Quality of care and monitoring in paediatric end stage renal disease
van Huis, M.
Publication date
2016
Document Version
Final published version
Link to publication
Citation for published version (APA):
van Huis, M. (2016). Quality of care and monitoring in paediatric end stage renal disease.
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CHAPTER 2
Maike van Huis, Nikki J. Schoenmaker, Jaap W. Groothoff, Johanna H. van der Lee and Karlien Cransberg
on behalf of the RICH-Q group
Pediatric Nephrology 2013 Jun;28(6):951-7.
Policy variation in donor and
recipient status in 11 paediatric
ABSTRACT
Background
Evidence based guidelines for pediatric renal transplantation (Tx) are lacking. This may lead to unwanted treatment variations. We aimed to quanitfy the variation in treatment policies and its consequences in daily practice in 11 centers that provide renal Tx for children in 3 European countries.
Methods
We surveyed Tx policies in all ten centers in the Netherlands and Belgium and one center in Germany. We compared Tx policies with the actually provided therapies and with recommendations from available published guidelines and existing literature. Information on treatment policies was obtained by a questionnaire; information on actually provided care was registered prospectively from 2007-2011. The clinical guidelines were identified by searches of MEDLINE and websites of paediatric nephrology organizations.
Results
Between centers, we found discrepancies in policies on: the minimum accepted recipient weight (8-12 kilograms), the maximum living and deceased donor age (50-75 and 45-60 years, respectively). HLA-match policies varied between acceptation of all mismatches to at least 1A1B1DR match. Living donor transplantations amounted to 49% in the Netherlands versus 26% in Belgium (p=0.006).
Conclusion
Management policies for renal Tx in children vary considerably between centers and nations. This has a direct impact on the delivered care, and by extrapolation, on health outcome.
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BACKGROUND
End-Stage Renal Disease (ESRD) in children is a rare but serious disorder [1;2]. In the Western world, the yearly incidence rate of ESRD in people younger than 19 years is about 6-8 per million age related population. Renal transplantation (Tx) is the preferred chronic renal replacement therapy (RRT) for children with ESRD. The management of patients pre-Tx and following successful pre-Tx is essential to maximize the chance of good long-term graft function [3].
In order to maintain acceptable travel distances to the hospital, patients can choose between several, and consequently all very small, Tx centers, of which there are 4 in the Netherlands, 6 in Belgium and 14 in Germany. The low prevalence of childhood ESRD and the overall small center sizes worldwide both have been a barrier for adequately sized randomized clinical trials necessary for the development of evidence based guidelines for treatment of children with ESRD worldwide. The Renal Insufficiency in Children – Quality assessment and improvement (RICH-Q) [4] project started in 2007 as a collaborative initiative of all four Dutch and six Belgian centers for pediatric RRT. In 2011 one German center in a geographically adjacent area, joined RICH-Q, since then comprising eleven pediatric centers which offer RRT. RICH-Q aims to improve the quality of care (QoC) for children with ESRD by peer review and plenary discussion of prospectively recorded data on treatment characteristics and physical and psychosocial health outcomes, applying the latest scientific evidence and guidelines on RRT in children.
In 2012, we reported on large variation in dialysis management policies between the RICH-Q centres [5]. In this paper, we report on variation in policy of acceptance of donors and recipients in children within the 11 RICH-Q sites. We also compare the reported treatment policies with currently available guidelines and with the actually performed care between 2007 and 2011.
MATERIALS AND METHODS
In this study information was obtained from 3 sources. A survey was conducted on management policies, a literature search was performed to identify guidelines, and clinical data were collected prospectively as part of the RICH-Q project. Each of the 3 methods of data-collection are described below.
Survey on treatment policies
In October 2011, we asked one pediatric nephrologist per participating center to complete a questionnaire on local Tx policies. The questionnaire was developed with input from all participating pediatric nephrologists, to ensure content validity. The questionnaire included 22 questions on 10 topics within the 2 main topics; pre-transplantation work-up and transplantation.
