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NDT Advance Access originally published online on January 8, 2008
Nephrology Dialysis Transplantation 2008 23(4):1323-1329; doi:10.1093/ndt/gfm809
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© The Author [2008]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org


Current structure and organization for renal patient assistance in Italy

Sandro Alloatti1, Giovanni FM Strippoli2,3, Gherardo Buccianti4, Giuseppe Daidone5, Francesco P Schena6 and on behalf of the Italian Society of Nephrology

1 Renal and Dialysis Unit, Regional Hospital, Aosta, Italy 2 NHMRC Centre for Clinical Research Excellence in Renal Medicine, University of Sydney School of Public Health, Australia 3 Cochrane Renal Group and Mario Negri Sud Consortium, S. Maria Imbaro (Ch), Italy 4 Renal and Dialysis Unit, S. Gerardo Hospital, Cinisello Balsamo, Italy 5 Renal and Dialysis Unit, Umberto I Hospital, Siracusa, Italy 6 Renal, Dialysis and Transplant Unit, University of Bari, Policlinico, Bari, Italy

S. Alloatti, 3 Viale Ginevra, 11100 Aosta, Italy. Tel: +39-165-543226; Fax: +39-165-543246; E-mail: alloatti.sandro{at}uslaosta.com



   Abstract
Top
 Abstract
Introduction
 Methods
 Structure of the questionnaire
 Results
 Discussion
 References
 
Background. Given the public health challenge and burden of chronic kidney disease, the Italian Society of Nephrology (SIN) has compiled a national census of Renal Units (RU) existing in the twenty Italian regions related to the year 2004.

Methods. An on-line questionnaire including 158 items explored structural and human resources, organization aspects, activities and epidemiological data in SIN, 2004.

Results. The census identified 363 public RU, 303 satellite Dialysis Centres (DC) and 295 private DC totalling 961 DC [16.4 per million population (pmp)]. The inpatient renal beds were 2742 (47 pmp). Renal and dialysis activity was performed by 3728 physicians (64 pmp), of whom 2964 (80%) were nephrologists. There was no permanent medical assistance in 41% of satellite DC. There were 1802 renal admissions pmp and 99 renal biopsies pmp. The management of acute renal failure (13 456 cases; 230 pmp) represented a relevant proportion of the activities conducted in public RU. In 2004 there were 9858 new cases of end-stage kidney disease requiring renal replacement therapy (RRT) (169 pmp). On 31 December 2004, 60 058 patients were on RRT (1027 pmp), 43 293 of which (740 pmp) were on dialysis and 16 765 (287 pmp) with renal graft.

Conclusions. This census of the Italian RU and DC in 2004 provides decision makers and healthcare stakeholders with detailed data for benchmarking and has financial implications for the public health system. Similar analyses may be conducted in other countries permitting standardization of medical and cost-related aspects of renal care.

Keywords: census; dialysis; nephrology; registry; transplantation



   Introduction
Top
 Abstract
 Introduction
Methods
 Structure of the questionnaire
 Results
 Discussion
 References
 
Chronic kidney disease is a multifactorial condition attributed mainly to diabetes mellitus, hypertension and ageing of the population [1,2]. The high cost of managing end-stage kidney disease (ESKD) is a challenge for the public health system, and action plans are needed to face the current and expected increasing burden [3,4].

The acceptance rate of ESKD and the prevalence of renal replacement therapy (RRT) patients vary widely between countries. These differences appear clearly in national renal registries and, beyond different acceptance criteria on dialysis, can be explained in various ways. Epidemiological differences, for example, were hypothesized to justify the lower RRT prevalence in England and Wales in comparison to Germany where a greater incidence of diabetes, hypertension and vascular diseases is observed [5]. Also, the availability and the distribution of dialysis facilities on the territory can influence the acceptance rate of new ESKD patients in relation to travelling time [6,7].

For correct nephrological resource planning in each country a detailed analysis of the existing status of structures, personnel, organization and epidemiological data is therefore essential.

