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The so-called 4P medicine, preventive, predictive, participatory, and personalized, which places the patient at the center has influenced the latest recommendations for the management of common low back pain. The management of low back pain in the acute, subacute, and chronic phase is currently based on the profile of each patient with their risk factors, their prognosis, and the respect of their preferences, promoting an integrative approach. During the first consultation, it is important to identify factors of moderate to poor prognosis, including kinesiophobia and to search for false beliefs, through a detailed medical history. The non-pharmacological approaches are more effective and have less side effects than the medications. Reassurance and therapeutic education are the first steps in good management of common low back pain.La médecine dite des 4P, préventive, prédictive, participative et personnalisée, a influencé les dernières recommandations de prise en charge des lombalgies communes. La prise en charge de ces dernières en phases aiguë, subaiguë et chronique se base sur le profil de chaque patient avec ses facteurs de risque, son pronostic et le respect de ses préférences, en valorisant une approche intégrative. Dès la première consultation, il est important d’identifier des facteurs de pronostic moyen à mauvais dont la kinésiophobie et la recherche de fausses croyances grâce à une anamnèse détaillée. Les approches non pharmacologiques sont plus efficaces et ont moins d’effets secondaires que les médicaments. La réassurance et l’éducation thérapeutique sont les ingrédients d’une bonne prise en charge des lombalgies communes.

Background Lung auscultation is fundamental to the clinical diagnosis of respiratory disease. However, auscultation is a subjective practice and interpretations vary widely between users. The digitization of auscultation acquisition and interpretation is a particularly promising strategy for diagnosing and monitoring infectious diseases such as Coronavirus-19 disease (COVID-19) where automated analyses could help decentralise care and better inform decision-making in telemedicine. This protocol describes the standardised collection of lung auscultations in COVID-19 triage sites and a deep learning approach to diagnostic and prognostic modelling for future incorporation into an intelligent autonomous stethoscope benchmarked against human expert interpretation. Methods A total of 1000 consecutive, patients aged ≥ 16 years and meeting COVID-19 testing criteria will be recruited at screening sites and amongst inpatients of the internal medicine department at the Geneva University Hospitals, starting from October 2020. COVID-19 is diagnosed by RT-PCR on a nasopharyngeal swab and COVID-positive patients are followed up until outcome (i.e., discharge, hospitalisation, intubation and/or death). At inclusion, demographic and clinical data are collected, such as age, sex, medical history, and signs and symptoms of the current episode. Additionally, lung auscultation will be recorded with a digital stethoscope at 6 thoracic sites in each patient. A deep learning algorithm (DeepBreath) using a Convolutional Neural Network (CNN) and Support Vector Machine classifier will be trained on these audio recordings to derive an automated prediction of diagnostic (COVID positive vs negative) and risk stratification categories (mild to severe). The performance of this model will be compared to a human prediction baseline on a random subset of lung sounds, where blinded physicians are asked to classify the audios into the same categories. Discussion This approach has broad potential to standardise the evaluation of lung auscultation in COVID-19 at various levels of healthcare, especially in the context of decentralised triage and monitoring. Trial registration: PB_2016-00500, SwissEthics. Registered on 6 April 2020.

Persistent symptoms of SARS-CoV-2 are prevalent weeks to months following the infection. To date, it is difficult to disentangle the direct from the indirect effects of SARS-CoV-2, including lockdown, social, and economic factors.The study aims to characterize the prevalence of symptoms, functional capacity, and quality of life at 12 months in outpatient symptomatic individuals tested positive for SARS-CoV-2 compared to individuals tested negative.From 23 April to 27 July 2021, outpatient symptomatic individuals tested for SARS-CoV-2 at the Geneva University Hospitals were followed up 12 months after their test date.At 12 months, out of the 1447 participants (mean age 45.2 years, 61.2% women), 33.4% reported residual mild to moderate symptoms following SARS-CoV-2 infection compared to 6.5% in the control group. Symptoms included fatigue (16% vs. 3.1%), dyspnea (8.9% vs. 1.1%), headache (9.8% vs. 1.7%), insomnia (8.9% vs. 2.7%), and difficulty concentrating (7.4% vs. 2.5%). When compared to the control group, 30.5% of SARS-CoV-2 positive individuals reported functional impairment at 12 months versus 6.6%. SARS-CoV-2 infection was associated with the persistence of symptoms (adjusted odds ratio [aOR] 4.1; 2.60-6.83) and functional impairment (aOR 3.54; 2.16-5.80) overall, and in subgroups of women, men, individuals younger than 40 years, those between 40-59 years, and in individuals with no past medical or psychiatric history.SARS-CoV-2 infection leads to persistent symptoms over several months, including in young healthy individuals, in addition to the pandemic effects, and potentially more than other common respiratory infections. Symptoms impact functional capacity up to 12 months post infection.

