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JTS patient safety bibliography 02.09.05
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Patient Safety:
An unsystematic review
and bibliography
Authors:
1. Nathalie Maillard BMedSci – Research Associate
1. Seonaid Stirling – Summer Research Associate
3. Richard Lilford FRCOG, FRCP, PhD – Professor
of Clinical Epidemiology
4. Amirta Johal BSc MSC – Research Officer
5. Nicola Gilbert BSc PhD – Research Fellow
Department of Public Health & Epidemiology
University of Birmingham
Edgbaston
Birmingham
B15 2TT
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1. Introduction: historical context
The topic of patient safety is certainly not new – the concept of iatrogenic
harm originated with the Ancient Greeks. We would like to single out two
iconic figures from the 19th century. Semmelweiss compared infection rates
in the post-natal wards in Vienna. He found that maternal mortality was 3 or 4
times higher in the medical wards than in the midwifery wards. He performed
a epidemiological comparative study and traced the cause of infections to
cross contamination between the mortuary and the clinic (Raju, 1999).
Florence Nightingale is our second choice of an inspirational historical figure.
Her tireless campaigns for greater hygiene and improved care are the
subjects of many biographies.
We have conducted an analysis of the citations under the topics of quality
and patient safety and normalised this against the biomedical literature as a
whole (figure 1).
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0.00
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1966
1968
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1994
1996
1998
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2004
Year
%
Patient Safety
Quality in Health care
Medical errors / medication errors
It is easy to see from this figure, that there has been an exponential rise in the
number of papers labelled as ‘patient safety’. While doubtless some of these
would have been labelled ‘quality’ a few years earlier, it is clear that interest in
patient safety has gathered pace in the last ten years.
In this article we bring together the articles, which we think are classical, in
that they have played a part in shaping thoughts and practice in this area.
This is obviously a personal selection, but we plan to post the articles on the
Internet at URL: http://pcpoh.bham.ac.uk/publichealth/psrp with the number of
citations each paper had achieved by August 2005 and the average per year
since publication. We have ranked the papers in order of number of citations
as given by the ISI Web of Science (see Appendix 1), but we have also used
The incidence of adverse events
and negligence in hospitalized
patients: results of the Harvard
Medical Study
To err is human: Building a safer
health system
Building a safer National
Health Service
Error in Medicine
Figure 1: The growth of Medline citation counts in terms of ‘patient safety’,
‘quality in health care’ and ‘medical/medication errors’ from 1966 – 2005.
Each graph
was normalised by taking the data for the year 2005 as 100% (‘Patient Safety’ = 2,472; ‘Quality in Health care’
= 21,870; ‘Medical/Medication Error’ = 7,867).
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other citation counters and compared the results that these produced as
detailed in Appendix 2. At the above address we provide space for open
comment on our choices, along with fields where others can add their
personal favourite articles. In this way, we plan to create a living document to
encourage debate in the short term and provide an historic archive in the
longer term. We hope our efforts will compliment (they are certainly not
intended to replace) systematic reviews such as that sponsored by the
Agency for Healthcare Quality and Research (Shojania et al., 2001). We
classify our trawl of papers under three large themes. First, how common is
error (the epidemiology of error); second, what causes error (the basic
science of error); and third, what can be done about it (intervention studies).
2. Epidemiology of error
2.1 How common is error / harm?
The most well known studies on error rates enumerated adverse events and
then asked what proportion of those were the result of errors (Table 1). The
two most famous, Brennan et al (Brennan et al., 1991) and Leape et al (Leape
et al., 1991) are well on their way to becoming citation classics with
respectively 890 and 715 citations on Web of Science in August 2005.
It should be noted that the presence or absence of harm can be assessed
reliably, but judgements on whether such harm resulted from error are more
labile (Edwards A et al., 2004). These problems are dissected in meticulous
detail by Hayward and Hofer (Hayward and Hofer, 2001) in a classical
exposition on the methodological issues inherent in attributing a cause to
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cases of iatrogenic harm.. Some studies give an important breakdown of
where the system is most vulnerable. For example, with respect to
medication errors, 56% occur at the stage of ordering, 34% at administration,
but only 10% at transcribing or dispensing (Bates et al., 1995).
2.2 Reporting Systems
Much emphasis has been given to reporting systems as a method to obtain
information about threats to safety. A comparative study of reporting systems
across many industries and review of features that encourage reporting was
conducted by Barach and Small (Barach and Small, 2000). Willingness to
report is fostered when clinicians perceive that the organisation is likely to
respond and when disclosure will not result in censure. Anne O’Neil
compared a number of approaches to measurement of error (O'Neil et al.,
1993). This important work showed that medical record review and physician
reporting identified a very different set of errors. Standard quality assurance
programmes detect only a very small fraction of the errors that can be
detected by chart review or prospective data collection. Thus, error-reporting
systems have severe limitations as an epidemiological tool because only a
small proportion of problems get reported and that proportion may vary from
place to place and time to time. For this reason, comparative studies based
on reported error are liable to be severely biased. Furthermore, Gallagher et
al (Gallagher et al., 2003) showed that despite much brave talk about a blame
free culture, physicians feel much less inclined to openly report errors than
patients would wish them to be. Physicians feel vulnerable and poorly
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supported in reporting errors, despite promulgation of standards advocating
disclosure.
