Pilot non dialysis chronic renal insufficiency study (P-ND-CRIS): a pilot study of an open prospective hospital-based French cohort

BMC Nephrology

Research Article

Gérard Janin¹  Geoffroy Sainte-Claire Deville²  Christophe Gousset²  Camille Bachot²  Jacques Massol²  Jean-Marc Chalopin³ 

[1] Centre Hospitalier de Mâcon, 350, boulevard Escande, 71018, Mâcon, Cedex, France;Institut PHISQUARE, 20, rue Saint Saëns, 75015, Paris, France;Nephrology, CHRU de Besançon, Hôpital Jean Minjoz, 3, boulevard Alexandre Fleming, 25030, Besançon, France;

关键词: Chronic renal disease;    Renal insufficiency;    Cohort;    Epidemiology;    Pilot study;    Pharmacoepidemiology;   

DOI  :  10.1186/s12882-017-0463-3

 received in 2016-04-16, accepted in 2017-01-26,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundBefore establishing a prospective cohort, an initial pilot study is recommended. However, there are no precise guidelines on this subject.This paper reports the findings of a French regional pilot study carried out in three nephrology departments, before realizing a major prospective Non Dialysis Chronic Renal Insufficiency study (ND-CRIS).MethodsWe carried out an internal pilot study. The objectives of this pilot study were to validate the feasibility (regulatory approval, providing patients with information, availability of variables, refusal rate of eligible patients) and quality criteria (missing data, rate of patients lost to follow-up, characteristics of the patients included and non-included eligible patients, quality control of the data gathered) and estimate the human resources necessary (number of clinical research associates required).ResultsThe authorizations obtained (CCTIRS – CNIL) and the contracts signed with hospitals have fulfilled the regulatory requirements. After validating the information on the study provided to patients, 1849 of them were included in three centres (university hospital, intercommunal hospital, town hospital) between April 2012 and September 2015. The low refusal rate (51 patients) and the characteristics of non-included patients have confirmed the benefit for patients of participating in the study and provide evidence of the feasibility and representativeness of the population studied. The lack of missing data on the variables studied, the quality of the data analyzed and the low number of patients lost to follow-up are evidence of the quality of the study. By taking into account the time spent by CRAs to enter data and to travel, as well as the annual patient numbers in each hospital, we estimate that five CRAs will be required in total.ConclusionWith no specific guidelines on how to realize a pilot study before implementing a major prospective cohort, we considered it pertinent to report our experience of P-ND-CRIS. This experience confirms that i) feasibility, ii) quality of data and iii) evaluating the resources required must be validated before carrying out a large prospective cohort study such as ND-CRIS.

【 授权许可】

CC BY   
© The Author(s). 2017