Title
Priority setting in kidney transplantation in Sweden
Authors
Faisal Omar: Department of Medical and Health Sciences Linköping University, Sweden
E-mail: faisal.omar@liu.se
Per Carlsson: Centre for Medical Technology Assessment, National Centre for Priority Setting in
Healthcare, Linköping University
Email: per.carlsson@liu.se
Marie Omnell Persson: Department of Nephrology and Transplantation, Skåne University Hospital
(Malmö), Lund University, Malmö, Sweden
E-mail: Marie.Omnell-Persson@med.lu.se
Stellan Welin: Department of Medical and Health Sciences Linköping University, Sweden
E-mail: stellan.Welin@liu.se
Correspondence:
Marie Omnell Persson: Department of Nephrology and Transplantation, Skåne University Hospital
(Malmö), Lund University, Malmö, Sweden
E-mail: Marie.Omnell-Persson@med.lu.se
1
ABSTRACT
Background: Kidney transplantation is the established treatment of choice for end-stage renal disease; it
increases survival, and quality of life, while being more cost effective than dialysis. It is, however, limited
by the scarcity of kidneys. The aim of this paper was to investigate the fairness of the priority setting
process underpinning Swedish kidney transplantation in reference to the accountability for
reasonableness framework. To achieve this, two significant stages of the process influencing access to
transplantation were examined: (1) assessment for transplant candidacy, and (2) allocation of kidneys
from deceased donors.
Methods: Semi-structured interviews were the main source of data collection. Fifteen Interviewees
included transplant surgeons, nephrologists, and transplant coordinators representing transplant
centers nationwide. Thematic analysis was used to analyze interviews, with the Accountability for
reasonableness serving as an analytical lens.
Results and Discussion: Decision-making both in assessment and allocation are based on clusters of
factors that belong to one of three levels: patient, professional, and the institutional levels. The factors
appeal to values such as maximization of benefit, favoring the worst off, and equal treatment, which are
traded off.
Conclusions: The factors described in this paper and the values on which they rest on the most part
satisfy the relevance condition of the framework. There are however potential sources for unequal
treatment which we have identified. These are clinical judgment and institutional policies relating both
to assessment and allocation.
The appeals and revisions mechanisms are well developed. However,
there is room for improvement in the areas of publicity and enforcement. The development of explicit
national guidelines for assessing transplant candidacy and the creation of a central kidney allocation
system would contribute to better publicity and enforcement. The benefits of these policy proposals in
the Swedish transplant system should be studied further.
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1. IINTRODUCTION
End-stage renal disease (ESRD) is a condition in which kidney function decreases significantly and
permanently requiring renal replacement therapy. Kidney transplantation is the established treatment
of choice; it improves survival rates and offers higher quality of life compared with dialysis [1,2];
furthermore, it is significantly more cost-effective [3]. Despite these advantages, the availability of
transplantation to all who can benefit from it is limited by the scarcity of kidneys. In 2009, less than half
of Swedish patients on the kidney transplant list had access to a deceased donor kidney.
ESRD patients in Sweden are treated in one 65 nephrology clinics, 90% hospital bases, which refer
transplant candidates to one of four transplant programs [4]. Each program manages independent
waiting lists both in terms of accepting patients to the transplant list as well as allocating organs:
Sahlgrenska University Hospital in Göteborg, Huddinge University Hospital in Stockholm, Skåne
University Hospital in Malmö, and Uppsala University Hospital. Scandiatransplant, a Nordic network,
facilitates a limited number of organs exchanged between centers (approx. 12%) [5]. Given the existing
resource constraints, transplant programs naturally employ various criteria to prioritize among potential
recipients as a means of rationing the limited pool of kidneys. Considering the decentralised nature of
Swedish healthcare and in the absence of national guidelines either for assessing eligibility for
transplantation or the allocation of kidneys, important questions arise regarding the fairness of the
priority setting process determining access to transplantation.
The aim of this study was to investigate the fairness of the priority setting process underpinning Swedish
kidney transplantation in reference to the Accountability for Reasonableness framework [6]. Two stages
with significant influence on access to transplantation were examined: (1) assessment for transplant
candidacy, and (2) allocation of deceased donor kidneys once patients are on the waiting list. This is the
first empirical study to specifically examine the unique aspects related to priority setting in kidney
transplantation using the A4R framework. To achieve our aims and create and accessible structure, the
paper is divided into a number of sections. We first introduce the A4R framework and methodological
details of the study. Next we elucidate the priority setting process in Swedish kidney transplantation
covering both aspects of assessment and allocation. This account is important for two reasons. First
this priority setting process has never been described before; secondly this description is necessary for
carrying out a purposeful evaluation of the process in reference to the A4R. We next present factors
3
and values which emerged as playing a role in priority setting decisions. This is followed by an
evaluation of the fairness of the overall priority setting process (including factors and values) in