The questionnaire included one question regarding altruistic donation, which we defined as ‘a situation in which someone chooses to donate an organ to a recipient with whom the donor has neither genetic nor emotional relationship’ [6].
Literature search
Clinical guidelines on the management of children with renal Tx were retrieved by searching MEDLINE using the following MeSH terms and text words combined as “either/or”: “renal transplantation”, “end-stage renal disease”, “guideline”, “child” and “children”. There was no limit for publication date. Furthermore, we searched websites of organizations known to produce guidelines for patients with ESRD (KDIGO [7], KDOQI [8], CARI [9], UK Renal Association [10], CSN Canada [11], Renal Physicians Association [12], ISPD [13] and ESPN [14]). Included were published clinical guidelines, written in English, which concerned children (0-18 years) with renal Tx.
Clinical data collection in the RICH-Q project
In RICH-Q anonymous data on treatment characteristics and physical and psychosocial health outcomes are registered prospectively concerning all children with ESRD treated in the 11 RICH-Q associated hospitals. In the RICH-Q registry we included all prevalent Dutch and Belgian patients aged < 19 years on chronic dialysis on October 1st 2007, and
all Dutch and Belgian patients aged < 19 years who started RRT or were transplanted from October 1st, 2007 to date. Since 2011, all incident patients treated in the centre of Cologne
aged < 19 years are included in the database. For this paper data regarding Tx from the centre of Cologne were collected retrospectively back to 2007. We obtained ethical approval from the ethical boards of all participating hospitals and written Informed Consent from all parents of all participants and the participant themselves if possible. An independent research institute (the Hans Mak Institute [15]) assures the quality of the data by monitoring 10% of all data. Time on dialysis prior to the first non-pre-emptive Tx, weight and age of the recipient at the time of Tx, age of both living donor (LD) and deceased donor (DD) and cold ischemia time (CIT) of the allograft were the variables used for the present analysis. Statistics
Analyses were performed using SPSS 18. Values are presented as median [range] unless stated otherwise. Kruskal Wallis and Mann-Whitney tests were used for testing differences in waiting time on dialysis between the Netherland, Belgium, and Cologne and between the Netherlands and Cologne on the one hand and Belgium on the other. A P-value < 0.05 was considered statistically significant.
RESULTS
Reported policies and information from the registry
Paediatric nephrologists of all 11 centres completed the questionnaire. All centres reported to have a pre-transplantation protocol. For an overview of all pre-transplantation policies, consultations and imaging see table 1.
All RICH-Q centres stated to strive for pre-emptive transplantation in paediatric ESRD. At all sites, patients are informed about the two donor sources of Tx (LD and DD). In
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the Belgian centres, living donation is not emphasized as being the first choice for Tx. In contrast, all Dutch centres and the centre of Cologne underline the superiority of LD, over DD Tx with respect to graft survival. Participating centres stated that there were no differences in providing information between different ethnic, cultural and religious groups of patients. From October 2007 up to December 2011, 197 transplantations were recorded in our registry. 44 out of the total of 197 Tx (22%) were pre-emptive and 85 out of 197 Tx (43%) were from living donors.
In the Netherlands and Cologne the proportion of transplantations from LD (72/147, 48%) was significantly larger than in Belgium (13/51, 26%) (p=0.006). We did not find statistically significant differences in time on dialysis before their first non-pre-emptive Tx in children who had received a DD kidney transplant (p=0.81, Table 2a), nor a non-pre-emptive Tx from a LD (p=0.56) (Table 2b) between patients from The Netherlands and Cologne on the one hand and from Belgium on the other. Table 3 shows the reported policies with respect to minimum accepted recipient weight and maximum accepted age in comparison with the actual median weight at Tx as reported in the registry over 2007-2011. Centre policies varied between a recommended minimum weight of 8 and 12 kilograms. Two patients had a lower weight at the moment of Tx than what was accounted as minimal acceptable according to the centre policy. Nevertheless, both were considered suitable for Tx according to the performing surgeons.
