A protocol was lively discussed in Vienna. The first draft was based on the concept to implement a relatively uniform and solid standard of care as also suggested by the European Best Practice Guideline (EBPG) work groups. The discussion on the protocol draft was exciting but members of the convention initially were not enthusiastic about the name of the trial ANIMA (Additional Nurse involvement and Intentionally driven Medical Attention). However, we all agreed later on the name PRIMA (Protocol Intensified Multifactorial Approach) which still may be subject to change according to the emotions within our multilingual European society.  

PRIMA is going to test the hypothesis, that a structural higher level of care may increase survival in a relatively short period of time (3 years) in patients on dialysis therapy. The primary aim of the study is to assess the effects of “treatment by protocol” versus “standard treatment” on the time to death due to all-causes in more than 6000 men or women of all age groups on maintenance haemodialysis treatment for less than 12 months across Europe. Treatment by protocol can also be called treatment by EBPG, translated into clinical action plans and administered by doctors with the help of nurses in the form of check lists. PRIMA is therefore also a guideline implementation tool and a quality initiative spread in a controlled way. A centre randomization procedure (not single patient randomization) and a limited number of patients in each centre will meet the requirements outlined above. Control centres will be provided with EBPG guideline material in a way that standard treatment or intensified or even special treatment for a specified patient group, but not for another, will not anymore be an ethical issue. It is assumed that control centres try their best and will provide the best treatment available to-date.

Most of the issues discussed in Vienna will be solved or eliminated by randomization but still the protocol and the clinical action plans need major refinement. Currently, the protocol is under review by clinical trialists and standard randomization or a factorial design (i.e. two by two) is under elaboration. It is anticipated that the protocol may further discussed again later during 2006. If widely accepted and agreed upon PRIMA is ready to start early in 2007.