Anti-dsDNA IgE: a potential non-invasive test for prediction of lupus nephritis relapse.

OBJECTIVES: Discontinuation or continuation of maintenance immunosuppressive therapy (MIST) after a severe lupus nephritis (LN) requires measuring the risk of relapse but reliable clinical and biological markers are lacking. The WIN-IgE study assesses the value of serum anti-dsDNA IgE autoantibodies as a biomarker for the prediction of relapse in severe LN. METHODS: WIN-IgE is an ancillary study of the WIN-Lupus study (NCT01284725), a prospective controlled clinical trial which evaluated the discontinuation of MIST after 2-3 years in class III or IV±V LN with active lesions. WIN-IgE included all patients with available serum collected at randomisation for continuation or discontinuation of MIST. In these sera, anti-dsDNA antibodies, IgE and IgG, were quantified by ELISA and compared between patients who experienced LN relapse and those who did not during the 24 months of follow-up. RESULTS: 52 patients were included, 25 in the MIST continuation group and 27 in the MIST discontinuation group, 12 experienced a biopsy-proven relapse of LN. Initial anti-dsDNA IgE antibodies levels were higher in patients with subsequent LN relapse. Anti-dsDNA IgG was not associated with relapse. Survival without LN relapse was lower in patients with anti-dsDNA IgE levels above vs below a threshold of 1.9 arbitrary units (p=0.019), particularly in the subgroup of patients randomised to discontinue MIST (p=0.002). In all patients, anti-dsDNA IgE above 1.9 arbitrary units had a positive predictive value of 0.8 for severe LN relapse. CONCLUSIONS: These results suggest blood anti-dsDNA IgE as a non-invasive predictive marker of LN relapse.

The Effects of a Laparoscopy by Single-Port Endoscopic Access in Benign Adnexal Surgery: A Randomized Controlled Trial.

STUDY OBJECTIVE: To evaluate whether laparoendoscopic single-site surgery (LESS) offers advantages over conventional laparoscopy (CL) in benign adnexal surgery. DESIGN: Randomized controlled study. SETTING: Gynecology-Obstetrics Unit of the University Hospital of the Conception in Marseille, France. PATIENTS: Patients older than 18 years requiring ovarian cystectomy or salpingo-oophorectomy by laparoscopy for symptomatic ovarian cysts requiring benign or prophylactic surgery. INTERVENTIONS: In the case of ovarian cysts, premenopausal patients typically undergo a unilateral cystectomy, whereas postmenopausal patients undergo a unilateral or bilateral salpingo-oophorectomy upon a patient's request. In cases requiring prophylactic surgery, a bilateral salpingo-oophorectomy was performed. All participants were randomly assigned to either the LESS or the CL group. MEASUREMENTS AND MAIN RESULTS: Patients in both groups reported similar levels of pain at 24 hours: Simple Numerical Scale was 1.3 (standard deviation, 1.5) in the LESS group vs 1.7 (standard deviation, 1.5) in the CL group (p = .12), and there were no significant differences in postoperative pain at 2 hours, 4 hours, 6 hours, and 7 days. Furthermore, there was no difference in analgesic consumption. Regarding intraoperative criteria, the only difference was the longer operating time in the LESS group than the CL group. We also found that patients' satisfaction with their scar at 1 month may be higher with LESS than with CL. CONCLUSION: There was no significant difference between the 2 techniques in postoperative pain, although the LESS technique necessitated a longer operative time than the CL technique, while providing better aesthetic result patients.

Legalisation of euthanasia and assisted suicide: advanced cancer patient opinions - cross-sectional multicentre study.

OBJECTIVES: The French government voted a new law in February 2016 called the Claeys-Leonetti Law, which established the right to deep and continuous sedation, confirmed the ban on euthanasia and ruled out physician-assisted suicide. The aim of this work was to gather the opinion of patients on continuous sedation and the legalisation of medical assistance in dying and to explore determinants associated with favourable and unfavourable opinions. METHODS: This was a French national prospective multicentre study between 2016 and 2020. RESULTS: 331 patients with incurable cancer suffering from locally advanced or metastatic cancer in 14 palliative care units were interviewed. 48.6% of participants expressed a favourable opinion about physician-assisted suicide and 27.2% an unfavourable opinion about its legalisation. Regarding euthanasia, 52% of patients were in favour of its legalisation. In univariate analysis, the only factor determining opinion was belief in God. CONCLUSIONS: While most healthy French people are in favour of legalising euthanasia, only half of palliative care patients expressed this opinion. Medical palliative care specialists were largely opposed to euthanasia. The only determining factor identified was a cultural factor that was independent of the other studied variables. This common factor was found in other studies conducted on cohorts from other countries. This study contributes to the knowledge and thinking about the impact of patients' personal beliefs and values regarding their opinions about euthanasia and assisted suicide. TRIAL REGISTRATION NUMBER: NCT03664856.

