Conservative management versus systematic suture of isolated vaginal or first-degree perineal tears after delivery: A preliminary randomized efficacy trial.

BACKGROUND: The objective of this study was to assess the preliminary efficacy and safety of conservative management compared with systematic suture in isolated vaginal or first-degree perineal tears after birth. METHODS: We conducted a preliminary efficacy, open-label, randomized, controlled, and prospective trial. This study implemented Simon's 2-step plan (interim analysis and final analysis) to test the success rate of the digital compression strategy group. Primiparous women aged ≥18 years with isolated vaginal or first-degree perineal tears after spontaneous vaginal birth of a cephalic presenting term (≥37 weeks) neonate were randomly allocated to the conservative management (CM) group (digital compression if bleeding followed by suture if persistent bleeding) or a systematic suture (SS) group. The primary outcome was the success of the intervention 10 days after delivery, defined by pain as evaluated using a visual analog scale < 3, satisfactory healing defined by a REEDA score ≤ 2, and no bleeding or infection. Sexual well-being was assessed at 2 and 6 months postpartum. RESULTS: Among 861/2209 eligible women, 143 consenting women with a superficial perineal tear were randomized: 72 in the systematic suture group and 71 in the conservative management group. Success rate was 87.8% (90% CI [70.5-93.54]) (42/55) in the systematic suture group vs 90% (90% CI [78.3-93.8]) (53/61) in the conservative management group. The REEDA score was significantly higher in the systematic suture group (1.4 vs 0.9; P = 0.036). Perineal pain was significantly higher at day 1 in the systematic suture group (2.38 vs 1.69; P = 0.034). For the Female Sexual Functional Index score, no significant difference was found between the two groups at inclusion or at 2 and 6 months postpartum. CONCLUSIONS: Conservative management of superficial perineal tears shows an efficacy rate ≥90%. Women in the conservative management group had less pain at the 1st day follow-up and lower REEDA scores at the 10th day follow-up.

Characteristics of Anaplastic Oligodendrogliomas Short-Term Survivors: A POLA Network Study.

BACKGROUND: Anaplastic oligodendrogliomas IDH-mutant and 1p/19q codeleted (AO) occasionally have a poor outcome. Herein we aimed at analyzing their characteristics. METHODS: We retrospectively analyzed the characteristics of 44 AO patients with a cancer-specific survival <5 years (short-term survivors, STS) and compared them with those of 146 AO patients with a survival ≥5 years (classical survivors, CS) included in the POLA network. RESULTS: Compared to CS, STS were older (P = .0001), less frequently presented with isolated seizures (P < .0001), more frequently presented with cognitive dysfunction (P < .0001), had larger tumors (P = .= .003), a higher proliferative index (P = .= .0003), and a higher number of chromosomal arm abnormalities (P = .= .02). Regarding treatment, STS less frequently underwent a surgical resection than CS (P = .= .0001) and were more frequently treated with chemotherapy alone (P = .= .009) or with radiotherapy plus temozolomide (P = .= .05). Characteristics independently associated with STS in multivariate analysis were cognitive dysfunction, a number of mitosis > 8, and the absence of tumor resection. Based on cognitive dysfunction, type of surgery, and number of mitosis, patients could be classified into groups of standard (18%) and high (62%) risk of <5 year survival. CONCLUSION: The present study suggests that although STS poor outcome appears to largely result from a more advanced disease at diagnosis, surgical resection may be particularly important in this population.

Prenatal quantification of human foetal lung and liver elasticities between 24 and 39 weeks of gestation using 2D shear wave elastography.