reference to the conditions of the A4R. Finally we address the limitation, implications and provide
concluding remarks.
Accountability for Reasonableness
The A4R priority setting framework has received increased attention over the past decade, becoming a
prominent paradigm in health policy. It has been employed in empirical studies examining priority
setting at different decision-making levels, in various countries, and within different medical specialties
[7-11]. The framework emphasizes the establishment of a fair and legitimate priority setting process
rather than relying on overarching substantive principles. Traditional methods appealing to
comprehensive philosophical approaches such as utilitarianism and egalitarianism, it is argued, take as
their starting point different values that lead us to different decisions, none of which can be claimed to
be completely correct[9, 12]. The framework stipulates four conditions which contribute to the fairness
of priority setting processes [6, 12]. The hope is that if we agree on the fairness of the process, we are
more likely to agree on decision outcomes also.
Figure 2. The conditions of the A4R framework [6, 12]
While procedural fairness in the allocation of scarce medical resources is vital, it cannot be dismissed
that “substantive, morally relevant values and principles are indispensable for just allocation” [13]. In
line with this observation, the framework has been criticized on the grounds of the diminished role it
assigns to substantive values that underlie priority setting processes, even if there is no unanimous
agreement on such values [14-16]. It is argued that being explicit about the substantive principles
fosters legitimacy for the decisions reached.
It has also been criticized for limiting the range of
stakeholders included into the priority setting process [17, 18].
Despite the criticism, there remain valuable contributions regarding procedural fairness that the
application of the A4R can make. Our approach will be to use the framework’s strengths as a tool for
examining issues related to procedural fairness while also highlighting the substantive values found in
the priority setting process.
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2. METHODS
Data collection and analysis
During the design phase different methodological options were considered. A survey based study had
the benefit of being less time intensive since the study sites are spread across a vast geographical area;
additionally it would eliminate the logistic challenge of arranging interviews with busy professionals who
are often on call. Despite the benefits of a survey study, it was agreed a qualitative interview based
study would be more suitable to understanding the underlying factors contributing to priority setting
decisions. It better acknowledges the importance of the social worlds that the events take place, which
can be lost when conducting a survey study [19]. Visiting the environments where decision making
occurs, and meeting the decision makers in person for in-depth interviews would provide a nuanced
understanding of the context in which priorities are set, helping to generate a richer data set. Further it
would allow probing interesting topics during interviews which wouldn’t be possible with a survey. For
these reasons interviews were chosen as the approach for data collection. A semi-structured interview
guide was developed, which was broadly based to provide a complete depiction of the priority setting
processes in Swedish kidney transplantation. The guide also addressed topics related to the conditions
of the A4R framework. All interviews were recorded and transcribed verbatim.
The method chosen for analyzing the interviews was thematic analysis.
Grounded theory, while
considered, was ruled out for two reasons. Primarily because the object of the study was not theory
generation, in which case grounded theory would be more appropriate. The central role of the A4R in
the study required a flexible method to allow bringing in an external framework which would have been
more difficult with grounded theory. Thematic analysis is a more flexible approach which facilitates the
identification and extraction of emerging themes which are particularly significant for the research
questions and aims [20]. In the present study it would better allow us to use the A4R as an analytical
lens through which relevant themes within the data could be extracted, analyzed and discussed.
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Study Sites
We investigated priority setting at all centers performing kidney transplantation in Sweden. In addition,
a selection of satellite nephrology clinics that refer patients to the centers was included. This was done
to gain a comprehensive representation of the referral process from the point of view of both the
transplant centres and the referring nephrology units. Centers were sampled for representativeness.
Subjects
In total, 15 professionals were interviewed for this study. This included 6 surgeons, 7 nephrologists, and
2 transplant coordinators. At least one surgeon was included from each of the transplant centres. The 7
nephrologists were from nephrology clinics located in different regions of the country representing the 4
transplant regions. Finally, a recipient transplant coordinator and a donor transplant coordinator were
also included. Gender distribution was almost equal, with 8 male and 7 female interviewees.
The sampling techniques purposefully included the key decision-makers at transplant center and
nephrology units. The majority of respondents were senior physicians and surgeons with an average of
over 20 years of experience in this field. A number of the interviewees were either actively involved in or
had had previous administrative responsibilities within their departments. This was a critical component
of the study, since these responsibilities often require engagement in priority setting issues, which
