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.

[Reporting of harms in clinical trials: Vigilant support to the investigator. A guideline of REVISE' Group]. / Sécurité des essais cliniques : accompagnement de l'investigateur par le vigilant pour la publication des données de sécurité. Une ligne directrice du groupe REVISE.

Since August 9, 2004, the 2001 European Directive for clinical trials is applied to the French law. Since the 2006 implementing decree amending public health law on biomedical researches, safety data are managed by sponsor vigilant. Competent authorities collect sponsor's data, implement the vigilance system (Article L. 1123-12 of French Health Code) and supervise drastically safety data in clinical research from clinical trial authorization to final report. However, although available to competent authorities, final reports are not addressed to scientific community, who has only access to scientific publications for clinical trials safety data. Final report is under sponsor's responsibility (Article R. 1123-60 of French Health Code), but scientific publication is written by the study coordinating investigator. Therefore, at the end of the clinical trial, two actors will interpret safety data from the same database but with different scientific objectives. The lack of reporting of harms in scientific communications impacts the information. The REVISE group (safety officers of French institutional sponsors) suggests help to investigators in the safety data writing for their trial scientific publication. The group published a guideline, based on the international recommendations for publications of safety data in randomized clinical trials and expanded its scope to all clinical trials.

New regulations on medical devices in Europe: what to expect?

Medical devices (MDs) contribute to improve quality and effectiveness of healthcare. The MD industry is a heterogeneous, innovative, dynamic and growing sector. The existing regulatory framework for MDs has been in place for 20 years and needed a revision. In September 2012, the European Commission published a proposal for a new regulation on MDs which was amended by the Parliament in October 2013. This new regulation aims to harmonize practices, increase transparency and guarantee a high level of health protection. We conducted an analysis of the proposal to highlight the major upcoming changes.

Adverse drug reaction reporting by patients: an overview of fifty countries.

BACKGROUND: The modalities and contributions to drug safety of patient adverse drug reaction reporting systems in 50 countries have been reviewed and analysed. METHODS: The means made available by National Health Competent Authorities (NCAs) for patients to report drug side effects were compared through literature review and questionnaire. RESULTS: Among the 50 countries included in this study, we found that direct patient reporting systems exist in 44 countries and represent 9 % of total reports, the rest coming from healthcare professionals. Australia was the first, in 1964, and the United States has the system in which patients are the most involved. A total of 27 countries have a patient-specific reporting form, and 31 countries provide a form to complete online. In order to help patients, four countries constrain the description of the reaction and 12 constrain the choice of drug on the reporting form. Most of the surveyed countries request the patient's medical history (30 countries) and concomitant therapies (41 countries). The total number of fields per form ranges from 6 to 59, with a mean of 36 items. CONCLUSIONS: Most of the surveyed countries have implemented a patient adverse drug reaction reporting system. From this study, it seems that an online reporting form increases the rate of reporting. Currently, many different forms exist worldwide; these should be harmonized by considering the strengths and weaknesses of all existing forms. But above all, to increase the number of reports, each country should promote NCA-initiated adverse drug reactions reporting systems.

Differential responses of frequency components of renal sympathetic nerve activity to arterial pressure changes in conscious rats.