2.3. If not reported errors, then what?
Thomas and Peterson (Thomas and Petersen, 2003) provide a review of all
methods of measuring safety and error, from case note review, through
immediate error reporting by clinicians, real time observation by researchers
to simulated and actual patients. Given the rather different profile of errors
detected by different methods, some studies have used a combination of
methods - for example Donchin et al (Donchin et al., 1995) used a
combination of immediate reporting and observation. They found the average
ITU patient experiences 178 activities per day, with a mean error rate per
activity of nearly 1%.
The limitations of outcomes as measurements of quality were summarised by
Lilford and colleagues (Lilford et al., 2004) who explain the ‘case mix
adjustment fallacy’ and who coined the term ‘institutional stigma’ to describe
the sense of victimisation induced by penalising institutions on the basis of
outcome data. Mant and Hicks (Mant and Hicks, 1995) compare the
sensitivity of measures of process and outcome and demonstrate the much
greater precision in use of process/error rates in the context of cardiovascular
disease. Nevertheless, measurement of error (process) can be biased when
patients in different institutions care for patients with different levels of severity
and hence different needs for care. All errors are contingent on the situation
arising where an error can arise. Lilford and colleagues (Lilford et al., 2003)
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argue that differences in case-mix can be mitigated by using `opportunity for
error’ (not patients) as the denominator when conducting any sort of research
or audit in which one institution is compared to another .
3. Basic Science
3. 1 Introduction
Improving safety for patients requires solutions, which in turn derive from
ideas about what might cause error and how it might be prevented. That is to
say, there is a theoretical base (which is not always explicit), from which
attempts to improve safety arise.
Safety is a function of individuals and the systems in which they work. Much of
the relevant basic science therefore relates to psychology and to
organisational sociology. There is also a growing interest in the role of the
physical environment. We will deal with these in turn.
3.2 Psychological factors and human error
3.2.1 Cognition In table 2, we list some of the classic studies relating human
cognition to error. Firstly, Rasmussen (Rasmussen J, 1987) conceptualised
error, not in terms of its effects or the setting in which it occurred, but
according to the underlying cognitive processing operating at the same time.
He came up with his famous distinction between skills based errors (which
occur when a person is working under ‘autopilot’), rule based errors (when a
person knowingly or unknowingly violates a rule) and knowledge based errors
(when a person is cognitively overloaded or simply does not have the
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information they need). Clearly these distinctions are crucial when designing
interventions to improve matters. For example, education is not likely to be
effective in preventing skills based errors – on the contrary, such errors are
the result of lapses among highly skilled people. It is worth noting in passing,
that IT (in different forms) has the potential to assist in reducing the incidence
of all of these errors. Computers can issue a warning when a skills based
error is about to be perpetrated, remind people of rules (and even over-rule
clinical actions where an important rule is about to be violated) and produce
knowledge as required.
James Reason took Rasmussen’s context free cognitive model further and
used a diary card method to study errors in ordinary life. He developed the
idea of ‘mental programmes’ that are set in train in the mind. Once one has
operated the wrong ‘programme’ then an error is likely to occur(Reason JT,
1987).
More recently, Wu et al (Wu et al., 1991) transferred some of these ideas into
a clinical context and found that the majority of errors could be classified into 4
main types – not knowing, overload, faulty judgement and hesitation. This is
important, because it includes the simple idea that not having information at
ones fingertips is inimical to safety in some contexts and undermines the
facile dogma that learning ‘facts’ is not important because they can always be
looked up. It is clearly important that healthcare professionals have certain
crucial information in working memory.
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3.2.2. Factors affecting cognition Helmreich (Helmreich, 2000) showed that
doctors, like pilots, systematically underestimate the negative impact of stress
and fatigue on performance. Developing the topic of stress and fatigue,
Friedman (Friedman et al., 1971) showed that compared with staff who were
fresh, interns (young doctors) make twice as many errors in reading the
electrocardiogram after a 24 hour work shift . Bringing this up to the common
day, Lockley et al (Lockley et al., 2004) showed that sleep deprivation causes
young doctors to have greater attention failures on the electro-oculograph,
that is they have what road safety experts sometimes dub ‘mini-sleeps’.
Stress also has an adverse effect on error prone-ness as shown by
Easterbrook back in 1959 (Easterbrook, 1959).
Pillcher and Huffcutt (Pilcher and Huffcutt, 1996) conducted a meta-analysis
of 19 primary studies and showed that performance of sleep deprived people
was 1.37 standard deviations lower than subjects who were not sleep
deprived. Sleep deprivation affects cognitive factors more than motor tasks.
Even so, Grantcharov et al (Grantcharov et al., 2001) found that simulated
performance of complex laparoscopic tasks deteriorated in tired surgeons.
Lastly, Dawson and Reid (Dawson and Reid, 1997) were interested in
determining the way in which both alcohol and fatigue impact on performance
impairment. Forty subjects took part in two counterbalanced experiments. In
the first experiment they were kept awake for 28 hours and in the second they
were made to drink alcohol until their blood-alcohol concentration reached
0.10% and their cognitive psychomotor performance was measured at half-
hourly intervals during both conditions. The study demonstrated that relatively
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moderate levels of fatigue impaired performance to an extent equivalent to
that of moderate alcohol intoxication. Dawson and Reid suggested that the
ability to express the impairment caused by fatigue by equating it with
impairment due to alcohol intoxication could offer a vivid metaphor for policy
makers.