Gastric peroral endoscopic myotomy versus botulinum toxin injection for the treatment of refractory gastroparesis: results of a double-blind randomized controlled study.

INTRODUCTION: Gastric peroral endoscopic myotomy (G-POEM) is a promising technique for treating refractory gastroparesis. We present the first double-blind randomized study comparing the clinical efficacy of G-POEM versus pyloric botulinum toxin injection (BTI). METHODS: This randomized study, conducted in two expert centers, enrolled patients with refractory gastroparesis, medically managed for >6 months and confirmed by gastric emptying scintigraphy (GES), into two groups, G-POEM versus BTI, with follow-up of 1 year. The primary end point was the 3-month clinical efficacy, defined as a >1-point decrease in the mean Gastroparesis Cardinal Symptom Index (GCSI) score. Secondary end points were: 1-year efficacy, GES evolution, adverse events, and quality of life. RESULTS: 40 patients (22 women; mean age 48.1 [SD 17.4]), with mean symptom duration of 5.8 (SD 5.7) years, were randomized. Etiologies included idiopathic (n=18), diabetes (n=11), postoperative (n=6), and mixed (n=4). G-POEM showed a higher 3-month clinical success than BTI (65% vs. 40%, respectively; P=0.10), along with non-significantly higher 1-year clinical success (60% vs. 40%, respectively) on intention-to-treat analysis. The GCSI decreased in both groups at 3 months and 1 year. Only three minor adverse events occurred in the G-POEM group. The GES improvement rate was 72% in the G-POEM group versus 50% in the BTI group (non-significant). CONCLUSION: G-POEM seems to have a higher clinically relevant success rate than BTI, but this was not statistically demonstrated. This study confirms the interest in treatments targeting the pylorus, either mechanically or chemically, for managing refractory gastroparesis.

Effectiveness of Surgeon-Performed Paravertebral Block Analgesia for Minimally Invasive Thoracic Surgery: A Randomized Clinical Trial.

Importance: In minimally invasive thoracic surgery, paravertebral block (PVB) using ultrasound (US)-guided technique is an efficient postoperative analgesia. However, it is an operator-dependent process depending on experience and local resources. Because pain-control failure is highly detrimental, surgeons may consider other locoregional analgesic options. Objective: To demonstrate the noninferiority of PVB performed by surgeons under video-assisted thoracoscopic surgery (VATS), hereafter referred to as PVB-VATS, as the experimental group compared with PVB performed by anesthesiologists using US-guided technique (PVB-US) as the control group. Design, Setting, and Participants: In this single-center, noninferiority, patient-blinded, randomized clinical trial conducted from September 8, 2020, to December 8, 2021, patients older than 18 years who were undergoing a scheduled minimally invasive thoracic surgery with lung resection including video-assisted or robotic approaches were included. Exclusion criteria included scheduled open surgery, any antalgic World Health Organization level greater than 2 before surgery, or a medical history of homolateral thoracic surgery. Patients were randomly assigned (1:1) to an intervention group after general anesthesia. They received single-injection PVB before the first incision was made in the control group (PVB-US) or after 1 incision was made under thoracoscopic vision in the experimental group (PVB-VATS). Interventions: PVB-VATS or PVB-US. Main Outcomes and Measures: The primary end point was mean 48-hour post-PVB opioid consumption considering a noninferiority range of less than 7.5 mg of opioid consumption between groups. Secondary outcomes included time of anesthesia, surgery, and operating room occupancy; 48-hour pain visual analog scale score at rest and while coughing; and 30-day postoperative complications. Results: A total of 196 patients were randomly assigned to intervention groups: 98 in the PVB-VATS group (mean [SD] age, 64.6 [9.5] years; 53 female [54.1%]) and 98 in the PVB-US group (mean [SD] age, 65.8 [11.5] years; 62 male [63.3%]). The mean (SD) of 48-hour opioid consumption in the PVB-VATS group (33.9 [19.8] mg; 95% CI, 30.0-37.9 mg) was noninferior to that measured in the PVB-US group (28.5 [18.2] mg; 95% CI, 24.8-32.2 mg; difference: -5.4 mg; 95% CI, -∞ to -0.93; noninferiority Welsh test, P ≤ .001). Pain score at rest and while coughing after surgery, overall time, and postoperative complications did not differ between groups. Conclusions and Relevance: PVB placed by a surgeon during thoracoscopy was noninferior to PVB placed by an anesthesiologist using ultrasonography before incision in terms of opioid consumption during the first 48 hours. Trial Registration: ClinicalTrials.gov Identifier: NCT04579276.

