As one of the initiatives set forth in the Scientific Collaboration Agreement between Amgen and Fresenius Medical Care (FMC), the ARO Work Group was established in mid-2007. Many nephrologists are still unaware of the characteristics and objectives of this group; they are not even familiar with the meaning of the acronym, group members, or the goals they attempt to achieve. However, this work group has produced several original articles of great interest in nephrological journals; it has also generated presentations at conferences of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) and the American Society of Nephrology (ASN) in the last two years.
ARO corresponds to the acronym for Analysing data, Recognising excellence, and Optimising outcomes in advanced chronic kidney disease. This group consists of the nephrologists Jürgen Floege, Kai-Uwe Eckardt, Iain Macdougall, Bernard Canaud, Tilman Drüeke, Peter Stevinkel, Ángel L.M. de Francisco, David Wheeler, and Pedro Aljama, as well as several cardiovascular, epidemiological, and database analysis experts, in addition to representatives of the administrations of both companies. Due to his recent appointment as the strategic medical board director in the medical department of FMC, Bernard Canaud will be replaced by another European nephrologist at the request of the group. Two or three meetings are held every year, in addition to conference calls whenever required by the activities of the work group.
The ARO initiative is based on the primary objective of searching for answers to current major clinical questions regarding the treatment of chronic kidney disease, with special emphasis on the unsatisfactory survival results obtained using the different methods of dialysis. To this end, the ARO group has set the goal of optimising clinical results in dialysis programmes through a detailed analysis of available epidemiological profiles. Using clinical information and patient health profiles, the ARO group applies an analytical methodology that provides the best possible scientific evidence to be used for making decisions and creating treatment paradigms.
In this manner, the agreement between the two companies, Amgen and FMC, includes establishing a framework for referencing and analysing the FMC database known as EuCliD®. Using the unrestricted information contained within this digital database, the work group uses protocols established in concrete studies previously approved by the group to carry out scientific research and management. Naturally, the initial idea seemed fascinating to all of us. In effect, here was a database providing information on a cohort of 11 000 incident and prevalent patients; in other words, approximately 15 000 patients-year in 2005-2006. We began to work in this context, and this collaboration has produced several publications on various subjects, such as a description of the clinical characteristics of the patient database,1 relevant parameters of osteodystrophy related to mortality,2 and a study on the variability of haemoglobin and its true clinical significance.3 This last contribution, which appeared in the Journal of the American Society of Nephrology, is without a doubt the most precise report to date of this interesting issue. Studies always stipulate the limitations inherent to observational and retrospective studies, yet this same type of methodology aids in generating our paradigms for clinical practice through a critical analysis of the results obtained.
In this context, in 2010, Ricardo Arias asked me, as I imagine he asked several other senior Spanish nephrologists, for my opinion regarding the establishment of a work group in our country with the goal of reviewing and establishing guidelines and treatment algorithms for caring for patients in the dialysis units managed by FMC in Spain. After considering the request, I formally proposed the creation of a Spanish ARO, with a similar framework and purpose to that of the European group. I had several reasons for making this suggestion, but my primary reason was the observation that the EuCliD system was working at the same level in Spain as in the rest of Europe. In addition, we had at our disposal the support and collaboration of Pedro Costa and Jose Ignacio Merello, who had invested considerable time and enthusiasm into the development and maintenance of the database, reaching a total of more than 5000 patients registered, corresponding to a total of 800 000 haemodialysis sessions per year. It was not difficult to convince him; Ricardo quickly accepted the idea and started working to materialise it and to organise the logistics. We came to an agreement that we would later establish in a document in which Ricardo Arias, in the name of FMC, would formally propose nephrologists for membership in the group. In return, we would be granted unrestricted access by FMC to the EuCliD® database for scientific purposes, including publications in specialist journals. I was provided with a list of the group members: Alejandro Martín-Malo, Ángel L.M. de Francisco, Manuel Praga, Jose Luño, Rafael Pérez-García, Francisco Maduell, Manuel Molina and Eduardo Mirapeix, who was replaced last year due to retirement by Jesus Bustamante. FMC was represented by Ciro Tetta, Daniele Marcelli, Jose Ignacio Merello, and Inés Palomares, in addition to the irreplaceable Pedro Costa.
