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Background: Pain management is an essential and complex issue for non-communicative patients undergoing sedation in the intensive care unit (ICU). The Behavioral Pain Scale (BPS), although not perfect for assessing behavioral pain, is the gold standard based partly on clinical facial expression. NEVVA© , an automatic pain assessment tool based on facial expressions in critically ill patients, is a much-needed innovative medical device. Methods: In this prospective pilot study, we recorded the facial expressions of critically ill patients in the medical ICU of Caen University Hospital using the iPhone and Smart Motion Tracking System (SMTS) software with the Facial Action Coding System (FACS) to measure human facial expressions metrically during sedation weaning. Analyses were recorded continuously, and BPS scores were collected hourly over two 8 h periods per day for 3 consecutive days. For this first stage, calibration of the innovative NEVVA© medical device algorithm was obtained by comparison with the reference pain scale (BPS). Results: Thirty participants were enrolled between March and July 2022. To assess the acute severity of illness, the Sequential Organ Failure Assessment (SOFA) and the Simplified Acute Physiology Score (SAPS II) were recorded on ICU admission and were 9 and 47, respectively. All participants had deep sedation, assessed by a Richmond Agitation and Sedation scale (RASS) score of less than or equal to -4 at the time of inclusion. One thousand and six BPS recordings were obtained, and 130 recordings were retained for final calibration: 108 BPS recordings corresponding to the absence of pain and 22 BPS recordings corresponding to the presence of pain. Due to the small size of the dataset, a leave-one-subject-out cross-validation (LOSO-CV) strategy was performed, and the training results obtained the receiver operating characteristic (ROC) curve with an area under the curve (AUC) of 0.792. This model has a sensitivity of 81.8% and a specificity of 72.2%. Conclusion: This pilot study calibrated the NEVVA© medical device and showed the feasibility of continuous facial expression analysis for pain monitoring in ICU patients. The next step will be to correlate this device with the BPS scale.
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AIM: The aim of the study was to assess the impact of a video training program (VTP) on primary school teachers' skills in using an adrenaline auto-injector (AAI), in correlation with knowledge regarding allergies, in cases of anaphylaxis. METHODS: A questionnaire on teachers' knowledge of allergies and on their level of confidence in using an AAI was distributed in primary schools in the French department of Manche (2173 teachers). A VTP followed this questionnaire. A second questionnaire was then distributed. Theoretical knowledge was assessed with a score out of 20. The confidence level was rated on a scale from 1 to 4. RESULTS: We collected 218 responses to the first questionnaire (10.0 % of the population included). The response rate to the second questionnaire was 4.7 % (103 participants), and from this group, 93 of the 103 participants viewed the video (90.3 %). Overall, 76 of the 218 (34.9 %) participants who completed the first questionnaire also completed the second questionnaire and watched the VTP. The number of participants who completed the whole survey was 76 (out of 2173, 3.5 %). The VTP significantly improved teachers' knowledge of the subject of allergies (the average score increased by 2.11 points, p < 0.001) as well as their confidence in recognizing the signs of a severe allergic reaction and in using an AAI: 85.4 % (n = 88) of self-confident teachers after the VTP versus 42.3 % (n = 92) before the VTP (p < 0.001). CONCLUSION: The VTP improved teachers' level of knowledge and confidence in using an AAI in cases of anaphylaxis. A similar VTP could be circulated more widely in schools to offer easy access to training tools about allergies.
