Advanced chronic kidney disease (ACKD) is considered to be the stages 4 and 5 of chronic kidney disease (CKD). It is therefore defined as CKD with a severe decrease in glomerular filtration rate (GFR ) (<30 mL/min).1 ACKD is a public health problem due to its high prevalence and cost of care, and which is conditioned by high cardiovascular morbidity.2,3 With data obtained from the latest estimates of the prevalence of CKD in Spain, there could be around 100,000 people in the ACKD phase.4

In this context, in recent times the ACKD units (ERCAU) have been developed in our country, they are multidisciplinary care units for patients with ACKD with aiming to offer comprehensive care, higher quality of life, improving survival and reducing morbidity in this phase of the disease. In fact, in the Framework Document on Chronic Kidney Disease (CKD) within the Strategy for Addressing Chronicity in the National Health System of 2015, it is highlighted among its specific objectives to guarantee good care to the patient with CKD, offer support to the ACKD patient in all hospitals with Nephrology consultation, and to the extent possible, establish an ACKD consultation with a specific structure.5 Among the specific objectives of these clinics or ERCAU are identified the following items6–10: early detection of progressive kidney disease, prevent and treat ACKD complications (anemia, mineral metabolism abnormalities, malnutrition, acidosis, etc.), treat associated comorbidity (hypertension, dyslipidemia, smoking, etc…), delay the progression of ACKD until the need for renal replacement therapy (RRT), inform the patient of the possibilities of RRT or conservative therapy, prepare the patient in a prearranged manner to receive the most appropriate therapeutic option for their needs, whether it is conservative treatment or RRT, or establish measures to analyze the quality of care of these patients.

In “Nefrologia”, the Journal of the Spanish Society of Nephrology (SEN), in a publication in 2008, the integral care of the patient with ACKD is recognized as the main objective of the UERCA and as priority, the following objectives : 1) Healthcare objectives (early referral, delay progression, etc. ); 2) Programs directed to the patient, with training or progressive education in self-care, and 3) Analysis of quality of care with the monitoring of biological indicators, the planning for scheduled initiation of dialysis, quality of life and user satisfaction.10 In other national and international documents can be identified the definition of standards on the structure and organization of the ERCAU.11–13 In various publications, it is observed the great variability in the organization of the ERCA processes14,15 and indicate that there is room from improvement on areas such designation of resources, processes and results of the ERCAU.16

To improve the care of the patient with ERCA, it is required to evaluate carefully, with evidence-based methodology, the achievement of predetermined standards.17 Some scientific societies, both in the national and European environment, have developed accreditation programs in their own body of knowledge. Examples of these initiatives are those of the Spanish Society of Internal Medicine (“SEMI”),18 European Clinical Research Infrastructure Network (ECRIN),19 Spanish Society of Coloproctology (“AECP”),20 Spanish Society of Neurology (SEN),21 accreditation criteria for hospital emergency services,22 etc. Accreditation is a method to improve the organization and results of a service with the help of an accrediting body that evaluates the activity, comparing them with predetermined standards.23 A general example of an accreditation process is illustrated in Fig. 1. The purpose of measuring and monitoring the standards is to document the quality of healthcare, establish comparisons (benchmarking), support accreditation, allow the improvement of healthcare, and provide support to healthcare professionals, managers and decision-makers. Standards can be derived from the literature and based on evidence or, if there is not scientific evidence, they can be determined by a panel of experts and/or healthcare professionals through a consensus process based on their own experience. In this sense, various quality initiatives have been developed over time by SEM in other aspects of the specialty.24–27

Fig. 1.

Graphic description of a general accreditation process.

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Regarding the care of the patient with ACKD, the working group of ACKD from the SEN has worked on publications on the structure and operation of ERCAUs. However until now, a systematic attempt to develop quality standards and indicators for ACKD patient care, as well as an accreditation process, has not been carried out.

In this context, the SEN's ACKD working group carries out this work aiming to improve the care of ACKD patients through the definition of quality standards for the operation of the ERCAU. Such standards are based on the literature, on the consensus of working group of experts and through a survey of a large number of nephrology specialists and nursing professionals with experience in Spanish ERCAU.

Initially, with the objective of providing advice and guiding the work to be carried out during the project, a working group was formed made up of nine members of the ERCA working group of the SEN. All members of the working group are nephrologists and have experience in management of ACKD patient in the ERCAU. Likewise, several of the members of this group also have experience in the accreditation of renal replacement treatment units, as well as specific knowledge in the different renal replacement treatment options (hemodialysis, peritoneal dialysis and kidney transplantation). The entire working group collaborated, participated and guaranteed the correct execution of all phases of the project.

