Background Severe acute respiratory syndrome coronavirus-2 (SARS–CoV-2)-induced acute respiratory distress syndrome (ARDS) causes high mortality. Umbilical cord-derived mesenchymal stromal cells (UC-MSCs) have potentially relevant immune-modulatory properties, whose place in ARDS treatment is not established. This phase 2b trial was undertaken to assess the efficacy of UC-MSCs in patients with SARS–CoV-2-induced ARDS. Methods This multicentre, double-blind, randomized, placebo-controlled trial (STROMA–CoV-2) recruited adults (≥ 18 years) with SARS–CoV-2-induced early (< 96 h) mild-to-severe ARDS in 10 French centres. Patients were randomly assigned to receive three intravenous infusions of 10 ⁶ UC-MSCs/kg or placebo (0.9% NaCl) over 5 days after recruitment. For the modified intention-to-treat population, the primary endpoint was the partial pressure of oxygen to fractional inspired oxygen (PaO 2 /FiO 2 )-ratio change between baseline (day (D) 0) and D7. Results Among the 107 patients screened for eligibility from April 6, 2020, to October 29, 2020, 45 were enrolled, randomized and analyzed. PaO 2 /FiO 2 changes between D0 and D7 did not differ significantly between the UC-MSCs and placebo groups (medians [IQR] 54.3 [− 15.5 to 93.3] vs 25.3 [− 33.3 to 104.6], respectively; ANCOVA estimated treatment effect 7.4, 95% CI − 44.7 to 59.7; P = 0.77). Six (28.6%) of the 21 UC-MSCs recipients and six of 24 (25%) placebo-group patients experienced serious adverse events, none of which were related to UC-MSCs treatment. Conclusions D0-to-D7 PaO 2 /FiO 2 changes for intravenous UC-MSCs-versus placebo-treated adults with SARS–CoV-2-induced ARDS did not differ significantly. Repeated UC-MSCs infusions were not associated with any serious adverse events during treatment or thereafter (until D28). Larger trials enrolling patients earlier during the course of their ARDS are needed to further assess UC-MSCs efficacy in this context. Trial registration : NCT04333368. Registered 01 April 2020, https://clinicaltrials.gov/ct2/history/NCT04333368 .
Background Varicella-zoster virus (VZV) is one of the main viruses responsible of acute encephalitis. However, data on the prognosis and neurologic outcome of critically ill patients with VZV encephalitis are limited. We aimed to describe the clinical features of VZV encephalitis in the ICU and to identify factors associated with a favorable neurologic outcome. We performed a multicenter cohort study of patients with VZV encephalitis admitted in 18 ICUs in France between 2000 and 2017. Factors associated with a favorable neurologic outcome, defined by a modified Rankin Score (mRS) of 0–2 1 year after ICU admission, were identified by multivariable regression analysis. Results Fifty-five patients (29 (53%) men, median age 53 (interquartile range 36–66)) were included, of whom 43 (78%) were immunocompromised. ICU admission occurred 1 (0–3) day after the onset of neurological symptoms. Median Glasgow Coma Score at ICU admission was 12 (7–14). Cerebrospinal fluid examination displayed a median leukocyte count of 68 (13–129)/mm ³ , and a median protein level of 1.37 (0.77–3.67) g/L. CT scan and MRI revealed brain lesions in 30% and 66% of the cases, respectively. Invasive mechanical ventilation was implemented in 46 (84%) patients for a median duration of 13 (3–30) days. Fourteen (25%) patients died in the ICU. One year after ICU admission, 20 (36%) patients had a favorable neurologic outcome (mRS 0–2), 12 (22%) had significant disability (mRS 3–5), and 18 (33%) were deceased (lost to follow-up n = 5, 9%). On multivariable analysis, age (OR 0.92 per year, (0.88–0.97), p = 0.01), and invasive mechanical ventilation (OR 0.09 CI 95% (0.01–0.84), p = 0.03) reduced the likelihood of favorable neurologic outcome. Conclusion One in every three critically ill patients with VZV encephalitis had a favorable neurologic outcome 1 year after ICU admission. Older age and invasive mechanical ventilation were associated with a higher risk of disability and death.
