<b>Bijsluiter</b>. De hyperlink naar het originele document werkt niet meer. Daarom laat Woogle de tekst zien die in dat document stond. Deze tekst kan vreemde foutieve woorden of zinnen bevatten en de opmaak kan verdwenen of veranderd zijn. Dit komt door het zwartlakken van vertrouwelijke informatie of doordat de tekst niet digitaal beschikbaar was en dus ingescand en vervolgens via OCR weer ingelezen is. Voor het originele document, neem contact op met de Woo-contactpersoon van het bestuursorgaan.<br><br>====================================================================== Pagina 1 ======================================================================

<pre>No evidence
without context
About the illusion
of evidence-based
practice in healthcare
</pre>

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<pre>0 We TD EV

mu —_

</pre>

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<pre>No evidence without context</pre>

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<pre>“Learn the rules like a pro, so you can break them like an artist” – Pablo Picasso</pre>

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<pre>No evidence
without context
About the illusion of
evidence-based
practice in
healthcare
Den Haag, June 2017
</pre>

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<pre>                                                                                4
Foreword
‘Evidence-based’: the magic formula that has penetrated every last nook and cranny
of the practice, policy and financing of care. First produce the evidence and then
start on the applications, payments or purchases. Guidelines, protocols, supervisory
frameworks, quality indicators and care contracts all bear witness to this. The
underlying assumption is that proven care will always be good care. These
recommendations take a critical look at this assumption: what evidence is there in
fact, how did it arise and is it tenable in various situations?
The evidence-based approach has already been a subject of discussion for quite
some time and numerous steps have been taken over the years to refine and
differentiate the research methods and to add nuances to the evidence presented.
The Council wants to go a step further with these recommendations, tackling the
misconceptions and shortcomings in a more fundamental sense. When the day-to-
day reality of care and welfare has so many different facets, the search for
unambiguous evidence is an illusion and an unjustified simplification of what good
care means. That is not to say that the quest for evidence should fall by the
wayside. On the contrary, what we need is a plethora of evidentiary studies that can
only be obtained if scientists and care professionals join forces. This means that
professionals will have to embrace the uncertainty in the argumentation and put the
focus on the context of their patients. For the scientists, it means acknowledging that
scientific evidence is never complete and must always be subject to new insights
and experiences. For health insurers, authorities and supervisory bodies, it means
that the frameworks they define must give scope for an experimental approach to
care practice and that they must prioritise the capacity of care professionals and
care organisations to learn from this and to improve.
These recommendations sketch out a different perspective, one that takes the
context as the baseline and rejects the idea that evidence can be made absolute.
The Council hopes for a fruitful discussion about the power of various genres of
good care and the necessity of linking that with a variety of types of knowledge
sources.
Pauline Meurs
Chair RVS
</pre>

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<pre>The Council for Public Health and Society
(Raad voor Volksgezondheid en Samenleving, RVS)
is an independent strategic advisory body.
The task of the RVS is to advise the government and
both houses of the Dutch parliament (the States General)
about the broad lines of both policy areas.
Composition of the Council
Chair: Pauline Meurs.
Council members: Daan Dohmen, Jan Kremer, Bas Leerink,
José Manshanden, Liesbeth Noordegraaf-Eelens,
Greet Prins, Dick Willems en Loek Winter.
Director/General Secretary ad interim: Luc Donners.
Deputy director: Marieke ten Have.
Council for Public Health and Society
Parnassusplein 5
Postbus 19404
2500 CK The Hague (NL)
T +31 (0)70 340 5060
mail@rvens.nl
www.raadrvs.nl
Twitter: @raadrvs
Publication 17-05
ISBN: 987-90-5732-267-9
Graphical design: Studio Koelewijn Brüggenwirth
Photography: Thijs Wolzak
Printing: Xerox/OBT
© Council for Public Health and Society,
The Hague, 2017
No part of this publication may be disclosed,
reproduced, stored in a data processing system or
transmitted by means of printing, photocopying,
microfilm or any other way whatsoever without
permission from the RVS.
You can also download this publication from our
website.
</pre>

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<pre>Foreword                                                4
Summary                                                 7
1   Background                                         11
2   The rise of EBP                                    14
3   The added value of EBP                             19
4   Criticism of EBP                                   20
    4.1 Evidentiary hierarchy open to discussion       20
    4.2 Evidence-based practitioners en evidence users 26
    4.3 Systemic failures in scientific research       27
    4.4 The “evidence-based”quality mark               28
5   Responses to criticism of EBP                      31
6   Continuing tensions in practice                    33
    6.1 Fundamental tensions in EBP                    33
    6.2 The institutional environment                  37
    6.3 EBP in the consultation room                   41
7   Solutions and recommendations                      50
    7.1 From evidence-based to context-based practice  50
    7.2 The consulting room                            51
    7.3 Learning care organisations                    53
    7.4 The institutional environment                  58
8   Recommendations                                    67
Literature                                             69
Preparation of advice                                  75
Consulted experts                                      76
Publications                                           78
</pre>

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<pre>                                                                                  7
Summary
Evidence-based practice (EBP) emphasises the scientific underpinnings of
professional actions. It has provided the impulse for the development of
professional guidelines, quality indicators and volume norms. EBP engendered
a revolution because any professional is able to claim authority after a critical
assessment of the scientific literature. As a result, the reliance on a consensus
within a specialist discipline has had to make way for reliance on statistics and
numbers. This development began in the 1980s in the professional domain of
medical care. In the meantime, other disciplines both within and beyond the
healthcare sector, governmental authorities, supervisory bodies and health
insurers have embraced the principles and tools of evidence-based practice.
Under the influence of EBP, external responsibility, transparency,
standardisation and checking have become the predominant control and
management principles within the healthcare sector.
EBP has substantially improved the quality and safety of care.
Uncertainty and evidence play an express role in practice, which has greatly
improved systemic reflection on the consequences of medical actions. Tools
have also been developed for converting scientific research into
recommendations for practice. There is however a flip side as well. This boils
down essentially to the fact that the knowledge that EBP is based on is a
simplification of reality.
Firstly, care is given in a context in which the question of the nature of good care
plays a role. An inherent risk of EBP is that it will reduce good, patient-oriented
care to what has been proven. The right thing to do can vary with the patient and
the situation. Moreover, opinions of what constitutes good care are subject to
change.
Secondly, the knowledge that EBP relies upon is based on standardised
situations and on what is quantifiable, preferably in randomised experiments.
Such knowledge does not take sufficient account of the differences between
patients and their personal values, the variation in implementation in practice, or
the dynamic setting in which care is given. There are also forms of care that
cannot be investigated using the EBP methodology. To put it another way, the
knowledge that EBP is based on claims to be universally applicable, and that
knowledge is impersonal: it has no relationship with the professional or the
patient as people. This is ignoring the multifaceted nature of real situations and
the fact that knowledge is always personal. Although EBP is formally the result
of integrating external knowledge, clinical expertise and patient preferences, the
EBP movement has not paid sufficient attention to how this must be done.
</pre>

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<pre>8                                                   RVS – No evidence without context
Thirdly, EBP and professional guidelines (plus the quality indicators based on
them) have become an authority in their own right. If guidelines and quality
indicators are not applied critically, this plays into the hands of undesirable
standardisation in the care sector. In particular, the environment within which
care professionals operate exacerbates this: high pressure of work, care that is
organised separately for each discipline, and the use of evidence-based
principles by governmental bodies, health insurers and disciplinary colleges.
Care professionals spend more time providing quality information for external
accountability than they gain by learning from it. Scientific research needs
attention as well. Unintentionally, a research system has arisen that can
encourage irrelevant and unreliable research, while many elements of
customary care have been investigated insufficiently. Taken as a whole, this is
pushing care practice in the direction of whatever can be investigated and
substantiated using the EBP methodology. This is at the expense of care
elements for which this is difficult or impossible, and of care that is commercially
not interesting.
Evidence as the basis of good care is therefore an illusion. In addition to
external knowledge, good and patient-oriented care requires other sources of
knowledge that EBP underutilises: clinical expertise, local knowledge,
knowledge from the patients themselves, knowledge of the context – the living
conditions and preferences of patients and the setting within which care is given
– and of the values that are involved. Because any decision involves a specific
request for assistance that is given in a specific context, decision-making in the
care sector can be seen as an experiment in linking together the various
sources of knowledge. The uncertainty that is inherent in this must not be denied
it should indeed be embraced. Every decision can be and should be a learning
moment.
Because of the lack of clarity in the content and the shortcomings of EBP, the
Council for Public Health and Society is pleading the case for context-based
practice rather than evidence-based practice. This is because of the importance
of the specific context, the patient and the setting where the various sources of
knowledge are used as the basis for the decisions that are taken. This goes
beyond a mere local implementation of external knowledge. It means a
continuous process of learning and improving together. It also signifies a
different approach to education, research and supervisory practices.
</pre>

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<pre>Summary                                                                           9
For the individual patients’ care, this means that care professionals must adjust
the practice of shared decision-making to fit the context of the patient, and pay
more attention to listening than to the dissemination of information. This practice
can be assisted by selection tools to help discover what patients find important.
Patients' organisations need to take the initiative for developing the selection
tools, together with care providers and other parties involved. An essential skill
for care professionals is that they must be capable of understanding the value of
various sources of knowledge and integrating them into practice, with an eye for
the context and the considerations involved. Developing this competence is
something they ought to be doing together with all relevant parties involved,
including colleagues from other disciplines and the patients. This capacity goes
hand in hand with embracing the uncertainty about the nature of good care.
There is already a great deal of attention paid to such skills in the training of
care professionals. However, there needs to be more space here for social and
mental sciences, for interdisciplinary education and active input from the
patients.
The capacity of care professionals and care organisations to learn is enhanced
when attention is paid to the working environment. In the early stages of care
processes, particularly during the diagnosis and decision-making phases, care
organisations should put more time aside for learning. This investment will pay
itself back because the effort spent in diagnosis and treatment will be reduced.
In the current care system, quality monitoring is outsourced to third parties and
has become divorced from the care professionals themselves. The emphasis
has shifted to external accountability, standardisation and checks. The Council
believes it is important to shift this practice towards a situation in which care
organisations and care professionals decide for themselves what constitutes
good care and arrange their organisations and working methods to suit.
</pre>

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<pre>10                                                  RVS – No evidence without context
To this end, care professionals should start up a dialogue about good care
within their own care organisations, not only amongst themselves but also with
their managers and with the patients. Care organisations should take the
initiative to enter this dialogue with other interested parties: other care providers
in the region, health insurers, patients' organisations and municipalities. Tools
for this could for instance include quality figures and other local data, the system
of patient tracers, annual reports and patients' stories. Because of the principles
involved, this dialogue has to take place in an open “moral forum”. This moral
forum or “agora” can be seen as the vehicle for legitimising decision-making in
the care sector about what goals are being aimed for and using what resources.
The importance of that legitimisation means that the dialogue is not optional: it
becomes obligatory. This is how the parties involved fulfil the public tasks that
they have been assigned, and how they can be held accountable for the results
achieved. In order to ensure the development and the quality of this moral
agora, it is important that it becomes part of the governance of care institutions.
This shift has consequences for the system of scientific research. Utilising
external evidence in the local situation is more than merely a question of
implementation. It must be part of a learning process in which the effect of
contextual factors on the care outcome is made explicit. Researchers and those
financing healthcare research must therefore pay more attention to the effect of
the context of the practice within which care is provided. This can be done for
example by making use of local data from practice, and by combining
quantitative and qualitative methods in the same studies.
When making recommendations about how packages should be managed, the
National Health Care Institute should take account of the context within which
care is provided and of other sources of knowledge than scientific evidence.
This can be encouraged by involving professionals, patients and the general
public.
Finally, the focus for quality supervision and care contracting needs to shift from
uniform quantitative outcomes of care towards learning and improving on the
part of care professionals and care organisations.
</pre>

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<pre>                                                                                    11
1          Background
Evidence-based medicine
It seems obvious nowadays that care professionals will rely on scientific
evidence. The evidence is, after all, an essential component of the legitimisation
and standardisation of professional treatment. Its roots go back to the 1980s. A
movement arose in healthcare that is now known as evidence-based medicine
(EBM), “the conscientious, explicit, and judicious use of current best evidence in
making decisions about the care of individual patients.” (Sackett et al., 1996).
EBM has provided an impulse for innovation of medical education and research
and for the development of professional guidelines or standards to help care
professionals when taking decisions in the care of individual patients.
From evidence-based medicine to evidence-based practice
Evidence-based working is now no longer restricted to the medical domain; it
has extended to other disciplines and domains both within the healthcare sector
and elsewhere, such as care provided by medically associated professions,
youth care, the public healthcare system, long-term care, social work and
education. Evidence-based principles have also made inroads in policy and
monitoring. To help develop this broader development, we will use the term
evidence-based practice (EBP) here. The term ‘EBM’ will however be used on
occasion when referring to specific historical developments.
Personalisation of care delivery
We are now decades further. There have been a variety of changes in the care
sector that are important for the role that evidence plays within it. Firstly, the
substantive content of care has changed a great deal. There has been an
increasing emphasis on the personalisation of care (i.e. patient-focused care):
care that it is tailored to suit the individual need for aid, the characteristics and
preferences of the patient, and their personal context. The type of evidence that
is typical for EBP (derived from research among selected populations and in
strictly controlled circumstances) is not always sufficient for this. This needs to
be translated to individual people and their situations. Solutions that are effective
in one situation will not necessarily be applicable to other situations.
</pre>

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<pre>12                                                RVS – No evidence without context
Changing environment
Secondly, not only the content but also the environment of care practice has
changed significantly (Noordegraaf et al., 2016). Professional activities are
increasingly becoming a question of teamwork. Several disciplines are often
involved with any given patient or client, each bringing in their specific expertise.
In addition, confidence in professional expertise has become less self-evident.
Professionals are increasingly being expected to provide accountability to third
parties. External supervisory bodies such as the Healthcare Inspectorate use
evidence-based tools such as professional guidelines and quality indicators
based on them to monitor that accountability. The same applies to package
management by the National Health Care Institute and the way that health
insurers contract care. These developments mean that scientific evidence is
becoming more and more institutionalised and subject to vested interests. This
creates tensions. Attention is also required for the relationship between
professional practice, scientific research and policy practice that are based upon
scientific evidence.
Care that has been proved to work is not necessarily good care
Medical activities and ‘using the best evidence’ always has a moral context in
which the question of the nature of good care plays a role. Moreover, opinions of
what constitutes good care are subject to change. An understanding of values is
therefore required for setting treatment goals and for weighing things up. The
entire process of providing evidence is in fact driven by values: the programming
and implementation of research, the selection of measures of outcome and
measurement methods, the translation of research results into guidelines,
manuals and protocols, and the use of that knowledge within individual patients’
care. Ethical considerations of what good care involves therefore also demand
attention in the way scientific evidence is used. Good care is therefore more
than merely that which has been proved to work.
Purpose of the recommendation
The personalisation of care, the changing environment and the morally charged
context of care all add to the tensions that exist between the ideal of EBP
(proven care is the same thing as good care) and its use in practice. The
proponents of EBP are themselves well aware of these tensions and are
working on improvements. Actual practice reveals further important bottlenecks,
however. At the same time, the tensions between the ideal of EBP and its
practice raise the question of how much that difference is a consequence of its
fundamental principles.
</pre>

