Setting The setting was a hospital. The economic study was carried out in five hospital in Spain.

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1 Significado pronostico de la dialisis programada en pacientes que inician tratamiento sustitutivo renal: un estudio multicentrico espanol [Prognostic significance of unplanned start of dialysis: a Spanish multicentrical study] Gorriz J L, Sancho A, Pallardo L M, Amoedo M L, Martin A, Sanz P, Barril G, Selgas R, Salgueira M, Palma A, de la Torre M, Ferreras I Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The use of planned or unplanned haemodialysis for patients starting chronic renal replacement therapy (RRT). Patients with a vascular or peritoneal access ready to use for initiating RRT were classified as planned dialysis (PL-D), while patients without access ready for RRT were classified as unplanned dialysis (UNPL-D). Type of intervention Dialysis. Economic study type Cost-effectiveness analysis. Study population The study population comprised patients who were started on chronic RRT. Patients who were started on RRT after acute renal failure were excluded. Setting The setting was a hospital. The economic study was carried out in five hospital in Spain. Dates to which data relate The effectiveness evidence and resource use data refer to 1996 and No price year was reported. Source of effectiveness data The effectiveness data were derived from a single study. Link between effectiveness and cost data The costing was carried out retrospectively on the same sample of patients as that used in the effectiveness analysis. Study sample The sample of patients included in the analysis was selected from those undergoing dialysis at the hospitals participating into the study in 1996 and Of the 375 patients initially selected, 13 were excluded because they presented with acute renal failure. In the PL-D group, there were 186 patients (51.4%) with a median age of 63.6 (+/- 17) years (range: 18-91), and 66.7% were male. In the UNPL-D group, there were 176 patients (48.6%) with a median age of 69.7 (+/- 13.8) years (range: 22-89), and 58.5% were male. Power calculations to determine the sample size were not carried out. Page: 1 / 5

2 Study design This was a retrospective case-control study carried out in five hospitals in Spain: Hospital Universitario Dr. Peset (Valencia), Hospital Arnau de Vilanova (Lleida), Hospital de la Princesa (Madrid), Hospital Virgen Macarena (Sevilla) and Hospital Alarcos (Ciudad Real). The mean follow-up after the start of dialysis was 39 (+/- 16) months (median follow-up: 21 months). Analysis of effectiveness The analysis of the effectiveness used a sample of 289 patients (80%) who had been correctly classified. Complete classification was not achieved for 73 patients (20%), 38 in the PL-D group and 35 in the UNPL-D group. The health outcomes assessed were demographic data, clinical data on the laboratory tests and hospitalisation, risk factors (multivariate analysis), mortality and survival rates (calculated using the Kaplan-Meir method). Effectiveness results There were some statistically significant differences among the study groups. In particular, the patients in the UNPL-D group were associated with greater age, non-nephrological follow-up, diabetes, haemodialysis as first mode of RRT, a higher co-morbidity risk, dialysis initiation with uraemic symptoms or fluid overload, increased blood transfusion requirement, than the patients in the PL-D group. The UNPL-D patients were also associated with lower serum albumin, creatinine clearance, haemoglobin concentration and weight. The number of patients hospitalised at the start of dialysis was 31 (16.7%) in the PL-D group and 159 (90.3%) in the UNPL-D group. The days of hospitalisation were 4 (+/- 6.2) in the PL-D group and 17.7 (+/- 14.6) in the UNPL-D group. The number of dialysis sessions during hospitalisation for initial RRT was 2.3 (+/- 2.7) in the PL-D group and 7.4 (+/- 6.7) in the UNPL-D group. The differences in the outcomes reported above were all statistically significant. The multivariate analysis identified the following statistically significant risk factors that were correlated with UNPL-D initiation: prior non-nephrological follow-up (odds ratio, OR 25.39, 95% confidence interval, CI: ; p=0.001); uraemic symptoms (OR 10.92, 95% CI: ; p=0.001); interstitial nephritis as primary renal disease (OR 3.24, 95% CI: ; p=0.01); and haemodialysis as first RRT (OR 2.72, 95% CI: ; p=0.037). After 6 months, there were 24 deaths (6.6%) in the PL-D group and 18 deaths (10.2%) in the UNPL-D group, (p=0.007). After 3 years, there were 45 deaths (24.2%) in the PL-D group and 65 deaths (36.9%) in the UNPL-D group, (p=0.008). The survival rates at 6 months were 97% in the PL-D group and 89% in the UNPL-D group. The survival rates at 3 years were 78% in the PL-D group and 66% in the UNPL-D group. The difference was statistically significant. The analysis of survival, stratified for morbidity (Wright and Kahn index), indicated that a statistically significantly higher mortality was observed only in patients at medium risk. There were no differences among patients at low and high risk. Page: 2 / 5