In most sites (6/11) of the centres minimum weight prevailed over age. The minimum age for receiving a kidney (derived from either a juvenile or adult donor) as stated in the policies varied between 10 months and 3 years. Accepting an adult kidney in a very small child depended on individual assessment by the performing surgeon. The stated policies with respect to the maximum donor age varied from 50 to 75 years and from 45 to 65 years, for LD and DD, respectively. Table 3 shows the stated policies regarding maximum age of both LD and DD in comparison with the actual median and range of the donor age as recorded in the registry. In three centres the actual LD age had exceeded the maximum donor age as stated in the policy. Upon inquiry this was explained by two factors. First, the age limit was not maintained very strictly, and second, the physical condition of these particular donors was considered excellent. The stated policies with respect to maximum accepted CIT varied between 18 hours (one centre), 24 hours (seven centres) and 36 hours (three centres). In only one case the actual CIT exceeded the centre policy with 3 hours, due to peri-operative complications.
The composition of the transplantation surgery teams varied between centres. In 6 centres the actual procedure was performed by a specialized transplantation surgeon, in 2 by a paediatric surgeon and in 3 by a vascular surgeon. A paediatric urologist assisted the transplantation surgeons on a routine base in 5 centres, while this occurred only on the demand in the other centres. In 2 centres the Tx was performed by both a paediatric surgeon and a vascular surgeon. In all centres the performing paediatric surgeon also participated in the adult Tx program.
Not all centres have the same policy with regard to ABO-incompatible Tx, non-heart-beating Tx, minimum accepted HLA-match and non-related LD Tx. Four centres stated to perform ABO-incompatible transplantations. Transplantation of kidneys from non-heart beating donors is performed in 3 centres. With respect to minimal accepted HLA-matches, policies varied from acceptation of all mismatches to a minimal match of 1A1B1DR. Five centres reported to accept non-related LD. Altruistic non-related donation was accepted in these centres as well, provided that the donor would remain anonymous.
Between October 2007 and December 2011, no ABO-incompatible transplantations were performed. Kidneys of non-related LD were used twice and of DD after cardiac death three times.
Guidelines
One [14] of the 19 potentially relevant guidelines identified by the search met the selection criteria. This guidelines was developed by The European Society for Pediatric Nephrology (ESPN). The ESPN provides paediatric specific guidelines [14] with respect to contra-indications for Tx in children, pre-transplant nephrectomy, pre-Tx vaccination and paediatric recipient age [14]. They recommend a minimum recipient age of 6 months and states that ABO-incompatible Tx is contraindicated in the paediatric patient. None of the guidelines provide specific recommendations with regard to the expertise of the surgeon performing the Tx. The ESPN guidelines recommend performing the paediatric Tx in specialized paediatric centres in multidisciplinary teams.
DISCUSSION
In this paper we demonstrate a considerable variation in Tx policies across the 11 hospitals providing Tx for children in the Netherlands, Belgium and part of Germany. This corresponds to what we previously found in dialysis management policies [5]. This variation implies structural differences in patient care with possible consequences for patient outcome even in a small geographical area. Sometimes physicians deviate from their own reported policies for the management of Tx in children. These deviations may be based on conscious decisions to tailor the treatment to the individual patient, due to practical challenges in adhering to the guidelines, or to uncertainty about the validity of certain clinical recommendations. Here we will discuss some of the most important differences between the various centres as well as between centres and current guidelines and literature.
Differences between centres
Belgian and Dutch centres reported different policies with respect to LD versus DD Tx, which was reflected by the actual number of living and post-mortem donation in both countries as reported in the registry. All Dutch centres actively recommended living donation, whereas the Belgian approach was to inform parents and patients as neutrally as possible on this
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subject. One of the arguments for not actively promoting living-related transplantation according to most Belgian centres was the advantage of having a LD donor in reserve, since children have a relatively long life expectancy and hence a high probability for the need of a second transplantation.
