Job description and perception of clinical research personnel working in a network of French intensive care units.

BACKGROUND: There is a lack of information about the organisation and management of clinical research personnel in Europe and of their professional activity in intensive care. We therefore conducted a cross-sectional survey among personnel currently working in a French intensive care research network that involves 41 centres nationwide. The aim of the survey was to describe the personnel's personal and institutional organisation and management, their job perception in terms of satisfaction and stress, and suggestions for improvement. METHODS: Over 3 months in 2023, the research personnel received an electronic questionnaire on their personal and professional profile, past and present training, workplace and functions currently performed, personal knowledge about job skills required, job satisfaction and stress by as measured on a rating scale, and suggested ways of improvement. RESULTS: Ninety seven people replied to the questionnaire (a response rate of 71.3%), of whom 78 (57.3%) were sufficiently involved in intensive care to provide complete answers. This core sample had profiles in line with French recruitment policies and comprised mainly Bachelor/Master graduates, with nurses accounting for only 21.8%. The female to male ratio was 77:23%. Many responders declared to have a shared activity of technician (for investigation) and assistant (for quality control). More than 70% of the responders considered that most of the tasks required of each worker were major. Figures were much lower for project managers, who were few to take part in the survey. On a scale of 10, the median of job satisfaction was 7 for personal work organisation, 6 for training and for institutional organisation, and only 5 for personal career management. The median of job stress was 5 and was inversely correlated with satisfaction with career management. Respect of autonomy, work-sharing activity between investigation and quality control, a better career progression, financial reward for demanding tasks, and participation in unit staff meetings were the main suggestions to improve employee satisfaction. CONCLUSION: This nationwide survey provides a new insight into the activity of French clinical research personnel and points to ways to improve the quality and efficiency of this workforce.

Fitness and metabolic response to exercise in young adult survivors of childhood lymphoma.

PURPOSE: Childhood lymphoma survivors (CLSs) are at high risk of reduced daily activity. This work studied metabolic substrate use and cardiorespiratory function in response to exercise in CLSs. METHODS: Twenty CLSs and 20 healthy adult controls matched for sex, age, and BMI took an incremental submaximal exercise test to determine fat/carbohydrate oxidation rates. Resting echocardiography and pulmonary functional tests were performed. Physical activity level, and blood metabolic and hormonal levels were measured. RESULTS: CLSs reported more physical activity than controls (6317 ± 3815 vs. 4268 ± 4354 MET-minutes/week, p = 0.013), had higher resting heart rate (83 ± 14 vs. 71 ± 13 bpm, p = 0.006), and showed altered global longitudinal strain (- 17.5 ± 2.1 vs. - 19.8 ± 1.6%, p = 0.003). We observed no difference in maximal fat oxidation between the groups, but it was reached at lower relative exercise intensities in CLSs (Fatmax 17.4 ± 6.0 vs. 20.1 ± 4.1 mL/kg, p = 0.021). At V̇O2 peak, CLSs developed lower relative exercise power (3.2 ± 0.9 vs. 4.0 ± 0.7 W/kg, p = 0.012). CONCLUSION: CLSs reported higher levels of physical activity but they attained maximal fat oxidation at lower relative oxygen uptake and applied lower relative power at V̇O2 peak. CLSs may thus have lower muscular efficiency, causing greater fatigability in response to exercise, possibly related to chemotherapy exposure during adolescence and childhood. Long-term follow-up is essential and regular physical activity needs to be sustained.

Effects of single and multiple sessions of lower body diastole-synchronized compressions using a pulsating pneumatic suit on endothelium function and metabolic parameters in patients with type 2 diabetes: two controlled cross-over studies.

BACKGROUND: Endothelium function is often impaired in patients with type 2 diabetes. We hypothesized that by improving endothelial function using diastole-synchronized compressions/decompressions (DSCD) to the lower body may improve the metabolic profile. The objective of this research was to evaluate the effects of single and multiple DSCD sessions on microcirculation, endothelium function and metabolic parameters of patients with type 2 diabetes. METHODS: Two monocentric, controlled, randomized cross-over studies (Study 1 and Study 2) were performed. In Study 1, 16 patients received one 20 min DSCD and one simulated (control) session at 2 week intervals; continuous glucose monitoring and cutaneous blood flow were recorded continuously before, during and after DSCD or Control session; other vascular assessments were performed before and after DSCD and control sessions. In Study 2, 38 patients received 60 min DSCD sessions three times/week for three months followed by a 4-6 week washout and 3 month control period (without simulated sessions); vascular, metabolic, body composition, physical activity and quality of life assessments were performed before and after 3 months. RESULTS: Both studies showed significant, multiplex effects of DSCD sessions. In Study 1, cutaneous blood flow and endothelium function increased, and plasma and interstitial glucose levels after a standard breakfast decreased after DSCD sessions. In Study 2, cutaneous endothelium function improved, LDL-cholesterol and non-HDL cholesterol decreased, extra-cell water decreased and SF-36 Vitality score increased after 3 months of DSCD sessions. CONCLUSIONS: Our findings support the beneficial effect of DSCD on the endothelium and show concomitant beneficial metabolic and vitality effects. Future clinical trials need to test whether DSCD use translates into a preventive measure against microvascular diabetic complications and its progression. Trial registration ClinicalTrials.gov identifiers: NCT02293135 and NCT02359461.