A census initiative was undertaken in 2004 by the Italian Society of Nephrology. It had the following main objectives: (1) to evaluate the number of renal, dialysis and transplant units; (2) to collect information on structural, human and organizational resources in nephrology, dialysis and transplantation; (3) to develop a strategy for continuous monitoring and updating of the census on a 5-year timeline and to combine resource data with epidemiological data; (4) to highlight some significant areas where epidemiological and health economy research is needed.



   Methods
Top
 Abstract
 Introduction
 Methods
Structure of the questionnaire
 Results
 Discussion
 References
 
Healthcare assistance in Italy is provided by the National Health Service (NHS) that coordinates the activity of the 20 regions. Each citizen is automatically booked into the NHS that guarantees cost-free medical assistance, i.e. general practitioner and hospital treatment. The patient contributes to the cost of some laboratory and instrumental tests and drugs by paying an additional charge. The renal assistance is given by the Renal Units (RU) located in public hospitals that have inpatient renal beds and dialysis stations. Renal beds are defined as hospital beds that are dedicated to the care of renal patients; dialysis stations are defined as dialysis chairs/beds linked to a dialysis machine. RU may have satellite Dialysis Centres (DC), which are distributed throughout the regional territory in order to minimize travelling time for dialysis patients. Satellite DC depend entirely on public RU for human resources and organization and there may be medical assistance during the dialysis sessions. In some regions private DC are also present and the dialysis sessions are reimbursed by the regional government according to cost and quality control factors. RU, satellite DC and private DC are all considered DC in this census.

Haemo- and peritoneal dialysis (PD) treatment and renal transplantation are totally cost free for resident Italian citizens, both in public and private structures.

The census of the Italian renal, dialysis and transplant units was carried out in 2005 based on 2004 data collected by means of an on-line questionnaire distributed via the website of the Italian Society of Nephrology (http://www. sin-italy.org) and monitored by the regional delegates.

On-line data collection was performed using an Active Server Page technology with outputs generated in Microsoft Access 2003 and passed to Excel spreadsheets for data quality assurance, descriptive analysis and correction of mistakes.

This report describes some important data of international interest, while other detailed analyses of the Italian census have already been published elsewhere [8–15].



   Structure of the questionnaire
Top
 Abstract
 Introduction
 Methods
 Structure of the questionnaire
Results
 Discussion
 References
 
The questionnaire included 158 items, grouped in five sections.

Section 1. Structural resources
This section included RU and other DC, number of nephrology beds and dialysis stations, systems for dialysis water treatments and distribution systems of the water to dialysis stations. The last two items were analysed in detail due to the importance of obtaining highly purified water quality levels in dialysis procedures.

Section 2. Organizational aspects
Data related to the location of centres in the regional territory, presence of nephrologists or other specialists assisting renal and dialysis activities (assistance 24/24 h or on-call presence, presence/absence of physician or nephrologist during dialysis activity) were collected. The use of dialysis stations was expressed as the ratio of RRT patients to dialysis station number.

Section 3. Human resources
Numbers of physicians, nephrologists, nurses and other professional figures such as psychologists and dieticians were obtained. The questionnaire considered whether the physicians were specialists in nephrology. Medical students, research fellows and residents were not included in the census.

Section 4. Activities
Information on clinical admissions, diagnosis related groups (DRGs), renal biopsies from native and transplant kidney, outpatient nephrology activity, management of acute renal failure, renal transplant activity and dialysis data was collected.

Section 5. Epidemiological data
Aggregated prevalence data on RRT on 31 December 2004 and incidence data in the year 2004 of RRT patients were obtained. Information on the number of vascular access types (vascular grafts, central venous catheters, artero-venous fistulas) was also collected.

The questionnaire was compiled by the Directors of RU and private DC or their delegates providing aggregated data. Data from satellite DC were collected by the hub RU. Regional Delegates were in charge of checking the quality and completeness of the returned questionnaires, including the comparison with the regional RRT registries. Whenever the on-line questionnaire could not be filled in, a brief 24-item questionnaire was administered by phone or sent out.