The falciform/round ligament "flooring," an effective method to reduce life-threatening post-pancreatectomy hemorrhage occurrence.

PURPOSE: Late post-pancreatectomy hemorrhage (PPH) represents the most severe complication after pancreatic surgery. We have measured the efficacy of major vessels "flooring" with falciform/round ligament to prevent life-threatening grade C late PPH after pancreaticoduodenectomy (PD) and distal pancreatectomy (DP). METHODS: All consecutive patients who underwent PD and DP between 2013 and 2021 were retrospectively reviewed on a prospectively maintained database. The cohort was divided in two groups: "flooring" vs. "no flooring" method group. The "no flooring" group had omental flap interposition. Patient characteristics and operative and postoperative data including clinically relevant postoperative pancreatic fistula (CR-POPF), late PPH (grade B and C), and 90-day mortality were compared between the two groups. RESULTS: Two hundred and forty patients underwent pancreatic resections, including 143 PD and 97 DP. The "flooring" method was performed in 61 patients (39 PD and 22 DP). No difference was found between the two groups concerning severe morbidity, CR-POPF, delayed PPH, and mortality rate. The rate of patients requiring postoperative intensive care unit was lower in the "flooring" than in the "no flooring" method group (11.5% vs. 25.1%, p = 0.030). Among patients with grade B/C late PPH (n = 30), the rate of life-threatening grade C late PPH was lower in the "flooring" than in the "no flooring" method group (28.6% (n = 2/7) vs. 82.6% (n = 19/24), p = 0.014). Risk factor analysis showed that the "flooring" method was the only protective factor against grade C late PPH occurrence (p = 0.013). CONCLUSION: The "flooring" method using the falciform/round ligament should be considered during pancreatectomies to reduce the occurrence of life-threatening grade C late PPH.

Pre-operative distraction using electric ride-on cars for children undergoing elective ambulatory surgery: A randomised controlled trial.

BACKGROUND: Pre-operative anxiety occurs in 18 to 60% of children undergoing surgery and results in poor outcomes. Nonpharmacological methods of distraction are effective in alleviating peri-operative anxiety. In our institution, ride-on electric cars (ride-on e-cars) are routinely used by children undergoing ambulatory surgery as a mean of nonpharmacological distraction. OBJECTIVES: The aim of this study is to assess the effect of pre-operative distraction with ride-on e-cars on children's pre-operative anxiety when undergoing elective ambulatory surgery. DESIGN: This was a prospective, randomised, controlled, open-label study. SETTING: The study was carried out from September 2019 to September 2021 in the ambulatory paediatric surgery unit of our teaching hospital, in Marseille, France. PATIENTS: Children aged 2 to 10 years and weighing less than 35 kg undergoing elective ambulatory surgery were eligible. One hundred and fifteen children were included, 56 in the control group and 59 in the intervention group. INTERVENTION: Children in the control group were transported from the operating room (OR) waiting area to the OR using a trolley, while children in the intervention group used the ride-on e-cars, without pharmacological premedication or parental presence. MAIN OUTCOME MEASURES: The primary outcome was pre-operative anxiety at the end of the transport (prior going into the OR assessed by the modified Yale Preoperative Anxiety Score Short Form (mYPAS-SF). Secondary outcomes were the anxiety levels in children over time, as well as postoperative pain and agitation assessed with the Face Legs Activity Cry Consolability (FLACC) and Paediatric Anaesthesia Emergence Delirium (PAED) scales, respectively. RESULTS: The mYPAS-SF anxiety scores did not differ between the control group and the intervention group (39 ±â€Š19 vs. 37 ±â€Š21, P  = 0.574). The secondary outcomes were similar between the two groups. CONCLUSIONS: Our randomised controlled trial showed that the use of ride-on e-cars did not alter pre-operative anxiety as compared with standard transport in children undergoing elective ambulatory surgery. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03961581.

Lymph node thyroglobulin in the diagnosis of metastases of thyroid carcinoma with the thyroid in situ: A prospective intraoperative study.

