Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study.

BACKGROUND: Non-randomised studies assessing intrarectal botulinum toxin type A (BoNTA) injections for faecal incontinence are promising. We aimed to evaluate the efficacy of BoNTA for the treatment of faecal incontinence in a randomised study. METHODS: In this randomised, double-blind, placebo-controlled study, we included adult patients who had at least one urgency or faecal incontinence episode per week for at least 3 months and who had experienced a failure of conservative or surgical treatment from eight French specialist hospital units with the skills to manage patients with faecal incontinence. Patients were randomly assigned (1:1) by a central web form to receive intrarectal submucosal injections of either 200 units of BoNTA (Botox; Allergan, Irvine, CA, USA; BoNTA group) or an equivalent volume of saline (placebo group), stratified by Cleveland Clinic Severity scores (CCS score; ≥12 or <12). Patients, investigators, study site staff, and sponsor personnel were masked to treatment allocation up to the 6-month visit. The primary endpoint was the number of episodes of faecal incontinence and urgency per day assessed using 21-day patient bowel diaries 3 months after the treatment. The primary analysis was performed using a modified intention-to-treat (mITT) approach (ie, in all the randomised patients who had received a treatment) with adjustment for baseline faecal incontinence and urgency episodes. After the final data collection at 6 months after injections, patients were unmasked and offered the BoNTA treatment if they were in the placebo group (rescue therapy) without masking, with an additional 6 months of safety follow-up. This trial is registered with ClinicalTrials.gov, number NCT02414425. FINDINGS: Between Nov 25, 2015, and Nov 25, 2020, we randomly assigned 200 patients to receive either BoNTA (n=100) or placebo (n=100) injections. Due to withdrawals before the injections, 96 patients were included in the BoNTA group and 95 patients were included in the placebo group (mITT analysis). The mean number of faecal incontinence and urgency episodes per day in the BoNTA group decreased from 1·9 (SD 2·2) at baseline to 0·8 (1·8) at 3 months after the injections, and from 1·4 (1·1) to 1·0 (1·0) in the placebo group, with a baseline-adjusted mean group difference at 3 months estimated at -0·51 (95% CI -0·80 to -0·21, p=0·0008). No serious treatment-related adverse events were reported in the trial. The most frequently reported non-serious adverse event (treatment related or not) following the BoNTA or placebo injections was constipation (reported in 68 [40%] of 169 patients who received the BoNTA injections and 38 [40%] of 95 patients who received placebo injections). INTERPRETATION: BoNTA injections are an efficacious treatment for urge faecal incontinence. Further research will define the optimum selection criteria, dose, site of injection, re-injection frequency, and long-term results. FUNDING: General Direction of Healthcare (French Ministry of Health).

An exposed/unexposed cohort study assessing the effectiveness, the safety and the survival of patients established on home non-invasive ventilation after 80 years old.

BACKGROUND: Little is known about the use of long-term non-invasive ventilation (NIV) in the elderly. We aimed to assess if the effectiveness of long-term NIV of patients ≥ 80 years (older) was not greatly inferior to that of patients < 75 years (younger). METHODS: This retrospective exposed/unexposed cohort study included all patients established on long-term NIV treated at Rouen University Hospital between 2017 and 2019. Follow-up data were collected at the first visit following NIV initiation. The primary outcome was daytime PaCO2 with a non-inferiority margin of 50% of the improvement of PaCO2 for older patients compared to younger patients. RESULTS: We included 55 older patients and 88 younger patients. After adjustment on the baseline PaCO2, the mean daytime PaCO2 was reduced by 0.95 (95% CI: 0.67; 1.23) kPa in older patients compared to1.03 (95% CI: 0.81; 1.24) kPa in younger patients for a ratio of improvements estimated at 0.95/1.03 = 0.93 (95% CI: 0.59; 1.27, one-sided p = 0.007 for non-inferiority to 0.50). Median (interquartile range) daily use was 6 (4; 8.1) hours in older versus 7.3 (5; 8.4) hours in younger patients. No significant differences were seen in the quality of sleep and NIV safety. The 24-months survival was 63.6% in older and 87.2% in younger patients. CONCLUSIONS: effectiveness and safety seemed acceptable in older patients, with a life expectancy long enough to expect a mid-term benefit, suggesting that initiation of long-term NIV should not be refused only based on age. Prospective studies are needed.