After the group was consolidated and charged with three established topics of investigation, I proposed a name for the group: ORD (Optimising Results in Dialysis). While the word “outcomes” is a better English translation for the Spanish word resultados, we preferred the word “results” in order to take into account not only clinical results, but also topics related to the efficiency and sustainability of dialysis treatments, which are of such great importance in the current economic situation.
During the first meeting, we established that the objectives of the ORD would be the same as those of the ARO, counting on the essential support of the company’s medical department: Ciro Tetta and Jose Ignacio Merello, in addition to the financial department represented by Pedro Costa. The logistics and delivery of specific Spanish data from the European EuCliD® system would be coordinated by Vice President Daniele Marcelli and Inga Bayh. Over time, and in light of the activities carried out, both Ciro and Daniele have requested permission to attend all work group meetings and sessions. We have accepted this proposal for obvious reasons.
In this manner, we started to function as a cohesive group, enjoying extensive and exciting work group sessions starting in June 2010. To date, we have met during 7 group sessions as well as in a multitude of e-mail communications and conference calls. In several of these meetings, we have invited guest speakers as well: Andrea Stopper, Jordi Martí, Flavio Mari, Alberto Rosati, and Inga Bayh have all received formal requests to elaborate on the topics that our group has been developing. Having known Bernard for more than 25 years, and having worked with him on innumerable projects and collaborative studies, I would dare to predict that he will join the ORD without even giving us time to suggest the idea. Without a doubt, his addition to the group will bring immeasurable benefits in the form of his ideas and experience. In effect, the joint work between Bernard and Ciro will be a productive collaboration that will bring us closer to our goals. This will be a unique, original, and distinctive experience for our group.
The current situation of the ORD work group involves 6 active projects assessing and analysing the Spanish EuCliD® database; three manuscripts have been concluded for the consideration of the editors at their respective nephrology journals. In addition, we have reviewed and updated three guidelines/algorithms for treatment strategies: Dosing in haemodialysis, Treatment of osteodystrophy, and Managing anaemia, for implementation in haemodialysis units. These projects were a response to the requests from Armin Karch, who has always closely monitored quality control of clinical health care provided in dialysis units. With time, we hope that these documents will come to be discussed in other European countries in a similar manner to the implementation taking place in the United States.
The first formal study published by the ORD work group appears in this issue of Nefrología4 as a starting shot on its journey through the nephrological literature. This publication is a description of the database with the most relevant hierarchical configuration for Spanish patients. It goes without saying that special acknowledgement of the work group is in order, but special mention is deserved for Rafael Pérez, Inés Palomares, and Ignacio Merello for their long hours spent organising and referencing the EuCliD® database. We would also like to thank the team directed by Daniele Marcelli, in particular Inga Bayh, for their dedication to ensuring the validity and reliability of the data; without their professional collaboration, our work would be impossible.
We hope that our other original articles, which will be sent for publication in the coming weeks, will be of interest to the editors and reviewers of nephrological journals, such that the group can emerge within the nephrological literature with a certain personality and style. Dedication, talent, and creativity will not be lacking; these qualities, together with the cooperation and mutual understanding shown among the active members of the FMC corporation, will ensure that the ORD follows the course set by the ARO. It goes without saying that Amgen should also be included and allowed to exert its influence and collaboration on our initiative due to both its analogy and talent. To this end, we hope that our message of inclusion to Amgen will reach and be deemed appropriate by the representatives of the administrations.
Without a doubt, given the current complex financial situation, it will require new efforts in imagination and creativity to guarantee the sustainability of our activities and system, including continued training, technological innovation, and excellence in research in order to continue our advancements. Therein lie our greatest and most relevant doubts. However, time, the nephrological community in Spain, and the renal patients treated in our field of medicine will be the ultimate judges of the results achieved under the ORD initiative. In any event, we have faith in our good judgement and firm commitment to improving the clinical results of patients with renal failure; without a doubt, this is the greatest scientific challenge facing the nephrological community today.5
