Muriel Rabilloud

BACKGROUND: Preoperative anxiety affects 30% to 80 % of ambulatory surgery patients and is associated with increased anesthetic requirements, postoperative pain, and delayed recovery. Virtual reality (VR) is a promising nonpharmacological anxiolytic, but evidence remains limited in the ambulatory setting. METHODS: The AMBLUMEEN (AMBulatory LUMEEN) trial is a single-center, randomized, open-label, superiority trial conducted in an adult ambulatory surgery unit. Patients with moderate-to-severe preoperative anxiety (State-Trait Anxiety Inventory Form Y-A [STAI-YA] > 45) were randomized 1:1 to standard care alone (control) or standard care and a single 20-minute preoperative VR session (immersive 360° natural contemplative scenes). The primary end point was the change in STAI-YA score from arrival in the ambulatory unit (baseline) to immediately before operating room transfer (presurgery), analyzed under the intention-to-treat principle with a linear mixed model. Secondary end points included preoperative benzodiazepine use, postoperative morphine requirement, unplanned overnight admission, patient satisfaction, and device acceptability. RESULTS: Of 106 randomized patients (53 per group) with a median [interquartile range] baseline STAI-YA of 49 [46–55] and 49 [46–58] respectively in the control and VR group, the VR group experienced a markedly greater reduction in state anxiety than controls. Adjusted mean between-group difference in STAI-YA change from baseline to presurgery was −18.7 95% confidence interval (CI) [−21.4 to −16.1] points in favor of VR. Although benzodiazepine requirement, postoperative pain, and unplanned overnight admission were comparable between groups, the morphine requirement in postanesthesia care unit was lower in the VR group (6/53 [11.3% 95% CI, 11.3 {4.3–23.0}] vs 0/53 [0.0%, 95% CI, {0.0–6.7}]; P = .027). Global perioperative satisfaction was high in both groups (median 8 [8–9] on 10). CONCLUSIONS: A single 20-minute session of medical-grade VR significantly reduced preoperative anxiety in ambulatory surgery patients, with high acceptability and an excellent safety profile.

For dengue, there is little evidence regarding community-level acceptance, facilitators and barriers for integrated vector management (IVM). We carried out a survey to measure these aspects in the context of a large cluster-randomized controlled trial of IVM against dengue vectors in urban Malaysia, in which the component control methods were (i) outdoor residual spraying, (ii) autodissemination devices (ADDs) and (iii) community engagement. The survey population comprised (i) members of the Joint Management Body (JMB) of building developments in both arms, and (ii) residents in the intervention arm. Members of both groups were requested to complete a structured questionnaire, through face-to-face interviews. Among JMB responders, 138 were the intervention clusters, and 94 from those receiving routine activities (control arm), and there were 604 responders among residents of intervention clusters. Among the JMB members, safety of the control methods (spraying and ADDs) was among the most important potential facilitators. Among barriers, the ones identified by over one-third of the participants were lack of information about the iDEM IVM methods, lack of communication and of involvement with the iDEM project personnel. Overall, the iDEM IVM methods were seen positively, and investment by the trial in community engagement may have contributed to this.

Objective: Acute symptomatic seizures (ASyS) occur in up to 30% of patients with intracerebral hemorrhage (ICH) when continuous electroencephalography (cEEG) is used, potentially worsening outcomes. Identification of early EEG biomarkers of ASyS may help guide personalized antiseizure medication (ASM) prophylaxis. Here, we aimed to describe early interictal EEG patterns, their dynamics, and their association with seizure risk, considering the effect of prophylactic levetiracetam. Methods: This prospective analysis used data from the PEACH phase 3 trial (2017–2020), which enrolled adults with acute spontaneous supratentorial ICH, randomized to receive levetiracetam or placebo. Patients underwent systematic 48‐h cEEG within 48 h of symptom onset. Electrographic seizures and interictal EEG patterns were analyzed using standardized terminology of the American Clinical Neurophysiology Society. Associations between rhythmic and periodic patterns (RPPs) and seizures with clinical and radiological variables were assessed using univariate analyses. We also conducted exploratory testing of the CAV (cortical involvement, age < 65 years, volume > 10 mL) score for predicting ASyS, incorporating RPPs and ASM exposure. Results: Forty‐two patients were included (median [Q1–Q3] age = 72 [60–79] years, 29% women), 19 in the levetiracetam group. Interictal EEG abnormalities were common and not influenced by ASM, including background asymmetry (73%), sporadic epileptiform discharges (62%), and RPPs (52%). RPPs were associated with ICH volume ( p = .039) and cortical involvement ( p = .003). Among patients with RPPs, 50% developed ASyS (20% in those treated with ASM vs. 75% in untreated patients, p = .030). Most patients (91.7%) with seizures had RPPs that preceded seizures, in >90% cases by 12 (Q1–Q3 = 4–25) h. Integrating RPPs into the CAV model led to an improvement of ASyS prediction (area under the curve = .949 vs. .918, p = .53) that was statistically nonsignificant. Significance: RPPs are strong markers of ictogenesis in acute ICH and precede ASyS, thus offering a potential therapeutic window. These findings support the use of early cEEG for risk stratification and personalized ASM prophylaxis.