OBJECTIVES: To quantify and model normal foetal lung and liver elasticities between 24 and 39 weeks of gestation (WG) using two-dimensional shear wave elastography (2D-SWE). To assess the impact of the distance between the probe and the target organ on the estimation of elasticity values. METHODS: Measurements of normal foetal lungs and liver elasticity were prospectively repeated monthly between 24 and 39 WG in 72 foetuses using 2D-SWE. Elasticity was quantified in the proximal lung and in the region inside the hepatic portal sinus. The distance between the probe and the target organ was recorded. Trajectories representing foetal lung and liver maturation from at least 3 measurements over time were modelled. RESULTS: The average elasticity for the lung and liver was significantly different from 24 WG to 36 WG (p < 0.01). Liver elasticity increased during gestation (3.86 kPa at 24 WG versus 4.45 kPa at 39 WG). From 24 WG to 32 WG, lung elasticity gradually increased (4.12kPa at 24 WG, 4.91kPa at 28 WG, 5.03kPa at 32 WG, p < 0.002). After 32 WG, lung elasticity decreased to 4.54kPa at 36 WG and 3.94kPa at 39 WG. The dispersion of the average elasticity values was greater for the lung than for the liver (p < 0.0001). Variation in the elasticity values was less important for the liver than for the lung. The values were considered valid and repeatable except for a probe-lung distance above 8cm. CONCLUSION: Foetal lung and liver elasticities evolve differently through gestation. This could reflect the tissue maturation of both organs during gestation. TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT03834805 KEY POINTS: • Prenatal quantification of foetal lung elasticity using 2D shear wave elastography could be a new prenatal parameter for exploring foetal lung maturity. • Liver elasticity increased progressively from 24 weeks of gestation (WG) to 39 WG, while lung elasticity increased first between 24 and 32 WG and then decreased after 32 WG. • The values of elasticity are considered valid and repeatable except for a probe-lung distance above 8cm.

Body interventional procedures: which is the best method for CT guidance?

OBJECTIVES: To compare sequential fluoroscopy guidance with spiral guidance in terms of safety, effectiveness, speed and radiation in interventional whole body procedures. METHODS: This study was a retrospective analysis of data from the prospective, randomised controlled, multicentre CTNAV2 study. The present analysis included 385 patients: 247 in the sequential group (SEQ) and 138 in the spiral group (SPI). Safety was assessed by the number of major complications. Effectiveness was measured according to the number of targets reached. Data on procedural time and radiation delivered to patients were also collected. RESULTS: There was no significant difference between the two groups (SEQ vs SPI) regarding the success rate (99.6% vs 99.3%, p = 0.680), procedural time (7 min 40 s ± 5 min 48 s vs 7 min 13 s ± 7 min 33 s, p = 0.507), or major complications (2.43% vs 5.8%, p = 0.101). Radiation dose to patients was 84% lower in the sequential group (54.8 ± 51.8 mGy cm vs 352.6 ± 404 mGy cm, p < 0.0001). CONCLUSIONS: Sequential CT fluoroscopy-guided whole-body interventional procedures seems to be as safe, effective and fast as spiral guidance, while also yielding a significant decrease in the radiation dose to patients. KEY POINTS: • Sequential CT fluoroscopy and spiral acquisition are comparable in terms of safety, effectiveness and speed. • Procedural times are comparable despite an increased number of acquisitions in sequential fluoroscopy. • Radiation dose to patients is 84% lower in sequential fluoroscopy compared with spiral CT.

How to quantify microparticles in RBCs? A validated flow cytometry method allows the detection of an increase in microparticles during storage.