results in a deeper understanding of the way that resource scarcity affects priority setting at the clinical
and departmental levels.
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3. RESULTS
There are three goals in this section. First we will describe the priority setting process as it relates both
the assessment for transplantation and allocation of deceased donor kidneys.
Next we provide an
overview of the factors which emerged as having an impact on priority setting decisions within both
stages. Finally we highlight the values which underpin the priority setting process in relation to the
decision making factors identified. The full list covering both factors and values is presented in Table 1.
The priority setting process
Transplant centers provide regional nephrology clinics with a list of medical investigations required for
all referents. The final decision regarding eligibility lies with the transplant center. While investigations
are more or less similar across centers, there are procedural differences in how listing decisions are
reached. Two centers hold “gatekeeper” meetings where patient cases are discussed and a group
consensus reached, the group shares responsibility for all decisions. The remaining two centers do not
require such meetings; however decisions are shared during daily rounds; only for particularly difficult
cases are group consensus sought. As well as being an opportunity to disseminate information about
decisions, gatekeeper meetings and daily rounds encourage consistency between professionals within
the centers by publicizing the decisions made and their rationales.
Once listing decisions are reached, some centers meet all patients personally to relay the decisions,
while others meet only some patients and communicate via the referring nephrologist to others. The
publicity and documentation of rationales underlying kidney allocation decisions differed between
centers. One centre has a long established documentation and rationalization procedure for each kidney
allocated, requiring the responsible surgeon to justify the allocation of a kidney to a particular patient
on the waiting list compared to alternative wait-listed patients. A second center has initiated similar
procedures; this was viewed positively by the centers as a mechanism to increase transparency and
accountability by tracking allocation decisions. The remaining centres did not indicate having any
systematic mechanism to document the rationales for the allocation decisions.
Second opinion mechanisms, after a denial for listing, are well developed and supported nationally. This
is the primary means of appeal in the system. However, before such a stage there are opportunities
within the centers to have decisions reconsidered, if for example the patients status changes.
For
practical reasons, allocation decisions cannot be appealed in the same way denial of admission to the
7
waiting list can. Once a kidney has been allocated, the decision cannot be reversed. Patients do not
generally have any knowledge of the kidneys that have become available or whether or not they were
being considered for such a kidney, since this information is limited to the transplant centres. However
the general criteria used in the allocation process (if they are seen as unfair) may be contested during
meetings which occur at regular intervals between the kidney foundation and the transplant programs.
There are no regulatory bodies responsible for monitoring kidney transplant procedures or outcomes in
a systemic way across centers as a result of Sweden’s decentralized health care structure. Second
opinions do however serve as an informal regulatory mechanism between the centers, since it would be
peculiar to have too divergent an opinion between centers serving patients in the same country.
Nonetheless procedures do differ and the centers are on the most part self-regulating.
Factors affecting priority setting decisions
Throughout the interviews, respondents raised various factors they consider when making decision at
both the listing and allocation stages. Themes that arose frequently were identified as stand-alone
factors such as cardiovascular status or waiting time. Themes such as alcohol dependence and
psychological problems required being identified as belonging to a particular factor such as ‘compliancerelated factors’.
The emergent factors were further grouped into more general categories that
connected them, such as ‘patient-level’, ‘professional-level ’, or ‘institutional-level’. In a single patient
case a cluster of factors from the different levels influence decisions simultaneously. This is true both for
listing and allocation decisions. We will in this section highlight a number of these factors; for a full
overview of the factors and the categories they fall under, see Table 1.
Patient level
The largest share of factors falls under the patient level. This is because whether transplantation as a
treatment is indicated depends on multiple patient specific factors which can be clinical, life style, or
quality of life based. Furthermore in the allocation stage the available organs are matched on multiple
levels to an individual patient to bring about the best post-operative results. While some factors at the
patient level are easily labeled as predominantly clinical, life style, or quality of life based others have
aspects appealing to more than one category at the same time. We will use some examples to illustrate.
8
Cardiovascular status and malignancies (listing stage), HLA compatibility and blood group (allocation
stage) are prominent clinically based patient level factors. On the other hand compliance-related
factors are related to life style choices and include issues such as continued alcohol abuse. These life
style factors are not considered as moral judgment against the patient, but rather because they have a
