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

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. CONCLUSION: 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.

A cohort study of therapeutic prescriptions after the end of phytotherapy drug reimbursement by French Social Security.

PURPOSE: The reimbursement of phytotherapy drugs for the treatment of mild anxiety and insomnia ended in March 2006 in France. The aim of this study is to investigate the short-term impact of stopping phytotherapy reimbursement. METHODS: We monitored the prescriptions of 27,422 patients who received hypnotic and sedative phytotherapy drug treatment at least once in the 12 months preceding the end of reimbursement and made contact with their prescribing physician at least once in the following 12 months. A control cohort was recruited from patients fulfilling the same inclusion criteria in the 24 months before de-reimbursement and their prescriptions in the following 12 months were monitored. The impact of the end of reimbursement is estimated comparing prescription switches in these cohorts. RESULTS: Before the end of reimbursement, 7684 (28%) patients being prescribed delisted phytotherapy drugs had the relevant drug marketing authorization approval (DMAA) indications. Co-prescriptions of hypnotic and sedative drugs concerned 40% of patients. Of the 4646 DMAA patients exclusively prescribed phytotherapy, 640 (14%) switched to hypnotic or sedative drugs only after the end of reimbursement, 3266 (70%) stopped all treatments and 740 (16%) carried on with a non-reimbursed phytotherapy prescription. When compared to the control cohort, patients exposed to de-reimbursement were more likely to switch to psychotropic drugs (OR = 1.46). CONCLUSIONS: Ending the reimbursement of common drugs on the basis of insufficient evidence regarding their effectiveness or the low level of severity of their target pathologies should be accompanied by information or advice to prescribing health care actors.