COVID-19 is a viral prothrombotic respiratory infection. Heparins exert antithrombotic and anti-inflammatory effects, and might have antiviral properties. We aimed to investigate whether thromboprophylaxis with enoxaparin would prevent untoward hospitalisation and death in symptomatic, but clinically stable outpatients with COVID-19.OVID was a randomised, open-label, parallel-group, investigator-initiated, phase 3 trial and was done at eight centres in Switzerland and Germany. Outpatients aged 50 years or older with acute COVID-19 were eligible if they presented with respiratory symptoms or body temperature higher than 37·5°C. Eligible participants underwent block-stratified randomisation (by age group 50-70 vs70 years and by study centre) in a 1:1 ratio to receive either subcutaneous enoxaparin 40 mg once daily for 14 days versus standard of care (no thromboprophylaxis). The primary outcome was a composite of any untoward hospitalisation and all-cause death within 30 days of randomisation. Analysis of the efficacy outcomes was done in the intention-to-treat population. The primary safety outcome was major bleeding. The study was registered in ClinicalTrials.gov (NCT04400799) and has been completed.At the predefined formal interim analysis for efficacy (50% of total study population), the independent Data Safety Monitoring Board recommended early termination of the trial on the basis of predefined statistical criteria having considered the very low probability of showing superiority of thromboprophylaxis with enoxaparin for the primary outcome under the initial study design assumptions. Between Aug 15, 2020, and Jan 14, 2022, from 3319 participants prescreened, 472 were included in the intention-to-treat population and randomly assigned to receive enoxaparin (n=234) or standard of care (n=238). The median age was 57 years (IQR 53-62) and 217 (46%) were women. The 30-day risk of the primary outcome was similar in participants allocated to receive enoxaparin and in controls (8 [3%] of 234 vs 8 [3%] of 238; adjusted relative risk 0·98; 95% CI 0·37-2·56; p=0·96). All hospitalisations were related to COVID-19. No deaths were reported during the study. No major bleeding events were recorded. Eight serious adverse events were recorded in the enoxaparin group versus nine in the control group.These findings suggest thromboprophylaxis with enoxaparin does not reduce early hospitalisations and deaths among outpatients with symptomatic COVID-19. Futility of the treatment under the initial study design assumptions could not be conclusively assessed owing to under-representation of older patients and consequent low event rates.SNSF (National Research Programme COVID-19 NRP78: 198352), University Hospital Zurich, University of Zurich, Dr-Ing Georg Pollert (Berlin), Johanna Dürmüller-Bol Foundation.

Background: Lung ultrasound (LUS) has a good performance with a high sensitivity and specificity for the diagnosis of pneumonia compared with chest X-ray, and it has been extensively used to assess patients during the COVID-19 pandemic. This study aims to evaluate the potential advantages of the regular use of LUS for the assessment of the severity and prognosis of COVID-19 pneumonia and to propose an adapted protocol with its inclusion in current local validated and published guidelines.Methods: This is a single-center prospective study conducted during the first (April–May 2020) and second (October 2020–January 2021) waves of the SARS-CoV2 pandemic in Switzerland. All adult patients presenting to dedicated test centers with a suspicion of mild-to-moderate COVID-19 pneumonia and not requiring hospitalization at the time of diagnosis were included. Patients with confirmed COVID-19 pneumonia were referred to an ambulatory follow-up unit at our institution for reassessment, with the inclusion of the use of LUS in a random selection. Descriptive statistics were calculated for demographics using percentages, means, and standard deviations according to the distribution of variables.Results: Eighty-eight ambulatory patients with a confirmed COVID-19 pneumonia were included (men = 57 [59%]; mean age, 52.1 ± 13.5 years). Among these, 19 (21%) were hospitalized and none died. Twenty-five lung assessments by ultrasound were performed during the follow-up consultation. All were consistent with the clinical examination and confirmed the clinician's opinion.Conclusion: The use of a standardized pleuro-pulmonary ultrasound protocol for ambulatory patients with COVID-19 could help to reduce the use of chest X-rays and improve overall management at the time of referral and eventual follow-up. However, a specific study including LUS in a systematic approach should be performed to evaluate the outcome of patients according to findings.