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<pre>1 – Background                                                                13
Question
The recommendation is based on the following question:
If good care is more than merely that which has been proved to work, how can
scientific evidence be used in providing good care and giving it legitimacy?
Scope of the recommendation
The Council is aiming to play a part through these recommendations in the
analysis of the tensions between the ideal of EBP and its practice, and wants to
suggest avenues for possible solutions for the appropriate use of scientific
evidence in care practice and care policy. The underpinnings and the examples
in these recommendations have largely been drawn from medical care practice,
because evidence-based working has made the most inroads there and
because it is the area where there is the most experience. The bottlenecks and
areas of tension that are associated with evidence-based working are however
present in other domains as well, both within the healthcare sector and
elsewhere, in practical work and in policy. These recommendations are
therefore relevant to a number of domains.
Reading guide
The tensions between the ideal of EBP and its practice are examined from the
perspective of professional conduct and possible avenues for solutions are
given. In order to do justice to the developments within EBP, the structure below
has been adopted. An outline description is first given of the development of
EBP (Chapter 2) and the added value that it has provided for the care sector
(Chapter 3). This is followed by the criticisms of EBP (Chapter 4) and the
responses to them by the proponents of the EBP movement (Chapter 5). The
recommendations then give an analysis of the current areas of tension within
EBP that are related to the fundamental principles of EBP and the use that care
professionals and institutional parties make of it (Chapter 6). The
recommendations end with a number of directions in which solutions can be
sought and recommendations for the bottlenecks (Chapter 7).
</pre>

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<pre>14
2 The rise of EBP
Background
The reason why EBM was developed lies in the fact that the effectiveness and
safety of a great deal of medical care practice were unknown or at least dubious.
That could be seen from the considerable variations in practice. Reducing that
variation in practice and cutting down on ineffective or even harmful care, plus
the associated waste of resources, was the key objective of EBM (Berwick,
2016; Timmermans, 2010; Wennberg, 1984). This means that EBM is in line
with one of the key Hippocratic principles of medicine, namely not to cause
harm.
It started with medical education
The EBM movement was aiming for radical renewal of medical actions, from
within. Related ideas and initiatives arose at a variety of places during the same
period. Key pioneers were the British epidemiologist Archie Cochrane
(Cochrane, 1972), David Sackett from McMaster University (Hamilton, Canada),
Feinstein in the USA, and the Danish gastroenterologist Henrik Wulff. EBM
began life as a new educational model that was developed at McMaster
University. Up–and-coming care professionals were trained to develop a critical
(and self-critical) mentality and to justify their own activities through a critical
assessment of the scientific literature. EBM is now part of the core of the
medical curriculum. EBM was however destined to become much more than the
renewal of medical education, providing inter alia the impulse for systematic
assessment of literature and the development of professional guidelines for
practice.
From authority to evidence
Before the introduction of EBM, medical actions were based on intuition, the
physicians own clinical experience and the basic medical knowledge that
allowed doctors to reason things out of in terms of pathophysiology or
mechanics (Bolt, 2015). This meant that the foundations of their activities were
primarily the consensus within their own specialist discipline and the people who
were deemed to be an authority within the discipline. Because of growing
awareness for the uncertainty, subjectivity and bias in medical knowledge, this
went hand-in-hand with falling confidence in professional expertise and
authority. EBM engendered a revolution because it rendered junior doctors
capable of challenging such authority by calling upon the scientific literature.
EBM can therefore also be seen as a democratisation of knowledge.
</pre>

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<pre>15                                                   RVS – No evidence without context
Through systematic use of scientific evidence, EBM aimed to eliminate the
uncertainty, subjectivity and bias in medical knowledge.
The best evidence
A central element in the EBM approach is that it makes distinctions in the levels
of proof when assessing scientific information. At the top of the evidentiary
hierarchy is the randomised controlled trial or RCT, in which a treatment is
compared against an alternative and in which the patients are randomly
assigned to one of two groups. This is followed by follow-up studies, case-
control studies, case reports and case series respectively as lower evidentiary
levels, with the opinions of experts right at the bottom. The best evidence that
EBM uses, the RCT, can therefore be seen as group-level evidence: hypotheses
are examined using statistical methods based on observations of groups.
EBM therefore signified a shift from relying upon consensus within a specialist
discipline (‘disciplinary objectivity’) to relying upon statistics and figures
(‘mechanical objectivity’) as a common basis for medical actions (Porter, 1995).
This shift in what objectivity involves means that the touchstone of medical
actions now involves figures and measurable outcomes from which the personal
element has been eliminated. This increasing reliance upon the figures – which
has incidentally occurred in multiple domains – moved the care sector into an
era in which external accountability, transparency, standardisation and
monitoring have become the dominant principles for control and assessment
(Porter, 1995).
Development of guidelines
As well as renewing medical education, EBP has provided an impulse to the
development of professional guidelines or standards. Key reasons for this
development are that the assessment of research results requires specific
expertise that care professionals do not always have, and that it is all but
impossible for any individual healthcare professional to keep up to date on the
scientific literature. In the Netherlands, the CBO (Dutch Institute for Healthcare
Improvement) and the NHG (Dutch College of General Practitioners) have taken
the lead in developing guidelines, which were initially above all based on
consensus. The scientific associations of the professional groups are currently
responsible for this, with support provided by the Knowledge Institute of the
Federation of Medical Specialists and the National Health Care Institute.The
implementation is dealt with by committees with clinical and methodological
expertise.
</pre>

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<pre>2 – The rise of EBP                                                              16
These committees assess the scientific literature about the diagnosis and
treatment of a specific condition, weigh up the evidentiary strength and base
their recommendations for practice upon it.
Institutional and social context
The development of EBP did not and does not stand alone; it is instead within a
changing institutional and social context. The prestige and authority of
professionals and of science itself are no longer so obvious. Stricter
accountability requirements are being imposed on these parties in order to
maintain authority and trust. This public pressure has a variety of causes,
inter alia the stronger position of patients, the pressure to use public resources
efficiently, the role of the media who denounce abuses in care and legal
procedures against healthcare professionals. Several of these developments
have been translated into legislation in which evidence-based professional
standards have a place, such as the Medical Treatment Contracts Act (Wgbo)
and the Healthcare Quality, Complaints and Disputes Act (Wkkgz). Scientific
evidence has therefore become part of external control and supervision. This will
be dealt with in following paragraphs.
A stronger position for patients
The responsibilities of care providers and those who receive care are legally laid
down in the Wgbo and are derived from the applicable professional standards
(Art. 7:453 of the Dutch Civil Code). Strengthening of the legal status of patients
was part of the background to the Wgbo. Care providers have a duty to provide
care in the way a good caregiver should, i.e. in accordance with the applicable
professional standards. These are not legally binding standards. Care providers
are allowed to deviate from the applicable guideline provided there is justification
for doing so. They may even have to deviate from it if required for quality
reasons. On the other hand, care providers who observe the guideline are not
exonerated from liability for any harmful consequences of their actions
(Supreme Court, 1 April 2005, Dutch Jurisprudence (NJ) 2006, 377).
Patients in turn have the option of deviating from a care provider’s advice by
exercising their right to refuse an examination or treatment. They are not entitled
to examinations or treatments that conflict with professional standards (RVZ,
2013).
Supervision of quality and safety
Quality supervision also uses evidence-based instruments such as professional
standards and volume standards.
</pre>

