title: [The need to revise the hemoglobin threshold value in the  German Quality Assurance Directive for Dialysis].
abstract: The German Quality Assurance Directive for Dialysis (QSD-RL) stipulates that no                     more than 15 % of all patients treated in a dialysis unit in any quarter may                     have a hemoglobin (Hb) value lower than 10 g/dl. For approximately 90 % of                     dialysis patients, this Hb threshold value can be simply achieved by                     administering erythropoiesis-stimulating agents (ESA). However, the question is                     raised as to wether this Hb threshold accords with the current state of                     knowledge. It is now evident from four randomized controlled trials (above all                     the TREAT study) and three meta-analyses that an ESA-induced increase in Hb does                     not produce any significant survival benefit in cases of chronic kidney disease                     (CKD), but may actually be detrimental. Critical attention must be focused in                     this regard on the higher risk of cardiovascular and cerebrovascular events, as                     well as malignoma-associated risks. In 2011, in response to these findings, the                     American Food and Drug Administration (FDA), the Drug Directive (AM-RL) of the                     German Federal Joint Committee and KDIGO (Kidney Disease: Improving Global                     Outcomes) amended guidelines for the treatment of renal anemia. Very restrictive                     recommendations were made regarding the use of ESA in CKD, according to which                     the Hb threshold value of 10 g/dl stipulated in the Quality Assurance Directive                     is now obsolete, thus necessitating prompt revision of the Directive. Two                     alternatives are available in this regard: either the 10 g/dl Hb threshold value                     applicable hitherto is withdrawn without replacement, and individualized                     treatment of renal anemia is practised ("individualization") instead, or a                     threshold value of 9 g/dl (modified "standardization") is applied in future.
authors.affiliation: KfH-Nierenzentrum Neuwied. norbert.maurin@kfh-dialyse.de
authors.forename: N
authors.initials: N
authors.lastname: Maurin
mesh_terms: D003956:Dialysis / Q000592:standards*; D005858:Germany; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood* / Q000534:rehabilitation; D007677:Kidney Function Tests / Q000592:standards*; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care / Q000592:standards*
chemical_list: D006454:Hemoglobins