3.2.3 Personality and error. What about the old chestnut of personality and
error / accidents? Not surprisingly most of the literature concentrates on
driving. It has become unfashionable to talk about error prone-ness. Yet,
actuaries are quite happy to load insurance against drivers with a poor
accident record. There are, thus, two separate questions:
1) Is there such a thing as an error accident-prone person?
2) Can we identify such people through personality tests?
The answer to the first question is yes, but the answer to the second is, by
and large, ‘no’ – there have been a number of reviews of this topic, and most
have yielded null or weakly positive results. Nevertheless no discussion of
this topic is complete without mention of the great classic – Shaw and Sichel’s
famous study of the (PUTCO) bus drivers in Johannesburg (Shaw and Sichel,
1971). They confirmed that a history of previous accidents was predictive, not
only of future accidents, but also of the type of accident – e.g., accidents due
to excess speed. They found that close supervision and monitoring of drivers
with prior records did not stop these drivers from having accidents. Shaw and
Sichel are often attributed with showing that selecting drivers based on
personality testing was associated with decreasing accidents, but this cause
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and effect relationship does not stand out clearly from their study, because
measures aimed to exclude drivers with a poor accident record were
introduced over the same time frame as psychological tests. Nevertheless,
this study, which started in 1953, is an undoubted landmark on the topic of
selection based on personality – an issue that remains controversial to this
day.
3.2.4 Clinicians who make errors: the second victim. The psychological
effects on doctors of making a serious error were studied in the above classic
paper (159 citations) by Wu et al(1991). They showed that young doctors
were deeply affected by the errors they made, were more likely to alter their
practice if they assumed personal responsibility (rather than blaming the
system) and that they almost always (95%) discussed the error with a
colleague, but they were seldom explicit about this in their dealings with
patients/families.
3.2.5 Psychology of training. In the next section, we discuss interventions,
including educational interventions, especially those involving training – drill,
simulation and team training. Here we briefly identify some classical work on
the basic psychological principles of training. A great deal of literature on the
science of training has accumulated over the years and it is quite difficult to
single out particular studies. Perhaps the best we can do is refer readers to a
review by Salas and Cannon-Bowers (Salas and Cannon-Bowers, 2001).
(These authors have not only reviewed the literature but they have also
contributed much primary research). In depth observational work, both in the
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field and the laboratory, has resulted in a well-developed theory of training
with a number of practical corollaries. For instance:
1. Simulations should be realistic in the sense that they replicate real life
in the minds of the trainees, not in ‘cold’ objective terms.
2. Trainees should receive immediate feedback on their performance
against predetermined training objectives.
3. Such feedback should be supportive/constructive.
4. Trainees should understand why certain actions are good or bad and
not be drilled like autometers.
The principles of good team work have also been examined by the above
authors and include division of labour by expertise, clear concise
communication, shared situational awareness, a tendency to back up and fill
in where necessary, a sense of shared priorities, conscious integration of new
joining members and both planning and debriefing.
3.3 Organisational theory
Much organisational theory has concentrated on the concept of culture;
‘corporate culture eats corporate structure for lunch’ is a widely quoted
aphorism.
One of the doyennes of this subject is Robert Helmreich. Along with Ashleigh
Merritt he wrote an important book on culture at work in aviation and medicine
(Helmreich, 1998). He introduced the concept of ‘crew resource
management’ and showed that it was important that hierarchies were not too
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rigid – junior staff members should feel able to question the actions of their
seniors, even in an emergency. Bryan Sexton and colleagues (J Bryan
Sexton et al., 2000) showed that pilots and intensive care staff were less
hierarchal in their attitudes than surgeons and that the pilots had the most
realistic views of their own fallibilities.
Lucien Leape reflected these ideas in an important article in the Journal of the
American Medical Association 1994 (Leape, 1994). Like Helmreich, Leape
argued for a change in culture within medicine. He said that instead of a
culture of infallibility and faultless performance, physicians should be helped in
admitting to errors and coping with the emotional impact of harming a patient.
He also made the point that a litigious climate within society reinforces the
unhelpful tendencies of secrecy and blame. It is hard to see how the medical
profession can change its culture in isolation from the broader society of which
it is a part?
A fascinating paper by Pinkus (Pinkus, 2001) took a historical perspective on
willingness to report error. She demonstrated that the problems that Lucian
Leape identified were the result of relatively recent trends and showed that in
the late 19th century there was a tradition of reporting mistakes honestly and
openly, even in medical journals. This was regarded as an educational tool.
It is only more recently that error has ‘gone underground’. So we really do
need to look outside medicine if we want to roll back the `blame culture’.
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Leval and colleagues (Leval, 2000) analysed inter-professional
communication in the operating theatre during complex heart operations in
young children. They found considerable differences between teams and the
results supported the idea that the ability of the surgeon to recover from
difficulties was affected by the quality of interpersonal communication.
One of the best reviews of the subject of organisational culture and the quality
of healthcare was carried out by Davies and colleagues (Davies et al., 2000).