Assess creatinine levels in French children with Down syndrome (DS) on the basis of the relationship between creatinine levels and age. The study included 279 children with DS aged 0 to 10 years who had been regularly monitored between 2004 and 2021 in a single genetics department and who had had at least one creatinine measurement. The creatinine level curves were established by estimating the median and the quantiles of order 2.5 and 97.5% according to age. A Generalized Additive Model for Location, Scale, and Shape was used. The results showed higher creatinine levels in children with DS than in children from the general population. Conclusion: The present results allow to propose an original chart of creatinine levels according to age in French children with DS, which should help optimize their medical management and improve the early detection of renal diseases. What is Known: • Creatinine is a product of muscle breakdown and depends on muscle mass and children with Down syndrome have muscle and growth characteristics that differ from those of the general paediatric population. • Serum creatinine values in Japanese children with DS are higher than those of children from the general Japanese population. What is New: • Creatinine values in French children with DS are higher than those of children from the general French population. • The proposed original chart for creatinine values according to age, specifically designed for individuals up to 10 years old, should serve for further investigation, prevention, and follow-up of children with DS.

Missing data may lead to bias and loss of information in epidemiological research. In this article, we propose an approach to analyze missing data on comorbidity variables in a register with consideration of the territorialized organization of the collection. To illustrate this approach, we used the national REIN registry as an application case.

Background and Objectives The question of the long-term safety of pregnancy is a major concern in patients with multiple sclerosis (MS), but its study is biased by reverse causation (women with higher disability are less likely to experience pregnancy). Using a causal inference approach, we aimed to estimate the unbiased long-term effects of pregnancy on disability and relapse risk in patients with MS and secondarily the short-term effects (during the perpartum and postpartum years) and delayed effects (occurring beyond 1 year after delivery). Methods We conducted an observational cohort study with data from patients with MS followed in the Observatoire Français de la Sclérose en Plaques registry between 1990 and 2020. We included female patients with MS aged 18–45 years at MS onset, clinically followed up for more than 2 years, and with ≥3 Expanded Disease Status Scale (EDSS) measurements. Outcomes were the mean EDSS score at the end of follow-up and the annual probability of relapse during follow-up. Counterfactual outcomes were predicted using the longitudinal targeted maximum likelihood estimator in the entire study population. The patients exposed to at least 1 pregnancy during their follow-up were compared with the counterfactual situation in which, contrary to what was observed, they would not have been exposed to any pregnancy. Short-term and delayed effects were analyzed from the first pregnancy of early-exposed patients (who experienced it during their first 3 years of follow-up). Results We included 9,100 patients, with a median follow-up duration of 7.8 years, of whom 2,125 (23.4%) patients were exposed to at least 1 pregnancy. Pregnancy had no significant long-term causal effect on the mean EDSS score at 9 years (causal mean difference [95% CI] = 0.00 [−0.16 to 0.15]) or on the annual probability of relapse (causal risk ratio [95% CI] = 0.95 [0.93–1.38]). For the 1,253 early-exposed patients, pregnancy significantly decreased the probability of relapse during the perpartum year and significantly increased it during the postpartum year, but no significant delayed effect was found on the EDSS and relapse rate. Discussion Using a causal inference approach, we found no evidence of significantly deleterious or beneficial long-term effects of pregnancy on disability. The beneficial effects found in other studies were probably related to a reverse causation bias.

Introduction: The COVID-19 pandemic placed an unprecedented overload on healthcare system globally. With all medical resources being dedicated to contain the spread of the disease, the pandemic may have impacted the burden of other infectious diseases such as dengue, particularly in countries endemic for dengue fever. Indeed, the co‐occurrence of COVID‐19 made dengue diagnosis challenging because of some shared clinical manifestations between the two pathogens. Furthermore, the sudden emergence and novelty of this global public health crisis has forced the suspension or slow-down of several research trials due to the lack of sufficient knowledge on how to handle the continuity of research trials during the pandemic. We report on challenges we have faced during the COVID-19 pandemic and measures that were implemented to continue the iDEM project (intervention for Dengue Epidemiology in Malaysia). Methods: This randomized controlled trial aims to assess the effectiveness of Integrated Vector Management (IVM) on the incidence of dengue in urban Malaysia by combining: targeted outdoor residual spraying (TORS), deployment of auto-dissemination devices (ADDs), and active community engagement (CE). Our operational activities started on February 10, 2020, a few weeks before the implementation of non-pharmaceutical interventions to contain the spread of COVID-19 in Malaysia. Results: The three main issues affecting the continuity of the trial were: ensuring the safety of field workers during the interventions; ensuring the planned turnover of TORS application and ADD deployment and services; and maintaining the CE activities as far as possible. Conclusions: Even though the pandemic has created monumental challenges, we ensured the safety of field workers by providing complete personal protective equipment and regular COVID-19 testing. Albeit with delay, we maintained the planned interval time between TORS application and ADDs services by overlapping the intervention cycles instead of having them in a sequential scheme. CE activities continued remotely through several channels (e.g., phone calls and text messages). Sustained efforts of the management team, significant involvement of the Malaysian Ministry of Health and a quick and smart adaptation of the trial organisation according to the pandemic situation were the main factors that allowed the successful continuation of our research.