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Anafilaxia , Epinefrina , Conhecimentos, Atitudes e Prática em Saúde , Professores Escolares , Humanos , Epinefrina/administração & dosagem , Feminino , Inquéritos e Questionários , França , Masculino , Gravação em Vídeo , Hipersensibilidade , Adulto , Capacitação de Professores/métodos , Injeções Intramusculares/instrumentação , Injeções Intramusculares/métodos , AutoadministraçãoRESUMO
BACKGROUND & AIMS: One-third of non-cirrhotic portal vein thrombosis (NCPVT) cases are associated with local factors. The risk of rethrombosis after anticoagulation withdrawal is unknown. We aimed to determine factors associated with new splanchnic or extrasplanchnic thrombotic events in this setting. METHODS: We performed a retrospective study including cases of recent NCPVT associated with local factors. High- and low-risk prothrombotic factors, prespecified according to RIPORT study criteria, were assessed. Univariate and multivariate Cox models assessed the influence of different variables on the occurrence of new thrombotic events. RESULTS: At baseline, 83/154 (53.9%) patients had at least one prothrombotic factor including 50 (32.5%) with a high-risk and 33 (21.4%) with a low-risk prothrombotic factor. Oestrogen-containing contraception was discontinued in all patients. During follow-up, 63/140 (45%) patients had at least one prothrombotic factor, including 47 (33.6%) with a high-risk and 16 (11.4%) with a low-risk prothrombotic factor. Seventeen new thrombotic events occurred after a median follow-up of 52 (IQR 14-62) (min-max 3.0-69.0) months. New thromboses were associated with high-risk factors (hazard ratio [HR] 3.817, 95% CI 1.303-11.180, p = 0.015), but were inversely related to recanalization (HR 0.222, 95% CI 0.078-0.635, p = 0.005) and anticoagulation (HR 0.976, 95% CI 0.956-0.995, p = 0.016). When a high-risk factor was present a new thrombotic event occurred in 7.4%, 14.6%, 14.6% and 28.8% of patients at 1, 3, 5 and 7 years under anticoagulants, respectively, compared to 21.2%, 21.2%, 58% and 58% without anticoagulants, respectively. CONCLUSIONS: In cases of recent NCPVT associated with local factors, high-risk factors for thrombosis are associated with new thrombotic events. Permanent anticoagulation appears beneficial in this high-risk situation. IMPACT AND IMPLICATIONS: In non-cirrhotic portal vein thrombosis (NCPVT) associated with local factors, systematic screening for prothrombotic factors is recommended, but the prevalence of the latter is not clearly established, and the risk of recurrent intra or extrasplanchnic thromboembolism is poorly described. Thus, interest in permanent anticoagulation remains. NCPVT associated with local factors is a matter of concern for hepatologists, gastroenterologists and digestive surgeons. Due to a lack of knowledge, practices are heterogeneous. Our findings highlight that systematic screening for prothrombotic factors in NCPVT is needed even when associated with local factors, as it may justify long-term anticoagulation for the prevention of new intra or extrasplanchnic thrombotic events in at least one-third of cases. The interest in long-term anticoagulation should be investigated prospectively in the absence of high-risk prothrombotic factors. CLINICAL TRIAL NUMBER: NCT0536064.
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BACKGROUND: Automated detection of sleep apnea (SA) by pacemaker (PM) has been proposed and exhibited good agreement with polysomnography to detect severe SA. We aimed to evaluate the usefulness of SA monitoring algorithm in elderly patients with diastolic dysfunction. METHODS: Consecutive patients referred to the Caen University Hospital for PM implantation between May 2016 and December 2018 presenting isolated diastolic dysfunction were eligible for the study. The respiratory disturbance index (RDI) measured by the PM, and the mean monthly RDI (RDIm), were compared to the apnea hypopnea index (AHI) assessed with portable monitor for severe SA diagnosis. RESULTS: During the study period, 68 patients were recruited, aged of 80.4 ± 8.2 years. 63 patients underwent polygraphy with a portable monitor: 57 presented SA (83.8%), including 16 with severe SA (23.5%). Eight were treated with continuous positive airway pressure (CPAP). We found the RDI cutoff value of 22 events/h to predict severe SA, with 71.4% sensitivity and 65.2%, specificity. The RDIm cutoff value to detect severe SA was 19 events/h, with a sensitivity of 60% and a specificity of 66%. There was a significant reduction in RDI (p = 0.041), RDIm (p = 0.039) and AHI (p = 0.002) after CPAP. Supraventricular arrhythmias were frequent in all patients, regardless of SA severity, considering either episodes occurrence or total burden. CONCLUSION: In a population of elderly patients with PM and diastolic dysfunction, the SA monitoring algorithm was able to detect severe SA, with good diagnostic performance values, but also to provide follow-up data for the patients treated with CPAP.
