title: Pilot non dialysis chronic renal insufficiency study (P-ND-CRIS): a pilot study of an open prospective hospital-based French cohort.
abstract: BACKGROUND
  Before 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).
  
  
  METHODS
  We 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).
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  With 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.
authors.affiliation: Institut PHISQUARE, 20, rue Saint Saëns, 75015, Paris, France. jmassol@phisquare.org.
authors.forename: Jacques
authors.identifier: http://orcid.org/0000-0003-0841-1608
authors.initials: J
authors.lastname: Massol
authors.affiliation: Centre Hospitalier de Mâcon, 350, boulevard Escande, 71018, Mâcon, Cedex, France.
authors.forename: Gérard
authors.initials: G
authors.lastname: Janin
authors.affiliation: Institut PHISQUARE, 20, rue Saint Saëns, 75015, Paris, France.
authors.forename: Camille
authors.initials: C
authors.lastname: Bachot
authors.affiliation: Institut PHISQUARE, 20, rue Saint Saëns, 75015, Paris, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Gousset
authors.affiliation: Institut PHISQUARE, 20, rue Saint Saëns, 75015, Paris, France.
authors.forename: Geoffroy Sainte-Claire
authors.initials: GS
authors.lastname: Deville
authors.affiliation: Nephrology, CHRU de Besançon, Hôpital Jean Minjoz, 3, boulevard Alexandre Fleming, 25030, Besançon, France.
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Chalopin
mesh_terms: D000368:Aged; D015331:Cohort Studies; D005260:Female; D005602:France / Q000453:epidemiology; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D010358:Patient Participation / Q000706:statistics & numerical data*; D010865:Pilot Projects; D015995:Prevalence; D011446:Prospective Studies; D012076:Renal Agents / Q000627:therapeutic use*; D006435:Renal Dialysis / Q000706:statistics & numerical data; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology* / Q000517:prevention & control*; D012307:Risk Factors
chemical_list: D012076:Renal Agents
keywords: Chronic renal disease; Cohort; Epidemiology; Pharmacoepidemiology; Pilot study; Renal insufficiency