Application of NKF-K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease: changes of clinical practices and their effects on outcomes and quality standards in three haemodialysis units.

BACKGROUND: The K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease was published in October 2003. The objective of this study was to analyse the effect of the application of those guidelines on clinical practices and on the achievement of bone disease targets and quality standards. METHODS: We included in the study 342 patients dialysed in our three HD units during 2003 and 2004. Starting October 2003, the K-DOQI recommendations were introduced into practice. Parathyroid hormone (PTH) was measured every 3 months and the serum Ca and P levels, monthly. In patients whose medications were modified, PTH was measured monthly and Ca and P levels, weekly or biweekly. RESULTS: The following are the main findings for 2004 (post-K/DOQI): an increased use of dialysates with a Ca concentration of 2.5 mEq/l (27.2-50.9%, P<0.001) and a reduced use of a dialysate calcium of 3.0 mEq/l (44.6-39.6%, P: NS) and 3.5 mEq/l (28-9.4%, P<0.001); a reduced use of calcium-based phosphate binders (891.9-565.5 mg Ca/day, P<0.001) and increased use of sevelamer hydrochloride (800 mg) (from 4.86 to 7.51 mg, tablets/day, P<0.001) lower serum Ca levels (9.7-9.4 mg/dl, P<0.01), and higher intact PTH levels (201.4-311.8 pg/ml, P<0.001), without changes in serum P levels; an increased proportion of patients with serum Ca levels within the K/DOQI target range (38.7-46.6%, P<0.01), resulting mainly from the reduced percentage of patients with hypercalcaemia (55-44.4%, P<0.01); a decreased proportion of patients with PTH<150 pg/ml (53.8-31.4%, P<0.001) but an increased proportion of patients with PTH>300 pg/ml, with no change in the proportion of patients with PTHs within the K/DOQI target range. Phosphorus levels and targets did not show significant differences between 2003 and 2004 (56.9-56.2%, P: NS). CONCLUSIONS: The only way to ensure that K/DOQI guidelines actually improve medical outcomes is to emphasize implementation strategies and also the scientific evaluation of their effectiveness in clinical settings. In spite of the application of the K-DOQI recommendations, a large proportion of our patients stayed outside the proposed targets, which points to the need for more effective therapeutic options.