Evaluation of clinical guidelines for the management of end-stage renal disease in Europe: the EU BIOMED 1 Study

Background. There are wide national and international variations in the man agement of patients with endstage renal disease (ESRD). The aim of this stu dy was to develop, harmonize, implement, and evaluate consensus-based clini cal guidelines for the management of renal anaemia and renal bone disease i n patients with ESRD, and for the prevention and management of cytomegalovi rus disease in renal transplant recipients across six renal centres in Euro pe. Methods. The trial was a prospective, multicentre, randomized balanced inco mplete block design. Nephrologists from the six European renal units were r andomized to develop and implement guidelines for two out of the three cond itions and to act as a control for the third condition. Data were collected pre- (1 year) and post- (9 months) intervention on aspects of patient moni toring, management, and outcome. Results. Eight hundred and twenty-nine dialysis patients from the six Europ ean dialysis centres were included in the study. Multivariate analysis (adj usting for case-mix and secular trends) showed a significant increase in th e number of monitoring events in the guideline group compared with control group (6%, 95% CI, 1-11%). There was no concomitant increase in either appr opriate management or the number of favourable patient outcomes. Conclusions. In the first European collaboration on renal guidelines, the i ntroduction of the guidelines improved the monitoring of the patients, but did not improve patient management or outcome. This study suggests the pote ntial for creating clinical guidelines with the aim of standardizing treatm ent protocols across international boundaries, and improving the quality of the medical care provided.