BACKGROUND: The use of thyroglobulin concentration in washout fluid of fine-needle aspiration (FNA-Tg) is a procedure advocated by international guidelines to diagnose metastatic LN in papillary thyroid cancer. With the increasing use of active follow-up or lobectomy alone for low-risk thyroid cancers, the determination of the diagnostic performance of FNA-Tg in the detection of metastatic PTC when the thyroid is in situ is paramount. MATERIALS AND METHODS: Prospective study with measurement of Tg in washout fluid obtained from intraoperative fine needle aspiration (FNA) cytology in order to avoid contamination from thyroid tissue and rigorously isolated punctured nodes. Receiver-operating characteristic (ROC) curve and area under the curve (AUC), optimal threshold to discriminate benign and malignant LN, sensitivity and specificity were provided. RESULTS: a total of 58 lymph nodes from 32 patients were analyzed. ROC analysis defined the optimal cutoff values of FNA-Tg at 60 ng/ml for the diagnosis of malignant LNs in patients with a thyroid in situ. Sensitivity and specificity were 75% (95% confidence interval 57.89-86.75) and 87.5% (95%CI: 69-95.66), respectively. CONCLUSION: Our results support the hypothesis that the Tg-FNA threshold for a safe diagnosis of LN metastasis in PTC is higher in presence of a thyroid gland in situ. The use of lower thresholds could result in false positive results and lead to unnecessary surgery.

Ultra-lung-protective ventilation and biotrauma in severe ARDS patients on veno-venous extracorporeal membrane oxygenation: a randomized controlled study.

BACKGROUND: Ultra-lung-protective ventilation may be useful during veno-venous extracorporeal membrane oxygenation (vv-ECMO) for severe acute respiratory distress syndrome (ARDS) to minimize ventilator-induced lung injury and to facilitate lung recovery. The objective was to compare pulmonary and systemic biotrauma evaluated by numerous biomarkers of inflammation, epithelial, endothelial injuries, and lung repair according to two ventilator strategies on vv-ECMO. METHODS: This is a prospective randomized controlled study. Patients were randomized to receive during 48 h either ultra-lung-protective ventilation combining very low tidal volume (1-2 mL/kg of predicted body weight), low respiratory rate (5-10 cycles per minute), positive expiratory transpulmonary pressure, and 16 h of prone position or lung-protective-ventilation which followed the ECMO arm of the EOLIA trial (control group). RESULTS: The primary outcome was the alveolar concentrations of interleukin-1-beta, interleukin-6, interleukin-8, surfactant protein D, and blood concentrations of serum advanced glycation end products and angiopoietin-2 48 h after randomization. Enrollment was stopped for futility after the inclusion of 39 patients. Tidal volume, respiratory rate, minute ventilation, plateau pressure, and mechanical power were significantly lower in the ultra-lung-protective group. None of the concentrations of the pre-specified biomarkers differed between the two groups 48 h after randomization. However, a trend to higher 60-day mortality was observed in the ultra-lung-protective group compared to the control group (45 vs 17%, p = 0.06). CONCLUSIONS: Despite a significant reduction in the mechanical power, ultra-lung-protective ventilation during 48 h did not reduce biotrauma in patients with vv-ECMO-supported ARDS. The impact of this ventilation strategy on clinical outcomes warrants further investigation. Trial registration Clinical trial registered with www. CLINICALTRIALS: gov ( NCT03918603 ). Registered 17 April 2019.

Unrelated Cord Blood Transplantation in Children, Adolescents, and Young Adults with Acute Leukemia or Myelodysplastic Syndrome: A Retrospective Comparative Study from the French Society for Bone Marrow Transplantation and Cellular Therapy Between Real-World Data and Previously Reported Results of a Randomized Clinical Trial.

We previously reported results of a French randomized clinical trial (RCT) comparing the risk of transplantation failure (including transplant-related mortality [TRM], engraftment failure, and autologous recovery) in single and double unrelated cord blood (UCB) transplantation in children and young adults with hematologic malignancies. We concluded that single-UCB transplantation with an adequate cell dose is the standard of care, leading to a 70% two-year overall survival (OS). It remains unclear, however, whether RCT participants have better outcomes than comparable patients not treated in the setting of a clinical trial. We compared the characteristics and outcomes of RCT participants (n = 137) to a Francophone population-based registry of patients (real-world [RW] group) fulfilling the eligibility criteria used in our RCT and transplanted with 1 or 2 UCB units after a myeloablative conditioning (MAC) regimen between March 2015 (end of inclusion in the RCT) and February 2019 (n = 141). The primary endpoint was the 2-year cumulative incidence (CI) of transplantation strategy failure as defined in our RCT. The 2 groups were comparable in terms of age, disease distribution, hematologic status at transplantation, follow-up, and HLA compatibility. Patients in the RW group were more likely to be transplanted with a single-unit UCB (87.9% versus 49.6%, P< .001) and to receive a radiation-free regimen (39.0% versus 60.6%, P< .001). The 2-year CI of transplantation strategy failure, TRM, and the 2-year probability of OS were similar between the 2 groups, although the relapse risk was higher in the RW group (31.2% ± 7.7% versus 20.4% ± 6.8%, P= .01), resulting in a significantly lower disease-free survival (DFS) (59.2% ± 8.4% versus 69.3% ± 8.0%, P= .047). This difference remained statistically significant only in the group of patients with acute lymphoid leukemia (ALL) who did not receive the conditioning regimen recommended by the RCT (fludarabine 75 mg/m2, total body irradiation 12 Gy, cyclophosphamide 120 mg/kg). The results of our RCT appear to be reproducible in real-world conditions, provided that the same cord blood selection criteria and conditioning regimen are used.