Impact of Clinical Pharmacist Consultations on Postoperative Pain in Ambulatory Surgery.

Post-operative pain is a common symptom of ambulatory surgery. The objective of this study was to evaluate a pain management protocol integrating a pharmacist consultation. We conducted a quasi-experimental, single center, before-after study. The control group was recruited between 1 March and 31 May 2018 and the intervention group between 1 March and 31 May 2019. Outpatients in the intervention group received a pharmacist consultation, in addition to the usual anesthesiologist and nurse consultations. Pharmacist consultations were conducted in two steps: the first step consisted of general open-ended questions and the second step of a specific and individualized pharmaceutical interview. A total of 125 outpatients were included in each group. There were 17% (95% CI 5 to 27%, p = 0.022) fewer patients with moderate to severe pain in the pharmaceutical intervention group compared with the control group, which corresponded to a decrease in the mean pain level of 0.9/10 (95% CI -1.5/10; -0.3/10; p = 0.002). The multivariate analysis did not reveal any confounding factors, showing that only the pharmaceutical intervention could explain this result. This study demonstrates a positive impact of pharmacist consultations on postoperative pain in ambulatory surgery.

Gastric electrical stimulation versus per-oral pyloromyotomy for the treatment of nausea and vomiting associated with gastroparesis: An observational study of two cohorts.

BACKGROUND: Both gastric electrical stimulation (GES) and gastric-peroral endoscopic myotomy (G-POEM) can be offered to patients with gastroparesis and predominant nausea and vomiting. The study's aim was to compare GES and G-POEM efficacy on nausea and vomiting scores in patients with gastroparesis. METHODS: Two multicenter cohorts of patients with medically refractory gastroparesis with predominant nausea and vomiting (defined as a score >2 on nausea and vomiting subscale that varied from 0 to 4) were treated either with GES (n = 34) or G-POEM (n = 30) and were followed for 24 months (M). Clinical response was defined as a decrease of ≥1 point in nausea and vomiting subscale without premature exclusion due to switch from one to the other technique before M24. Changes in symptomatic scales and quality of life were also monitored. KEY RESULTS: Patients from both groups were comparable although the mean score of nausea and vomiting subscale was higher in GES (3.0) compared to G-POEM group (2.6; p = 0.01). At M24, clinical response was achieved in 21/34 (61.7%) patients with GES and in 21/30 (70.0%; p = 0.60) patients with G-POEM. Mean scores of nausea and vomiting subscale decreased at M24 in both GES (from 3.0 to 1.6; p < 0.001) and G-POEM (from 2.6 to 1.2; p < 0.001) groups, although there was no difference between groups (difference adjusted from baseline: -0.28 [-0.77; 0.19]; p = 0.24). Likewise, symptomatic and quality of life scores improved at M24 in both groups, without difference according to treatment group. CONCLUSIONS AND INFERENCES: At M24, we did not observe significant difference in efficacy of GES and G-POEM in medically refractory gastroparesis with predominant nausea and vomiting.

Applicability of the Edinburgh CT Criteria for Lobar Intracerebral Hemorrhage Associated with Cerebral Amyloid Angiopathy.

OBJECTIVE: Based on histopathology, Edinburgh diagnostic criteria were proposed to consider a nontraumatic intracerebral lobar hemorrhage (ICH) as related to cerebral amyloid angiopathy (CAA) using the initial computed tomography (CT) scan and the APOE genetic status. We aimed to externally validate the Edinburgh prediction model, excluding the APOE genotyping and based on the modified Boston criteria on the MRI for CAA diagnosis METHODS: We included patients admitted for spontaneous lobar ICH in the emergency department between 2016 and 2019 who underwent noncontrast CT scan and MRI. According to the MRI, patients were classified into the CAA group or into the non-CAA group in the case of other causes of ICH. Two neuroradiologists, blinded to the final retained diagnosis, rated each radiological feature on initial CT scan described in the Edinburgh study on initial CT scan RESULTS: A total of 102 patients were included, of whom 36 were classified in the CAA group, 46 in the non-CAA causes group and 20 of undetermined cause (excluded from the primary analysis). The Edinburgh prediction model, including finger-like projections and subarachnoid extension showed an area under receiver operating characteristic curves (AUC) of 0.760 (95% confidence interval, CI: 0.660-0.859) for the diagnosis of CAA. The AUC reached 0.808 (95% CI: 0.714-0.901) in a new prediction model integrating a third radiologic variable: the ICH cortical involvement. CONCLUSION: Using the Boston MRI criteria as a final assessment, we provided a new external confirmation of the radiological Edinburgh CT criteria, which are directly applicable in acute settings of spontaneous lobar ICH and further proposed an original 3­set model considering finger-like projections, subarachnoid extension, and cortical involvement that may achieve a high discrimination performance.