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<pre>17                                                  RVS – No evidence without context
The implementation of the Care Institutions (Quality) Act in 1996 gave the
government more responsibility for the quality and safety of care, as well as the
legal authority to ensure it. The Care Institutions (Quality) Act has now been
replaced by the Wkkgz, which obliges institutions to comply with certain quality
requirements that reasonably guarantee the provision of good care, i.e. safe,
efficient, effective and client-oriented care. Like the Wgbo, the norm in the
Wkkgz has been based on professional standards.
The consequence of these quality requirements is that care providers must
measure and record the quality of care systematically. To that end, the National
Health Care Institute developed an assessment framework that quality
standards (including guidelines) and quality measurement instruments (quality
indicators and client questionnaires) must comply with before they are included
in the Quality Register (National Health Care Institute, 2014a). One of the
requirements is that a quality standard or measuring instrument must have been
jointly recommended by healthcare providers, healthcare insurers and patients.
The aim is to provide clarity about what these healthcare parties consider to be
good care and to ensure that the recommended measuring instruments can be
used for quality improvement, supervision, choice information by clients, and for
purchasing care.
The National Health Care Institute also has the legal power to develop quality
standards. If parties fail to deliver quality standards, the Quality Council of the
National Health Care Institute must write the standards, after which the National
Health Care Institute includes them in the Quality Register. This may help move
discussions forward that were not making any progress in terms of content.
Package management
The National Health Care Institute has adopted the principles of the EBP for
package management in the context of the Healthcare Insurance Act and the
Long-Term Care Act. Various steps have been taken in the working method to
ensure that the context is considered in the package recommendations. These
always refer to an intervention in the context of a specific indication. Checks are
made at the start to see what healthcare providers and patients consider to be
good care. After that, a check is made to determine what evidence should be
present (given the nature of the intervention and the indication), what evidence
is available, and what the causes of any discrepancies are. The available
evidence is then assessed against the legal criterion of the ‘current state of
knowledge and practice’ (Health Insurance Decree and Long-Term Care
Decree).
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<pre>2 – The rise of EBP                                                              18
This criterion is formally used as an integrated standard, in which insights from
scientific research, expertise and experience of healthcare providers and care
recipients are ‘combined and incorporated’ (National Health Care Institute,
2015). This integral assessment means that the quality of the available evidence
is weighed up; the evidentiary hierarchy mentioned earlier is key. The solidity of
the scientific evidence then determines what the insights and experiences
gained in practice actually signify. Higher or much lower quality of the scientific
evidence is in principle the deciding factor when the decision on reimbursement
is taken. Insights and experiences gained in practice can be important if the
quality of the scientific evidence is mediocre or low. The term ‘practice’ is taken
here to mean treatments that are normative for the professional group as a
whole or that are seen as ‘good’ treatment, i.e. not the individual experiences of
healthcare providers and care recipients.
Where possible, the assessment of care as part of the insured package is
aligned with the recommendations in professional guidelines. However, the
dichotomous nature of the package assessment – in which the care for a
specific indication type is assessed – differs from the more nuanced approach of
recommendations in professional guidelines for the care of individual patients.
Evidence-based purchasing of care
The quality standards (including professional guidelines) and quality
measurement instruments of the National Health Care Institute are also the
basis on which health insurers contract care.
Evidence-based medicine (EBM) has led to a radical shift in medical care from
reliance upon the authority of the physician to scientific evidence and
measurable quality. Although EBM was initially ‘owned’ by the medical
profession, policy makers, supervisors, health insurers and patients have also
adopted EBM’s principles and the associated tools in order to control
professional actions.
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<pre>19
  3 The added value of EBP
The evidence-based approach has made important contributions to the quality
of medical care.
Evidence is more explicit
Firstly, scientific evidence is playing a more explicit role in medical care, which
reduces uncertainty, subjectivity and bias. A great deal of ineffective or harmful
care has been identified and then eliminated. Furthermore, EBP helps curb the
introduction of new technology that is insufficiently proven and helps identify
domains where insufficient research has been carried out.
Systematic reflection
Secondly, EBP can be considered to be a systematic form of reflexivity.
Reflection on the consequences of medical actions takes place jointly and in a
more systematic and organised way, compared to ‘authority-based’ medicine.
Under the influence of EBP, an international knowledge platform has developed
where clinical experiences are bundled, tested and distributed.
The answer to the knowledge explosion
Thirdly, the emergence of EBP was accompanied by developments that have
made it increasingly easy to generate and distribute knowledge. The
development of guidelines is therefore also an answer to this explosion of
knowledge. The methodology that is applied for assessing and weighing up
measurement results has become ever more refined, so that translation into
recommendations takes greater account of the degree of certainty or
uncertainty.
Development of statistical methods
Fourthly, an important spin-off of EBP is the development of statistical methods
for identifying and quantifying the consequences of medical actions.
EBP has made a significant contribution to the quality of medical care because
the supporting evidence now plays a more explicit role and because it has
encouraged systematic reflection upon the consequences of medical actions.
Tools have also been developed for translating scientific research into
recommendations for practice.
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<pre>                                                                                  20
4 Criticism of EBP
The ambition of the EBP movement was gradually moderated somewhat and
the criticism grew. This also came from the evidence-based movement itself,
fitting the attitude advocated by EBP. Some have even raised the question of
whether EBP was in a crisis (Greenhalgh et al., 2014).
     4.1   Evidentiary hierarchy open to discussion
This criticism targets the evidentiary hierarchy and the position of the RCT first
of all. Leaders of the EBP movement have also expressed their doubts and
proposed alternatives (Howick et al., 2008). The claim of proponents is that only
RCTs provide pure evidence about the effects of diagnosis and treatment.
Two scientific paths: evaluate and explain
The first counterargument here is that science is more than evaluating. For
explaining diseases and the efficacy of interventions, and therefore for finding
new causes of disorders and new targets for treatment, observational research
is more appropriate and more efficient than RCTs. The evidentiary hierarchy for
this explanatory research is in fact the reverse of that for evaluation research
(Vandenbroucke, 2008). This path of scientific research is erratic and non-linear.
Systematic analysis of laboratory experiments, case descriptions and analysis of
medical datasets allow existing hypotheses to be made and tested and new
hypotheses to be formulated. The spectrum of possible explanations or causes
is in principle broad, and the chance of finding something during any given
analysis is small. Coincidental findings can mean a new breakthrough, but
recognising such coincidences requires a lot of knowledge and experience.
RCTs, on the other hand, focus on the effect of a single intervention, making
them ideally suited for evaluating diagnostics and treatment. Due to the high
costs and relatively long lead times, these only take place if the chance of
showing an effect is estimated to be high, based on all the prior research. How
high these ‘prior odds’ should be is in principle the result of ethical and financial
considerations (‘do the risks outweigh the potential benefits for patients’, or ‘is
the research worth the investment’).
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<pre>21                                                 RVS – No evidence without context
Observational research and randomised studies are thus different but
complementary approaches to scientific research. Neither can exist without the
other. In principle, the nature of the research question determines the research
setup. Every setup has its strengths and weaknesses, and the internal validity
has to be weighed against the generalisability of the results (Ottes, 2016).
Limits of RCTs for evaluation studies
In addition to criticism of the evidentiary hierarchy as such, the claim that RCTs
provide the most convincing evidence for the effectiveness of care is only partly
justified. Without knowledge of the mechanisms that can explain a proven
difference, doubts will remain about a causal relationship. In addition, various
forms of medical care have never been studied in an RCT but are nevertheless
part of regular care. This applies for example to penicillin and to organised
screening for cervical cancer (Peto et al., 2004). The results of observational
research can be so convincing that it becomes unethical or inefficient to use an
RCT to evaluate care that is already customary.
RCTs are not always possible either. This may be due to legal or ethical
objections, such as research among the legally incapacitated, children or
terminal patients. There can also be methodological reasons for this, such as is
the case in research among elderly people with multiple morbidity or research of
rare diseases. Blinding is sometimes impossible, distorting the results e.g. in
research into the quality of the therapeutic relationship in the treatment of mental
disorders (see the boxed text on “Psychotherapy”).
Psychotherapy: the role of non-specific factors and context
The success of the approach adopted can sometimes only be attributed to a
limited extent to the method that was followed. People with mental problems
who get help usually get a form of psychotherapy to regulate their emotions,
behaviour, thinking patterns or personal characteristics. There are many
different forms of psychotherapy, all with their own starting points or
approaches. Cognitive behavioural therapy, psychodynamic therapy and
solution-oriented therapy are some of the most well-known.
However, a great deal is still unknown about why psychotherapy works and
about the contribution made by the specific methodology.
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<pre>     4 – Criticism of EBP                                                          22
There is discussion about the exact extent, but the specific methodology seems
to be of only limited importance. This is also called the “dodo bird verdict”,
inspired by the quote from the book Alice in Wonderland: “Everyone has won so
all shall have prizes”. An explanation for this is that all methodologies share
generalised, effective, non-specific factors and placebo effects that partially
determine the effect of therapy. An example of an important generalised
effective factor is the quality of the relationship between the client and the care
provider. Factors from outside the therapy, such as events in their private lives
or finding work, also have an influence on the treatment effect.
These observations have far-reaching consequences. They determine whether
it is sensible to invest in the development of specific care methods. For care
providers, the question is whether it is sensible to look for specific interventions
that could be helpful, or whether they are better off investing in training skills
that help create good relationships with clients.
And finally, despite strict methodical requirements, many RCTs are not free
from systematic distortion of the results (Ottes, 2016). The mere fact that a
patient knows they are participating in a study leads to distortions. That this is
not a matter of doom and gloom has been shown in a recent overview study of
research in various fields. This concludes that, on the whole, the extent of
distortion in research results is small (Fanelli et al., 2017).
The context matters
Ultimately, the strength of this flagship of the EBP movement is also its
weakness. RCTs follow a strict protocol to prevent influences on the results
from factors other than the intervention. Participants, outcome measures and
interventions are standardised. Because of this standardisation, less attention is
paid to the variation that exists between patients, the desired outcomes and
performance practices of interventions, and the dynamics of the setting in which
the care is given.
In reality, the results on an individual level within the group studied will vary, and
these results can differ for people outside the group studied. Some groups that
are systematically excluded from RCTs are at an additional disadvantage here:
children, women, the elderly and people with a comorbidity or multiple morbidity
(see the boxed text on “RCTs and drug research”).
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<pre>23                                                 RVS – No evidence without context
A great deal of clinical research is carried out in second-line patient groups and
is not necessarily usable in primary care where there is a different mix of
patients (Steel et al., 2014). Additionally, the personal situations of patients can
affect the treatment outcomes and the meaning attributed to them. This shows,
for example, the role that parents and teachers play for children with ADHD (see
the boxed text on “ADHD”).
RCTs and drug research
After earlier research phases are completed, the effectiveness and safety of
pharmaceuticals are tested in RCTs from which the elderly and patients with
comorbidity and concomitant medication are usually excluded. This makes it
harder to translate research results into everyday practice. There is also the risk
that medicines are not licensed for the patients who need them most. TNF-alpha
inhibitors against rheumatism, for example, are mainly studied in patients with a
high disease activity. This medication is less effective for patients with lower
disease activity. Another example is protease inhibitors against hepatitis C.
Patients with cirrhosis of the liver and severe portal hypertension are excluded
from the trials. The risk of complications is higher in these patients, which
hinders therapy compliance and thus reduces the effectiveness of the treatment
(Kievit et al., 2016). Medication for preventing fractures in patients with
osteoporosis is only tested on women and not on men.
ADHD: should you ask the children, or the parents and teachers?
After the discovery of an amphetamine derivative called methylphenidate in the
1950s, it became incredibly important for the treatment of ADHD in children and
adolescents. The place of the medication differs from one guideline to the next.
In the multidisciplinary guideline for ADHD, it is the first choice for the treatment
of symptoms, whereas the guideline from the NHG (Dutch College of General
Practitioners) recommends it if parent/teacher guidance and any psychotherapy
is not helping sufficiently. These differences can be traced back to the meaning
given to the roles of parents and teachers. The recommendations are based to a
great extent on a major study in the 1990s, known as the MTA study. It
compared the value of behavioural therapy against medication, or a combination
of the two. It was notable that medication resulted in better reduction of
symptoms, while parents and teachers were more satisfied with behavioural
therapy.
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<pre>4 – Criticism of EBP                                                         24
This was shown in the quality of life and general functioning. Behavioural
therapy allowed parents and teachers to deal with the behavioural problems
of the children better. The researchers also suggested this as an explanation
for the fact that many parents stopped the medication after the end of the
study (Boer, 2007).
Interventions are messier in practice than in a standardised experiment. This
even applies to relatively simple interventions like medication, where
carelessness or taking medication with or without food can influence the
result (see the boxed text on “Cancer medication with breakfast”).
Cancer medication with breakfast
Some cancer medications appear to be absorbed by the body better if
patients take them with a light breakfast. The dosage can then be lowered
and the patient is less affected by side effects such as nausea, and there can
be cost savings. The Patient Information Leaflet for these medicines says that
they should be taken on an empty stomach to ensure an even concentration
throughout the body. This happens when clinical research shows that food
influences the absorption in the body. Such research is required by the
licensing authorities. In the study on the effectiveness of the medicine, that it
should be taken on an empty stomach is now part of the protocol. More
research to check the influence of different types of breakfast on each
medicine could help achieve more personalised pharmacotherapy. It is
important that patients do comply with certain breakfast regulations
(Volkskrant, 27 March 2017).
Finally, the research results are not universally applicable because they are
partly dependent on the setting in which the care is given. The experiment
with free provision of heroin that took place in the 1990s is a good example of
this. The circumstances under which it was to be used were substantially
different from normal heroin use, and therefore the results could not be
considered as representative for a natural situation (see the boxed text on
“Free provision of heroin: a created reality”).
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<pre>25                                                  RVS – No evidence without context
Another example of the influence of the treatment context is measuring high
blood pressure (see “White coat hypertension”).
Free provision of heroin: a created reality
To back up the policy of the ‘Purple’ (Left Right coalition) cabinet to provide free
heroin (“heroin on prescription”) to those heavily addicted, the parliament
decided in 1999 to conduct a randomised study. The then Minister Els Borst
argued that only an RCT could pass judgement on this politically controversial
issue. The study was conducted under the responsibility of the medical/scientific
Central Committee on the Treatment of Heroin Addicts (CCBH). For various
reasons, it is doubtful whether such a randomised experiment could give the
final answer on an issue as complex as heroin addiction (Dehue, 2002). One of
the reasons is that the addicts taking part knew that the outcomes were a
deciding factor in whether heroin was provided. It was in the interests of those
who got heroin to show progress, which was not the case for those in the control
group. Another reason is that they had to work with a group of heavily addicted
people.
This is problematic, given that it is known that addiction is to a large extent a
matter of subculture and social factors. Use is connected to specific
circumstances and rituals. In the experiment, heroin was provided in strictly
controlled circumstances, namely under supervision and with a strict regime of
use. It is therefore unlikely that the participants were representative. Additionally,
this research setup reduces heroin addiction to a problem of the individual;
social factors that play a role in addiction are ignored. The results are therefore
the result of a created reality that is far from the natural situation. This example
also shows that an excessively close relationship between science and politics
has its downsides because the experiment stifled political discussion of the
problem of heroin addiction.
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<pre>4 – Criticism of EBP                                                              26
     White coat hypertension
     Detecting high blood pressure is not as easy as it seems.
     It appears that the setting in which the blood pressure measurement takes
     place can make a difference. Some patients have higher blood pressure if a
     doctor does the measurement than when they measure at home. This
     difference is generally attributed to increased stress. This is the case in up
     to 20% of people. The result is that more patients than necessary use