The different approaches between the two countries may also have been influenced by the higher availability of organ donors in Belgium compared to the other 2 countries, as is reflected by data from Eurotransplant, the allocation authority of DD organs of all 3 countries [16]. In 2011, organs of 29.3 DD per million population were used in Belgium, compared with 13.3 and 14.4 in the Netherlands and Germany, respectively [16]. Both a different legislation on organ donation and different overall death rates are associated with the relatively high availability of organs in Belgium in comparison to the Netherlands and Germany. Since 1987 the Belgian law comprises a presumed consent system which authorizes the removal of the organs of a Belgian citizen or someone who has lived in Belgium for more than 6 months unless this person has declared that his/hers organs cannot be used for donation. This contrasts with the Dutch and German so-called active informed consent system, which is a voluntary system of organ donation whereby relatives give permission at the time of death, usually in the knowledge that the potential donor had expressed a wish to become a donor. As a result, in the Netherlands, 47% of the paediatric transplantations were kidneys originating from DD, whereas in Belgium 72% of all paediatric transplantations were from DD.
Contrary to what would have been expected from the Eurotransplant reports on donor availability of both countries, we did not find a shorter stay on dialysis of Belgian as compared to Dutch children on dialysis. This accounted both for LD and DD transplantations. A Type II error caused by the small number of patients might be one explanation.
Taken into account the overall better outcome of LD Tx versus DD [17-19], we think that under all circumstances, decisions on either LD or DD Tx should be taken together with parents and patients in an open discussion, independent from the availability of DD organs. This will give patients and parents the optimal opportunity to consider what is the best option in their particular situation, either to go immediately for the option with the best forecast or to keep a family organ in reserve.
There were remarkable differences between the centres with regard to the minimum accepted weight of the recipient and the maximum accepted age of the donor. The reasons for these differences are not clear. A minimum threshold of recipient weight or age may be determined by the skills of the local surgeon or paediatric nephrology team. This may lead to a longer waiting time on dialysis for those children who are considered too small or too young for Tx in a particular centre.
Differences between centre policies and current guidelines
There has been much discussion about the minimum accepted recipient age. To date, the ESPN recommends 6 months to be the minimum acceptable recipient age. A prospective cohort study in 321 transplanted children by Humar et al. [20] showed no difference in
delayed graft function and graft survival after living related Tx in children in three different age groups (<1 year, 1 through 4 years, and 5 through 13 years). This may have been due to a type II error cases by the small number (n=30) of patients aged less than 1 year vs. n=122 and n=169 for 1 through 4 years and 5 through 13 years, respectively. In contrast, in a report of the North American Pediatric Renal Transplant Cooperative Study (NAPRTCS), Elshihabi et al. [21] reported a higher risk of graft failure in younger recipients of kidneys from DD, below the age of two years (RR 1.95). The comparability of these reports is limited due to the difference in study designs. However, a minimum accepted recipient age might depend on whether the child is receiving a kidney of either a LD or a DD. In transplanting small children, technical difficulties arise. Therefore, instead of age, body weight might be the decisive factor in accepting a child for Tx. In the RICH-Q centres, the decision about transplantability was more often determined by body weight than by age.
The RICH-Q centres based their maximum accepted donor age on the availability of donor organs, local paediatric guidelines and guidelines used in adult Tx policies. Adult recipients receiving a kidney from older (deceased) donors (>50 years)) are reported to have a high incidence of delayed graft function [3;22;23]. In contrast, some studies found an excellent outcome in adult recipients of DD even over 70 years [24;25]. Thus, the available information about the maximum accepted age of the donor in adult Tx is not consistent. Moreover, it is not known to what extent these results can be extrapolated to paediatric Tx. Fact is that the mean age of the donors in the Eurotransplant area is increasing [16]. Furthermore, until recently, organs from paediatric donors (aged < 18 years) were not preferentially allocated to children. A change in policy in December 2010 resulted in a higher number of paediatric grafts being allocated to children than before.