BACKGROUND: The procoagulant and proinflammatory microparticles (MPs) released during storage of packed red blood cells (pRBCs) can potentially modify transfusion benefits. A robust method to quantify MPs in pRBCs is needed to evaluate their impact in clinical trials. STUDY DESIGN AND METHODS: The objective was to validate the preanalytic conditions required to prepare pRBC supernatant as well as a method to quantify and evaluate MP variations over 42 days of pRBC storage.A flow cytometry method with size-calibrated beads was developed and fully validated. Quantification of MPs in pRBCs (n = 109) was assessed during short-term (7 days) and long-term (42 days) storage at 4°C, during short-term storage (8 hours) at room temperature, and after 2 years frozen. RESULTS: Repeatability, reproducibility, and linearity of the quantification method were validated, and variations during conservation are presented. There was high variability in RBC (erythrocyte) MP (ERMP) and platelet MP (PMP) levels between RBC units, depending on the filter used for leukocyte reduction. During the 42 days of storage at 4°C, significant increases in ERMPs and PMPs occurred (from 58 to 138 ERMPs/µL from Day 2 to Day 42; p = 0.0002; and from 326 to 771 PMPs/µL from Day 2 to Day 42; p = 0.00026). CONCLUSION: We use a robust method to confirm that ERMPs and PMPs are present to various degrees in pRBCs and that storage for 42 days significantly increases their generation. This method is robust enough to allow MP quantification in pRBCs and is adapted to evaluate the clinical impact of transfused MPs in prospective clinical trials.

Prospective 1-year follow-up pilot study of CT-guided microwave ablation in the treatment of bone and soft-tissue malignant tumours.

PURPOSE: The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation (MWA) in the treatment of malignant musculoskeletal tumours. MATERIALS AND METHODS: Sixteen bone and soft-tissue malignant tumours were prospectively included and were treated by CT-guided MWA. The percentage and size of necrosis of the lesions were measured by contrast-enhanced MRI before the procedure and after 1, 3, 6 and 12 months. mRECIST criteria were used to assess tumour response. Procedural success was defined as ≥80 % necrosis. Patient pain (as assessed using a numeric visual scale (NVS)) and side effects were noted. RESULTS: Six osteolytic metastases, five osteoblastic metastases and five soft tissue sarcomas were treated. At 1 month, 40 % were treated completely, the percentage of necrosis was 85 ± 30.4 %, and the success rate was 80 %. At 3, 6 and 12 months the success rate was 80 %, 76.9 % and 63.6 %, respectively. At 12 months, four lesions (36.3 %) still had no recurrence. Mean NVS during the procedure was 3.5 ± 2.8. One patient had transitory sciatica without neurological deficit that was treated medically. CONCLUSION: CT-guided MWA of bone and soft-tissue malignant tumours is efficient, well tolerated and has good short-term anti-cancer effects. KEY POINTS: • CT-guided MWA is efficient in treating musculoskeletal malignant tumours. • This prospective pilot study showed MWA induces high percentages of tumour necrosis. • MWA has good short-term anti-cancer effects. • MWA has healing potential when lesions can be completely necrosed. • CT-guided MWA under equimolar mixture of oxygen-nitrous oxide inhalation is well tolerated.

Incidence of acute intussusception among infants in eastern France: results of the EPIstudy trial.

The incidence of intussusception in infants varies around the world. The epidemiology of intussusception in France has never been prospectively studied. We performed a prospective observational study with systematic inclusion of all infants aged <1 year with suspected intussusception admitted to the emergency departments of the hospitals in the eastern region of France (98,000 live births per year), from 4/1/2008 to 3/31/2012. Cases were classified using the Brighton Collaboration classification. In total, 185 infants with suspected intussusception were included of which 169 were idiopathic intussusception. Among these 169 cases, 115 (68%) were classed as Brighton level 1 (confirmed cases). Overall incidence of intussusception over the 4 years of the study was 29.8 (95% CI 24.6-35.7) cases per 100,000 live births for level 1 and 37.5 (95% CI 31.7-44.2) cases per 100,000 live births for all cases (levels 1-4). Annual incidence rates of level 1 intussusception were as follows: 44 (95% CI 31.9-59.3), 30.9 (20.9-44.2), 21.7 (13.4-33.2) and 22.1 (13.7-33.8) per 100,000 live births in the 1st, 2nd, 3rd and 4th study years, respectively. CONCLUSION: The incidence rate of intussusception in the eastern part of France is comparable to that of other European countries. There was a significant trend towards a decrease in the incidence of intussusception. What is known • Intussusception is the most frequent causes of intestinal obstruction in infants and young children. Overall incidence of intussusception in infants aged <1 year varies widely around the world. No specific epidemiological studies have not been conducted in France on intussusception. What is new: • This prospective and multicenter study provides important information about the epidemiology of intussusception in infants in France over a period of 4 years.

