Approach for guideline development

Abstract

The first wave of European Best Practice Guidelines (EBPG) in haemodialysis was completed in spring 2002 and was published in November 2002 in Supplement 7 of Volume 17 of Nephrology, Dialysis and Transplantation [1]. This issue contained the guidelines on: (i) measurement of renal function, when to refer and when to start dialysis; (ii) haemodialysis adequacy; (iii) biocompatibility; (iv) dialysis fluid purity; (v) chronic intermittent haemodialysis and prevention of clotting in the extracorporeal system; (vi) haemodialysis-associated infection and (vii) vascular disease and risk factors. From the start of the development procedure of the first wave, it had been decided that a second wave would follow, dealing with a remaining number of topics of interest. The first meeting of the work group responsible for the writing process was held on 8 April 2003. The following topics were to be dealt with: (i) intradialytic haemodynamic instability; (ii) vascular access; (iii) malnutrition and acidosis and (iv) dialysis strategies. Two other topics had originally been planned as well, but were abandoned at this early stage: (i) interdialytic hypertension, because it appeared that the Kidney Diseases Outcomes Quality Initiatives (K/DOQI), the body responsible for the generation of nephrological guidelines for the National Kidney Foundation (NKF) in the United States, was planning at that moment to produce extensive guidelines on this topic, as a section of the ‘Clinical practice guidelines for cardiovascular disease in dialysis patients’; in spring 2003 the K/DOQI were already far advanced in the preparation of these guidelines which were due for the beginning of 2005; (ii) Bone disease and mineral metabolism, because K/DOQI was on the verge of finalizing guidelines on this topic, whereas also the Kidney Disease: Improving Global Outcomes (KDIGO) initiative, a new emerging organization aiming at harmonization of guidelines worldwide and at producing new global guidelines, was preparing a consensus on the topic as well [2]. In June 2003, during the World Congress of Nephrology (WCN) in Berlin, representatives of the K/DOQI, KDIGO and EBPG met to discuss these issues. It was decided to offer the EBPG work group ample opportunity to have an input on the sections on interdialytic hypertension in the upcoming clinical practice guidelines for cardiovascular disease in dialysis patients of K/DOQI. As the latter were planned to contain recommendations on intradialytic haemodynamic instability as well, it was likewise decided that the EBPG work group would have an input in the generation of these recommendations as well. Since EBPG was planning specific and extended guidelines on this topic, however, rather than recommendations, and had the intension to cover a broader spectrum of questions based on a more extended literature review, it was decided to continue the foreseen development of guidelines on intradialytic haemodynamic instability by the EBPG. While starting the guideline development, it was decided to abandon the concept followed during the previous wave, where each topic was covered by one work group member, under peer review by the entire work group. For the upcoming wave, it was decided to compose subgroups with 3 to 4 experts, each with a chairman, having a coordinating role. The concept of peer review by the entire work group during the whole development process was, however, maintained. It was also decided that the work group on malnutrition would contain a dietician, and that the subgroup on vascular access would contain a vascular surgeon and an interventional radiologist. Furthermore, it was taken into account that the Vascular Access Society had published recommendations on vascular access, and care was taken to include members in the subgroup on vascular access, who had taken part in the development of these recommendations as well. The work group was composed after approval of its members by the European Renal Association – European Dialysis and Transplantation Association (ERA–EDTA) (Table 1). Each guideline was divided into a number of major subheadings (Table 2). Correspondence and offprint requests to: Raymond Vanholder, Department of Internal Medicine, Nephrology Science, OK12, University Hospital, Ghent, Belgium. Email: raymond.vanholder@ugent.be Nephrol Dial Transplant (2007) 22 [Suppl 2]: ii1–ii4