Incidence, management, and outcome of lung cancer in patients with long-term oxygen therapy.

BACKGROUND: Here, we aimed to assess the specific features of lung cancer in patients with long-term oxygen therapy (LTOT), and compare their outcomes with patients suffering from lung cancer without LTOT. METHODS: This retrospective, case-controlled study included patients with LTOT and an incident diagnosis of lung cancer treated at Rouen University Hospital. RESULTS: Out of 2201 patients with LTOT, 31 were diagnosed with lung cancer. Among 24 patients with proven lung cancer, the most frequent histological type was squamous cell carcinoma (n = 12/24, 50%). Active treatment of any type was given in 19/31 (61%) and 41/62 (66%) of patients in the LTOT and control groups, respectively (p = 0.83). In the LTOT group, median survival was 38 days with best supportive care and 462 days with active treatment (p = 0.003). However, when adjusting on performance status and disease stage, LTOT was not significantly associated with a worse outcome. Hazard ratio (HR): 1.56 (95% confidence interval [CI]: 0.87 to 2.81) (p = 0.137). Administration of any treatment was associated with a better prognostic: HR: 0.35 (95% CI: 0.19 to 0.66). Both groups had a similar treatment safety profile. CONCLUSION: Incidence of lung cancer in patients with LTOT was comparable to the general population. The proportion of LTOT patients who received active treatment was similar to controls, and overall survival did not differ from controls in a multivariate analysis. Although reaching a histological diagnosis may be challenging in LTOT patients, the efficacy and safety of the management strategies of lung cancer seem preserved.

Safety and efficacy of NOAC vs. VKA in patients treated by PCI: a retrospective study of the FRANCE PCI registry.

Introduction: Dual antithrombotic therapy (DAT) combining oral anticoagulation (OAC), preferentially Non-vitamin K antagonist OAC (NOAC) and single antiplatelet therapy (SAPT) for a period of 6-12 months is recommended after percutaneous coronary intervention (PCI) in patients with an indication for OAC. Objective: To compare outcomes between vitamin K antagonist (VKA) and NOAC-treated patients in the nation-wide France PCI registry. Methods: All consecutive patients from the France PCI registry treated by PCI and discharged with OAC between 2014 and 2020 were included and followed one-year. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) classification ≥3 and major adverse cardiac events (MACE) as the composite of all-cause mortality, myocardial infarction (MI), and ischemic stroke. A propensity-score analysis was used. Results: Of the 7,277 eligible participants, 2,432 (33.4%) were discharged on VKA and 4,845 (66.6%) on NOAC. After propensity-score adjustment, one-year major bleeding was less frequent in NOAC vs. VKA-treated participants [3.1% vs. 5.2%, -2.1% (-3.6% to -0.6%), p = 0.005 as well as the rate of MACE [9.2% vs. 11.9%, -2.7% (-5.0% to -0.4%), p = 0.02]. One-year mortality was also significantly decreased in NOAC vs. VKA-treated participants [7.4% vs. 9.9%, -2.6% (-4.7% to -0.5%), p = 0.02]. The area under ROC curves of the anticoagulant treatment propensity score was estimated at 0.93, suggesting potential indication bias. Conclusions: NOAC seems to have a better efficacy and safety profile than VKA. However, potential indication bias were found.

Impact of the Lubrizol factory fire in Rouen on coronary events: A retrospective study from the France PCI registry.

