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An Emerging Science of Improvement in Health
Care
ARTICLE in QUALITY ENGINEERING Ā· JANUARY 2015
Impact Factor: 0.36 Ā· DOI: 10.1080/08982112.2015.968042
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An Emerging Science of Improvement in Health Care
Bo Bergman
ab
, Andreas Hellstrƶm
a
, Svante Lifvergren
ac
& Susanne M. Gustavsson
ac
a
Centre for Healthcare Improvement, Chalmers University of Technology, Gothenburg,
Sweden
b
Meij i University, Tokyo, Japan
c
Skaraborg Hospital Group, VƤstra Gƶtaland Region, Sweden
Published online: 21 Dec 2014.
To cite this article: Bo Bergman, Andreas Hellstrƶm, Svante Lifvergren & Susanne M. Gustavsson (2015) An Emerging Science
of Improvement in Health Care, Quality Engineering, 27:1, 17-34, DOI: 10.1080/ 08982112.2015.968042
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An Emerging Science of Improvement in
Health Care
Bo Bergman 1, 2
,
Andreas Hellstrā‚¬
om 1
,
Svante Lifvergren 1, 3
,
Susanne M. Gustavsson 1, 3
1
Centre for Healthcare
Improvement, Chalmers
University of Technology,
Gothenburg, Sweden
2
Meiji University, Tokyo, Japan
3
Skaraborg Hospital Group,
Vā‚¬
astra Gā‚¬
otaland Region, Sweden
ABSTRACT The purpose of this article is to describe the emerging science of
improvement in health care and to add a perspective from the industrial quality
improvement movement, the use of data from quality registers, and to give
some personal reļ¬‚ections and suggestions. Furthermore, we want to introduce
to the broader quality management community what is happening in health
care with respect to quality improvement. We will discuss some of the
challenges of the health care system and the current status of a science of
improvement and give some suggestions for further improvements to the area.
We discuss a possible extension of improvement knowledge and the
theoretical and practical arsenal of a science of improvement, in particular,
understanding variation and implications for the use of, for, example control
charts. In addition, the normative side of a science of improvement is
discussed. The article ends with some brief reļ¬‚ections of use for future research
agendas.
KEYWORDS health care, quality improvement, improvement science, science of
improvement, profound knowledge
INTRODUCTION
Health care is increasingly facing a lot of challenges. The demands are
increasing and reports about health care shortcomings have become increas-
ingly common. Thus, there is a need to introduce new ways of working. Health
care of today is said to be evidence driven with high requirements for data from
randomized controlled trials and from careful observational studies. However,
even though huge amounts of data are collected in quality registers and by other
means, clinical practice is often not governed utilizing these data for learning,
improvement, and innovation. Thus, even though individual health care work-
ers are providing excellent and dedicated work, the health care system might be
ļ¬‚awed and patient outcome might be less than optimal, perhaps unsatisfactory,
or even unacceptable without anybody noticing it, more than individual
patients.
During the last decades there has been a movement toward a view that clinics
and health care systems should not only have a systematic way of improving
This article was presented at the
Second Stu Hunter Research
Conference in Tempe, Arizona,
March 2014.
Address correspondence to Bo
Bergman, Chalmers University of
Technology, Gothenburg SE-412 96,
Sweden. E-mail: boberg@chalmers.se
Color versions of one or more of the
figures in the article can be found
online at www.tandfonline.com/lqen.
17
Quality Engineering, 27:17ā€“34, 2015
Copyright Ɠ Taylor & Francis Group, LLC
ISSN: 0898-2112 print / 1532-4222 online
DOI: 10.1080/08982112.2015.968042
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medical treatment and nursing utilizing evidence from
research but also have a systematic way of improving
how health care is delivered to the patientsā€”how the
health care system supports its patients to better health
without risking any harm. An attempt to provide a
basis for such initiatives is called improvement science or
a science1
of improvement. The purpose of this article
is to describe this emerging ļ¬eld and to add a perspec-
tive from the industrial quality improvement move-
ment, the use of data from quality registers, and to give
some reļ¬‚ections and suggestions. In this introductory
section we will ļ¬rst discuss some challenges of the
health care system and give a short outline of the rest
of the article where the current status of a science of
improvement is discussed as well as some suggestions
for further developments of the area.
The increasing demand on the health care system is
due to, ļ¬rst, the growing population of elderly people
suffering from multiple diseases. At the same time, the
productive part of the population has become rela-
tively smaller and therefore health care funding may be
jeopardized (Weisz et al. 2013). A second reason is the
appearance of new and much improved possibilities to
give life supporting cure and care. Some of these possi-
bilities are very costly, and even if many may indeed
reduce the total costs to society, the cost reductions do
not always beneļ¬t those that have the cost burdens
from new treatments. Systems handling this unbalance
are not common. Furthermore, the rate of innovations
in health care is increasingā€”it has been argued (Dixon-
Woods, Alamberti et al. 2011; Sjohania et al. 2007)
that the half-life of knowledge is 5.5 years. A third
argument is an increased focus on health and well-
being in the populationā€”how does the health care sys-
tem in a productive way take care of an increased health
literacy and requirements on patient autonomy and
patient empowerment? (Anderson and Funnell 2005;
Reach 2014).
Another kind of challenge is the stream of reports on
the shortcomings of health care systems. In the UK, for
example, the Bristol heart scandal (Weick and Sutcliff
2001) at the Bristol Royal Inļ¬rmary a number of years
ago revealed unacceptable shortcomings and later the
Mid Staffordshire scandal attracted a lot of attention,
with many investigations and government reportsā€”
similar shortcomings were reported in these inquiries:
No clear visions and goals, no culture of patient cen-
teredness, boards and top management not taking the
lead on these questions, insufļ¬cient feedback loops on
what is really going on in the organization with respect
to quality and safety, etc. In a recent study (Dixon-
Woods et al. 2014) of the National Health Service
(NHS) many good things were reported, speciļ¬cally
the ambitions and goodwill of the health care profes-
sionals to provide good care; on the negative side, how-
ever, it reported that the above-mentioned
shortcomings might be more widespread than so far
revealed. We will return to this study later.
It is not only in the UK that these types of problems
are frequent. In Swedish newspapers we read almost
every day about mistreatments, long waiting times, and
scarcity of personnel. Just to mention one recent story
revealed by a Swedish TV program, the deteriorating
screening procedures of cervix cancer samples may
have caused malign tissue samples to remain undiscov-
ered. Even though results were fed into a database,
there was no feedback to the person performing the
screening. In all work correct feedback is impor-
tantā€”without correct feedback any work process may
deteriorate.
The high cost of the U.S. health care system2
is, of
course, also well known. For example, the U.S. health
care expenditure in relation to the gross national prod-
uct is almost double that of Sweden and the medical
results are not better; in many respects, in fact, they are
much worse. Furthermore, in a recent paper (James
2013) it was reported that as many as 200,000 and per-
haps even 400,000 deaths per year in the United States
may be caused by avoidable harm.
Of course, there are no silver bullets to solve these
problems (Shojania and Grimshaw 2004). However, as
one part of a solution, a focus on quality and quality
improvement seems necessary. As illustrated by the
study of the NHS, a mindset, close to what in indus-
trial settings has been known as total quality management
(Bergman and Klefsjā‚¬
o 2010), should be strived forā€”
perhaps a new management paradigm in health care. In
this direction we ļ¬nd the emerging science of improve-
ment in health care.
In this article, we will ļ¬rst discuss the ļ¬ndings of
the NHS study mentioned above and relate these to
1
The concept science might be considered problematic; see, for
example, Wilmott (1997).
2
Based on Oganization for Economic Cooperation and
Development data comparisons between the cost and medical
outcomes were compared in a report from Swedish Association of
Local Authorities and Regions (SALAR).
18 B. Bergman et al.
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the early discussions on quality in health care by Ernest
Amory Codman3
and Avedis Donabedian (1992,
2002)4
but also to the early discourse on quality
improvement in industry. Based on these discussions
we will inquire into the scope of a science of improve-
ment. During the course of the article we will come
back to the NHS study mentioned above for illustra-
tive purposes. Illustrations from the Swedish health
care will also be used. As part of a brief review, some
earlier discussions on the emerging science of improve-
ment will be given. Then, in the main part of the arti-
cle, the core of a science of improvement will be
discussed. It should, however, be emphasized that a sci-
ence of improvement in health care really is in a prepar-
adigmatic stage, to use the words of Kuhn (1962). Thus,
many interpretations and outlines have been given, per-
haps under different headings, and probably many
more will comeā€”and should come. Indeed, this article
will give our interpretations and suggestions, which
might go further in scope than many other alternatives.
A science of improvement must, of course, address
how improvement issues are identiļ¬ed and elaborated
upon, eventually leading to successful interventions
with even better outcomes for the patients. It must also
address how these improvements are evaluated and
how lessons are learned from them. But it is equally
important to foster an environment where improve-
ments are seen as normal and inspiring parts of the
daily life in an organization. This environment is a piv-
otal requirement for a transformed health care system.
How is that achieved? These latter questions are much
harder and more pressing than the operating work with
improvements themselves, however important they
are. Of course, these aspectsā€”that is, the operational
improvement interventions and the improvement of
the organizationā€™s readiness (capability and capacity) to
improve and innovateā€”should go hand in hand, and
no simple recipe can be expected.
THE SCOPE OF A SCIENCE OF
IMPROVEMENT
The NHS study mentioned above was a multime-
thod study of the NHS during the years 2010ā€“2012
with interviews, surveys, board protocols, and direct
observations together with data from 2007 to 2011 on
staff experiences, patient experiences, and patient mor-
tality rates. A large number of ļ¬ndings in this study
corroborate our view of what is important in a science
of improvement. Some ļ¬ndings were highly encourag-
ing; for example, a consistent focus from front line
people to do their best for their patients to create the
best possible care.
However, in some organizations there were no clear
goals, no vision, and no culture for continually reļ¬ning
patient quality and safety. In such organizations the
front line staff observed severe system deļ¬ciencies but
felt powerless to deal with them, whereas management
perceived problems with quality and safety as caused
by the front line people. That is, the staff and the man-
agement had no common understanding about how to
solve their problems and to improve patient quality
and safety. In addition, there was a lack of intelligen-
ceā€”that is, poor follow-up of both their own results
and results from similar unitsā€”in order to ļ¬nd
improvement opportunities. Interestingly, the research-
ers were able to observe that
. . . hospital standardised mortality ratios were inversely asso-
ciated with positive and supportive organisational climates.
Higher levels of staff engagement and health and wellbeing
were associated with lower levels of mortality, as were staff
reporting support from line managers, well structured apprais-
als (e.g., agreeing objectives, ensuring the individual feels val-
ued, respected and supported), and opportunities to
inļ¬‚uence and contribute to improvements at work. NSS
[NHS Staff Survey] data also showed that staff perceptions
of the supportiveness of their immediate managers, the extent
of staff positive feeling, staff satisfaction and staff commit-
ment were associated with other important outcomes, including
patient satisfaction. (Dixon-Woods et al. 2014, p. 112)
Let us compare these results with the simpliļ¬ed
model of health care that was suggested by Avedis
Donabedian, who observed that health care (1) out-
comes are produced in (2) processes that are imbedded
in systems and their (3) structures. According to Dona-
bedian (2003), ā€œstructureā€ is meant ā€œto design the con-
ditions under which care is providedā€ (p. 46).
Examples include material and human resources, the
presence of teaching and research, performance
reviews, etc. In our interpretation aspects like gover-
nance, leadership, learning mechanisms, organizational
climate, organizational design, intelligence, attractors,
incentives, norms, values, and similar ā€œsoftā€ issues
should be included. Process signiļ¬es ā€œthe activities that
constitute health care ā€“ including diagnosis, treatment,
3
For a short biography of Codman, see Neuhauser (2002).
4
For a short biography about Donabedian, see Best and Neuhauser
(2004).
Improvement in Health Care 19
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prevention, and patient education. . . .ā€ (Bergman et al.
2011, p. 41). Finally, outcome measures are the resulting
states from care processes, both technical (for instance,
absence of complications) and interpersonal outcomes
(for instance, patient satisfaction).
However, we also want to add how individuals in
the organization would react to different change inter-
ventions; that is, individual predispositions.5
It should
also be noted that we interpret the concept structure
rather freely, not as it is often interpreted as something
that is but rather as something that is in a constant
becoming and ļ¬‚ux; see, for example, Sztompka (1991).
Indeed, this view on structure is pivotal to our view on
the health care system.6
With a serious ambition to improve outcome for
patientsā€”that is, quality and safetyā€”a science of
improvement has to address improvements on all levels
of the Donabedian model. It is not enough to make
improvements on the process level only. In addition,
soft aspects of the environment of the process (and its
microsystems) have to be addressed: How is the climate
for change generally and how are the individualsā€™ pre-
dispositions for change? How is patient centeredness
supported? How is intrinsic motivation of the staff sup-
ported? What are the norms and values? How is reļ¬‚ec-
tion and learning supported? It is only at such levels
that we can assure some sort of long-term survivability
of improvement efforts, see e.g. Docherty et al. (2003)
and Docherty and Shani (2008).
From this discussion, the following deļ¬nition of
quality improvement suggested by Batalden and
Davidoff (2007, p. 2) is adequate; that is, quality
improvement is seen
. . . as the combined and unceasing efforts of everyo-
neā€”health care professionals, patients and their families,
researchers, payers, planners and educatorsā€”to make the
changes that will lead to better patient outcomes (health),
better system performance (care) and better professional
development (learning).
When talking about system performance in the
above deļ¬nition we should also include the predisposi-
tions for change (or readiness for change) of the
individuals within the organization. Depending on
past experiences, these predispositions could look very
different in different organizations. The organizationā€™s
drive for change (i.e., improvements including innova-
tions) should be a very important target of improve-
ment efforts.
A SCIENCE OF IMPROVEMENT: A
BRIEF REVIEW
An important starting point of the quality move-
ment was the seminal books by Shewhart (1931, 1939);
Shewhart was very much inļ¬‚uenced by pragmatic phi-
losophy (Lewis 1929), eventually leading to the much
used Plan-Do-Study-Act (PDSA) cycle and his thoughts
about predictability and corresponding criteria have
been central. Later, the experiences from the Japanese
wonder and the reawakening (Cole 1999) of the Ameri-
can industry were important. In health care, Ernest
Amory Codman was already a pioneer in advocating
the reporting of failures in order to encourage improve-
ment before WWI. Later, after WWII, Avedis Donabe-
dian developed the model referred to previously.
