagnostic treatment or an operation can been done on the basis of the highestevidence level and without complications but not be effective Disturbed relation-ships are common between doctors and nurses or surgeons and anaesthesiologists.Auditing in a multiprofessional setting can improve the culture of communication[6, 7] However, one should be aware that creating a change in culture takes muchlonger than making a change in daily routines (Table 2)

prob-Table 2 Audits improve changes in daily routine and in hospital culture

Changes in daily routine Changes in hospital culture

Improvement of care Improvement of multiprofessional

acceptanceMore effective and more efficient

Clinical audit - the process

Clinical audit is a kind of cyclic process, which can be described in six steps [8]:

1 Identify the problem/issue to be audited

2 Define the criteria and standards

3 Observe the practice and collect data

4 Compare the performance measured with the given standards and criteria

5 Implement a change

6 Do a re-audit after an agreed period

These six steps need some more highlighting to be well understood:

Identify the problem/issue to be audited

The selection of an audit topic will be influenced by earlier studies that have beenshown to produce best outcomes for patients In this case, measuring of adherence

to recommended procedures/protocols will be one issue of the audit When looking

at recent studies dealing with improvement in perioperative care, this can be in thefield of structure (e.g is every OR equipped with pulse-oximetry? Is there a recoveryroom available 24/7?), in the field of processes (e.g how many patients with knownrisk factors receive beta blockers perioperatively? How many patients are seen by

an acute pain team postoperatively?) and in the fields of results (e.g is the length

of hospital stay after hemicolectomy comparable to that in other hospitals? Is thesuccess of in-hospital reanimation comparable to that in other hospitals?) Ofcourse, the findings in any of these fields can lead to the implementation of achange-project in another field, too: for example, bad results might be influenced

by better structures and better processes

Besides the comparison of daily practice with current standards and practiceguidelines, the selection of an audit topic can also be influenced by other factors,including recommendations from the government or other authorities, acuteproblems encountered in clinical practice and areas of high volume, high risk orhigh cost in which improvements are possible (Table 3)

Table 3 Points to consider when formulating audit objectives

Effectiveness Is the treatment being administered correctly and does it

have the desired effect?

Efficiency Is this approach achieving the desired outcome with

minimum effort, expense, and wastage?

Equity Do all patients have equal access to care?

Accessibility Is it easy for patients to get appointments with general

practitioners?

Appropriateness Is this the right management strategy?

Acceptability Is the treatment acceptable to patients?

Timeliness Is the care provided at the correct time?

Define the criteria and standard

Criteria are defined as a measurable outcome of care, aspect of practice or capacity,whilst the standard is defined as the threshold of compliance for each criterion In

intensive care medicine, for example, a criterion might be: tight glycaemic control

of the patients and the standard might be set at: more than 90% of the patients with

blood glucose no higher than 8 mmol/l during their stay in the ICU The leadingquestions when defining the criteria and standards are: What should happen as aresult of the audit? And: What question do you want the audit to answer?

Remember that standards have to be SMART! This means Specific, MeasurableAchievable and Agreed, Relevant and Theoretically sound

Observe the practice and collect data

To avoid unnecessary data collection and to gain high data precision, the details ofthe data collected must be defined before starting the audit process This definitionshould include: The population observed, the period observed, the care providersinvolved and all possible exceptions Also confidentiality and privacy (of the

patient and the health care practitioner!) issues should be addressed; in case of

doubt a consultation of the local ethics committee is strongly recommended Somedata are available in hospital information systems, while others need to be collectedmanually using special registration forms

Compare the performance measured with the given standard and criteria

This step can be summarised as analysis, finally resulting in the conclusion on howwell standards were met and, if possible and applicable, identifying reasons whythe standards were not met in all cases There are two options in looking for suchreasons: the reason might be considered acceptable, in which case this will formanother exception criterion for definition of the standard in future, or it will suggest

a possible improvement project If the standard is not met 100% in all cases, resultsclose to 100% suggest that further improvement will be difficult to obtain, but—depending of the topic (think of a “life-and-death” question)—it might neverthe-less be important to make the effort it will require In general, results further awayfrom 100% must be considered to be the main target points for improvementprojects