     antihypertensive medication.
Absence of proof is no evidence of absence of effect
These nuances in the evidentiary hierarchy and the purity of RCTs, and the role
of context, mean that the absence of proof is not necessarily proof that there is
no effect. Strict application of EBP can crowd out potentially good but unproven
care.
4.2         Evidence-based practitioners en evidence users
A second point of criticism levelled against EBP is that the focus has shifted
more to developing systematic overview articles and professional guidelines
rather than to developing a critical (or indeed self-critical) attitude among
practising doctors. Only a limited few have managed to acquire knowledge of
the methods and techniques for critical assessment of the literature. According
to the Dutch Federation of Medical Specialists, there are over 500 guidelines for
medical specialist care, of which about 100 are renewed or developed further
every year; there are about 100 NHG standards for general practitioners.
Assessment of literature and the development of guidelines has become its own
specialist field, and care professionals are more “evidence users” than
“evidence-based practitioners” (Gordon Guyatt, quoted in Daly, 2005). For them,
guidelines and guideline developers are a new authority (Greenhalgh, 2014).
What started as an anti-authoritarian movement has itself become a new
authority.
Standardisation of care
Standardisation of care through the use of guidelines is not necessarily
undesirable. When variation in practice is the result of subjectivity, bias and
uncertainty, standardisation helps to reduce randomness and differences
inaccess to care that cannot be justified. However, guidelines can also play into
the hands of undesirable standardisation of healthcare.
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<pre>27                                                  RVS – No evidence without context
This risk increases if guidelines suppress people’s own professional expertise
and experience, if substantive medical reasons for deviating from the guideline
do not get enough attention, if contextual factors are not sufficiently taken into
account, if the experiences and preferences of patients are not given sufficient
space and if guidelines are applied rigidly for purchasing and supervision. ‘Better
avoided’ lists can add to this, despite the fact that their intention is to reduce
ineffective care (see the boxed text on “Better avoided list”). The trick is to not let
reduction of undesirable variation come at the expense of desirable variation.
‘Better avoided’ list
Under the responsibility of the Netherlands Federation of University Medical
Centres (NFU), a ‘better avoided’ list was created based on evidence-based
recommendations from existing guidelines. It includes more than 1300 medical
actions that, after assessment of the underlying proof, are discouraged or
strongly advised not to be applied as a matter of routine. The list aims to reduce
unnecessary care that has no added value or can be harmful (Wammes et al.,
2016).
4.3      Systemic failures in scientific research
A third point of criticism is that a number of undesirable and interrelated
research practices arose that were exacerbated by well-meaning rules and
stimuli in the research system (Reijmerink, 2014).
A group of scientists exposed these practices in the journal the Lancet. This
includes excessive attention to small differences in randomised studies that are
statistically significant, which impacts negatively on the attention paid to what is
clinically or socially relevant, research that has been set up poorly, omitting
displeasing results in publications, or even not publishing disappointing results
at all.
The result is that a lot of clinical research is unreliable, even research that is
widely cited (Ioannidis, 2005a; Ioannidis, 2005b). Consequently, there is
considerable and potentially avoidable wastage in healthcare research. Forty
per cent of pharmaceutical trials do not get published, a large proportion of the
research results in psychology are not replicable if the study is repeated, and a
critical assessment of the underlying research has raised serious doubts about
the benefits of psychopharmaceuticals (see the boxed text on “Serious doubts
about the benefits of psychopharmaceuticals).
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<pre>4 – Criticism of EBP                                                               28
    Serious doubts about the benefits of psychopharmaceuticals
    In an extensive study, physician and epidemiologist Peter Gøtzsche criticism
    include the facts that the proven benefits of these drugs are too small to be
    significant, harmful side effects such as suicidality are systematically
    concealed, and problems that occur when discontinuing or reducing
    medication are ignored (Gøtzsche, 2016). A great deal of knowledge has
    been accumulated about the complicated interplay of biological and
    environmental factors in the development of psychological disorders.
    Gøtzsche’s observations mean that the practical benefits of this knowledge
    are minimal as of yet for the pharmacotherapeutic treatment of patients.
  4.4         The “evidence-based” quality mark
  A final point of criticism is that “evidence-based” has become a quality mark for
  good, proper care that has benefited the pharmaceutical and medicinal
  industry (Greenhalgh, 2014). The RCT, the most expensive form of research,
  has become their instrument for determining the agenda, execution and
  publication of research. As a result there is a relatively large amount of studies
  into medication, published results are often disproportionately positive, and
  pharmacotherapy takes up a key position in guidelines. Areas of research that
  are not commercially interesting or that are not backed by financially strong
  parties are at a disadvantage.
  The rhetorical power of the term “evidence-based” has also not failed to affect
  other domains within healthcare and beyond, as well as the management,
  policy, supervision and contracting of care. Taken as a whole, these
  developments have resulted in healthcare being directed towards whatever
  can be investigated and substantiated using the EBP methodology.
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<pre>29                                                    RVS – No evidence without context
In this context it is remarkable that scientific research pays more attention to the
effectiveness of treatments than to diagnostics. There are more therapeutic trials
than diagnostic ones. This is surprising, given the finding that a lot of
unnecessary care and complications in practice are the result of under-diagnosis
or over-diagnosis. Knowledge of treatments exists in principle only for the
patients on whom they have been studied, and is therefore linked to the disease
concept that was adopted, to how it is defined and to how it is diagnosed.
Advancing insights into the nature and causes of disorders and diagnostic
innovations can in practice lead to a shift in diagnoses. As diagnostic tests
become more sensitive, for instance more sophisticated imaging diagnostics,
more cases of a disease can be detected; this can however also lead to over-
diagnosis and over-treatment (see the boxed text on “Over-diagnosis”).
   Over-diagnosis
   A prime example of over-diagnosis is care for patients with suspected
  pulmonary embolisms (blood clots in the pulmonary vessels). The advent of CT
  angiography (X-ray combined with contrast agent) in the 1990s has greatly
  changed the care for these patients. Before that time, pulmonary angiography
  and perfusion scintigraphy (a test using radioactivity) had the key position in
  the diagnosis.
  The Dutch guideline recommends CT angiography if clinical investigations
  mean there is a strong suspicion of pulmonary embolism. Because CT scans
  are much more sensitive, the incidence of pulmonary embolism has almost
  doubled Treatment with anticoagulants is recommended as standard for these
  patients. It is striking that the overall mortality rate from pulmonary embolisms
  decreased slightly after the introduction of CT scanning, whereas the number
  of complications – haemorrhages are a known complication – increased by
  about half. It can be deduced that over-diagnosis has increased due to CT
  scanning:
  more patients were found with small clots who would never have experienced
  symptoms or other consequences if left untreated.
  There are many other examples of over-diagnosis, such as with organised
  cancer screening, the preventive consultations in GP practices, the removal of
  gallstones, and the shifting limits of risk factors in general.
  Sources: Bossuyt, 2011; Wiener et al., 2011; Welch et al., 201
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<pre>4 – Criticism of EBP                                                                 30
  There is growing criticism of EBP. First of all, the idea of an unambiguous
  evidentiary hierarchy with randomised controlled trials (RCT) as its flagship has
  been called into question. The standardisation inherent in RCTs is also the
  greatest weakness, including underemphasising variation between patients and
  the context of healthcare. The results of RCTs are consequently not universally
  applicable. Conversely, this means that care that is not underpinned according to
  evidence-based principles is not necessarily unproven.
  A second point of criticism is that EBP and professional guidelines have become
  an authority in themselves. Insufficiently critical application can also lead to
  undesirable standardisation of healthcare.
  Thirdly, EBP has unintentionally contributed to a research agenda that is
  insufficiently controlled by what is clinically or socially relevant. Together with the
  institutionalisation of evidence-based practice, this reinforces development in
  which healthcare practice is directed towards whatever can be investigated and
  substantiated using the EBP methodology.
  Finally, a research system has been unintentionally created under the influence
  of EBP that has embedded stimuli for research that is unreliable and not clinically
  or socially relevant. As a result, questions are not answered properly and
  research resources are wasted.
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<pre>                                                                                31
    5 Responses to criticism
            of EBP
The criticisms mentioned above have led to various adjustments that were
initiated by the EBP movement itself.
Reflexive research practices
One of the criticisms concerns the standardisation in RCTs. In much
experimental research, situations and events that may occur in practice are
taken into account. Reflecting on these circumstances leads to adjustments in
the research setup. Research practice is thus becoming less formalistic in its
methodology, which benefits the links with practice (Bal, 2015). Various types of
research have been developed that form an alternative to the conventional RCT
(Tavecchio, 2014). These alternatives pay greater attention to whether the
intervention and the study population match the practice, to the various
perspectives and values of the stakeholders involved, or to the learning process
during the experiment.
The development of alternatives is related to the fact that research financiers
such as ZonMW (the Netherlands Organisation for Health Research and
Development) use “suitable evidence” as a criterion. The basic assumption is
that there will be a check of whether the research setup fits the question, which
creates scope for alternatives to RCTs. The criticism of RCTs is thus not being
resolved by a methodological battle but by an approach with multiple
methodologies in which different types of research complement each other.
Nuanced approach to uncertainty in guidelines
Another criticism is that professional guidelines can also play into the hands of
undesirable standardisation of healthcare. However, the development of
guidelines has changed so that there is a better link between guidelines and
practice. Guidelines increasingly make distinctions between subgroups. The
GRADE methodology for guideline development that is now the standard makes
a strict distinction between weighing up the available evidence and making
recommendations for decision making. This helps make the uncertainty more
explicitly clear and helps nuance the use of the available evidence when making
recommendations. Attention is now also paid more explicitly to the clinical
relevance of research results.
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<pre>32                                                  RVS – No evidence without context
Limited number of guidelines per specialism
Thirdly, the huge growth in the number of guidelines can be put into perspective.
Although there are more than 500 medical specialist guidelines, the average
medical specialist has to deal with about 10-15 of them, of which 2 to 3 are
updated annually. General practitioners are expected to know about 100 NHG
standards that have been made available in digital form.
Reflexive use of guidelines
Finally, the use of professional guidelines in consulting rooms usually involves
reflection too: they are not applied unthinkingly. The existing picture of this has
become clouded by the way it is researched. This mainly concerns research that
is based on an approach in which national or international guidelines are
implemented locally. Compliance then means applying the decision-making
rules of the guideline. When a closer look is taken at the practice, it turns out
that the recommendations in guidelines are generally considered carefully.
Deviations from them are usually for a good reason.
  The practice of research, guideline development and the use of guidelines in
  individual patient care shows that various reflexive mechanisms are
  incorporated in this that ensure a better link between research and guidelines
  in practice. It is important to make a distinction in the criticism of EBP between
  the formalistic version and the way it is developing in practice.
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<pre>                                                                                   33
    6 Continuing tensions in
           practice
The developments in the previous chapter do not change the fact that evidence-
based practices mean that care professionals are confronted with various areas
of tension and bottlenecks that need solutions. The reasons for this can
primarily be found at a fundamental level and in the institutional care
environments, as well as in the GP’s surgery.
6.1      Fundamental tensions in EBP
The following bottlenecks and tensions are present at a fundamental level.
EBP gives a reduced picture of reality
EBP features a scientific approach to reality. Just as in natural sciences, EBP
focuses on deriving generally applicable laws from experimental observations
(induction). It is about universal, generic knowledge about (in the medical
domain) the causes and the course of diseases, the characteristics of
diagnostic tests and the effects of treatments.
This type of evidence is attractive because of its claim to universality, but
remains a reduced synthesis of reality. It assumes that the reality is a closed
whole (“totality”). Moreover, it can only be unlocked through empirical
observations (positivism). The underlying assumption is that this form of
knowledge can ultimately answer all questions (scientism). We will comment on
these elements in order.
To begin with the “ultimate reality” or “reality as a whole” is not an a priori fact,
but a product of our own thinking. It exists alongside other products of our
thinking, so the reality can logically speaking not be a totality (Gabriel, 2014).
On the other hand, there are various possible cognitive and normative
perspectives on reality. This pluralism means that there are countless true
stories about reality that cannot be derived from any single coherent scientific
narrative (Staman et al., 2012).
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<pre>34                                                RVS – No evidence without context
In the case of a social problem such as obesity, a physician may point to a
genetic component, while a sociologist looks for a link to people’s education,
and an urban planner looks at the design of public spaces. This multifaceted
perspective also means that the concepts used in empirical research are not
neutral. Scientific research focuses not only on revealing or uncovering a
previously stated reality, but also on shaping that reality (see the boxed text on
“Science is discovering and shaping reality”).
Science is discovering and shaping reality
It is a misunderstanding that science is only about ‘discovering’ a previously
determined reality. Science is also about how it is “shaped” or “designed”
(Dehue, 2016). This is the core of the constructivist perspective on science.
Diagnoses are an example of this. These are by definition constructs or
concepts. Diseases do not exist a priori (Smulders, 2016). The concepts that we
use to describe them are only tools for carrying out a focused survey and
determining the treatment plan. This means in abstract terms that facts do not
exist separately from interpretations and meanings. Nietzsche put this insight
concisely: “There are no facts, only interpretations”. That insight is hugely
important. Diagnoses are not neutral: there are underlying values and opinions
that determine our perspective on the facts (Ralston et al., 2015). They are fluid
and dynamic and can change under the influence of scientific and cultural
developments.
In psychiatry, for example, DSM is a widely used classification of disorders that
is modified every few years.
EBP is based on statistical evidence, so only measurable, quantifiable factors
count. Disease and care are about existential matters and often impinge upon
the essence of life and how we think about it. Not everything has a value that
can be measured. This applies e.g. to non-measurable aspects of quality,
ethical choices, professional expertise, or the behaviour and emotions of
patients.
Finally, due not only to the complexity of the reality but also because financial
resources and human subjects are scarce, it is an illusion to think that all
disease mechanisms and interventions can someday be researched according
to the principles of EBP.
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<pre> 6 – Continuing tensions in practice                                              35
There will always be uncertainty and there will always be patients who do not ‘fit’
the guideline. This applies specifically to the increasing number of patients with
comorbidity or multiple morbidity.
Contextual factors matter
Related to the insight that reality is multifaceted in nature is the relevance of
context. The scientific evidence that EBP is based on is universal and generic,
suggesting that its validity is independent of context. Randomised studies are
characterised by standardisation in terms of the actual practice. As indicated in
Chapter 4, the context – that of the patient, the practice and the setting in which
care is provided – has an influence on the effectiveness of interventions and
therefore on the validity of research results. This is even more the case in the
social domain than in the medical domain, due to the larger part played by the
environment in which social interventions take place.
People are not intrinsically separate from their context: their social networks,
their norms and values and their economic and cultural capital also influence
their health, what it means to them and the way they deal with it. This context
can also determine the treatment plan. The emphasis on scientific, empirical
knowledge in medical education conflicts with this insight. It yields a
schizophrenic situation: it is a human science that we are approaching without
using the humanities.
Additionally, care is always given in a specific context with specific professional
capital and resources, and it always has its own history. Innovations or policy
that are developed elsewhere cannot just be rolled out, implemented or
replicated. The wheel must be partly reinvented by adapting something that was
developed and researched elsewhere. It has to be experimented with and
people then have to use the results to improve their own practice.
Episteme, techne and phronesis
Given the multifaceted perspectives of reality, it is natural that there are various
sources of knowledge. The philosopher Aristotle distinguished between
episteme, techne and phronesis. Episteme is the theoretical, universal
knowledge that teaches how the world works and is aimed at explaining
(“to know”, “know why”).
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<pre>RVS – No evidence without context                                                  36
 This knowledge is context-independent and easily transferable. Techne is the
 technical or instrumental knowledge corresponding to professionalism and a
 specific skills set (“know how”). This knowledge is aimed at realising a product.
 The third form of knowledge is phronesis, which concerns practical knowledge
 and practical ethics. This knowledge is aimed at practical use, is context-
 dependent and includes the ability to weigh up considerations and reflect
 critically on the consequences. This knowledge is aimed at understanding and it