Viscoelasticity in Achilles tendonopathy: quantitative assessment by using real-time shear-wave elastography.

PURPOSE: To investigate the differences in viscoelastic properties between normal and pathologic Achilles tendons (ATs) by using real-time shear-wave elastography (SWE). MATERIALS AND METHODS: The institutional review board approved this study, and written informed consent was obtained from 25 symptomatic patients and 80 volunteers. One hundred eighty ultrasonographic (US) and SWE studies of ATs without tendonopathy and 30 studies of the middle portion of the AT in patients with tendonopathy were assessed prospectively. Each study included data sets acquired at B-mode US (tendon morphology and cross-sectional area) and SWE (axial and sagittal mean velocity and relative anisotropic coefficient) for two passively mobilized ankle positions. The presence of AT tears at B-mode US and signal-void areas at SWE were noted. RESULTS: Significantly lower mean velocity was shown in tendons with tendonopathy than in normal tendons in the relaxed position at axial SWE (P < .001) and in the stretched position at sagittal (P < .001) and axial (P = .0026) SWE. Tendon softening was a sign of tendonopathy in relaxed ATs when the mean velocity was less than or equal to 4.06 m · sec(-1) at axial SWE (sensitivity, 54.2%; 95% confidence interval [CI]: 32.8, 74.4; specificity, 91.5%; 95% CI: 86.3, 95.1) and less than or equal to 5.70 m · sec(-1) at sagittal SWE (sensitivity, 41.7%; 95% CI: 22.1, 63.3; specificity, 81.8%; 95% CI: 75.3, 87.2) and in stretched ATs, when the mean velocity was less than or equal to 4.86 m · sec(-1) at axial SWE (sensitivity, 66.7%; 95% CI: 44.7, 84.3; specificity, 75.6%; 95% CI: 68.5, 81.7) and less than or equal to 14.58 m · sec(-1) at sagittal SWE (sensitivity, 58.3%; 95% CI: 36.7, 77.9; specificity, 83.5%; 95% CI: 77.2, 88.7). Anisotropic results were not significantly different between normal and pathologic ATs. Six of six (100%) partial-thickness tears appeared as signal-void areas at SWE. CONCLUSION: Whether the AT was relaxed or stretched, SWE helped to confirm and quantify pathologic tendon softening in patients with tendonopathy in the midportion of the AT and did not reveal modifications of viscoelastic anisotropy in the tendon. Tendon softening assessed by using SWE appeared to be highly specific, but sensitivity was relatively low.

Anogenital distribution of mucosal HPV in males and females before and after renal transplantation.

INTRODUCTION: Immunosuppressive drugs taken by transplant recipients may favor HPV infection at anogenital sites. HPV-type prevalence was studied in males and females before and after renal transplantation. PATIENTS AND METHODS: Anal, cervical and penile samples were taken from 62 patients before transplantation and from 41 patients after transplantation. HPV DNA was investigated using the INNO-LiPA HPV genotyping extra test and HPV-type distribution determined. RESULTS: Before transplantation, up to 30% of analyzed samples harbored HPV DNA, with the highest prevalence found in cervical specimens (60%). After transplantation, a trend toward HPV clearance was observed in females. By contrast, a trend toward incident infections by a wide variety of HPV genotypes at the penis and anal level was documented in men. CONCLUSION: High prevalence of HPV at anogenital sites was documented before and after renal transplantation. Immunosuppressive drugs taken after transplantation may impact HPV acquisition or reactivation, especially in males. Special attention should be paid in view of preventing HPV-associated diseases in this vulnerable population.

Acute effect of transcranial direct current stimulation (tDCS) on postural control of trained athletes: A randomized controlled trial.