direct impact on graft survival if the patient continues engaging in these behaviors.
Patient-specific risk benefit considerations is an example of a quality of life based patient level factor.
For instance, a patient who is deeply unhappy with dialysis has more to gain from a transplant and is
permitted to take a greater risk to undergo transplantation. Conversely, a patient who is doing relatively
well on dialysis physiologically and psychologically and enjoys the social aspect of coming to hospital for
dialysis treatment does not have as much to gain. In such cases, carrying out a transplant that can result
in severe complications can have detrimental effects on the patient.
Obesity plays a central role in decision-making for transplantation; however, the precise cut-off for this
is not clearly stipulated and can differ somewhat between centers with some centers having clear BMI
cutoffs. What is clear is that extreme obesity is generally considered a contraindication. More significant
is a patient’s overall fitness which is an important factor indicating how well a patient will cope with
transplantation. It is clear that this overall fitness is more than a simple measurement of BMI, and is
rather patient-specific. The following quotation captures how consideration of overall fitness and
obesity manifest in the clinical setting and influence the assessment for transplantation. At the same
time, it captures the significant role of clinical judgment:
“I have had patients where it says (on their medical record) they have had a stroke, they have had an infarction,
they have had a coronary by-pass, and in walks a tanned man, back from playing an 18-hole game of golf, who
works in his garden every day. Or in comes a patient on a wheelchair who is 20 kilos overweight, mainly on the
belly, and steps out of the wheelchair because I have to look at him; he lies down on the bed in the room as I have
to palpate his belly, and he can hardly get his trousers off“ (surgeon).
Obesity is an example of a patient level factor which has aspects that are clearly clinical and others
which are life style based. Furthermore it includes aspects which bridge over to the professional (clinical
judgment), and institutional levels factors (BMI cut off). It aptly demonstrates the complexity of the
priority setting process in kidney transplantation.
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Professional level
Clinical judgment plays a significant role in priority setting and was considered particularly important in
borderline cases where it can tip the balance regarding the final decisions:
“Most cases are not borderline cases, but there will always be borderline cases in medicine, and because of that I
think that whether or not we have the same criteria, it really does not matter—there will always be personal
opinions…….You should not make an important judgment on just a hunch or a feeling; you should also look at the
data, but then you should try to make it all come together in the end. Sometimes this feeling or hunch is the factor
that makes you say yes or no, if you are on the line. Then you have to use your clinical judgment; this is your job,
this is what you are paid for”
With no central (algorithm based) allocation system in Sweden, such as that employed at UNOS [21],
each surgeon on duty must decide on how to weigh the various factors in every single allocation
decision. This depends heavily on the surgeon’s interpretation of the factors that are seen as relevant
further cementing clinical judgment’s central role in the priority setting process. Clinical judgment is
often an implicit decision making tool. It is according to our analysis a potential source of unequal
treatment between patients. As indicated in the quote above professionals believe that this is an
inevitable part of medical practice. Second opinions do play a role in restraining the impact of
differences in opinion as a potential source of unequal treatment. There is however no guarantee that
patient will seek second opinions. Clinical judgment has clear implications on the fairness of the
process. This will be discussed further (in reference to the A4R) in the evaluations section which will
follow.
Professional consideration of resource scarcity is another professional level factor which emerged as
having a clear influence on decision-making:
“We have this shortage of kidneys. We must not waste kidneys on poor cases; you have to have a certain degree of
certainty that this will be successful. If it is not, if the patient is too old or too sick or whatever, there is no use in
accepting him”
The symbolism of gatekeeping in this context portrays the role of centers, and decision makers, as
guardians of society’s resources (deceased donor kidneys) which mustn’t be squandered. The allocation
process similarly builds on the concept of gatekeeping. In the absence of explicit national allocation
system, decisions fall to the surgeon (gatekeeper) on duty at each center in cooperation with an
immunologist to determine the best fit allocation of a kidney.
10
Institutional level
Difference in policy between centers is an important part of institutional level factors. An example is
policies regarding obesity and BMI cut-offs, which can lead to different decisions for similar patients
between centers:
“I know the data on obesity are contradictory, and we are very strict about that here… We are somewhat stricter (
than other centers) perhaps” (surgeon)
Similar to clinical judgment, institutional policies can be a source of unequal treatment, leading to
different decision outcomes. As a result of where a patient resides, and which transplant center they
are referred to their chances of being accepted to the transplant list can differ. As mentioned in the
above quote this is in part because evidence regarding obesity is contradictory on this subject it is an
area where reasonable disagreement could be expected; we will return to the implications this has on
