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Néphrologie & Thérapeutique

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Towards an extension of the REIN registry to patients with chronic kidney disease at stage 5 not treated with dialysis or transplantation? A pilot study Volume 15, issue 3, Juin 2019

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Authors

Objectives

Patient's perception analysis appears recently in numerous studies. Conjoint analysis has been used extensively by market researchers for studying how people value the characteristics of products and services. This technique was used in a clinical study to describe perceptions and preferences of anaemic patients suffering from chronic kidney disease not on dialysis (CKDnd), regarding erythropoietin stimulating agents (ESA).

Methods

PERCEPOLIS was a French multicenter prospective non-interventional study designed to describe the relative importance of ESA attributes according to CKDnD patients. Patients fulfilled questionnaires using an electronic device (digital tablet) at baseline and after 6 months under continuous erythropoietin receptor activator (CERA) treatment. Choice-based conjoint (CBC) questionnaires were developed with multiple components: 7 ESA attributes (2 or 3 levels per attribute), 2 partial profiles per task (2 out of the 7 attributes), and 7 tasks per questionnaire. Analyses were performed according to previous ESA treatment or not.

Results

From 789 analyzed patients, 433 non ESA-naive patients were more than 80% to declare treatment efficacy as the most important expectative in ESA choice process (direct question) but CBC analyses revealed that frequency of injections was more crucial (relative mean weight: ∼30% versus ∼20% for efficacy). Pain at injection site and haemoglobin not exceeding the recommended target were confirmed as important criteria for patients (relative mean weights: ∼15%). No new or unexplained safety signals were noted.

Conclusions

Using CBC design for the first time in a non-interventional ESA study with an electronic Patient Reported Outcome (ePRO) in an elderly population, these data showed that monthly injections and treatment efficacy were key patients’ expectations relative to ESAs. CERA efficacy to maintain stable haemoglobin within the recommended range was confirmed in real-life conditions.

Il semble, à ce jour, important de mieux connaître la population des patients MRC stade 5 non traités par suppléance afin de mieux comprendre les pratiques d’accès aux traitements de suppléance ou au traitement conservateur, et d’anticiper les besoins futurs. En avril 2015, à l’instigation du Conseil scientifique de REIN, un groupe de travail a été constitué afin de réfléchir à l’opportunité et la faisabilité d’un recueil sur ces patients. Entre septembre 2017 et mars 2018, 21 centres participant ont inclus, sur une durée d’au moins un mois, 390 patients. Les données recueillies concernaient les conditions de vie du patient, son niveau d’étude, le mode d’entrée à la consultation du néphrologue, des données cliniques et le projet thérapeutique. L’âge médian à l’inclusion était de 71,4 ans (IQR : 58,4–80,4), 39,9 % étaient diabétiques. Le eDFG médian était de 12mL/min/1,73m2 (IQR : 9–14). À l’inclusion, 77 % des patients étaient déjà suivis en néphrologie, 11 % avaient été adressés par un médecin généraliste. Pour la majorité des patients inclus (81 %), il y avait un projet de suppléance. Dans 10 % des cas, il y avait un projet de prise en charge sans suppléance, dans 5 % des cas le projet n’était pas encore décidé et dans 7 % le projet n’avait pas encore été discuté. Aux dernières nouvelles (délai médian 4,0 mois), 35 % des patients étaient dialysés, 9 (2 %) ont été greffés pré-emptivement, 25 (6 %) étaient décédés, 210 (54 %) étaient toujours au stade 5 sans suppléance. Notre étude pilote a permis de montrer la faisabilité et l’intérêt de mettre en place un tel recueil. Un tel registre apportera des informations importantes en termes de santé publique au regard de la démographie des néphrologues et des IDE de pratiques avancées pour les années à venir. À l’échelon local, ces informations aideront les services à se structurer pour organiser l’information pré-IRCT, la mise en place d’IDE de parcours de soins et de réunions pluridisciplinaires sur la prise en charge des cas difficiles. Cependant, notre phase pilote montre que pour garantir l’exhaustivité du recueil, le repérage en amont ou en aval des consultations de néphrologie des patients éligibles est indispensable et nécessite donc du temps humain dédié sur place.

To date, it is important to know more about the population of CKD stage 5 patients in order to better understand the practices of access to renal replacement therapy (RRT) or conservative treatment and to anticipate future needs. In April 2015, at the instigation of the Scientific Committee of REIN, a working group was formed to reflect on the opportunity and feasibility of a data collection on these patients. Between September 2017 and March 2018, 21 participating centers included 390 patients over a period of at least one month. The data collected included the patient's living conditions, level of study, mode of referral, clinical data and the therapeutic project. The median age at baseline was 71.4years (IQR: 58.4–80.4), 39.9% were diabetic. The median eGFR was 12mL/min/1.73m2 (IQR: 9–14). At inclusion, 77% of the patients were already followed in nephrology, 11% had been referred by a general practitioner. For the majority of patients included (81%), there was a RRT project. In 10% of cases, there was a project of conservative care, in 5% of cases the project was not yet decided and in 7% the project had not been yet discussed. At the latest news (median time 4.0months), 35% of patients were dialyzed, 9 (2%) have been pre-emptively transplanted, 25 (6%) died, 210 (54%) were still with a CKD stage 5. Our pilot study has shown the feasibility and interest of setting up such a data collection. Such a registry will provide important public health information regarding the demographic of nephrologists and advanced practices nurses. At the local level, this information will help the department to organize themselves to set-up pre-RRT information, implementation of care pathway nurses and multidisciplinary meetings for difficult cases. However, our pilot study shows that to ensure the completeness of the collection, the tracking upstream or downstream of nephrology consultations for eligible patients is essential and therefore requires dedicated human time on site.