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Marca-Passo Artificial , Síndromes da Apneia do Sono , Idoso , Humanos , Sono , Síndromes da Apneia do Sono/diagnóstico , Síndromes da Apneia do Sono/terapia , Polissonografia , AlgoritmosRESUMO
BACKGROUND: The technique of arteriovenous fistula (AVF) puncture is currently taught by colleagues within hemodialysis units. Even if the main principles of the technique are well known and common to all hemodialysis units, strong rationales are still missing to standardize fine practices such as the relative position of the needles, the angle of the needle at puncture, and the position of the bevel at the time of puncture and after the needle is in the vascular lumen. METHODS: We are conducting a prospective, comparative, center-randomized, multicenter study involving 8 hemodialysis centers. The primary objective is to compare the number of adverse events related to AVF puncture between a group receiving theoretical training plus simulation-based training (4 centers) and a group receiving only theoretical training (4 centers). The study will include all adult patients who are scheduled to have an AVF puncture performed by a hemodialysis-trained nurse during a scheduled chronic dialysis session. DISCUSSION: We hypothesize that a training program for nurses on the AVF approach in procedural simulation versus theoretical input alone would decrease the adverse events related to AVF punctures and would be beneficial for the patient. This study is innovative for several reasons. First, simulation-based training in continuing education among professionals is not widely used. Furthermore, training allows for the standardization of practices within the team, both technically and relationally. TRIAL REGISTRATION: ClinicalTrials.gov NCT05302505 . Registered on March 17, 2022.
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Fístula Arteriovenosa , Derivação Arteriovenosa Cirúrgica , Falência Renal Crônica , Enfermeiras e Enfermeiros , Adulto , Humanos , Estudos Prospectivos , Derivação Arteriovenosa Cirúrgica/efeitos adversos , Derivação Arteriovenosa Cirúrgica/métodos , Diálise Renal/efeitos adversos , Diálise Renal/métodos , Fístula Arteriovenosa/etiologia , PunçõesRESUMO
BACKGROUND: According to European clinical research legislation, no undue influence, including financial incentives, should be used to encourage participation in clinical trials. Financial compensation should be based on the inconvenience experienced by patients and is determined by the sponsor. OBJECTIVES: The objective of this study was to assess the adequacy of patients' financial compensation by obtaining an external ethical opinion compared to the actual compensation provided. METHODS: We randomly selected and reviewed 50 clinical drug trials, including 25 academic and 25 industry-sponsored studies. An external ethics group consisting of three members from French ethics committees, blinded to the actual compensation and the sponsor, retrospectively reviewed the study characteristics and assessed whether financial compensation was appropriate. Cohen's Kappa test measured agreement between actual compensation and the ethics group's opinion, and the McNemar test measured discrepancies. RESULTS: There was no agreement between the actual financial compensation and the ethics group's opinion (K = -.07; 95% CI = [-.16-.02]). More discrepancies were found in favour of financial compensation according to the ethics group than provided by sponsors (12 vs. 2, p = .016). The ethics group recommended financial compensation in 12 out of 50 studies (24%), which were studies with a higher number of additional visits (p = .004) and were more frequently sponsored by industry (p = .008). Sponsors only provided financial compensation in 2 out of 50 studies (4%). CONCLUSION: Patients are rarely compensated despite the perceived inconvenience. Both sponsors and ethics members struggle to determine the need for financial compensation, indicating a need for more precise recommendations for both parties.
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Conflito de Interesses , Humanos , Estudos RetrospectivosRESUMO
Malabsorption is a consequence of gastric bypass (GB). GB increases the risk of kidney stone formation. This study aimed to evaluate the accuracy of a screening questionnaire for assessing the risk of lithiasis in this population. We performed a monocentric retrospective study to evaluate a screening questionnaire administered to patients who underwent gastric bypass surgery between 2014 and 2015. Patients were asked to answer a questionnaire that included 22 questions divided into four parts: medical history, episodes of renal colic before and after bypass surgery, and eating habits. A total of 143 patients were included in the study, and the mean age of the patients was 49.1 ± 10.8 years. The time between gastric bypass surgery and the completion of the questionnaire was 50.75 ± 4.95 months. The prevalence of kidney stones in the study population was 19.6%. We found that with a score of ≥6, the sensitivity and specificity were 92.9% and 76.5%, respectively. Positive and negative predictive values were 49.1% and 97.8%, respectively. The ROC curve showed an Area Under the Curve (AUC) of 0.932 ± 0.029 (p < 0.001). We developed a reliable and short questionnaire to identify patients at a high risk of kidney stones after gastric bypass. When the results of the questionnaire were equal to or greater than six, the patient was at a high risk of kidney stone formation. With a good predictive negative value, it could be used in daily practice to screen patients who have undergone gastric bypass and are at a high risk of renal lithiasis.