However, inspiration from the industrial quality move-
ment hit health care in the 1980s, ļ¬rst with quality
circles and later in a much broader scope; see, for exam-
ple, Berwick (1989), Berwick et al. (1990), and Batalden
and Stoltz (1993). In the late 1980s, the Institute of
Healthcare Improvement was founded by Don Berwick
and a number of his colleagues. Many more initiatives
started in the beginning of the 1990s.
Some important milestones were the roundtable
around quality that was arranged by the Institute of Med-
icine; see Chassin and Garvin (1998) and the subsequent
publications To Err Is Human: Building a Safer Health Sys-
tem (Institute of Medicine 1999) and Crossing the Quality
Chasm: A New Health System for the 21st Century (Institute
of Medicine 2001). These publications have had a great
impact; for example, in Sweden they changed the ear-
lier dominant punitive7
view on health care errors and
quality dimensions of health care were identiļ¬ed as
those suggested by the Institute of Medicine (Swedish
National Board of Health and Welfare 2006).
In Sweden, Mā‚¬
olndals Hospital (Alā‚¬
ange and Steiber
2011) was a forerunner focusing on quality improve-
ment of its processes; a clinic at Linkā‚¬
oping University
5
Individual predispositions were suggested by Walker et al. (2007)
as an important factor for the effect of change interventions in an
organization; see also Moore and Buchanan (2013).
6
In the language of researchers on change we have a process view;
see, for example, Pettigrew (1987) and Walker et al. (2007).
However, here we have a somewhat conflicting usage of the word
process; thus, we keep the concept structure and interpret it in a
more open way than it its often done in social sciences.
7
Of course, there were also earlier many proponents for a
nonpunitive view on health care errors, but these views had not
reached the governments, legislation, and media.
20 B. Bergman et al.
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Hospital (Bergman and Klefsjā‚¬
o 2010) was one of the
ļ¬rst organizations, in competition with many otherwise
successful manufacturing companies, to win the Swed-
ish Quality Award; and in Jā‚¬
onkā‚¬
oping County they ini-
tiated a journey on quality improvement that is still
going on (Andersson-Gā‚¬
are and Neuhauser 2007).
Deming (1994) identiļ¬ed that for leaders to work
ļ¬rmly in what he called the ā€œNew Economyā€ they have
to have some understanding of a number of important
interrelated knowledge areas. He emphasized ā€œa system
of profound knowledgeā€ and ā€œappreciation for a sys-
tem; knowledge about variation; theory of knowledge;
psychologyā€ (p. 96). These knowledge areas and their
extensions will be discussed more in the next section.
Here we only mention that these areas were introduced
to the health care community in a paper by Batalden
and Stoltz (1993) under the concept improvement knowl-
edge; see Figure 1. In a seminal book (Langley et al.
1996) on health care improvement the name improve-
ment science seems to have been introduced for the ļ¬rst
time (Perla et al. 2013; see also Berwick 2008).
They also suggested, as illustrated in Figure 2, how
improvement of performance as experienced by
patients (3) is achieved by the application of generaliz-
able scientiļ¬c knowledge (1) to the special context
based on careful planning (4) and then a careful execu-
tion of the plan (5).
In Batalden and Stoltzā€™s approach, eight domains of
interest with associated tools and methods are of
importance. These domains are health care as processes
within systems; variation and measurement; customer/
beneļ¬ciary knowledge; leading, following, and making
changes; collaboration; social context and
accountability; and developing new knowledge. They
are similar to but formulated differently than the prin-
ciples for organizing we present in the section The Nor-
mative Side of a Science of Improvement. In Sweden,
professional societies (nurses, doctors, nutritionists,
physiotherapists, work therapists, etc.) have joined
forces to create a common ground for professional edu-
cation on improvement knowledge.
During April 12ā€“16, 2010, a colloquium8
on the
epistemology of improving quality convened at Clive-
den (see, e.g., Batalden et al. 2011). One important
outcome of this colloquium was the awareness and
importance of taking many different perspectives on
quality improvement in health care and to base training
programs on multiple epistemologies informing health
care improvement. Not only does traditional evidence-
based medicine, resting on a natural science founda-
tion, have to be called upon but also social science and
deeper understandings of social change processes.
Recently, Perla et al. (2013) suggested some theoreti-
cal and philosophical foundations on which ā€œthe sci-
ence of improvementā€ rests. For example, learning and
the development of actionable knowledge is stressed
and they refer back to philosophical pragmatism, espe-
cially that of Lewis (1929) and his conceptualistic
pragmatism and subsequent interpretations and transla-
tions of Shewhart and Deming.
Concerns that improvement efforts too often are
lacking in a thorough scientiļ¬c basis has been aired by,
for example, Marshall (2011) and Marshall et al.
(2013). There is also a tendency that too much focus
has been on implementation of solutions and on oper-
ational process improvement rather than on improve-
ment and innovation of the health care system itself;
that is, improvement of the organizational abilities and
transformational changes of the health care system.
Another striking observation is the relative lack of a
patientā€™s perspective. Not that the patient is forgotten,
but quite a lot of the literature is more operations
focused than really patient focused. Works on the
patient perspective (Bergman et al. 2011), patient
empowerment (for a review, see Aujoulat et al. 2007),
patient involvement in health care design and improve-
ment (Bate and Robert 2006; Gustavsson 2013) should,
we think, be much more in focus.
FIGURE 1 This figure is an enhanced version of the illustra-
tion by Batalden and Stoltz (1993). It illustrates how improvement
knowledge should be integrated with professional knowledge
for the improvement of outcomes.
8
The Vin McLoughlin Colloquium on the Epistemology of
Improving Quality, resulting in 23 papers downloadable from
http://qualitysafety.bmj.com/content/20/Suppl_1/i99.full.html#ref-
list-1
Improvement in Health Care 21
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It is quite natural for an emerging ļ¬eld that its theo-
ries are discussed quite extensively and also that results
close to the very aim of the ļ¬eld are discussed. Educa-
tional aspects are, of course, also very important. What
would be needed, though, are more empirical papers
contributing to our understanding of how an organiza-
tionā€™s capability and capacity9
for improvement and
innovation are enhanced.10
The NHS study described
earlier is a good illustration. A Ph.D. thesis on a similar
theme but limited to one hospital group including the
surrounding municipalities and the primary care cen-
ters has been presented by Lifvergren (2013).
IMPROVEMENT KNOWLEDGE
As emphasized in Figure 1 based on Demingā€™s ā€œpro-
found knowledge,ā€ improvement knowledge takes a
central position in most descriptions of a science of
improvement. However, the different knowledge
domains have deepened since the days of Deming and
the need to broaden these areas has become obvious.
In the following we will discuss each one of the basic
knowledge domains separately, emphasizing their deep-
ening and possible ways to extend them. However, we
will leave most of the ā€œunderstanding variationā€
domain until the next section.
Appreciation for a System
Some basic features of the understanding that
Deming drew onā€”for example the insight that enlarg-
ing the system boundary may give opportunities to bet-
ter solutions to pressing issuesā€”are still important and,
unfortunately, in these respects health care still has a
lot to do to integrate their different parts as well as to
integrate with other organizations outside health care
for the beneļ¬t of their patients (see the section
Understanding Variation). This is also an important
part of what Deming called winā€“win solutions.
However, our understanding of systems has
increased substantially since the days of Deming. The
theories of complexity (see, for example, Waldrop
[1992] and Stacey [2003]) and complex systems had
just started in the beginning of the 1990s. Recent
knowledge from complex adaptive systems research
shows that the complexity increases11
and thus the
manageability and predictability decreases (e.g., Axel-
rod and Cohen 1999; Stacey 2003). In complex systems
the concept of attractorsā€”that is, what attracts the sys-
tem to develop toward a certain set of statesā€”is also
important for our understanding of how change efforts
may work. In order to try to understand social systems
better we also have to draw much more on social scien-
ces in our basic improvement knowledgeā€”we will
come back to that later in this section, giving the
knowledge area psychology a much wider deļ¬nition than
in the original one suggested by Deming.
Understanding Variation
Deming emphasized reduction of variation (see also
Bergman 2003); however, there is much more to it. We
will come back to that later but let us ļ¬rst make a note
on the control chart, suitable for ļ¬nding assignable or
(as Deming put it) special cause variation.12
Shewhart
emphasized the need to have predictable processes,
Shewhartā€™s (1939) deļ¬nition of such processes is the
same (see Bergman [2009] and references cited therein)
as that of exchangeability used by de Finetti (1974).
Shewhart (1931) gave ļ¬ve criteria for such processes.13
One of these is based on the control chartā€”the one
that is most well known and for which Shewhart is the
FIGURE 2 The ā€œequationā€ for improvement as suggested by Batalden and Davidoff (2007) (adapted from Batalden and Davidoff 2007).
9
Note that an organization might have the capability to make
improvements but due to resources restrictions their capacity is
limited.
10
This is also emphasized by Marshall et al. (2013); see also Parry
et al. (2013).
11
It could, of course, be argued whether it is the complexity that
increases or our understanding thereof.
12
The use of control charts in health care is discussed in, for example,
Langley et al. (1996), Benneyan et al. (2003), Woodall (2006),
Neuhauser et al. (2011), and Woodall and Montgomery (2014).
13
Interestingly, these have been graphically explained by Ishikawa
(1982, 1985) in the seven quality control tools.
22 B. Bergman et al.
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most famous. Violations of these criteria may be used
to identify assignable causes. Speciļ¬cally, if we have
made an intervention hoping for an improvement,
then that should result in an assignable cause indicating
a positive result. That used to be one of the corner-
stones in the philosophy of Joseph Juran.14
We will dis-
cuss variation more in the next section.
Knowledge Theory
This theory originated in the conceptualistic prag-
matic philosophy of Clarence I. Lewis, professor of
philosophy at Harvard University. It provided a back-
ground for the PDSA cycle (see, for example, Mauleon
and Bergman 2009; Peterson 1999; Wilcox 2004). In
addition, it is emphasized that theory is the basis for
predictionā€”prediction is the basis for action and if the
action does not lead to the predicted result there is a
need for reļ¬‚ection and revision of the theory (i.e.,
learning) in order to perform better actions in the
future. Lewis emphasized that knowledge is for action
(Lewis 1929). Indeed, this is what Dixon-Woods, Bosk
et al. (2011) wrote in their reļ¬‚ections on the Michigan
case. Furthermore, when different humans observe the
same phenomenon, they may experience it very differ-
ently due to their a priori understanding. This under-
standing sometimes leads to conļ¬‚icts in a group if it is
not understood that the differences depend on differ-
ent mental models, as Peter Senge (1990) would state it.
Closely related is how we as individuals create mean-
ingā€”and even more important how individuals trans-
form their ways of creating meaningā€”something that is
important in many quality improvement efforts, espe-
cially on the structural and system levels in the Dona-
bedian model. When there is a need for second-order
type of learning, how is that achieved? We have to call
in much more from current research around meaning
creation, transformative learning (Mezirow & Associ-
ates 2000), and learning to learn (Argyris 2003; Visser
2003). Note that ļ¬rst-order learning means that we
learn something within our earlier understanding of
reality, and second-order learning means to change our
way of understanding reality, to get a new way of creat-
ing meaning. Third-order learning means achieving a
way of reļ¬‚ecting on self and question the current way
of creating meaning. In this learning, reļ¬‚ection is an
important process: to use a statistical metaphor, the
Bayesian learn more and more about the current model
when the given likelihood function changes due to an
increasing amount of data (single loop learning). How-
ever, to change the shape of the likelihood function or
recognizing that no likelihood function exists due to
assignable causes of variation (not in themselves under
statistical control; see Bergman and Chakhunashvili
2007) is an illustration of a kind of second-order learn-
ing. Within this metaphor, third-order learning should
mean to have a systematic approach to ļ¬nd out whether
the current assumed likelihood function really is relevant
for the problem at hand or not. Usually, the above forms
of learning are taken as individual learning; however, in
an organization it is important to attach these types
of learning to the organization. Learning is the achieve-
ment of knowledgeā€”knowledge is for actionā€”and com-
mon knowledge is for common action.15
Psychology
What Deming emphasized here was the importance
of intrinsic motivation. Currently, there is much more
evidence about the importance of intrinsic motivation
and how that has been put into systematic use in some
organizations. A popular book by Dan Pink (2010)
illustrates this nicely. Closely related to research results
on intrinsic motivation and self-determination theory
(see the introductory chapter of Deci and Ryan 2002)
is the new research ļ¬eld called positive psychology (see,
for example, Csikszentmihalyi and Nakamura 2011)
with an interesting forerunner, Mihaly Csikszentmiha-
lyi (1990), and his research on creativity and the con-
cept of optimal experiences, also known as ļ¬‚ow.
Under the heading psychology, Deming emphasized
not only individual psychology but also interactions
between people. This should lead us into a much
broader research ļ¬eld to integrate into a science of
improvement. Indeed, a lot of social science should be
incorporated here; there might be a need for a new
heading for this broad knowledge ļ¬eld, which has been
proven to be of great interest to a science of improve-
ment (see, e.g., Dixon-Woods, Bosk et al. 2011). For
example, an important research tradition with much in
common with the quality movement is action research;
14
This is called the Juran trilogy: designā€“controlā€“improvement; see
Juran (1986).
15
This is a reformulation of a comment in Lewis (1929); an
interesting framework connecting the individual with the
common is given by Crossan et al. (1999).
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see, for example, Lewin (1948) and Coghlan and Bran-
nick (2010). For some recent applications within health
care see, for example, Lifvergren, Gremyr et al. (2010),
Lifvergren, Docherty et al. (2010), Lifvergren et al.
(2011), Lifvergren et al. (2012), Gustavsson (2014), and
Lifvergren (2013).
A System of Knowledge
Deming emphasized that profound knowledge is a
system of knowledgeā€”the different parts are interre-
lated. Even though Dixon-Woods, Bosk et al. (2011) do
not explicitly use this conceptualization in their study
of the Michigan project, it is an excellent illustration.