There is much discussion in the literature regarding the optimal CIT in adult Tx [26;27]. As far as we know, no studies have been performed in paediatric kidney recipients from DD. Despite the fact that the ESPN guideline [14] states that ABO-incompatible Tx is contraindicated in paediatric practice, seven of the 11 centres do provide ABO-incompatible Tx. Not much information concerning ABO-incompatible Tx in children has been published yet. A Japanese study [28] in 52 consecutive ABO-incompatible Tx found no significant difference in long term (15 years) allograft and patient survival between ABO-incompatible and ABO-compatible Tx in children. Given the scarcity of donor organs, ABO-incompatible Tx may be a valid alternative in paediatric Tx in the future.
The above shows that there are large variations in management policies, possibly due to a lack of evidence-based guidelines. Introduction of evidence based guidelines might improve patient outcome, as was shown in a systematic review by Grimshaw and Russel [29].
CONCLUSIONS AND RECOMMENDATIONS FOR FURTHER
RESEARCH
Our observations show that paediatric Tx management policies on the acceptability of donors and recipients vary within a relatively small geographic area. Analysis of the impact of this
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variation on patient outcome after Tx awaits larger patient numbers and longer follow-up. The differences may be explained by a lack of evidence based paediatric guidelines. Guideline development in this field is hampered by a profound lack of systematically gathered prognostic information that is clearly reported. This emphasizes the need for more multi-centre prospective studies on determinants of health after Tx in children, enabling paediatric nephrologists to generate evidence-based guidelines. Eventually this may lead to better health outcome in paediatric ESRD.
Acknowledgments
This study was performed on behalf of the RICH-Q group. Other authors that contributed to this article are: Antonia H. M. Bouts, Laure Collard, Maria van Dyck, Nathalie Godefroid, Koenraad van Hoeck, Bernd Hoppe, Linda Koster-Kamphuis, Marc R. Lilien, Ann Raes, and Nadedja Ranguelov. RICH-Q is mainly funded by the Dutch Kidney Foundation. Additional funding was provided by Astellas, Ferring Pharmaceuticals, Sanovi, Roche and Shire. The funders had no role in the design and conduct of the project, data gathering or interpretation, or in the preparation of the manuscript. We are grateful to all patients and the participating centres in the RICH-Q study and to Dr. Els Boeschoten, Lucia ten Brinke, Lara Heuveling, Martijn Leegte and Helga Schrijvers from the Hans Mak Institute for their support with data registration and monitoring.
Conflict of interest statement
TABLES
Table 1 Pre-transplantation policies
Number of centres
Policy Yes No Only on indication
Pre-transplantation protocol 11 0 0 Vaccination protocol 10 1 0 Pre-transplantation consultations Surgeon 11 0 0 Urologist 3 1 7 Social worker 7 2 2 Psychologist 9 0 2 Dentist 9 1 1 Pre-transplantation imaging Cardiac ultrasound 11 0 0 Electrocardiogram 10 1 0 X-hand 9 1 1 X-thorax 9 1 1
Kidney, Urinary tract ultrasound 9 1 1
DXA-scan 5 4 2
Vascular ultrasound 8 0 3
Cystography 1 0 10 Pre-transplantation serology
IgG Eppstein Bar Virus 11 0 0
IgG Cytomegaly Virus 11 0 0
IgG Herpes Simplex Virus 9 2 0
IgG Hepatitis C 11 0 0
IgG Toxoplasmosis 8 3 0
IgG measles, mumps, rubella 8 2 1
Factor V leiden 6 3 2 Pre-transplantation surgery
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Table 2a Time on dialysis (months) before 1st Tx in children older than 2 years, only non-pre-emptive post- mortem kidney transplantations
Median IQR# N* p
Netherlands 26 11-47 50
Belgium 20 11-34 28 0.704
Cologne 25 15-37 19
Table 2b Time on dialysis (months) before 1st Tx in children older than 2 years
Median IQR# N* p
Netherlands 11 0-33 106
Belgium 13 3-32 47 0.185