Background: Patients with maple syrup urine disease (MSUD) experiencing metabolic decompensations have traditionally been treated with branched-chain amino acid (BCAA)-free mixture via oral or nasogastric administration routes. In some patients, enteral administration is not possible, either because the patient presents with vomiting, coma, or refuses nasogastric administration, thus intravenous (IV) BCAA-free solution is an appropriate intervention for these challenging cases. Aims: This study aimed to evaluate the effectiveness and safety of managing metabolic decompensations by administering an IV BCAA-free solution. Methods: This is an observational prospective study of data from MSUD patients hospitalised for decompensation episodes between 2010 and 2016 at 6 centres for rare metabolic diseases in France. Results: A total of 24 patients (16 males; 8 females) experiencing 126 MSUD metabolic decompensation episodes (39 in children; 87 in adults) were admitted to hospital. At presentation, mean leucine plasma concentration was ≥ 381 µmol/L in 113/126 (89.7%) episodes. Children were treated with continuous IV BCAA-free solution at doses of 0.8 to 2.0 g/kg/day, for 4.8 days and adults for 3.8 days at doses of 0.5 to 2.6 g/kg/day. In the efficacy set of 102 analysable episodes leucine concentrations were normalised (to below 381 µmol/L) in 82% (n = 18/22) of episodes in children and in 84% (n = 67/80) of episodes in adults. Mean time to leucine normalisation was 3.0 days. This was significantly (p < 0.001) shorter than the algorithmically predicted time to leucine normalisation with traditional BCAA-free mixture. Duration of hospitalisation was significantly longer for children than for adults (7.1 days in children vs 5.2 days in adults, p = 0.012). No treatment-related adverse events were reported in any patients on IV BCAA-free solution. Conclusion: The IV BCAA-free solution is safe and effective in normalising leucine concentrations during MSUD decompensation episodes in both children and adults, offering a practical treatment alternative for those patients who cannot receive BCAA-free mixture via oral or nasogastric routes.
Background Hospital-acquired pneumonia (HAP) is the most common and severe complication in patients treated with venoarterial extracorporeal membrane oxygenation (VA ECMO) and its diagnosis remains challenging. Nothing is known about the usefulness of lung ultrasound (LUS) in early detection of HAP in patients treated with VA ECMO. Also, LUS and chest radiography were performed when HAP was suspected in cardiac critically ill adult VA ECMO presenting with acute respiratory failure. The sonographic features of HAP in VA ECMO patients were determined and we assessed the performance of the lung ultrasound simplified clinical pulmonary score (LUS-sCPIS), the sCPIS and bioclinical parameters or chest radiography alone for early diagnosis of HAP. Results We included 70 patients, of which 44 (63%) were independently diagnosed with HAP. LUS examination revealed that color Doppler intrapulmonary flow ( P = 0.0000043 ) and dynamic air bronchogram ( P = 0.00024 ) were the most frequent HAP-related signs. The LUS-sCPIS (area under the curve = 0.77) yielded significantly better results than the sCPIS (area under the curve = 0.65; P = 0.004 ), while leukocyte count, temperature and chest radiography were not discriminating for HAP diagnosis. Discussion Diagnosis of HAP is a daily challenge for the clinician managing patients on venoarterial ECMO. Lung ultrasound can be a valuable tool as the initial imaging modality for the diagnosis of pneumonia. Color Doppler intrapulmonary flow and dynamic air bronchogram appear to be particularly insightful for the diagnosis of HAP.