BACKGROUND: On 26 September 2019, an industrial fire occurred in the Lubrizol factory in Rouen (France), exposing the population to the inhalation of many volatile toxic agents secondary to combustion. AIM: To assess the impact of the Lubrizol factory fire on the incidence of coronary artery events. METHODS: All coronary angiograms performed in Rouen (exposed) and Le Havre (unexposed) from May 2019 to December 2019 were extracted from the prospective France Percutaneous Coronary Intervention (France PCI) registry. To study the impact of the fire on coronary events, an interrupted time series analysis was performed in Rouen, with adjustment on Le Havre in an autoregressive moving average (ARMA)(1,1) model with the precision of 1 week. The primary outcome was the incidence of acute coronary syndrome, and the secondary outcome was the incidence of ST-segment elevation myocardial infarction. RESULTS: The mean number of acute coronary syndromes per week in the exposed zone (Rouen) increased non-significantly from 37.5±9.4 before the fire to 43.2±6.2 after the fire, for an estimated effect of +5.5 (95% confidence interval -0.7 to 11.8; P=0.09) events per week. In municipalities exposed to the plume of smoke (subgroup of Rouen), the mean number of acute coronary syndromes increased non-significantly from 7.3±2.8 before the fire to 8.7±3.6 after the fire, for an estimated effect of +1.0 (95% confidence interval -2.0 to 4.0; P=0.51) events per week. The results were similar when taking into account only ST-segment elevation myocardial infarctions or all coronary events. CONCLUSIONS: Our study did not find a significant effect of the Lubrizol factory fire on the incidence of acute coronary syndrome. Further studies are needed to investigate the impact of industrial accidents on air pollution and coronary events.

Long-Term Survival Following Minimally Invasive Lung Cancer Surgery: Comparing Robotic-Assisted and Video-Assisted Surgery.

BACKGROUND: Nowadays, video-assisted thoracoscopic surgery (VATS) and robotic-assisted thoracoscopic surgery (RATS) are known to be safe and efficient surgical procedures to treat early-stage non-small cell lung cancer (NSCLC). We assessed whether RATS increased disease-free survival (DFS) compared with VATS for lobectomy and segmentectomy. METHODS: This retrospective cohort study included patients treated for resectable NSCLC performed by RATS or VATS, in our tertiary care center from 2012 to 2019. Patients' data were prospectively recorded and reviewed in the French EPITHOR database. Primary outcomes were 5-year DFS for lobectomy and 3-year DFS for segmentectomy, compared by propensity-score adjusted difference of Kaplan-Meier estimates. RESULTS: Among 844 lung resections, 436 VATS and 234 RATS lobectomies and 46 VATS and 128 RATS segmentectomies were performed. For lobectomy, the adjusted 5-year DFS was 60.9% (95% confidence interval (CI) 52.9-68.8%) for VATS and 52.7% (95%CI 41.7-63.7%) for RATS, with a difference estimated at -8.3% (-22.2-+4.9%, p = 0.24). For segmentectomy, the adjusted 3-year DFS was 84.6% (95%CI 69.8-99.0%) for VATS and 72.9% (95%CI 50.6-92.4%) for RATS, with a difference estimated at -11.7% (-38.7-+7.8%, p = 0.21). CONCLUSIONS: RATS failed to show its superiority over VATS for resectable NSCLC.

Outcomes following prenatal diagnosis of isolated persistent left superior vena cava.