Cologne 19 7-34 31
# Inter Quartile Range * Number of transplantations
Table 3 Minimum accepted weight of the recipient (kg) according to policy, median [range] recipient weight reported in registry, and recommendations for recipient weight in guidelines
Centre Policy Median [range] N*
1 12 29 [10-80] 30 2 12 28 [13-74] 27 3 12 31 [13-55] 24 4 12 40 [17-81] 31 5 10 34 [13-44] 4 6 10 33 [13-74] 15 7 10 33 [11-64] 16 8 10 32 [9-47] 10 9 10 42 [20-84] 6 10 10 NA# 0 11 8 28 [8-64] 35
Guideline Minimum weight according to guideline
KDIGO No recommendation
EPSN No recommendation
* Number of transplantations # Not applicable
Table 4 Maximum accepted donor age (years) according to policy, median [range] donor age reported in registry, and recommendations in guidelines
Living Donor Post-mortem
Reported Registry Reported Registry
Centre Policy Median [range] N* Policy Median [range] N*
1 65 46 [30-68] 21 55 17 [3-44] 9 2 60 38 [30-67] 14 60 50 [9-58] 13 3 NS 46 [37-60] 8 55 45 [9-35] 15 4 65 50 [22-60] 15 60 45 [14-62] 16 5 60 NA# 0 45 26 [9-38] 4 6 75 44 [19-51] 4 NS† 30 [15-47] 11 7 50 43 [40-47] 5 NS† 23 [4-47] 11 8 55 39 [33-44] 3 50 20 [2-44] 7 9 50 52 1 60 35 [11-41] 5 10 55 NA# 0 45 NA# 0 11 55 45 [35-51] 13 50 42 [13-52] 22
Guideline Maximum age living donor Maximum age post-mortem donor
KDIGO No recommendation No recommendation
ESPN No recommendation No recommendation
* Number of transplantations # Not applicable
† Not specified
Table 5 Maximum accepted Cold Ischemia Time (hours) according to policy, median [range] Cold Ischemia Time reported in registry, and recommendations in guidelines
Registry
Centre Policy Median [range] N*
1 36 16 [11-19] 9 2 24 12 [8-27] 13 3 24 14 [9-22] 15 4 24 14 [4-21] 16 5 24 14 [12-21] 4 6 18 15 [5-18] 11 7 24 15 [12-19] 11 8 36 14 [11-16] 7 9 36 11 [5-17] 5 10 24 NA# 0 11 24 14 [4-20] 22
Guideline Maximum accepted Cold Ischemia Time (hours)
KDIGO No recommendation
ESPN No recommendation
* Number of transplantations # Not applicable
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APPENDIX
Appendix I Questionnaire regarding transplantation policies
Pre-transplantation work-up
Consultations Is there prior to the transplantation a consultation with the
• surgeon? • urologist? • social worker? • transplant coordinator? • transplantation nurse? • psychologist?
Imaging studies Which pre-transplantation imaging/ examination is performed prior to the transplantation?
(e.g. echocardiogram, ECG, X-ray of the hand etc.)
Serology/ laboratory Which serologic and laboratory investigation is performed prior to the transplantation?
(e.g. CMV serology, coagulation) Pre-transplantation
vaccination Which vaccinations are provided prior to the transplantation?
Patient information How do you inform patients about the two types of transplantation (living and deceased)? Do you emphasize the benefits of living transplantation? Do you inform every patient the same (dependent on religion, ethnicity)? Transplantation
Possibility transplantation type
Do you provide in your centre the possibility of: Non related living donation/ altruistic* donation? ABO incompatible transplantation?
(paediatric) non heart beating transplantation?
Ischaemia time What is the maximum accepted Cold Ischemia Time (hrs) in your centre?
HLA-matching What is the minimum accepted HLA match in your centre (e.g. 1A 0B 0DR)?
Donor characteristics What is the maximum accepted age of the donor in both living and deceased donors?
Recipient
characteristics What is the minimum accepted age and weight of the recipient in your centre?
Operator Which surgeon performs the actual procedure in your centre and does he/
she participate in adult transplantation? Is there an urologist present during the transplantation?
* altruistic donor: Who choose to donate a kidney to a recipient with whom they have neither a genetic nor an emotional relationship6.
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