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INTRODUCTION: Epilepsy is a common and disabling disease for patients and their families. The care of these patients is no longer limited to the simple control of seizures, but considers, in a more global way, their quality of life (QOL). Improving the QOL is precisely one of the main objectives of therapeutic education. The aim of this study was to evaluate the impact of educational actions on the global QOL of patients with epilepsy. MATERIALS AND METHODS: This study was carried out between October 2016 and August 2018. 80 patients were included over 18 years old with an epileptic condition diagnosed for at least 6 months and treated in the University Hospital of Caen Normandy in France. They were randomised to either the control group with usual care or the experimental group with the group educational sessions. The overall score for the QOLIE-31 survey was assessed from the inclusion (M0) and 6 months late. RESULTS: At the M0 mark, the score of the control group (58.1 ± 12.3) was significantly lower than that of the experimental group (61.1 ± 14.3). After 6 months, the overall QOL score, was significantly higher for the experimental group compared to the control group (p = 0.002). In the experimental group, the overall score went from 61.1 ± 14.3-69 ± 14.2 and in the control group it went from 58.1 ± 12.3-58 ± 16.2. DISCUSSION: The quality-of-life overall score for patients having participated in educational actions provided by epilepsy specialist nurses improved significantly. Complementary research is necessary to assess the sustainability of these effects and interactions with the caregivers.
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Epilepsia , Qualidade de Vida , Humanos , Adolescente , Epilepsia/terapia , Cuidadores , Convulsões , FrançaRESUMO
Purpose: Engagement in activities promotes healthy living. Evaluating it is a challenging issue. Assessing engagement in activities while differentiating the physical, cognitive, and social component of each activity and taking into account the intensity level involved in each of the three components would be very relevant. Since none of the currently available cognitive reserve and questionnaires on the activities practiced takes into consideration both points, the purpose of this new questionnaire, called Pertinent Activities Practice in Adults (PAPA) questionnaire, is to fill these gaps. Patients and Methods: The questionnaire was developed through a literature review and interviews with older adults (n=177 ≥55 years). The intensity level of each item (none, light, moderate, or high) was determined by the compendium of physical activities for the physical component and consensus for the cognitive and social components, then validated by 56 professional experts (6 groups: physiotherapists, neuropsychologists, occupational therapists, geriatricians, etc.). Results: The PAPA questionnaire includes 75 items that give rise to 4 scores (sedentary lifestyle and physical, cognitive, and social activity scores) weighted by the frequency, duration, and intensity level for each component. The weighted percentage of agreement of the expert groups for the intensity levels was never significantly lower than the minimum target threshold (80% of the hypothetical median) except in a single domain (cognitive) for an expert group non-specialized in cognition. Cronbach's alpha was ≥0.85. Conclusion: This questionnaire, which assesses long-term engagement in activities, with separate quantification of the physical, cognitive, and social components of a wide range of activities, should help guide actions to promote healthy aging and reduce dementia risk.