BACKGROUND: Prenatal diagnosis of persistent left superior vena cava is increasing, but little is known about outcomes of infants with prenatally diagnosed isolated persistent left superior vena cava. OBJECTIVE: To assess the outcomes of infants with isolated persistent left superior vena cava diagnosed prenatally compared with infants with associated malformations. METHODS: All cases of persistent left superior vena cava confirmed by specialized fetal echocardiography in pregnant women were included from a single-centre prospective registry. Unfavourable outcome was defined as termination of pregnancy, in utero death, postnatal death or severe genetic syndrome missed prenatally. RESULTS: A total of 256 infants were included: 113 cases (44.1%) with isolated persistent left superior vena cava and 143 cases (55.9%) with associated malformations; respectively, 111 (98.2%) and 101 (70.6%) had a live birth. The median postnatal clinical follow-up was 3.6 years. Five-year postnatal survival with good outcome was estimated at: 100% (95% confidence interval 90.7% to 100%) in infants with isolated persistent left superior vena cava; 91.0% (74.0% to 98.1%) in infants with associated cardiac anomalies; 87.5% (51.8% to 97.3%) in infants with associated extracardiac anomalies; 81.0% (52.6 to 94.6%) in infants with both cardiac and extracardiac anomalies; and 78.9% (36.7% to 95.9%) in infants with non-structural anomalies. All genetic findings and syndromes were detected in fetuses or infants with non-isolated persistent left superior vena cava. CONCLUSION: Infants with isolated persistent left superior vena cava have good short-term outcomes postnatally, but persistent left superior vena cava is frequently associated with other malformations that have an effect on outcomes, which should be thoroughly searched for prenatally.

Optimized 3D-FLAIR sequences to shorten the delay between intravenous administration of gadolinium and MRI acquisition in patients with Menière's disease.

OBJECTIVES: The aim of this study was to shorten the 4-h delay between the intravenous administration of gadolinium and MRI acquisition for hydrops evaluation using an optimized 3D-FLAIR sequence in patients with Menière's disease. METHODS: This was a single-center prospective study including 29 patients (58 ears), recruited between November 2020 and February 2021. All patients underwent a 3-T MRI with an optimized 3D-FLAIR sequence without contrast then at 1 h, 2 h, and 4 h after intravenous administration of gadobutrol. The signal intensity ratio was quantitatively assessed with the region of interest method. We also evaluated the volume of endolymphatic structures (saccule, utricle) then the presence of endolymphatic hydrops and blood-labyrinthine barrier impairment at each acquisition time. RESULTS: For all ears, the signal intensity ratio was significantly non-inferior at 2 h compared to 4 h, with a mean geometric signal intensity ratio at 0.83 (95% CI: 0.76 to 0.90, one-sided p < .001 for non-inferiority at -30% margin). Mean volume equivalence of saccule and utricle between 2 and 4 h was proven at a ± 0.20 standardized deviation equivalence margin. Intra-rater agreements (Cohen's kappa) were all greater than 0.90 for all endolymphatic hydrops location and blood-labyrinthine-barrier impairment between the 2- and 4-h assessments. CONCLUSIONS: We demonstrated that using an optimized 3D-FLAIR sequence we could shorten the acquisition from 4 to 2 h with a high reliability for the diagnosis of endolymphatic hydrops and blood-labyrinthine-barrier impairment. CLINICAL TRIAL REGISTRATION: Clinical trial no: 38RC15.173 KEY POINTS: • Magnetic resonance imaging with delayed 3D-FLAIR sequences allows the diagnosis of endolymphatic hydrops in patients with definite Menière's disease. • An optimized 3D-FLAIR sequence with a long TR of 16000 ms and a constant flip angle allows for reducing the delay between intravenous injection of gadobutrol and MRI acquisition from 4 to 2 h to diagnose endolymphatic hydrops. • Reducing this delay between intravenous injection and MRI acquisition could have implications for clinical practice for both patients and imaging departments.

Acceptance Factors for In-Hospital Pharmacist Interventions in Daily Practice: A Retrospective Study.