Transcultural validation of a French-European version of the Prescription Opioid Misuse Index Scale (POMI-5F).

PURPOSE: The Prescription Opioid Misuse Index scale (POMI) is a brief questionnaire used to assess opioid prescription misuse. In view of the increase in the prescription of opioid analgesics for chronic noncancer pain (CNCP), this tool is particularly useful during medical consultations to screen opioid misuse in patients using opioids. We sought to generate and validate a French-European translation of the POMI. METHODS: We conducted an observational, longitudinal, and multicenter psychometric study with crosscultural validation. All adult CNCP patients who were treated with opioids for at least three months, were followed in pain clinics, and spoke French were eligible. From September 2015 to November 2017, we included 163 patients and analyzed 154. We performed a pretest on a sample of representative patients to evaluate acceptability and understanding of translation. Study patients completed the POMI scale at a pain clinic (test phase), and we assessed test-retest reliability after two to four weeks by a second completion of the POMI scale at home by patients (retest phase). We subsequently explored psychometric properties of the POMI (acceptability, internal consistency, reproducibility, and external validity). RESULTS: Due to poor internal consistency and reproducibility, items 4, 7, and 8 of the original POMI scale were removed, and we proposed a five-question French-European version (POMI-5F). The internal consistency of POMI-5F was good (Cronbach's α = 0.71), as was test-retest reliability (r = 0.65 [0.55-0.67]). The external validity of POMI-5F, compared with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, was moderate but significant (r = 0.45; P < 0.001). The optimal POMI-5F cut-off score to indicate misuse was 2/5 (sensitivity = 0.95 and specificity = 0.54). CONCLUSION: We generated and validated a French-European translation of the POMI scale, POMI-5F, for use by French researchers and physicians to identify opioid misuse in CNCP patients.

RéSUMé: OBJECTIF: L'échelle Prescription Opioid Misuse Index (POMI) est un questionnaire court utilisé pour évaluer le mésusage de la prescription d'opioïdes. Face à l'augmentation de la prescription d'antalgiques opioïdes pour les douleurs chroniques non cancéreuses (DCNC), cet outil est particulièrement utile lors des consultations médicales pour dépister le mésusage chez les patients utilisateurs d'opioïdes. Nous avons cherché à générer et à valider une traduction franco-européenne de la POMI. MéTHODES: Nous avons mené une étude psychométrique observationnelle, longitudinale et multicentrique avec une validation transculturelle. Tous les patients souffrant de DCNC, traités par opioïdes depuis au moins trois mois, suivis en structures douleur chronique et parlant le Français étaient éligibles. De septembre 2015 à novembre 2017, 163 patients ont été inclus et 154 analysés. Un pré-test a été réalisé sur un échantillon de patients représentatifs pour évaluer l'acceptabilité et la compréhension de la traduction. Les patients de l'étude ont rempli l'échelle POMI (phase TEST) au sein du centre investigateur et la fiabilité du test­retest a été évaluée après deux à quatre semaines par un second remplissage de l'échelle POMI à domicile par les patients (phase RETEST). Ensuite, les propriétés psychométriques de l'échelle POMI ont été explorées (acceptabilité, cohérence interne, reproductibilité et validité externe). RéSULTATS: En raison d'une faible cohérence interne et reproductibilité, les items 4, 7 et 8 de l'échelle POMI originale ont été supprimés, et nous avons proposé une version française (Europe) à cinq questions (POMI-5F). La cohérence interne de l'échelle POMI-5F était bonne (α de Cronbach = 0,71), tout comme la fiabilité test­retest (r = 0,65 [0,55­0,67]). La validité externe du POMI-5F, comparée à la cinquième édition du Manuel diagnostique et statistique des troubles mentaux (DSM-5), était modérée mais significative (r = 0,45; P < 0,001). Le score seuil optimal du POMI-5F pour indiquer un mésusage était de 2/5 (sensibilité = 0,95 et spécificité = 0,54). CONCLUSION: Nous avons généré et validé une traduction franco-européenne de l'échelle POMI, POMI-5F, pour une utilisation par les chercheurs et les médecins français afin d'identifier le mésusage des opioïdes chez les patients souffrant de DCNC.