Even though Demingā€™s profound knowledge serves
well as a starting point, we now need a broader set of
basic scientiļ¬c knowledgeā€”perhaps under different
headings. Indeed, this is underway even if the headings
have remained the same. However, it is important to
understand that the theories we use in our interpreta-
tions are important for our continual learning how to
better achieve our organizational goals; as Deming
(1994) said, ā€œExperience by itself teaches nothing. . . .
Without theory, experience has no meaning. Without
theory, one has no questions to ask. Hence, without
theory, there is no learningā€ (p. 106).
UNDERSTANDING VARIATION
In the Beginning There Was Variation
Already with the Big Bang variation was thereā€”if it
had not, we would probably still have a homogenous
universeā€”and no ā€œweā€! And so it goes onā€”heavier
and heavier atoms, the creation of stars and galaxies,
and eventually some things that replicate, vary, inter-
act, and compete for energyā€”the organic life has
begun.16
And eventually intelligent creatures who cre-
ate ideas and thereby a new evolution starts. And here
we areā€”the results of a long chain of results from varia-
tion, selection, and interaction.17
Indeed, variation is a
central part of our lives.
In discussions of variation it is important to see dif-
ferences and similarities between two different kinds of
variation: variation between units when time is not in
focus, or synchronic variation, and variation over time,
or diachronic variation. Too often, only the synchronic
variation is discussed, though in many cases diachronic
variation is the most interestingā€”how is it possible to
predict future outcomes given the data? Did an inter-
vention give the intended result? Much medical
research in terms of randomized controlled trials
emphasizes synchronic variation. A stronger emphasis
on diachronic variation would be an important contri-
bution to medical research. And, of course, diachronic
variation is of great importance for the improvement
of health care. An illustration where a quality improve-
ment intervention seems to have had a very important
effect is illustrated in Figure 3. For some further reļ¬‚ec-
tions see the following subsection.
Variation in Health Care
We are all differentā€”patients are all different. Most
often health care professionals have a good sense for
thatā€”meeting each patient here and now on the condi-
tions of this patient. Thus, on an individual level there
is often a deep understanding of variation. However,
when it comes to clinical research, variation has often
been kept under the carpetā€”what have been counted
are averagesā€”mean values. At least, that has very often
been the case in randomized controlled clinical studies,
known as the golden standard of clinical research. Vari-
ation is used mostly through the standard error of the
mean to judge whether mean values are statistically sig-
niļ¬cant or not. If it is not mean values it is often per-
centages of individuals reaching a certain target; HbA1c
is a typical case18
where changes have been made a
FIGURE 3 Number of sudden infant death syndrome cases; a
reasonable assumption is that these deaths occur as in a Poisson
process.
16
Richard Dawkins has written many popular books on this theme,
starting with The Selfish Gene in 1976.
17
Some interesting references are Dawkins (1976); Jablonka and
Lamb (2005) on evolution in four dimensions, and Dennett (1995).
18
HbA1c measures the long-range blood sugar level and is an
important measure in diabetes care.
24 B. Bergman et al.
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number of timesā€”not only target values but also mea-
surement methods. This is, of course, very problemat-
icā€”target values change and thus operating deļ¬nitions
change and possibilities to compare with history are
lost. This may partly be due to a lack of insight con-
cerning diachronic variation.
Nowadays, with the insights and the possibilities for
genetic testing, an increasing understanding for varia-
tion and that randomized testing is not always the best
answer is emerging. But genetic variation is just one
source of variationā€”also important are epigenetic vari-
ation, behavioral variation, and perhaps even cultural
variation (Jablonka and Lamb 2005). These types of
variation must be taken into account. That is often not
done in the current clinical research paradigm. As
many interventions and improvement activities have to
be adopted in a social system, the variation in contexts
is very important and can explain sometimes confusing
results and large variations; see, for example, Pettigrew
and Whipp (1991), Bate (2014), and the Health Foun-
dation (2014). Today, there is quite a lot of focus on
quality registers and thereby a potential to evaluate
new interventions. From the registers random selec-
tions taking different factors into accountā€”the use of
design of experiments based on registers and follow-up
through the registers and then subsequent analysis of
resultsā€”seems to be a very interesting possibility not
yet utilized.
Quality Registers
The worldā€™s ļ¬rst national quality register was created
by Ove Guldberg HĆøegh to register patients suffering
from leprosy in Norway 1856. In the beginning of the
20th century, Ernest Amory Codman created a register
on shoulder surgery. However, it was not until the end
of the 20th century that registers for a large number of
diseases became common. In Sweden, we have around
100 such registers todayā€”each recording a number of
different diagnoses and corresponding process and out-
come measures. They were ļ¬rst created by enthusiastic
physicians to get better hold of their specialities as well
as for research purposes. An illustration is the ļ¬rst regis-
ter in Sweden, a knee replacement register, initiated in
1975 and shortly after followed by a hip replacement
register. Due to the registers it has been possible to
increase reliability of these types of replacements with
great beneļ¬ts both for patients and for replacement
costs. The situation in Sweden, where all citizens have
a unique personal number, is especially beneļ¬cial for
research. It is, for example, possible to combine results
from different types of registers. Of course, efforts are
needed to assure that integrity aspects are taken into
account.
Registers are increasingly thought of as a huge possi-
bility for improvement activities. However, it has still
very much stayed at a rhetoric level and much has to
be done to educate health care professionals to utilize
these registers in their daily improvement work (see,
e.g., Bergman 2013). Among the best registers to pro-
mote improvement work is the diabetes register, where
today it is possible to get information online concern-
ing different hospitals and their results with respect to
smoking cessation, blood pressure, HbA1c, patient
recorded outcome measures, etc.
Reflections on Variation, Statistics,
and the Theory of Probability
As we observed in an earlier section, variation is a
basic concept in our understanding of the universe. In
this section, we want to explore further some of the
basic aspects of knowledge theory and variation. When
observing the world we ļ¬nd variation, and that gives
rise to uncertainty when we try to make predictions
about the futureā€”and, in a way, such predictions lie
behind our decisions and subsequent actions, even if
not always as rational as we would like to think; see, for
example, Kahneman (2011). In this way of looking at
things, which is very much in line with the ideas of C.
I. Lewis that inļ¬‚uenced Deming and Shewhart, proba-
bilities describing our uncertainty exist in our theories
about the world, not in the world itself. In fact, that
leads us to a subjective (or Bayesian) interpretation of
probabilities as promoted early by Ramsay (1926), de
Finetti (1974), and Savage (1954). Bayesian statistics
has gained a lot of attention in medical statistics lately
(see, e.g., Ashby 2006).
The Subjectivist Interpretation of
Probabilities and Conceptualistic
Pragmatism
Lewis (1929), in his conceptualistic pragmatism,
emphasized that theories are a priori, which however,
we are free to choose. He also emphasized that it is
only in the light of this a priori that we experience what
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happens in the world. According to Lewis, experiences
are an interpretation of the sensuously given based on
the a priori. It is indeed also a basic ingredient in our
possibility to reļ¬‚ect upon and learn from our experien-
ces. We ļ¬nd a striking similarity between the thinking
of Lewis and that of Bayesians.
There is another interesting connection between
Bayesian statistics and traditional quality improvement

a la Shewhart and Deming. The control chart makes an
interesting bridge investigated by Bergman (2009).
When Shewhart (1939) made a formal deļ¬nition of a
process under statistical controlā€”that is, about pre-
dictabilityā€”he used a criterion that in the Bayesian/
subjectivist literature is called exchangeability.19
It was
introduced by de Finetti (1974) as a prerequisite for a
predictive distribution to exist. However, in the Bayes-
ian/subjectivist literature the judgment of a process
being exchangeable is left to the decision maker and no
tools are provided. However, here the Shewhart control
chart comes in handy. It is designed exactly as a tool for
judging predictability of a process. We will come back
to this in the next section. First, however, we will make
an important note that is sometimes forgotten when
discussing the contributions of Shewhart. He not only
suggested the control chart to be used for judging if a
process is under statistical control, but he also pointed
to four more criteria to be fulļ¬lled for a process to be
free from assignable causes of variation.20
Four of these
ļ¬ve criteria of Shewhartā€™s were later transformed into a
graphical form by Kaoru Ishikawa (1982) to form some
of the well-known seven QC tools: histogram, stratiļ¬-
cation, scatter diagram, and control chart.
Control Charts
When Shewhart introduced the control chart in his
seminal book from 1931 he recognized that not all pro-
cesses were predictable in a statistical senseā€”some-
times assignable causes of variation interfered and
predictability was lost. It is important to identify such
assignable causes of variation and to eliminate them in
order to get a predictable process. But not all predict-
able processes give an acceptable result. We have to
make more drastic improvements in the process, not
only to remove assignable causes of variation but to
more radical changes in the process/system. This was
illustrated in what Juran called the Juran quality tril-
ogy (Juran 1986): planning a process, controlling it
(and take away assignable causes of variation), and
then improving the process. After a successful
improvement we go into a control phase again; see
Figure 4.
As seen in Figure 4, the control chart works in three
different ways. First, to judge whether a process is pre-
dictable, take away assignable causes, estimate parame-
ters, etc. (phase I); second, to survey the process (phase
II) to guard against new assignable causes that hope-
fully will be eliminated to give a predictable process;
and thirdly, to work as a conļ¬rmation that an inter-
vention, a change of some kind, really was an
improvement (phase III). It should be mentioned
that phase III is usually not mentioned in a system-
atic way in the literature on control charts even
though it should be regarded as a very important
aspect of the use of control charts. In Figure 3 on
sudden infant death syndrome we saw that a sub-
stantial improvement in the process had occurred.
The occurrence of an assignable cause of variation
of a positive kind could be taken as a strong indica-
tion that the intervention (in this case a campaign)
really was successful. Of course, it is important to
make sure that no other changes have been active
that could have affected the process.
In health care today, both process measures and out-
come measures are documented in quality registers.
This provides us with an excellent possibility to evalu-
ate improvement interventionsā€”if the relevant meas-
ures come from a process under statistical control it is
possible to conclude whether an intervention really is
FIGURE 4 The quality trilogy (Planning, Control, Improve)
suggested by Juran (1986) with a more refined division in phases
I-IV.
19
It could also be called permutabilityā€”each permutation of the
stochastic variables has the same distribution.
20
Note that sometimes the process may be predictable even
though assignable causes exist.
26 B. Bergman et al.
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an improvement or not because it should show up as a
positive assignable cause. In many respects, such a strat-
egy for evaluating an intervention has many advantages
over the usual gold standard of clinical medical
research; however, we will not go further into this
debate here.
When reļ¬‚ecting on the ideas behind Figure 4 it
becomes obvious that the usual phase I and phase
II descriptions of the work with a control chart are
not quite enough. A phase III should be added
when improvements are in focus. The special assign-
able cause that might have occurred due to an inter-
vention usually takes some time to mature (if
positive as intended). How long do we need to run
the process until we can judge predictability (and
the new level)? A possible phase IV should be very
similar to phase II. We will come back to this later
in this section.
A Bayesian Control Chart
In the literature on Bayesian control charts we do
not see the type of control charts that Shewhart advo-
cated; that is, a chart for judging whether a process is
under statistical control or not. Rather, the state under
statistical control is determined from the beginning
and an out-of-control state is deļ¬ned. The argument
for the name Bayesian is because these states are given
subjective probabilities and if the out-of-control state
gets a high enough probability an out-of-control situa-
tion is declared. In fact, the out-of-control state is in
itself assumed to be a process under statistical control.
Depending on the purpose, this might be perfectly all
right. However, we just want to determine whether the
process is under statistical control or not; that is,
whether it is reasonable to judge it predictable or not.
Based on the nature of the process, some sort of model
might be judged if the process is under statistical
control.21
When we observe the process, we also increase our
knowledge about the process and increase our possibil-
ity to predict what will happen in the future of the
processā€”at least if it is under statistical control; that is,
still predictable. But how do we judge that? A simple
way would be that the observation at time t C 1 is
within what could be called the predictive interval as
judged from observations up to time t. And that should
also be the case for all of the past observations due to
the fact that the process under statistical control is
exchangeable.22
The only thing to ļ¬nd out is how the
predictive interval should be calculated. In the spirit of
Shewhart it may be taken as the 3s limits of the predic-
tive distribution. However, just as Shewhart indicated,
another choice could be relevant depending on the sit-
uation. It should be noted that it is necessary to go
back also to old observations because in the beginning
of the observation period the knowledge about the pro-
cess is not as strong as later on. That means that an
observation at time s might be within the predictive
interval based on observations up to time s Ā” 1 but
when time has passed to time t  s we know much
more and therefore the observation at time s may be
outside the new predictive interval and judged to be
due to an assignable cause of variation. This is an inter-
pretation of what Lewis (1934) meant by ā€œ[. . .] know-
ing begins and ends in experience; but it does not end
in the experience in which it beginsā€ (p. 134). Based on
more knowledge, we may reinterpret the history that
gave us the knowledge we have.
We still have a task to think about how the process
should be handled after an improvement has been
made and found effective as described by the Juran tril-
ogy. In fact, we could proceed just as beforeā€”we have
an improvement and we have to reformulate a priori in
order to predict the future. When starting to observe
the process it was natural to assume a noninformative a
priori distribution. However, after observing a positive
effect of an intervention it is not quite clear how a
renewed a priori would look like. A pessimistic choice
would probably be to use a noninformative a priori
before the observation that has just been seen to be
outside the predictive limitsā€”most probably due to
the intervention madeā€”and then start anew from
there. As is often the case, the process has not yet
reached a steady state and thus it would be natural to
ļ¬nd the next point outside its predictive interval. The
procedure goes on until a new steady state may be
concluded.
21
Such an assumption could be based on a judgment concerning
statistics that are judged to be sufficient.
22
A small problem is that the prediction interval for an observation
at time s  t is based on all observations including the one we want
to have a predictive interval for. If a recalculation should be made
for the predictive interval for the observation at time s, utilizing all
observations but that at time s is a matter of being purist or not.