Background Post‐intensive care syndrome (PICS) encompasses physical, cognition, and mental impairments persisting after intensive care unit (ICU) discharge. Ultimately it significantly impacts the long‐term prognosis, both in functional outcomes and survival. Thus, survivors often develop permanent disabilities, consume a lot of healthcare resources, and may experience prolonged suffering. This review aims to present the multiple facets of the PICS, decipher its underlying mechanisms, and highlight future research directions. Main text This review abridges the translational data underlying the multiple facets of chronic critical illness (CCI) and PICS. We focus first on ICU-acquired weakness, a syndrome characterized by impaired contractility, muscle wasting, and persisting muscle atrophy during the recovery phase, which involves anabolic resistance, impaired capacity of regeneration, mitochondrial dysfunction, and abnormalities in calcium homeostasis. Second, we discuss the clinical relevance of post-ICU cognitive impairment and neuropsychological disability, its association with delirium during the ICU stay, and the putative role of low-grade long-lasting inflammation. Third, we describe the profound and persistent qualitative and quantitative alteration of the innate and adaptive response. Fourth, we discuss the biological mechanisms of the progression from acute to chronic kidney injury, opening the field for renoprotective strategies. Fifth, we report long-lasting pulmonary consequences of ARDS and prolonged mechanical ventilation. Finally, we discuss several specificities in children, including the influence of the child’s pre-ICU condition, development, and maturation. Conclusions Recent understandings of the biological substratum of the PICS’ distinct features highlight the need to rethink our patient trajectories in the long term. A better knowledge of this syndrome and precipitating factors is necessary to develop protocols and strategies to alleviate the CCI and PICS and ultimately improve patient recovery.
Aims Antiphospholipid syndrome (APS) is a rare autoimmune disease defined by thrombotic events occurring in patients with persistent antiphospholipid antibodies. Cardiac manifestations in critically-ill APS patients are poorly investigated. We conducted a study to assess the prevalence, the characteristics and the prognosis of cardiac manifestations in thrombotic APS patients admitted to intensive care unit (ICU). Methods and results A French, national, multicentre, retrospective study, conducted, from January 2000 to September 2018, including all APS patients admitted to 24 participating centres’ ICUs with any new thrombotic (arterial, venous or microvascular) manifestation. Cardiac manifestations were defined as any new cardiac abnormalities relying on clinical examination, cardiac biomarkers, echocardiography, cardiac magnetic resonance (CMR) and coronarography. One hundred and thirty-six patients (female 72%) were included. Mean age at ICU admission was 46 ± 15years. Cardiac manifestations were present in 71 patients (53%). In patients with cardiac involvement, median left ventricular ejection fraction (LVEF) was 40% [28–55], troponin was elevated in 93% patients, coronary angiogram (n = 19, 27%) disclosing a coronary obstruction in 21%. CMR (n = 21) was abnormal in all cases, with late gadolinium enhancement in 62% of cases. Cardiac manifestations were associated with a non-significant increase of mortality (32% vs. 19%, p = 0.08). After 1-year follow-up, median LVEF was 57% [44–60] in patients with cardiac involvement. Conclusion Cardiac involvement is frequent in critically-ill thrombotic APS patients and may be associated to more severe outcome. Increased awareness on this rare cause of myocardial infarction with or without obstructive coronary artery is urgently needed.
Objectif Les phéochromocytomes/paragangliomes (PPGL) sont des tumeurs caractérisées par un fort déterminisme génétique. Parmi les gènes de susceptibilité connus, EPAS1, codant pour le facteur de réponse à l’hypoxie HIF2α, est muté au niveau tumoral dans ≈5 % des PPGL. Un fort taux de mutations somatiques activatrices du gène EPAS1 a été rapporté dans les PPGL de patients atteints de cardiopathie cyanogène, suggérant un rôle favorisant de l’hypoxie chronique dans la survenue de ces tumeurs. La forte prévalence de mutations EPAS1 dans la cohorte de PPGL étudiés dans notre laboratoire, chez des patients sans cardiopathie congénitale, suggère que d’autres contextes cliniques pourraient favoriser l’émergence de ces tumeurs. Notre objectif est de déterminer la prévalence de pathologies hypoxémiantes chez les patients atteints de PPGL EPAS1-muté. Patients et méthodes Dans une cohorte rétrospective de 37 patients avec PPGL EPAS1-dépendants, nous avons recherché l’existence d’une pathologie induisant une hypoxie chronique via un questionnaire clinique adressé aux médecins ayant prescrit l’analyse génétique. Résultats Trois patients présentent une cardiopathie cyanogène congénitale (8 %) et 12 une anomalie de l’hémoglobine (32 %). Lorsqu’un résultat d’électrophorèse de l’hémoglobine est connu (21/37), celui-ci montre une hémoglobinopathie dans 57 % des cas (12/21) : drépanocytose (n = 6), trait drépanocytaire (n = 5) ou hémoglobinose C (n = 1). Discussion Cette étude suggère que l’hypoxie chronique, liée notamment à une hémoglobinopathie, augmenterait le risque de développer un PPGL. Des analyses complémentaires permettront de determiner si ces tumeurs présentent un facteur de gravité particulier et si des recommandations de dépistage de PPGL doivent être établies chez les patients avec hypoxie chronique.