Implement a change and do a re-audit after an agreed period

The results of an audit must be discussed and (at least inside the organisationaudited) published Based on these findings a change plan must be implemented,and recommendations for change should be made It is important to record whohas agreed to do what and by when Individual responsibilities and an agreedtimescale are mandatory parts of such a change project Sometimes the results

make refinement of the audit tool necessary, for example, if the audit results incriticism of other departments or individuals not involved in the actual auditprocess, a new joint audit has been shown to be more profitable For this importantorganisational issues the implementation of a clinical audit lead and manager must

be strongly recommended (as it is in the UK) [9]

After an agreed period the effects of the change-project should be re-evaluated

by a re-audit The same steps must be taken again, resulting in a re-audit thatdemonstrates successful implementation of the changes and improved adherence

to protocol This step is considered to be critical for successful outcome of an auditprocess, giving direct feedback to all care-providers and finally resulting in acultural change, which means deep implementation of a new/different way ofworking inside a department/hospital/organisation It should not remain unmen-tioned that sometimes second and third re-audits are necessary for optimal per-formance to be reached

Clinical audit in anaesthesiology

There are some small examples showing the use of audit in anaesthesiology:Recently the first national audit conducted by the Royal College of Anaesthetistswas published The anaesthetic audit coordinators had chosen the topic “supervi-sion and responsibility” and analysed the availability of a consultant in differentsettings in UK hospitals [10] The results show many interesting aspects: manyconsultants find the conflicting demands of service and supervision difficult Many

of them work in systems that do not permit direct, immediate support to thosesupervised However, whilst most anaesthetists think supervision is very impor-tant, around half of them disagree with the national guideline stating that everyNHS patient should have a named consultant These few, summarised results give

a great example of the possible impact of an audit: you might think about thestructure, the amount of staffing needed to work in accordance with the nationalguidelines You might think about the processes, how the staff organise theirsupervision and their daily workload, and you might think about a new researchproject and whether the outcomes in the badly organised hospitals are really worsethan elsewhere This might be interesting, because low adherence to and disagree-ment with the guideline was observed

Another study has demonstrated the value of clinical audit in the establishment

of acute pain services [11]: the authors performed a survey of current practice indifferent hospitals, implemented an educational programme for staff and patients

on pain and its management combined with formal assessment of pain and analgorithm to allow more flexible, yet safe, intramuscular opioid analgesia and, afterthat, a repeat survey of clinical practice They found a marked reduction in theproportions of patients experiencing severe pain at rest and on movement: from32% to 12% and from 37% to 13%, respectively

A third published audit deals with the successful implementation of measures

to prevent perioperative hypothermia [12]: in this study the authors demonstrated

that the more frequent use of intraoperative measures to prevent hypothermia(heat and moisture exchanger, circle breathing system, foil hat, forced air warmer)

led to a highly significant (P<0.0001) increase in core temperature on arrival in the

recovery room from 35.5°C to 36.6°C, although on average the procedures lastedabout 20 min longer (154.7 vs 133.5 min) in the second audit

These three examples show different aspects of the (possible) impact of audits

in anaesthesiology on structures, processes and outcomes There are many solved problems in daily anaesthesiological patient care, which should also beaddressed!

un-Clinical audit in intensive care medicine

Whilst the aspects of structures, processes and outcomes can also easily be ferred to innumerable topics in the ICU setting, too, there is one recent paperdescribing a different methodological approach to auditing in the setting of an ICU,

trans-a technique ctrans-alled trans-a “retrans-al-time ptrans-atient strans-afety trans-audit”, which is derived from trial methods providing timely error detection, including feedback to the respon-sible person in the frontline [13] It is obviously not always necessary to performlong-lasting studies with complex observations, but even the use of a brief checklistreminding the members of the care staff of the existing standards can improvehealthcare outcomes and avoid disasters: in one study of ICU a 36-item checklistwas used, which focused on errors associated with delays in care, equipment failure,diagnostic studies, information transfer and noncompliance with hospital policy.This checklist revealed a lot of errors in a short period of time; for example,unlabelled medication was used at the bedsides, some of the patients had no IDbands and the alarm settings of the pulse oximeter were inappropriate Based onthese findings many policies were changed and many educational initiatives werelaunched, with the intention of making patient care in this ICU setting much safer

indus-Auditing the audit—where are the limitations?