Intensive end-of-life care in acute leukemia from a French national hospital database study (2017-2018).

BACKGROUND: A better understanding of how the care of acute leukemia patients is managed in the last days of life would help clinicians and health policy makers improve the quality of end-of-life care. This study aimed: (i) to describe the intensity of end-of-life care among patients with acute leukemia who died in the hospital (2017-2018) and (ii) to identify the factors associated with the intensity of end-of-life care. METHODS: This was a retrospective cohort study of decedents based on data from the French national hospital database. The population included patients with acute leukemia who died during a hospital stay between 2017 and 2018, in a palliative care situation (code palliative care Z515 and-or being in a inpatient palliative care support bed during the 3 months preceding death). Intensity end-of-life care was assessed using two endpoints: High intensive end-of-life (HI-EOL: intensive care unit admission, emergency department admission, acute care hospitalization, intravenous chemotherapy) care and most invasive end-of-life (MI-EOL: orotracheal intubation, mechanical ventilation, artificial feeding, cardiopulmonary resuscitation, gastrostomy, or hemodialysis) care. RESULTS: A total of 3658 patients were included. In the last 30 days of life, 63 and 13% of the patients received HI-EOL care and MI-EOL care, respectively. Being younger, having comorbidities, being care managed in a specialized hospital, and a lower time in a palliative care structure were the main factors associated with HI-EOL. CONCLUSIONS: A large majority of French young adults and adults with acute leukemia who died at the hospital experienced high intensity end-of-life care. Identification of factors associated with high-intensity end-of-life care, such as the access to palliative care and specialized cancer center care management, may help to improve end-of-life care quality.

Mask-Based versus Frame-Based Gamma Knife ICON Radiosurgery in Brain Metastases: A Prospective Randomized Trial.

BACKGROUND: Radiosurgery is performed with a diversity of instruments relying usually either on a stereotactic frame or a mask for patient head fixation. Comfort and safety efficacy of the 2 systems have never been rigorously evaluated and compared. MATERIAL AND METHOD: Between February 2016 and January 2017, 58 patients presenting with nonsmall cell lung cancer brain metastases have been treated by Gamma Knife radiosurgery (GKS) with random use of a frame or a mask for fixation were included patients older than 18, with <5 brain metastases (at the exclusion of brainstem and optic pathway's locations) and no earlier history of radiotherapy. The primary outcome measure was the pain scale assessment (PSA) at the beginning of the GKS procedure. RESULTS: The PSA at the beginning of the GKS procedure was not different between the 2 groups. The PSA at the day before GKS, before magnetic resonance imaging, just after frame application, and the day after radiosurgery (departure) has shown no difference between the 2 groups. At the end of the radiosurgery itself (just after frame or mask removal) and 1 h after, the mean pain scale was higher in patients treated with the frame (p < 0.05 and p < 0.001, respectively) but 2 patients were not able to tolerate the mask discomfort and had to be treated with frame. Tumor control and morbidity probability were demonstrated to be no difference between the 2 groups in this population of patients with BM not in highly functional area. The median of the extra dose to the body due to the cone-beam computed tomography was 7.5 mGy with a maximum of 35 mGy in patients treated with a mask fixation (null in the others treated with frame). Mask fixation was associated to longer treatment time although the beam on time was not different between the 2 groups. CONCLUSION: In selected patients, with brain oligo-metastases out of critical location, single-dose mask-based GKS can be done with a comfort and a safety efficacy comparable to frame-based GKS. There seems to be no clear patient data that confirm the value of the mask system with regards to comfort.

Pregnancy, delivery and neonatal complications in women with schizophrenia: a national population-based cohort study.

