title: Intervention thresholds and ceilings can determine the haemoglobin outcome distribution in a haemodialysis population.
abstract: We have explored the consequences of setting different thresholds and ceilings for erythropoietin dose changes in two randomized controlled studies of renal anaemia management based on an established algorithm. STUDY 1: A large (n=236) unselected haemodialysis cohort was randomized to monthly intervention (increased erythropoietin (Epo)) at haemoglobin (Hb) levels falling below either 10.5 g/dl (group A) or 11.5 g/dl (group B) and followed for 6 months. The mean Hb was 0.6 g/dl higher in the 11.5 g/dl threshold group (11.1 g/dl vs 11.7 g/dl) at 6 months (P=0.001++). The Epo dose did not differ between them (median 133 IU/kg/week, Interquartile range (IQR) 86-217 and 140, IQR 74-227 respectively) (P=NS(**)). STUDY 2: A large (n=211) unselected haemodialysis cohort was randomized to a reduction in Epo dose at Hb levels above either 12.0 g/dl (group C) or 13.0 g/dl (group D). The Hb outcome at 8 months differed between group C (mean 11.5 g/dl, SD 1.4) and group D (12.2, SD 2.1) (P=0.03++). The Epo dose did not significantly differ between groups C and D (median 60 IU/kg/week, IQR 32-142 and 71, IQR 38-117 respectively) (P=NS(**)). Study 1 showed that an intervention threshold of 11.0 g/dl with a mean Hb outcome of 11.6 g/dl and SD 1.6 g/dl would produce the desired UK Renal Association Standards outcome of 85% Hb > or =10.0 g/dl. Study 2 demonstrated that a ceiling of 12.0 g/dl narrowed the range of Hb values (P:<0.001##), achieving a SD of 1.37 g/dl, and reduced the number of patients with a Hb >13.0 g/dl from 25 to 12%. This narrowing of the distribution has cost implications for reaching minimum standards in a haemodialysis population. Formal use of threshold and ceiling values for intervention within an anaemia management system enabled the haemodialysis population outcome mean and SD to be literally prescribed.
authors.affiliation: Department of Renal Medicine, St James's University Hospital, Leeds, UK.
authors.forename: D
authors.initials: D
authors.lastname: Richardson
authors.forename: C
authors.initials: C
authors.lastname: Bartlett
authors.forename: E J
authors.initials: EJ
authors.lastname: Will
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D004056:Differential Threshold; D004305:Dose-Response Relationship, Drug; D004921:Erythropoietin / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D016896:Treatment Outcome
chemical_list: D006454:Hemoglobins; D004921:Erythropoietin