Introduction L’hypoparathyroïdie est une maladie chronique qui impacte fortement la qualité de vie des personnes atteintes. La maladie étant rare, la mise en place d’un programme d’éducation thérapeutique du patient à distance est proposée comme une solution adaptée aux problématiques de la pathologie. Méthode La construction de ce programme a été financée par la DGOS via la Filière OSCAR (maladies rares de l’os, du calcium et du cartilage). Les bilans éducatifs partagés et les ateliers collectifs ont eu lieu sur la plateforme d’e-ETP Félix Santé (financée par l’ARS Pays de la Loire). Résultats Le programme a été co-construit avec les équipes de la Filière OSCAR du CHU de Nantes, des Hospices Civils de Lyon, de l’AP–HP et l’association de patients Hypoparathyroïdisme France (https://www.hypopara.fr/). La construction du programme (focus-groups, groupes de travail) s’est faite en visioconférence. Les outils pédagogiques (blob tree, photo-expression, métaplan, étoile de compétences) ont été adaptés afin de proposer un niveau d’interactivité au plus proche du présentiel. Notre programme d’e-ETP a été déclaré à l’ARS Pays de la Loire en janvier 2022 et répond au cahier des charges des programmes d’ETP. Deux cycles éducatifs incluant 5 patients ont eu lieu. Conclusion L’apport de notre programme sur les indicateurs objectifs de qualité de vie est à l’étude. Si le développement de programmes d’e-ETP est un apport indéniable à l’accessibilité de l’ETP, en particulier dans une maladie rare et/ou en cas de pathologies limitant les déplacements, elle peut également se révéler excluante, notamment pour les personnes illectroniques.
Chimeric antigen receptor (CAR) T-cell therapy is a promising immunotherapeutic approach in the treatment of multiple myeloma, and the recent approval of the first two CAR T-cell products could result in improved outcomes. However, it remains a complex and expensive technology, which poses challenges to health-care systems and society in general, especially in times of crises. This potentially accelerates pre-existing inequalities as access to CAR T-cell therapy varies, both between countries, depending on the level of economic development, and within countries, due to structural disparities in access to quality health care—a parameter strongly correlated with socioeconomic status, ethnicity, and lifestyle. Here, we identify two important issues: affordability and access to CAR T-cell treatment. This consensus statement from clinical investigators, clinicians, nurses, and patients from the European Society for Blood and Marrow Transplantation (EBMT) proposes solutions as part of an innovative collaborative strategy to make CAR T-cell therapy accessible to all patients with multiple myeloma.