Reliability and coverage of data collection
Reliability of the collected data was checked using the following indicators:

  1. Assessment of the consensus between data collected by the 2004 Census and data reported in the Italian 2003 RRT Registry: agreement between the 2004 Census and 2003 Registry data occurred when the prevalent number of patients on 31 December 2004, present in the regional census, corresponded to the prevalent number of patients declared by the regional registry on 31 December 2003 + incident patients 2004 – deaths 2004 – transplant patients 2004. Results of each region have been reported as the difference in percentage between the census and renal registry.
  2. Consensus between prevalent patients receiving extracorporeal treatments and the number of vascular accesses: consensus existed when in each centre the discrepancy between the two data was <5%. Results were expressed as percentage of regional centres with consensus.

Statistical analysis
Standard descriptive statistics including Student's t test, chi-square test and univariate regression analysis were used for description and comparison of data. The Pearson coefficient was used to test for correlations. Statistical significance was considered for P < 0.05.



   Results
Top
 Abstract
 Introduction
 Methods
 Structure of the questionnaire
 Results
Discussion
 References
 
All RU compiled the on-line questionnaire, whereas in 126/295 private DC (42.7%) phone enquiries (77 cases) or written questionnaires (49 cases) were needed. Since phone or written interviews explored only basic items, the complete questionnaires were available for 835/961 DC (86.9%).

Reliability of data collection in each region is reported in Table 1. In three regions (Campania, Friuli and Sicily) the absence of RRT registry data did not allow for evaluation of the first indicator used to assess census reliability. Two regions (Campania and Sicily) used the on-line questionnaire less. Data reliability from these regions is therefore lower.


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  		Table 1 Reliability of the 2004 Census data

 
The main results of the 2004 Census relating to structural and human resources, activity and epidemiological data are shown in Table 2. Data were expressed as the absolute number and per million population (pmp). The main Italian regional data regarding structural resources and epidemiology are reported in Table 3.


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  		Table 2 Data from the 2004 Census of the Italian Society of Nephrology. The Italian population on 31 December 2004 was 58 462 375 inhabitants

 

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  		Table 3 Italian regional data regarding structural resources and epidemiology

 
Structural resources
The census identified 363 RU (6.2 pmp), 303 satellite DC (5.2 pmp) and 295 private DC (5.0 pmp). Therefore the total number of DC in Italy was 961 (16.4 pmp).

The satellite DC/RU ratio ranged widely in Italian regions, with an upper limit of 3.2 in one region, ≥1 in seven regions and <1 in the remaining regions.

The presence of private DC was not uniform throughout the regions. Private DC were not present in seven regions; the majority of private DC were in Campania, Sicily and Lazio (81%, 74% and 43%, respectively). The proportion of private DC in these three regions was significantly higher than that in the remaining regions (69.5% versus 6.3%, P < 0.01).

In 74% of RU (268/363) there were 2 742 inpatient renal beds (47 pmp; range 32–88). In 90% of regions (18/20) the number of renal beds ranged between 32 and 62 pmp while in two regions (Liguria and Puglia) renal beds were 72 and 88 pmp, respectively, a number which exceeded the national mean (47 pmp, P < 0.01).

The 295 private DC (31% of total centres) provided care for 26% of dialysis patients. Overall, there were 12 748 dialysis stations in DC (219 pmp, range 137–356). Forty of 363 RU also provided immediate post-renal transplant assistance.

Data regarding water treatment were available from 884 DC. The reverse osmosis system was present in 857 DC (97%) and the double reverse osmosis system in 638 DC (72%). The double reverse osmosis system in series with double pass through osmosis membranes was available in 371 DC (42%). The ring system in the water distribution system was present in 734 DC (83%), while 133 centres (15%) did not have such a system. Polyvinyl chloride was most frequently used for the water distribution system (61% of centres) followed by cross-linked polyethylene (12%), polyvinylidene fluoride (11%), steel (13%) and other materials (2%).