In health communication, issues that are rooted in cultural norms and values are controversial and challenging. Researchers on medical communication argue that communicative challenges in medical interactions are to a great extent context-specific (Cox & Li, 2020; Keifenheim et al., 2015). As Stewart (2005) stated, topics such as sexual health are taboo and do not comfortably fit into language use. Thus, a distinctive speech genre is used in medical communication related to sexual or reproductive health, illustrating the importance of social values, norms and taboos in communicative practices (Brown et al., 2006; Kagawa-Singer & Kassim-Lakha, 2003; Priebe et al., 2011). The present study intended to investigate communicative strategies, namely, what is termed euphemism, that medical doctors (henceforth doctors) use (Brown et al., 2006; Tayler & Ogden, 2005) in emergency medicine to ask patients sensitive or technical questions associated with sexual health and bodily functions. It focused on the Persian translations of a speech-enabled fixed phrase translator called BabelDr developed at the Geneva University Hospitals (HUG) and Geneva University (Spechbach et al., 2019) and in use at HUG since the beginning of 2019. The system is intended for French clinical triage in different medical domains and includes sentences referring to specific fields including sexual health. It contains 12,000 core sentences translated by human translators, following the defined process of translation for the BabelDr, that is “1) translation, 2) revision and 3) correction, where steps 1 and 3 are carried out by the same person” (Gerlach et al., 2019, p. 61). For this study, a group of French sentences that relate to sexual health and bodily functions were selected in the BabelDr. Then six doctors, all Persian native speakers, were asked to read the Persian translation of the selected sentences translated by a nonmedical translator and provide the version that they would use in real emergency situations. The provided versions were compared to check the communicative strategies used by the doctors with regard to sensitive sentences, with the goal of consolidating the speech-enabled phraselator. The findings showed that the doctors resorted to types of euphemism as a communication strategy more than the nonmedical translator.

BACKGROUND Many factors influence patient satisfaction during an emergency department (ED) visit, but the perception of the waiting time plays a central role. A long wait time in the waiting room increases the risk of hospital-acquired infection, as well as the risk of a patient leaving before being seen by a physician, particularly those with a lower level of urgency who may have to wait for a longer time. OBJECTIVE We aimed to improve the perception of waiting time through the implementation of a semi-automatic text message (SMS) system that allows patients to wait outside the hospital and facilitates the recall of patients closer to the scheduled time of meeting with the physician. METHODS We performed a cross-sectional survey to evaluate the system using a tailored questionnaire to assess the patient perspective and the Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT) for the caregiver perspective. We also monitored the frequency of system use with logs. RESULTS In total, 110 usable responses were collected (patients, 100; caregivers, 10). Findings revealed a very high level of patient satisfaction (97%), with most patients waiting outside the ED, but inside the hospital. Caregiver evaluation showed that it was very easy to use, but adoption of the system was more problematic because of the perceived additional workload associated with its use. CONCLUSIONS Although not suitable for all patients, our system allows those with a low severity sign to wait outside the waiting room and to be recalled according to the dedicated time defined in the Swiss Emergency Triage Scale. It not only reduces the risk of hospital-acquired infection, but also improves the patient experience and was perceived as a real improvement. Further automation of the system needs to be explored in order to reduce caregiver workload and increase its utilization.