fairness in the evaluation section to follow.
Another institutional-level factor is the marginal donor program at one of the centers; with a separate
waiting list for patients who accept kidneys from donors defined as marginal donors or extended-criteria
donors. This list is only used when kidneys from marginal donors are available. The patient remains on
the ordinary waiting list as well, and still has the same chance as any other patient to get a kidney from a
standard-criteria donor. Other centres, while they indicated the use of similar-quality kidneys, do not
label them as marginal and prefer to indicate that these kidneys are matched to a suitable recipient
11
Values effecting priority setting decisions
Maximizing benefit
Maximizing benefit can denote different meanings depending on the desired outcome. One common
distinction is saving the most lives vs. saving the most life years. The availability of dialysis as a
maintenance treatment contributes to the fact that many of the factors identified in table 1 lean
towards the second sense of maximizing benefit (saving most life years). This differentiates kidney
transplantation from other areas of organ transplantation such as heart or liver transplantation, where
replacement therapies to keep patients alive are not available and receiving a transplant is an urgent
matter of life or death. Taking this into account, and in light of the organ shortage and the availability of
dialysis, the centers place a greater weight placed on maximizing benefit in terms of most life years.
Decision making is also influenced by consideration of maximizing benefit for a particular kidney vs.
maximizing benefit for a particular patient. In the first instance, the goal in the centers is to maximize
the benefit of the kidney as a scarce medical resource, where decision-makers look to transplant the
organ in a patient where its longevity will be maximized. Here it is driven by a responsibility of decisionmakers to act as gatekeepers of society’s resource. On the other hand maximizing benefit for a
particular patient, is measured from the point of view of the gains that a particular patient will have
from transplantation compared to remaining on dialysis.
While factors which appeal to maximizing benefit are found in both stages (malignancies, age, HLA, agematching), it plays a greater role at the allocation stage. Technically speaking, the transplant list can
always be expanded to include more patients; however, centers cannot increase the number of kidneys
that are available for transplantation at will. It is at the allocation stage that the maximization of benefit
becomes pronounced. This maximization of benefit is balanced against considerations of justice for the
individual. If maximization of benefit was the only concern, it could mean that older and sick patients
would not be transplanted; this is, however, not the case according to our analysis and other values are
considered in the decision-making process.
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Priority to the worst off
An example of giving priority to the worst off is illustrated by the consideration given to a patient’s
negative experience with dialysis, where the patient’s relative well-being taken as a value input at the
assessment stage. At the allocation stage, it is seen when prioritizing those with dialysis access
complications, although they may not be the most ideal patients from a pure benefit maximization
perspective, compared to another patient. However, without dialysis such patients are in urgent need of
transplantation.
While age-based prioritization (whether positive or negative) is not allowed in the Swedish health
system [22] a preference for younger recipients is defended primarily because they fare badly on
dialysis in the long term due to special needs related to growth and development, which cannot be met
through dialysis. At the same time, there is an appeal to maximization of benefit since younger patients
have gains in quality of life that are higher than for older patients; they will predictably also have a
longer graft life, thus making use of the donor kidney to a larger degree. This example illustrates how
more than one ethical value can influence an individual priority decision.
Equal treatment
Treating people equally is most robustly illustrated by the appeal to waiting times as a prioritization tool
for allocation. Waiting time is used as an “objective” measure of deservedness for transplantation in a
first–come-first-served approach. There is a risk that first-come–first-served can give advantage to those
better inform about the benefits of transplantation (often tied to higher socio economic status) [13].
Swedish transplant programs have tried to overcome this potential source of unequal treatment by
counting waiting time from the start day of dialysis rather than the date of being placed on the waiting
list. It is agreed that this is a more equal measurement of waiting time since it reduces inequalities
resulting from late referrals. Furthermore Sweden has a unique Uremia education program for all ESRD
patients informing them of the various treatment options as a way of bridging knowledge disparities
between patient groups.
Equal treatment is also illustrated by the exclusion of particular factors in decision making. Not
considering social status, or chronological age in the strict sense are appeals to equal treatment.
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4. DISCUSION
Evaluating the process in reference to the A4R
With range of factors and values identified there is a potential for reasonable disagreement leading to
different decision outcomes between decision makers. There is also the potential for wrong (unfair)
decisions to be reached in some cases. In instances where several relevant criteria have the potential to
