French Pilot Research Articles

Efficacy and safety of mammalian target of rapamycin inhibitors in systemic mastocytosis: A nationwide French pilot study.

Systemic mastocytosis (SM) corresponds to a rare and heterogeneous spectrum of diseases characterized by the accumulation of atypical mast cells (MCs). Advanced mastocytosis (Adv-SM) is associated with poor survival; in contrast, patients with non-advanced SM (non-Adv-SM) usually have a normal life expectancy but may experience poor quality of life. Despite recent therapeutic progress including tyrosine kinase inhibitors, new treatment options are needed for refractory and/or intolerant patients with both severely symptomatic and Adv-SM. In vitro, the mTOR pathway is activated in MCs from patients bearing the KIT D816V mutation. Furthermore, rapamycin induces the apoptosis of KIT D816V MCs selectively. In this nationwide study, we report the outcomes of patients diagnosed with SM and treated with a mammalian target of rapamycin inhibitor (imTOR) within the French National Reference Center for mastocytosis (CEREMAST). All patients registered were relapsing, treatment-refractory, or ineligible for other cytoreductive therapy. Non-Adv-SM patients received imTOR as a monotherapy (rapamycin/everolimus), and Adv-SM patients received imTOR as a monotherapy or in combination with cytarabine. The objective response rate (ORR) in non-Adv-SM was 60% (partial response in 40% and major response in 20%), including reductions in skin involvement, mediator release symptoms, and serum tryptase. In the Adv-SM group, the ORR was 20% (including one major response and one partial response, both in patients with a KIT D816V mutation), which enabled a successful bridge to allogeneic stem cell transplantation in one patient. Our results suggest that imTOR treatment has potential benefits in patients with SM harboring a KIT D816V mutation.

Accompagnement du chien d’assistance judiciaire auprès de mineur(e)s présumé(e)s victimes. Étude pilote menée en France en 2021

ObjectivesIn France, 10% of the population's 13,700,000 minors are recognized as abused, and 50% of abused minors are under the age of 2. Article 19 of the International Convention on the Rights of the Child obliges States to protect children against all forms of violence, hence the concern, in France, for efficient justice and the least possible impact on minors presumed to be victims during proceedings. Legal proceedings conducted by investigators, and in particular those hearings of minors presumed to be victims, can be a trying time. To ensure that the conditions for giving evidence are as untraumatizing as possible, an experiment involving the accompaniment of minors by a courthouse dog (CHD) was begun in Cahors in 2019 and was extended to other towns such as Orléans. This accompaniment by a CHD, inspired by an initiative developed in the United States in 2012, can take place during all stages of the legal process. Currently, France is the only European country to experiment with this accompaniment. Before proposing a systematization of the use of CHD, it is necessary to assess the feelings of those involved in this accompaniment, particularly those of the victims, which is the aim of this study. MethodThis study is multicentric (conducted in Orléans and Cahors), retrospective, and descriptive. Data were collected in 2021 using hetero-questionnaires proposed to the minors and focusing on their behaviors and feelings (n=111), before presentation of the CHD; during the presence of the CHD; and at the end of the hearing. The feelings of the interviewers, caregivers, and other professionals were also collected. ResultsBefore the CHD presentation, 60% of the minors were worried and 17% were smiling. After the hearing and on departure, in the presence of the dog: 4.5% were still showing signs of anxiety and 27% were smiling. The CHD had a calming effect on all those involved, too. It did not disrupt the course of the hearings. The CHD guaranteed total neutrality, did not induce any suggestibility, and was able to position himself with the minors in a discreet, gentle, and effective manner. DiscussionThe triangular relationship – juvenile, investigator, CHD – appears to be beneficial for all involved, according to the testimonies of both juveniles and professionals. The CHD is a catalyst for the minors’ attention, a protector in the face of the unknown; it seems to encourage the freeing of speech and establishes a calming dynamic. Physical and visual contact with the CHD had a reassuring effect. For the investigators, who were generally meeting the minor for the first time, the CHD was appreciated as a real support, as a working partner and a neutral positive reinforcer, as investigators must exercise their profession according to a legal approach of absolute neutrality that does not necessarily correspond to the needs of the traumatized minors they receive, which sometimes makes it difficult to establish a connection. The results also underline the possible protective effect of the CHD on professionals who may be prone to vicarious trauma, as well as on those close to and/or accompanying the minors, who were also reassured by the animal's presence. As far as refusal to be accompanied by the CHD is concerned, there may be a notion of danger or aggressiveness on the part of the dog, hence the importance of proposing this accompaniment in the knowledge of possible reticence or even phobia. This French pilot study on the accompaniment of minors by a legal assistance dog has its limitations due to the small number of participants. It does, however, have the advantage of being original and paving the way for future studies. ConclusionThe impact of the CHD's support on all minors and caregivers was positive overall. The interest in extending this type of study to other sites with CHD, by associating the views of child psychiatrists and behaviorists, could provide an even more significant overview and optimize support for minors based on observation of animal-human interactions.