In the first phase, it was generated a proposal of quality standards on the operation of the ERCAU; this was created by consulting the main sources of references: documentation corresponding to the ERCAU of the different Nephrology Services that are part of the working group, scientific guides of the SEN,2,26–30 Framework Document of the Ministry of health on Chronic Kidney Disease,5 and international guidelines.31 This proposed standards was reviewed and adjusted by the working group through face-to-face and non-face-to-face meetings. Through telematic interviews it was obtained and taken into consideration the opinion of representatives from the National Transplant Organization (ONT), the Spanish Society of Nephrological Nursing (SEDEN) and from patients through the Association for the Fight against Kidney Diseases (ALCER). In this way, an initial proposal of quality standards for the operation of a ERCAU was put together. The standards were grouped into five blocks (Fig. 2): (1) General requirements of the ERCAU; (2) Material and human resources; (3) Processes; (4) Rights and safety of patients; (5) Results. The working group validated this initial proposal of standards and assessed each of them as mandatory or recommended. A proposed standard was determined to be mandatory if more than 50% of the working group members considered it mandatory, and a standard was determined to be recommended when less than 50% of the working group members considered it mandatory.

Fig. 2.

Five blocks of standards for the operation of a ERCAU.

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In a second phase, based on the initial proposal of standards, a survey was designed to determine the suitability of each standard by collecting the opinion of nephrology specialists and nursing personnel. The objective of this survey was to obtain a broad external evaluation by experts to determine the value of the initial proposal of standards designed by the working group. A total of 121 nephrologists and nursing personnel from the national territory with work experience in ERCAU and part of the SEN and SEDEN were invited to participate via email. The selection of these experts was made based on the recommendations of the members of the working group. All invited professionals received the same standard email in which they were informed about the project, the objective of the survey was indicated and a link to access the survey was provided with the corresponding instructions. Access to the survey was allowed from the same day of the invitation, July 16, 2018, until September 26, 2018. During this time, reminders to complete the survey were sent periodically via email.

The survey included two parts. In one part, there were questions aiming to identify each professional (professional profile, hospital, Autonomous Community, email) and to know the degree of activity in the ERCAU consulted (number of patients treated at ERCAU / year, and criteria for referral to ERCAU according to GFR ( mL/min/1.73 m2 ). Four categories were established according to the volume of patients seen (0–99, 100–200, 201–300, 301–500) and referral criteria by GFR used in the center (15–19, 20–24, 25−29, >30). A second part was dedicated to obtain information on the relevance, nature and possible modifications of each of the standards of the initial proposal agreed upon by the working group were consulted. Therefore, for each of the 82 standards, three questions were asked: (1) Do you consider appropriate to include this standard in the manual? (relevance). The response was requested was limited to two options: "Yes" and "No". (2) Do you consider that it should be "mandatory" to obtain quality accreditation or should be just "recommended" (nature). A closed response was requested to two options: "mandatory" and "recommended". (3) Do you want to add any additional comments about this? (modifications). A response was requested in an open text field. The entire survey was developed on the 123FormBuilder® platform.

After finishing the deadline to respond to the survey, in a third phase, the results of the responses obtained were analyzed. On the one hand, the response rate of the participants and the results were analyzed in relation to the number of patients seen at the ERCAU/year and the criteria for referral to ERCAU according to GFR, with the aim of knowing the burden of care activity. On the other hand, an analysis of the suitability of each standard was carried out in order to adjust the proposed standards. For this analysis, the evaluation criteria for each of these aspects were decided in consensus with working group. Regarding the relevance of the standard, it was determined that a standard was included in the manual if at least 80% of the participants considered it appropriate to include it; if this assessment was less than 80%, it was determined that the standard was not included. Regarding the category of the standard, it was determined that a standard was mandatory if at least 50% of the participants considered it mandatory, and it was determined that a standard was recommended when less than 50% of the participants considered it mandatory. Regarding the possible modifications, comments were registered for most of the standards, and they were analyzed with the aim of improving the definition of each standard.

Finally, after obtaining the results of the analysis, the conclusions were presented to the working group in a meeting with the aim of reaching a consensus on a final proposal of quality standards for the operation of ERCAU, that was based on their experience and results of the analysis of the survey. This final proposal served as the basis and was later added to a final document that was approved by representatives of SEN, SEDEN, ONT and ALCER for publication.

After completion of the work of the first phase through the review of the references, the contributions of representatives of scientific societies (SEN, SEDEN, ONT) and patients association (ALCER) and, the adjustment made by the work group there were identified a total of 82 quality standards for the operation of a ERCAU. Of these standards, 12 (14.6%) refer to general requirements of the ERCAU, 13 (15.8%) are related to material and human resources, 25 (30.4%) are directly linked to the processes of ERCAU, 14 (17%) are associated with the rights and safety of the patient and 18 (21.9%) with results. In addition, the working group classified 52 (63.4%) standards as mandatory and 30 (36.5%) standards as recommended (Table 1).

Regarding the results of the survey, of the 121 health professionals invited to participate (nephrology specialists and nursing staff), a total of 95 (78.5%) accepted and completed the entire survey; of these, 80 were nephrology specialists and 15 nursing professionals, obtaining a varied representation of professionals from the Spanish geography as it is shown in Table 2. Given a total of 121 invited professionals, it is considered that with a confidence level of 95%, with a precision of 5%, and assuming an expected proportion of 50%, with a sample size of 93 participants the results are representative. Regarding the number of patients seen in the ERCAU/year and the criterion for referral to the ERCAU according to GFR, the participants indicated that the volume of patients seen in the UERCA is usually above 100 patients (Fig. 3) and that the referral criterion is a GFR generally below 25−29 mL/min/1.73 m2 (Fig. 4).