Transcranial direct current stimulation (tDCS) is used to modulate brain function, and can modulate motor and postural control. While the acute effect of tDCS is well documented on patients, little is still known whether tDCS can alter the motor control of healthy trained participants. This study aimed to assess the acute effect of tDCS on postural control of parkour practitioners, known for their good balance abilities and their neuromuscular specificities that make them good candidates for tDCS intervention. Eighteen parkour practitioners were tested on three occasions in the laboratory for each stimulation condition (2 mA; 20 minutes)-primary motor cortex (M1), dorsolateral prefrontal cortex (dlPFC) and sham (placebo). Postural control was evaluated PRE and POST each stimulation by measuring Center of Pressure (CoP) displacements on a force platform during static conditions (bipedal and unipedal stance). Following M1 stimulation, significant decreases were observed in CoP area in unipedal (from 607.1 ± 297.9 mm2 to 451.1 ± 173.9 mm2, P = 0.003) and bipedal (from 157.5 ± 74.1 mm2 to 117.6 ± 59.8 mm2 P<0.001) stances. As well, the CoP total length was significantly reduced in bipedal (from 3416.8 ± 295.4 mm to 3280.6 ± 306.2 mm, P = 0.005) as well as in unipedal stance (from 4259.6 ± 398.4 mm to 3846.5 ± 468.9 mm, P<0.001), only after M1 stimulation. Relative pre-post changes observed after M1 stimulation were negatively correlated to experience in parkour only after unipedal stance (r = 0.715, P<0.001), meaning that the more participants were trained the less tDCS was effective. No significant changes were noticed after sham and dlPFC stimulation. These results suggested that the modulation of gait performance in athletes following an acute intervention of tDCS is specific to the targeted brain region, and that postures with reduced base of support (such as unipedal stance) were more sensitive to tDCS.

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.

Validation of a new quality of life scale related to multiple sclerosis and relapses.

PURPOSE: Multiple sclerosis (MS) has a significant impact on all aspects of patient quality of life (QoL). Furthermore, the fear of relapses and the feelings of patients during relapses must be taken into account in care. The objective of this work was to validate the PERSEPP scale ("PERception de la Sclérose En Plaques et de ses Poussées"), a new QoL evaluation scale for relapsing-remitting forms of MS. METHODS: Relapsing-remitting patients were included in a multicenter study. Various validation criteria of this scale were analyzed: acceptability, construct validity (internal and external validity), and reliability (internal consistency and reproducibility test-retest). Responsiveness will be studied in order to complete the validation process. RESULTS: The responses of 305 MS patients were analyzed. The process of reducing the items led us to retain 66 items of a total of 112 items. The 66-item PERSEPP scale (final version) was well accepted. Five dimensions (33 items) make up the scale: social support (α = 0.81), relationship difficulties (α = 0.71), fatigue (α = 0.74), state of mind and associated sleep disorders (α = 0.78), and time perspective (α = 0.75). Three additional modules (33 items) explore coping (α = 0.60), symptoms (α = 0.89), and treatment (α = 0.92). Test-retest reliability, measured by the intraclass correlation coefficient (ICC), was acceptable (0.72 < ICC < 0.92). CONCLUSIONS: The PERSEPP scale has been validated and could be used in clinical trials and in daily practice. Additional studies will then complete the validation process.

Anxiety and hospitalization in adolescence: relations to attachment style and parental support.

This exploratory study examined attachment style and state/trait anxiety in adolescents - 30 recently hospitalized psychiatric patients, and 49 school controls. All were aged 13-18, with the majority (67%) female. The attachment style interview (ASI, Bifulco et al. 2002) was administered, together with the Recent Life Events questionnaire (Brugha & Cragg 1990) and the STAI anxiety questionnaire (Spielberger et al. 1983). Results showed the hospitalised group to have significantly more negative interactions with parents and poorer support than the comparison group. They had significantly more insecure attachment style (96% s 37%). Among the hospitalized adolescents, both the Anxious and the Avoidant attachment style group had higher anxiety scores on the STAI-trait scores than on the STAI-state scores assessed during the first days of hospitalisation. This suggests adolescents, even those with Avoidant attachment feel less anxious after admission. Implications for assessing attachment style in adolescent patients to aid with care planning is discussed.