Organizational aspects
Besides the varying number of private DC in Italian regions, different organizational aspects were observed. Private DC of Campania and Sicily were mainly independent from RU while in Lazio each private DC was connected to a public reference RU. Mainly in Lazio, private DC did not only provide RRT but also a relevant proportion of renal outpatient follow-up activities (in 23/37 private centres; 62%).

Twenty-four hours of medical assistance was present in 82/363 (23%) RU while physicians were present only during medical activity time frames in 281/363 units (77%). The on-call physician was present in 314/363 units (87%). All private DC had permanent medical assistance during the dialysis session. In 124/303 satellite DC (41%) permanent medical assistance was lacking. In the remaining 179 satellite DC, 47% of dialysis shifts were only provided by the on-call or programmed physician assistance. This model was more widely present in northern and central Italy (120/257 satellite DC; 47%) than in southern Italy (4/46 satellite DC; 9%). The index of dialysis station use (extracorporeal patients/dialysis stations) was 3.2. It was inversely correlated with the number of DC and the number of dialysis stations (r = –0.74, P < 0.01 and r = –0.87, P < 0.01, respectively).

Human resources
Renal and dialysis activity in Italy was performed by 3 728 physicians (64 pmp), of whom 2 964 were specialists in nephrology (80%). The patient/physician ratio was 11.6 (range 7.4–19.7). There were a significantly higher number of physicians in Campania, Sicily and Lazio compared to other regions (n = 102 versus 50 pmp, P < 0.01). There were 10 208 dialysis nurses (175 pmp); the patient/nurse ratio was 4.0 (range 3.1–4.7).

Other additional professional figures were identified in the renal and dialysis activities, including psychologists, dieticians and others who were present in 28.3–40.3% of centres.

Activities
The census registered 1800 renal admissions pmp (range 974–3 439). The mean value of DRGs was 1.41 (range 1.18–1.60). The number of renal biopsies was 5 774 (99 pmp).

The nephrologist was the main professional figure in charge of these procedures (196 nephrologists/237 operators; 83%). In RU the outpatient service was available as follows: 49% of RU had outpatient assistance for the following services: renal transplant outpatient (49%), pre-dialysis follow-up (77%), hypertension (57%), renal stones (38%) and diabetic nephropathy (51%). The number of outpatient visits per year was 477 831 (8 184 pmp). In private DC the core activity was dialysis assistance.

A relevant proportion of activities in RU was the management of acute renal failure and other conditions requiring RRT in the DC (5 073 cases, 86.8 pmp); in intensive care units or other hospital units (8 383 cases; 143.4 pmp). Kidney transplants were carried out in 1 601 subjects during 2004.

Epidemiological data
In 2004 there were 9 858 new cases of ESKD (169 pmp, range 130–199) (Tables 2 and 3). Of these, 8 216 patients (83%) started haemodialysis, 1 556 (16%) PD and 86 (0.9%) pre-emptive transplantation. On 31 December 2004 there were 43 293 patients on dialysis (740.5 pmp) of whom 10.3% were on PD. The use of this latter RRT technique ranged between 1.4% and 19.5% across regions in Italy and was lower in Campania, Sicily and Lazio compared to the remaining regions (4.6 versus 12.9%, P < 0.01).

The census also identified a low use of other RRT approaches: home dialysis (134 patients), daily haemodialysis (213 patients) and night-long haemodialysis (46 patients).

The prevalence of renal transplants was 16 708 individuals (286 pmp, range 134–471). The reliability of these data was somewhat imperfect because patients were attributed to the centres that performed the renal transplant or to referral centres alternatively that could result in multiple counting; hence a slight overestimation of total number may have occurred.

The total number of vascular accesses was 34 258 of which vascular grafts, central venous catheters and artero-venous fistulas were 5%, 12% and 83%, respectively.