They point out that the notion of culture has deep roots in sociology and
anthropology. One of the points they make is that the more visible artefacts of
culture may be manipulated more easily than the deep-seated beliefs and
values that people hold. This is germane to various questionnaires commonly
used to measure culture – some of these seem rather superficial, and they
may be said to measure climate, rather than the more deep-seated notion of
culture. One of the issues discussed in this paper is the notion of the
managerial culture, and the potential clash with a professional culture. The
other point that is well made is that culture may be rather specific to certain
parts of an organisation. At the other end of the scale, organisations receive
many cultural signals from outside of the organisation – a point stressed in the
preceding paragraph. The authors argue that wholesale organisational
change in culture is probably not achievable – at least in the absence of a
crisis. According to this view, cultural change cannot easily be wrought from
the top down by simple exhortation, no matter what the leadership properties
of the managers. The example of seat belts is often used in this context; the
law requiring the use seat belts drove culture change (Louise Parker personal
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communication). However, this remains a nuanced topic and it may be best
to follow combined – top down and bottom up – approaches. A certain
groundswell of support was necessary before instituting systems of sanction
and reward. After all, the law on seat belts, like as smoking in pubs, followed
many years of proselytising by politicians and others.
The acid test for any measurement of culture / climate is whether it predicts
propensity to make errors – whether it has construct validity. The evidence on
this point was reviewed systematically by Scott and colleagues who found
little evidence on this crucial point. Such evidence as they were able to glean
suggested little correlation between the results of culture surveys and actual
safety of patients (Scott et al., 2003).
De Leval and colleagues (de Leval et al., 2000) drilled down into the culture
on operating theatres in the context of highly skilled and potentially high risk
paediatric heart surgery. They found that ‘team work’ differed quite markedly
from team to team and that effective communication and good working
relationships were associated with more rapid recovery from critical incidents
that occurred during surgical operations.
3.4 Incident Analysis
The analysis of incidents to discover root causes has become a mainstay of
safety practice. It has the advantage that it drills down into organisations,
deflecting blame from front line clinicians, and seeking to strengthen the
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system in which they work. However it should come with a health warning.
Runciman (Runciman et al., 1993) wrote persuasively about the limitations of
using accident investigation/root cause analysis as the central plank of error
improvement initiatives. He pointed out that these strategies are confounded
by distorted memory, poor records of events in real time and the pet theories/
prejudices of investigators. It has been shown that investigators are effected
by hindsight and outcome biases, even when they have been specifically
warned of these dangers (Baron and Hershey, 1988;Fischhoff, 1975). These
findings hark back to the classical work of Sir Frederick Bartlett, who found
that memory is “more reconstructed then reproduced”. Bartlett uses the term
“schemata” to describe the pre-existing framework into which new experience
is mapped (Bartlett, 1932) – cited by Henriksen and Kaplan (Henriksen and
Kaplan, 2003). These mental heuristics can result in flawed analysis that
might result in complex and expensive safeguards which are themselves
prone to failure (Hofer et al., 2000). The AHRQ critical review of safety
literature (Shojania et al., 2001) also emphasises that investigation of single
incidents is not necessarily innocuous and makes it clear that we need to
know much more about the overall effect of root cause analysis in different
contexts. Prospective hazard analysis seeks to develop solutions by taking a
broad view of a topic, assembling evidence and expertise and then modelling
processes imaginatively to discern where they may be most valuable.
Proposed solutions should be tested empirically as we describe in the next
section. Epidemiological studies of many instances may shed more light than
deep analysis of singles cases. The ideal study would contain many
unselected incidents, matched contacts and matched observers and the
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closer we can get to this standard, the more valid the results. Investigation of
single cases of aircraft crashes due to mechanical failure could never have
uncovered the fact that aeroplanes are most vulnerable following, rather than
before, maintenance checks (Reason, 1997). More widely spaced scheduling
of aeroplane maintenance was predicated on these findings.
3.5 The physical environment and safety
The importance of the built environment was brought to wide attention by an
article by Roger Ulrich in Science (Ulrich, 1984) This was a quasi randomised
trial showing that patients who viewed trees during their recovery from a gall
bladder operation made less use of analgesia than those who looked out on
a stark brick wall. Using an experimental design in the current era, Ulrich and
colleagues (Ulrich R.S and Gilpin L, 2003) showed that scenes of nature were
much more calming than urban scenes or no scene at all.
Roger Ulrich has now carried out a detailed systematic review of more than
600 papers examining the effect of the physical environment on safety in
hospitals (Ulrich R and Zimring C, 2004). This study does not comment in
much detail on the methodology of the various studies cited. However, many
of the findings are consistent across studies and we think they have
verisimilitude. For example, an alcohol rub situated next to the patient’s bed
is more effective than additional sinks in prompting staff to wash their hands.
Single bedded rooms appear superior in many respects, including infection,
privacy, reduction in stress and (perhaps counter-intuitively) in enhancing
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social contact; it turns out that visitors stay for longer with patients in single
rooms. One of the quoted studies conducted in bone marrow transplantation
even found a beneficial effect on survival rates. There is a considerable body
of research which has documented the negative effects of noise on patient
outcomes and this is also reduced in single bedded rooms. A consistent
finding between studies is that seascapes and landscapes were much
preferred to abstract art in health-care settings.