Background Many factors influence patient satisfaction during an emergency department (ED) visit, but the perception of wait time plays a central role. A long wait time in the waiting room increases the risk of hospital-acquired infection, as well as the risk of a patient leaving before being seen by a physician, particularly those with a lower level of urgency who may have to wait for a longer time. Objective We aimed to improve the perception of wait time through the implementation of a semiautomatic SMS text message system that allows patients to wait outside the hospital and facilitates the recall of patients closer to the scheduled time of meeting with the physician. Methods We performed a cross-sectional survey to evaluate the system using a tailored questionnaire to assess the patient perspective and the Unified Theory of Acceptance and Use of Technology questionnaire for the caregiver perspective. We also monitored the frequency of system use with logs. Results A total of 110 usable responses were collected (100 patients and 10 caregivers). Findings revealed that 97 of 100 (97%) patients were satisfied, with most patients waiting outside the ED but inside the hospital. The caregiver evaluation showed that it was very easy to use, but the adoption of the system was more problematic because of the perceived additional workload associated with its use. Conclusions Although not suitable for all patients, our system allows those who have a low-severity condition to wait outside the waiting room and to be recalled according to the dedicated time defined in the Swiss Emergency Triage Scale. It not only has the potential to reduce the risk of hospital-acquired infection but also can enhance the patient experience; additionally, it was perceived as a real improvement. Further automation of the system needs to be explored to reduce caregiver workload and increase its use.

ObjectivesTo develop and validate a rule-out prediction model for the risk of hospitalisation among patients with SARS-CoV-2 infection in the ambulatory setting to derive a simple score to determine outpatient follow-up.DesignProspective cohort study.SettingSwiss university hospital.Participants1459 individuals with a positive result for SARS-CoV-2 infection between 2 March and 23 April 2020.MethodsWe applied the rule of 10 events per variable to construct our multivariable model and included a maximum of eight covariates. We assessed the model performance in terms of discrimination and calibration and performed internal validation to estimate the statistical optimism of the final model. The final prediction model included age, fever, dyspnoea, hypertension and chronic respiratory disease. To develop the OUTCoV score, we assigned points for each predictor that were proportional to the coefficients of the regression equation. Sensitivity, specificity, positive and negative likelihood ratios were estimated, including positive and negative predictive values in different thresholds.Main outcome measureThe primary outcome was COVID-19-related hospitalisation.ResultsThe OUTCoV score ranged from 0 to 7.5 points. The two threshold parameters with optimal rule-out and rule-in characteristics for the risk of hospitalisation were 3 and 5.5, respectively. Outpatients with a score ConclusionsThe OUTCoV score allows to rule out two-thirds of outpatients with SARS-CoV-2 infection presenting a low hospitalisation risk and to identify those at high risk that require careful follow-up to assess the need for hospitalisation. The model provides a simple decision-making tool for an effective allocation of resources to maintain quality care for outpatient populations.

Several SARS-CoV-2 variants of concern (VOC) are spreading rapidly in different regions of the world. The underlying mechanisms behind their transmission advantage remain unclear. We measured viral load in 950 individuals and found that infections with variant Alpha exhibit a higher viral load and longer viral shedding compared to non-VOC. We then used a transmission model to analyze the spread of variant Alpha in Geneva, Switzerland, and variant Beta in South Africa. We estimated that Alpha is either associated with a 37% (95% compatibility interval, CI: 25–63%) increase in transmissibility or a 51% (95% CI: 32–80%) increase of the infectious duration, or a combination of the two mechanisms. Assuming 50% immune evasion for Beta, we estimated a 23% (95% CI: 10–37%) increase in transmissibility or a 38% (95% CI: 15–78%) increase of the infectious duration for this variant. Beta is expected to outgrow Alpha in regions where the level of naturally acquired immunity from previously circulating variants exceeds 20% to 40%. Close monitoring of Alpha and Beta in regions with different levels of immunity will help to anticipate the global spread of these and future variants.

