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RESEARCH PAPER
Correspondence: Matthew McMillan, Queens Veterinary School Hospital, Department of Veterinary Medicine, University of Cambridge,
Madingley Road, Cambridge CB3 0ES, UK. E-mail: mwm32@cam.ac.uk
Present address: Hannah Darcy, Chaseview Veterinary Clinic, Ross-on-Wye, UK
128
Adverse event surveillance M McMillan and H Darcy
One major obstacle to large-scale audit is the lack lance tool. The study was approved by the local
of consensus over what to report and also how ethics and welfare committee as part of a larger
events should be defined and classified. This incon- study proposal (reference QVSH/CR41).
sistency means that data collected from individual
Development of the surveillance tool
studies are difficult to aggregate and compare,
limiting efforts to produce evidence-based recom- Applying the principles set out in Bhatt et al. (2009)
mendations (Green & Yealy 2009). As a conse- and Mason & Green (2012), AEs were defined as
quence, the development of uniform definitions and undesirable perianaesthetic events that required
reporting templates has been recommended in remedial intervention in an attempt to prevent or
human medicine (Cummins et al. 1991; Bhatt et al. limit patient morbidity, mortality, distress or dis-
2009; Mason et al. 2012). Key examples of such comfort.
templates are seen in the fields of cardiopulmonary Using previous reports in the literature regarding
resuscitation (the Utstein style) and sedation [the AEs and complications in both human and veteri-
Quebec guidelines and the World Society of Intra- nary anaesthesia, a reference list of AEs and inter-
venous Anaesthesias International Sedation Task ventions was drawn up (Cooper et al. 1987; Clarke
Force (ISTF) AE reporting tool] (Cummins et al. & Hall 1990; Dyson et al. 1998; Gaynor et al. 1999;
1991; Bhatt et al. 2009; Mason & Green 2012). Callum et al. 2000; Redondo et al. 2007). This
Both the Quebec guidelines and the ISTF suggest initial list was abbreviated by amalgamating indi-
moving away from a traditional event and thresh- vidual AEs into broader categories (e.g. apnoea,
old approach to an intervention-based system of respiratory arrest, hypoventilation and abnormal
AE definition and reporting. Event and threshold respiratory patterns into a single ventilation cate-
definitions are based on a parameter reaching a gory). AEs were selected based on their reported
specified critical threshold (e.g. mean blood pressure frequency of occurrence (Clarke & Hall 1990;
dropping below 60 mmHg could define hypoten- Gaynor et al. 1999) and on their general signifi-
sion). In contrast, the basis of intervention-based cance in terms of patient morbidity and mortality (as
definitions of AEs is whether or not remedial actions judged by the authors). Generic intervention-based
are made in response to a particular event with the definitions were developed for each of these AE
aim of halting escalation and limiting consequences categories using the definitions outlined by Bhatt
(e.g. an intervention such as a crystalloid or colloid et al. (2009) as a basic framework. Remedial
bolus made in response to a drop in blood pressure actions, treatments, procedures or an escalation in
could define hypotension). Despite appearing less the level of care were all considered as interventions.
intuitive and more subjective, reported benefits of Some of the more serious events (such as hypox-
this approach include providing a better reflection of aemia) also had a secondary component to their
the clinical relevance of AEs and more objective, descriptors to assist in their assessment.
unambiguous and reproducible data that can be A total of 11 AEs were included in the predom-
more readily aggregated and compared (Bhatt et al. inantly checkbox-based surveillance tool, which was
2009; Green & Yealy 2009; Mason & Green 2012). circulated on a single page of A4 paper on the
Our initial objectives were threefold: first, to develop reverse side of the anaesthetic pricing sheet used to
and implement an intervention-based, AE surveil- bill for anaesthesia services. AE definitions, further
lance tool in a university teaching hospital; secondly, descriptors and interventions associated with them
to report its findings over a year-long pilot period; and, are shown in Fig. 1. In addition, a number of free
finally, to describe its evolution over the first year of text areas and a section for AEs that did not fall into
reporting. The overall aim of the project was to the main categories were provided. Finally, an
suggest a potential template for a surveillance tool for outcomes section which included death, euthanasia
veterinary anaesthesia by which readily comparable and various potential escalations in the level of care
AE data could be captured in a wide-scale fashion. that could be prescribed as a direct consequence of
the AE(s) (above and beyond standard postanaes-
thetic care for that type of procedure), was included.