Fig. 3.

Number of patients attended UERCAU per year. Number and percentage of responses of the participants for each category (0–99, 100–200, 201–300, 301–500).

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Fig. 4.

Criteria for referral to ERCA consultation according to the GFR value in mL/min / 1.73 m2. Number and percentage of responses of the participants for each category (15-19, 20-24, 25-29, >30).

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Regarding the assessment of the 82 standards proposed by the working group, the survey participants rated 68 (82.9%) as appropriate to include in a manual of standards and 14 (17.07%) as not relevant to include in a standards manual. Of these 68 standards, 37 (54.4%) were rated as mandatory and 31 (45.5%) as recommended (Table 3). Table 4 shows the definition of each standard with details of its assessment of its relevance for inclusion in a manual and its nature, mandatory or recommended. For the drafting of the standards, it begins with "must" when it was considered mandatory and begins with "recommended" when it is recommended. In addition, there were proposed modifications and improvements in the wording of the definition of the standards. These considerations were assessed to subsequently adjust the wording in the development of the standards manual.

With these results, the working group, based on its experience, adjusted the final proposal for the operation of an ERCAU to 70 quality standards. This final result has been added and included in the Manual of Standards Accreditation Project ERCA Units.32

The Spanish Society of Nephrology (SEN), for years, given the health priority posed by CKD, has worked to improve care for the ACKD patient through the development of multidisciplinary care units, UERCA.1 The implementation of these units has also been promoted at international level.14 However, both in the Spanish and international literature, there is variability in the organization and operation of these units.14–16

Therefore, this work constitutes the first attempt to describe ERCAU operating standards in Spain in relation to general aspects of organization, resources (material and human), processes, patient safety and results. The contributions of the project's working group, representatives of scientific societies and the evaluations by a wide panel of experts from the national level allow establishing a series of criteria for the configuration and optimal development of an ERCA Unit.

The definition of standards in the section of results allows for a systematic measurement and analysis of quality indicators that provide key information to objectively monitor healthcare activity at ERCAU and identify the improvements made in service management. The aim is to promote the achievement of the objectives of a ERCAU in accordance with the definition of standards according to the consensus of experts and the available scientific evidence.

Therefore, an ERCAU must, among other things, promote that all patients receive adequate information prior to choosing RRT, and that the indication of their RRT will take place on a scheduled basis. Also, it is recommended that patients starting hemodialysis have a mature arteriovenous fistula performed and that the percentage of patients electing peritoneal dialysis be encouraged.

The ERCAU should collect, analyze and respond to the written complaints received from patients and relatives, establishing an improvement plan based on these responses.21 Along these lines, it is also recommended to carry out and analyze an annual satisfaction survey of all patients and establish improvement plans based on the results obtained.21,35

Like in all studies, the present work has strengths and limitations. Despite the intention and interest ofcontacting all the nephrologists who work on ACKD, this has not been possible and consequently there is the possibility of some bias. This survey is based on the perception/opinion of nephrology specialists and nursing staff about how the structure, resources, processes, safety and patient outcomes should be, therefore, its results are probably closely connected with the daily practice of the ERCAU in Spain, and in some cases it may be distant from formal aspects of more structured documents and/or sources of knowledge. Another possible weakness is that at some point the formulation of the indicator has not been understood and there is a misinterpretation, as in the case of establishing the eligibility of the treatments that has not been deemed mandatory. In addition, we recognize the need to work in future studies on the definition of standards focused on the evaluation of clinical aspects, in addition to those more related to the optimization of the healthcare process. In addition, it is urgent to evaluate the feasibility of achieving the standards in subsequent works. Certainly, the evaluations reported will allow to establish a first balance of mandatory and recommended standards as an initial starting point to carry out the development of actions in relation to the operation of a ERCAU. In addition, in this evaluation the representation of patients through the Association for the Fight against Kidney Diseases (ALCER) and the National Transplant Organization (ONT) must be highlighted, parties clearly interested in patient-centered care and clarity and lack of bias in the inflows to the various RRT options.

In conclusion, this work has allowed the configuration of a first proposal of standards for the operation of a ERCAU. After a subsequent work and review of these standards by the working group, 70 quality standards were defined, collected in the first version of the document, Manual of Standards Project Accreditation Units ERCA.33 The first version of this manual is a first approach to advance towards improving the quality of ERCAU, establishing a starting framework that reduces the variability between the different centers in the development of ERCAU and offers CKD patients the same opportunities care, regardless of where they are cared for. The definition of the standards in this manual is understood as an open process, that recognizes the possibility of requiring a reduction, an increase or a redefinition of standards according to new evidences or needs of clinical practice.

The company Baxter SL® has financed the work required to carry out the opinion survey analyzed in this study.

The authors declare that they have no conflicts of interest.