Polymeric Nanoparticles' Accumulation in Atopic Dermatitis: Clinical Comparison between Healthy, Non-Lesional, and Lesional Skin.

A major limitation in the current topical treatment strategies for inflammatory skin disorders is the inability to selectively target the inflamed site with minimal exposure of healthy skin. Atopic dermatitis is one of the most prevalent types of dermatitis. The use of polymeric nanoparticles for targeting inflamed skin has been recently proposed, and therefore the aim of this proof-of-concept clinical study was to investigate the skin penetration and deposition of polymeric biodegradable nanoparticles in the atopic dermatitis lesions and compare the data obtained to the deposition of the particles into the healthy skin or lesion-free skin of the atopic dermatitis patients. For that, fluorescent PLGA nanoparticles in sizes of approximately 100 nm were prepared and applied to the skin of healthy volunteers and the lesional and non-lesional skin of atopic dermatitis patients. Skin biopsies were examined using confocal laser scanning microscopy to track the skin deposition and depth of penetration of the particles. Immunohistochemistry was performed to investigate the alteration in tight-junction protein distribution in the different types of skin. Results have shown that nanoparticles were found to have higher deposition into the atopic dermatitis lesions with minimal accumulation in healthy or non-lesional skin. This has been primarily correlated with the impaired barrier properties of atopic dermatitis lesions with the reduced production of Claudin-1. It was concluded that polymeric nanoparticles offer a potential tool for selective drug delivery to inflamed skin with minimal exposure risk to healthy skin.

ATHLETIQUE: interest of an adapted physical activity program in patients with juvenile idiopathic arthritis: a feasibility and preliminary effectiveness study.

Background: Juvenile Idiopathic Arthritis (JIA) is associated with joint inflammation, pain and limited joint mobility, impacting the practice of physical activities. Adapted Physical Activities (APA) are an increasingly used method of rehabilitation, but additional studies are needed to define the nature of the most appropriate physical activity for patients with JIA. The "ATHLETIQUE" project aims to evaluate the impact of a program integrating APA sessions with use of a pedometer watch, on disease activity in patients with JIA. Methods: This study will be a randomized, multicenter, open-label, controlled clinical trial with 2 parallel arms. The patients included in this study will be children and adolescents with JIA, aged 6 to 17 years. The experimental group (30 patients) will participate in an APA program for 3 months and will use a pedometer watch for one year. We will evaluate and compare the change in disease activity measurements (primary objective), fatigue, pain, quality of life, level of physical activity, functional capacities, and muscle strength (secondary objectives) after 14, 26 and 50 weeks. The control group (10 patients) will undergo the same evaluations as the experimental group but will not participate in the APA program and will not wear the pedometer watch. Expected results: The APA program may help to promote an active lifestyle with regular physical activity, preventing comorbidities and motor disability. Promising results on disease activity, functional capacities and quality of life would enable us to envisage a larger research program with a view to optimizing and assessing APA for children with JIA. Discussion: This study will be conducted in the short and medium-term, with one-year follow-up, including 3 months of APA sessions for the experimental group. The sessions proposed during the APA program will mainly be aerobic and bodyweight exercises. Furthermore, in contrast to previous studies on this topic, our study will integrate a novel element, namely the use of a pedometer watch. This watch will help to implement strategies to address motivation. This study aims to improve physical and mental well-being, provide a basis for the design of a larger study, and propose recommendations adapted to children with JIA. Trial registration: Registered with ClinicalTrials.gov under the number NCT05572424.

"Card sorting": a tool for research in ethics on treatment decision-making at the end of life in Alzheimer patients with a life threatening complication.