Materials and methods
Testing of the surveillance tool
The study was designed as a prospective, voluntary
reporting audit of small animal anaesthetic AEs A prospective, voluntary reporting audit of AEs
using a purpose-built, intervention-based AE surveil- encountered during small animal anaesthetics was
2015 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia, 43, 128135 129
Adverse event surveillance M McMillan and H Darcy
Please complete for all patients: WERE THERE ONE OR MORE ADVERSE EVENTS (AEs) DURING THIS ANAESTHESIA?
NO (this form is now complete) YES (please fill out the remainder of the form)
Outcomes as direct consequences of the AE(s): *Which severity statement best fits the AE(s) encountered?
*Cancelled or shortened procedure MINOR Presented little threat of permanent harm to the patient
*Additional treatments MODERATE Threatened significant harm but was managed well
Additional monitoring, observations *or diagnostics
MAJOR Caused morbidity but outcome attenuated by
*Additional hospitalisation intervention
Escalation of patient care requiring <24 h (additional) ICU care
CATASTROPHIC Caused mortality or significant morbidity
Escalation of patient care requiring >24 h (additional) ICU care
Patient euthanased Further details:
Patient died
Figure 1 The final revised adverse event surveillance tool. An asterisk (*) indicates that the following description, intervention
or section (including all subsequent descriptions and interventions associated with it) was not present on the original tool. In
addition, the order of interventions and the position of the ongoing intervention section, which was formerly at the bottom of
the tool, have been altered from the original. All other areas (including definitions) are consistent with the original.
performed in a multidisciplinary, university teaching case load, respectively). All small animal anaesthet-
hospital. The hospital admits both referral and first ics, with the exclusion of anaesthesia for radiother-
opinion patients (approximately 75% and 25% of apy, were eligible. Anaesthetists were asked to fill in
130 2015 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia, 43, 128135
Adverse event surveillance M McMillan and H Darcy
the AE surveillance tool immediately after every AE report with the retrospective global assessment of
eligible anaesthetic, but, although it was strongly the anaesthetist.
encouraged, completion was not made compulsory. At the end of the pilot period, each individual item
No guidance as to how it should be completed was in the tool was analysed for reporting trends and
given. patterns. AE descriptor and intervention sections
Data were collected from all AE reports submitted (including free text sections) were assessed in terms
between June 2012 and June 2013. During the pilot of their frequency of reporting/use, structure and
period, anaesthetic AEs were reportable up until the format and their importance to the audit. Based on
point at which the patient was transferred to the these findings and a final consultation with members
recovery room and no attempt was made to gather of the anaesthesia team, a revised version of the
follow-up data. AEs were investigated in isolation, surveillance tool was developed. Amendments con-
i.e. variables such as patient signalment, health sidered included addition of questions, expanding or
status, anaesthetic technique and surgical procedure removing descriptors and options, rewording of
were not collected. No effort was made to gather questions, increasing the emphasis on particular
information from anaesthetics with missing AE questions by altering their position on the form or
reports. Each paper report was uploaded manually even complete removal of the question from the
by a single investigator onto a purpose-built elec- form.
tronic database (Microsoft Access, Microsoft, WA,
USA) for analysis. An accurate total for the number
Statistical analysis
of anaesthetics performed during the period was
determined from hospital records. Data were analysed using mainly descriptive statis-
Clinical monitoring (consisting of assessment of tics. Compliance was calculated as the percentage of
pulse rate and quality, mucous membrane colour forms completed as compared with the total number
and capillary refill time, respiration and depth of of anaesthetics performed during the same time
anaesthesia), capnography and pulse oximetry period. Overall and monthly compliance rates were
were utilized in all anaesthetized patients. Nonin- calculated. Where forms were absent it was assumed
vasive blood pressure monitoring (either Doppler that no significant AEs had occurred. Fishers exact
flowmetry or oscillometry) was used in all but the tests were used to assess the difference in frequency
shortest anaesthetics. Beyond this, the manage- of overall and individual AEs between cats and dogs.
ment of patients, including selection of drugs, All calculations were performed using a standard
additional monitoring devices and AE interven- spreadsheet program (Microsoft Excel 2007) or a
tions, was left entirely to the discretion of the standard statistical software package (Graphpad
attending anaesthetist. Electronic monitoring was Prism; Graphpad Software Inc, CA, USA).
performed using monitors of various makes and
models.