Fine Detection of Human Motion During Activities of Daily Living as a Clinical Indicator for the Detection and Early Treatment of Chronic Diseases: The E-Mob Project.

Methods to measure physical activity and sedentary behaviors typically quantify the amount of time devoted to these activities. Among patients with chronic diseases, these methods can provide interesting behavioral information, but generally do not capture detailed body motion and fine movement behaviors. Fine detection of motion may provide additional information about functional decline that is of clinical interest in chronic diseases. This perspective paper highlights the need for more developed and sophisticated tools to better identify and track the decomposition, structuration, and sequencing of the daily movements of humans. The primary goal is to provide a reliable and useful clinical diagnostic and predictive indicator of the stage and evolution of chronic diseases, in order to prevent related comorbidities and complications among patients.

Enhanced pain facilitation rather than impaired pain inhibition in burning mouth syndrome female patients.

BACKGROUND: Deficient endogenous pain modulation has been implicated in the development and exacerbation of chronic orofacial pain. To date, relatively little is known regarding the function of the endogenous pain modulation in patients with burning mouth syndrome (BMS). This case-control study investigated endogenous pain modulation in women with BMS. METHODS: Conditioned pain modulation (CPM) was assessed upon temporal summation (TSP) of thermal pain. Forty female subjects, 20 BMS patients and 20 age-matched control subjects, were included in a 2 session-protocol. Mechanical and thermal pain thresholds were measured on the forearm and hand. TSP was obtained using repetitive laser-evoked thermal stimuli applied on the non-dominant hand, at an intensity yielding to moderate pain. During TSP, CPM was produced by immersing the contralateral foot in a water bath at painful cold (8 °C) temperature. In control conditions, the foot was immersed in a water bath at not painful (30 °C) temperature. RESULTS: BMS was not associated with any impairment in thermal as well as mechanical extracephalic pain thresholds. TSP and CPM efficacy were similar in BMS patients and control subjects. However, BMS patients exhibited enhanced extracephalic heat hyperalgesia. CONCLUSION: This study reveals that there is no impairment of endogenous pain inhibition mechanisms in BMS patients, but rather an increase in pain facilitation.

Effects of Totum-63 on glucose homeostasis and postprandial glycemia: a translational study.

Global prevalence of type 2 diabetes (T2D) is rising and may affect 700 million people by 2045. Totum-63 is a polyphenol-rich natural composition developed to reduce the risk of T2D. We first investigated the effects of Totum-63 supplementation in high-fat diet (HFD)-fed mice for up to 16 wk and thereafter assessed its safety and efficacy (2.5 g or 5 g per day) in 14 overweight men [mean age 51.5 yr, body mass index (BMI) 27.6 kg·m-2] for 4 wk. In HFD-fed mice, Totum-63 reduced body weight and fat mass gain, whereas lean mass was unchanged. Moreover, fecal energy excretion was higher in Totum-63-supplemented mice, suggesting a reduction of calorie absorption in the digestive tract. In the gut, metagenomic analyses of fecal microbiota revealed a partial restoration of HFD-induced microbial imbalance, as shown by principal coordinate analysis of microbiota composition. HFD-induced increase in HOMA-IR score was delayed in supplemented mice, and insulin response to an oral glucose tolerance test was significantly reduced, suggesting that Totum-63 may prevent HFD-related impairments in glucose homeostasis. Interestingly, these improvements could be linked to restored insulin signaling in subcutaneous adipose tissue and soleus muscle. In the liver, HFD-induced steatosis was reduced by 40% (as shown by triglyceride content). In the subsequent study in men, Totum-63 (5 g·day-1) improved glucose and insulin responses to a high-carbohydrate breakfast test (84% kcal carbohydrates). It was well tolerated, with no clinically significant adverse events reported. Collectively, these data suggest that Totum-63 could improve glucose homeostasis in both HFD-fed mice and overweight individuals, presumably through a multitargeted action on different metabolic organs.NEW & NOTEWORTHY Totum-63 is a novel polyphenol-rich natural composition developed to reduce the risk of T2D. Totum-63 showed beneficial effects on glucose homeostasis in HFD-fed mice, presumably through a multitargeted action on different metabolic organs. Totum-63 was well tolerated in humans and improved postprandial glucose and insulin responses to a high-carbohydrate breakfast test.

Non-specific analgesia during a clinical trial in fibromyalgia.