lead to different decision outcomes, the procedure used becomes important as a safeguard for fairness.
It is in this respect that the A4R framework makes its most important contribution to the evaluation of
priority setting process. We also recognize that the factors used in the allocation of scarce medical
resources must be based on morally relevant values; otherwise, the resultant decisions would not be
accepted as either fair or legitimate irrespective of the characteristics of the process in which they are
allocated. One of the important criticisms the A4R has received is the diminished role it assigns to
substantive values in the priority setting process. It can certainly be argued that Daniels and Sabin do
make an allowance for the values that inform decision-making within the relevance condition of the
framework [12]. The extent to which such values should be emphasized within the procedural approach
of the framework is not very clear, however. A number of studies that have applied the framework have
failed to address the underlying values and ethical norms on which decisions rest [9, 10]. We
incorporate the substantive ethical values identified above into the evaluation of the priority setting
process in relation to the A4R framework.
Relevance
Relevance has various dimensions; one being the perspective of the immediate stakeholders. This
includes professionals who manage the transplant programs. The factors and values presented are
those they report to using for decision–making, so we assume that they consider these relevant. Other
stakeholders would be the ESRD population as those directly affected by the decision outcomes.
Considering that there has been an ongoing dialogue with the kidney foundation which has not raised
serious objections, it can be said that they too find the general factors made available to them to be
relevant. It should be mentioned, however, that no study has measured the perceptions of the ESDR
population. Perceptions of fairness in kidney allocation, amongst patient groups, are an important
compliment to actual fairness, which would be an interesting area of enquiry [23].
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It may be argued that the general public should also be included in the discussion as stakeholders; since
the field is so heavily dependent on public participation through organ donation. They are more
intimately involved than in any other area of medicine. Input from the general population may
contribute with relevant values which have been overlooked.
Inclusiveness can have spin-off benefits,
such as increasing awareness about the need for organs. Furthermore, it can lead to better appreciation
for the difficult task that transplant programs perform, highlighting how centers balance complex and
competing priorities to meet individual and population needs.
A second dimensions is the degree that factor and values correspond with those identified in the
literature, which other decision-makers in similar situations, and others involved in the discussion on
resource allocation consider to be relevant. Investigating priority setting in the area of cardiac surgery,
Walton et al. have identified a list of factors, considered in clusters similar to our finding, in the decisionmaking process, which contains a number of the factors identified in our study such as risk assessment,
waiting time, and obesity. This illustrates the similarity in factors that have a role in priority setting in
surgical specialties [9]. From a purely technical and clinical point of view, the factors that are identified
in Table 1 are based on accepted evidence-based medicine and or experience supported by the
literature.
Brock (1988) states that, “there are no value-neutral selection criteria that could permit by-passing of
the need to make ethical judgments in the recipient selection process” [24]. Even amongst what might
be considered morally relevant values, there is certainly no unanimous consensus on the way they
should be traded off in different cases. In his assessment of the ethical values in the distribution of
organ transplantation, Brock identifies two major competing values that are traded off: achieving the
most good with the limited resource and distributing it fairly [24]. In a more recent paper, Persad et al.
[13] discuss four core ethical categories for the allocation of scarce medical resources: maximizing total
benefit, treating people equally, favoring the worst off, and promoting and rewarding social usefulness;
(this is often used during vaccination in pandemics by prioritizing healthcare workers, for example).
These ethical values are clearly related to the two major categories identified by Brock. They also reflect
the values to which decision try to balance in this study. These values identified in the study we believe
are clearly based on morally relevant grounds.
Even if a decision-making factor is generally agreed to be relevant, there remains a risk that it will be
applied unfairly. This is true, for example, if its application undermines a formal requirement of justice
15
that similar cases be treated similarly. Clinical judgment and center specific policies, which fall under the
professional and institutional levels respectively, are two factors which have the potential to lead to
unfair decision outcomes. Clinical judgment we acknowledge is an integral and relevant part of medical
practice. However it is important that variances stemming from this factor are contained. This is
arguably already done through second opinions, but there is the possibility that some patients may not
seek a second opinion. We believe that group decision making via gate keeper meetings, as practiced
by some centers, is an approach with the potential to quell variations between decision makers by
inviting more perspectives and adding to consistency.
On the institutional level, center specific policies are another potential source of unequal treatment. An