BACKGROUND: Existing studies evaluating the association between schizophrenia and complications associated with pregnancy, delivery and neonatal outcomes are based on data prior to 2014 and have reported heterogeneous results. The objective of our study was to determine whether pregnant women with schizophrenia were at increased risk of pregnancy, delivery and neonatal complications compared with women without severe mental disorders. METHODS: We performed a population-based cohort study of all singleton deliveries in France between Jan. 1, 2015, and Dec. 31, 2019. We divided this population into cases (i.e., women with schizophrenia) and controls (i.e., women without a diagnosis of severe mental disorder). Cases and controls were matched (1:4) inside the same hospital and the same year by age, social deprivation, parity, smoking, alcohol and substance addictions, malnutrition, obesity, and comorbidities. Univariate and multivariate models with odds ratios and 95% confidence intervals (ORs [95% CIs]) were used to estimate the association between schizophrenia and 24 pregnancy, delivery and neonatal outcomes. FINDINGS: Over 5 years, 3,667,461 singleton deliveries were identified, of which 3,108 occurred in women with schizophrenia. Compared to controls, women with schizophrenia were found to be older; have more frequent smoking, alcohol and substance addictions; suffer from obesity, diabetes and chronic obstructive pulmonary disease; and often be hospitalized in tertiary maternity hospitals. Compared to matched controls, women with schizophrenia had more pregnancy complications (adjusted OR=1.41[95%CI 1.31-1.51]) (i.e., gestational diabetes, gestational hypertension, genito-urinary infection, intrauterine growth retardation and threatened preterm labour). They had more delivery complications (aOR=1.18[95%CI 1.09 1.29]) with more still births/medical abortions (aOR=2.17[95%CI 1.62-2.90]) and caesarean sections (aOR=1.15[95%CI 1.05-1.25]). Newborns of women with schizophrenia had more neonatal complications (aOR=1.38[95%CI 1.27-1.50]) with more born preterm (aOR=1.64[95%CI1.42 -1.90]), small for gestational age (aOR=1.34[95%CI 1.19-1.50]) and low birth weight (aOR=1.75[95%CI 1.53-2.00]). INTERPRETATION: Our results highlight the importance of health disparities between pregnant women with and without schizophrenia, as well as in their newborns. Our study calls for health policy interventions during and before pregnancy, including proportionate intensified care to the level of needs, effective case management and preventive and social determinant approaches. FUNDING: No funding.

Lack of delayed neurocognitive side effects of Gamma Knife radiosurgery in acromegaly: the Later-Ac study.

INTRODUCTION: Persistent growth hormone hypersecretion can be observed in roughly 50% of patients operated for somatotroph adenomas, requiring additional treatments. Despite its proven antisecretory efficacy, the use of Gamma Knife radiosurgery (GK) is limited probably due to the lack of data on long-term side effects, including potential cognitive consequences. METHODS: The LATe Effects of Radiosurgery in Acromegaly study was a cross-sectional exposed/unexposed non-randomized study. The primary objective was to determine the long-term neurocognitive effects of GK focusing on memory, executive functions, and calculation ability. Exposed patients had been treated by GK for acromegaly at least 5 years before inclusion. Unexposed patients (paired for age) had to be cured or controlled at last follow-up without any radiation technique. Patients of both groups were cured or controlled at the last follow-up. RESULTS: Sixty-four patients were evaluated (27 exposed and 37 unexposed). Mean follow-up after GK was 13 ± 6 years (including 24 patients followed for at least 10 years). While up to 23.8% of the patients of the whole cohort presented at least one abnormal cognitive test, we did not observe any significant difference in neurocognitive function between both groups. During the follow-up, 11 patients presented at least one new pituitary deficiency (P = 0.009 for thyroid-stimulating hormone deficiency with a higher rate in exposed patients), two presented a stroke (1 in each group), and one presented a meningioma (12 years after GK). CONCLUSIONS: While GK exposes patients to a well-known risk of pituitary deficiency, it does not seem to induce long-term cognitive consequences in patients treated for acromegaly.

Quality of life of transplanted children and their parents: a cross-sectional study.