When citizen science meets radon building diagnosis: Synthesis of a French pilot project developed in the framework of the European RadoNorm research project.

As part of the European RadoNorm research project, citizen science pilot projects focusing on the management of radon risk in houses have been implemented in four countries. This article describes the methodological basis, the development and the results of the French pilot project. Building on an initial review of existing literature, the pilot project aims to frame a 'participatory approach' aligned with the standards and recognized practices of citizen science. Particular attention was given to the management of data and the inclusion of ethical considerations. The focal point of the project was the process of radon building diagnosis which is supposed to be carried out whenever (high) radon concentrations are measured and should be prerequisite to mitigation works. As experience shows, however, this diagnosis is hardly implemented in France. To help remedy this situation, the pilot project recruited citizens already aware about radon from Pays Vesoul Val-de-Saône (East of France) to test an existing online self-evaluation guide for radon diagnosis, report on their operational experience and meet with radon/building experts. This enabled citizens to contribute to improvements in form and content to the guide and to ensure that it would be better fit for purpose. Comparison of the guide with experts' practices offered additional perspectives on what building diagnosis should entail. The pilot project produced rich and high-quality data that will nurture the evolution of the guide. The project demonstrated both the viability and the utility of applying the citizen science approach to radon post-measurement phases, with measurable benefits in bridging knowledge gaps and in encouraging behavioural changes. The results of using a citizen science approach in the field of radon management and research are encouraging, and they far outweigh the challenges involved in the implementation.

When citizen science meets radon building diagnosis: Synthesis of a French pilot project developed in the framework of the European RadoNorm research project

As part of the European RadoNorm research project, citizen science pilot projects focusing on the management of radon risk in houses have been implemented in four countries. This article describes the methodological basis, the development and the results of the French pilot project. Building on an initial review of existing literature, the pilot project aims to frame a ‘participatory approach’ aligned with the standards and recognized practices of citizen science. Particular attention was given to the management of data and the inclusion of ethical considerations. The focal point of the project was the process of radon building diagnosis which is supposed to be carried out whenever (high) radon concentrations are measured and should be prerequisite to mitigation works. As experience shows, however, this diagnosis is hardly implemented in France. To help remedy this situation, the pilot project recruited citizens already aware about radon from Pays Vesoul Val-de-Saône (East of France) to test an existing online self-evaluation guide for radon diagnosis, report on their operational experience and meet with radon/building experts. This enabled citizens to contribute to improvements in form and content to the guide and to ensure that it would be better fit for purpose. Comparison of the guide with experts’ practices offered additional perspectives on what building diagnosis should entail. The pilot project produced rich and high-quality data that will nurture the evolution of the guide. The project demonstrated both the viability and the utility of applying the citizen science approach to radon post-measurement phases, with measurable benefits in bridging knowledge gaps and in encouraging behavioural changes. The results of using a citizen science approach in the field of radon management and research are encouraging, and they far outweigh the challenges involved in the implementation.