 is meaningful. It is not easily transferable and has to be learned in practice.
 EBP misaligned with the relationships between parties
 The definition of EBM at the beginning of these recommendations goes even
 further, designating clinical expertise as a source of knowledge in addition to
 externally obtained scientific evidence: “the conscientious, explicit, and judicious
 use of current best evidence in making decisions about the care of individual
 patients. The practice of evidence based medicine means integrating individual
 clinical expertise with the best available external clinical evidence from
 systematic research.” (Sackett et al., 1996). Another definition also mentions the
 input from patients: “the integration of best research evidence with clinical
 expertise and patient values” (Sackett et al., 2000). This later definition started in
 reaction to earlier criticism that EBP overemphasises epidemiological, generic
 evidence (Bolt et al., 2015). Besides that, this definition assumes a relationship
 between the parties that does not reflect reality and may never have existed:
 science provides knowledge, professionals provide expertise, and patients have
 preferences. However, science is not value-neutral, professionals also have
 values and interests, and patients bring knowledge accumulated through
 experience.
 Provisional conclusions
 Several provisional conclusions can be drawn from the above. The evidence
 that EBP uses is based on a reduction of reality, ignoring the context in which
 this knowledge is applied. There is therefore an intrinsic gap between EBP’s
 knowledge and its decision-making rules on one hand and the reality of
 individual patient care on the other. This gap still remains if these decision-
 making rules are individualised as much as possible by taking characteristics of
 the patient into account, for instance in clinical decision making. This calls into
 question the fact that there can be evidence-based actions.
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<pre> 6 – Continuing tensions in practice                                           37
There is at most a fragile basis to which other sources of knowledge should also
be added; at the very least, speaking about evidence as the basis for
professional actions or policy leads to false expectations or suggests a false
sense of security.
Secondly, because every decision is ultimately made with regard to a specific
help requirement and in a specific context, that decision may not necessarily be
derived from knowledge. Every decision and every action that follow can be
seen as an experiment in putting together the various sources of knowledge.
This also makes each decision in itself a new experience that can be learned
from. Putting together various sources of knowledge also yields practical
knowledge or practical ethics that can be distinguished from universal
knowledge and technical knowledge (see boxed text on “Episteme, techne and
phronesis”).
Thirdly there are tensions in the relationship between EBP and learning.
Knowledge is the dynamic product of a continuous accumulation of learning
experience. On the other hand, results of experimental research and
professional guidelines can be seen as a form of solidified knowledge.
Guidelines comprise a summary and an assessment of explicit knowledge at a
certain moment, translated into practice. Guidelines themselves are not focused
on personal learning; they only lead to new knowledge when they are consulted
and applied. They are by definition based on knowledge from the past, so they
become out of date and have a conservative effect on medical practice. The
dominant position of RCTs in these guidelines reinforces this. RCTs take years
and the intervention or other aspects of the protocol must not be changed
throughout the duration, so as not to influence the results (for example due to
new insights); the results are therefore often already outdated by the time they
are published.
On the other hand, personal learning experiences do get included in guidelines.
Committee members bring along their own experiences, reasons and
considerations when translating explicit knowledge into practice. Expert opinions
may possibly play a greater role than intended or expected as ‘lower’ forms of
evidence.
6.2        The institutional environment
As stated in Chapter 2, EBP has not remained limited to the professional domain
but has also been embraced by institutional parties. Supervisors, disciplinary
courts, care insurers and policy making bodies use scientific evidence in their
work.
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<pre>38                                                 RVS – No evidence without context
These parties derive their authority in part from the same scientific evidence and
from professional standards. Tensions may arise when these parties interpret
and make practical use of scientific evidence, guidelines and measuring
instruments in a different way than healthcare providers and care professionals
do.
Package management
In Chapter 2, it was noted in the case of package decisions by the National
Healthcare Institute within the context of the Healthcare Insurance Act and
Long-Term Care Act that the quality of scientific evidence is in principle the
deciding factor when the decision on reimbursement is taken. Although EBP is
formally the integration of scientific evidence, expertise and experience, the
National Healthcare Institute actually uses a hierarchy of sources of knowledge
to deal with the inherent tension that can exist between the three. This practice
relates to the macro-perspective on decisions about healthcare packages and it
has in the meantime also acquired legal force (see boxed text on “Evidentiary
hierarchy legally legitimised”).
This has various consequences. First of all, the scope of the insured package
does not necessarily have to comply with the recommendations in professional
guidelines, even though both are based on the same scientific evidence. A
negative reimbursement decision reduces the options available and therefore
also the room for considerations in individual patient care. Secondly, due to
pressure on public expenditure or changed political views, EBP can be used to
‘clear away’ unwanted practices. Thirdly, this working method is threatening to
marginalise care professionals and patients as a source of knowledge (Carel
et al., 2014). This may have far-reaching consequences for elements of
healthcare where RCTs are difficult or impossible, such as in the case of rare
disorders, disorders that can become manifest in very diverse ways, or forms of
care that make a blinded study setup impossible.
Evidentiary hierarchy legally legitimised
Using EBP principles for healthcare package management was ratified in a
recent court judgement (Moes et al., 2016). The case concerned a lawsuit filed
against the National Healthcare Institute because of a negative reimbursement
decision regarding bladder fluids in interstitial cystitis, a specific type of bladder
inflammation. The effectiveness of this treatment could not be sufficiently
demonstrated based on two RCTs and the applicable professional guidelines.
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<pre>6 – Continuing tensions in practice                                               39
 The heterogeneous character of the condition made it particularly difficult to
 prove this.
 The defence argued that this makes experimental research impossible and that
 witness statements from patients who claim to benefit from the treatment had
 been given too little weight. Unfortunately, this defence did not offer a remedy.
 Although the National Healthcare Institute did not deny that individual patients
 can benefit from bladder fluids, individual experiences are too susceptible to
 subjectivity and placebo effects to support the statement that this intervention
 meets the “state of science and practice” reimbursement criterion (Moes et al.,
 2016). This ruling also added legal weight to the idea that experimental
 research has added value compared to other sources of knowledge (Moes
 et al., 2016). As a result of the verdict, the National Healthcare Institute did
 decide to systematically involve patients’ organisations in package decisions.
 Healthcare procurement
 The contracting of medical curative care by healthcare insurers may include
 conditions about following professional guidelines. This is then tested using
 benchmark information, and practices that deviate from a predetermined
 standard – such as the average of all practices – can be identified. This method
 turns professional guidelines that are meant to be recommendations into
 standards that care should meet for all patients with the indication in question.
 The standard thus adopted may conflict with the way guidelines are interpreted
 and applied in practice. This can mean not compensating actions that are
 recommended in guidelines in exceptional cases due to the low quality of
 underlying evidence. However, the lack of evidence does not mean that
 something has been proved to be ineffective (see Chapter 4). There may also
 be a different local patient mix. In that case, the standard that compliance with
 guidelines is tested against does not reflect the complex assessment process in
 practice, and it also involves patients who fall outside of the scope of the
 guideline. The consequence is an undesired uniformity and standardisation of
 care, with less room to experiment and learn.
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<pre>40                                                   RVS – No evidence without context
Concentration of specialist medical care
In quality supervision and healthcare procurement, the concentration of complex
medical care is a key principle for improving quality. This policy is motivated by an
assumed relationship between the volume and quality of care and it is implemented
based on volume standards. The consequences of this policy can be far-reaching
for the institutions concerned and for society at large (Paauw, 2016).
Although the concentration policy is based on alleged evidence it conceals the
commercial reasons that parties have for concentrating care. Furthermore, the
evidence consists of a statistical relationship between volume and quality,
particularly in the case of high-risk surgical procedures (Mesman et al., 2015). It is
not clear whether there is a causal relationship, nor is it known what explains this
relationship: better compliance with protocols, certain institutional characteristics,
the degree of specialisation, or otherwise (Mesman et al., 2015). Other sources of
knowledge, such as ethnographic research into the quality of care, could throw light
on this. The results of a treatment are also determined by the care after the
intervention and outside the hospital. A higher concentration of specialist medical
care requires aftercare to have been adequately dimensioned for it.
Quality indicators
Quality indicators are often used in quality supervision and healthcare procurement:
quantitative data that gives an indication of the quality and safety of healthcare
institutions. The Healthcare Inspectorate, healthcare insurers and patient
associations come up with one indicator after another: process indicators that show
whether the professional standards and internal agreements are complied with;
outcome indicators; institution-wide indicators, and patient experience data (CQ-
index, complaints).
Although this is intended to create transparency about quality, in practice this is
hardly the case at all. Several years ago, the General Court of Audit concluded that
the stability and quality of most indicator sets that measure quality are limited and
that barely any indicators have been developed to measure the results of care
(General Court of Audit, 2013). The accumulation of indicators and the
contradictions that can exist between indicators may cause institutions to lose track
of the overall picture. Many indicators are inconsistent with practical experience and
as a result employees lose the motivation to work on quality improvement. The
result is that the institution is busier collecting quality information while losing sight
of the underlying goal of quality improvement and greater learning capacity
(Weggelaar et al., 2016).
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<pre> 6 – Continuing tensions in practice                                                41
This illustrates that an absolute ‘mechanical objectivity’ (reliance on numbers) is
an inadequate alternative for the ‘disciplinary objectivity’ of medicine that is
based on authority, and it is met with resistance from health care providers.
Besides the fact that there is no emphasis on the intended transparency of
quality, there are also objections to the content of this approach. A set of quality
indicators, no matter how broadly formulated, can be at odds with a multifaceted
concept of quality. Quality is not always measurable, and there is a risk that
attention will only be paid to aspects that can be measured (“teaching to the
test”). These substantive dilemmas and considerations that are associated with
healthcare cannot be described in quality indicators, but they can provide useful
experience to learn from.
6.3        EBP in the consultation room
In individual patient care, there are the following bottlenecks and areas of
tension relating to the application of EBP.
Care that has been proved to work is not necessarily good care
As stated in Chapter 1, individual patient care is provided in a morally charged
context in which values and preferences play a role: those of the patient,
professional values (professional ethics) and organisation-wide values, as well
as public interests. Patients can decide against effective care, or may prefer an
option that is less effective but in their eyes offers them a better quality of life.
Scarce resources and local circumstances (available clinical experience,
availability of specific equipment) can play a part in the choice of what is right or
justified. The right thing to do can vary with the patient and the situation
(Kremer, et al., 2017). Care that has been proved to work is thus not the same
thing as good care.
To provide good care, every situation inevitably requires considerations to
bridge the “normative gap” that exists between scientific evidence and practice
(Tonelli, 1998).
The preferences of healthcare providers and patients are not necessarily the
same, so healthcare providers face the task of separating facts and values when
giving choice options. On the one hand, this is to prevent them from imposing
their own set of norms and standards, on the other hand because respecting the
preferences of patients too much can put pressure on their own judgement.
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<pre>42                                                 RVS – No evidence without context
It’s not always clear beforehand what the right thing to do will be. In particular if
there are multiple problems, the object or mechanism that you are focusing on – the
disease, side effects, lack of control, debts, parenting issues, addiction – is a part of
a search process that may involve multiple disciplines. This search process means
that goals should be continually adjusted and that the practice is fluid.
Good care: the result is what counts?
As can be seen in the definition mentioned earlier, the intention of EBP is to use the
best evidence to make decisions while taking patient preferences into account. EBP
emphasizes the outcome of care: clinical results and increasingly relevant
outcomes for the patient (patient-reported outcome measures, PROMs). One
example of this is the Value-Based Health Care initiative of the International
Consortium for Health Outcome Measurement (ICHOM). This initiative is based on
systematically measuring outcomes of care that are relevant for patients – including
health, safety, quality of life and patient-centred care – and it aims to improve
hospital care.
However, for various reasons, this emphasis on outcomes can conflict with offering
good healthcare. The first reason is that outcomes are used as a general criterion
for every patient and every situation, whereas the right thing to do can vary with the
patient and the situation. Secondly, this approach assumes that care is by definition
good if the outcomes are good. Other ethical perspectives on care are also possible
in addition to this consequentialist approach (see boxed text on “What is good
care?”). Thirdly, emphasising one specific, quantifiable outcome of care means that
other values that are relevant for patients but that cannot be measured or
objectivised come under pressure. The quality of the relationship between
healthcare provider and client, plus values such as presence and attention or the
possibility of participating in decision-making cannot be expressed in terms of size
and number (RVZ, 2007). This can result in forms of care that focus specifically on
these values but do not fit the EBP research methodology unintentionally getting
less space or a lower status (Delnoij, 2016). In particular, this creates a watershed
between medical care and long-term care; Askheim et al., 2017
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<pre>6 – Continuing tensions in practice                                               43
What is good care?
There are no generally applicable, unambiguous standards for good care. There
are various perspectives in ethics on how to decide what good care is
(Beauchamp, 1991). Consequentialist theories focus on the outcomes of care:
care is good if the result is good. In this vision, the care provider as a person does
not matter and is purely instrumental. According to obligation ethics, good care
reflects certain intrinsic principles that people use consciously, such as doing no
harm and being respectful. These standards are intrinsic because they
automatically follow on from moral laws that are ‘ingrained’ in healthcare. These
can be traced by sensible reasoning. Virtue ethics does focus on the healthcare
provider as a person and emphasises the importance of developing an
appropriate attitude and character. These determine the provider’s actions
towards patients. In this vision, good healthcare providers are the key to good
care.
Uncertainty has the upper hand
It has been noted previously that it is an illusion to say that all medical actions can
be investigated scientifically. Incomplete information and uncertainty are inherent
to medical actions. Medical actions have only been experimentally researched in
a small minority of the patients in which they are used. This epistemic gap
between what is known based on scientific research and the requests for
assistance by patients frequently leaves care professionals on the horns of a
dilemma (see boxed text on ‘Case studies’). It is not always evident whether you
can or should deviate from the guideline, given the specific characteristics of a
patient. There may also be treatment options that have been researched in
different patient groups or for which no research has been done at all, although
there are reasonable grounds to suspect that it may be effective. Generally the
number of treatment options is increasing and so multiple, more or less equal
options may exist for a given situation.
EBP puts professional expertise under pressure
In uncertain situations, research, professional guidelines and protocols can offer
guidance; they can however also put personal professional expertise under
pressure. Uncritical use leads to undesirable standardisation and uniformity of
healthcare, and unnecessary diagnostics and treatment. Experience seems to
play a major role in this.
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<pre>44                                                 RVS – No evidence without context
The insecurity of inexperienced care professionals makes them more inclined to
follow treatment protocols than experienced care professionals, even where a
different approach may be justified. In other words experience helps
professionals to make use of the space that guidelines give. In addition to
experience, contextual factors also play a role. In particular this includes the fear
of disciplinary measures and a high workload. The latter also means that there is
not enough time to talk with patients and that there are insufficient possibilities
for consulting an experienced colleague who then sees the patient themselves.
EBP puts the input from patients under pressure
EBP also puts the input from patients and adjustment of care to their situation
under pressure (Greenhalgh et al., 2015). One example of this is, surprisingly,
the use of decision aids for medical decision making. In the conversation with
the patient, these help give a picture of the benefits and disadvantages of the
options that are available. Although the aim is to involve patients more in
decision-making, these decision aids depend heavily on scientific research and
are therefore mainly framed from a medical perspective (Greenhalgh et al.,
2015). Sending information gets given more space than listening to the context.
Although the importance of shared decision-making and an equal role for
patients is being acknowledged more and more, the way healthcare providers
handle patients who are uncertain is crucial. The way they translate scientific
evidence and their own expertise into treatment options can be the opposite of
what might have been expected of them (Fried, 2016). Healthcare providers
may in particular be intuitively inclined to leave patients to make a decision when