BACKGROUND: End stage dementia is a particularly difficult aspect of care for patients with Alzheimer's disease and related dementias. In care institutions, caregivers and family are concerned by treatment decision-making for an acute life threatening complication occurring in Alzheimer patients at the end of life. How should the best treatment pathway be decided: to treat or not to treat? Which arguments are used for decision-making? These are mainly ethical questions which are currently difficult to express and investigate. METHODS/DESIGN: Cross sectional multicentre study of clinical cases involving 67 health centres (university hospitals, general hospitals, local hospitals and homes for the elderly) in the east of France. The method was based on the "card sorting" technique, with a set of 36 cards, each labelled with a different item relating to arguments for treatment decision-making. For each clinical case, medical staff and carers expressed in a meeting the pieces of information which they believed had been taken into account in the decision. Each participant received a card game, selected fewer than ten and ranked them according to the importance they attached to each one. All selected cards were then put on the table anonymously for participants, respecting the order of importance of the cards in each pile. Lastly, all games were photographed together in order to analyse occurrence and order frequencies. The cards were then classified on the table by frequency to open the discussion. Discussion time, which was conducted by the head carer of the department, concerned the clinical situation of the patient based on the shared responses. DISCUSSION: During team meetings, the "card sorting" method was quickly adopted by professionals as a tool to assist with discussion beyond the context of the study. The participants were not compelled to mention their feelings in relation to a case, and it is significant that the anonymity which we tried to maintain so that each person felt "listened to" without value judgement was very often discarded by the individuals themselves.

Effect of transcranial direct current stimulation on the psychomotor, cognitive, and motor performances of power athletes.

In sports science, transcranial direct current stimulation (tDCS) has many unknown effects on neuromuscular, psychomotor and cognitive aspects. Particularly, its impact on power performances remains poorly investigated. Eighteen healthy young males, all trained in a jumping sport (parkour) performed three experimental sessions: anodal tDCS applied either on the left dorsolateral prefrontal cortex (dlPFC, cathode in supraorbital area) or on the primary motor cortex (M1, cathode on contralateral shoulder), and a placebo condition (SHAM), each applied for 20 min at 2 mA. Pre and post, maximal vertical and horizontal jumps were performed, associated to leg neuromuscular assessment through electromyography and peripheral nerve stimulations. Actual and imagined pointing tasks were also performed to evaluate fine motor skills, and a full battery of cognitive and psychomotor tests was administered. M1 tDCS improved jump performance accompanied by an increase in supraspinal and spinal excitabilities. dlPFC stimulation only impacted the pointing tasks. No effect on cognitive tests was found for any of the tDCS conditions. To conclude, the type of performance (maximal versus accurate) affected depended upon the tDCS montage. Finally, athletes responded well to tDCS for motor performance while results to cognitive tests seemed unaffected, at least when implemented with the present rationale.

Added value of functional neuroimaging to assess decision-making capacity of older adults with neurocognitive disorders: protocol for a prospective, monocentric, single-arm study (IMAGISION).

INTRODUCTION: Assessment of decision-making capacity (DMC) is essential in daily life as well as for defining a person-centred care plan. Nevertheless, in ageing, especially if signs of dementia appear, it becomes difficult to assess decision-making ability and raises ethical questions. Currently, the assessment of DMC is based on the clinician's evaluation, completed by neuropsychological tests. Functional MRI (fMRI) could bring added value to the diagnosis of DMC in difficult situations. METHODS AND ANALYSIS: IMAGISION is a prospective, monocentric, single-arm study evaluating fMRI compared with clinical assessment of DMC. The study will begin during Fall 2021 and should be completed by Spring 2023. Participants will be recruited from a memory clinic where they will come for an assessment of their cognitive abilities due to decision-making needs to support ageing in place. They will be older people over 70 years of age, living at home, presenting with a diagnosis of mild dementia, and no exclusion criteria of MRI. They will be clinically assessed by a geriatrician on their DMC, based on the neuropsychological tests usually performed. Participants will then perform a behavioural task in fMRI (Balloon Analogue Risk Task) to analyse the activation areas. Additional semistructured interviews will be conducted to explore real life implications. The main analysis will study concordance/discordance between the clinical classification and the activation of fMRI regions of interest. Reclassification as 'capable', based on fMRI, of patients for whom clinical diagnosis is 'questionable' will be considered as a diagnostic gain. ETHICS AND DISSEMINATION: IMAGISION has been authorised by a research ethics board (Comité de Protection des Personnes, Bordeaux, II) in France, in accordance with French legislation on interventional biomedical research, under the reference IDRCB number 2019-A00863-54, since 30 September 2020. Participants will sign an informed consent form. The results of the study will be presented in international peer-reviewed scientific journals, international scientific conferences and public lectures. TRIAL REGISTRATION NUMBER: NCT03931148.