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Cognição , Comportamento Social , Humanos , Idoso , Exercício Físico , Comportamento Sedentário , Inquéritos e QuestionáriosRESUMO
Risk factors involved in the different osteoporotic fracture locations are not well-known. The results of this study suggest that there is not one typical profile characterising a particular fracture site but that the occurrence of a fracture may result from the combination of different bone, cognitive, and anthropometrics characteristics. PURPOSE: Risk factors involved in the different osteoporotic fracture locations are not well-known. The aim of this study was to identify the differences in bone, cognitive, and anthropometric characteristics between different fracture sites, and to determine whether the site of a fall-related fracture is related to a specific profile. METHODS: One hundred six women aged 55 years and older with a recent fall-related fracture of the hip (n = 30), humerus (n = 28), wrist (n = 32), or ankle (n = 16) were included. Bone, cognitive, and anthropometric characteristics were first compared among the four fracture site groups. Then, a principal component analysis (PCA) was performed and a comparison was made between the four profiles identified by the first two PCA components. RESULTS: The four fracture site groups differed significantly in their education level, bone mineral density (BMD), body mass index (BMI), fear of falling, and number of errors in the Trail Making Test B, an executive function test. Each of the four fracture sites was found in each four PCA profiles, albeit with a different distribution. The profiles differed mainly by bone, cognitive, and anthropometric characteristics, but also by fear of falling. CONCLUSIONS: The fall-related fracture sites differ significantly in anthropometric and bone parameters, in fear of falling and in cognitive abilities. There is not one typical bone, cognitive, and anthropometric profile characterising a particular fall-related site, but rather several possible profiles for a given site. This suggests that the fracture site depends on a combination of several characteristics of the patient.
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Fraturas por Osteoporose , Humanos , Feminino , Fraturas por Osteoporose/etiologia , Fraturas por Osteoporose/epidemiologia , Estudos Transversais , Medo , Densidade Óssea , Fatores de RiscoRESUMO
BACKGROUND AND AIMS: This work aimed to evaluate the impact of sarcopenia and sarcopenic obesity on the occurrence of severe pancreatitis and to study the performance of anthropometric indices to predict severe forms. METHODS: We conducted a single-center retrospective study at Caen University Hospital between 2014 and 2017. Sarcopenia was assessed by measuring the psoas area on an abdominal scan. The psoas area /body mass index ratio reflected sarcopenic obesity. By normalizing the value to the body surface, we obtained an index called sarcopancreatic index, avoiding sex differences in measurements. RESULTS: Among 467 included patients, 65 (13.9%) developed severe pancreatitis. The sarcopancreatic index was independently associated with the occurrence of severe pancreatitis (1.455 95% CI [1.028-2.061]; p = 0.035), as was the Visual Analog Scale, creatinine or albumin. The complication rate was not different depending on sarcopancreatic index value. Based on variables independently associated with the occurrence of severe pancreatitis, we constructed a score called Sarcopenia Severity Index. This score presented an area under the receiver operating characteristics curve of 0.84, comparable to the Ranson score (0.87) and superior to body mass index or the sarcopancreatic index to predict a severe form of acute pancreatitis. CONCLUSIONS: Sarcopenic obesity seems to be associated with severe acute pancreatitis.
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Pancreatite , Sarcopenia , Humanos , Masculino , Feminino , Pancreatite/complicações , Sarcopenia/complicações , Sarcopenia/diagnóstico , Estudos Retrospectivos , Doença Aguda , Obesidade/complicações , PrognósticoRESUMO
BACKGROUND: Cemiplimab is a monoclonal antibody targeting the PD-1, and phase II trials have shown its efficacy in the treatment of advanced cutaneous squamous cell carcinoma in patients who are not candidates for curative surgery or radiation therapy as a first- or later-line treatment. A synergistic antitumoral response has been demonstrated with concurrent radiotherapy and PD1-immunotherapy. However, no real-life study has demonstrated this effect in advanced cutaneous squamous cell carcinoma. METHODS: We conducted a real-life retrospective cohort study to investigate the benefit of concomitant therapy in 33 patients treated with cemiplimab at the University Hospital of Caen, alone (C group) or concomitant to radiotherapy (C/RT group). Our primary objectives were to evaluate the best overall response and objective response rate. Our secondary objectives were the disease control rate, median time to response, progression-free survival, overall survival, clinical benefit of radiotherapy, and safety data. After stopping cemiplimab administration, we performed a follow-up of our patients and performed a descriptive study. RESULTS: We reported an objective response rate of 45.5%, including 47.6% in the cemiplimab group versus 41.6% in the concomitant group. The addition of radiotherapy to cemiplimab enables an earlier clinico-radiological response, with a median duration of 5.5 months in the cemiplimab group versus 3 months in the concomitant therapy group. The response to treatment was prolonged despite discontinuation of cemiplimab, with 91.6% (n = 11/12) and 83.3% (n = 10/12) patients in complete or partial remission at 6 months and 1 year after cessation of cemiplimab and no switch to another oncological treatment, respectively. Radiation therapy also provided a therapeutic effect in 83.3% of the patients in the concomitant group, without increasing the occurrence of adverse events. CONCLUSIONS: Our study confirms the efficacy of cemiplimab and radiotherapy in the management of advanced cutaneous squamous cell carcinoma. Concomitant therapy permitted to obtain an earlier radiological response, a beneficial local therapeutic effect of radiotherapy, without any safety alert.