BACKGROUND: When patients suffering from fibromyalgia undergo a therapeutic trial, a non-negligible part of analgesia is not explained by the drug itself. The mechanisms of this non-specific effect need to be understood. MATERIALS AND METHODS: We undertook secondary analyses of a double-blind randomized trial in fibromyalgia patients in which 100 mg/day milnacipran was not found superior to placebo. Data from 49 patients belonging to both groups were pooled. Both before treatment and one month after treatment, all patients underwent a CaNTAB® neuropsychological test (related to spatial planning, reaction time, decision-making and risk-taking, and ability to name objects), and measurements of sensation and pain thresholds to heat and cold, supraliminal heat pain threshold, punctuate mechanical pain threshold and temporal summation, mechanical allodynia to skin brushing, and response to conditioned pain modulation. We studied the baseline predictors of analgesia and the indicators of change associated to analgesia separately. A stepwise approach was used to select the factors to enter into the final ANCOVAs, in which age, body mass index, treatment group and pain at baseline were covariates. RESULTS: No baseline predictor of non-specific analgesia other than pain at baseline was found to be predictive. Conversely, several neuropsychological (higher performance) or psychophysical (lower sensitivity) changes correlated with analgesia in unadjusted analyses. Multivariable analyses identified increases in warm/heat thermal thresholds and an increased ability to name objects, as factors associated with analgesia. CONCLUSIONS: The changes observed concomitantly to non-specific pain analgesia might be related to mild changes in brain functioning, based on convergent literature data.

Transcultural validation of a French version of the Iowa Satisfaction with Anesthesia Scale (ISAS-F).

PURPOSE: We sought to validate a French translation of the Iowa Satisfaction with Anesthesia Scale (ISAS), a tool to assess the patient's satisfaction with monitored anesthesia care for surgery. The ISAS tool is particularly pertinent as surgery with monitored anesthesia care is increasingly used in ambulatory surgery settings. METHODS: We studied content validity, internal consistency, convergent validity (vs physician-estimated satisfaction), and test-retest reliability of the French version of the ISAS (ISAS-F) in 122 adult patients undergoing a brief outpatient invasive procedure under conscious sedation. The ISAS-F was answered twice by the patient, once in the postanesthesia care unit and once before discharge from the ambulatory care unit. RESULTS: The median [interquartile range (IQR)] time of completion at the first assessment was 2 [2-4] min. The total median [IQR] ISAS-F score was 2.3 [1.8-2.7]. Internal consistency of the ISAS-F was found to be good (Cronbach's α = 0.68). Test-retest reliability was significant, with an intra-class correlation coefficient at 0.74 (95% confidence interval [CI], 0.63 to 0.85). The ISAS-F score correlated with the physician-estimated satisfaction score, with an intra-class correlation coefficient of 0.28 (95% CI, 0.12 to 0.44; P = 0.01). DISCUSSION: This validated version of the ISAS can now be used by French-speaking researchers and physicians to assess patient satisfaction with the anesthesia technique.

RéSUMé: OBJECTIF: Nous avons voulu valider une traduction française de l'échelle de satisfaction par rapport à l'anesthésie de l'Iowa (ISAS), un outil d'évaluation de la satisfaction du patient par rapport aux soins sous surveillance anesthésique lors de chirurgies. L'outil ISAS est particulièrement pertinent étant donné que les chirurgies réalisées sous surveillance anesthésique sont de plus en plus fréquemment utilisées dans le contexte de chirurgie ambulatoire. MéTHODE: Nous avons étudié la validité de contenu, la cohérence interne, la validité convergente (vs la satisfaction estimée par le médecin) et la fiabilité de test-retest de la version française de l'ISAS (ISAS-F) auprès de 122 patients adultes subissant une courte intervention ambulatoire sous sédation légère. Les patients ont répondu deux fois au ISAS-F, soit une fois en salle de réveil et une seconde fois avant de recevoir leur congé de l'unité de soins ambulatoires. RéSULTATS: Le temps médian [écart interquartile (ÉIQ)] pour compléter le test lors de la première évaluation était de 2 [2­4] min. Le score total médian [ÉIQ] sur l'ISAS-F était de 2,3 [1,8­2,7]. La cohérence interne de l'ISAS-F était bonne (α de Cronbach = 0,68). La fiabilité de test-retest était appréciable, avec un coefficient de corrélation intraclasse de 0,74 (intervalle de confiance [IC] 95 %, 0,63 à 0,85). Le score sur l'ISAS-F était corrélé au score de satisfaction tel qu'estimé par le médecin, avec un coefficient de corrélation intraclasse de 0,28 (IC 95 %, 0,12 à 0,44; P = 0,01). DISCUSSION: Cette version validée de l'ISAS peut désormais être utilisée par les chercheurs et médecins francophones afin d'évaluer la satisfaction des patients avec la technique anesthésique employée.