172P Early impact of a personalised cancer interception programme for women at non-genetic high risk of breast cancer (BC)

Risk-based cancer prevention is a major future strategy. “Interception” is a French pilot, mixed community-hospital and digital-physical programme based on 4 pillars: 1. community-based identification of people at high risk of cancer; 2. a One-Stop Shop (OSS) including individual visits and group workshops to inform and empower patients and design their shared personalised prevention plan; 3. Implementation of this plan in community practice; 4. Fast cancer care pathway if required. We assessed the pathway dedicated to women at increased non-genetic risk of BC (CANRISK-based 5-year risk of invasive BC >2.5%). We analysed data of women at high risk of BC non linked to a germline variant seen between 02/2021 and 12/2022. Nutritional habits and physical activity assessments used the WCRF score. Perception of knowledge on risk, prevention and screening, and self-evaluated lifetime probability and compared probability of BC, were assessed before and 8 days after OSS (analogue visual scales); comparisons used paired Wilcoxon tests. 141 women at high non-genetic BC risk entered the programme. Mean age was 40.5 years [32.2-49], 81% had tertiary education. Recommended BC screening scheme was modified in 64% (increased mammography frequency: 36 (50%), addition of yearly MRI: 36 (50%)). Identified BC prevention targets were: insufficient physical activity (83%), overweight or obesity (36%), alcohol consumption (57% incl. 5% with >1 alcohol drink/day), current smoking (21%). 97% had at least 1 prevention target. The mean perceived knowledge on BC risk improved (58.0% before vs 87.4% after, p<0.05). Self-evaluated risk of BC dropped significantly after OSS (Perceived lifetime risk 70% (σ=17.1) before vs 35% (σ=22.5) after, p<0.05). Compared perceived probability of BC remained unchanged. 98% of women were highly or very highly satisfied with the programme. A programme dedicated to women at high BC risk has the ability to improve screening measures in conformity with current guidelines (51%), identify relevant prevention targets (97%), improve knowledge on one’s individual situation by 50%, and improve perceived cancer risk’s accuracy.

How does the quality of care for type 2 diabetic patients benefit from GPs-nurses' teamwork? A staggered difference-in-differences design based on a French pilot program.

In many countries, policies have explicitly encouraged primary care teams and inter-professional cooperation and skill mix, as a way to improve both productive efficiency gains and quality improvement. France faces barriers to developing team working as well as new and more advanced roles for health care professionals including nurses. We aim to estimate the impact of a national pilot experiment of teamwork between general practitioners (GPs) and advance practitioners nurses (APN)-who substitute and complement GPs-on yearly quality of care process indicators for type two diabetes patients (T2DP). Implemented by a not-for-profit meso-tier organisation and supported by the Ministry of Health, the pilot relied on the voluntary enrolment of newly GPs from 2012 to 2015; the staffing and training of APNs; skill mixing and new remuneration schemes. We use latent-response formulation models, control for endogeneity and selection bias by using controlled before-after and quasi-experimental design combining coarsened exact matching-prior to the treatment, at both GPs (435 treated vs 973 control) and T2DP levels -, with intention to treat (ITT; 18,310 in each group) and per protocol (PP, 2943 in each group) perspectives, as well as difference-in-differences estimates on balanced panel claims data from the National Health Insurance Fund linked to clinical data over the period 2010-2017. We show evidence of a positive and significant positive impact for T2DP followed-up by newly enrolled GPs in the pilot compared to the pretreatment period and the control group. The effect magnitudes were larger for PP than for ITT subsamples.

Deep remission improves the quality of life of patients with Crohn's disease and anoperineal fistula treated with darvadstrocel: results of a French pilot study.

The injection of allogeneic adipose tissue-derived mesenchymal stem cells (MSC) into anal fistulas in patients with Crohn's disease has never been evaluated in "real-life" conditions in France. We prospectively studied the first patients receiving MSC injections at our center and undergoing 12months of follow-up. The primary endpoint was the clinical and radiological response rate. The secondary endpoints were symptomatic efficacy, safety, anal continence, quality of life (Crohn's anal fistula-quality of life scale, CAF-QoL), and predictive factors of success. We included 27 consecutive patients. The complete clinical and radiological response rates at M12 were 51.9% and 50%, respectively. The combined complete clinical-radiological response (deep remission) rate was 34.6%. No major adverse effects or changes in anal continence were reported. The perianal disease activity index decreased from 6.4 to 1.6 (p < 0.001) for all patients. The CAF-QoL score also decreased from 54.0 to 25.5 (p < 0.001). At the end of the study, M12, the CAF-QoL score was significantly lower only in patients with a complete combined clinical-radiological response relative to those without a complete clinical-radiological response (15.0 versus 32.8, p = 0.01). Having a multibranching fistula and infliximab treatment were associated with a combined complete clinical-radiological response. This study confirms reported efficacy data for the injection of MSC for complex anal fistulas in Crohn's disease. It also shows a positive impact on the quality of life of patients, particularly those for whom a combined clinical-radiological response was achieved.