4.Interventions
4.1 A systems approach
Reason (Reason, 2000) was one of many people to argue for a systems
approach to error, rather than concentration on the individual. He pointed out
the limitations of reducing error through litigation, exhortation and blame and
even felt that training had a limited role. He argued for the importance of
creating systems with inbuilt defences. A large number of systems based
interventions to improve safety have been studied.
4.2 Information Technology
Prominent among these are interventions concerned with the role of IT. A
classic in this genre is McDonald’s famous New England Journal article
‘Protocol based computer reminders, the quality of care and the non-
perfectability of man’ 1976 (McDonald, 1976), where he showed that
computer prompts could reduce clinical error. A selection of important
subsequent studies are listed in table 3. Most of these studies are case
studies or summaries of case studies. One of the findings from the literature
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on IT solutions is the relatively large effect size typically observed, with 25, 50
or even 80 per cent reductions in error being recorded. Hunt carried out a
systematic review and 43 of the 65 included studies showed improvement in
physician performance (Hunt et al., 1998) with decision support systems of
different sorts. Walton’s (Cochrane) review of drug dosage advice by
computer found a 6% decrease in adverse events due to medication error
(Walton et al., 2001), but the overall decrease in errors was, we suspect,
much greater. Two authoritative systematic reviews have been published
recently on the subject of the effectiveness of clinical decision support
systems (Kawamoto et al., 2005; Garg et al., 2005) but it is too early to see
whether these will be influential in terms of citations.
4.3 Communication and involving patients in their care
It is widely accepted that improved communication can reduce the number of
errors in health care. Braddock and colleagues (Braddock, III et al., 1997)
identified 6 tenets of good communication when decisions must be made and
found that the majority of these were not covered in any one consultation.
There is good randomised trial evidence that involving patients in determining
their own Warfarin dose reduces under and over treatment and that asking
patients (tactfully) to repeat crucial information from the consultation improves
their recall. The papers dealing with these issues are systematically reviewed
in the famous AHRQ review (Shojania et al., 2001).
4.4 Education
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The role of education and training is crucial to the issue of safety and we
summarise some important studies in table 4. These results suggest that
Reason is wrong to downplay education and training – perhaps we should
think of education and drill as a part of the system.
4.5 Organisation of work
In table 5, we start to summarise some high impact studies involving the
organisation of work. There has been a long-standing issue turning on
whether the advantages of a less fatigued medical work force would be more
than offset by the risks inherent in more frequent staff change-overs, given
that discontinuities are also a risk (Petersen et al., 1994) Landrigan and
colleagues’ New England Journal paper (Landrigan et al., 2004) shows that
the net effect is beneficial at least in the context of ITU care. However, the
reductions in working hours were from a base line of 80 hours per week or
more. Since it is reasonable to suppose that the risk of error rises with the
extent of sleep deprivation (see section 3.2.2) there must come to point where
the disadvantages of increased handovers come to exceed the advantages of
further reductions in working hours.
4.6 Engineering solutions
An important and interesting finding emerges in Chapter 26 of the AHRQ
review (Shojania et al., 2001). Physical restraint to prevent falls among
elderly inpatients not only fails to reduce falls, but may increase them along
with the other adverse psychological and physical effects of such restraint.
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4.7 Some interventions often felt to be of particular relevance to
‘safety’
The AHRQ review (Shojania et al., 2001) also systematically examines a large
number of particular treatments or methods which may improve outcome and
safety. These are summaries of health technology assessments, rather than
system wide improvements and therefore we have not included them in our
review of citation classics. Included amongst the topics covered are:
§ the use of ultrasound to insert central venous lines (now increasingly
incorporated into standard practice)
§ the use of antibiotic impregnated central lines, various manoeuvres
(such as upright posture and `ventilator holidays’) to reduce ventilator
acquired pneumonia
§ physical appliances and nursing manoeuvres to reduce the risk of
pressure sores, prophylaxis against stress ulcers for patients in the
Intensive Care Unit
§ beta-blockade for high risk patients having major surgery, prophylactic
antibiotics (single dose) for patients undergoing surgery involving a
contaminated viscous
§ use of supra-pubic catheters to avoid urinary infection, use of maximum
sterile barriers when placing central intravenous catheters
§ the appropriate provision of nutrition (with particular emphasis on early
enteral nutrition) in critically ill surgical patients.
Since the time of the AHRQ report (Shojania et al., 2001) many new
standards could be added. These would include tight glucose control for
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patients in the Intensive Care Unit, the use of anti-factor C in severe sepsis,
avoiding steroids in head injury, but these belong in the general province of
evidence based medicine and technology assessment, rather than the subject
of safety which concerns itself more with ensuring that the service delivers the
right treatment, than in finding out what the right treatment consists should be
5. Conclusion
This bibliography includes a wide variety of papers that we consider to be the
most influential for patient safety practice and research. Whist we have
outlined and critiqued some of these papers in detail, and meta-analytic and
systematic reviews are included amongst the selected articles, it is by no
means a systematic review. Rather we have hand-picked those pieces of
research that we feel have made the greatest contribution to our
understanding of the topic of patient safety – regardless of whether they take
the form of anecdotal evidence, empirical work or comprehensive reviews.
Whilst we have done our best to ensure that all relevant papers have been
included, the selection process was based on personal opinion alone and it is
entirely likely that there will be additional articles that we have overlooked. To
this end we would welcome any feedback alerting us to such work.