It must be stressed that auditing is a cyclic business and part of a continuousimprovement and educational programme which ultimately will lead to a culturalchange in a hospital or department Therefore, it is mandatory not only to detectthe “weak points” of a process, but also to try to improve them by education andtraining and later to check whether this training has been successful by re-auditing.Gnalalingham et al evaluated the standard of 213 clinical audits performed in ateaching hospital and found disappointing results [14]: only 14% of the auditssatisfied the fifth step, and only 24% of the audits were followed by a re-audit duringthe subsequent 3 years When discussing the reasons for this poor performance,they see structural problems (audits are frequently performed by the junior medicalstaff, and the rotational nature of their posts hinders completion of the cycle) andproblems in the processes (e.g lack of interest on the part of some care providers,

the time-consuming work of data collection), leading to incomplete audits that willnot really contribute to health care improvement.

The value of an audit

The value of audit and feedback, with reference to their effects on professionalpractice and health care outcomes, was recently the topic of a Cochrane Review[15]: Providing healthcare professionals with data about their performance (auditand feedback) may help improve their practice Audit and feedback can improveprofessional practice, but the effects are variable When it is effective, the effectsare generally small to moderate The relative effectiveness of audit and feedback islikely to be greater when baseline adherence to recommended practice is low andwhen feedback is delivered more intensively The results of this review do notsupport mandatory or unevaluated use of audit and feedback as an interventiondirected at changing practice However, it must be stressed that only 118 studieshave been considered for this review and that many of these had some methodo-logical weakness Therefore, the conclusion must tend more towards: “There must

be more and better audit-research performed!” than towards “Forget it, it is worthless.”

What can I do?

Whoever is thinking critically about structures, processes and outcomes in his orher personal working environment will identify some problems Addressing theseproblems, creating alertness, building a base on which a change-process can bestarted, developing oneself and one’s co-workers, getting a more precise picture ofthe structure, the processes and the outcomes—an audit can be recommended forany and all of these There are many supportive textbooks and web resourcesavailable, which enable almost anyone to perform an audit The results gainedshould be interpreted carefully and widely discussed before a change-process isstarted When the need for a change-process is agreed the goal is announced and theway in which a successful change-process might be started is described However,this must include a re-audit, to evaluate whether the goal is reached and patient care

is improved The results of audit processes should be published, to encourage aculture of blame-free risk management Auditing demands staying power!

Nine steps to starting a first audit

For those who want to start an audit cycle in their own department / hospital, thefollowing checklist summarises the questions it is most important to answer beforethe process is started

1 Choice of topic Which topic is most important and most

urgent?

2 Authorisation Approval! Are we talking about a department

or a hospital audit?

3 Workgroup Should we invite everybody?

4 Moderation Internal or external?

5 Power of the first meeting Introduction to auditing

Rules of communicationVisions and/or aims

6 Scheduling an audit When will we reach what?

7 Evaluation Measuring what and how long?

8 Implementation Possible techniques in my hospital?

References

1 National Institute of Health and Clinical Excellence (2002) Principles for best practice

in clinical audit Radcliffe Medical Press lAudit.pdf)

(http://www.nelh.nhs.uk/BestPracticeClinica-2 United Bristol NHS Trust (2005) published at: http://www.ubht.nhs.uk/clinicalaudit/

3 Hughes R (2005) Is audit research? The relationship between clinical audit and socialresearch Int J Health Care Qual Assurance 18:288–299

4 Smith R (1992) Audit and research BMJ 305:905–906

8 Jones T, Cawthorn S (2002) What is clinical audit? Evidence based medicine HaywardMedical Communications

(http://www.evidence-based-medicine.co.uk/ebmfiles/WhatisClinAudit.pdf)

9 Copeland G and the Clinical Governance Support Team (2005) A practical handbookfor clinical audit NHS, UK (http://www.cgsupport.nhs.uk/downloads/Practical_Clini-cal_Audit_Handbook_v1_1.pdf)