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Evidence-Based Medicine
The gold standard of clinical research has been the
randomized controlled trial for a long time. However,
some problems are surfacing. Too much focus has
been on differences in averages (or median), though of
course variation is also very important, as well as factors
underlying that variation. The Plavix case is an interest-
ing illustrationā€”due to genomics, 30% of patients do
not have the possibility to transform the drug into its
active component. Emphasis is also almost always on
one-factor-at-a-time experimentation. Furthermore, the
population used for the test was different from the one
in which the results will be utilized, and the controls
may be different and not adequate for the application
area. For a long time treatments that have been shown
to have efļ¬cacy for one type of population have been
used for a very different population (for example, the
elderly or small children). Thus, much more emphasis
should be put on methods utilized in industrial set-
tings: design of experiments, control charts, data taken
from the treatment processes, etc.
Control charts are an excellent illustration: Assume
that an intervention to a process under statistical con-
trol has been performed (after Phase II in Figure 4),
and that after the intervention the process again is
under statistical control but on a better level (better
mean, lower standard deviation etc.). Then there are
good reasons to assume that the intervention had a pos-
itive effect on the process, at least if no other changes
to the process are found.
We will not go further into these interesting areas
here, but there is a great potential in letting improve-
ment methodologies stimulate the development of
complementary medical research methodology.
THE NORMATIVE SIDE OF A SCIENCE
OF IMPROVEMENT
A science of improvement is not a science that is
purely objective and without a purpose; on the con-
trary, its purpose is quite clear. The knowledge needs
that a science of improvement has to fulļ¬ll are how
improvements are achieved and sustained. In a health
care context, it should be understood that improve-
ments are directed toward health in society: For
patients here and now and in the future and, more gen-
erally, for the health of the citizens here and now and
in the future. In the quality movement this has been
formulated as a value or a principle for organizing. As a
support to this main principle some other principles
have been promoted (see, e.g., Anderson et al. 1994;
Bergman and Klefsjā‚¬
o 2010; Cole and Scott 2010; Dean
and Bowen 1994; Hackman and Wageman 1995; ISO-
9000, International Organization for Standardisation
(ISO) 2000). As we emphasized earlier, it has to address
operational improvements not only at the operational
process level but on the organization as well as on the
overall health system level. An illustration is given in
Figure 5. The different principles are related to those
presented in Bergman and Klefsjā‚¬
o (2010) but with a
slightly different wording. These and similar principles
have been suggested in many other publications, in
research papers on the quality movement, and in more
popular books as well as in ISO-9000. Sometimes these
principles are formulated as values. Here we prefer to
talk about principles for organizingā€”principles that
should be possible to test for when decisions and other
kinds of actions are taken in the organization. Do they
follow or are they breaking against these principles? In
the next section we will discuss these principles. Then
we will discuss the relations between principles, practi-
ces, and tools.
Principles for Organizing
In Figure 5 the principles advocated in Bergman and
Klefsjā‚¬
o (2010) are displayed but with slightly different
formulations. Below, we only give a very brief descrip-
tionā€”more detailed descriptions are found in text-
books like Bergman and Klefsjā‚¬
o (2010).
FIGURE 5 Principles for organizing; see Bergman and Klefsjā‚¬
o
(2010).
28 B. Bergman et al.
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Take a Customer Perspective
This means that we always should try to understand
things from the patientā€™s point of view and also to sup-
port the empowerment23
of the patient. We judge this
to be a huge revolution in health care because better
informed patients are able to be equal partners in the
curing and caring processes, resulting in higher quality
and lower costs. Of course, not all patients have the
possibility, but the lower the resource needs for capable
patients, the more there is for those who are not as
capable and therefore in need of more support. It is
also worth considering that health care in a strict meaning
seldom create direct value to the patientsā€”the value is
created in the life world of the person who is, has been,
or is close to the current or former patient. Health careā€™s
contribution is of cause very important, but it is only one
of the components in the creation of value.
As observed by Normann (2001), it seems to be a
general trend in different industries to change the way
customers are looked upon. First, customers are looked
upon as only consumers on a market, mass production
is in focus and the decisive competence is production
competence. Later on, customers are seen as a source of
information (i.e., what is quality from a customer point
of view), a customer basis becomes important and the
decisive competence is the ability to build relations
with the customers. In the ļ¬nal stage, the customer is
seen as a co-producer and even as a co-creator of the
value creation process. Value creation networks are in
focus and the creation of such networks becomes a
decisive competence.
Patient empowerment, co-production of care, and
even in some cases codesign of care are currently dis-
cussed.24
A case of the last kind has been performed as
an action research project on the rebuilding of neonatal
care at the Skaraborg Hospital Group (SkaS). The
method applied has been that of experienced based
co-design developed by Bate and Robert (2006) based
on concepts from the design industry. The method is
based on four key steps: capturing experiences from
patients and staff, understanding these experiences,
improving based on these experiences, and ļ¬nally mea-
suring the results. In all of these steps patients are
actively working ļ¬rst in their own group (the ļ¬rst and
part of the second step) and then together with the
staff. The experiences from the project at SkaS led to a
number of changesā€”experiences from the patients
indicated improvement possibilities of not only trivial
kinds but regarding quite complex issues such as the
cooperation between different wards, which showed
new ways to coordinate work. Interestingly, the issues
noted by the patients differed markedly from those of
the staff (for a discussion of this and similar projects
see Gustavsson 2013).
Use Intelligence for Decisions about Future
Actions
How do we know about our customers preferences
and needs and wantsā€”how are our decisions in line
with the life situation of the patient? Understanding
the situation of the patient is an important starting
point even though in decisions regarding treatment
many other factors have to be taken into account. It is
also important to understand the value creation pro-
cesses and their functioning. How do we measure and
with which results? But also intelligence concerning
the processes and results of providers that are similar
to us. From whom is it possible to learn? How do we
keep track of new research results of importance to
our activities? Earlier (Bergman and Klefsjā‚¬
o 2010) we
called this ā€œbase decisions on factsā€; however, replac-
ing this with ā€œintelligenceā€ is a quest for an active
process for gathering necessary information of impor-
tance for decisions. In addition, a focus on a high
degree of intelligence is pivotal for learning in the
organization.
Focus on the Value Creation Processes
The value creation processes in a system is all of those
activities that repetitively create value. These activities
may be value streams as emphasized in Lean manufactur-
ing, more complex networks of activities, or shop solu-
tions.25
Value is more and more created in networks of
individualsā€”it has to be emphasized that these networks
not only consist of the patient and other patients and
health care personnel but also of others in society. For
23
Patient empowerment has grown to a very intense area of both
practical applications and theoretical research; see, for example,
Nordgren (2008), Ekman et al. (2012), and Gustavsson (2013).
24
For illustrations of how patients have been involved in the
creation of new health care solutions, see, for example, Bate and
Robert (2007), Iedema et al. (2010), and Maher and Baxter (2009).
25
Unfortunately, the concepts here have become blurredā€”in many
treatises processes are thought of as linear streams of activities;
that is, value streams. Here it is interpreted as all of those
arrangements that repetitively create value.
Improvement in Health Care 29
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further discussions on processes see e.g. Hellstrā‚¬
om
(2007), and Hellstrā‚¬
om et al. (2010).
Improve Continuously
Improvement is, of course, at the heart of a science
of improvement but is also very demanding for an
organization that has to be able to, at the same time,
exploit the knowledge, capabilities, and capacities to
deliver value to its customers. Simultaneously, the
organization must explore new ways of working both
in small incremental improvement steps but also in
more innovative ways. Improvement in many cases
means innovationā€”it is important for health care to
rethink its capability and capacity for innovation; see
also Dixon-Woods, Alamberti et al. (2011). Continual
improvement is also very close to organisational learn-
ing.26
From a management point of view it is important
to understand and help the organization to build
learning mechanisms of different kinds: cognitive,
structural, and procedural learning mechanisms (see
Shani and Docherty 2003).
Support Employee Intrinsic Motivation
Earlier we discussed the importance of intrinsic
motivation. As described by Dixon-Woods et al.
(2014), most people in health care really want to help
their patientsā€”they have a strong intrinsic motivation.
However, this is not always a principle that has been
used for organizing, which is a serious waste.
Take a Systems Perspective
Everything goes on in systemsā€”todayā€™s health care
is a very complex system that might sometimes make it
unpredictable. System understanding should be uti-
lized as a basis for decision making.
Lead According to All of the Other
Principles
Good management and visionary leadership are
important assets in all organizations. The support of
employeesā€™ inner motivation is an art. It is also a radical
shift from many contemporary leadership and manage-
ment ideals.
It should be noted that these principles are close to
those advocated in ISO-9000 (2000) and not very far
from what Anderson et al. (1994) described as concepts
in a theory underlying the Deming management
method.
Improvement Domains
It is easy to see that the principles described above
are closely related to the domains described in the brief
review above. The reason we have chosen to describe
similar things as principles rather than domains is to
clearly show the normative side of a science of
improvement. Of course, the selection of domains is
also governed by a normative will. However, it is not
very clearly expressed.
Principles, Practices, and Tools
A large number of practices and tools are related to
the principles and are necessary for the principles to be
applied in everyday work. In many treatises on quality
management, practices are not as clearly stated as
opposed to principles and tools. One reason for this
may be that practices have to be tailored to the context
of the organization and its operation. On the high level
of principles it is easy to give these principles a near-
universal applicability. The same goes for the precise
tools, whether quantitative or qualitative. However,
when it comes to practicesā€”the actual work processes
applied in an organizationā€”they have to be tailored to
the speciļ¬c situation and the tasks to be performed in
the organization. To give universally valid descriptions
of work practices would be hard even though recom-
mendations could be given.
REFLECTIONS
When reļ¬‚ecting upon an emerging science of
improvement in health care, a number of issues arise.
Some of these reļ¬‚ections are very practical with respect
to the development of health care in the future and
some more philosophical. Only a few points will be
given an initial reļ¬‚ection and some important ques-
tions and agendas for future research will be raised.
26
Learning and organizational learning are a controversial area
from a theoretical point of view; what should be meant by double
loop, triple loop, or deuteron learning are discussed by Argyris
(2003), Visser (2003), and Tosey et al. (2012). A related concept is
that of transformative learning as discussed by Mezirow and Asso-
ciates (2000).
30 B. Bergman et al.
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Practical Reflections
Reļ¬‚ecting on the challenges that health care faces,
it could be asked whether it is really enough with a
science of improvement. Will the use of improve-
ment activities alone solve the problem or perhaps
only lock health care even stronger in the current
dead-end trajectory? Probably not. But technologies
exist that could provide us with a completely differ-
ent health care, but there seems to be no strong pull
for these new technologiesā€”health care is the last
industry taking information technology solutions to
heart. With a stronger focus on improvement
issuesā€”areas for reļ¬‚ection and an awareness of the
possibility to ļ¬nd better waysā€”we believe that the
ability to adopt new ways of working utilizing new
technologies will be improved. Transformative learn-
ing is needed at all levels of health care and some-
times even on the patient side. But how is
transformative learning supported in a health care
system that is fully occupied with todayā€™s problem
(and sometimes yesterdayā€™s omissions)?
As emphasized by Walker et al. (2007), working with
improvements makes it easier to adopt more improve-
ments and even disruptive innovations (see also Moore
and Buchanan 2013). Today, skilful people work so
hard that they have no time to ļ¬nd solutions just
around the corner. ā€œBest efforts are not enoughā€
(Deming 1986, p. 19).
Philosophical Questions on an
Improvement Science
Is a science of improvement really a science? What is
a science? What is its ontology? What about its episte-
mology? How is it related to other kinds of sciences?
What about its universality? As a combination of dif-
ferent knowledge areas, it could possibly be character-
ized by what Gibbons and collaborators (1994) called
Mode 2 research. Many of its methods have been
inspired by statistical improvement from other areas of
application, but it is also about social change. How are
these different ontologies and epistemologies com-
bined in noncontradictory ways?
If we look upon health care as a service industry, we
should perhaps learn more from the knowledge area of
service management. It is often emphasized that value
is not created by the deliverer only but together with
the customer and in the customerā€™s own processes.
This seems to be very much related to issues in the
patient empowerment movement. How far can we go
in that direction?
What about fashions and fads? Many researchers of
the critical management school are talking about the
problems with what they call ā€œnew public manage-
ment.ā€ Is there something to take care of and be wor-
ried about from their critique? How is that done in a
constructive way? And whatever theories and sciences
we come up with, they are in a sense socially construc-
tedā€”they cannot be otherwise (Hacking 1999). But the
real test is their usefulnessā€”still a science of improve-
ment is only in an initial phase, but it is important that
its usefulness is proven not only on local scales but on
more universal ones!
. . . and the world moves onā€”who wants to be left
behind?
ABOUT THE AUTHORS
Bo Bergman is partly retiring from a chair in Quality
Sciences at Chalmers University of Technology and
currently also a guest professor at Meiji University,
Tokyo. His career started with 15 years in aerospace
industry during which period he also became a PhD in
Mathematical statistics from Lund University 1978 and
was a part time professor in Reliability at Royal Insti-
tute of Technology, Stockholm. In 1983 he became a
professor in Quality Technology at Linkā‚¬
oping Univer-
sity and 1999 the SKF professor in Quality Manage-
ment at Chalmers University of Technology. He was a
co-founder of Centre for Healthcare Improvement
(CHI) at Chalmers and its ļ¬rst director (2004ā€“2009).
As a professor he has supervised a large number of PhD
students many of which now are themselves professors.
He is a member of the International Statistical Institute
(ISI) and an Academician of the International Academy
for Quality (IAQ).
Andreas Hellstrā‚¬
om is a senior lecturer at the Depart-
ment of Technology Management and Economics at
Chalmers University of Technology, Sweden and co-
director of Centre for Healthcare Improvement (CHI)
at Chalmers ā€“ a research and education center focusing
on quality improvement, innovation, and transforma-
tion in health care. In 2007, he successfully defended
his Ph.D. thesis on the diffusion and adoption of man-
agement ideas. In 2013, he was one of four selected in
the ļ¬rst cohort of Vinnva

rdā€™s Improvement Science
Improvement in Health Care 31
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Fellowship. He has led research projects in both the pri-
vate sector and the public sector.