Effects of adding a combined femoral and sciatic nerve block with levobupivacaine and clonidine to general anaesthesia in femoropopliteal bypass surgery: A randomised, double-blind, controlled trial.

BACKGROUND: Adding a regional block to general anaesthesia can prevent postoperative pain and improve peripheral circulation. OBJECTIVE: To seek improved postoperative analgesia and care due to a long-acting combined femoral and sciatic nerve block in patients undergoing femoropopliteal bypass surgery. DESIGN: A randomised, double-blind, controlled trial. SETTING: Vascular surgery unit of a French university hospital. PATIENTS: Forty-four adults scheduled for bypass surgery under general anaesthesia. INTERVENTION: Patients were allocated to receive either an active nerve block with 20 ml of 0.375% levobupivacaine and clonidine 0.5 µg kg, or a simulated (sham) block only, but with local anaesthesia of the skin, before general anaesthesia. General anaesthesia was standardised with propofol, then sevoflurane and sufentanil adjusted according to clinical need. Postoperative analgesia was standardised with paracetamol 1 g every 6 h, and intravenous morphine, initially titrated in the postanaesthesia care unit and then patient-controlled. Oral analgesics were repeated up to day 3. MAIN OUTCOME MEASURES: The primary outcome was morphine consumption during the first 24 postoperative hours. In a subgroup of postoperative patients distal tissue oxygen saturation was recorded at the lateral side of the blocked calf. RESULTS: Patients in the active group received less intra-operative sufentanil (median dose 25 vs. 41 µg), needed less morphine during the first 24 h (15 vs. 27 mg) and 72 (20 vs. 35 mg) postoperative hours, than in the control group. They also had less pain on movement, but pain at rest, the tissue oxygen saturation and other rehabilitation outcomes were unaffected by the treatment. Tolerance outcomes were also similar between groups. CONCLUSION: Combining the two regional blocks improves the quality of postoperative care in this frail population, probably by reducing the amount of peri-operative opioid. TRIAL REGISTRATION: ClinicalTrials.gov (ref. NCT01785693).

Transcultural adaptation and French validation of the Pain Sensitivity Questionnaire.

PURPOSE: To validate a French translation of the Pain Sensitivity Questionnaire (PSQ), which is a valuable tool to predict an individual's natural disposition to feel pain that could be used after surgery. METHODS: We studied content validity, internal consistency, convergent validity (anxiety, depression and catastrophism) and test-retest reliability of the French version of the PSQ (PSQ-F) in 146 patients either before scheduled surgery or during pregnancy; then, convergent and concurrent validity in 85 healthy volunteers submitted to nociceptive tests. RESULTS: Internal consistency of the PSQ-F was found to be excellent, with Cronbach's α at 0.866, 0.886, and 0.927, respectively for its "minor", "moderate" and "total" scores. Test-retest reliability was significant, with intraclass correlation coefficients at 0.629, 0.629, and 0.635, respectively for the above- mentioned scores. These three scores correlated with anxiety, depression and catastrophizing scores in patients, but not in healthy volunteers, possibly because of low and few variant psychometric scores in this group. They were inversely correlated to the temperature needed to evoke heat pain rated 6 out of 10, but not to the mechanical pain threshold (electronic von Frey), nor to the heat pain threshold. Finally, they directly correlated to the pain induced by the cold pressor test (minor and total scores only). DISCUSSION: This validated version can now be used by French-speaking researchers and physicians. TRIAL REGISTRATION: www.ClinicalTrials.gov (NCT03113903); 14 April, 2017.

RéSUMé: OBJECTIF: Valider une version en langue française du Pain Sensitivity Questionnaire (PSQ), qui permet d'identifier la sensibilité naturelle d'un individu à la douleur, ce qui pourrait être applicable après une chirurgie. MéTHODE: Nous avons étudié la validité de structure interne, la validité convergente (anxiété, dépression et catastrophisme) et la reproductibilité par test-retest de la version française du PSQ (PSQ-F) chez 146 patients en situation préopératoire ou en cours de grossesse, puis la validité convergente et de structure contre critère externe chez 85 sujets volontaires sains soumis à des tests nociceptifs. RéSULTATS: La consistance interne du PSQ-F était excellente avec des α de Cronbach égaux à 0,866, 0,886 et 0,927, respectivement pour ses scores « mineur ¼, « modéré ¼ et « total ¼. La reproductibilité était satisfaisante, avec des coefficients de corrélation intra-classe, respectivement à 0,629, 0,629 et 0,635. Ces trois scores étaient corrélés à l'anxiété, la dépression et le catastrophisme, mais pas chez les volontaires sains qui avaient des scores psychométriques bas et peu variables. Ils étaient anti-corrélés au seuil de nociception thermique chaud en épreuve supra-liminale, mais pas au seuil de nociception mécanique ponctuelle, ni au seuil de nociception thermique chaud en épreuve liminale. Enfin, les scores « mineur ¼ et « total ¼ étaient corrélés à la douleur moyenne ressentie à l'immersion du pied en eau froide. CONCLUSION: Cette version validée peut être utilisée par les chercheurs et cliniciens francophones. ENREGISTREMENT DE L'éTUDE: www.ClinicalTrials.gov (NCT03113903); le 14 avril 2017.