A study on passenger satisfaction level of AirAsia India

French pilot Monseigneur Piguet flew the first commercial flight in India from Allahabad to Naini on February 18, 1911. However, it wasn’t until 1932 that Jahangir Ratanji Dadabhoy, the ‘Father of Indian Aviation’, established India’s first licensed commercial carrier.1 Tata Airlines was based out of Mumbai and transported both mail and passengers across India. In 1946 it changed its name to Air India. Two years later, the Indian Government acquired 49% of the company, and fully nationalized the airline in 1953 pursuant to the Air Corporations Act, 1953.2 this law not only allowed the Government to gain control over the erstwhile Tata Airlines, but also nationalized the entire sector. All existing airlines were merged into either Indian Airlines Corporation or Air India International.3 This monopoly continued for the next forty years. It wasn’t until the Indian economic liberalization of the 1990’s that the aviation sector was again open to private participation.

Results of a French pilot database of standard of care of chronic subdural hematoma

BackgroundA registry of chronic subdural hematoma does not exist in France yet. ObjectiveTo present a monocentric pilot project of a French registry of surgical management of chronic subdural hematoma. MethodA monocentric pseudonymized formal database was created. From May 2020 to May 2021, all patients undergoing surgical evacuation of chronic subdural hematoma were entered into the database. ResultsOne hundred and twenty four surgeries from 113 patients were entered in the database. Patients’ demographic and surgical data as well as follow-up are described. ConclusionA local database is easy to implement. We propose a national registry of chronic subdural hematoma management.

Auricular Neuromodulation for Mass Vagus Nerve Stimulation: Insights From SOS COVID-19 a Multicentric, Randomized, Controlled, Double-Blind French Pilot Study.

Importance: An exacerbated inflammatory response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is believed to be one of the major causes of the morbidity and mortality of the coronavirus disease 2019 (COVID-19). Neuromodulation therapy, based on vagus nerve stimulation, was recently hypothesized to control both the SARS-CoV-2 replication and the ensuing inflammation likely through the inhibition of the nuclear factor kappa-light-chain-enhancer of activated B cells pathway and could improve the clinical outcomes as an adjunct treatment. We proposed to test it by the stimulation of the auricular branch of the vagus nerve, i.e., auricular neuromodulation (AN), a non-invasive procedure through the insertion of semipermanent needles on the ears.Objective: The aim of this study was to assess the effect of AN on the clinical outcomes in patients affected by COVID-19.Design, Setting, and Participants: A multicenter, randomized, placebo-controlled, double-blind clinical trial included 31 patients with respiratory failure due to COVID-19 requiring hospitalization. Within 72 h after admission, patients received either AN (n = 14) or sham neuromodulation (SN, n = 15) in addition to the conventional treatments.Main Outcome and Measures: The primary endpoint of the study was the rate of a clinical benefit conferred by AN at Day 14 (D14) as assessed by a 7-point Clinical Progression Scale. The secondary endpoint of the study was the impact of AN on the rate of transfer to the intensive care unit (ICU) and on the survival rate at D14.Results: The AN procedure was well-tolerated without any reported side effects but with no significant improvement for the measures of both primary (p > 0.3) and secondary (p > 0.05) endpoints at the interim analysis. None of the AN-treated patients died but one in the SN group did (81 years). Two AN-treated patients (73 and 79 years, respectively) and one SN-treated patient (59 years) were transferred to ICU. Remarkably, AN-treated patients were older with more representation by males than in the SN arm (i.e., the median age of 75 vs. 65 years, 79% male vs. 47%).Conclusion: The AN procedure, which was used within 72 h after the admission of patients with COVID-19, was safe and could be successfully implemented during the first two waves of COVID-19 in France. Nevertheless, AN did not significantly improve the outcome of the patients in our small preliminary study. It is pertinent to explore further to validate AN as the non-invasive mass vagal stimulation solution for the forthcoming pandemics.Clinical Trial Registration: [https://clinicaltrials.gov/], identifier [NCT04341415].