example of this is related to obesity, which is an important risk factor for a number of conditions and
complications [25, 26]. However data regarding obesity and transplantation is inconclusive which leads
to different policies [27]. While a centre with a rigid BMI cut-off denies a patient, a similar patient could
be accepted at another center. Considering that patient under the Swedish health care have a right to
equal treatment in having their health needs met, and that this unequal treatment runs counter to
fairness, such differences should be minimized. One approach is to institute uniform BMI cut-off points
between centres to ensure standardization. This can, of course, be extended to other criteria such as
age or time elapsed since a malignancy (which is another area where differences were reported). This,
however, is not the most ideal solution since it promotes over-reliance on rigid cut-off criteria. A better
approach would be to try to discourage the use of defined cut-off values and to rely on more
comprehensive criteria such as the overall fitness of the patient, of which BMI is a component but not
the sole determinant. This we recognize will mean further reliance on clinical judgment, however we
hold as mentioned above that these decisions are best made in a groups setting to invite as many
perspectives.
Publicity
The general rules made available on hospitals websites do not reflect the full range of factors according
to our analysis; nor do they reflect the underlying values on which they are based. The criteria for the
allocation stage are generally better publicized than those for the assessment stage, which can in one
way be explained by the increased cooperation between centres as a consequence of organ-sharing
through Scandiatransplant. Generally speaking the patient level factors are better publicized than
16
professional and institutional levels factors. However as the relevance discussion above shows these
levels are the potential sources of unequal treatment. Publicity of the full range of factors and the values
on which priority setting decisions rest is necessary for any meaningful discussion on the fairness of the
priority setting process.
Publicity and transparency about the actual decisions and of the rationales underlying them is
important. Transparency can have the added benefit that some patients who are unfit to seek a second
opinion will not waste further public resources, which is likely if they are not satisfied by the rationale
given by the first center. According to Walton et al., transparency regarding the rationales underlying
decision-making is also important for patients who should seek a second opinion, so they may make the
most informed decision together with their nephrologist [9].
Appeals/revisions
Mechanisms for appeals and revisions are established and supported at all transplantation centres and
nephrology units at the assessment stage. These are appeals within individual centres or appeals
through second opinions. This openness to second opinion is beneficial for patients, as it increases
opportunities for transplantation. It also has the potential to act as an informal regulatory mechanism of
practices between centres, motivating them not to diverge too much from one another in their
evaluation process.
While appeals in the allocation stage are not possible in the traditional sense, it is important that the
factors that form the basis of allocation decisions can be discussed and appealed against if found to be
unfair. It is promising that such discussions do take place with the kidney foundation, which represents
the ESRD population.
Enforcement
In Sweden’s decentralized healthcare, the centres are fairly autonomous relative to each other and to
the national level. There were examples of informal regulatory mechanisms within the centers to
counterbalance variations arising from individual clinical judgment decisions.
The gate-keeper meetings are a way of inviting more points of view on individual cases in a collaborative
effort. This decision-making within the centers has the potential to enhance fairness by ensuring that
similar cases are treated similarly by a consistent group of decision–makers, which can reduce the
influence of factors that lead to variation between decision-makers.
17
With regards to allocation once center had a sophisticated system of documenting and regulating
allocation decisions at two levels: (1) it required all surgeons to justify their individual allocation, and (2)
there was also a concerted effort to track allocation data in a computerized system, which provided an
opportunity to draw links between certain allocation patterns and post-operative results. Another
center recently began a similar initiative, which is not as developed. Together the above practices we
believe are two best practices which deserve highlighting.
5. LIMITATIONS
There are some methodological limitations which deserve mention. The first is that we did not have the
resources to observe day to day priority setting in the centers which would have contributed to a richer
data set by capturing decision-making in practice. Secondly we did not include any non-professionals as
study subjects. Patients affected by ESRD, and even the general public who provide the resources
necessary for transplantation, certainly have views that should be considered in the priority setting
process. The study was mainly concerned with the professional point of view; it is, however, important
to acknowledge that these are other perspectives that deserve attention in the future, which will create
a more comprehensive depiction of the priority setting process. Finally, we chose the particular
framework A4R; this approach is only one of a number of approaches to assess fairness in priority
setting processes. However, given our interest in the procedural aspect of the priority setting process,
the framework had some clear advantages over alternative approaches.