the benefits and risks of the options are uncertain and they themselves are
ambivalent about it. The reverse is also true: the more certain the expected
outcomes of the various options are, the more healthcare providers will be
inclined to recommend them.
The information puzzle
Although the EBP movement states that in practice external scientific knowledge
must be integrated with clinical expertise and patient preferences, no statement
is made about how this should be done and what expertise is necessary for this.
Healthcare professionals in individual patient care have to deal with diverse
types of knowledge: scientific knowledge from external sources, research
results, findings from physical examinations, information from the patient
themselves, and knowledge about values, preferences and the context.
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<pre> 6 – Continuing tensions in practice                                              45
This knowledge is transferred through various information carriers such as
literature, guidelines, images, figures, graphs, stories and emotions. Care
providers have the task of using their basic medical knowledge and experience
to solve this jigsaw puzzle of information and turn the pieces into a coherent
image. This image acts as a tool for formulating and testing hypotheses, and for
weighing up the considerations and taking decisions (Van Baalen et al., 2014).
The linear and rational, rule-based way of decision-making that typifies EBP falls
short when integrating these puzzle pieces: explicit, scientific knowledge is
distributed and then translated to the individual patient case using systematic
reviews and guidelines. Practice can be very dynamic and creative when it
comes to the styles of reasoning that healthcare professionals use for making
the links between all the pieces of information and deriving and testing
hypotheses. ‘Embracing’ the uncertainty and integrating different sources of
knowledge within the specific context in which care is provided requires a more
active role than that of the passive ‘evidence user.
   Case studies
   A few cases are described below to illustrate the dilemmas when using
   evidence and professional guidelines. We have endeavoured to provide a
   spread of examples that have no evidence or hard evidence, have one or
   more options, and the role of the patient and the healthcare professional in the
   decision-making process.
    Case 1: Prostate cancer surgery or radiation – patient preference
    Mr Harmsen is told at the age of 59 that he has prostate cancer. His doctor
    explains the treatment options: surgical removal of the prostate gland or
    radiation. After prostate gland surgery there is a chance that the patient will
    be unable to stop the flow of urine or may get erectile dysfunction. On the
    other hand, radiation leaves a slightly higher chance of the cancer coming
    back and can be associated with urinary and stool complaints. There is
    scientific evidence for both options, but there is no “best” treatment.
    Mr Harmsen’s preference will ultimately be the deciding factor in opting for
    treatment by radiation.
    (multiple options with hard evidence, patient decides)
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<pre>46                                                 RVS – No evidence without context
   Case 2: Gall bladder infection – remove or wait?
   Mrs Jansen (age 47) arrives at Accident & Emergency with abdominal pain
   and vomiting. She turns out to have an acute gall bladder infection due to
   gallstones. In some cases, the gallbladder is removed in its entirety and
   sometimes it is possible to wait and treat with antibiotics. Removing the gall
   bladder comes with the risks of surgery, whereas waiting can also cause
   complications such as the infection returning. Studies have shown that both
   strategies are comparable in preventing disease and mortality, but that
   immediate surgery ultimately leads to a shorter duration of the illness. Based
   on this evidence, it was decided to operate on Mrs Jansen. (multiple options
   with hard evidence, clinical expertise decides)
    Case 3: Two blood thinners
    Mr Huisman had a cerebral infarction when he was 64. To reduce the risk of
    a stroke in the future, he takes medicines, including a blood thinner. Despite
    the medication, he shows symptoms of loss of function again. One option is
    to take two different blood thinners. This option is not described in the
   guideline because it increases the risk of large haemorrhages in the long
   term. The doctor decides to temporarily prescribe two blood thinners because
   for this patient the risk of a new cerebral infarction is greater in the shorter
   term than the risk of a haemorrhage. (little evidence, clinical expertise
   decides)
   Case 4: Puncturing the eardrum for a middle ear infection Sam, aged 6,
   has a fever and severe ear pain due to an infection in his middle ear. Despite
   painkillers, the pain has persisted for three days. The pain is unbearable for
   Sam and his mother asks if there is something that can be done immediately.
   An option that works quickly is to puncture the eardrum. Puncturing a bulging
   eardrum can be beneficial as pain relief in the initial phase. This treatment is
   not described in the guideline. Studies show that other treatments such as
   antibiotics work better for children with persistent complaints. In consultation
   with Sam’s mother, the choice is made to puncture the eardrum to relieve the
   pain at that moment.
   (no evidence, treat anyway)
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<pre>6 – Continuing tensions in practice                                              47
       Case 5: Surgery with stoma for intestinal cancer
       Mr de Boer, aged 85, has been diagnosed with rectal cancer. He
       recently became a widower. The doctor suggests operating on his
       intestine and fitting a stoma. A stoma is an artificial exit of the
       intestine via the skin of the abdomen, where the stools are collected
       in a bag on the stomach. There is evidence for better survival after
       surgery for intestinal cancer as opposed to waiting. In research,
       people with a stoma say that they have a poorer general quality of life
       than people without a stoma. Mr de Boer does not want to undergo
       major surgery and get a stoma. Despite the evidence for the
       effectiveness of that treatment he chooses not to have surgery.
       (hard evidence, patient prefers quality of life instead of a longer life)
       Case 6: Success of rheumatism treatment
       Mrs Plaat (42) has rheumatism in her joints. The aim of the treatment
       is to achieve the lowest possible disease activity score. This score
       measures inter alia the experience of the patient and the number of
       swollen or painful joints. It has been proved that intensive
       measurement of the disease activity, followed by adjustment of
       medication, has a positive effect on the occurrence of recovery. The
       treatment seems to work well for Mrs Plaat, because her disease
       score decreases. She herself does not consider the treatment to be
       so successful because of the side effects she has experienced. She
       suffers from nausea, diarrhoea and inflammation in the mucous
       membrane of her mouth. Together with the doctor, she chooses not to
       keep going with the treatment until she reaches a lower disease score
       because the side effects are causing her too much trouble. Instead
       she starts taking a different rheumatism medication.
      (hard evidence, dilemma of continuing treatment versus side effects)
       Case 7: A patient with multiple morbidity
       A woman aged 79 has osteoporosis, osteoarthritis, diabetes mellitus
       type II, hypertension and COPD. How should this patient be treated?
       Based on the guidelines for the various conditions, this patient should
       be taking a total of 12 different medications at five different times of
       day (Boyd et al., 2005).
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<pre>48                                                  RVS – No evidence without context
The guidelines are often based on RCTs in which patients with just a single
condition such as osteoporosis, diabetes or hypertension have been studied.
Additionally, they are often younger patients, sometimes a lot younger. There is
also the phenomenon of ‘reversed epidemiology’, in which the classical
relationships between risk factors and results change direction. For example,
people over 85 with lower blood pressure and/or low levels of cholesterol in the
blood die earlier than elderly people with higher blood pressure and/or higher
level of cholesterol. There is also a lack of scientific evidence for combination
treatments for multiple morbidity, while the different medications have all sorts of
side effects that can amplify or counteract each other. Medication to lower blood
pressure can cause dizziness. If a patient with osteoporosis falls, there is a
significant risk of a hip fracture which is high-risk at this age.
(lack of hard evidence for combinations of treatments)
The heart of the problem
Based on professional practice, the Council has produced the following
summary of bottlenecks of EBP. EBP has the risk that it will reduce good,
patient-oriented care to what is evidence-based. Due to its reductionist concept
of knowledge and because it ignores the (morally charged) context in which
evidence is used, EBP offers a false claim to reality that under-utilises the
wealth of knowledge from other sources (clinical expertise, local expertise,
knowledge of patients and context). There is no evidence as a basis for medical
treatment, and uncertainty is inherent in medical actions. Evidence as the
dominant foundation of good healthcare is therefore an illusion. In individual
patient care, each decision can be seen as an experiment in putting together the
various sources of knowledge. This also makes each decision in itself a new
experience that can be learned from.
The EBP movement does not pay enough attention to the ways in which care
professionals can integrate external sources of knowledge (such as personal
expertise, the experiences and preferences of patients and local data). EBP
allows the healthcare professional to keep denying the uncertainty that is
inherent in patient care.
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<pre>6 – Continuing tensions in practice                                        49
   EBP and the development of professional guidelines and quality
   indicators have been embraced by health research, policy, supervision
   and the contracting of care. Taken as a whole, this is directing
   healthcare towards whatever can be investigated and substantiated
   using the EBP methodology. This is at the expense of healthcare
   domains for which this is difficult or impossible, and of healthcare that is
   not commercially interesting. Unintentionally, a research system has
   arisen that contains incentives for irrelevant and unreliable research,
   while many elements of customary care have been investigated
   insufficiently. The use of professional standards by external parties and
   high workloads are also leading to uncritical use of guidelines and
   protocols. As a result there is less of a focus on differences between
   patients and situations than is desirable. Healthcare professionals spend
   more time providing accountability information than they gain by learning
   from it.
   .
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<pre>                                                                                 50
    7 Solutions and
           recommendations
The Council concludes that proper care is more than proven care. Evidence-
based practice (EBP) is an illusion. In order to answer the question of how
scientific evidence can be used to provide proper care and legitimise it, the
tensions within EBP and its shortcomings must be recognised and tackled. In
this chapter, the Council presents solutions for this issue and makes
recommendations to that end.
We will start with a general, overarching solution and recommendation. After
that, we will discuss the effects at various levels: the consulting room, the
healthcare organisation and the institutional context. The same distinction as
used in the previous chapter has been adopted.
7.1       From evidence-based to context-based practice
Whereas EBP was originally limited to the professional domain in order to
support individual patient care, policy bodies, supervisory bodies, care insurers
and other parties have also welcomed scientific evidence and professional
standards as instruments. Because these parties assign different meanings to
‘evidence’, EBP has become a layered concept, the content of which has also
become more and more elusive. The Council intends these recommendations to
help determine the position of scientific evidence for providing and legitimising
good care. The Council is doing so by stating the results of EBP (Chapter 3)
and its shortcomings in providing proper, patient-oriented care (Chapters 4
and 5) and by listing the tensions between the various stakeholders who rely on
‘evidence’ (Chapter 6). Because of the unclear content and the shortcomings of
EBP, the Council recommends that the term ‘evidence-based practice’ should
no longer be used.
Others, including the precursors of the EBP movement, previously
recommended that evidence-informed practice should be used, as the concept
of ‘evidence-based’ raises false expectations (Glasziou, 2005). However, the
Council prefers context-based practice. This is how the Council wants to draw
attention to the importance of the specific context, of both the patient and the
setting in which various knowledge sources are used and decisions are made.
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<pre>51                                                RVS – No evidence without context
This context is morally charged, multifaceted and dynamic. Decisions do not
automatically or deterministically follow from the ‘best evidence’. Uncertainty is
inherent in healthcare practice. Against this background, it would be better to
consider decisions in care as experiments that connect various knowledge
sources, explicit and implicit knowledge, and the experiences of care
professionals and patients. In addition, every decision inherently consists of
weighing up the interests, standards and values of stakeholders: those of the
patient, the professional, the organisation and society as a whole.
Recommendation 1: The council recommends that ‘context-based practice’ be
used rather than ‘evidence-based practice’. Although evidence plays a role as a
source of information, it does so alongside many other sources of information.
The specific context determines how these knowledge sources are connected
together.
How context-based practice is implemented and what is required for it will be
dealt with in the sections below. We will start in the consulting room; after that
we will also show what consequences the recommendations at the consulting-
room level have for organising care provision and for the institutional context in
which care is provided.
7.2       The consulting room
Shared decision-making
Context-based practice requires the participation of patients in the decision-
making regarding their care. The aim is to create a partnership between care
provider and patient. The importance of this is becoming increasingly widely
recognised (RVZ, 2013). It allows patients to communicate their wishes and
preferences, permitting insights into their personal context, and make a choice
that suits them, together with the care provider.
Digital medical records, patients’ versions of guidelines and medical information
from the Internet and social media have greatly improved the information
position of patients. Despite this, shared decision-making is complex in practice.
Because of their lack of knowledge and the uncertainty, stress, anxiety and
dependence associated with being ill, active involvement of patients is not
necessarily obvious. There are also differences between patients regarding the
degree to which they wish to be involved and can be involved. There is nothing
wrong with this, provided they were able to make that choice for themselves.
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<pre>7 – Possible solutions and recommendations                                          52
The form that shared decision-making can take may therefore be different for
every patient and every situation. It should therefore not become a dogma
(Smulders, 2016). If the emphasis is on the question of who takes part in
decision-making and to what extent, people may lose sight of the fact that this is
ultimately about care that is tailored to the patient’s needs and lifestyle (Mol,
2008). A care provider must therefore be able to verify whether the choice being
made is one that suits the patient. To that end, listening is more important than
dispensing context-independent information. Developing a good client-caregiver
relationship is essential for this.
Recommendation 2: Shared decision-making is essential to determine what
constitutes good care. Care professionals tailor it to the patient’s context, and
pay more attention to listening than to dispensing information.
The input of patients can come under pressure if decision-making is dominated
by what is considered to be proven care. This may also be the case if,
vice versa, care professionals leave the decision up to the patient because they
themselves are uncertain about what the best option is in a given situation
(Fried, 2016).
Input from patients should be improved by designing decision aids that help to
find out what patients think is important, using reasoning that is not based on a
medical perspective or on the available care. Patients’ organisations must take
the lead in this, working together with the professional group and the other
parties involved.
Recommendation 3: Patients’ organisations should take the initiative to develop
decision aids (together with care providers and other parties involved) that are
based on what patients feel is important.
Connecting knowledge sources
An essential skill for care professionals is the ability to integrate or link multiple
sources of knowledge: external knowledge from manuals, guidelines and
scientific literature; experience; information about the patients and their personal
situation, values and preferences; information about the local setting, and the
options and their limitations. Successive steps are targeted searching for
information that is relevant for the decision-making, making connections and
testing hypotheses, and then assessing the collected information for the
decision-making.
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<pre>53                                                RVS – No evidence without context
The use of guidelines is part of this process: a rule-based way of reasoning in
which observed frequencies in epidemiological research are generalised to
individual patients. However, it is not always clear in clinical practice where
deviating from a guideline is possible, where other forms of reasoning are required,
and where care professionals have to be able to cope with uncertainty and ethical
considerations. Care professionals must therefore be able to reason and weigh
things up, have an eye for the context, welcome uncertainty, and utilise the scope
that is offered by the guidelines in a responsible way.
Recommendation 4: Care professionals should embrace the uncertainty about what
constitutes good care. Together with the relevant parties, they must learn to assess
and integrate various sources of information.
These recommendations, which are based on context-based practice, are not only
significant for the practice in the consulting room but also have consequences for
care organisations and the institutional context of care. In the following sections, we
will describe a number of solutions and make a number of recommendations.
7.3       Learning care organisations
For context-based practice, care organisations should focus on learning together
and improving care: learning to connect various knowledge sources together within
the morally changed and multifaceted context of patient care. All relevant parties
must be involved in this, which will put the various relevant perspectives in the right
places. Learning therefore becomes learning together. A number of years ago, a
recommendation from the Health Council of the Netherlands centred on learning
professionals and learning care organisations. They are expected to put flesh on
the bones of their own learning processes by continuously reflecting upon their own
actions, by learning from them, by bidding farewell to old routines and by making
room for new ones (Health Council of the Netherlands, 2000). In a learning
practice, the result of one process is the input for the next.
Attention to learning during training and in everyday practice
A great deal of attention is paid to learning and developing these skills during
training and in the everyday practice of care professionals (see boxed text on “Mind
lines: internalising knowledge through collective learning”). Medical education also
pays a great deal of attention to clinical reasoning – excluding the improbable,
identifying diseases as early as possible and preventing complications and to the