Acknowledgement
Firstly, we acknowledge the Chief Medical Officer for England, Professor Sir
Liam Donaldson whose idea this bibliography was. Secondly, for commenting
clarifying and suggesting further work to include we thank: Tim Hofer of Ann
Arbor Michigan, Jane Carthey, Sue Osborne and Susan Williams, of the
National Patient Safety Agency of England and Wales.
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Table 1 Ground breaking papers on the epidemiology of adverse events;
broken down by whether they were attributable to error or other causes
Author Paper Journal
(Brennan et
al., 1991)
Incidence of adverse events and
negligence in hospitalised patients:
results of the Harvard Medical
Practice Study
N Engl J Med 1991
(Leape et al.,
1991)
The nature of adverse events in
hospitalised patients: results of the
Harvard Medical Practice Study
N Engl J Med 1991
(Wilson et al.,
1995)
The quality in Australian Health
Care Study Med J Aust 1995
(Vincent et
al., 2001)
Adverse events in British hospitals:
preliminary retrospective record
review
BMJ 2001
(Davis et al.,
2002)
Adverse events in New Zealand
public hospitals I: occurrence and
impact
N Z Med J 2002
(Davis et al.,
2003)
Adverse events in New Zealand
public hospitals II: preventability
and clinical context
N Z Med J 2003
(Baker et al.,
2004)
The Canadian Adverse Events
Study: the incidence of adverse
events among hospital patients in
Canada
CMAJ 2004
(Schioler et
al., 2001)
Danish Adverse Events Study.
Incidence of adverse events in
hospitals: a retrospective study of
medical records
Ugerskr Laeger 2001
(Gawande et
al., 1999) The incidence and nature of
surgical adverse events in
Colorado and Utah in 1992
Surgery 1999
JTS patient safety bibliography 02.09.05
24
Table 2 Basic Science: Human Factors and Cognition
Author Journal/Date Message
Rasmussen In: New technology and
human error 1987. John
Wiley
Psychological control
and human error/skill-
based, rule-based and
knowledge based errors
Reason In: New technology and
human error 1987. John
Wiley
Context free model
relating cognitive
limitations to error: skills
and lapses; rule based
and knowledge based
Wu et al, 2003 Qual and Safety in H
care, 2003 Deconstructs medical
errors into 4 main types:
1) not knowing
2) overload
3) faulty judgement
4) hesitation
Helmreich R L BMJ 2000 Doctors, like pilots,
underestimate the
negative impact of
stress and fatigue
Friedman et al N Eng J Med 1971 Interns make twice as
many errors in reading
ECGs after a 24 hour
shift
Lockley et al N Eng J Med 2004 Sleep deprivation
causes young doctors to
have greater attentional
failures on the electro-
oculograph
Easterbrook J Psychological reviews
1959 Stress reduces the
ability to respond in an
emergency
JTS patient safety bibliography 02.09.05
25
Table 3 Role of IT in improvement
Author Journal/Date Design Finding
Bates (Bates et
al., 1998) JAMA Summary case
studies 5.5% decrease in
non-intercepted
serious
medication errors
(p=0.01)
Nightingale et al
(Nightingale et
al., 2000)
BMJ 2000 Case study Computer based
decision support
results in large
reductions in
prescribing error
Overhage et al
(Overhage et al.,
1997)
J Am Med Inform
Assoc RCT with
physicians
randomised to
receive reminders
or not
25%
improvement in
ordering
medications
(p = 0.0001)
Bates et al
(Bates et al.,
1999)
J A Med Inform
Assoc Time series 8 % decrease in
medication error
(p<0.0001)
JTS patient safety bibliography 02.09.05
26
Table 4 Role of Education and Training in Improvement
Authors Journal/Date Design Finding
Espinosa and
Nolan(Espinosa
and Nolan, 2000)
BMJ 2000 Longitudinal
study Reduced errors
by training staff to
read radiographs
JTS patient safety bibliography 02.09.05
27
Table 5 Role of organisation of work in improving safety
Authors Journal/date Design Finding
Landrigan et al
New Eng J Med
2004 RCT to standard
or reduces
waiting times
Junior doctors
when working
longer shifts,
made 36% more
serious medical
errors and 57%
more non-
intercepted
errors. Five times
more diagnostic
errors and 20%
more medication
errors
Oren et al(Oren
et al., 2003) Am J Health-Syst
Pharm 2003 Systematic
review building a
AHRQ review
Computerised
physician order
with decision
support reduces
error – large
effect sites in
before/after
studies. Bar
coding reduces
administration
error.
JTS patient safety bibliography 02.09.05
28
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Appendix 1: Chart showing Web of Science citation counts and average
citation counts per year
Principal Author
Title
Year
Publication
Web of Science citations (16/08/05)
Average citations per year
Brennan,TA
Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I
1991 N.Engl.J.Med., v. 324, p. 370-376 890 64
Leape,LL
The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II
1991 N.Engl.J.Med., v. 324, p. 377-384 715 51
Bates,DW
Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group
1995 JAMA, v. 274, p. 29-34. 630 63
Leape,LL Error in medicine 1994 JAMA, v. 272, p. 1851-1857 563 51
Fischhoff,B
Hindsight not equal to foresight: the effect of outcome knowledge on judgment under uncertainty
1975
J Exp Psychol: Hum Percept Perform, v. 1, p. 288-299.