The present study examined the effects of baroreceptor loading and unloading on the various rhythms present in the renal sympathetic nerve activity (RSNA) of 10 conscious rats. Short-lasting (4-5 min), steady-state decreases (from -10 to -40 mmHg) and increases (from 5 to 30 mmHg) in arterial pressure (AP) were induced by the intravenous infusion of sodium nitroprusside and phenylephrine, respectively. The relationship between changes in AP level and RSNA total power (fast Fourier transform analysis; 0-25 Hz) was characterized by an inverse sigmoid function. Basal AP was located 6.3 mmHg above AP at the midrange of the curve, that is, near the lower plateau. Sigmoid relationships were also observed for spectral powers in the low (LF, 0.030-0.244 Hz), respiratory (0.79-2.5 Hz) and high-frequency (HF, 2.5-25 Hz) bands. In contrast, in the MF band (0.27-0.76 Hz) containing oscillations associated with Mayer waves, the AP-RSNA power relationship showed a bell curve shape with a maximum at 21 mmHg below basal AP. Similarly, changes in RSNA power at the frequency of the heart beat were well characterized by a bell curve reaching a maximum at 22 mmHg below basal AP. Under baseline conditions, LF, MF, respiratory and HF powers contributed approximately 3, 10, 18, and 69% of the total RSNA power, respectively. The pulse-synchronous oscillation of RSNA accounted for only 11 +/- 1% of HF power. The contribution of HF power to total power did not change consistently with AP changes. Therefore, most of the baroreflex-induced changes in RSNA are mediated by changes in the amplitude of fast, irregular fluctuations.

Differential evolution of blood pressure and renal lesions after RAS blockade in Lyon hypertensive rats.

The present work aimed to assess, in Lyon hypertensive (LH) rats, whether an early and prolonged inhibition of the renin-angiotensin system (RAS) could result in a blood pressure (BP) lowering and nephroprotection that persist after its withdrawal. Male LH rats received orally from 3 to 12 wk of age either an angiotensin-converting enzyme inhibitor perindopril at the doses of 0.4 and 3 mg x kg(-1) x day(-1) or an AT(1) receptor antagonist losartan at the dose of 10 mg x kg(-1) x day(-1). BP, histological changes in the kidney, and urinary protein excretion were examined during and 10 wk after cessation of the treatments. Both perindopril and losartan decreased BP, prevented renal lesions, and limited urinary protein excretion. After cessation of the treatment, BP returned to the level of never-treated LH rats in rats having received 3 mg x kg(-1) x day(-1) of perindopril while it remained slightly lower in those treated with 0.4 mg x kg(-1) x day(-1) of perindopril or with losartan. This lack of marked persistent antihypertensive effect contrasted with a durable decrease in urinary protein excretion and improvement of the renal histological lesions. In conclusion, it is possible to separate the BP-lowering effects of RAS blockade from those on glomerulosclerosis and urinary protein excretion.

Stress-induced renal alterations in normotensives offspring of hypertensives and in hypertensives.

BACKGROUND: Scarce information is available on stress-induced renal behavior in humans, especially in normotensives offspring of hypertensives (HP) and in hypertensives (HT). METHODS: Ten HP and 10 HT were compared to 10 normotensives with normotensive parents (NP). Systolic blood pressure (SBP) and renal functional parameters were determined during rest and stress periods. RESULTS: The stress SBP reactivity was significantly (P < .05) higher in HP than in NP and HT. At rest, HP were characterized by a significantly (P < .05) higher glomerular filtration rate. Stress significantly reduced glomerular filtration rate (-14 +/- 4 mL/min/1.73 m2, P < .05) only in HT. Renal plasma flow significantly (P < .05) decreased during stress in NP (-35 +/- 16 mL/min/1.73 m2) and in HT (-49 +/- 25 mL/min/1.73 m2), whereas it did not change in HP. The resulting filtration fraction increased significantly during stress only in NP (1.5% +/- 0.6%, P < .05). Despite the increase in BP, stress induced a similar decrease in sodium excretion rate in NP (-52 +/- 26 micromol/min) and in HT (-56 +/- 24 micromol/min). The stress-induced sodium reabsorption occurred only in the proximal part of the tubules (lithium clearance). In HP, stress did not alter either sodium excretion rate or plasma renin activity. CONCLUSIONS: The stress-induced renal modifications are characterized by an efferent vasoconstriction and a paradoxical increase in sodium reabsorption that occurred in the proximal part of the tubules in NP. In HP, genetically at risk of hypertension, basal renal alterations may explain a different stress-induced renal behavior. In HT, stress-induced increase in sodium reabsorption may be involved in the sustained BP level.