use of professional standards.
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<pre>7 – Possible solutions and recommendations                                        54
Furthermore, discussions about patients, multidisciplinary meetings, necrology
and discussions about complications are common forms of peer review. Such
meetings give care professionals the chance to test the picture that they have
constructed of their patients, using all the available information. The criterion is
not whether this picture represents ‘the truth’, but whether it is logically
consistent and coherent and whether it is suitable or had been suitable for
making considerations and taking decisions (Van Baalen et al., 2016).
Mind lines: internalising knowledge through collective learning
How are knowledge sources linked together in practice? Observations show that
care professionals hardly use formal guidelines at all but that they rely on
‘mind lines’, i.e. internalised guidelines (Gabbay et al., 2004). These ‘mind lines’
are a mixture of explicit and implicit (see boxed text on “Tacit knowledge”),
individual and shared knowledge. Their ‘mind lines’ serve as a vehicle for
handling the many facets of reality and integrating multiple knowledge sources:
knowledge originating from their own experiences, guidelines, and knowledge
sources that care professionals deem to be reliable. These could be colleagues
in their own practice or in the region, opinion leaders, guideline developers,
scientists or patients. Care professionals exchange knowledge and validate it in
the consulting room, in consultations with colleagues, in meetings and working
groups. The internalisation of knowledge therefore takes place collectively and
in interaction within the networks of care professionals (Wieringa et al., 2015).
Tacit knowledge
What is the difference between an expert and a layman? Why is it that
experienced doctors are able to diagnose better and more quickly? Polanyi has
analysed the nature of knowledge thoroughly (Polanyi, 1962). He defined the
problem of the ‘false ideal’ in science that universal, objective knowledge exists
independently of people. Knowledge, he argues on the other hand, never exists
independently from a person: all knowledge is personal knowledge. A typical
feature of this personal knowledge is ‘tacit knowing’, the implicit or tacit
knowledge that is produced and used in practice. Tacit knowledge is not the
opposite of objective or explicit knowledge – knowledge that exists
independently from a specific context – but it is the flip side of it (Tsoukas,
2003).
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<pre>55                                                RVS – No evidence without context
To Polanyi, there is therefore no strict difference between universal, technical
and practical knowledge (see the boxed text on “Episteme, techne and
phronesis”). The ‘implicit’ element is that the person is not aware of the rules
that they are following when applying knowledge. For instance, people usually
recognise a face without being able to explain how they do it. In fact, a
subconscious perception process takes place rapidly using a number of physical
facial characteristics. Similarly, experienced doctors are able to use large
amounts of knowledge and information, gained through study and experience,
when assessing a patient. They also have less difficulty than inexperienced
doctors in targeting their search for information and identifying patterns.
Although implicit knowledge remains elusive and unspoken, in essence, its
transfer and the associated learning processes usually take place by interaction.
Implicit knowledge includes skills that can be identified and reflected upon in
order to learn from them. This could for instance be reconstructing a decision
later on to see what information had been used, the reasoning and the way that
the decision was taken (Van Baalen, 2016).
However, there is greater room for improvement if it is about being able to
connect multiple knowledge sources, and the use of evidence in the morally
charged context of practice. The Council specifically asks attention to be paid
to:
  — Training for carrying out qualitative research.
  — The interpretation of research results and their meaning for practice.
  — The limitations of professional guidelines and the scope provided by
      guidelines. This requires knowledge about how guidelines are created,
      the underlying assumptions, the weighting of evidence and the
      translation into recommendations.
  — Making it possible to talk about uncertainty and doubt, including
      talking with colleagues who are higher in the (informal) hierarchy.
  — The personal context of patients.
  — Learning together with various parties involved, such as patients, the
      general public and other care professionals.
  — Weighing the considerations up carefully in the decision-making,
      and identifying ethical issues as well as the medical considerations.
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<pre>7 – Possible solutions and recommendations                                       56
      The Council suggests the following solutions for this.
      — More room for social science and humanities in medical education,
          preferably integrated into existing subjects and modules, and linked
          to practical situations.
      — Participation in interdisciplinary education.
      — An active role for patients in education, for instance as buddies for
          students, or by having patients tell about their experiences of their
          care and treatment as an element of lectures.
Recommendation 5: Residency programme directors should include social science
and humanities, interdisciplinary education and active contributions from patients in
their curriculums.
Organising learning processes
The learning ability of care professionals and care organisations must be enhanced
by paying attention to the working environment. High pressure of work in healthcare
and the vertical organisation of medical care into professional groups and disciplines
puts pressure on the scope for learning processes. As a result, the possibilities for
assessing a patient jointly and testing your own arguments against those of an
experienced colleague who has a broad substantive expertise are limited in the
event of doubt. Under time pressure, it is more difficult for care professionals to
resist their more demanding patients; there is less time for an exchange of
knowledge and recording a previous history that takes a broader look. Super-
specialists predominantly focus on their own guidelines and do not take sufficient
account of the vulnerability and multiple morbidity in their patients. High work
pressure and the organisation of care therefore make care professionals rely on
guidelines and protocols more easily, and use them to justify diagnostics and
therapy even where leaving them out is justified.
Good, patient-oriented care can therefore benefit from a reduction in the pressure of
work and a different organisation of medical care, provided this creates more room
for learning processes. An example is the availability of experienced care
professionals with a broad expertise of what the front line of the care process
involves. Additionally, checks should be made to see what the benefits are if the
organisation of medical specialist care is shifted from single disciplines to
multidisciplinary teams that are tailored to patients’ care needs and situations.
Reduction of workload pressure and organisational changes do not necessarily
result in higher care costs if the expenditure is recouped through fewer diagnoses
and treatments.
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<pre>57                                                   RVS – No evidence without context
Recommendation 6: Care organisations should reserve more time at the front line
of care processes, in particular during the phase of diagnosis and decision-making.
Moral forum
In the current healthcare system, quality monitoring is outsourced to third parties
and has become separated from the healthcare professionals themselves. The
emphasis has shifted to external accountability, standardisation and control of care
(see also the section below). As part of context-based practice at organisational
levels, the Council believes it is important to tilt this practice of external
accountability towards situations in which care organisations and care professionals
are given more scope to steer behaviour towards good care, and to tailor their
organisations and working method to this.
Care professionals must therefore embark upon a dialogue about good care, not
only with each other but also with their managers and patients. They must regularly
discuss quality ratings and other local data in order to learn from them and improve
performance. A system of ‘patient tracers’ was recommended previously in order to
assess whether the organisation is meeting the targets set and the standards for
delivering good care (Council for Public Health and Care, 2013). It is an
assessment method that looks at the entire care process that a patient has been
through. Information about complaints is also a useful source of data that we can
learn lessons from that extend beyond people’s own departments.
Care professionals and care organisations must also enter into a dialogue about
good, patient-oriented care and how to deploy scarce resources to deal with
external stakeholders, e.g. other care providers in the region, care insurers, patient
organisations and municipalities. This approach fits in with the horizontal nature of
the relationships in the healthcare sector and the mutual dependencies between
care providers and other stakeholders. This is therefore conditional on the parties
involved recognising that there is no single party that dominates and decides.
Because of the principles involved, this dialogue has to take place in an open
‘moral forum’. This moral forum is the vehicle for the legitimisation of decision-
making in care about what targets have to be aimed for and with what resources.
For the decisions to be legitimate, it is not only important how they came about (for
instance which knowledge sources were used), it is also about which stakeholders
have taken part in the realisation of choices. The importance of that legitimisation
means that the dialogue is not optional: it becomes obligatory.
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<pre>7 – Possible solutions and recommendations                                       58
This is how the parties involved fulfil the public tasks that they have been
assigned, and how they can be held accountable for the results achieved. In
order to ensure the development and the quality of this moral forum, it is
important that it becomes part of the governance of healthcare institutions.
To shape this moral forum, care providers must invest in regional consultation
structures. The parties involved develop a shared assessment framework that
can be used as a moral compass for decision-making.
They develop indicators using everyday practice as the starting point and then
focus on quantifying and interpreting it, and on improvements and quality
assurance. The principle is that results – effectiveness, safety, patient-
orientation – can be used and learned from e.g. to ensure improvement. As a
secondary purpose, they can be used for external accountability and choice
information. Other sources that can be used in this dialogue are annual reports
and analyses of local practice data. Care parties that are part of the network can
emulate each other, exchange data, knowledge and learning experiences, and
draw conclusions at an umbrella level. This means that the results are indicative
for changes in the patients’ health, and that it must be possible to create a link to
an intervention.
Recommendation 7: Care organisations must take the initiative to invest in a
dialogue about good care with interested parties in the region (moral forum).
This moral forum is part of the governance of care institutions.
7.4        The institutional environment
Using a context-based approach no longer puts the emphasis on evidence but
instead on critical interpretation of evidence jointly with other information
sources within the morally charged context in which care takes is given. This
requires new activities and competences from care professionals and care
organisations. To give them room to realise the aspects mentioned above, the
parties in the environment of care professionals and organisations – and in
particular parties who depend heavily on evidence-based instruments such as
policy bodies, care insurers, supervisory bodies and research organisations –
must be encouraged to adopt a different approach.
The Council is giving the initial impetus for this and providing solutions and
recommendations relating to research, package management, development of
guidelines and quality supervision.
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<pre>59                                                    RVS – No evidence without context
To that end, we are focusing first on the way that various stakeholders in care
interpret and use evidence.
A stratified concept of evidence
Because of its emphasis on epidemiological, generic knowledge as the
cornerstone of professional actions, EBP suggests that evidence is an
unambiguous concept. However, ‘evidence’ can have multiple meanings and
functions, thereby raising different expectations (De Jong, 2016). This layering
results in the first instance from the fact that there are multiple sources of
knowledge that contain indications about the truth – scientific research, clinical
expertise and experience, the experiences and personal situations of patients,
and local practice data (to name but a few). Furthermore, there is always
someone involved who interprets these knowledge sources and links them
together. The way that this is done depends on the context and the values and
interests that are at stake. It is important for patients to get access to the care
that suits them best, for care professionals it is about being able to provide care
in accordance with the standards of their own professional group, for care
insurers the interest is efficient care for the people they have insured –
i.e. affordable high-quality care – and the interest for quality supervision is that
care providers meet the preconditions that reasonably guarantee the quality and
safety of care.
Tensions between the parties in care that use scientific evidence as an
instrument are connected with the various meanings that they give to ‘evidence’
(De Jong, 2016). To one party, the evidence is an indication for an objective
truth. The parties hope to get closer to this truth by testing hypotheses. This idea
of evidence fits in with the perspectives of both scientists and care providers. At
the same time, care providers are not ultimately (or not exclusively) aiming to
uncover objective truths. Their primary task is finding solutions for and with their
patients, weighing things up and making compromises (Van Baalen et al., 2014).
To that end they create a picture of the patient using everything they know about
the patient, utilising all the explicit and implicit knowledge sources at their
disposal, and this picture can be used for clinical reasoning. This design does
not have to represent the truth: what is important is that it works in practice (Van
Baalen et al., 2014). This is therefore a pragmatic idea of evidence.
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<pre>7 – Possible solutions and recommendations                                       60
Evidence is also everything that convinces. The better a new fact can be framed
within existing knowledge, the greater its persuasive strength. This idea of
evidence fits in with the perspectives of not only care providers but also patients.
It is because they have to be convinced of the assessment of their situation and
of the suitability of a prescribed treatment.
Finally, evidence may also function as a neutral referee, for instance between
effective and non-effective or harmful care. The use of evidence as a referee in
order to make decisions dominates quality supervision, healthcare procurement
and package management.
In order to handle the tensions between them, parties in the care sector will
have to recognise these different conceptualisations of evidence. How they
assess and weigh up evidence – such as the interpretation of certain outcome
measures or quality indicators – is intertwined with the interests that these
parties represent. Agreement about the interpretation and weighing up of the
available evidence must be promoted by making these interests explicit and
weighing them jointly in mutual dialogue.
A better research system
As has been explained in previous chapters, EBP contributed unintentionally to
creating a research system in which some patient groups, regular care,
diagnostics and forms of care that cannot be assessed properly using
randomised controlled trials (RCTs) systematically receive less attention. The
research system also often contains stimuli and rules that unintentionally allow
space for flawed research and selective publication. The Council specifically
asks for attention to be paid to the fact that guidelines and research results that
are obtained externally cannot be simply implemented in any setting, and to the
existing gap with respect to the way that various knowledge sources must be
integrated.
There is no ‘magic bullet’ for promoting proper, socially relevant and efficient
health research (i.e. based on both the disease burden and the care costs). This
requires a joint, multi-faceted approach by research financers, the people who
perform scientific research, scientific journals and regulatory bodies. Research
financers in particular play a key role. ZonMw (the Netherlands Organisation for
Health Research and Development) maintains an active policy for this (Nasser
et al., 2017).
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<pre>61                                               RVS – No evidence without context
To start with, more knowledge is needed about the causes of systemic failure in
order to get a picture of new solutions and to improve research practices. The
first steps have already been made for this (see the boxed text on “Scrutiny of
the research system”).
Research financers may impose requirements on the content in order to steer
research agendas towards what is socially needed. An example of this is the
financial support from ZonMw for the initiative taken by medical/scientific
associations of the professional groups to assess regular care. This may look at
healthcare interventions where there is doubt about the effectiveness and
safety, or comparative research into various options that are both used in
practice. These associations have undertaken to include the results in their
guidelines.
However, the bulk of government financing of the research at university medical
centres (UMCs) comes from the Ministry of Education, Culture and Science. No
requirements are imposed on this in terms of the content. These resources are
predominantly spent on research themes that university medical centres score
well at in terms of publications (performance financing) and/or themes that are
predominantly about healthcare (Health Council of the Netherlands, 2016).
UMCs focus predominantly on fundamental and translational research, and on
research into medical specialist care. In addition, their patient population is
becoming more and more complex, which is caused by the concentration of
highly complex medical specialist care. It is therefore desirable that UMCs
should start to function as the “motor of research and innovation for care and
prevention across the full breadth”, in cooperation with all the providers of care
and prevention, knowledge centres, patients and municipalities (Health Council
of the Netherlands, 2016). Government, municipalities and healthcare insurers
must finance this research jointly and structurally.
In addition to paying attention to the research agenda, the way research is
carried out also needs to be examined. Better access for researchers to
methodological expertise and better access to research data helps identify the
distortion of research results and helps improve the setup of research (Health
Council of the Netherlands, 2016). This also promotes reuse of existing research
data. The use of checklists by research financers to test the soundness and
efficiency of research proposals must be encouraged. When assessing research
results, research financers must check if a research design will provide evidence
that fits with the local need for knowledge. This leaves more space for forms of
research other than the RCT and promotes efficient use of research resources
(see boxed text on “Surgical care safety”). Furthermore, in order to avoid
distortion, research financers must demand that all research results are
published.
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<pre>7 – Possible solutions and recommendations                                        62
Researchers and research financers must also involve other stakeholders –
such as patients and user groups – in the programming, setup, assessment and
execution of the research. This will enhance the relevance and quality of
research.
Recommendation 8: To promote good, socially relevant and efficient health
research, financers of health research must impose requirements on the