The Soviet Press of the Great Patriotic War about the French Squadron “Normandie-Niemen“

The article is devoted to the participation of French pilots of the Normandy squadron in battles on the Soviet-German front as part of the Red Army in 1943-1945. After the defeat of France at the first stage of World War II (1940), the occupation of its territory by Germany and the organization of the Resistance movement “Fighting France” in London by General Charles de Gaulle, the pilots joined him expressed a burning desire to fight the enemy in the skies over Soviet soil. Their participation in the ranks of the Soviet Air Force was a unique event in the history of the Great Patriotic War of the Soviet Union (1945-1945). The article analyzes the information of the Soviet press during the war years about the French squadron “Normandie-Niemen”, which fought in the Soviet Air Force on the Soviet-German front. It is shown that Soviet readers during the Great Patriotic War could get a very complete and reliable idea of the military exploits of French pilots, find out the names of heroes, get acquainted with the military everyday life of officers, appreciate their patriotism and sincere friendly feelings for the Soviet Union and its people. Along with stories about the air battles of the Normandy, the articles of Soviet correspondents contained information about the history of France, how the pilots reacted to the defeat of their country, how and where they fought in the first stage of the Second World War. The press of the war years gave brief sketches of the everyday life of French fighters on Soviet soil, about the curious events that happened to the pilots of the squadron. On the example of newspaper publications 1943-1945. about the military alliance of our and French pilots, you can get an idea of how the cooperation of the countries of the anti-Hitler coalition developed and strengthened.

ФРАНЦУЗЬКІ АВІАТОРИ ТА АВІАЦІЙНІ ЧАСТИНИ НА СХІДНОМУ ФРОНТІ ПЕРШОЇ СВІТОВОЇ ВІЙНИ

One of the forms of military assistance that France provided to allied Russia during the First World War was the deployment of aviation specialists. During 1916-1917, two air contingents were sent to Russia. The first of them numbered only 30 people and was not the consolidated unit – the aviators who were part of it were distributed among the various Russian aviation units. This approach proved unsuccessful: a few weeks after the arrival of the French pilots, they had to move from one section of the front to another, more important one. This negative experience was taken into account when forming the second contingent. In 1917, France sent two full-fledged air squadrons to Russia, as well as the necessary units to provide a total of almost 270 people. The second air contingent operated on the South-Western Front (and the adjacent section of the Romanian Front). The choice of the South-Western Front was conditioned by the fact that in 1917 the largest operations of the Russian army were planned here.The French aviation contingent was armed with quite modern fighter planes and reconnaissance aircraft. The personnel was largely formed at the expense of volunteers, which contributed to the high morale and activity of the aviation contingent. This is evidenced by the results of a series of air battles conducted by French pilots. At the same time, the fighting of the French squadrons was affected by the general situation at the front. They suffered significant losses in equipment during the retreat in July 1917. However, despite the collapse of the Russian army in the autumn of 1917, French aviators continued their hostilities until the armistice between the Bolshevik government of Russia and Germany. Their further stay on the territory of Ukraine, which lasted until February 1918, was characterized by the desire to maintain neutrality and ensure repatriation.

Efficiency of telemedicine for acute stroke: a cost-effectiveness analysis from a French pilot study.

Telestroke is an effective way to improve care and health outcomes for stroke patients. This study evaluates the cost-effectiveness of a French telestroke network. A decision analysis model was built using population-based data. We compared short-term clinical outcomes and costs for the management of acute ischemic stroke patients before and after the implementation of a telestroke network from the point of view of the national health insurance system. Three effectiveness endpoints were used: hospital death, death at 3 months, and severe disability 3 months after stroke (assessed with the modified Rankin scale). Most clinical and economic parameters were estimated from the medical files of 742 retrospectively included patients. Sensitivity analyses were performed. The analyses revealed that the telestroke strategy was more effective and slightly more costly than the reference strategy (25 disability cases avoided per 1,000 at 3 months, 6.7 avoided hospital deaths, and 13 avoided deaths at 3 months for an extra cost of EUR 97, EUR 138, and EUR 154, respectively). The results remained robust in the sensitivity analyses. In France, telestroke is an effective strategy for improving patient outcomes and, despite the extra cost, it has a legitimate place in the national health care system.