Introduction: Performing pharmacist interventions (PIs) during the medication review helps to improve the quality of care. The acceptance by the physician of these PIs is a good indicator of the quality of this clinical pharmacy activity. The objective of this study was to determine, in the Amiens-Picardie teaching hospital (France), factors of acceptance in a variable environment of activity (central pharmacy, in the care units, computer assisted). Methods: All PIs transcribed by pharmacists on the Act-IP© site between November 2018 and April 2019 were analyzed using a complementary search in patient records. The environment, type, and clinical impact on patient health of each PI was collected. Linear mixed-effects models with a random pharmacist intercept were used to investigate the relationship between PI modalities and their chance of being accepted. Results: A total of 3,100 PIs were traced, of which 2,930 had been followed over time. Of these, 2,930 PIs, 1,504 (51.3%) were performed by a postgraduate pharmacist and 1,426 (48.7%) by a pharmacy resident, 1,623 (55.4%) were performed by verbal exchange, 455 (15.5%) by telephone, 846 (28.9%) by computer software, and 6 (0.2%) by paper. The clinical impact on patient health was major for 976 PIs (33.3%) and vital for 26 PIs (0.9%). According to the Anatomical Therapeutic Chemical Classification (ATC), they were mainly related to anti-infectives (30.3%), the nervous system (18.7%), and blood and blood-forming organs (17.3%). In total, 2,415 PIs (82.4%) were accepted. According to the multivariate model, a PI was more often accepted when it was transmitted orally rather than by software (+27.7%, 95% CI: +23.2 to +32.1%) and when it was transmitted to a medical resident rather than a postgraduate physician (+4.4%, 95% CI: 1.2-7.6%). In these cases, there was a major rather than a moderate clinical impact on patient health (+4.3%, 95% CI: +1.1-+7.6%). Conclusion: This study highlights the importance of the quality of the exchange with the prescriber and the prioritization of high-risk interventions as key points of medication review to improve rate of pharmacist interventions accepted by physician.

The 6-minute stepper test and the sit-to-stand test predict complications after major pulmonary resection via minimally invasive surgery: a prospective inception cohort study.

QUESTIONS: How well do the 6-minute stepper test (6MST) and sit-to-stand test (STST) predict complications after minimally invasive lung cancer resection? Do the 6MST and STST provide supplementary information on the risk of postoperative complications in addition to the prognostic variables that are currently used, such as age and the American Society of Anesthesiology (ASA) score? DESIGN: Prospective inception cohort study with follow-up for 90 days. PARTICIPANTS: Consecutive sample of adults undergoing major lung resection with video-assisted thoracic surgery (VATS) or robot-assisted thoracic surgery (RATS). OUTCOME MEASURES: Patients had a preoperative functional evaluation with the 6MST and STST. The number of steps, heart rate change, saturation and dyspnoea during the 6MST and the number of lifts during the STST were recorded. Complications graded ≥ 2 on the Clavien-Dindo classification were recorded for 90 days after surgery. RESULTS: Between November 2018 and November 2019, 118 patients with a mean age of 65 years (SD 9) were included and analysed. Their surgeries were via VATS in 88 (75%) and via RATS in 30 (25%). For predicting a postoperative complication graded ≥ 2 on the Clavien-Dindo classification, the area under the Receiver Operating Characteristic curve was: 0.82 (95% CI 0.75 to 0.90) for the number of steps during the 6MST, with an optimum cut-off of 140 steps; and 0.85 (95% CI 0.77 to 0.93) for the number of lifts during the STST, with an optimum cut-off of 20 lifts. CONCLUSION: The 6MST and STST predicted morbidity and mortality after lung cancer resection via minimally invasive surgery. The preoperative use of these exercise tests in clinical practice may be useful for risk stratification. REGISTRATION: NCT03824977.

Evaluation of the Duration of Preanesthesia Consultation: Prospective and Multicenter Study.

BACKGROUND: The time allocated to the preanesthesia consultation (PAC) of a patient undergoing an elective surgical procedure is an important factor to optimize consultation sessions. The main objective of this study was to build a model predictive of the duration of the PAC. METHODS: We prospectively studied 1007 patients undergoing a PAC from January 2016 to June 2018 in 4 different hospitals. A general linear model was fitted to predict the overall duration of the PAC. Secondary models predicted the time spent on clinical evaluation and the time assigned to delivering information. RESULTS: After exclusion of 40 patients with major data inconsistencies, the mean (standard deviation [SD]) overall duration of the PAC was 11.2 (5.8) minutes, split into 6.8 (4.1) minutes of information and 4.4 (2.7) minutes of clinical evaluation. It was, respectively, 11.4 (5.9), 6.9 (4.2), and 4.4 (2.7) in the 924 patients ≥16 years of age and, respectively, 8.3 (2.3), 4.3 (1.8), and 4.1 (1.8) in 43 children. The American Society of Anesthesiologists (ASA) score, the number of comorbidities or treatment, surgery discipline, and context (ambulatory, conventional hospitalization, and intensive care unit) were significantly correlated to PAC time. In the 924 adult patients, the models had an R2 adjusted for overfitting at 0.47 for the total duration of PAC, 0.45 for the clinical examination time, and 0.24 for the information time. The estimated residual standard deviations were, respectively, 4.3, 3.1, and 2.7 minutes. CONCLUSIONS: The predictive performances of the model explaining the overall duration of PAC were average (R2 = 0.47) and should be confirmed by further studies to use it for optimizing the organization of the consultation by individualizing the time dedicated to each consultation.