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OBJECTIVE: This study evaluates the implementation of an ERAS program in the gynecological surgery department of Caen University Hospital and its impact on the management of endometrial cancer. The objective was to show its impact on the length of hospitalization of patients before and after its implementation. PATIENTS AND METHOD: We conducted a retrospective study including all women treated surgically for endometrial cancer at Caen University Hospital between January 1, 2015 and December 31, 2021. The ERAS program started in September 2017. We compared the pre-, intra- and postoperative characteristics of two groups: the first one concerning the period before the implementation of ERAS called « prior ERAS group ¼ and the second one after implementation called « post ERAS group ¼. RESULTS: A total of 198 patients were included in our study. 139 patients were included after ERAS implementation. Our study shows that there is a significant reduction in median length of stay between the post ERAS and prior ERAS groups respectively 3 and 4 days (p = 0.004). There was also a reduction of time to resume ambulation (p < 0.001) and re-feeding (p < 0.001) for the post ERAS group compared to the prior ERAS group. Complication rates (p = 0.87) and readmission rates (p = 0.28) were not significant. Overall survival was not significant (p = 0.28). CONCLUSION: ERAS is a safe and effective method in the overall management of patients allowing an improvement in the quality of patient care and accelerating recovery to a previous physiological state. Finally, this results in a reduction in the patient's length of stay, without impacting morbidity and readmission rate.
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Neoplasias do Endométrio , Recuperação Pós-Cirúrgica Melhorada , Humanos , Feminino , Estudos Retrospectivos , Complicações Pós-Operatórias , Hospitais UniversitáriosRESUMO
BACKGROUND: The number of strokes has been steadily increasing due to the aging of the population, and its management has changed dramatically in recent years. Nevertheless, there are few unbiased epidemiological studies to investigate the incidence of strokes and their long-term prognosis. METHODS: The Normandy Stroke Study (NSS) is a prospective population-based study of all strokes and transient ischemic attacks in a large urban, suburban, and rural area in the Northwest of France. It was designed to meet the current gold standard in stroke epidemiological study by using multiple overlapping sources for case identification. It also aimed to assess the impact of socioeconomic disparities and long-term prognosis of stroke through an additional follow-up up to 3 years after the event to better understand the functional and cognitive prognostic of stroke as well as the quality of life in patients after stroke. CONCLUSION: NSS will provide important data on the epidemiology and long-term consequences of stroke at the population level and will help care providers adapt resource allocation.