There was a statistically significant correlation between the prevalence of patients undergoing dialysis and incidence of new entry in dialysis (Figure 1, P < 0.05).


Figure 1
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  		Fig. 1 Correlation between the prevalence of dialysis patients and incidence of new cases of ESRD.

 


   Discussion
Top
 Abstract
 Introduction
 Methods
 Structure of the questionnaire
 Results
 Discussion
References
 
We performed, for the first time, a detailed descriptive analysis of current resources, organization, activities with epidemiological data obtained by RU and DC in Italy.

There was a marked difference in adhesion to the initiative by public centres (full adhesion) and private centres (57% adhesion) due to the greater motivation of public physicians mainly involved not only in dialysis activity but also in nephrology.

In terms of structural resources, we found a large network of RU in Italy managing renal beds and dialysis stations. Satellite DC, which depend strictly on RU for diagnostic and therapeutic needs, contributed to increasing the size of the network. However, the distribution of these centres varied from region to region. The dialysis network was completed by private DC in 13 Italian regions. There were 16.4 public and/or private DC pmp in Italy as compared to 14.8 dialysis units in Germany [16] and only 3.1 in the United Kingdom [5].

We found a wide regional variability in the number of private DC and therefore explored the potential correlations between the regional percentage of private DC with some factors listed in Table 4. We found a direct correlation between the incidence and prevalence of patients undergoing dialysis and regional percentage of private DC. This finding is similar to the major incidence and prevalence on haemodialysis observed in the USA, in comparison to the neighbouring Canada [17,18]. The index of dialysis station use (extracorporeal patients/dialysis stations) was correlated inversely with the proportion of private DC. This may be due to the handling of a larger number of dialysis machines due to increasing demand, as well as the ability to handle technical problems more efficiently without causing variations to scheduled dialysis treatments.


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  		Table 4 Correlations between regional percentages of private centres and some regional data

 
The frequency of renal beds showed wide variations at the regional level in spite of efforts to reduce National Health Expenditure thorough alternative healthcare approaches (e.g. day-hospital and day-services). This process is still in progress and not yet completed in some regions.

In our census, we also analysed in detail the type of water treatment and water distribution systems available in DC. This was a main priority given the importance of these systems for adequate dialysis care. The overall data were positive, given the large diffusion of mainly double reverse osmosis systems. It could be important that the double pass through osmosis membranes was more widely used to guarantee optimal dialysis water quality.

In comparison to other data, human resources in the present Italian system for renal assistance appear to be higher. There were 64 physicians pmp in Italy compared to 33 pmp in Germany (or 44 pmp by extrapolation, considering that only 75% of German centres participated in the enquiry) [16]. In Germany, 64% of physicians were nephrologists, in comparison to 80% in Italy. Data on ‘whole-time-equivalent’ nephrologists were available from UK studies, and were set to 3.8 pmp [5]. The wide difference in the number of physicians in regions with a high presence of private DC compared to the remaining regions (n = 102 versus 50 pmp) may be explained by a lower presence in the former of satellite DC (1.4 pmp versus 6.6 pmp, P < 0.01) allowing savings in medical resources. Moreover, while in public centres physicians generally work full-time, in private centres many physicians are only part-time employees and we cannot exclude that some of them would work in two or more private centres. For these reasons we believe that the physician value of 50 pmp (frequency of physicians in 17/20 regions excluding the three regions with the high presence of private DC) is more suitable for comparisons with other countries. As for dialysis nurses, there were 175 pmp in Italy as compared to 120–181 pmp in Germany [16] and to only 43 pmp in the United Kingdom (nurses + healthcare assistants) [3]. These profound differences in DC, human resources, incident and prevalent patients require specific in-depth analysis of data collection and the different renal assistance systems.