Background Dyspnea is common and severe in intensive care unit (ICU) patients managed for acute respiratory failure. Dyspnea appears to be associated with impaired prognosis and neuropsychological sequels. Pain and dyspnea share many similarities and previous studies have shown the benefit of morphine on dyspnea in patients with end-stage onco-hematological disease and severe heart or respiratory disease. In these populations, morphine administration was safe. Here, we hypothesize that low-dose opioids may help to reduce dyspnea in patients admitted to the ICU for acute respiratory failure. The primary objective of the trial is to determine whether the administration of low-dose titrated opioids, compared to placebo, in patients admitted to the ICU for acute respiratory failure with severe dyspnea decreases the mean 24-h intensity of dyspnea score. Methods In this single-center double-blind randomized controlled trial with 2 parallel arms, we plan to include 22 patients (aged 18–75 years) on spontaneous ventilation with either non-invasive ventilation, high flow oxygen therapy or standard oxygen therapy admitted to the ICU for acute respiratory failure with severe dyspnea. They will be assigned after randomization with a 1:1 allocation ratio to receive in experimental arm administration of low-dose titrated morphine hydrochloride for 24 h consisting in an intravenous titration relayed subcutaneously according to a predefined protocol, or a placebo (0.9% NaCl) administered according to the same protocol in the control arm. The primary endpoint is the mean 24-h dyspnea score assessed by a visual analog scale of dyspnea. Discussion To our knowledge, this study is the first to evaluate the benefit of opioids on dyspnea in ICU patients admitted for acute respiratory failure. Trial registration ClinicalTrials.govNCT04358133. Registered on 24 April 2020.
Aspergillus fumigatus is a ubiquitous mold that can cause severe infections in immunocompromised patients, typically manifesting as invasive pulmonary aspergillosis (IPA). Adaptive and innate immune cells that respond to A. fumigatus are present in the endogenous repertoire of patients with IPA but are infrequent and cannot be consistently isolated and expanded for adoptive immunotherapy. Therefore, we gene-engineered A. fumigatus–specific chimeric antigen receptor (Af-CAR) T cells and demonstrate their ability to confer antifungal reactivity in preclinical models in vitro and in vivo. We generated a CAR targeting domain AB90-E8 that recognizes a conserved protein antigen in the cell wall of A. fumigatus hyphae. T cells expressing the Af-CAR recognized A. fumigatus strains and clinical isolates and exerted a direct antifungal effect against A. fumigatus hyphae. In particular, CD8+ Af-CAR T cells released perforin and granzyme B and damaged A. fumigatus hyphae. CD8+ and CD4+ Af-CAR T cells produced cytokines that activated macrophages to potentiate the antifungal effect. In an in vivo model of IPA in immunodeficient mice, CD8+ Af-CAR T cells localized to the site of infection, engaged innate immune cells, and reduced fungal burden in the lung. Adoptive transfer of CD8+ Af-CAR T cells conferred greater antifungal efficacy compared to CD4+ Af-CAR T cells and an improvement in overall survival. Together, our study illustrates the potential of gene-engineered T cells to treat aggressive infectious diseases that are difficult to control with conventional antimicrobial therapy and support the clinical development of Af-CAR T cell therapy to treat IPA.
Pathogenic variants in the ABCD1 gene cause adrenoleukodystrophy (ALD), a progressive metabolic disorder characterized by three core clinical syndromes: a slowly progressive myeloneuropathy, a rapidly progressive inflammatory leukodystrophy (cerebral ALD), and primary adrenal insufficiency. These syndromes are not present in all individuals, and are not related to genotype. Cerebral ALD and adrenal insufficiency require early detection and intervention and warrant clinical surveillance because of variable penetrance and age of onset. Newborn screening has increased the number of presymptomatic individuals under observation, but clinical surveillance protocols vary. We used a consensus-based modified Delphi approach among 28 international ALD experts to develop best-practice recommendations for diagnosis, clinical surveillance, and treatment of ALD patients. We identified 39 discrete areas of consensus. Regular monitoring to detect the onset of adrenal failure and conversion to cerebral ALD is recommended in all male patients. Hematopoeitic cell transplant (HCT) is the treatment of choice for cerebral ALD. This guideline addresses a clinical need in the ALD community worldwide as the number of overall diagnoses as well as presymptomatic individuals is increasing due to newborn screening and greater availability of next generation sequencing. The poor ability to predict the disease course informs current monitoring intervals but remains subject to change as more data emerges. This knowledge gap should direct future research and illustrates once again that international collaboration amongst physicians, researchers and patients is essential to improving care.