substantive targets, and on publication of research. They must actively involve
stakeholders such as user groups and patients in this.
Using external evidence in the local situation is more than a question of
implementation: it is part of a learning process. RCTs aim to standardise the
care setting, the intervention and the target group. Checking the results in
everyday practice requires research that can explicitly show the influence of
contextual factors on the results. This could involve a non-standard patient mix,
the link between outcome measures and patient preferences, specific expertise
and skills of the caregivers, the presence of specific infrastructure or cooperation
agreements with other disciplines or chain partners. Having a better picture of
the influence of contextual factors lets the parties involved obtain insights into
the required preconditions for successful use of interventions. This requires a
variety of research forms, both quantitative and qualitative. Important aspects of
this are having a picture of the strengths and weaknesses of alternative
research methods, and acquiring experience in combining various methods into
a single piece of research.
Recommendation 9: Researchers and financers of health research must pay
attention to the influence of the context of the practice in which care is provided.
This can be done by using local practice data and by combining quantitative and
qualitative methods into one and the same form of research.
Imposing more requirements on research also means that more resources have
to be reserved for the programming and assessment of research. This could
mean that less research funding is spent directly on research. This is not a
problem if these additional overheads compare favourably to the more efficient
use of research resources.
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<pre>63                                                  RVS – No evidence without context
    Scrutiny of the research system
     With the BVO research programme (‘Promoting Responsible
     Research Practices’) ZonMw is improving knowledge about the
     research system, and the stimuli and rules that determine the
     quality, integrity, social relevance and efficiency of research. This
     could involve factors such as the peer review system for scientific
     articles, publication pressure, data accessibility and remuneration
     mechanisms. The following studies have recently been awarded
     grants:
    — Researcher allegiance in research on psychosocial
        interventions: Impact on effects and mechanisms.
    — Optimizing the responsible researcher: towards fair and
        constructive academic advancement.
    — Fostering the responsible use of residual biospecimens and
        data in medical research in the Netherlands.
    — The myth of null-hypothesis significance testing in scientific research.
    — Fostering responsible conclusions in Health Services Research.
    — Follow the Money: Does Competitive Research Funding
        Contribute to Questionable Research Practices?
    — A systematic approach to identify determinants of
        questionable research practices in clinical trials.
    — Improving Peer Review: interventions that work (IMPER).
Safety during surgery
The fact that assessing the suitability of a research design can be effective is
illustrated by the introduction of the ‘goal-directed fluid therapy’. This is an
anaesthesiological intervention that reduces the risk of complications during
surgery. The effectiveness and efficiency had already been shown in foreign
research. A request for a Dutch clinical trial was therefore rejected. The
development of a business case to transpose foreign results into the Dutch
situation was chosen in consultation with the requesting party. This is
considerably less expensive than a clinical trial. Because it was also more in line
with the questions from hospitals and anaesthetists, it promoted the use of the
intervention in operating theatres.
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<pre>7 – Possible solutions and recommendations                                        64
Package management
There are differences between decision-making about reimbursement of care as
part of the Healthcare Insurance Act and the Long-Term Care Act (in which the
National Healthcare Institute has an advisory task) and the recommendations in
professional guidelines and the decision-making in individual patient care. This
is partly caused by the different meanings and functions of ‘evidence’ adopted
by the National Healthcare Institute, scientific associations of the professional
groups – which are responsible for the development of professional guidelines –
and care professionals. It is linked to the various interests that they represent:
mutual solidarity in the basic insurance package, and the provision of care to
individual patients in accordance with these parties’ own professional standards.
Because of the hierarchy of knowledge sources used by the parties just listed,
this particularly affects care forms and patient groups that are difficult to assess
through randomised clinical trials.
As has already been described in Chapter 2, the National Healthcare Institute
has already taken a number of steps in order to consider the context in the
package recommendations. To bridge the differences between remuneration
decisions, guidelines and decision-making in practice, the National Healthcare
Institute, professional associations and patients must enter into a dialogue with
each other about how they interpret the available evidence, and about the
evidence required for the decision about remuneration to be positive. This is
because the assessment framework of the National Healthcare Institute leaves
room for other research methods than randomised clinical trials.
Professional groups and patient organisations can then check the possibilities
for achieving the required burden of proof, for instance through systematic
analysis of clinical databases, local practice data and patient experiences. This
lets professional groups see whether they can adopt a consensus point of view.
An example of this approach is the remuneration of epilepsy dogs (see boxed
text on ‘Epilepsy dogs’).
Recommendation 10: When giving advice about package management, the
National Healthcare Institute provides space for the context in which healthcare
is delivered, and it also uses other knowledge sources besides scientific
evidence. To achieve this, the National Healthcare Institute involves
professionals, patients and the general public in its advice.
Epilepsy dogs: from double-blind to appropriate evidence
Epilepsy dogs (dogs that help their owner during and after an epileptic seizure)
are not paid for from the basic package.
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<pre>65                                                    RVS – No evidence without context
In 2014, the National Healthcare Institute judged that providing them fails to
meet the current state of science and practice (National Healthcare Institute,
2014b). The few existing studies are too small and of low quality. The National
Healthcare Institute then determined what minimum burden of proof is required
to reach a positive judgment, which included a sufficient number of patients and
an appropriate description of the patient’s situation before and after the
deployment of an epilepsy dog. A randomised trial is therefore not required and
there are objections to the approach anyway, as patients may prefer having or
not having a dog. Although the assessment framework of the National
Healthcare Institute assumes a hierarchy of evidence, this example shows that
‘lower’ levels of evidence can also be acceptable, however without giving
assurances beforehand about the final decision. As a result of the Potters
amendment, the Ministry of Health, Welfare and Sport granted a subsidy for the
research through ZonMw. A feasibility study was started at the end of 2016 to
check if research that meets the requirements imposed is a possibility.
Development of guidelines
To promote patient-oriented professional guidelines, the involvement of patients
must be encouraged. Practice tells us that this requires a nuanced approach. It
turns out that the adage “the more involvement the better” does not hold water.
For patient-oriented guidelines, there seems to be no connection with the
degree of patient participation (Van den Bovenkamp et al., 2013). Because of
their lack of knowledge, it is difficult to exert influence, whereas their
representativeness is bought into doubt if they professionalise by developing
such expertise. Additionally, it is difficult to make the input of patients
transparent and traceable in guideline committees. Patients should in particular
be involved in the development of guidelines at the right moment. There have
been good experiences with input from patients in the preparation phase. The
scope of a guideline and the choice of outcome measurements are determined
in this phase and important moments of choice can be identified, in which the
desires and preferences of patients play a role (Den Breejen, 2017).
Recommendation 11: Guideline developers are working on the patient
orientation of professional guidelines by involving patients, the general public
and other stakeholders systematically in setting up and changing them.
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<pre>7 – Possible solutions and recommendations                                        66
Quality supervision and care contracting
Evidence-based instruments are an important element of quality supervision and
healthcare contracting: compliance with professional guidelines, centrally
determined quality indicators based on guidelines, and volume standards for
specialist medical care. This approach fits in with steering care towards a
situation in which external accountability and control are the leading principles.
This approach has resulted in a ‘quality industry’ in which quality has become
disconnected from professionalism – it has been outsourced to the quality
departments of care institutions and to external supervisory bodies. This way of
creating accountability does not fit in sufficiently well with everyday practice,
does not result in learning and quality improvement, and reduces the motivation
of care professionals to record quality (Weggelaar et al., 2016).
This approach should therefore be replaced by an approach in which quality is
appropriated by care professionals and care organisations who make it part of
their learning and improvement cycle. External quality supervision and
healthcare procurement must focus on this cycle and on verifiable criteria that
this learning practice must comply with. Preconditions that reasonably guarantee
the medical quality and safety of care and that care providers must meet for their
‘licence to operate’ are part of these criteria.
Recommendation 12: The focus of quality supervision and care contracting must
shift from uniform quantitative results of care to learning and improving care
professionals and care organisations.
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<pre>                                                                                 67
8 Recommendations
‘‘No evidence without context’ is the title of these recommendations. That is
because evidence is always used in a concrete context, and evidence only then
acquires its meaning. Context-based practice requires care professionals who
listen to their patients, who dare to welcome uncertainty, and who will enter a
dialogue about good care. This results in suitable, patient-oriented care in which
evidence has a place and is part of the accountability for the care provided.
Care professionals cannot do this alone, but have to do it together with patients
and other parties involved. This requires a different approach in scientific
research, education and supervisory practices.
Care professionals and organisations in domains outside healthcare that EBP
has managed to access can learn from these recommendations. The Council
calls upon them to follow the recommendations in this advice and to translate
them into their own practice.
Context-based practice
The Council recommends that the term ‘context-based practice’ should be used
rather than ‘evidence-based practice’. Although evidence plays a role as a
source of information, it does so alongside many other sources of information.
The specific context determines how these knowledge sources are connected
together.
The consulting room: patients and healthcare professionals
Shared decision-making is essential to determine what constitutes good care.
Care professionals tailor it to the patient’s context, and pay more attention to
listening than to dispensing information.
Patients’ organisations should take the initiative to develop decision aids
(together with healthcare providers and other parties involved) that are based
on what patients feel is important.
Care professionals should embrace the uncertainty about what constitutes good
care. Together with the relevant parties, they must learn to assess and integrate
various sources of information.
Learning care organisations
Care organisations should reserve more time at the front line of healthcare
processes, in particular during the phase of diagnosis and decision-makin
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<pre>68                                               RVS – No evidence without context
Care organisations must take the initiative to invest in a dialogue about good care
with interested parties in the region (moral forum). This moral forum is part of the
governance of care institutions.
Education
Residency programme directors should include social science and humanities,
interdisciplinary education and active contributions from patients in the curriculum.
Research
To promote good, socially relevant and efficient health research, financers of health
research impose requirements on the substantive targets, and on publication of
research. They must actively involve stakeholders such as user groups and
patients in this.
Researchers and financers of health research must pay attention to the influence of
the context of the practice in which care is provided. This can be done by using
local practice data and by combining quantitative and qualitative methods into one
and the same form of research.
Package management
When giving advice about package management, the National Healthcare Institute
provides space for the context in which healthcare is delivered, and it also uses
other knowledge sources besides scientific evidence. To achieve this, the National
Healthcare Institute involves professionals, patients and the general public in its
advice.
Development of guidelines
Guideline developers are working on the patient orientation of professional
guidelines by involving patients, the general public and other stakeholders
systematically in setting up and changing them.
Supervision and care contracting
The focus of quality supervision and care contracting must shift from uniform
quantitative results of care to learning and improving care professionals and care
organisations.
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<pre>                                                                                 69
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<pre>                                                                           75
Preparation of advice
These recommendations have been drawn up by Jan Kremer (Council
member with primary responsibility), Liesbeth Eelens-Noordegraaf (Council
member), Willem Jan Meerding, Leo Ottes and Martijn Felder (advisers).
Gabie de Jong (surgeon, Rijnstate) wrote one of the background studies. Noor
Mutsaerts (medicine student, UMC Utrecht) prepared the patient case
histories.
The following background studies have been written as preparation: They are
available from www.raadrvs.nl. (Only in Dutch)
Martijn Felder, Willem Jan Meerding (2016). Een toekomst voor evidence-
based medicine? [A future for evidence-based medicine?] The Hague: RVS.
Gabie de Jong, Willem Jan Meerding (2016). Betekenissen van bewijs
[Meanings of evidence].
The Hague: RVS.
Leo Ottes (2016). Het bewijs [The evidence]. The Hague: RVS.
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<pre>                                                                              76
Consulted experts
The following people were consulted during the preparation of the advice:
Dr. Annemijn Aarts                 Radboud UMC
Dr. Arend Arends                   Havenziekenhuis
Prof. dr. Roland Bal               Erasmus University
Dr. Teus van Barneveld             Knowledge Institute, Federation of Medical
                                   Specialists
Prof. dr. Didi Braat               Radboud UMC
Dr. Timo Bolt                      Erasmus University
Dr. Sophie van Baalen              University of Twente
Dr. Elvira den Breejen             Federation of Medical Specialists
Dr. Jaco Burgers                   Nederlands Huisartsen Genootschap
                                   [Dutch College of General Practitioners]
Dr. Marcel Daniëls                 Federation of Medical Specialists
Dr. Diana Delnoij                  National Health Care Institute
Dr. Jeroen van Dillen              Radboud UMC
Dr. Hans Duvekot                   Erasmus University
Dr. Robert Ensink                  Gelre Hospitals
Dr. Annefloor van Enst             Knowledge Institute, Federation of Medical
                                   Specialists
Dr. Pieter van Eijsden             UMC Utrecht
Dr. Roland Friele                  Nivel
Rimke Geels, MD                    Zilveren Kruis
Dr. Wim Gorissen                   Nederlands Jeugdinstituut
                                    [Netherlands Youth Institute]
Prof. dr. Frank van den Hoogen     Radboud UMC
Dr. Jur Koksma                     Radboud University
Prof. dr. Bertine Lahuis           Karakter
Dr. Barbara van der Linden         ZonMw
Prof. dr. Jim van Os               Maastricht University
Esther Rake                        Knowledge Institute, Federation of Medical
                                   Specialists
Alan Ralston, psychiatrist         Mental Healthcare Services Dijk en Duin,
                                   Castricum
Dr. Federica Russo                 Amsterdam University
Dr. Rob Segaar                     Ministery of Health, Welfare and Sports
Vicky Soomers, MD                  Radboud UMC
Dr. Henk Smid                      ZonMw
Prof. dr. Yvo Smulders             VU University Amsterdam Medical Centre
Nadine van Veenendaal, MD          VU University Amsterdam Medical Centre
Sjaak Verduijn, MD                 CZ
Prof. dr. Trudy van der Weijden    Maastricht University
Sietse Wieringa, general           University of Oxford
practitioner
Prof. dr. Niek de Wit              UMC Utrecht
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<pre>77                                              RVS – No evidence without context
The following peoples gave comments on a draft of the advice:
  Prof. dr. Yvo Smulders            VU University Amsterdam Medical Centre
  Dr. Timo Bolt                     Erasmus University
  Sietse Wieringa, MD               University of Oxford
The Council provides advice independently. The discussions during the
preparation of the advice were not aimed at acquiring support. The people
taking part in the discussions have made no commitment to the
recommendations.
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<pre>                                                                                78
Publications
Wisseling van perspectief. De werkagenda van de RVS
[Changing perspectives. The working agenda of the Council for Public Health and
Society] Publication, number 15-01, December 2015.
Verlangen naar samenhang. Over systeemverantwoordelijkheid en pluriformiteit
[Longing for cohesion. On system responsibility and pluriformity].
Recommendation, number 16-01, April 2016.
Een gedurfde ambitie. Veelzijdig samenwerken met kind en gezin
[A daring ambition. Multifaceted cooperation with child and family].
Recommendation, number 16-02, May 2016
Grensconflicten. Toegang tot sociale voorzieningen voor vluchtelingen
[Border conflicts. Access to social facilities for refugees].
Essay, number 16-03, October 2016.
Wat ik met Kerst mis. Een bundel met wisselende perspectieven over eenzaamheid
[No Christmas presents. A bundle showing various perspectives about loneliness].
Bundle, number 16-04, December 2016.
Implementatie van e-health vraagt om durf en ruimte
[Implementation of e-health requires courage and space].
Advisory letter, number 17-01, January 2017.
Inkoopsafari. Verkenning van de praktijk van zorginkoop
 [Procurement safari. Exploring the practice of healthcare procurement]
Advisory letter, number 17-02, 7 February 2017.
Recept voor maatschappelijk probleem. Medicalisering van levensfasen
[Recipe for a social problem. Medicalisation of phases of life].
Recommendation, number 17-03, March 2017.
De Zorgagenda voor een gezonde samenleving
[The care agenda for a healthy society].
Publication, number 17-04, April 2017.
Zonder context geen bewijs. Over de illusie van evidence-based practice in de
zorg. [No evidence without context. About the illusion of evidence-based practice
in healthcare].
Recommendation, number 17-05, June 2017.
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<pre></pre>

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<pre>__ olksgezondheid en
_amenleving

raad voo |
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<br><br>