Repetitive transcranial magnetic stimulation for patients with functional paralysis: a randomized controlled study.

BACKGROUND AND PURPOSE: Repetitive transcranial magnetic stimulation (rTMS) has been proposed to treat functional neurological disorders. Here, the aim was to assess the efficacy of rTMS to treat functional paralysis in a controlled randomized trial. METHODS: Patients received two sessions of active or sham 0.25 Hz rTMS (60 stimuli each), with a 1-day interval, applied over the motor cortex contralateral to the paralysis. The primary outcome was the number of patients with an increase in motor score between baseline and after the second rTMS session, rated by two investigators blinded to the treatment allocation. Secondary outcomes were changes in global and fine motor scores between groups after rTMS, and the occurrence of adverse events. RESULTS: Sixty-two patients (46 female; mean [SD] age, 35.2 [13.9] years) were enrolled and randomized. Thirteen out of 32 (41%) and 11/30 (37%) patients had increased motor strength after active or sham rTMS, respectively (p = 0.80). Changes in both global and fine motor scores after rTMS relative to baseline were also not significantly different between treatment groups (median difference in the global motor score 0.62 [0.83] and 0.37 [0.61], and in the fine motor scores 0.12 [0.18] and 0.08 [0.11], in active and sham rTMS groups, respectively; p = 0.14). Six serious adverse events, consisting of three cephalalgia in the active group and two cephalalgia and one asthenia in the sham group, were observed. CONCLUSIONS: Two sessions of sham or active low frequency rTMS were effective to improve functional paralysis, suggesting a placebo effect of this non-invasive brain stimulation technique.

A Cognitive Aid Improves Adherence to Guidelines for Critical Endotracheal Intubation in the Resuscitation Room: A Randomized Controlled Trial With Manikin-Based In Situ Simulation.

INTRODUCTION: Emergency endotracheal intubation (ETI) is a high-risk procedure. Some of its adverse events are life-threatening, and guidelines emphasize the need to anticipate complications by thorough preparation. The emergency department (ED) can be an unpredictable environment, and we tested the hypothesis that a cognitive aid would help the emergency practitioners better follow guidelines. The main objective of this study was to determine whether the use of a cognitive aid focusing on both preintubation and postintubation items could improve ETI preparation and implementation in the ED resuscitation room regarding adherence to guidelines. The secondary objective was to measure and describe procedure times. METHODS: We conducted a single-blind randomized controlled trial with manikin-based in situ simulation. The participants were not aware of the purpose of the study. The cognitive aid was developed using national guidelines and current scientific literature. The most relevant items were the preparation and implementation of a rapid sequence induction for ETI followed by mechanical ventilation. Emergency department physician-nurse pairs were randomized into a "cognitive aid" group and a "control" group. All pairs completed the same scenario that led to ETI in their own resuscitation room. An adherence to guidelines score of 30, derived from the 30 items of the cognitive aid (1 point per item), and preparation and intubation times were collected. RESULTS: Seventeen pairs were included in each group. Adherence to guidelines scores were significantly higher in the cognitive aid group than in the control group (median = 28 of 30, interquartile range = 25-28, vs. median = 24 of 30, interquartile range = 21-26, respectively, P < 0.01). Preparation, intubation, and total procedure times were slightly longer in the cognitive aid group, but these results were not significant. CONCLUSIONS: In an in situ simulation, a cognitive aid for the preparation and implementation of an emergency intubation procedure in the ED resuscitation room significantly improved adherence to guidelines without increasing procedure times. Further work is needed in a larger sample and in different settings to evaluate the optimal use of cognitive aids in critical situations.

