Overview of literature monitoring practice of clinical trials vigilance units in French institutional sponsors - A study from the REVISE working group.

INTRODUCTION: The evaluation of clinical trial (CT) safety is the main task of CT vigilance units. In addition to the management of adverse events, the units must review the literature to identify information that may impact the benefit-risk assessment of studies. In this survey, we investigated the literature monitoring (LM) activity of French Institutional Vigilance Units (IVU) from the working group "REflexion sur la VIgilance et la SEcurite des essais cliniques" (REVISE). MATERIAL AND METHODS: We sent a questionnaire of 26 questions, divided into four themes, to the 60 IVU: (1) Presentation of the IVU and the LM activity; (2) Used sources, queries and criteria for selecting articles; (3) Valuation of the LM and (4) Practical organisation. RESULTS: Of the 27 IVU that responded to the questionnaire, 85% of them carried out LM. This was mainly provided by medical staff to improve general knowledge (83%), to detect Adverse Reactions (AR) not listed in the reference documents (70%) and to detect new safety information (61%). Due to lack of time, staff, available recommendations and sources, only 21% of IVU conducted LM for all CT. On average, units reported four sources: ANSM information (96%), PubMed database (83%), EMA alerts (57%) and the subscription to APM international (48%). The LM had an impact on the CT of 57% of the IVU such as changing the conditions of a study (39%) or suspending a study (22%). DISCUSSION/CONCLUSION: LM is an important but time-consuming activity with heterogeneous practices. According to the results of this survey, we proposed seven ways to improve this practice: (1) Target the highest risk CT; (2) Refine the PubMed queries; (3) Use other tools; (4) Create a decision flowchart for the selection of PubMed articles; (5) Improve training; (6) Value the activity and (7) Outsource the activity.

Evaluation of a safe infusion device on reducing occupational exposure of nurses to antineoplastic drugs: a comparative prospective study. Contamoins-1.

PURPOSE: Despite the decreasing of environmental contamination throughout the anticancer drug circuit, the administration of chemotherapies remains at risk of occupational exposure for nurses. Many medical devices aim at securing administration, but none have been scientifically evaluated to verify the actual improvement. METHODS: A monocentric comparative before/after study was carried out in an oncology day hospital to evaluate the efficacy of Safe Infusion Devices in reducing drug exposure compared to usual infusion practices. The rate of nurses' gloves contamination was estimated. To avoid false negatives and to ensure sampling reproducibility, each sample of gloves was contaminated with a drop of topotecan. Association between contamination and other variables was investigated using a multivariate logistic regression analysis. RESULTS: The usual practice led to a rate of 58.3% of contaminated samples while Safe Infusion Devices to a rate of 15%: Safe Infusion Devices reduced the risk of gloves contamination by 85% in multivariate analysis (Odds ratio = 0.15; 95% confidence interval = 0.05-0.46; p < 0.001). Topotecan was identified in 100% of the samples. Only one case of cross-contamination has occurred. CONCLUSION: Despite the current practice of using neutral solvent-purged infusers, the occupational exposure remains high for nurses and Safe Infusion Devices significantly reduced this risk of exposure. However, glove contamination is only a surrogate endpoint. The results confirmed that the disconnection of empty bags resulted in occupational exposure. Except a contamination due to the leakage of a bag, no cross-contamination was detected. Safe Infusion Devices were highly effective but did not completely eliminate exposure.

A comparative evaluation of the publications of French public teaching hospitals from 2004 to 2014.

Care, teaching, and research are all priorities of the French public teaching hospitals. In 2004, the remuneration method evolved from a global endowment to a fee-for-services system, based on the use of bibliometric tools. These were used in the present study to describe the research patterns of public teaching hospitals in regards to care and teaching activities. The present study was based on data from the 32 French public teaching hospitals, between 2004 and 2014. Records concerning the publications number, hospital stays, full-time equivalent (FTE) practitioners, and residents per FTE physician were accessed. Statistical analyses were performed using means, Pearson correlation coefficients, and regression lines. The mean number of publications per FTE physician was 0.73, the mean number of hospital stays per FTE physician was 235.8 and the mean number of residents per FTE physician was 0.63. There was a moderate positive correlation between the number of publications per FTE physician and the number of residents per FTE physician (R=0.53) and a negligible correlation between the number of residents per FTE physician and the number of hospital stays per FTE physician (R=0.12). There was a low negative correlation between publication numbers per FTE physician and the number of stays per FTE physician (R=-0.41). All public teaching hospitals presented different patterns in terms of care, teaching, and research activities. None of the 32 hospitals performed well in all three activities. Only nine performed well in at least two out of the three missions.

Bibliometrics and French healthcare institutions from 2004 to 2014.

INTRODUCTION: Research activity evaluation in French hospitals is based on the number of publications, author position (first, second, third, second-to-last, last, investigator list, and "Other") and journal category (A being the highest category followed by B, C, D, E, and NC). METHODS: The profile of publications over the 2004-2014 period in terms of these indicators was evaluated. Hospitals were classified into six groups according to administrative status. Time trends were analysed by three models. One-way ANOVA followed by Tukey's test was performed. RESULTS: A total of 192886 publications were analysed. The increase in the number of publications ranged from 628% for for-profit private hospitals to 141% for public teaching hospitals. The most frequent category was B for cancer centres (25%), whereas this was E in public teaching (22%) and non-teaching hospitals (28%), in not-for-profit private hospitals (25%), in the military hospital (30%), and in for-profit private hospitals (24%). The first position was the most frequent for public teaching hospitals (38%) and the military hospital (44%), whereas the "Other" position was the most frequent in cancer centres (26%), in public non-teaching hospitals (28%), in not-for-profit private hospitals (27%), and in for-profit private hospitals (29%). DISCUSSION: Different patterns were identified. The author position indicated that all types of hospital are involved in research projects. This study also found that public non-teaching hospitals, not-for-profit private hospitals, for-profit private hospitals, and cancer centres collaborated with other institutions which were often distinguished by publishing in high-category journals.