Genetics and postsurgical neuropathic pain: An ancillary study of a multicentre survey.

BACKGROUND: Neuropathic pain following surgery could be a useful model for the study of the genetic mechanisms of peripheral neuropathic pain. OBJECTIVE: The aim of this study was to identify genetic predictors of persistent postsurgical neuropathic pain. DESIGN: An ancillary study from a prospective cohort. SETTING: Eighteen French university hospitals. PATIENTS: Five hundred and sixty-one patients at risk of persistent postoperative pain who underwent scheduled surgery were classified as 159 cases and 402 controls. INTERVENTION: Pre-operative blood sampling for DNA analysis and questionnaires sent at the third and sixth month after surgery. MAIN OUTCOME MEASURES: The phenotype was the report of pain at the site of surgery with a positive response in the DN4 questionnaire within 6 months after surgery. Out of a list of 126 candidate genes involved in the initial processes of peripheral neuropathic pain, a set of 4599 single nucleotide polymorphisms was tested on an Illumina chip. We carried out the association tests, based on an additive model, on 4422 single nucleotide polymorphisms. RESULTS: After correcting for type-I error inflation, only one suggestive association was reached for one single nucleotide polymorphism, the rs2286614, which we had selected to tag KCNK4. This gene encodes for TRAAK, a two-pore domain background K channel involved in the modulation of the primary thermoreceptors of the transient receptor potential channels family. CONCLUSION: This is the first genetic association study specifically investigating the occurrence of persistent postsurgical neuropathic pain. Its results help target future research to better understand the mechanisms of peripheral neuropathic pain. TRIAL REGISTRATION: ClinicalTrials.gov (ref. NCT00812734).

Compared effects on cerebral oxygenation of ephedrine vs phenylephrine to treat hypotension during carotid endarterectomy.

While both ephedrine and phenylephrine are currently used to treat hypotension occurring during carotid endarterectomy (CEA) under general anaesthesia, phenylephrine may have deleterious effects on the cerebral watershed, due to its exclusively vasoconstrictive action. In this controlled, double-blind randomised trial, we compared the effects of ephedrine and phenylephrine administered in a standardised algorithm to treat the first hypotensive event occurring since induction of anaesthesia until carotid cross-clamping. The algorithm consisted of 1-to-3 boluses of 6 mg of ephedrine or 50 µg of phenylephrine, after a goal-directed fluid therapy. In case of failure, the treatment switched to the other study drug. Cerebral tissue oxygen saturation (SctO2 ) was monitored by near infrared spectroscopy (NIRS), and the primary outcome was the restoring effect of SctO2 (ipsilateral to surgery) to baseline values. Secondary postoperative outcomes were: contralateral SctO2 , neurological outcomes, and plasma S100B protein measured at discharge from post-anaesthesia care unit. Ephedrine treatment provided a higher rate of restoration of ipsilateral SctO2 than phenylephrine (93.2% vs 85.1%, P=.034); this was also noted for contralateral SctO2 (93.5% vs 90.7%, P=.026). The gain in SctO2 on the lowest value during hypotension was also higher under ephedrine than phenylephrine (6.4% vs 4.3% ipsilateral, 5.1% vs 4% contralateral), but not significantly so. Clinical outcomes were unaffected by the treatment, but S100B protein plasma concentration was higher in the phenylephrine group. To conclude, this pilot trial, focusing on intermediate outcomes, suggests that ephedrine should be preferred to phenylephrine to treat hypotension during CEA.

Bilateral sternal infusion of ropivacaine and length of stay in ICU after cardiac surgery with increased respiratory risk: A randomised controlled trial.