Svante Lifvergren, MD, is a specialist in internal and
respiratory medicine. He is quality director at the Skar-
aborg Hospital Group (SkaS), Sweden, having also
worked as a senior physician at SkaS since 1998. Fur-
ther, he holds a Ph.D. in Quality Sciences and he is
co-director for the Centre for Healthcare Improvement
(CHI) at Chalmers University of Technology. His
research mainly focuses on organizational development
in complex healthcare organizations.
Susanne M. Gustavsson, RN and Midwife, is Nurs-
ing Director at the Skaraborg Hospital Group (SkaS),
Sweden. She is also an external PhD student at the
Centre for Healthcare Improvement (CHI) at Chalm-
ers University of Technology, Gothenburg Sweden.
Her research is focused on experience-based co-design
with patients and relatives in health care processes.
ACKNOWLEDGMENTS
First, we want to thank all those devoted health care
personnel who have participated in our research and in
our courses and have given us tremendous support. In
particular, the Skaraborg Hospital Group has been very
important as well as the Vā‚¬
astra Gā‚¬
otaland Region.
FUNDING
We want to acknowledge the important support
from the research foundation VINNVA

RD, providing
resources for our health care improvement research
journey.
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An Emerging Science Of Improvement In Health Care

  • 1. See discussions, stats, and author profiles for this publication at: http://www.researchgate.net/publication/271856985 An Emerging Science of Improvement in Health Care ARTICLE in QUALITY ENGINEERING Ā· JANUARY 2015 Impact Factor: 0.36 Ā· DOI: 10.1080/08982112.2015.968042 CITATION 1 4 AUTHORS: Bo Bergman Chalmers University of Technology 94 PUBLICATIONS 899 CITATIONS SEE PROFILE Andreas Hellstrƶm Chalmers University of Technology 16 PUBLICATIONS 47 CITATIONS SEE PROFILE Svante Lifvergren Chalmers University of Technology 19 PUBLICATIONS 33 CITATIONS SEE PROFILE Susanne Gustavsson Chalmers University of Technology 3 PUBLICATIONS 2 CITATIONS SEE PROFILE Available from: Svante Lifvergren Retrieved on: 21 August 2015
  • 2. This article was downloaded by: [ Svante Lifvergren] On: 25 December 2014, At: 09: 50 Publisher: Taylor & Francis Informa Ltd Registered in England and Wales Registered Number: 1072954 Registered office: Mortimer House, 37-41 Mortimer Street, London W1T 3JH, UK Click for updates Quality Engineering Publication details, including instructions for authors and subscription information: http:/ / www.tandfonline.com/ loi/ lqen20 An Emerging Science of Improvement in Health Care Bo Bergman ab , Andreas Hellstrƶm a , Svante Lifvergren ac & Susanne M. Gustavsson ac a Centre for Healthcare Improvement, Chalmers University of Technology, Gothenburg, Sweden b Meij i University, Tokyo, Japan c Skaraborg Hospital Group, VƤstra Gƶtaland Region, Sweden Published online: 21 Dec 2014. To cite this article: Bo Bergman, Andreas Hellstrƶm, Svante Lifvergren & Susanne M. Gustavsson (2015) An Emerging Science of Improvement in Health Care, Quality Engineering, 27:1, 17-34, DOI: 10.1080/ 08982112.2015.968042 To link to this article: http:/ / dx.doi.org/ 10.1080/ 08982112.2015.968042 PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the ā€œContentā€) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http: / / www.tandfonline.com/ page/ terms-and-conditions
  • 3. An Emerging Science of Improvement in Health Care Bo Bergman 1, 2 , Andreas Hellstrā‚¬ om 1 , Svante Lifvergren 1, 3 , Susanne M. Gustavsson 1, 3 1 Centre for Healthcare Improvement, Chalmers University of Technology, Gothenburg, Sweden 2 Meiji University, Tokyo, Japan 3 Skaraborg Hospital Group, Vā‚¬ astra Gā‚¬ otaland Region, Sweden ABSTRACT The purpose of this article is to describe the emerging science of improvement in health care and to add a perspective from the industrial quality improvement movement, the use of data from quality registers, and to give some personal reļ¬‚ections and suggestions. Furthermore, we want to introduce to the broader quality management community what is happening in health care with respect to quality improvement. We will discuss some of the challenges of the health care system and the current status of a science of improvement and give some suggestions for further improvements to the area. We discuss a possible extension of improvement knowledge and the theoretical and practical arsenal of a science of improvement, in particular, understanding variation and implications for the use of, for, example control charts. In addition, the normative side of a science of improvement is discussed. The article ends with some brief reļ¬‚ections of use for future research agendas. KEYWORDS health care, quality improvement, improvement science, science of improvement, profound knowledge INTRODUCTION Health care is increasingly facing a lot of challenges. The demands are increasing and reports about health care shortcomings have become increas- ingly common. Thus, there is a need to introduce new ways of working. Health care of today is said to be evidence driven with high requirements for data from randomized controlled trials and from careful observational studies. However, even though huge amounts of data are collected in quality registers and by other means, clinical practice is often not governed utilizing these data for learning, improvement, and innovation. Thus, even though individual health care work- ers are providing excellent and dedicated work, the health care system might be ļ¬‚awed and patient outcome might be less than optimal, perhaps unsatisfactory, or even unacceptable without anybody noticing it, more than individual patients. During the last decades there has been a movement toward a view that clinics and health care systems should not only have a systematic way of improving This article was presented at the Second Stu Hunter Research Conference in Tempe, Arizona, March 2014. Address correspondence to Bo Bergman, Chalmers University of Technology, Gothenburg SE-412 96, Sweden. E-mail: boberg@chalmers.se Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/lqen. 17 Quality Engineering, 27:17ā€“34, 2015 Copyright Ɠ Taylor & Francis Group, LLC ISSN: 0898-2112 print / 1532-4222 online DOI: 10.1080/08982112.2015.968042 Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 4. medical treatment and nursing utilizing evidence from research but also have a systematic way of improving how health care is delivered to the patientsā€”how the health care system supports its patients to better health without risking any harm. An attempt to provide a basis for such initiatives is called improvement science or a science1 of improvement. The purpose of this article is to describe this emerging ļ¬eld and to add a perspec- tive from the industrial quality improvement move- ment, the use of data from quality registers, and to give some reļ¬‚ections and suggestions. In this introductory section we will ļ¬rst discuss some challenges of the health care system and give a short outline of the rest of the article where the current status of a science of improvement is discussed as well as some suggestions for further developments of the area. The increasing demand on the health care system is due to, ļ¬rst, the growing population of elderly people suffering from multiple diseases. At the same time, the productive part of the population has become rela- tively smaller and therefore health care funding may be jeopardized (Weisz et al. 2013). A second reason is the appearance of new and much improved possibilities to give life supporting cure and care. Some of these possi- bilities are very costly, and even if many may indeed reduce the total costs to society, the cost reductions do not always beneļ¬t those that have the cost burdens from new treatments. Systems handling this unbalance are not common. Furthermore, the rate of innovations in health care is increasingā€”it has been argued (Dixon- Woods, Alamberti et al. 2011; Sjohania et al. 2007) that the half-life of knowledge is 5.5 years. A third argument is an increased focus on health and well- being in the populationā€”how does the health care sys- tem in a productive way take care of an increased health literacy and requirements on patient autonomy and patient empowerment? (Anderson and Funnell 2005; Reach 2014). Another kind of challenge is the stream of reports on the shortcomings of health care systems. In the UK, for example, the Bristol heart scandal (Weick and Sutcliff 2001) at the Bristol Royal Inļ¬rmary a number of years ago revealed unacceptable shortcomings and later the Mid Staffordshire scandal attracted a lot of attention, with many investigations and government reportsā€” similar shortcomings were reported in these inquiries: No clear visions and goals, no culture of patient cen- teredness, boards and top management not taking the lead on these questions, insufļ¬cient feedback loops on what is really going on in the organization with respect to quality and safety, etc. In a recent study (Dixon- Woods et al. 2014) of the National Health Service (NHS) many good things were reported, speciļ¬cally the ambitions and goodwill of the health care profes- sionals to provide good care; on the negative side, how- ever, it reported that the above-mentioned shortcomings might be more widespread than so far revealed. We will return to this study later. It is not only in the UK that these types of problems are frequent. In Swedish newspapers we read almost every day about mistreatments, long waiting times, and scarcity of personnel. Just to mention one recent story revealed by a Swedish TV program, the deteriorating screening procedures of cervix cancer samples may have caused malign tissue samples to remain undiscov- ered. Even though results were fed into a database, there was no feedback to the person performing the screening. In all work correct feedback is impor- tantā€”without correct feedback any work process may deteriorate. The high cost of the U.S. health care system2 is, of course, also well known. For example, the U.S. health care expenditure in relation to the gross national prod- uct is almost double that of Sweden and the medical results are not better; in many respects, in fact, they are much worse. Furthermore, in a recent paper (James 2013) it was reported that as many as 200,000 and per- haps even 400,000 deaths per year in the United States may be caused by avoidable harm. Of course, there are no silver bullets to solve these problems (Shojania and Grimshaw 2004). However, as one part of a solution, a focus on quality and quality improvement seems necessary. As illustrated by the study of the NHS, a mindset, close to what in indus- trial settings has been known as total quality management (Bergman and Klefsjā‚¬ o 2010), should be strived forā€” perhaps a new management paradigm in health care. In this direction we ļ¬nd the emerging science of improve- ment in health care. In this article, we will ļ¬rst discuss the ļ¬ndings of the NHS study mentioned above and relate these to 1 The concept science might be considered problematic; see, for example, Wilmott (1997). 2 Based on Oganization for Economic Cooperation and Development data comparisons between the cost and medical outcomes were compared in a report from Swedish Association of Local Authorities and Regions (SALAR). 18 B. Bergman et al. Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 5. the early discussions on quality in health care by Ernest Amory Codman3 and Avedis Donabedian (1992, 2002)4 but also to the early discourse on quality improvement in industry. Based on these discussions we will inquire into the scope of a science of improve- ment. During the course of the article we will come back to the NHS study mentioned above for illustra- tive purposes. Illustrations from the Swedish health care will also be used. As part of a brief review, some earlier discussions on the emerging science of improve- ment will be given. Then, in the main part of the arti- cle, the core of a science of improvement will be discussed. It should, however, be emphasized that a sci- ence of improvement in health care really is in a prepar- adigmatic stage, to use the words of Kuhn (1962). Thus, many interpretations and outlines have been given, per- haps under different headings, and probably many more will comeā€”and should come. Indeed, this article will give our interpretations and suggestions, which might go further in scope than many other alternatives. A science of improvement must, of course, address how improvement issues are identiļ¬ed and elaborated upon, eventually leading to successful interventions with even better outcomes for the patients. It must also address how these improvements are evaluated and how lessons are learned from them. But it is equally important to foster an environment where improve- ments are seen as normal and inspiring parts of the daily life in an organization. This environment is a piv- otal requirement for a transformed health care system. How is that achieved? These latter questions are much harder and more pressing than the operating work with improvements themselves, however important they are. Of course, these aspectsā€”that is, the operational improvement interventions and the improvement of the organizationā€™s readiness (capability and capacity) to improve and innovateā€”should go hand in hand, and no simple recipe can be expected. THE SCOPE OF A SCIENCE OF IMPROVEMENT The NHS study mentioned above was a multime- thod study of the NHS during the years 2010ā€“2012 with interviews, surveys, board protocols, and direct observations together with data from 2007 to 2011 on staff experiences, patient experiences, and patient mor- tality rates. A large number of ļ¬ndings in this study corroborate our view of what is important in a science of improvement. Some ļ¬ndings were highly encourag- ing; for example, a consistent focus from front line people to do their best for their patients to create the best possible care. However, in some organizations there were no clear goals, no vision, and no culture for continually reļ¬ning patient quality and safety. In such organizations the front line staff observed severe system deļ¬ciencies but felt powerless to deal with them, whereas management perceived problems with quality and safety as caused by the front line people. That is, the staff and the man- agement had no common understanding about how to solve their problems and to improve patient quality and safety. In addition, there was a lack of intelligen- ceā€”that is, poor follow-up of both their own results and results from similar unitsā€”in order to ļ¬nd improvement opportunities. Interestingly, the research- ers were able to observe that . . . hospital standardised mortality ratios were inversely asso- ciated with positive and supportive organisational climates. Higher levels of staff engagement and health and wellbeing were associated with lower levels of mortality, as were staff reporting support from line managers, well structured apprais- als (e.g., agreeing objectives, ensuring the individual feels val- ued, respected and supported), and opportunities to inļ¬‚uence and contribute to improvements at work. NSS [NHS Staff Survey] data also showed that staff perceptions of the supportiveness of their immediate managers, the extent of staff positive feeling, staff satisfaction and staff commit- ment were associated with other important outcomes, including patient satisfaction. (Dixon-Woods et al. 2014, p. 112) Let us compare these results with the simpliļ¬ed model of health care that was suggested by Avedis Donabedian, who observed that health care (1) out- comes are produced in (2) processes that are imbedded in systems and their (3) structures. According to Dona- bedian (2003), ā€œstructureā€ is meant ā€œto design the con- ditions under which care is providedā€ (p. 46). Examples include material and human resources, the presence of teaching and research, performance reviews, etc. In our interpretation aspects like gover- nance, leadership, learning mechanisms, organizational climate, organizational design, intelligence, attractors, incentives, norms, values, and similar ā€œsoftā€ issues should be included. Process signiļ¬es ā€œthe activities that constitute health care ā€“ including diagnosis, treatment, 3 For a short biography of Codman, see Neuhauser (2002). 4 For a short biography about Donabedian, see Best and Neuhauser (2004). Improvement in Health Care 19 Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 6. prevention, and patient education. . . .