BACKGROUND: Transplantation is a saving therapeutic that has heavy consequences. The quality of life (QoL) of transplanted children and their parents has been little studied and should help physicians better manage these patients. The objectives of the study were to assess: (1) the QoL of transplanted children and parents and compare it with that of children with other chronic conditions associated with long-term consequences, and (2) potential variables modulating the QoL. METHODS: This cross-sectional study was performed in a multidisciplinary paediatric unit (Timone Hospital, Marseille, France). Children were less than 18 years old; had a liver, kidney or heart transplant; and had a time since transplantation of 1-10 years. Socio-demographics and clinical data were recorded from medical forms. The QoL was assessed using the VSP-A (Vécu et Santé Perçue de l'Adolescent et de l'Enfant) and the WhoQoL self-reported questionnaires. RESULTS: Forty-five families were included (response rate: 76%). The transplanted organs were the liver for 20 children, the kidney for 15 children, and the heart for 10 children. The QoL of transplanted children reported by their parents was better than that of children with inborn errors of metabolism and similar to that of childhood leukaemia survivors. The QoL of parents of transplanted children was better than that of parents of children with inborn errors of metabolism and did not differ from French norms. The QoL did not differ according to the nature of the transplanted organ, sex or the main sociodemographic data. The main modulators decreasing QoL were residual treatment level, medications switch and the presence of another regular treatment. CONCLUSION: Transplanted children and their families reported a fairly preserved QoL compared to children with other chronic health conditions. Special attention should be given to QoL modulators related to therapeutic management (medication switches, regular treatments) that might be amenable to improve the QoL. Trial registration Ethics committee of Aix-Marseille University, France (reference number: 2014-08-04-03, 24/4/2015; https://www.univ-amu.fr/fr/public/comite-dethique ).

End of life breast cancer care in women with severe mental illnesses.

Little is known on the end-of-life (EOL) care of terminal breast cancer in women with severe psychiatric disorder (SPD). The objective was to determine if women with SPD and terminal breast cancer received the same palliative and high-intensity care during their end-of-life than women without SPD. Study design, setting, participants. This population-based cohort study included all women aged 15 and older who died from breast cancer in hospitals in France (2014-2018). Key measurements/outcomes. Indicators of palliative care and high-intensity EOL care. Multivariable models were performed, adjusted for age at death, year of death, social deprivation, duration between cancer diagnosis and death, metastases, comorbidity, smoking addiction and hospital category. The analysis included 1742 women with SPD (287 with bipolar disorder, 1075 with major depression and 380 with schizophrenia) and 36,870 women without SPD. In multivariate analyses, women with SPD had more palliative care (adjusted odd ratio aOR 1.320, 95%CI [1.153-1.511], p < 0.001), longer palliative care follow-up before death (adjusted beta = 1.456, 95%CI (1.357-1.555), p < 0.001), less chemotherapy, surgery, imaging/endoscopy, and admission in emergency department and intensive care unit. Among women with SPD, women with bipolar disorders and schizophrenia died 5 years younger than those with recurrent major depression. The survival time was also shortened in women with schizophrenia. Despite more palliative care and less high-intensity care in women with SPD, our findings also suggest the existence of health disparities in women with bipolar disorders and schizophrenia compared to women with recurrent major depression and without SPD. Targeted interventions may be needed for women with bipolar disorders and schizophrenia to prevent these health disparities.

Pain Associated With Cervical Priming for First-Trimester Surgical Abortion: A Randomized Controlled Trial.

OBJECTIVE: To compare the effect of cervical priming with mifepristone with that of misoprostol on pain perception during surgical induced abortion under paracervical block. METHODS: We conducted a randomized, single-blind, two-center study of women undergoing surgical induced abortion at less than 14 weeks of gestation under paracervical block. Participants were randomized to receive cervical priming with 200 mg of oral mifepristone 36 hours or 400 micrograms buccal misoprostol 3 hours before surgery. The primary outcome was pain during mechanical cervical dilation evaluated by a 100-mm visual analog scale (VAS). Secondary outcomes were pain during aspiration, preoperative and postoperative pain, participant satisfaction, duration of the procedure, occurrence of complications, and ease of performing the procedure (assessed by a 100-mm VAS). We estimated that 110 women would have to be included to have 90% power to detect a 13mm-difference of VAS for pain. RESULTS: Between June 2017 and May 2019, 314 women were eligible and 110 were randomized (55 in each group). Patient characteristics were similar in the two groups. The mean VAS score during mechanical cervical dilation was lower in the mifepristone group (35.6±21 vs 43.5±21, P=.04) as was the mean VAS during aspiration (34±24 vs 47.8±23, P=.003). The preoperative and postoperative mean VAS, satisfaction and duration of procedures were similar between groups. The procedure was significantly easier to perform in the mifepristone group (88±16 vs 80±23, P=.004). CONCLUSION: Cervical priming with mifepristone for surgical induced abortion under paracervical block up to 14 weeks of gestation is more effective than misoprostol in reducing pain perception. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03043014.

Acceptability of a Novel Telemedication Review for Older Adults in Nursing Homes in France: A Qualitative Study.