BACKGROUND: The continuous bilateral infusion of a local anaesthetic solution around the sternotomy wound (bilateral sternal) is an innovative technique for reducing pain after sternotomy. OBJECTIVE: To assess the effects of the technique on the need for intensive care in cardiac patients at increased risk of respiratory complications. DESIGN: Randomised, observer-blind controlled trial. SETTING: Single centre, French University Hospital. PATIENTS: In total, 120 adults scheduled for open-heart surgery, with one of the following conditions: age more than 75 years, BMI >30 kg m, chronic obstructive pulmonary disease, active smoking habit. INTERVENTION: Either a bilateral sternal infusion of 0.2% ropivacaine (3 ml h through each catheter; 'intervention' group), or standardised care only ('control' group). Analgesia was provided with paracetamol and self-administered intravenous morphine. MAIN OUTCOME MEASURES: The length of time to readiness for discharge from ICU, blindly assessed by a committee of experts. RESULTS: No effect was found between groups for the primary outcome (P = 0.680, intention to treat); the median values were 42.4 and 37.7 h, respectively for the control and intervention groups (P = 0.873). Similar nonsignificant trends were noted for other postoperative delays. Significant effects favouring the intervention were noted for dynamic pain, patient satisfaction, occurrence of nausea and vomiting, occurrence of delirium or mental confusion and occurrence of pulmonary complications. In 12 patients, although no symptoms actually occurred, the total ropivacaine plasma level exceeded the lowest value for which neurological symptoms have been observed in healthy volunteers. CONCLUSION: Because of a small size effect, and despite significant analgesic effects, this strategy failed to reduce the time spent in ICU. TRIAL REGISTRATION: EudraCT (N°: 2012-005225-69); ClinicalTrials.gov (NCT01828788).

French academic's views on financial compensation of participants.

BACKGROUND: Whether and how participants in biomedical research should receive financial compensation is debated. We wished to explore how this issue was perceived by French professionals, focusing on different conditions of research. MATERIALS AND METHODS: We surveyed referent responders of Clinical Investigation Centres, Research Ethics Committees and hospital administrative departments for clinical research, via referent responders who completed an online questionnaire on behalf of their respective teams. Financial compensation was addressed in terms of general perception, justifications, interpretation of French law, concrete clinical situations and compensation of incurred expenses. Descriptive analyses and correlations were carried out based on scalar responses. RESULTS: The questionnaire was answered by 54/116 (45·6%) centres. The ethical aspects of compensation were viewed differently by Clinical Investigation Centres and Research Ethics Committees, whereas the practical aspects were viewed similarly. Agreement to compensation for patients was lower than for healthy volunteers (74·1 vs. 98·2%). The most frequently cited justifications for compensation apart from the inconveniences of research were the potential risk and the absence of medical benefit. Most of the proposed expenses incurred were to be compensated, but agreement to reimbursement of petrol bills or childcare expense was lower. CONCLUSIONS: Although some of the responses align with previous surveys in other countries, this information may help French professionals to harmonise their practices. We also addressed practical issues which could be studied in other European countries, for professionals and participants. Finally, the reluctance to compensate patients requires further study, taking into account welfare environment and consequences for recruitment.

FAAH inhibitors in the limelight, but regrettably.

This short review focuses on the recent drug development of FAAH inhibitors, as recent serious adverse events have been reported in a phase I study with a compound of this class. The authors overview the potential interest in targeting FAAH inhibition, the current programs, and the available information on the recent dramatic events.

Stress among nurses working in emergency, anesthesiology and intensive care units depends on qualification: a Job Demand-Control survey.

BACKGROUND: The nurse stress literature reports an overwhelming culture of acceptance and expectation of work stressors, ironically linked to the control of the workplace to effectively and proactively manage stress. The stressors involved in delivering "stress management" have been well studied in nursing-related workplaces, especially in acute care settings in accordance with the Karasek Job Demand-Control-Support (JDCS) model. However, little is known about the effects of specificity of an acute care unit and the level of qualifications on stress experienced by nurses. METHODS: A survey using the JDCS model was conducted among 385 nurses working in three different acute care units (anesthesiology, emergency and intensive care unit) from a university hospital. Specific questions explored variables such as gender, acute care units, level of qualification and working experience. RESULTS: Two hundred questionnaires were returned. A high level of job strain was highlighted without a gender effect and in the absence of isostrain. Nurses from acute care units were located in the high stress quadrant of the JDCS model. Conversely, other nurses were commonly located in the "active" quadrant. Independent of acute care settings, the highest level of education was associated with the highest job strain and the lowest level of control. CONCLUSIONS: In an acute care setting, a high level of education was a key factor for high job stress and was associated with a perception of a low control in the workplace, both of which may be predictors of adverse mental health. In particular, the lack of control has been associated with moral distress, a frequently reported characteristic of acute care settings. To enhance the personal and professional outcomes of the advanced registered nurses, strategies for supporting nurses manage daily stressors in acute care are urgently required.