Painful post-traumatic trigeminal neuropathy (PPTTN) can result from iatrogenic injury to one or more branches of the trigeminal nerve during oral surgical procedures such as tooth extractions. Like other chronic neuropathic pain conditions, PPTTN can significantly alter the patient’s quality of life, especially when pharmacological treatment is ineffective or not tolerated. As such, new treatment options have been investigated, including local injections of botulinum toxin type A (BTX-A). A 29-year-old woman presented to our tertiary orofacial pain clinic for evaluation of chronic electric shock-like pain attacks and severe allodynia in the territory of the right inferior alveolar nerve and buccal nerve following right mandibular third molar extraction 3 years prior. Following several failed attempts at classic pharmacological management (including carbamazepine, venlafaxine, duloxetine, pregabalin, clonazepam, and amitriptyline), BTX-A injections were administered in the vicinity of the right mental nerve. This treatment provided significant improvement in the patient’s condition and overall quality of life with no significant adverse effects. Because both neuropathies were significantly improved by remote BTX-A injections, this case report provides preliminary clinical evidence supporting spinopetal transport of BTX-A, as shown in animal models, as an underlying pathophysiological mechanism of BTX-A-mediated analgesia.
Aim New technologic tools for continuous ECG monitoring have been developed to detect and treat atrial fibrillation (AF) in specific populations with high cardiovascular risk. We evaluated the prevalence and the management of AF diagnosed in patients with high cardiovascular risk and non-documented clinical palpitation undergoing systematic 14-day continuous ECG–Holter monitoring. Methods Patients were prospectively enrolled from December 2019 to December 2021 in this multicentre study, sponsored by the French National College of Cardiology. Patients met the following criteria: CHA2DS2VASc score ≥ 2 in males and ≥ 3 in females and clinical palpitations without previously documented arrhythmia. Enrolled patients underwent a continuous 14-day Holter–ECG monitoring for arrhythmia detection. Results Among the 336 included patients, 39% were male, 75% were greater than 65 years of age and 46.5% had suffered a prior stroke. AF was detected in 14% of patients, among which 23.4% were detected in the first 24 h of monitoring. Finally, age ≥ 65 years (p = 0.037) was significantly associated with AF, as well as male gender (p = 0.023) and a lower rate of antiplatelet therapy (p = 0.018). Patients with diagnosed AF had a prescription of anticoagulation therapy in 90%. Antiarrhythmic drugs were administered in 90% of AF patients and 13% underwent AF ablation. Conclusions The systematic AF screening of patients with palpitations and high cardiovascular risk resulted in a diagnostic yield of AF in 14% of the population with a 14-day continuous ECG–Holter monitor. This strategy resulted in the prescription of anticoagulation and antiarrhythmic therapy in 90% of the AF detected population. Graphical abstract
Advances in deep learning can be applied to acute stroke imaging to build powerful and explainable prediction models that could supersede traditionally used biomarkers. We aimed to evaluate the performance and interpretability of a deep learning model based on convolutional neural networks (CNN) in predicting long-term functional outcome with diffusion-weighted imaging (DWI) acquired at day 1 post-stroke. Ischemic stroke patients (n = 322) were included from the ASTER and INSULINFARCT trials as well as the Pitié-Salpêtrière registry. We trained a CNN to predict long-term functional outcome assessed at 3 months with the modified Rankin Scale (dichotomized as good [mRS ≤ 2] vs. poor [mRS ≥ 3]) and compared its performance to two logistic regression models using lesion volume and ASPECTS. The CNN contained an attention mechanism, which allowed to visualize the areas of the brain that drove prediction. The deep learning model yielded a significantly higher area under the curve (0.83 95%CI [0.78-0.87]) than lesion volume (0.78 [0.73-0.83]) and ASPECTS (0.77 [0.71-0.83]) (p < 0.05). Setting all classifiers to the specificity as the deep learning model (i.e., 0.87 [0.82-0.92]), the CNN yielded a significantly higher sensitivity (0.67 [0.59-0.73]) than lesion volume (0.48 [0.40-0.56]) and ASPECTS (0.50 [0.41-0.58]) (p = 0.002). The attention mechanism revealed that the network learned to naturally attend to the lesion to predict outcome.