10 McHugh GA, Thoms GMM (2005) Supervision and responsibility: The Royal College

of Anaesthetists National Audit Br J Anaesth 95:124–129

11 Harmer M, Davies KA (1998) The effect of education, assessment and a standardizedprescription on postoperative pain management Anaesthesia 53(5):424–430

12 Gallagher GA, McLintock T, Booth MG (2003) Closing the audit loop—prevention ofpreoperative hypothermia: audit and reaudit of perioperative hypothermia Eur JAnaesthesiol 20:750–752

13 Ursprung R, Gray JE, Edwards WH et al (2005) Real time patient safety audits: ving safety every day Qual Saf Health Care 14:284–289

impro-14 Gnanalingham J, Gnanalingham MG, Gnanalingham KK (2001) An audit of audits: are

we completing the cycle? J R Soc Med 94:288–289

15 Jamtvedt G, Young JM, Kristoffersen DT et al (2006) Audit and feedback: effects onprofessional practice and health care outcomes Cochrane Database Syst Rev Apr19;(2):CD000259

Focus on entropy and surgical stress index

M SORBELLO, S MANGIAMELI, A GULLO

Monument to Morton, Mt Auburn Cemetery, Boston

Inventor and Revealer of Anaesthetic Inhalation

Born August 9, 1819; died July 15, 1868

BEFORE WHOM in all time Surgery was agony.

BY WHOM Pain in surgery was averted and annulled.

SINCE WHOM Science has control of pain.

H.G Bigelow, Surgeon

Few words for a great discovery

According to the words of Dr Bigelow, one of the most important goals achieved

by Dr Morton’s discovery of anaesthesia was, as is obvious from the point of view

of a surgeon, that pain was abolished from surgery This is quite true whenanaesthesia is in the skilled hands of an able anaesthetist; the same cannot be said

of the idea that science has control of pain

In effect, more than 160 years later, we really have very few certainties about ouranaesthetised patients What we can be sure of is muscular paralysis, as on one hand

we are able to measure all parameters of neuromuscular block and, on the other,pharmacokinetics, sites of action and pharmacodynamics of neuromuscular block-ing agents (NMBAs) are fully understood; besides we can also objectively assess thedegree of muscular paralysis, simply by the surgeon’s complaint (more often thannecessary, indeed) or by the awakening patient respiratory difficulty Finally, wemust not forget the valuable possibility of pharmacological block reversal

What, then, about unconsciousness? First of all let us decide to consider it as

“hypnosis”, to clearly identify it as one of the three components of generalanaesthesia (GA) And, so on, what about analgesia/nociception imbalance? Fewdata, many hypotheses, and a huge amount of uncertainties; that could be a goodanswer; but what is the question?

If we explore other aspects of anaesthesia we have few or no answers at all Weare discussing anaesthetic depth (AD) or antinociception monitors, but we hadbetter discuss what it is we want to measure! It has been claimed that we will notunderstand GA and its effects on consciousness until we understand what con-sciousness itself is [1]

Chapter 27

“Gentlemen, this is no humbug.” A few words from Dr Warren, also a surgeon,

to announce the wonder of something that would change medicine for ever It was

16 October 1846, in Massachusetts General Hospital, Boston (see a wonderful onlineslideshow at http://www.etherdome.org/Humbug.html) when Thomas Morton of-ficially discovered anaesthesia and started the “ether era” [2]; ironically, some timebefore, a similar demonstration attempted by Horace Wells in the same hospitalbut using nitrous oxide had failed through technical problems with the animalbladder used as reservoir for anaesthetic gas delivery Probably he would havesucceeded, anticipating the birth of anaesthesia, if he could have used an ADmonitor (the patient awoke, experiencing pain, less than usual, but nonethelesspain)

Even nearer the present, up to the early 1990s, Dr Wells would not have foundsuch a monitor And if, as a curious scientist, he could have jumped forward toyesterday, he still would not have found anyone able to explain him exactly how,when and where old and modern anaesthetic agents act

Let us try to help him imagine…

Anatomy and physiology of hypnosis

What is hypnosis?