ā€ (Bergman et al. 2011, p. 41). Finally, outcome measures are the resulting states from care processes, both technical (for instance, absence of complications) and interpersonal outcomes (for instance, patient satisfaction). However, we also want to add how individuals in the organization would react to different change inter- ventions; that is, individual predispositions.5 It should also be noted that we interpret the concept structure rather freely, not as it is often interpreted as something that is but rather as something that is in a constant becoming and ļ¬‚ux; see, for example, Sztompka (1991). Indeed, this view on structure is pivotal to our view on the health care system.6 With a serious ambition to improve outcome for patientsā€”that is, quality and safetyā€”a science of improvement has to address improvements on all levels of the Donabedian model. It is not enough to make improvements on the process level only. In addition, soft aspects of the environment of the process (and its microsystems) have to be addressed: How is the climate for change generally and how are the individualsā€™ pre- dispositions for change? How is patient centeredness supported? How is intrinsic motivation of the staff sup- ported? What are the norms and values? How is reļ¬‚ec- tion and learning supported? It is only at such levels that we can assure some sort of long-term survivability of improvement efforts, see e.g. Docherty et al. (2003) and Docherty and Shani (2008). From this discussion, the following deļ¬nition of quality improvement suggested by Batalden and Davidoff (2007, p. 2) is adequate; that is, quality improvement is seen . . . as the combined and unceasing efforts of everyo- neā€”health care professionals, patients and their families, researchers, payers, planners and educatorsā€”to make the changes that will lead to better patient outcomes (health), better system performance (care) and better professional development (learning). When talking about system performance in the above deļ¬nition we should also include the predisposi- tions for change (or readiness for change) of the individuals within the organization. Depending on past experiences, these predispositions could look very different in different organizations. The organizationā€™s drive for change (i.e., improvements including innova- tions) should be a very important target of improve- ment efforts. A SCIENCE OF IMPROVEMENT: A BRIEF REVIEW An important starting point of the quality move- ment was the seminal books by Shewhart (1931, 1939); Shewhart was very much inļ¬‚uenced by pragmatic phi- losophy (Lewis 1929), eventually leading to the much used Plan-Do-Study-Act (PDSA) cycle and his thoughts about predictability and corresponding criteria have been central. Later, the experiences from the Japanese wonder and the reawakening (Cole 1999) of the Ameri- can industry were important. In health care, Ernest Amory Codman was already a pioneer in advocating the reporting of failures in order to encourage improve- ment before WWI. Later, after WWII, Avedis Donabe- dian developed the model referred to previously. However, inspiration from the industrial quality move- ment hit health care in the 1980s, ļ¬rst with quality circles and later in a much broader scope; see, for exam- ple, Berwick (1989), Berwick et al. (1990), and Batalden and Stoltz (1993). In the late 1980s, the Institute of Healthcare Improvement was founded by Don Berwick and a number of his colleagues. Many more initiatives started in the beginning of the 1990s. Some important milestones were the roundtable around quality that was arranged by the Institute of Med- icine; see Chassin and Garvin (1998) and the subsequent publications To Err Is Human: Building a Safer Health Sys- tem (Institute of Medicine 1999) and Crossing the Quality Chasm: A New Health System for the 21st Century (Institute of Medicine 2001). These publications have had a great impact; for example, in Sweden they changed the ear- lier dominant punitive7 view on health care errors and quality dimensions of health care were identiļ¬ed as those suggested by the Institute of Medicine (Swedish National Board of Health and Welfare 2006). In Sweden, Mā‚¬ olndals Hospital (Alā‚¬ ange and Steiber 2011) was a forerunner focusing on quality improve- ment of its processes; a clinic at Linkā‚¬ oping University 5 Individual predispositions were suggested by Walker et al. (2007) as an important factor for the effect of change interventions in an organization; see also Moore and Buchanan (2013). 6 In the language of researchers on change we have a process view; see, for example, Pettigrew (1987) and Walker et al. (2007). However, here we have a somewhat conflicting usage of the word process; thus, we keep the concept structure and interpret it in a more open way than it its often done in social sciences. 7 Of course, there were also earlier many proponents for a nonpunitive view on health care errors, but these views had not reached the governments, legislation, and media. 20 B. Bergman et al. Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 7. Hospital (Bergman and Klefsjā‚¬ o 2010) was one of the ļ¬rst organizations, in competition with many otherwise successful manufacturing companies, to win the Swed- ish Quality Award; and in Jā‚¬ onkā‚¬ oping County they ini- tiated a journey on quality improvement that is still going on (Andersson-Gā‚¬ are and Neuhauser 2007). Deming (1994) identiļ¬ed that for leaders to work ļ¬rmly in what he called the ā€œNew Economyā€ they have to have some understanding of a number of important interrelated knowledge areas. He emphasized ā€œa system of profound knowledgeā€ and ā€œappreciation for a sys- tem; knowledge about variation; theory of knowledge; psychologyā€ (p. 96). These knowledge areas and their extensions will be discussed more in the next section. Here we only mention that these areas were introduced to the health care community in a paper by Batalden and Stoltz (1993) under the concept improvement knowl- edge; see Figure 1. In a seminal book (Langley et al. 1996) on health care improvement the name improve- ment science seems to have been introduced for the ļ¬rst time (Perla et al. 2013; see also Berwick 2008). They also suggested, as illustrated in Figure 2, how improvement of performance as experienced by patients (3) is achieved by the application of generaliz- able scientiļ¬c knowledge (1) to the special context based on careful planning (4) and then a careful execu- tion of the plan (5). In Batalden and Stoltzā€™s approach, eight domains of interest with associated tools and methods are of importance. These domains are health care as processes within systems; variation and measurement; customer/ beneļ¬ciary knowledge; leading, following, and making changes; collaboration; social context and accountability; and developing new knowledge. They are similar to but formulated differently than the prin- ciples for organizing we present in the section The Nor- mative Side of a Science of Improvement. In Sweden, professional societies (nurses, doctors, nutritionists, physiotherapists, work therapists, etc.) have joined forces to create a common ground for professional edu- cation on improvement knowledge. During April 12ā€“16, 2010, a colloquium8 on the epistemology of improving quality convened at Clive- den (see, e.g., Batalden et al. 2011). One important outcome of this colloquium was the awareness and importance of taking many different perspectives on quality improvement in health care and to base training programs on multiple epistemologies informing health care improvement. Not only does traditional evidence- based medicine, resting on a natural science founda- tion, have to be called upon but also social science and deeper understandings of social change processes. Recently, Perla et al. (2013) suggested some theoreti- cal and philosophical foundations on which ā€œthe sci- ence of improvementā€ rests. For example, learning and the development of actionable knowledge is stressed and they refer back to philosophical pragmatism, espe- cially that of Lewis (1929) and his conceptualistic pragmatism and subsequent interpretations and transla- tions of Shewhart and Deming. Concerns that improvement efforts too often are lacking in a thorough scientiļ¬c basis has been aired by, for example, Marshall (2011) and Marshall et al. (2013). There is also a tendency that too much focus has been on implementation of solutions and on oper- ational process improvement rather than on improve- ment and innovation of the health care system itself; that is, improvement of the organizational abilities and transformational changes of the health care system. Another striking observation is the relative lack of a patientā€™s perspective. Not that the patient is forgotten, but quite a lot of the literature is more operations focused than really patient focused. Works on the patient perspective (Bergman et al. 2011), patient empowerment (for a review, see Aujoulat et al. 2007), patient involvement in health care design and improve- ment (Bate and Robert 2006; Gustavsson 2013) should, we think, be much more in focus. FIGURE 1 This figure is an enhanced version of the illustra- tion by Batalden and Stoltz (1993). It illustrates how improvement knowledge should be integrated with professional knowledge for the improvement of outcomes. 8 The Vin McLoughlin Colloquium on the Epistemology of Improving Quality, resulting in 23 papers downloadable from http://qualitysafety.bmj.com/content/20/Suppl_1/i99.full.html#ref- list-1 Improvement in Health Care 21 Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 8. It is quite natural for an emerging ļ¬eld that its theo- ries are discussed quite extensively and also that results close to the very aim of the ļ¬eld are discussed. Educa- tional aspects are, of course, also very important. What would be needed, though, are more empirical papers contributing to our understanding of how an organiza- tionā€™s capability and capacity9 for improvement and innovation are enhanced.10 The NHS study described earlier is a good illustration. A Ph.D. thesis on a similar theme but limited to one hospital group including the surrounding municipalities and the primary care cen- ters has been presented by Lifvergren (2013). IMPROVEMENT KNOWLEDGE As emphasized in Figure 1 based on Demingā€™s ā€œpro- found knowledge,ā€ improvement knowledge takes a central position in most descriptions of a science of improvement. However, the different knowledge domains have deepened since the days of Deming and the need to broaden these areas has become obvious. In the following we will discuss each one of the basic knowledge domains separately, emphasizing their deep- ening and possible ways to extend them. However, we will leave most of the ā€œunderstanding variationā€ domain until the next section. Appreciation for a System Some basic features of the understanding that Deming drew onā€”for example the insight that enlarg- ing the system boundary may give opportunities to bet- ter solutions to pressing issuesā€”are still important and, unfortunately, in these respects health care still has a lot to do to integrate their different parts as well as to integrate with other organizations outside health care for the beneļ¬t of their patients (see the section Understanding Variation). This is also an important part of what Deming called winā€“win solutions. However, our understanding of systems has increased substantially since the days of Deming. The theories of complexity (see, for example, Waldrop [1992] and Stacey [2003]) and complex systems had just started in the beginning of the 1990s. Recent knowledge from complex adaptive systems research shows that the complexity increases11 and thus the manageability and predictability decreases (e.g., Axel- rod and Cohen 1999; Stacey 2003). In complex systems the concept of attractorsā€”that is, what attracts the sys- tem to develop toward a certain set of statesā€”is also important for our understanding of how change efforts may work. In order to try to understand social systems better we also have to draw much more on social scien- ces in our basic improvement knowledgeā€”we will come back to that later in this section, giving the knowledge area psychology a much wider deļ¬nition than in the original one suggested by Deming. Understanding Variation Deming emphasized reduction of variation (see also Bergman 2003); however, there is much more to it. We will come back to that later but let us ļ¬rst make a note on the control chart, suitable for ļ¬nding assignable or (as Deming put it) special cause variation.12 Shewhart emphasized the need to have predictable processes, Shewhartā€™s (1939) deļ¬nition of such processes is the same (see Bergman [2009] and references cited therein) as that of exchangeability used by de Finetti (1974). Shewhart (1931) gave ļ¬ve criteria for such processes.13 One of these is based on the control chartā€”the one that is most well known and for which Shewhart is the FIGURE 2 The ā€œequationā€ for improvement as suggested by Batalden and Davidoff (2007) (adapted from Batalden and Davidoff 2007). 9 Note that an organization might have the capability to make improvements but due to resources restrictions their capacity is limited. 10 This is also emphasized by Marshall et al. (2013); see also Parry et al. (2013). 11 It could, of course, be argued whether it is the complexity that increases or our understanding thereof. 12 The use of control charts in health care is discussed in, for example, Langley et al. (1996), Benneyan et al. (2003), Woodall (2006), Neuhauser et al. (2011), and Woodall and Montgomery (2014). 13 Interestingly, these have been graphically explained by Ishikawa (1982, 1985) in the seven quality control tools. 22 B. Bergman et al. Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 9. most famous. Violations of these criteria may be used to identify assignable causes. Speciļ¬cally, if we have made an intervention hoping for an improvement, then that should result in an assignable cause indicating a positive result. That used to be one of the corner- stones in the philosophy of Joseph Juran.14 We will dis- cuss variation more in the next section. Knowledge Theory This theory originated in the conceptualistic prag- matic philosophy of Clarence I. Lewis, professor of philosophy at Harvard University. It provided a back- ground for the PDSA cycle (see, for example, Mauleon and Bergman 2009; Peterson 1999; Wilcox 2004). In addition, it is emphasized that theory is the basis for predictionā€”prediction is the basis for action and if the action does not lead to the predicted result there is a need for reļ¬‚ection and revision of the theory (i.e., learning) in order to perform better actions in the future. Lewis emphasized that knowledge is for action (Lewis 1929). Indeed, this is what Dixon-Woods, Bosk et al. (2011) wrote in their reļ¬‚ections on the Michigan case. Furthermore, when different humans observe the same phenomenon, they may experience it very differ- ently due to their a priori understanding. This under- standing sometimes leads to conļ¬‚icts in a group if it is not understood that the differences depend on differ- ent mental models, as Peter Senge (1990) would state it. Closely related is how we as individuals create mean- ingā€”and even more important how individuals trans- form their ways of creating meaningā€”something that is important in many quality improvement efforts, espe- cially on the structural and system levels in the Dona- bedian model. When there is a need for second-order type of learning, how is that achieved? We have to call in much more from current research around meaning creation, transformative learning (Mezirow & Associ- ates 2000), and learning to learn (Argyris 2003; Visser 2003). Note that ļ¬rst-order learning means that we learn something within our earlier understanding of reality, and second-order learning means to change our way of understanding reality, to get a new way of creat- ing meaning. Third-order learning means achieving a way of reļ¬‚ecting on self and question the current way of creating meaning. In this learning, reļ¬‚ection is an important process: to use a statistical metaphor, the Bayesian learn more and more about the current model when the given likelihood function changes due to an increasing amount of data (single loop learning). How- ever, to change the shape of the likelihood function or recognizing that no likelihood function exists due to assignable causes of variation (not in themselves under statistical control; see Bergman and Chakhunashvili 2007) is an illustration of a kind of second-order learn- ing. Within this metaphor, third-order learning should mean to have a systematic approach to ļ¬nd out whether the current assumed likelihood function really is relevant for the problem at hand or not. Usually, the above forms of learning are taken as individual learning; however, in an organization it is important to attach these types of learning to the organization. Learning is the achieve- ment of knowledgeā€”knowledge is for actionā€”and com- mon knowledge is for common action.15 Psychology What Deming emphasized here was the importance of intrinsic motivation. Currently, there is much more evidence about the importance of intrinsic motivation and how that has been put into systematic use in some organizations. A popular book by Dan Pink (2010) illustrates this nicely. Closely related to research results on intrinsic motivation and self-determination theory (see the introductory chapter of Deci and Ryan 2002) is the new research ļ¬eld called positive psychology (see, for example, Csikszentmihalyi and Nakamura 2011) with an interesting forerunner, Mihaly Csikszentmiha- lyi (1990), and his research on creativity and the con- cept of optimal experiences, also known as ļ¬‚ow. Under the heading psychology, Deming emphasized not only individual psychology but also interactions between people. This should lead us into a much broader research ļ¬eld to integrate into a science of improvement. Indeed, a lot of social science should be incorporated here; there might be a need for a new heading for this broad knowledge ļ¬eld, which has been proven to be of great interest to a science of improve- ment (see, e.g., Dixon-Woods, Bosk et al. 2011). For example, an important research tradition with much in common with the quality movement is action research; 14 This is called the Juran trilogy: designā€“controlā€“improvement; see Juran (1986). 