Finally Sweden has a small population, and the priority setting process for kidney allocation differs from
those found in the larger transplant systems such as Euro transplant and UNOS which are algorithm
based, these together limits the generalizability of this study. However the assessment stage is similar
across health care systems which all share the pervasive concerns for fairness. Findings and the
discussion regarding the potential for professional and institutional level factors to lead to unfair
treatment should of practical concern to all transplant programs.
18
6. CONCLUSIONS
We believe that generally speaking the process can be considered to be fair. The factors described in
this paper and the values on which they rest on the most part satisfy the relevance condition of the
framework. There are however potential sources for unequal treatment which we have identified.
These are clinical judgment and institutional policies relating both to assessment and allocation. The
types of situation where these factors lead to unequal treatment such as in the case of BMI are certainly
areas where reasonable disagreement can be expected since the medical evidence can be scant or
contradictory. These differences in opinion across centers are equalized in some respect by the wellestablished appeal and revision mechanisms that we have reported.
There is room for improvement in the areas of publicity and enforcement. The overall level of publicity
of general guidelines is satisfactory, but it is fragmented— with some factors being better publicized
than others. Publicity and rationalization of allocation decisions is an area that can be improved, since
there was only one center with a well-established system for rationalizing allocation decisions. Even if
this does not lead to opportunities for appeal in the traditional sense, it could act as a mechanism to
facilitate consistency in decision-making within and between centres.
We believe there are two policy proposals which merit consideration that would address issues of
unequal treatment, as well as strengthen publicity and enforcement. These are the creation of national
guidelines for the assessment for transplant candidacy and a national waiting list with centralized
allocation.
Swedish health care law requires that patients be treated equally. National consensus guidelines for
the assessment for transplantation would contribute to better meet this requirement. It would clarify
across the centers what factors are relevant for assessment. National Guidelines would by their nature
be more accessible enhancing publicity.
It would also contribute to further strengthen appeals and
revisions since patients can defer to the guidelines if they believe they have been denied access unfairly.
Finally they will also act as an enforcement mechanism to standardize practices.
A national allocation system is where all patients are placed on one list and kidneys allocated to the
(most appropriate) person near the top of the list no matter where they reside. The allocation would
occur automatically, by a computer algorithm using criteria agreed upon nationally. This we believe will
19
reduce variance and generally contribute to a fairer allocation system. Again this system would better
meet the condition for fairness in the A4R framework. Agreed upon criteria, that is widely accessible
and enforced centrally.
These policies would improve the consistency in decision-making between centers, and would generally
better fulfill the requirements for fairness, in reference to the A4R framework. Participants in the study
did not see a need for national guidelines or central allocation and believed that such guidelines would
reduce flexibility in decision-making and would require more resources. The trade-off between reduced
flexibility and in increased cost, on the one hand and the impact of a national assessment and allocation
system on fairness, on the other hand, should be studied further.
20
Competing interests
No competing interests
Authors' contributions
FO was involved in design of the study, was responsible for data collection, and was involved in data
analysis. PC was involved in design of the study and data analysis. SW was involved in design of the
study and data analysis. MOP was involved in data analysis. All authors were involved in drafting and
critical revision of various versions of the manuscript. All authors have read and approved the final
manuscript.
Acknowledgements
We thank all the surgeons, nephrologists, and transplant coordinators who took the time from their
busy schedules to participate in the interviews and to share their knowledge of the field and their
experiences in it. We also thank Gustav Tinghög for his valuable feedback on the manuscript
21
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Figure 1. The conditions of the A4R framework [5,12].
25
Table 1. Overview of factors and values impacting on priority setting decisions in Swedish kidney transplantation
Patient level factors

Cardiovascular status

Malignancies

Obesity

Overall fitness

Technical issues due to patient physiology

Age ( biological age in assessment, age matching in allocation)

Compliance-related issues (continued alcohol abuse, functioning social network)

Risk benefit ratio (well-being on dialysis and patient motivation)

Availability of living donor

Other medical indications (reason for kidney disease, co-morbidities, urological complications, ,
immunological status, virological.)

Blood group

HLA compatibility

Waiting time

Special priority for young patients

Need (rare situations)
Professional Level factors

Clinical judgment

Risk aversion

Resource utilization (constraints)
26
Institutional level factors

Institutional policies ( obesity, marginal donor program)

Scandiatransplant kidney exchange obligation
Values

Maximizing benefit

Priority to the worst off

Equal treatment
27