3 Clinical conclusions UPL-D was associated with statistically significantly worse outcomes and clinical conditions than PL-D. Measure of benefits used in the economic analysis No summary benefit measure was used in the effectiveness analysis. A cost-consequences analysis was therefore carried out. Direct costs Only the cost of hospitalisation for the dialysis was included in the analysis. This was calculated on the basis of a system that classified dialysis sessions according to five categories. The unit cost of a dialysis session was reported for each category and was derived from published studies. The quantities of resources (hospitalisation days) were reported. The cost/resource boundary adopted was that of the hospital. Discounting was irrelevant as the costs were estimated over a time horizon of 6 months. The price year was not reported. Statistical analysis of costs No statistical analysis of the costs was performed. Indirect Costs The indirect costs were not included. Currency Spanish pesetas (Pta). Sensitivity analysis No sensitivity analysis was carried out. Estimated benefits used in the economic analysis See the 'Effectiveness Results' section. Cost results The total costs were Pta 28,313,039 in the PL-D group and Pta 146,806,032 in the UNPL-D group. There was a cost difference of Pta 118,492,993 in favour of the PL-D group. Synthesis of costs and benefits Not relevant. Authors' conclusions Unplanned dialysis (UNPL-D) was associated with worse overall clinical conditions at the initiation of chronic renal replacement therapy (RRT), increased morbidity and mortality, and a subsequent increase in the costs. CRD COMMENTARY - Selection of comparators UPL-D or PL-D was selected as the comparator, as the aim of the study was to assess whether the presence or absence of a vascular or peritoneal access, ready to use for initiating RRT, could affect the morbidity and mortality of patients. You should consider whether they represent widely used interventions in your own setting. Page: 3 / 5

4 Validity of estimate of measure of effectiveness The analysis of the effectiveness used a multicentre retrospective case-control study. The study sample appears to have been representative of the study population. Several statistical analyses were carried out to assess the impact of some factors on the outcome results. However, the internal validity of the analysis was limited by the lack of power calculations. Also, by the statistically significant differences in the study groups at baseline. The effectiveness analysis was restricted to a smaller sample than that initially enrolled, due to the lack of data. Validity of estimate of measure of benefit The health outcomes were left disaggregated and no summary benefit measure was used in the economic analysis. Thus, a cost-consequences analysis was carried out. It would have been interesting had the patients' preferences for the two interventions been assessed. Validity of estimate of costs The perspective adopted appears to have been that of the hospital. Only the costs related to hospitalisation were included in the analysis. The unit costs and the quantities of resources were reported separately. However, the price year was not reported and statistical analyses were not carried out on the costs or quantities. Other issues The authors made some comparisons of their findings with those from other studies. The generalisability of the study to other settings was limited since sensitivity analyses were not performed. The study included patients who were started on chronic RRT and this was reflected in the conclusions. Implications of the study The authors suggest that further research should analyse the patients' preferences, and the coordination of different sectors of care involved in the management of patients undergoing vascular access for haemodialysis. Source of funding None stated. Bibliographic details Gorriz J L, Sancho A, Pallardo L M, Amoedo M L, Martin A, Sanz P, Barril G, Selgas R, Salgueira M, Palma A, de la Torre M, Ferreras I. Significado pronostico de la dialisis programada en pacientes que inician tratamiento sustitutivo renal: un estudio multicentrico espanol. [Prognostic significance of unplanned start of dialysis: a Spanish multicentrical study] Nefrologia 2002; 22(1): PubMedID Indexing Status Subject indexing assigned by NLM MeSH Adolescent; Adult; Aged; Aged, 80 and over; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prognosis; Renal Dialysis /methods; Retrospective Studies; Spain AccessionNumber Page: 4 / 5

5 Powered by TCPDF ( Date bibliographic record published 31/01/2003 Date abstract record published 31/01/2003 Page: 5 / 5