15 This is a reformulation of a comment in Lewis (1929); an interesting framework connecting the individual with the common is given by Crossan et al. (1999). Improvement in Health Care 23 Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 10. see, for example, Lewin (1948) and Coghlan and Bran- nick (2010). For some recent applications within health care see, for example, Lifvergren, Gremyr et al. (2010), Lifvergren, Docherty et al. (2010), Lifvergren et al. (2011), Lifvergren et al. (2012), Gustavsson (2014), and Lifvergren (2013). A System of Knowledge Deming emphasized that profound knowledge is a system of knowledgeā€”the different parts are interre- lated. Even though Dixon-Woods, Bosk et al. (2011) do not explicitly use this conceptualization in their study of the Michigan project, it is an excellent illustration. Even though Demingā€™s profound knowledge serves well as a starting point, we now need a broader set of basic scientiļ¬c knowledgeā€”perhaps under different headings. Indeed, this is underway even if the headings have remained the same. However, it is important to understand that the theories we use in our interpreta- tions are important for our continual learning how to better achieve our organizational goals; as Deming (1994) said, ā€œExperience by itself teaches nothing. . . . Without theory, experience has no meaning. Without theory, one has no questions to ask. Hence, without theory, there is no learningā€ (p. 106). UNDERSTANDING VARIATION In the Beginning There Was Variation Already with the Big Bang variation was thereā€”if it had not, we would probably still have a homogenous universeā€”and no ā€œweā€! And so it goes onā€”heavier and heavier atoms, the creation of stars and galaxies, and eventually some things that replicate, vary, inter- act, and compete for energyā€”the organic life has begun.16 And eventually intelligent creatures who cre- ate ideas and thereby a new evolution starts. And here we areā€”the results of a long chain of results from varia- tion, selection, and interaction.17 Indeed, variation is a central part of our lives. In discussions of variation it is important to see dif- ferences and similarities between two different kinds of variation: variation between units when time is not in focus, or synchronic variation, and variation over time, or diachronic variation. Too often, only the synchronic variation is discussed, though in many cases diachronic variation is the most interestingā€”how is it possible to predict future outcomes given the data? Did an inter- vention give the intended result? Much medical research in terms of randomized controlled trials emphasizes synchronic variation. A stronger emphasis on diachronic variation would be an important contri- bution to medical research. And, of course, diachronic variation is of great importance for the improvement of health care. An illustration where a quality improve- ment intervention seems to have had a very important effect is illustrated in Figure 3. For some further reļ¬‚ec- tions see the following subsection. Variation in Health Care We are all differentā€”patients are all different. Most often health care professionals have a good sense for thatā€”meeting each patient here and now on the condi- tions of this patient. Thus, on an individual level there is often a deep understanding of variation. However, when it comes to clinical research, variation has often been kept under the carpetā€”what have been counted are averagesā€”mean values. At least, that has very often been the case in randomized controlled clinical studies, known as the golden standard of clinical research. Vari- ation is used mostly through the standard error of the mean to judge whether mean values are statistically sig- niļ¬cant or not. If it is not mean values it is often per- centages of individuals reaching a certain target; HbA1c is a typical case18 where changes have been made a FIGURE 3 Number of sudden infant death syndrome cases; a reasonable assumption is that these deaths occur as in a Poisson process. 16 Richard Dawkins has written many popular books on this theme, starting with The Selfish Gene in 1976. 17 Some interesting references are Dawkins (1976); Jablonka and Lamb (2005) on evolution in four dimensions, and Dennett (1995). 18 HbA1c measures the long-range blood sugar level and is an important measure in diabetes care. 24 B. Bergman et al. Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 11. number of timesā€”not only target values but also mea- surement methods. This is, of course, very problemat- icā€”target values change and thus operating deļ¬nitions change and possibilities to compare with history are lost. This may partly be due to a lack of insight con- cerning diachronic variation. Nowadays, with the insights and the possibilities for genetic testing, an increasing understanding for varia- tion and that randomized testing is not always the best answer is emerging. But genetic variation is just one source of variationā€”also important are epigenetic vari- ation, behavioral variation, and perhaps even cultural variation (Jablonka and Lamb 2005). These types of variation must be taken into account. That is often not done in the current clinical research paradigm. As many interventions and improvement activities have to be adopted in a social system, the variation in contexts is very important and can explain sometimes confusing results and large variations; see, for example, Pettigrew and Whipp (1991), Bate (2014), and the Health Foun- dation (2014). Today, there is quite a lot of focus on quality registers and thereby a potential to evaluate new interventions. From the registers random selec- tions taking different factors into accountā€”the use of design of experiments based on registers and follow-up through the registers and then subsequent analysis of resultsā€”seems to be a very interesting possibility not yet utilized. Quality Registers The worldā€™s ļ¬rst national quality register was created by Ove Guldberg HĆøegh to register patients suffering from leprosy in Norway 1856. In the beginning of the 20th century, Ernest Amory Codman created a register on shoulder surgery. However, it was not until the end of the 20th century that registers for a large number of diseases became common. In Sweden, we have around 100 such registers todayā€”each recording a number of different diagnoses and corresponding process and out- come measures. They were ļ¬rst created by enthusiastic physicians to get better hold of their specialities as well as for research purposes. An illustration is the ļ¬rst regis- ter in Sweden, a knee replacement register, initiated in 1975 and shortly after followed by a hip replacement register. Due to the registers it has been possible to increase reliability of these types of replacements with great beneļ¬ts both for patients and for replacement costs. The situation in Sweden, where all citizens have a unique personal number, is especially beneļ¬cial for research. It is, for example, possible to combine results from different types of registers. Of course, efforts are needed to assure that integrity aspects are taken into account. Registers are increasingly thought of as a huge possi- bility for improvement activities. However, it has still very much stayed at a rhetoric level and much has to be done to educate health care professionals to utilize these registers in their daily improvement work (see, e.g., Bergman 2013). Among the best registers to pro- mote improvement work is the diabetes register, where today it is possible to get information online concern- ing different hospitals and their results with respect to smoking cessation, blood pressure, HbA1c, patient recorded outcome measures, etc. Reflections on Variation, Statistics, and the Theory of Probability As we observed in an earlier section, variation is a basic concept in our understanding of the universe. In this section, we want to explore further some of the basic aspects of knowledge theory and variation. When observing the world we ļ¬nd variation, and that gives rise to uncertainty when we try to make predictions about the futureā€”and, in a way, such predictions lie behind our decisions and subsequent actions, even if not always as rational as we would like to think; see, for example, Kahneman (2011). In this way of looking at things, which is very much in line with the ideas of C. I. Lewis that inļ¬‚uenced Deming and Shewhart, proba- bilities describing our uncertainty exist in our theories about the world, not in the world itself. In fact, that leads us to a subjective (or Bayesian) interpretation of probabilities as promoted early by Ramsay (1926), de Finetti (1974), and Savage (1954). Bayesian statistics has gained a lot of attention in medical statistics lately (see, e.g., Ashby 2006). The Subjectivist Interpretation of Probabilities and Conceptualistic Pragmatism Lewis (1929), in his conceptualistic pragmatism, emphasized that theories are a priori, which however, we are free to choose. He also emphasized that it is only in the light of this a priori that we experience what Improvement in Health Care 25 Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 12. happens in the world. According to Lewis, experiences are an interpretation of the sensuously given based on the a priori. It is indeed also a basic ingredient in our possibility to reļ¬‚ect upon and learn from our experien- ces. We ļ¬nd a striking similarity between the thinking of Lewis and that of Bayesians. There is another interesting connection between Bayesian statistics and traditional quality improvement a la Shewhart and Deming. The control chart makes an interesting bridge investigated by Bergman (2009). When Shewhart (1939) made a formal deļ¬nition of a process under statistical controlā€”that is, about pre- dictabilityā€”he used a criterion that in the Bayesian/ subjectivist literature is called exchangeability.19 It was introduced by de Finetti (1974) as a prerequisite for a predictive distribution to exist. However, in the Bayes- ian/subjectivist literature the judgment of a process being exchangeable is left to the decision maker and no tools are provided. However, here the Shewhart control chart comes in handy. It is designed exactly as a tool for judging predictability of a process. We will come back to this in the next section. First, however, we will make an important note that is sometimes forgotten when discussing the contributions of Shewhart. He not only suggested the control chart to be used for judging if a process is under statistical control, but he also pointed to four more criteria to be fulļ¬lled for a process to be free from assignable causes of variation.20 Four of these ļ¬ve criteria of Shewhartā€™s were later transformed into a graphical form by Kaoru Ishikawa (1982) to form some of the well-known seven QC tools: histogram, stratiļ¬- cation, scatter diagram, and control chart. Control Charts When Shewhart introduced the control chart in his seminal book from 1931 he recognized that not all pro- cesses were predictable in a statistical senseā€”some- times assignable causes of variation interfered and predictability was lost. It is important to identify such assignable causes of variation and to eliminate them in order to get a predictable process. But not all predict- able processes give an acceptable result. We have to make more drastic improvements in the process, not only to remove assignable causes of variation but to more radical changes in the process/system. This was illustrated in what Juran called the Juran quality tril- ogy (Juran 1986): planning a process, controlling it (and take away assignable causes of variation), and then improving the process. After a successful improvement we go into a control phase again; see Figure 4. As seen in Figure 4, the control chart works in three different ways. First, to judge whether a process is pre- dictable, take away assignable causes, estimate parame- ters, etc. (phase I); second, to survey the process (phase II) to guard against new assignable causes that hope- fully will be eliminated to give a predictable process; and thirdly, to work as a conļ¬rmation that an inter- vention, a change of some kind, really was an improvement (phase III). It should be mentioned that phase III is usually not mentioned in a system- atic way in the literature on control charts even though it should be regarded as a very important aspect of the use of control charts. In Figure 3 on sudden infant death syndrome we saw that a sub- stantial improvement in the process had occurred. The occurrence of an assignable cause of variation of a positive kind could be taken as a strong indica- tion that the intervention (in this case a campaign) really was successful. Of course, it is important to make sure that no other changes have been active that could have affected the process. In health care today, both process measures and out- come measures are documented in quality registers. This provides us with an excellent possibility to evalu- ate improvement interventionsā€”if the relevant meas- ures come from a process under statistical control it is possible to conclude whether an intervention really is FIGURE 4 The quality trilogy (Planning, Control, Improve) suggested by Juran (1986) with a more refined division in phases I-IV. 19 It could also be called permutabilityā€”each permutation of the stochastic variables has the same distribution. 20 Note that sometimes the process may be predictable even though assignable causes exist. 26 B. Bergman et al. Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 13. an improvement or not because it should show up as a positive assignable cause. In many respects, such a strat- egy for evaluating an intervention has many advantages over the usual gold standard of clinical medical research; however, we will not go further into this debate here. When reļ¬‚ecting on the ideas behind Figure 4 it becomes obvious that the usual phase I and phase II descriptions of the work with a control chart are not quite enough. A phase III should be added when improvements are in focus. The special assign- able cause that might have occurred due to an inter- vention usually takes some time to mature (if positive as intended). How long do we need to run the process until we can judge predictability (and the new level)? A possible phase IV should be very similar to phase II. We will come back to this later in this section. A Bayesian Control Chart In the literature on Bayesian control charts we do not see the type of control charts that Shewhart advo- cated; that is, a chart for judging whether a process is under statistical control or not. Rather, the state under statistical control is determined from the beginning and an out-of-control state is deļ¬ned. The argument for the name Bayesian is because these states are given subjective probabilities and if the out-of-control state gets a high enough probability an out-of-control situa- tion is declared. In fact, the out-of-control state is in itself assumed to be a process under statistical control. Depending on the purpose, this might be perfectly all right. However, we just want to determine whether the process is under statistical control or not; that is, whether it is reasonable to judge it predictable or not. Based on the nature of the process, some sort of model might be judged if the process is under statistical control.21 When we observe the process, we also increase our knowledge about the process and increase our possibil- ity to predict what will happen in the future of the processā€”at least if it is under statistical control; that is, still predictable. But how do we judge that? A simple way would be that the observation at time t C 1 is within what could be called the predictive interval as judged from observations up to time t. And that should also be the case for all of the past observations due to the fact that the process under statistical control is exchangeable.22 The only thing to ļ¬nd out is how the predictive interval should be calculated. In the spirit of Shewhart it may be taken as the 3s limits of the predic- tive distribution. However, just as Shewhart indicated, another choice could be relevant depending on the sit- uation. It should be noted that it is necessary to go back also to old observations because in the beginning of the observation period the knowledge about the pro- cess is not as strong as later on. That means that an observation at time s might be within the predictive interval based on observations up to time s Ā” 1 but when time has passed to time t s we know much more and therefore the observation at time s may be outside the new predictive interval and judged to be due to an assignable cause of variation. This is an inter- pretation of what Lewis (1934) meant by ā€œ[. . .] know- ing begins and ends in experience; but it does not end in the experience in which it beginsā€ (p. 134). Based on more knowledge, we may reinterpret the history that gave us the knowledge we have. We still have a task to think about how the process should be handled after an improvement has been made and found effective as described by the Juran tril- ogy. In fact, we could proceed just as beforeā€”we have an improvement and we have to reformulate a priori in order to predict the future. When starting to observe the process it was natural to assume a noninformative a priori distribution. However, after observing a positive effect of an intervention it is not quite clear how a renewed a priori would look like. A pessimistic choice would probably be to use a noninformative a priori before the observation that has just been seen to be outside the predictive limitsā€”most probably due to the intervention madeā€”and then start anew from there. As is often the case, the process has not yet reached a steady state and thus it would be natural to ļ¬nd the next point outside its predictive interval. The procedure goes on until a new steady state may be concluded. 21 Such an assumption could be based on a judgment concerning statistics that are judged to be sufficient. 