Background The optimal duration of antibiotic therapy for treating orthopaedic implant infections after surgical drainage and complete implant removal is unknown. Methods This was a single-centre, unblinded, prospective trial randomizing (1:1) eligible patients to either 4 or 6 weeks of systemic, pathogen-targeted antibiotic therapy. Clinical trial registration number: ClinicalTrials.gov (NCT0362209). Results We analysed 123 eligible patients (62 in the 4 week antibiotic arm and 61 in the 6 week arm) in the ITT analysis. The patients’ median age was 64 years, 75 (61%) were men and 38 (31%) were immunocompromised. The most common types of infection treated included: two-stage exchange procedure for prosthetic joint infection (n = 38); orthopaedic plate infection (44) and infected nail implants (11). The median duration of post-explant intravenous antibiotic therapy was 4 days. Overall, 120 episodes (98%) were cured microbiologically and 116 (94%) clinically after a median follow-up period of 2.2 years. During follow-up, four patients had a clinical recurrence with a pathogen other than the initial causative agent. We noted recurrence of clinical infection in four patients in the 4 week arm and three patients in the 6 week arm (4/62 versus 3/61; χ2 test; P = 0.74); in all cases, this occurred at around 2 months following the end of antibiotic treatment. Conclusions We found no statistically significant difference in the rates of clinical or microbiological remission between patients randomized to only 4 compared with 6 weeks of systemic antibiotic therapy after removal of an infected osteoarticular implant.

Whether in-hospital management of patients with newly identified vertebral fractures leads to a higher rate of osteoporosis medication than delayed outpatient management remains unknown. Our study showed that early osteoporosis therapy initiation in a fracture liaison service during hospital stay was a more efficacious strategy for secondary fracture prevention. Fracture liaison services are standard care for secondary fracture prevention. A higher rate of osteoporosis treatment initiation may be considered when introduced in the hospital rather than an outpatient recommendation to a primary care physician (PCP). Whether this applies to patients with newly detected vertebral fractures in a general internal medicine ward remains unknown. We prospectively investigated whether in-hospital management of newly identified vertebral fractures led to a higher rate of osteoporosis medication initiation and persistence at 3 and 6 months than delayed outpatient management by a PCP. We conducted a prospective study including hospitalized patients > 60 years systematically searched for asymptomatic vertebral fractures on lateral chest and/or abdominal radiographs. Patients were included either in phase 1 (outpatient care recommendations on osteoporosis management to a PCP) or in phase 2 (inpatient care management initiated during hospitalization). The percentage of patients under osteoporosis treatment was evaluated by telephone interview at 3 and 6 months. Outpatients’ (84 with fracture/407 assessed (21%); 75.7 ± 7.7 years) and inpatients’ (100/524 (19%); 77.8 ± 9.4 years) characteristics were similar. Osteoporosis medication was more often prescribed in inpatients at 3 (67% vs. 19%, respectively; p

Today's healthcare systems are increasingly confronted with communication problems between allophone patients and health care staff. Geneva, due to its cosmopolitan character, is at the core of this phenomenon. Several studies attest to the negative effects of the language barrier and its consequences on the quality of care, ethics, safety and financial costs. Different tools, such as semi-professional interpreters or translation applications, make it possible to deal with situations where a lack of communication can be crucial. However, they have many drawbacks. Therefore, the Geneva University Hospitals, in collaboration with the Faculty of Translation and Interpretation, have developed a reliable and innovative tool for the translation of medical language.Les systèmes de santé actuels sont de plus en plus confrontés à des problèmes de communication entre des patients allophones et le personnel soignant. Genève, du fait de son aspect cosmopolite, est au centre de ce phénomène. Plusieurs études attestent des effets négatifs de la barrière de la langue et ses conséquences sur la qualité des soins, l’éthique, la sécurité et les coûts financiers. Différents outils, comme les interprètes semi-professionnels ou les applications de traduction, permettent de faire face à des situations où un défaut de communication peut s’avérer crucial. Cependant, ils présentent de nombreux inconvénients. Par conséquent, les HUG, en collaboration avec la Faculté de traduction et d’interprétation, ont développé un outil fiable et innovant pour la traduction du langage médical.

SARS-CoV-2 viral load (VL) can serve as a correlate for infectious virus presence and transmission. Viral shedding kinetics over the first week of illness for symptomatic children (n = 279), adolescents (n = 639), and adults (n = 7109) show VLs compatible with infectious virus presence, with slightly lower VL in children than adults.