559 19
McDonald,CJ
Protocol-based computer reminders, the quality of care and the non-perfectability of man
1976 N.Engl.J.Med., v. 295, p. 1351-1355 398 14
Bates,DW
Effect of computerized physician order entry and a team intervention on prevention of serious medication errors
1998 JAMA, v. 280, p. 1311-1316 364 52
Wilson,RM The Quality in Australian Health Care Study 1995 Med.J.Aust., v. 163, p. 458-471 325 33
Hunt,DL
Effects of computer-based clinical decision support systems on physician performance and patient outcomes: a systematic review
1998 JAMA, v. 280, p. 1339-1346 316 45
Reason,J Human error: models and management 2000 BMJ, v. 320, p. 768-770 201 40
Ulrich,RS View through a window may influence recovery from surgery 1984 Science, v. 224, p. 420-421 190 9
Friedman,RC The intern and sleep loss 1971 N.Engl.J.Med., v. 285, p. 201-203 177 5
Bates,DW
The impact of computerized physician order entry on medication error prevention
1999 J.Am.Med.Inform.Assoc., v. 6, p. 313-321 161 27
Wu,AW Do house officers learn from their mistakes? 1991 JAMA, v.265, p2089-2094 159 11
Pilcher,JJ Effects of sleep deprivation on performance: a meta-analysis 1996 Sleep, v. 19, p. 318-326 152 17
Vincent,C Adverse events in British hospitals: preliminary retrospective record review 2001 BMJ, v. 322, p. 517-519 132 33
Mant,J
Detecting differences in quality of care: the sensitivity of measures of process and outcome in treating acute myocardial infarction
1995 BMJ, v. 311, p. 793-796 116 12
Donchin,Y A look into the nature and causes of human errors in the intensive care unit 1995 Crit Care Med., v. 23, p. 294-300 114 11
Sexton,JB Error, stress, and teamwork in medicine and aviation: cross sectional surveys 2000 BMJ, v. 320, p. 745-749 113 23
Petersen,LA
Does housestaff discontinuity of care increase the risk for preventable adverse events?
1994 Ann.Intern.Med., v. 121, p. 866-872 106 10
Runciman,WB
The Australian Incident Monitoring Study. Errors, incidents and accidents in anaesthetic practice
1993 Anaesth.Intensive Care, v. 21, p. 506-519 103 9
Hayward,RA
Estimating hospital deaths due to medical errors: preventability is in the eye of the reviewer
2001 JAMA, v. 286, p. 415-420. 100 25
Helmreich,RL On error management: lessons from aviation 2000 BMJ, v. 320, p. 781-785 100 20
Baron,J Outcome bias in decision evaluation 1988 J.Pers.Soc.Psychol., v. 54, p. 569-579 98 6
O'Neil,AC
Physician reporting compared with medical-record review to identify adverse medical events
1993 Ann.Intern.Med., v. 119, p. 370-376 97 8
Dawson,D Fatigue, alcohol and performance impairment 1997 Nature, v. 388, p. 235 91 11
Overhage,JM A randomized trial of "corollary orders" to prevent errors of omission 1997 J.Am.Med.Inform.Assoc., v. 4, p. 364-375 80 10
Barach,P
Reporting and preventing medical mishaps: lessons from non-medical near miss reporting systems
2000 BMJ, v. 320, p. 759-763. 77 15
Gawande,AA
The incidence and nature of surgical adverse events in Colorado and Utah in 1992
1999 Surgery, v. 126, p. 66-75 62 10
Braddock,CH
How doctors and patients discuss routine clinical decisions. Informed decision making in the outpatient setting
1997 J.Gen.Intern.Med., v. 12, p. 339-345 60 8
Nightingale,PG
Implementation of rules based computerised bedside prescribing and administration: intervention study
2000 BMJ, v. 320, p. 750-753 44 9
Davies,HT Organisational culture and quality of health care 2000 Qual.Health Care, v. 9, p. 111-119 43 9
Gallagher,TH Patients' and physicians' attitudes regarding the disclosure of medical errors 2003 JAMA, v. 289, p. 1001-1007 38 19
Espinosa,JA
Reducing errors made by emergency physicians in interpreting radiographs: longitudinal study
2000 BMJ, v. 320, p. 737-740 36 7
de Leval,MR Human factors and cardiac surgery: a multicenter study 2000 J.Thorac.Cardiovasc.Surg., v. 119, p. 661-672 35 7
Baker,GR
The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada
2004 CMAJ., v. 170, p. 1678-1686 30 30
Landrigan,CP
Effect of reducing interns' work hours on serious medical errors in intensive care units
2004 N.Engl.J.Med., v. 351, p. 1838-1848 29 29
Salas,E The science of training: a decade of progress 2001 Annu.Rev.Psychol., v. 52, p. 471-499 29 7
Grantcharov,TP
Laparoscopic performance after one night on call in a surgical department: prospective study
2001 BMJ, v. 323, p. 1222-1223 27 7
Lockley,SW Effect of reducing interns' weekly work hours on sleep and attentional failures 2004 N.Engl.J.Med., v. 351, p. 1829-1837 22 22
Thomas,EJ Measuring errors and adverse events in health care 2003 J.Gen.Intern.Med., v. 18, p. 61-67 15 8
Lilford,R
Use and misuse of process and outcome data in managing performance of acute medical care: avoiding institutional stigma
2004 Lancet, v. 363, p. 1147-1154 13 13
Oren,E
Impact of emerging technologies on medication errors and adverse drug events
2003 Am.J.Health Syst.Pharm., v. 60, p. 1447-1458 7 4
Garg,AX
Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review
2005 JAMA, v. 293, p. 1223-1238. 5
Pinkus,RL Mistakes as a social construct: an historical approach 2001 Kennedy.Inst.Ethics J., v. 11, p. 117-133 3 1
Kawamoto,K
Improving clinical practice using clinical decision support systems: a systematic review of trials to identify features critical to success
2005 BMJ, v. 330, p. 765. 2
Lilford,RJ The measurement of active errors: methodological issues 2003 Qual.Saf Health Care, v. 12 Suppl 2, p. ii8-12 0 0
Henriksen,K Hindsight bias, outcome knowledge and adaptive learning 2003 Qual.Saf Health Care, v. 12 Suppl 2, p. ii46-ii50 0 0
Helmreich,RL
Culture at work in aviation and medicine: national, organizational, and professional influences:
1998
Culture at work in aviation and medicine: national, organizational, and professional influences: Aldershot; Brookfield, Vt., USA: Ashgate
Raju,TN Ignac Semmelweis and the etiology of fetal and neonatal sepsis 1999 J.Perinatol., v. 19, p. 307-310.