22 A small problem is that the prediction interval for an observation at time s t is based on all observations including the one we want to have a predictive interval for. If a recalculation should be made for the predictive interval for the observation at time s, utilizing all observations but that at time s is a matter of being purist or not. Improvement in Health Care 27 Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 14. Evidence-Based Medicine The gold standard of clinical research has been the randomized controlled trial for a long time. However, some problems are surfacing. Too much focus has been on differences in averages (or median), though of course variation is also very important, as well as factors underlying that variation. The Plavix case is an interest- ing illustrationā€”due to genomics, 30% of patients do not have the possibility to transform the drug into its active component. Emphasis is also almost always on one-factor-at-a-time experimentation. Furthermore, the population used for the test was different from the one in which the results will be utilized, and the controls may be different and not adequate for the application area. For a long time treatments that have been shown to have efļ¬cacy for one type of population have been used for a very different population (for example, the elderly or small children). Thus, much more emphasis should be put on methods utilized in industrial set- tings: design of experiments, control charts, data taken from the treatment processes, etc. Control charts are an excellent illustration: Assume that an intervention to a process under statistical con- trol has been performed (after Phase II in Figure 4), and that after the intervention the process again is under statistical control but on a better level (better mean, lower standard deviation etc.). Then there are good reasons to assume that the intervention had a pos- itive effect on the process, at least if no other changes to the process are found. We will not go further into these interesting areas here, but there is a great potential in letting improve- ment methodologies stimulate the development of complementary medical research methodology. THE NORMATIVE SIDE OF A SCIENCE OF IMPROVEMENT A science of improvement is not a science that is purely objective and without a purpose; on the con- trary, its purpose is quite clear. The knowledge needs that a science of improvement has to fulļ¬ll are how improvements are achieved and sustained. In a health care context, it should be understood that improve- ments are directed toward health in society: For patients here and now and in the future and, more gen- erally, for the health of the citizens here and now and in the future. In the quality movement this has been formulated as a value or a principle for organizing. As a support to this main principle some other principles have been promoted (see, e.g., Anderson et al. 1994; Bergman and Klefsjā‚¬ o 2010; Cole and Scott 2010; Dean and Bowen 1994; Hackman and Wageman 1995; ISO- 9000, International Organization for Standardisation (ISO) 2000). As we emphasized earlier, it has to address operational improvements not only at the operational process level but on the organization as well as on the overall health system level. An illustration is given in Figure 5. The different principles are related to those presented in Bergman and Klefsjā‚¬ o (2010) but with a slightly different wording. These and similar principles have been suggested in many other publications, in research papers on the quality movement, and in more popular books as well as in ISO-9000. Sometimes these principles are formulated as values. Here we prefer to talk about principles for organizingā€”principles that should be possible to test for when decisions and other kinds of actions are taken in the organization. Do they follow or are they breaking against these principles? In the next section we will discuss these principles. Then we will discuss the relations between principles, practi- ces, and tools. Principles for Organizing In Figure 5 the principles advocated in Bergman and Klefsjā‚¬ o (2010) are displayed but with slightly different formulations. Below, we only give a very brief descrip- tionā€”more detailed descriptions are found in text- books like Bergman and Klefsjā‚¬ o (2010). FIGURE 5 Principles for organizing; see Bergman and Klefsjā‚¬ o (2010). 28 B. Bergman et al. Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 15. Take a Customer Perspective This means that we always should try to understand things from the patientā€™s point of view and also to sup- port the empowerment23 of the patient. We judge this to be a huge revolution in health care because better informed patients are able to be equal partners in the curing and caring processes, resulting in higher quality and lower costs. Of course, not all patients have the possibility, but the lower the resource needs for capable patients, the more there is for those who are not as capable and therefore in need of more support. It is also worth considering that health care in a strict meaning seldom create direct value to the patientsā€”the value is created in the life world of the person who is, has been, or is close to the current or former patient. Health careā€™s contribution is of cause very important, but it is only one of the components in the creation of value. As observed by Normann (2001), it seems to be a general trend in different industries to change the way customers are looked upon. First, customers are looked upon as only consumers on a market, mass production is in focus and the decisive competence is production competence. Later on, customers are seen as a source of information (i.e., what is quality from a customer point of view), a customer basis becomes important and the decisive competence is the ability to build relations with the customers. In the ļ¬nal stage, the customer is seen as a co-producer and even as a co-creator of the value creation process. Value creation networks are in focus and the creation of such networks becomes a decisive competence. Patient empowerment, co-production of care, and even in some cases codesign of care are currently dis- cussed.24 A case of the last kind has been performed as an action research project on the rebuilding of neonatal care at the Skaraborg Hospital Group (SkaS). The method applied has been that of experienced based co-design developed by Bate and Robert (2006) based on concepts from the design industry. The method is based on four key steps: capturing experiences from patients and staff, understanding these experiences, improving based on these experiences, and ļ¬nally mea- suring the results. In all of these steps patients are actively working ļ¬rst in their own group (the ļ¬rst and part of the second step) and then together with the staff. The experiences from the project at SkaS led to a number of changesā€”experiences from the patients indicated improvement possibilities of not only trivial kinds but regarding quite complex issues such as the cooperation between different wards, which showed new ways to coordinate work. Interestingly, the issues noted by the patients differed markedly from those of the staff (for a discussion of this and similar projects see Gustavsson 2013). Use Intelligence for Decisions about Future Actions How do we know about our customers preferences and needs and wantsā€”how are our decisions in line with the life situation of the patient? Understanding the situation of the patient is an important starting point even though in decisions regarding treatment many other factors have to be taken into account. It is also important to understand the value creation pro- cesses and their functioning. How do we measure and with which results? But also intelligence concerning the processes and results of providers that are similar to us. From whom is it possible to learn? How do we keep track of new research results of importance to our activities? Earlier (Bergman and Klefsjā‚¬ o 2010) we called this ā€œbase decisions on factsā€; however, replac- ing this with ā€œintelligenceā€ is a quest for an active process for gathering necessary information of impor- tance for decisions. In addition, a focus on a high degree of intelligence is pivotal for learning in the organization. Focus on the Value Creation Processes The value creation processes in a system is all of those activities that repetitively create value. These activities may be value streams as emphasized in Lean manufactur- ing, more complex networks of activities, or shop solu- tions.25 Value is more and more created in networks of individualsā€”it has to be emphasized that these networks not only consist of the patient and other patients and health care personnel but also of others in society. For 23 Patient empowerment has grown to a very intense area of both practical applications and theoretical research; see, for example, Nordgren (2008), Ekman et al. (2012), and Gustavsson (2013). 24 For illustrations of how patients have been involved in the creation of new health care solutions, see, for example, Bate and Robert (2007), Iedema et al. (2010), and Maher and Baxter (2009). 25 Unfortunately, the concepts here have become blurredā€”in many treatises processes are thought of as linear streams of activities; that is, value streams. Here it is interpreted as all of those arrangements that repetitively create value. Improvement in Health Care 29 Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 16. further discussions on processes see e.g. Hellstrā‚¬ om (2007), and Hellstrā‚¬ om et al. (2010). Improve Continuously Improvement is, of course, at the heart of a science of improvement but is also very demanding for an organization that has to be able to, at the same time, exploit the knowledge, capabilities, and capacities to deliver value to its customers. Simultaneously, the organization must explore new ways of working both in small incremental improvement steps but also in more innovative ways. Improvement in many cases means innovationā€”it is important for health care to rethink its capability and capacity for innovation; see also Dixon-Woods, Alamberti et al. (2011). Continual improvement is also very close to organisational learn- ing.26 From a management point of view it is important to understand and help the organization to build learning mechanisms of different kinds: cognitive, structural, and procedural learning mechanisms (see Shani and Docherty 2003). Support Employee Intrinsic Motivation Earlier we discussed the importance of intrinsic motivation. As described by Dixon-Woods et al. (2014), most people in health care really want to help their patientsā€”they have a strong intrinsic motivation. However, this is not always a principle that has been used for organizing, which is a serious waste. Take a Systems Perspective Everything goes on in systemsā€”todayā€™s health care is a very complex system that might sometimes make it unpredictable. System understanding should be uti- lized as a basis for decision making. Lead According to All of the Other Principles Good management and visionary leadership are important assets in all organizations. The support of employeesā€™ inner motivation is an art. It is also a radical shift from many contemporary leadership and manage- ment ideals. It should be noted that these principles are close to those advocated in ISO-9000 (2000) and not very far from what Anderson et al. (1994) described as concepts in a theory underlying the Deming management method. Improvement Domains It is easy to see that the principles described above are closely related to the domains described in the brief review above. The reason we have chosen to describe similar things as principles rather than domains is to clearly show the normative side of a science of improvement. Of course, the selection of domains is also governed by a normative will. However, it is not very clearly expressed. Principles, Practices, and Tools A large number of practices and tools are related to the principles and are necessary for the principles to be applied in everyday work. In many treatises on quality management, practices are not as clearly stated as opposed to principles and tools. One reason for this may be that practices have to be tailored to the context of the organization and its operation. On the high level of principles it is easy to give these principles a near- universal applicability. The same goes for the precise tools, whether quantitative or qualitative. However, when it comes to practicesā€”the actual work processes applied in an organizationā€”they have to be tailored to the speciļ¬c situation and the tasks to be performed in the organization. To give universally valid descriptions of work practices would be hard even though recom- mendations could be given. REFLECTIONS When reļ¬‚ecting upon an emerging science of improvement in health care, a number of issues arise. Some of these reļ¬‚ections are very practical with respect to the development of health care in the future and some more philosophical. Only a few points will be given an initial reļ¬‚ection and some important ques- tions and agendas for future research will be raised. 26 Learning and organizational learning are a controversial area from a theoretical point of view; what should be meant by double loop, triple loop, or deuteron learning are discussed by Argyris (2003), Visser (2003), and Tosey et al. (2012). A related concept is that of transformative learning as discussed by Mezirow and Asso- ciates (2000). 30 B. Bergman et al. Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 17. Practical Reflections Reļ¬‚ecting on the challenges that health care faces, it could be asked whether it is really enough with a science of improvement. Will the use of improve- ment activities alone solve the problem or perhaps only lock health care even stronger in the current dead-end trajectory? Probably not. But technologies exist that could provide us with a completely differ- ent health care, but there seems to be no strong pull for these new technologiesā€”health care is the last industry taking information technology solutions to heart. With a stronger focus on improvement issuesā€”areas for reļ¬‚ection and an awareness of the possibility to ļ¬nd better waysā€”we believe that the ability to adopt new ways of working utilizing new technologies will be improved. Transformative learn- ing is needed at all levels of health care and some- times even on the patient side. But how is transformative learning supported in a health care system that is fully occupied with todayā€™s problem (and sometimes yesterdayā€™s omissions)? As emphasized by Walker et al. (2007), working with improvements makes it easier to adopt more improve- ments and even disruptive innovations (see also Moore and Buchanan 2013). Today, skilful people work so hard that they have no time to ļ¬nd solutions just around the corner. ā€œBest efforts are not enoughā€ (Deming 1986, p. 19). Philosophical Questions on an Improvement Science Is a science of improvement really a science? What is a science? What is its ontology? What about its episte- mology? How is it related to other kinds of sciences? What about its universality? As a combination of dif- ferent knowledge areas, it could possibly be character- ized by what Gibbons and collaborators (1994) called Mode 2 research. Many of its methods have been inspired by statistical improvement from other areas of application, but it is also about social change. How are these different ontologies and epistemologies com- bined in noncontradictory ways? If we look upon health care as a service industry, we should perhaps learn more from the knowledge area of service management. It is often emphasized that value is not created by the deliverer only but together with the customer and in the customerā€™s own processes. This seems to be very much related to issues in the patient empowerment movement. How far can we go in that direction? What about fashions and fads? Many researchers of the critical management school are talking about the problems with what they call ā€œnew public manage- ment.ā€ Is there something to take care of and be wor- ried about from their critique? How is that done in a constructive way? And whatever theories and sciences we come up with, they are in a sense socially construc- tedā€”they cannot be otherwise (Hacking 1999). But the real test is their usefulnessā€”still a science of improve- ment is only in an initial phase, but it is important that its usefulness is proven not only on local scales but on more universal ones! . . . and the world moves onā€”who wants to be left behind? ABOUT THE AUTHORS Bo Bergman is partly retiring from a chair in Quality Sciences at Chalmers University of Technology and currently also a guest professor at Meiji University, Tokyo. His career started with 15 years in aerospace industry during which period he also became a PhD in Mathematical statistics from Lund University 1978 and was a part time professor in Reliability at Royal Insti- tute of Technology, Stockholm. In 1983 he became a professor in Quality Technology at Linkā‚¬ oping Univer- sity and 1999 the SKF professor in Quality Manage- ment at Chalmers University of Technology. He was a co-founder of Centre for Healthcare Improvement (CHI) at Chalmers and its ļ¬rst director (2004ā€“2009). As a professor he has supervised a large number of PhD students many of which now are themselves professors. He is a member of the International Statistical Institute (ISI) and an Academician of the International Academy for Quality (IAQ). Andreas Hellstrā‚¬ om is a senior lecturer at the Depart- ment of Technology Management and Economics at Chalmers University of Technology, Sweden and co- director of Centre for Healthcare Improvement (CHI) at Chalmers ā€“ a research and education center focusing on quality improvement, innovation, and transforma- tion in health care. In 2007, he successfully defended his Ph.D. thesis on the diffusion and adoption of man- agement ideas. In 2013, he was one of four selected in the ļ¬rst cohort of Vinnva rdā€™s Improvement Science Improvement in Health Care 31 Downloaded by [Svante Lifvergren] at 09:50 25 December 2014
  • 18. Fellowship. He has led research projects in both the pri- vate sector and the public sector. Svante Lifvergren, MD, is a specialist in internal and respiratory medicine. He is quality director at the Skar- aborg Hospital Group (SkaS), Sweden, having also worked as a senior physician at SkaS since 1998. Fur- ther, he holds a Ph.D. in Quality Sciences and he is co-director for the Centre for Healthcare Improvement (CHI) at Chalmers University of Technology. His research mainly focuses on organizational development in complex healthcare organizations. Susanne M. Gustavsson, RN and Midwife, is Nurs- ing Director at the Skaraborg Hospital Group (SkaS), Sweden. She is also an external PhD student at the Centre for Healthcare Improvement (CHI) at Chalm- ers University of Technology, Gothenburg Sweden. Her research is focused on experience-based co-design with patients and relatives in health care processes. 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