Purpose: To assess the diagnostic performances of five automated anti-SARS-CoV-2 immunoassays, Epitope (N), Diasorin (S1/S2), Euroimmun (S1), Roche N (N), and Roche S (S-RBD), and to provide a testing strategy based on pre-test probability. Methods: We assessed the receiver operating characteristic (ROC) areas under the curve (AUC) values, along with the sensitivity, specificity, positive predictive values (PPVs), and negative predictive values (NPVs), of each assay using a validation sample set of 172 COVID-19 sera and 185 negative controls against a validated S1-immunofluorescence as a reference method. The three assays displaying the highest AUCs were selected for further serodetection of 2033 sera of a large population-based cohort. Results: In the validation analysis (pre-test probability: 48.1%), Roche N, Roche S and Euroimmun showed the highest discriminant accuracy (AUCs: 0.99, 0.98, and 0.98) with PPVs and NPVs above 96% and 94%, respectively. In the population-based cohort (pre-test probability: 6.2%) these three assays displayed AUCs above 0.97 and PPVs and NPVs above 90.5% and 99.4%, respectively. A sequential strategy using an anti-S assay as screening test and an anti-N as confirmatory assays resulted in a 96.7% PPV and 99.5% NPV, respectively. Conclusions: Euroimmun and both Roche assays performed equally well in high pre-test probability settings. At a lower prevalence, sequentially combining anti-S and anti-N assays resulted in the optimal trade-off between diagnostic performances and operational considerations.

During the first wave of the Covid-19 pandemic, access to health care was limited, and patients encountered important delays for scheduled appointments and care. Empirical data relying on patients' reports of forgoing health care are scarce. This study investigated Covid-19-related self-reports of forgoing health care in a sample of vulnerable outpatients in Geneva, Switzerland. We collected data from 1167 adult outpatients, including clinically vulnerable patients (with chronic diseases), geriatric patients (involved in a health care network for people aged 60 or older), and socially vulnerable patients (involved in a migrant health program or a mobile outpatient community care center) in June 2020. Data on sociodemographic factors, forgoing health care, and anti-SARS-CoV-2 antibodies were collected. Of the patients, 38.5% reported forgoing health care. Forgoing health care was more frequent for younger patients, women, patients with a low level of education, and patients with a chronic disease (p, Preventive Medicine, 150

Background: Emergency services are often confronted with patients who have no language in common with medical staff. As interpreters are not always available, medical personnel must rely on alternative solutions such as machine translation or medical fixed-phrase translators, which are sometimes lacking in usability. We aimed to evaluate patient and doctor satisfaction and perceived efficacy of a novel, speech-enabled, fixed-phrase translation tool (“BabelDr”) in real-life situations. Methods: We did a survey-based evaluation of BabelDr among a cohort of 30 of 42 eligible allophone patients visiting the outpatient emergency unit of Geneva University Hospitals (Geneva, Switzerland) between Nov 29, 2018, and Jan 31, 2020 (mean age, 38·2 years; male, 53·3% [n=16]) and their assigned doctors. Selected patients had no understanding of the local (French) language. Languages evaluated were Albanian (n=1), Arabic (n=4), Farsi (n=7), Spanish (n=11), and Tigrinya (n=7). Findings: Ninety percent (n=27) of patients and 86·6% (n=26) of doctors had a positive impression of the translation tool. Additionally, 90% (n=27) of patients felt that the tool enabled them to tell the doctor why they came to the emergency room and 93·3% (n=28) expressed that they understood the tool’s translations. Forty percent (n=12) of patients also stated that they would not have preferred to use an interpreter during the consultation. Concerning perceived efficacy, 93·3% (n=28) of doctors affirmed that they could understand the patient’s health problem and 80% (n=24) were able to make a diagnosis. Results showed a significant positive association (P

In this overview article we describe an application designed to enable communication between health practitioners and patients who do not share a common language, in situations where professional interpreters are not available. Built on the principle of a fixed phrase translator, the application implements different natural language processing (NLP) technologies, such as speech recognition, neural machine translation and text-to-speech to improve usability. Its design allows easy portability to new domains and integration of different types of output for multiple target audiences. Even though BabelDr is far from solving the problem of miscommunication between patients and doctors, it is a clear example of NLP in a real world application designed to help minority groups to communicate in a medical context. It also gives some insights into the relevant criteria for the development of such an application.