As far as organizational aspects are concerned, several satellite DC (mainly in northern and central Italy) provide dialysis without continuous medical assistance. This model, so-called limited care dialysis, was first used for self-dialysis in satellite DC [19] where uraemic patients with minor comorbid conditions could be treated. Since then, several changes have occurred in regional territories, including a large increase in the number of satellite DC and an increase in the mean age of dialysis patients starting haemodialysis, with an overall worsening of the clinical scenarios handled in these centres. To provide dialysis in the absence of continuous medical assistance may be a positive (rational use of medical resources) or a negative aspect (not optimal patient care) particularly when there are many comorbidities. This interesting issue should be explored and discussed in future analyses.

We also found a wide variability in the number of renal inpatient admissions, which confirms different regional criteria for hospitalization. As expected, the number of inpatient admissions directly correlated with the number of renal beds (r = 0.60, P < 0.01), to indicate a direct relationship between demand and offer, inversely correlated with DRGs (r = –0.46; P < 0.01). These results may also be explained by inappropriate inpatient admissions. It is also possible that there is a large use of renal beds for dialysis patients presenting dialysis complications, who are admitted to renal or other internal medicine units depending on the type of complications. This aspect may be an additional explanation for the variable number of inpatient admissions.

Our census also identified a variability in the values of DRGs, which may be explained by both different criteria for hospitalization or different clinical activity during inpatient admissions.

Lower utilization of PD was found in regions with a high percentage of private centres that could be ascribed to lower remuneration of this technique compared to haemodialysis. Other factors affecting the different distribution of PD in Italy, including cultural and motivational aspects of healthcare workers, have been explored in detail elsewhere [20].

The comparison between our incidence and prevalence data and those reported in the literature is described in Table 5. The prevalence on dialysis in Italy (741 pmp) is similar to that of Germany (739 pmp), and higher than that of other European countries of which data are available. In terms of incidence, Italy (169 pmp) is placed in the upper band of European countries. The observed differences pose important questions: can different nephropathy risk in European countries be explained by genetic or environmental reasons? Do different criteria for acceptance on dialysis or different organizational structures available in European countries influence these data?


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  		Table 5 Incidence and prevalence of RRT patients in some European countries

 
As a next step, the Italian Society of Nephrology intends to continue collecting data, although more limited, with a similar questionnaire, to compare data over time and to increase the reliability of collected data. As far as incidence and prevalence data collection are concerned, the Society intends in the future to avoid duplication of data; therefore, regional registries will be responsible for the collection of epidemiological data and patient-level outcomes. The results of this census ask several stimulating questions with potential interesting debates for future research. Which factors influence the regional differences of the incidence and prevalence of dialysis patients? Which is the ideal organization model for better assistance? What is the ideal (if any) percentage of public and private DC in a regional territory?

In conclusion, we believe that this 2004 Census of the Italian Renal and Dialysis Units offers nephrologists and healthcare administrators data for a benchmarking process at regional, national and international levels. Similar initiatives, if undertaken more widely, should represent a powerful tool for planning resources and obtaining optimal renal assistance.



   Acknowledgments
 
The authors acknowledge the delegates of the Italian regions: Abruzzo: Bonomini M; Basilicata: Iannuzziello F; Calabria: Cicchetti T; Campania: Avella F; Emilia-Romagna: Cagnoli L; Friuli-Venezia Giulia: Panzetta O; Lazio: Simeoni P; Liguria: Garibotto G; Lombardia: Pedrini L; Marche: Concetti M; Molise: Brigante M; Piemonte: Triolo G; Puglia: Gesualdo L; Sardegna: Cogoni G; Sicilia: Marrocco L; Toscana: Rindi P; Trentino-Alto Adige: Rovati C; Umbria: Standoli M; Valle d’Aosta: Alloatti S; Veneto: Marchini P.

Conflict of interest statement. Giovanni FM Strippoli has provided clinical and scientific services for Gambro Healthcare. The other authors have no conflict of interest to declare.



   References
Top
 Abstract
 Introduction
 Methods
 Structure of the questionnaire
 Results
 Discussion
 References
 

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Received for publication: 19.12.06
Accepted in revised form: 16.10.07


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