Results
Prior to commencing the pilot audit, all staff
involved with the provision of anaesthesia (three
Quantitative results
specialist veterinary anaesthetists, two anaesthesia
residents and one anaesthesia nurse) were made A total of 1386 anaesthetics were logged on the
aware that, although the reports would not be hospitals electronic patient record system during
anonymous, the data collected were for quality the pilot period. In all, 972 dogs, 387 cats, 18 rabbits
improvement and research purposes only and that and nine other animals from various species (in-
it was not intended as an audit of their individual cluding guinea pigs, ferrets and rats) were anaes-
performance. thetized, and 1114 AE reports were submitted.
Overall compliance was 80.4% with monthly com-
pliance rates varying from 70% to 100%. Peaks of
Refinement of the surveillance tool
poor compliance were observed during periods when
Informal interviews with members of the anaesthe- the lead investigator was not on clinical duty or
sia team and final-year undergraduate students where there were staff shortages or locum anaes-
exposed to the surveillance tool were used to reveal thetists working in the clinic.
limitations and weaknesses with the tool. Open case A total of 1001 AEs were reported in 572 patients,
discussion permitted subjective comparison of the with 258 patients having more than one AE reported
2015 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia, 43, 128135 131
Adverse event surveillance M McMillan and H Darcy
132 2015 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia, 43, 128135
Adverse event surveillance M McMillan and H Darcy
Table 2 Absolute and relative frequencies of anaesthetic cases with individual adverse events (AEs) from a voluntary
reporting audit of 1114 small animal anesthesia cases in a university teaching hospital
NA, not applicable. *Denotes statistically significant difference (p < 0.05) between cats and dogs.
Table 3 Absolute and relative frequencies of interventions 80.4%, which is comparable to similar voluntary
performed in the 143 anaesthetics during which hypoten-
self-reporting systems in human anaesthesia (Haller
sion was reported. Significant intraoperative haemorrhage
et al. 2011). This would appear to be a positive
was thought to be the cause of hypotension in only 12.6%
(n = 18) of cases
finding, but it is likely that sustaining this level would
require considerable and continued effort.
Finally, although the form itself could be com-
Absolute Relative
pleted rapidly, additional time was required to enter
Intervention performed frequency (n) frequency (%)
this data into the electronic database. In a university
Significant decrease in 127 88.8
hospital setting, this posed only a minor problem but
vaporizer setting it may make the surveillance tool difficult to intro-
Crystalloid bolus 59 41.3
duce into an environment where there are greater
Colloid bolus 47 32.9
Direct pharmacological 42 29.4 time constraints.
intervention with Despite these limitations, we believe this study
vasopressors,
inotropes or chronotropes
demonstrates that a simple reporting tool using an
Blood transfusion 5 3.5 intervention-based approach to defining AEs can be
Total 280
successfully integrated into small animal anaes-
thetic practice. Such tools could be used to gener-
ate useful data with minimal effort. The generic
agement, judgement and clinical decision-making descriptors and checkbox design of the tool
being scrutinized; a reluctance in clinicians to report appeared to be intuitive to use and the data were
their own errors and misjudgements; uncertainty of easy to gather, code and analyse. The location of the
the clinical importance of events; and the lack of form on the reverse of a universal piece of patient
change following reporting (Garrouste-Orgeas et al. record-keeping helped to remind staff to report after
2012). During the pilot period, the compliance was each case.
2015 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia, 43, 128135 133
Adverse event surveillance M McMillan and H Darcy
Table 4 Intra-anaesthetic deaths, euthanasia and out- to individual cases requiring further in-depth review;
comes in terms of various potential escalations in the level and to study the impact of changes in clinical practice
of care (above and beyond standard postanaesthetic care on improving patient safety.
for that type of procedure) in the 353 cases where they As well as giving the opportunity to develop the
were predicted
surveillance tool, the pilot audit yielded some inter-
esting results with regard to AE incidence. Although
Relative our novel methodology makes direct comparison
Absolute frequency in with previous studies difficult, it is interesting to note
frequency cases where
that we observed similar incidences of some AEs
(number of outcome
Outcome cases) predicted (%) (such as hypotension) but not others (such as
hypoventilation and arrhythmia) (Gaynor et al.
No further action required 228 64.6 1999). The significance of this is uncertain and it
Increased level of 114 32.3 may be linked different tolerances to hypercapnia
monitoring/observations
Unintended period of 36 10.2 between the two hospitals and the fact that many
intensive care <24 hours arrhythmias that occur under anaesthesia require
Unintended period of 10 2.8
intensive care >24 hours
no intervention.