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Ataque Isquêmico Transitório , Acidente Vascular Cerebral , Humanos , Incidência , Estudos Prospectivos , Qualidade de Vida , Acidente Vascular Cerebral/epidemiologia , Ataque Isquêmico Transitório/epidemiologia , Fatores de RiscoRESUMO
BACKGROUND: Social inequalities in health are responsible for disparities in access to the kidney transplant waiting list (KTWL). The perception of disparities by nephrologists has consequences for the registration on the KTWL. The purposes of our study were to assess the perception of the factors implicated in the disparities in access to the KTWL by nephrology trainees and to assess the quality of the questionnaire. METHODS: A questionnaire was developed to assess the perception of the determinants of the inequities in access to waitlisting. Continuous variables were described by median, 1st and 3rd quartiles. Categorical variables were described by frequencies and percentages. A principal component analysis and a hierarchical cluster analysis were performed to approach the correlation between the variables. A scree plot and a factor analysis were performed to determine the dimensions of the questionnaire. The internal consistency was estimated by Cronbach's coefficient. RESULTS: The response rate was 98/110 (89%). The determinants of inequities in the access to KTWL not perceived by the nephrology trainees were "female sex", "income level" and "the centre provision to adapt the information to all of the patients" (18,3%, 36,7, 47% respectively). "Age", "being born abroad", "place of living", "education level", "transplant centre", "the health care provider" were determinants of disparities perceived by most of the trainees (85,7%, 75,5%, 82,6%, 78,6%, 73,5% et 78,5% respectively). Items related to the transplant centre were positively correlated, as well as "being born abroad", "education level" and "income level". The Cronbach's coefficient was 0,60. CONCLUSION: Social inequalities in health are partially perceived by nephrology trainees. A teaching session could raise nephrologists' awareness of this issue and could help reduce the impact of these disparities on the course of ESKD (end-stage kidney disease) patients.
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Transplante de Rim , Humanos , Feminino , PercepçãoRESUMO
INTRODUCTION: The EMPACOL Project aims to investigate the link between healthcare professionals' (HCPs) empathy and the results of the curative treatment of non-metastatic colorectal cancer (CRC). METHODS AND ANALYSIS: EMPACOL will be an observational multicentric prospective longitudinal study. It will cover eight centres comprising patients with non-metastatic CRC, uncomplicated at diagnosis in two French areas covered by a cancer register over a 2-year period. As estimated by the two cancer registries, during the 2-year inclusion period, the number of cases of non-metastatic CRCs was approximately 480. With an estimated participation rate of about 50%, we expect around 250 patients will be included in this study. Based on the curative strategy, patients will be divided into three groups: group 1 (surgery alone), group 2 (surgery and adjuvant chemotherapy) and group 3 (neo-adjuvant therapy, surgery and adjuvant chemotherapy). The relationship between HCPs' empathy at the time of announcement and at the end of the strategy, quality of life (QoL) 1 year after the end of treatment and oncological outcomes after 5 years will be investigated. HCPs' empathy and QoL will be assessed using the patient-reported questionnaires, Consultation and Relational Empathy and European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire, respectively. A relationship between HCPs' empathy and early outcomes, particularly digestive and genitourinary sequelae, will also be studied for each treatment group. Post-treatment complications will be assessed using the Clavien-Dindo classification. Patients' anxiety and depression will also be assessed using the Hospital Anxiety and Depression Scale questionnaire. ETHICS AND DISSEMINATION: The Institutional Review Board of the University Hospital of Caen and the Ethics Committee (ID RCB: 2022-A00628-35) have approved the study. Patients will be required to provide oral consent for participation. Results of this study will be disseminated by publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05447611.
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Neoplasias Colorretais , Empatia , Humanos , Neoplasias Colorretais/terapia , Comitês de Ética em Pesquisa , França/epidemiologia , Estudos Longitudinais , Estudos Prospectivos , Qualidade de Vida , Estudos Observacionais como Assunto , Estudos Multicêntricos como AssuntoRESUMO
Rapid and accurate diagnosis of SARS-CoV-2 infection is essential for the management of the COVID-19 outbreak. RT-LAMP LoopDeetect COVID-19 (LoopDeescience, France) is a rapid molecular diagnostic tool which operates with the LoopDeelab (LoopDeescience, France) device. RAPID COVID is a prospective double-blind research protocol which was conducted to evaluate the concordance between Loopdeetect COVID-19 and RT-PCR Allplex 2019 n-Cov (Seegene, Korea). Between 11 May 2020 and 14 June 2021, a total of 1122 nasopharyngeal swab specimens were collected, of which 741 were finally analysed. There were 32 "positive" and "indeterminate" RT-PCR results. The intrinsic performances of Loopdeetect COVID-19 are equivalent to other commercial RT-LAMP PCR COVID-19 kits, with a sensitivity and specificity of 69.23% [CI 95%: 48.21-85.67] and 100% [CI 95%: 99.58-100.00], respectively. To the best of our knowledge, LoopDeelab is the only LAMP PCR diagnostic device allowing such a fast and reliable analysis with low-cost equipment; this makes it a new and innovative technology, designed for field use. This device being portable, the development of other detection kits will be useful for the management of epidemics with a high attack rate and would facilitate the rapid application of health measures.