PURPOSE: In France, polypharmacy among older people living in nursing homes (NH) is a major public health concern. In this context, the randomized controlled trial TEM-EHPAD was recently launched in various NH in southern France to evaluate the impact of implementing a novel telemedication review (TMR) on hospital admission rates of NH residents at high risk of iatrogenic disease. A qualitative study was integrated into the main trial study to assess general practitioners' (GP) and other NH healthcare professionals' (HP) acceptability of the proposed TMR before its implementation. MATERIAL AND METHODS: A qualitative study using face-to-face semi-structured interviews was conducted with 16 HP before the beginning of the intervention. A manual thematic analysis was performed on the transcribed interviews. RESULTS: Four main themes emerged from the thematic analysis: HP perceptions of the TMR, difficulties related to medication management for NH residents, HP perceptions of the roles of different professionals, and facilitators of good practices. Most participants were favorable to the TMR, but some GP expressed fears about loss of control over their prescription writing. CONCLUSION: This study fulfilled its objective to assess pre-intervention acceptability by GP and other HP. Results provided important information about how to adapt the TMR intervention to make it more acceptable to HP who will be involved in TEM-EHPAD. One of the main recommendations is the importance of providing participating GP with the opportunity to take part in the process of reviewing prescriptions.

Palliative and high-intensity end-of-life care in schizophrenia patients with lung cancer: results from a French national population-based study.

Schizophrenia is marked by inequities in cancer treatment and associated with high smoking rates. Lung cancer patients with schizophrenia may thus be at risk of receiving poorer end-of-life care compared to those without mental disorder. The objective was to compare end-of-life care delivered to patients with schizophrenia and lung cancer with patients without severe mental disorder. This population-based cohort study included all patients aged 15 and older who died from their terminal lung cancer in hospital in France (2014-2016). Schizophrenia patients and controls without severe mental disorder were selected and indicators of palliative care and high-intensity end-of-life care were compared. Multivariable generalized log-linear models were performed, adjusted for sex, age, year of death, social deprivation, time between cancer diagnosis and death, metastases, comorbidity, smoking addiction and hospital category. The analysis included 633 schizophrenia patients and 66,469 controls. The schizophrenia patients died 6 years earlier, had almost twice more frequently smoking addiction (38.1%), had more frequently chronic pulmonary disease (32.5%) and a shorter duration from cancer diagnosis to death. In multivariate analysis, they were found to have more and earlier palliative care (adjusted Odds Ratio 1.27 [1.03;1.56]; p = 0.04), and less high-intensity end-of-life care (e.g., chemotherapy 0.53 [0.41;0.70]; p < 0.0001; surgery 0.73 [0.59;0.90]; p < 0.01) than controls. Although the use and/or continuation of high-intensity end-of-life care is less important in schizophrenia patients with lung cancer, some findings suggest a loss of chance. Future studies should explore the expectations of patients with schizophrenia and lung cancer to define the optimal end-of-life care.

Risk stratification of adrenal masses by [18 F]FDG PET/CT: Changing tactics.

CONTEXT: [18 F]FDG PET/CT improves adrenal tumour characterization. However, there is still no consensus regarding the optimal imaging biomarkers of malignancy. OBJECTIVES: To assess the performance of Tumour standardized uptake value (SUV)max :Liver SUVmax for malignancy-risk and to build and evaluate a prediction model. DESIGN/METHODS: The cohort consisted of consecutive patients with adrenal masses evaluated by [18 F]FDG PET/CT. The gold standard for malignancy was based on histology or a multidisciplinary consensus in nonoperated cases. The performance of the previously reported cut-off for Tumour SUVmax :Liver SUVmax (>1.5) was evaluated in this independent cohort. Additionally, a predictive model of malignancy was built from the training cohort (previous study) and evaluated in the validation cohort (current study). RESULTS: Sixty-four patients were evaluated; 28% of them had a Cushing's syndrome. Fifty-four adrenal masses were classified as benign and 10 as malignant (including 7 adrenocortical carcinomas). Compared to benign masses, malignant lesions were larger in size, had higher unenhanced densities and higher [18 F]FDG uptake. CT-derived anthropometric parameters did not differ between benign and malignant masses. A tumour SUVmax :Liver SUVmax  > 1.5 showed a good diagnostic performance: Se = 90.0%/Sp = 92.6%/PPV = 69.2%/NPV = 98.0% and accuracy = 92.2%. A predictive model based on tumour size and tumour-to-liver uptake SUVmax ratio for malignancy-risk was validated and provides a complementary approach to the ratio. CONCLUSIONS: Tumour SUVmax :Liver SUVmax uptake ratio is a useful biomarker for diagnosis of adrenal masses. Another tactic would be to calculate with the model an individual risk of malignancy and integrate this information into a shared decision-making process.