An excellent review recently provided by John et al [3] provides “theories” and

“proposed mechanisms” referring to the anaesthetic cascade, while Lydic et al [4],

in their recent review considering 40 years of research into the cellular and cular mechanisms contributing to arousal state control, conclude that a large body

mole-of data is available but still not enough to enable us to understand the underlyingmechanisms or to attempt any comparison with GA

For the first 100 years of anaesthetic practice the basic principles were tosuspend conscious awareness and produce a deep stage of anaesthesia to facilitatesurgery by profound relaxation of skeletal muscles This deep stage could beachieved only with high concentrations of general anaesthetic agents, and it wasdifficult to avoid the risk of “too-deep anaesthesia” with consequent cardiorespi-ratory depression The introduction of NMBAs in the 1940s produced neuromus-cular paralysis without the need for a high concentration of anaesthetic; the risk oftoo-deep anaesthesia then gave way to the potential condition of “too-lightanaesthesia”, making anaesthetists aware of patients’ conscious awareness [5].Let us make a break Anaesthesia can be considered as the condition achieved

by administration of different molecules aimed at allowing patients to tolerateotherwise painful or unpleasant procedures; all pharmacodynamic effects elicited

by anaesthetics can be typically classified as modification or loss of consciousness,amnesia, analgesia, muscle relaxation and control or suppression of autonomicresponses

In the modern anaesthetic era every single effect is generally and ideally chieved by a single molecular mechanism occurring in a certain anatomical site,

a-which is now largely, but not yet completely, identified There is an importantlimitation, indeed, for this schematic vision: it might let us underestimate the largenumber of molecular, anatomical, functional and pharmacological interactionsand pharmacodynamic interindividual variability in drug responses [6].

AD is hence a general “multimodal concept”, which can be variously definedaccording to the specific component of anaesthesia we are investigating, and it mustdefinitely be emphasised that most of the currently available AD monitors havebeen designed to explore only a single pharmacodynamic aspect of GA, i.e altera-tion of consciousness: even the best of them, then, is still exploring only one part

of a process and will not consider other factors (such as muscular responses) unlessperhaps as artefacts, when they might sometimes indicate incoming variations of

GA depth or imminent arousal or awareness phenomena

From the pharmacokinetic point of view, AD is easily achieved (just think ofthe stabilised end-tidal concentration of inhalatory anaesthetic agents, which isassumed to be equal to the concentration at the site of action [1] or the calculatedconcentration at the site of action for intravenous anaesthetics according to widelydemonstrated pharmacodynamic models); but from the pharmacodynamic point

of view, AD is different and more complex, as we still do not know exactly how andwhere the anaesthetic effect is exerted, whilst we do know that all aspects of GA arestrictly interrelated and influence each other: it is well known that surgical noxiousstimuli tend to lighten the depth of hypnosis [7], or, in other words, that strongnociception causes arousal or strong hypnosis causes antinociception [8]

Is it possible to assess AD?

This is also a good question; but first of all we should ask why we need ADassessment The principal risk in this era of too-light anaesthesia is undoubtedlyawareness

A large number of studies [9] have demonstrated that patients can rememberevents that have occurred during GA and that conscious retrieval of informationcan occur during GA (explicit memory or awareness): patients report having heardconversations or noises or having felt discomfort, such as being operated on orparalysed [10] This phenomenon is rare (0.1–0.2%) [11, 12], but its psychologicalconsequences can be dramatic Other studies suggest that automatic or uncon-scious retrieval of information presented during GA is also possible (implicit orautomatic memory) [13], with the evidence of an immediate postanaesthetic change

in behaviour or in performance on a memory test without conscious recall of theinformation presented during GA

This phenomenon could have far-reaching implications for anaesthesiologistactivity, including legal implications [14], so that according to the results of themost important studies on awareness [15], which show that the use of AD monitorsreduces its incidence, AD should be monitored [16] in high-risk patients such astrauma patients, those undergoing caesarean section, cardiac surgery, rigid bron-choscopy and emergency surgery, TIVA patients; patients with previous episodes

of awareness; patients with increased tolerance to anaesthetic drugs because of