Improving Radiographic Fracture Recognition Performance and Efficiency Using Artificial Intelligence.

Background Missed fractures are a common cause of diagnostic discrepancy between initial radiographic interpretation and the final read by board-certified radiologists. Purpose To assess the effect of assistance by artificial intelligence (AI) on diagnostic performances of physicians for fractures on radiographs. Materials and Methods This retrospective diagnostic study used the multi-reader, multi-case methodology based on an external multicenter data set of 480 examinations with at least 60 examinations per body region (foot and ankle, knee and leg, hip and pelvis, hand and wrist, elbow and arm, shoulder and clavicle, rib cage, and thoracolumbar spine) between July 2020 and January 2021. Fracture prevalence was set at 50%. The ground truth was determined by two musculoskeletal radiologists, with discrepancies solved by a third. Twenty-four readers (radiologists, orthopedists, emergency physicians, physician assistants, rheumatologists, family physicians) were presented the whole validation data set (n = 480), with and without AI assistance, with a 1-month minimum washout period. The primary analysis had to demonstrate superiority of sensitivity per patient and the noninferiority of specificity per patient at -3% margin with AI aid. Stand-alone AI performance was also assessed using receiver operating characteristic curves. Results A total of 480 patients were included (mean age, 59 years ± 16 [standard deviation]; 327 women). The sensitivity per patient was 10.4% higher (95% CI: 6.9, 13.9; P < .001 for superiority) with AI aid (4331 of 5760 readings, 75.2%) than without AI (3732 of 5760 readings, 64.8%). The specificity per patient with AI aid (5504 of 5760 readings, 95.6%) was noninferior to that without AI aid (5217 of 5760 readings, 90.6%), with a difference of +5.0% (95% CI: +2.0, +8.0; P = .001 for noninferiority). AI shortened the average reading time by 6.3 seconds per examination (95% CI: -12.5, -0.1; P = .046). The sensitivity by patient gain was significant in all regions (+8.0% to +16.2%; P < .05) but shoulder and clavicle and spine (+4.2% and +2.6%; P = .12 and .52). Conclusion AI assistance improved the sensitivity and may even improve the specificity of fracture detection by radiologists and nonradiologists, without lengthening reading time. Published under a CC BY 4.0 license. Online supplemental material is available for this article. See also the editorial by Link and Pedoia in this issue.

Static and dynamic stabilometric force platform study of spinopelvic anterior sagittal imbalance.

BACKGROUND DATA: Anterior sagittal imbalance (ASI) is a severity factor in spinal pathology. Stabilometric study of the dynamic position of the center of pressure (CoP) assesses orthostatic control. These analyses provide the energy expenditure used for this control. HYPOTHESIS: Stabilometric signs are associated with ASI indicate increased energy expenditure. PATIENTS AND METHODS: Healthy male volunteers were subjected to reversible ASI induced by wearing a kyphotic thermoformed thoracolumbar corset. The deformation was assessed by C7 tilt on EOS whole-spine views. Static and dynamic posturographic force platform study was performed under conditions of anteroposterior and mediolateral instability. Mean CoP position (Xmean, Ymean) was studied on statokinesigram, with scatter assessed as confidence ellipse (CE). Path length according to CE surface (LAS) indicated energy expenditure. The stabilogram quantified displacement over time as lengths (Lx, Ly) and amplitudes (Ax, Ay). RESULTS: The corset significantly increased C7 tilt (p<0.0001). This did not significantly change mean CoP positions (Xmean and Ymean), but LAS was significantly increased (p=0.003). Static tests showed changes in Ly (p=0.0008) and Ax (p=0.003), and dynamic tests showed changes in Ly (p<0.0001), Lx (p<0.0001), Ax (p<0.0001), Ay (p<0.05) and CE (p<0.004). DISCUSSION: Posturographic parameters were impacted by inducing ASI in healthy subjects. Significant differences were seen in stabilography, CE and LAS, were greater on dynamic testing, and correlated with radiologic sagittal balance. Force platforms can reveal increased energy expenditure in maintaining posture. LEVEL OF EVIDENCE: II; Single-center prospective study involving healthy volunteers.