Effect of transcranial direct current stimulation on sports performance for two profiles of athletes (power and endurance) (COMPETE): a protocol for a randomised, crossover, double blind, controlled exploratory trial.

BACKGROUND: Transcranial direct current stimulation (tDCS) is promising for improving motor and cognitive performance. Nevertheless, its mechanisms of action are unclear and need to be better characterised according to the stimulated brain area and the type of exercise performed. METHODS/DESIGN: This is a double-blind crossover study, organised into two parts: the first is to assess the effects of tDCS on explosive performance (jump task) and the second is to assess the effects on endurance performance (cycling time trial task). Participants, who are recreationally active or athletes (parkour practitioners, cyclists), will receive two active tDCS sessions (over the left dorsolateral prefrontal cortex and right motor cortex) and one sham tDCS session (part A), or two sequences (one active and one sham) of two daily tDCS sessions over 5 days (part B). Motor and cognitive performance will be compared before and after tDCS sessions (part A), and before and after the first session, after the last session and at day 12 and day 30 of each tDCS sequence (part B). DISCUSSION: This study investigates the acute and repeated effects of tDCS on the motor and cognitive performance of healthy subjects. It will try to evaluate if tDCS could be considered as a neuroenhancement technology according to the physical task investigated (endurance versus explosive). TRIAL REGISTRATION: ClinicalTrials.gov, NCT03937115. Registered on 3 May 2019; retrospectively registered.

Processing methods and storage duration impact extracellular vesicle counts in red blood cell units.

Extracellular vesicles (EVs) are active components of red blood cell (RBC) concentrates and may be associated with beneficial and adverse effects of transfusion. Elucidating controllable factors associated with EV release in RBC products is thus important to better manage the quality and properties of RBC units. Erythrocyte-derived EVs (EEVs) and platelet-derived EVs (PEVs) were counted in 1226 RBC units (administered to 280 patients) using a standardized cytometry-based method. EV size and CD47 and annexin V expression were also measured. The effects of donor characteristics, processing methods, and storage duration on EV counts were analyzed by using standard comparison tests, and analysis of covariance was used to determine factors independently associated with EV counts. PEV as well as EEV counts were higher in whole-blood-filtered RBC units compared with RBC-filtered units; PEV counts were associated with filter type (higher with filters associated with higher residual platelets), and CD47 expression was higher on EEVs in RBC units stored longer. Multivariate analysis showed that EEV counts were strongly associated with filter type (P < .0001), preparation, and storage time (+25.4 EEV/µL per day [P = .01] and +42.4 EEV/µL per day [P < .0001], respectively). The only independent factor associated with PEV counts was the residual platelet count in the unit (+67.1 PEV/µL; P < .0001). Overall, processing methods have an impact on EV counts and characteristics, leading to large variations in EV quantities transfused into patients. RBC unit processing methods might be standardized to control the EV content of RBC units if any impacts on patient outcomes can be confirmed. The IMIB (Impact of Microparticles in Blood) study is ancillary to the French ABLE (Age of Transfused Blood in Critically Ill Adults) trial (ISRCTN44878718).