Evaluation of the ’sophia’ asthma patient management program at two years

Abstract Objectives To evaluate the impact of a multi-faceted management support program deployed towards asthma patients by the French Health Insurance since February 2015 in 19 (20%) French pilot areas. Methods The population is composed of subjects aged 18 to 40 years in 2014, with at least 3 asthma medication deliveries in 2012 as well as in 2013 that were identified and followed-up within the SNDS French claims database. A controlled before-and-after design was used for assessing program impact. Unexposed subjects (i.e. living in non-pilot areas) were matched with exposed subjects (i.e. living in pilot areas) on a propensity score. Adherence to controller treatment (inhaled corticoids), measured by the medication refill adherence MRA, was the primary outcome. Secondary outcomes were medications and heathcare use, sick leaves, exacerbations, costs. Results Analysis concerned 29, 746 matched-pairs. With a baseline mean MRA of 40.17% in unexposed subjects, the difference-in-difference was non-significant (0.26%, p = 0.545). However, the program showed a significant impact on the percentage of subjects that moved to a better MRA category or maintained a high adherence (OR = 1.05,p=0.028). The program had no significant impact on the other secondary outcomes. In planned secondary analyses comparing the 11.5% exposed subjects who adhered to the program to their matched-unexposed subjects, the difference-in-difference showed a program impact on specialist consultations, asthma-related and all medication costs, and total asthma-related costs. However, results on this subpopulation must be examined with caution since the matching procedure couldn’t take into account the propensity to adhere. Conclusions Although SOPHIA had no impact on the MRA as a continuous variable, more exposed subjects moved to better adherence categories. The program had an impact on asthma-related costs in the adherents to the program, but this result should be considered with caution. Key messages Although SOPHIA had no impact on the MRA as a continuous variable, more exposed subjects moved to better adherence categories. The program had an impact on asthma-related costs in the adherents to the program, but this result should be considered with caution.

43O - Baseline results from a French pilot study on lung cancer screening by CT scan: DEP KP80

43O - Baseline results from a French pilot study on lung cancer screening by CT scan: DEP KP80

LUCSO-1—French pilot study of LUng Cancer Screening with low-dose computed tomography in a smokers population exposed to Occupational lung carcinogens: study protocol

IntroductionGuidelines concerning the follow-up of subjects occupationally exposed to lung carcinogens, published in France in 2015, recommended the setting up of a trial of low-dose chest CT lung cancer screening...

AD3 - EVALUATION OF THE “SOPHIA” ASTHMA PATIENT MANAGEMENT PROGRAM AT TWO YEARS

To evaluate the impact of a multi-faceted management support program deployed towards asthma patients by the French Health Insurance since February 2015 in 19 (20%) French pilot areas. The population is composed of subjects aged 18 to 40 years in 2014, with at least 3 asthma medication deliveries in 2012 as well as in 2013 that were identified and followed-up within the SNDS French claims database. A controlled before-and-after design was used for assessing program impact. Unexposed subjects (i.e. living in non-pilot areas) were matched with exposed subjects (i.e. living in pilot areas) on a propensity score. Adherence to controller treatment (inhaled corticoids), measured by the medication refill adherence MRA, was the primary outcome. Secondary outcomes were medications and heathcare use, sick leaves, exacerbations, costs. Analysis concerned 29, 746 matched-pairs. With a baseline mean MRA of 40.17% in unexposed subjects, the difference-in-difference was non-significant (0.26% [-0.58%;1.11%] p=0.545). However, the program showed a significant impact on the percentage of subjects that moved to a better MRA category (low, medium, high adherence) or maintained a high adherence (OR=1.05 [1.01;1.09],p=0.028). The program had no significant impact on the other secondary outcomes. In planned secondary analyses comparing the 11.5% exposed subjects who adhered to the program to their matched-unexposed subjects, the difference-in-difference showed a program impact on specialist consultations, asthma-related and all medication costs, and total asthma-related costs. However, results on this subpopulation must be examined with caution since the matching procedure couldn’t take into account the propensity to adhere. Although SOPHIA had no impact on the MRA as a continuous variable, more exposed subjects moved to better adherence categories. The program had an impact on asthma-related costs in the adherents to the program, but this result should be considered with caution.

Effect of Urinary Sheath Use on Hydration Status of Fighter Pilots Under Severe Thermal Stress: An Observational Study.