Improved informed consent documents for biomedical research do not increase patients' understanding but reduce enrolment: a study in real settings.

AIMS: The aim was to evaluate the comprehension of participants of an improved informed consent document (ICD). METHOD: This was a randomized controlled French multicentre study performed in real conditions. Participants were adult patients undergoing screening for enrolment in biomedical research studies, who agreed to answer a validated questionnaire evaluating objective and subjective comprehension scored from 0 (no comprehension) to 100 (excellent comprehension). Patients were provided either the original ICD or an ICD modified in terms of structure and readability. The primary end point was the score of objective comprehension. The secondary end-points were the enrolment rate in the clinical study and patient characteristics associated with the score of objective comprehension. RESULTS: Four hundred and eighty-one patients were included, 241 patients in the original ICD group and 240 patients in the modified ICD group. There was no difference between the two groups for the score of objective comprehension (original ICD 72.7 (95% CI 71.3, 74.1) vs. modified ICD 72.5 (95% CI 71.0, 74.0); P = 0.81). However, the rate of enrolment in the clinical study was lower in the group who received the modified ICD (64.4% (95% CI 58.3, 70.5)) than for the original ICD (73.0% (95% CI 67.4, 78.7)) (P = 0.042). Only female gender and high educational level were associated with a better objective comprehension. CONCLUSIONS: Improving ICDs had no effect on participants' understanding, whereas the rate of enrolment was lower in this group. In attempts at improving potential participants' understanding of clinical research information, efforts and future trials should focus on other ways to improve comprehension.

A French Nationwide Survey on Anesthesiologist-Perceived Barriers to the Use of Epidural and Paravertebral Block in Thoracic Surgery.

OBJECTIVES: To explore the barriers to the use of epidural block (EDB) or paravertebral block (PVB) for thoracotomy or thoracoscopy. DESIGN: Cross-sectional ancillary study. SETTING: French nationwide practice survey. PARTICIPANTS: Lead anesthesiologists at centers practicing thoracic surgery completed an online questionnaire. INTERVENTIONS: A 9-item electronic questionnaire regarding perceived barriers to the use of EDB and PVB was developed, including technical factors, nursing factors (training and supervision), and reluctance of non-anesthesiologist colleagues (eg, surgeons, nurses and hospital managers). Descriptive and factorial analyses were conducted, including the current use of the techniques in the model. MEASUREMENTS AND MAIN RESULTS: The questionnaire was answered by 84 of 103 (82%) centers. For both techniques, the most frequently cited barriers were the 4 technical ones and lack of nursing supervision. There was a high rate of do not know/no opinion responses regarding barriers to paravertebral block. The type of center did not influence the responses, but paravertebral block was used more often in university hospitals. Colleague reluctance and time consumption (for both techniques), nursing barriers (for epidural block), and perception of risk and complexity (for paravertebral block), were correlated inversely with actual use. Perception of cost had no influence on practice. CONCLUSIONS: This survey suggested that the use of epidural or paravertebral block to provide analgesia for thoracic surgery might be increased by multimodal actions focused on improved communication with surgical and managerial teams. Paravertebral block, as an emerging technique, still is insufficiently recognized in France.

The Algoplus Score to Assess Acute Postoperative pain in Elderly patients-A Pilot Observational Study.

Standard verbal or analogue scales may not be accurate to assess acute postoperative pain in elderly patients. This study was designed to field test the Algoplus tool, developed specifically for this population and based on observation of patient behavior. Prospective, observational cohort. Single center, French University hospital. Forty-eight patients, aged over 65, scheduled for surgery under general anesthesia, and observed on admission to the postanesthesia care unit, immediately after extubation, during the different steps of analgesic intervention (demand, relief with intravenous opioid titration, plus intermediate measures when relevant), and either at discharge or 3 hours after admission. A numerical rating scale (NRS) was used to guide analgesia. The Algoplus score and the state of alertness or sedation were noted. NRS scores and Algoplus scores were significantly related, and both scores significantly decreased under the effect of analgesia, but the correlation was low. In early observations, the Algoplus score was higher than that predicted by the NRS score, in relation to residual sedation. Female gender tended to lower the Algoplus score compared to the NRS score. When the NRS score exceeded 3/10, indicating the need for analgesic intervention, the Algoplus score was generally lower than the recommended trigger for analgesia (2/5). These results are promising, but further evidence of a clinical benefit to the use of Algoplus for acute postoperative pain is needed. In future studies, scoring should be adjusted to take into account the time from extubation, the state of sedation, and the patient's gender in order to interpret results.