Shojania,KG Making health care safer: a critical analysis of patient safety practices 2001
Evid.Rep.Technol.Asssess.(Summ.) Commissioned by the Agency for Healthcare Research and Quality
Edwards A
Inter-rater reliability measurements in the quality of medical care: a systematic review
2004 Ref Type: Unpublished Work
Rasmussen J The definition of human error and a taxonomy for technical system design. 1987
In Rasmussen J, Duncan K , Leplat J, eds.New techology and human error, London: John Wiley
Reason JT
Generic error-modelling system (GEMS): A cognitive framework for locating common human error form.
1987
In Rasmussen J, Duncan K , Leplat J, eds.New techology and human error, London: John Wiley.
Easterbrook,JA The effect of emotion on cue utilization and the organization of behavior 1959 Psychol.Rev., v. 66, p. 183-201
Shaw,L Accident Proneness, New York 1971 Accident Proneness, New York
Department of Health
Guidelines for Assessing Avoidable Factors, Missed Opportunities and Sub-Standard Care in Confidential Enquiries into Maternal Deaths.
2004 Ref Type: Electronic Citation
Scott,T
Does organisational culture influence health care performance? A review of the evidence
2003 Journal of Service Research and Policy, v. 8, p. 105-117
Bartlett,FC Remembering: an experimental and social study 1932
Remembering: an experimental and social study: Cambridge: Cambridge University Press
Hofer,TP What is an error? 2000 Eff.Clin.Pract., v. 3, p. 261-269
Ulrich, RS Healing arts: Nutrition for the soul 2003
In S.B Frampton, L.Gilpin, and P.Charmel (eds), Putting patients first: Designing and practicing patient-centred care: San Francisco, Jossey-Bass, p. 117-146.
Ulrich R
The Role of the Physical Evironment in the Hospital of the 21st Century: A Once-in-a-Lifetime Opportunity. Report to Tenter for Health Design for the Designing the 21st Century Hospital Project.
2004
Ref type: Report: www.rwjf.org/publications/publicationsPdfs/Role%20of%20the%20Physical%20Environment.pdf. 2004
JTS patient safety bibliography 02.09.05
34
Appendix 2: Correlations between different citation counters
We did an initial citation count using the ISI Web of Science and used this to
put the papers in rank order (see Appendix 1). We then repeated this exercise
using Google Scholar and Scopus, which produced many discrepancies
between the citation counts. In order to produce an accurate correlation, we
removed any of the papers where one or more of the citation counts was not
available. We also removed the paper by Reason, Human Error: Models and
Management, as the citation counts for this paper on Google Scholar were
over five times the values obtained from the other citation counters so this
seemed inaccurate. The graph produced is shown below:
Fig 2. Web of Science, Google Scholar and Scopus citation counts for papers with all three
values
0
100
200
300
400
500
600
700
800
900
Brennan,TA
Bates,DW
McDonald,CJ
Wilson,RM
Ulrich,RS
Bates,DW
Pilcher,JJ
Mant,J
Sexton,JB
Runciman,WB
Helmreich,RL
O'Neil,AC
Overhage,JM
Gawande,AA
Nightingale,PG
de Leval,MR
Salas,E
Grantcharov,TP
Lilford,R
Garg,AX
Lilford,RJ
Authors
Citation Counts
WoS Citations (16/08/05)
GS citations (23/08/05)
Scopus citations (24/08/05)
Correlations between the three citation counters seemed quite close, so we
calculated the Pearson Product Moment Correlation Coefficient (PPMC) for
the three sets of values:
PPMC for Web of Science and Google Scholar = 0.937100159
PPMC for Web of Science and Scopus = 0.960819415
PPMC For Google Scholar and Scopus = 0.951916328
All of these show a very strong correlation between the sets of values
obtained, indicating that although there may be discrepancies between
individual paper citation counts, the rank order for all three citation counters is
very similar.