Background: Since the beginning of the COVID-19 pandemic, no direct antiviral treatment is effective as post-exposure prophylaxis (PEP). Lopinavir/ritonavir (LPV/r) was repurposed as a potential PEP agent against COVID-19. Methods: We conducted a pragmatic open-label, parallel, cluster-randomized superiority trial in four sites in Switzerland and Brazil. Clusters were randomized to receive LPV/r PEP (400/100 mg) twice daily for 5 days or no PEP (surveillance). The primary outcome is the occurrence of COVID-19 within 21 days post-enrollment. Findings: Of 318 participants, 157 (49.4%) were women, median age was 39 (interquartile range, 28-50) years. A total of 209 (179 clusters) participants were randomized to LPV/r PEP and 109 (95 clusters) to surveillance. Baseline characteristics were similar, with the exception of baseline SARS-CoV-2 PCR positivity, which was 3-fold more frequent in the LPV/r arm (34/209 [16.3%] vs 6/109 [5.5%], respectively). During 21-day follow-up, 48/318 (15.1%) participants developed COVID-19: 35/209 (16.7%) in the LPV/r group and 13/109 (11.9%) in the surveillance group (unadjusted hazard ratio 1.44; 95% CI, 0.76 to 2.73). In the primary endpoint analysis adjusted for propensity score to receive LPV/r, the hazard ratio for developing COVID-19 in the LPV/r group vs surveillance was 0.53 (95% CI, 0.23 to 1.23, respectively; P =.14). Interpretation: LPV/r role as PEP for COVID-19 remains unanswered. In this trial, LPV/r over 5 days did not significantly reduce incidence of COVID-19 in exposed individuals. We observed a change in directionality of the effect in favor of LPV/r after adjusting for baseline SARS-CoV-2 PCR results, indicating a potential role of antivirals in COVID-19 prevention. Clinical Trial Registration Details: ClinicalTrials.gov (Identifier: NCT04364022); Swiss National Clinical Trial Portal: SNCTP 000003732. Funding Information: Fondation privee des HUG and Swiss National Fund (project number: 33IC30_166819). Declaration of Interests: None reported. Ethics Approval Statement: The protocol and amendments were approved by Swissmedic and local ethics committees in Switzerland and Brazil. Participants provided written informed consent before study entry.

ObjectivesTo validate the diagnostic accuracy of a Euroimmun SARS-CoV-2 IgG and IgA immunoassay for COVID-19.MethodsIn this unmatched (1:1) case-control validation study, we used sera of 181 laboratory-confirmed SARS-CoV-2 cases and 176 controls collected before SARS-CoV-2 emergence. Diagnostic accuracy of the immunoassay was assessed against a whole spike protein-based recombinant immunofluorescence assay (rIFA) by receiver operating characteristic (ROC) analyses. Discrepant cases between ELISA and rIFA were further tested by pseudo-neutralization assay.ResultsCOVID-19 patients were more likely to be male and older than controls, and 50.3% were hospitalized. ROC curve analyses indicated that IgG and IgA had high diagnostic accuracies with AUCs of 0.992 (95% Confidence Interval [95%CI]: 0.986-0.996) and 0.977 (95%CI: 0.963-0.990), respectively. IgG assays outperformed IgA assays (p=0.008). Taking an assessed 15% inter-assay imprecision into account, an optimized IgG ratio cut-off > 1.5 displayed a 100% specificity (95%CI: 98–100) and a 100% positive predictive value (95%CI: 97-100). A 0.5 cut-off displayed a 97% sensitivity (95%CI: 93–99) and a 97% negative predictive value (95%CI: 93–99). Substituting these thresholds for the manufacturer’s, improved assay performance, leaving 12% of IgG ratios indeterminate between 0.5-1.5.ConclusionsThe Euroimmun assay displays a nearly optimal diagnostic accuracy using IgG against SARS-CoV-2 in patient samples, with no obvious gains from IgA serology. The optimized cut-offs are fit for rule-in and rule-out purposes, allowing determination of whether individuals in our study population have been exposed to SARS-CoV-2 or not. IgG serology should however not be considered as a surrogate of protection at this stage.

In this paper we present work on creating and evaluating a Text-to-Speech system for the Albanian language to be used in the BabelDr medical speech translation system. Its quality was assessed by twelve native speakers who provided feedback on 60 prompts generated by the synthesizer and on 60 real human recordings across three dimensions, namely comprehensibility, naturalness and likeability. The results suggest that the newly created voice can be incorporated in the content creation pipeline of the BabelDr platform.