Did not recover from 11 0.8 The incidences of two AE categories, arousal or
anaesthesia
breakthrough pain and recovery excitation or
Intra-anaesthetic deaths 6 [2] 0.4 [0.1]
[of which were primarily (of all cases) emergence dysphoria, have not been reported
a result of anaesthesia] previously, which suggests that they are under-
Euthanased 5 0.4 (of all cases)
recognized problems in veterinary anaesthesia. The
increased incidence of AEs in dogs as compared with
cats is also an interesting finding. The reason for this
Not all components of the tool were fully success- is unclear, although it is possible that improved
ful and a number of amendments had to be made, functioning of electronic monitoring equipment in
but it should be noted that the intervention-based larger patients enables more marginal alterations in
definitions were consistent between the pilot and the physiological status to be recognized, thus triggering
final revision (apart from the addition of sections for an increased intervention rate.
reporting cardiopulmonary arrest and equipment We believe this method of gathering AE data is
and medication issues). One concern was that some more applicable to a wider range of circumstances
more clinically significant AEs were not distinguish- than other systems. Intervention-based systems do
able from lesser AEs. Expansion of the secondary AE not require specific data or precise measurements,
descriptors as a failsafe, a technique advocated by but rather rely on the interpretation of events by the
the ISTF, should attenuate this issue and enable the anaesthetist in light of the clinical situation. For
tool to consistently identify AEs of greater severity example, although clearly electronic devices such as
(Mason & Green 2012). On reflection, the least blood pressure monitors will facilitate decision-
successful section was the one investigating ongoing making, there is no absolute requirement for such
interventions. However, although redesign and re- equipment to trigger reporting of an event. Inter-
emphasis of this section were necessary, the princi- vention-based definitions allow the anaesthetist the
ple of reporting outcomes in terms of escalation of flexibility to consider interventions based on other
care was considered useful. clinical variables, such as pulse quality, to trigger a
Admittedly, the tools reports are not detailed report. This makes this method more applicable to
enough to give a full depiction of the anaesthetic and general practice and field settings.
any problems encountered during it. For example, Further adaptation and refinement are necessary
with the exception of hypotension caused by haem- for this tool to be useful on a wider scale. Developing it
orrhage, no attempt was made to separate the in an electronic format will enable easier, more rapid
aetiology of AEs. However, it is important to recognize data entry and allow integration into a practices
that this is not the objective of AE surveillance, which electronic patient record system (Haller et al. 2007).
is to give a global view of frequency and severity of Creation of smartphone or tablet computer applica-
AEs occurring during anaesthesia. This global view tions would open up further avenues for data
can be used to highlight areas warranting further collection in all environments where anaesthesia is
investigation, analysis and action; to draw attention performed, enabling rapid and large-scale data
134 2015 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesia and Analgesia, 43, 128135
Adverse event surveillance M McMillan and H Darcy
collection. Such methods have the potential to incidence of anesthesia complications. Anesthesiology
facilitate clinical auditing and large-scale AE data- 67, 686694.
bases. Cummins RO, Chamberlain DA, Abramson NS et al.
In conclusion, the intervention-based AE surveil- (1991) Recommended guidelines for uniform reporting
of data from out-of-hospital cardiac arrest: the Utstein
lance tool appeared to be a versatile, effective and
Style. A statement for health professionals from a task
efficient method with which to generate useful AE
force of the American Heart Association, the European
data. As with all methods of surveillance there are Resuscitation Council, the Heart and Stroke Foundation
some limitations to its use, but these limitations are of Canada, and the Australian Resuscitation Council.
balanced by the simplicity and applicability of the Circulation 84, 960975.
method. Department of Health (2000) An Organisation with a
Memory. Stationery Office, UK.
Acknowledgements Dyson DH, Maxie MG, Schnurr D (1998) Morbidity and
mortality associated with anesthetic management in
The authors would like to acknowledge the signif- small animal veterinary practice in Ontario. J Am Anim
icant contribution of Alex Chebroux in developing Hosp Assoc 34, 325335.
the surveillance tool and electronic databasing Garrouste-Orgeas M, Philippart F, Bruel C et al. (2012)
system used for this study. Overview of medical errors and adverse events. Ann
Intensive Care 2, 2.
Gaynor JS, Dunlop CI, Wagner AE et al. (1999)
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