Fighter jet pilots may adopt a voluntary hypohydration strategy hours before take-off to avoid urinating in flight. This may favor sortie-induced dehydration and potentially increase flying errors. Since 2015, French pilots have used a urinary sheath (US) that appears to have resolved this problem. However, its effect has never been assessed. Urine specific gravity (USG) before and after sorties, inflight intake (water and food) and loss (sweat and urine), and changes in bodyweight were measured during 44 long (~370 minutes) sorties (22 in 2015 without a US, No-US group, and 22 in 2017 with a US, US group). The USG before sorties was lower in the US than No-US group (1.019 ± 0.008 vs 1.028 ± 0.006, p = 0.008) and the proportion of hypohydrated pilots (>1.020) was lower in the US than No-US group (29 vs 90%, p = 0.007). Total loss and intake were higher in the US group (1,793 ± 640 and 927 ± 585 g, respectively) than in the No-US group (1,337 ± 382 and 359 ± 191 g, respectively; p < 0.006). Changes in bodyweight, both absolute (-977 ± 367 g for the No-US and -866 ± 593 g for the US group) and relative (1.16 ± 0.51% for the No-US and 1.13 ± 0.77% for the US group) during sorties were not altered by wearing a US. The use of a US successfully mitigates preflight dehydration, as reflected by decreases in USG, showing that pilots, at least partially, abandon preflight voluntary hypohydration strategies. It also favored water and food intake during flight without enhancing inflight dehydration, shown by the parallel increases in loss (urine and sweat) when wearing a US.

First French Pilot Quality Assessment of the EndoPredict Test for Early Luminal Breast Carcinoma.

Genomic signatures are needed for the determination of prognosis in patients with early stage, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancers. EndoPredict test is a RNA-based multigene assay that assesses the risk of 10-year relapse in this context. Quality assessment is a mandatory requirement for a laboratory to address the analytical quality of these molecular analyses. The aim of the study was to demonstrate the robustness of this prognostic test, its usefulness for the patient's treatment strategy, at the national level. This study presents a pilot quality assessment (QA) of the EndoPredict test using composite design, including the follow-up of internal control values (qREF) of the 12 genes of the assay for 151 independent tests and one formalin-fixed paraffin embedded (FFPE) breast cancer sample. The evaluation of the test was performed by comparing the results of six independent medical laboratories. All measures were highly reproducible and quantification of the qREF showed a standard deviation of less than 0.50 and a coefficient of variation always of <2%. All laboratories found concordant results for the breast cancer samples. The mean EndoPredict (EP) score for the breast cancer sample was 4.97±0.24. The mean of EPclin score was 3.07±0.05. This first French independent reported QA assessed the robustness and reproducibility of the EndoPredict test. Such a simple composite design could represent an adapted QA for an expensive diagnostic test.

Driving style indicator using UDRIVE NDS data

ABSTRACTObjective: In order to analyze specific events while driving (such as a safety critical event [SCE] or secondary task), we were interested in studying whether driving behavior was unusual around the event. An indicator characterizing driving style (driving style indicator [DSI]) was estimated for each driver by using naturalistic data. The analysis of the gap in driving style could be calculated for a specific trip or even a time window and could help characterize events: a more risky situation when DSI was above average, increase in safety margins when under average.Methods: Lateral acceleration and longitudinal acceleration were used for DSI calculation. The first step consisted in filtering the signal acquired by the inertial measurement unit (60 Hz). The noise was filtered out with an eighth order, phase-compensated digital low-pass Butterworth filter with a cut-out frequency of 5 Hz and offsets were compensated for. The second step consisted in calculating the jerk of the acceleration in lateral and longitudinal directions for each trip. The third step summarized the distribution of these jerks for all trips of each driver. Finally, the DSI was defined as the standard deviation of this distribution. A driver was represented by lateral DSI and longitudinal DSI.Results: The indicator was used on French pilot data (10 drivers) and on UK data (30 drivers) from the UDRIVE project. To assess this indicator, tests on track were conducted by professional drivers simulating two opposite driving style. The first results were promising and discriminated a smooth from a rough driving style. Indeed, in the pilot data, the classification was in accordance with our expectations and confirmed by videos. The same kind of distribution was observed in the UK data and needs to be confirmed when the UDRIVE database is complete.Conclusion: DSI is a new parameter that will be used to define clusters of drivers and study variation of driving parameters in each class during selected events (SCE, secondary task, etc.) in the UDRIVE project.