Background To compare the rate of postpartum depression (PPD) during the first COVID-19 lockdown with the rate observed prior to the pandemic, and to examine factors associated with PPD. Methods This was a prospective study. Women who gave birth during the first COVID-19 lockdown (spring 2020) were offered call-interviews at 10 days and 6–8 weeks postpartum to assess PPD using the Edinburgh Postnatal Depression Scale (EPDS). Post-traumatic symptoms (Perinatal Post-traumatic Stress Disorder Questionnaire, PPQ), couple adjustment, and interaction and mother-to-infant bonding were also evaluated. The observed PPD rate was compared to the one reported before the pandemic. Factors associated with an increased risk of PPD were studied. The main outcome measures were comparison of the observed PPD rate (EPDS score > 12) to pre-pandemic rate. Results Of the 164 women included, 27 (16.5% [95%CI: 11.14–23.04]) presented an EPDS score > 12 either at 10 days or 6–8 weeks postpartum. This rate was similar to the one of 15% reported prior to the pandemic (p = 0.6). Combined EPDS> 12 or PPQ > 6 scores were observed in 20.7% of the mothers [95%CI: 14.8–0.28]. Maternal hypertension/preeclampsia (p = 0.007), emergency cesarean section (p = 0.03), and neonatal complications (p = 0.008) were significantly associated with an EPDS> 12 both in univariate and multivariate analysis (OR = 10 [95%CI: 1.5–68.7], OR = 4.09[95%CI: 1.2–14], OR = 4.02[95%CI: 1.4–11.6], respectively). Conclusions The rate of major PPD in our population did not increase during the first lockdown period. However, 20.7% of the women presented with post-traumatic/depressive symptoms. Trial registration NCT04366817.
Background: While quitting smoking dramatically decreases overall mortality, general practitioners (GPs) are less likely to prescribe medications for smoking cessation than other cardiovascular risk factors. Guidelines recommend providers first assess patients' "readiness" to quit, an "opt-in" strategy, but only a minority of tobacco users are ready to quit on a given day. An "opt-out" strategy offering treatment as the default choice increased quit attempts in hospital and with pregnant women, but has not been tested in primary care. We will assess the efficacy of training GPs to offer treatment as the default choice using an encounter decision aid with current smokers seen in primary care. Methods: This is a pragmatic cluster-randomized controlled superiority trial with block randomization at the GP level in private practice in French-speaking Switzerland. GPs will be blinded to the arm allocation. The intervention is a half-day training course teaching an 'opt-out' approach to smoking cessation using an encounter decision aid (paper or electronic). GPs in the enhanced usual care group receives a brief refresher training about smoking cessation without changing their behaviour. GPs in both arms will recruit 23 patients each prior to routine primary care visits. The primary outcome is the effect of consulting a GP who received the intervention on the 7-day, point prevalence, smoking abstinence 6 months after the baseline appointment. Secondary outcomes include continuous abstinence; number of quit attempts; use of smoking cessation aids; patient-perceived involvement in discussions; and changes in GP behaviour. Patient outcomes will be collected using paper and telephone questionnaires. Assuming 15% drop-out, recruiting 46 GPs with 23 patients each will give us 80% power to detect an increase in smoking cessation from 4% (control) to 10.5% (intervention), with an alpha < 0.05. Discussion: GP visits are an opportunity to administer proven smoking cessation treatments. We hypothesize GPs offering smoking cessation treatment as the default choice using an encounter decision aid will increase the number of patients who quit. This study could significantly change our approach to smoking cessation in primary care. Default choices and the electronic decision aid are low-cost, easily diffusible interventions. Trial registration: ClinicalTrials.gov Identifier: NCT04868474, First Posted May 3, 2021, Last Update Posted October 6, 2021.
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