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COVID-19 , COVID-19/diagnóstico , COVID-19/epidemiologia , Teste para COVID-19 , Humanos , Técnicas de Amplificação de Ácido Nucleico/métodos , Pandemias , Estudos Prospectivos , SARS-CoV-2/genética , Sensibilidade e EspecificidadeRESUMO
PURPOSE: The objectives of the present study was to evaluate the implementation of the program in real life and the evolution of the quality of life (QoL) in breast cancer patients after 3 months of supervised PA in real life and to determine the factors associated with changes in various QoL dimensions. METHODS: This prospective cohort study was carried out in female patients with breast cancer diagnosed within a maximum of 3 yr. QoL and physical exertion intensity during the supervised physical activity (PA) sessions were assessed by the Quality of Life Questionnaire for Cancer and Borg scale, respectively. Statistical analyses comparing QoL scores between the start and the end of supervised PA program were assessed using paired Student's t -tests. Multivariate analysis was performed by linear regression with only variables with a P value <0.15 in univariate model. RESULTS: A total of 93 patients were included in the analyses. There was a significant improvement of social functioning at T3 (∆ = 11.5; P < 0.001). The improvement of social functioning was significantly and independently associated with the Borg improvement ( ß = 2.66 ± 1.31, P = 0.046), chemotherapy ( ß = 11.03 ± 5.45, P = 0.046), hormone therapy ( ß = -13.91 ± 5.51, P = 0.013), social isolation ( ß = -14.81 ± 6.55, P = 0.026), and comorbidities ( ß = -15.32 ± 5.59, P = 0.007). CONCLUSIONS: We observed a real enthusiasm and need among patients for practicing PA supervised by a sport trainer near their home. The increase in the intensity of exercise over time contributes to the improvement of the QoL, especially on the social functioning. These results, consistent with previous literature, reinforce the importance of exercise intensity on many dimensions of QoL. In addition, patients expressed great satisfaction with the supervised program, resulting in a strong desire to maintain long-term PA.
Assuntos
Neoplasias da Mama , Qualidade de Vida , Humanos , Feminino , Neoplasias da Mama/terapia , Terapia por Exercício/métodos , Estudos Prospectivos , Exercício FísicoRESUMO
Objectives: Two surgical techniques used for peritoneal metastasis involve a risk of exposure to antineoplastic drugs (ADs): hyperthermic intraperitoneal chemotherapy (HIPEC) and pressurized intraperitoneal aerosol chemotherapy (PIPAC). The objective of this study was to assess the differences in perception, training, and knowledge of the risks as well as in the protection practices and occupational exposures of all worker categories. Methods: This descriptive study, led in two hospitals from two distant French regions, was performed through a face-to-face interview and assessed the perception, knowledge and handling practices of ADs by a questionnaire consisting of 52 questions. Results: Fifty-one professionals participated in this survey. A total of 29.4% (n=15) professionals were afraid to handle ADs. Very few workers have been trained on handling ADs during initial training dedicated to all caregiver (5.9%; n=3). HIPEC is considered to involve a higher risk of exposure to ADs than PIPAC (81.6% (n=31) vs. 57.9% (n=22), respectively, p=0.022, agreement 65.8%). Protective equipment is considered to be less suitable for HIPEC than for PIPAC (29% (n=11) vs. 10.5% (n=4), respectively, p=0.016, agreement 81.6%). Concerning the potential AD contamination location, the participants identified a significant difference between these two practices. During HIPEC, 15.7% (n=6) of caregivers indicated that they had negative symptoms perceived in their practice vs. 2.6% (n=1) during PIPAC. Conclusions: This study shows that perception, knowledge and protection practices are different between HIPEC and PIPAC. It also shows a difference between the worker categories. In view of the difficulties in making operating room staff available, the related training programmes must have an adapted format.