[The psychotrauma prevention algorithm, a paramedical pilot study]. / L'algorithme de prévention du psychotraumatisme, une étude pilote paramédicale.

The aim of the psychotrauma prevention algorithm is to limit the occurrence of psychotrauma in a subject who has experienced a serious life event, by carrying out an initial assessment to define the severity criterion and the monitoring modality best suited to his or her clinical condition. This approach is in line with the philosophy of outreach and the ethics of concern. Recontacting the patient during the course of treatment helps to maintain the therapeutic link and prevent any deterioration in his condition, thus limiting the risk of his traumatic state becoming chronic.

PRESOLRE: study protocol for a primary school-based, cluster randomised controlled trial of three sun exposure risk prevention strategies on Reunion Island.

INTRODUCTION: Reunion Island, a French overseas department, is located in the southern hemisphere, close to the Capricorn tropic. This island has a multicultural and multiethnic population of 860 000 inhabitants, a quarter of whom are at high risk of developing skin cancer due to intense ultraviolet radiation. Melanoma is responsible for the majority of skin cancer deaths. The early prevention of melanoma is based on sun protection in childhood, but French regulations are not adapted to the environmental conditions of this tropical region.The main objective of our study is to evaluate the effectiveness of three sun protection programs conducted in Reunionese primary schools through a pupil knowledge questionnaire. METHODS AND ANALYSIS: PRESOLRE is an interventional, open-label, cluster-randomised controlled trial, in four parallel arms, that is being conducted throughout 2022-2023 on Reunion Island. The trial design assumes an escalation interventional effect using: first, a control arm without proposed intervention (arm 1); second, an arm whose classes are encouraged to use the validated educational programme 'Living With the Sun' (LWS) (arm 2); third, an arm whose classes are encouraged to use both 'LWS' combined with 'Mission Soleil Réunion's sun protection awareness programme (arm 3); fourth, an arm benefiting from an intervention similar to arm 3, combined with the distribution of hats, sunglasses and sun creams (arm 4). In all, 1780 pupils from 18 classes of 20 pupils, on average, will be included. Randomisation applies to the classes of pupils (so defined as clusters). The primary outcome is based on the proportion of correct answers to the knowledge questions after the awareness programme, compared between the four arms using a linear mixed model with random intercept. ETHICS AND DISSEMINATION: The study obtained ethics approval in 2022 (ID: 2022-A00350-43). Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05367180.

Psychometric properties of a Creole version of Medical Outcome Study - Short Form 36 among type II diabetes patients on Reunion Island.

Introduction: Health quality of life assessment is particularly important to measure the impact of chronic diseases. The aims of this study were to provide a cross-culturally adapted Creole-translation of the Medical Outcome Study Short-Form 36 (SF-36) and to assess psychometric performance of the Creole and French versions of the SF-36 among patients with type II diabetes in Reunion Island. Materials and methods: The Creole translation and cross-cultural adaptation processes were based on the International Quality Of Life Assessment (IQOLA) methods. Internal consistency, test-retest reliability, convergent and discriminant validity using Multi-Trait-Multi-Method analysis and structural validity using exploratory factor analysis of the SF-36 for both versions were performed. Results: In the Creole version of the SF-36, Cronbach's alpha exceeded 0.70 for all subscales except general health. In the French SF-36, Cronbach's alpha exceeded 0.70 on all subscales except general health and bodily pain. In the Creole SF-36, intraclass correlation coefficient (ICC) for reproducibility was suboptimal. Multi-trait multi-method analysis showed that item-scale correlation exceeded 0.4 for all items except two general health items of the Creole SF-36 and one of the French SF-36. Factor analysis of 2 versions showed that the physical functioning, vitality, and mental health were each divided into two subscales. Discussion: Overall, our findings provided evidence that the SF-36 is adapted to Reunion Island in both Creole and French versions. However, further research could be conducted to investigate French-Creole differences in perceived health status and a cultural adaptation of the French version will be considered.

Quality of life assessment in diabetic patients: validity of the creole version of the EQ-5D-5L in Reunion Island.

Introduction: Due to the high prevalence of diabetes and its complications, evaluating the patient's quality of life is critical. EQ-5D-5L is a valid tool for assessing health-related quality of life (HRQOL) in chronic diseases, including diabetes. However, no psychometric measures have been validated in a Creole-speaking population. Therefore, this study aimed for the first time to validate and cross-culturally adapt Creole and French versions of EQ-5D-5L on Type II diabetes patients in Reunion Island. Materials and methods: The Creole translation and cross-cultural adaptation process were based on the EUROQOL methods. Internal consistency and construct validity were determined using confirmatory factor analysis (CFA) of EQ-5D-5L for both versions. CFA model for HRQOL and global fit measures were calculated based on the EQ-5D-5L items using the maximum likelihood (ML) method. Results: From November 2016 to October 2017, 148 patients were included in the Creole group and 152 in the French group. EQ-5D-5L measures were unidimensional for both versions. Cronbach's coefficient alpha was 0.76 for the Creole version and 0.81 for the French version in CFA models. The root mean square error of approximation (RMSEA) was 0.06 for the Creole version and 0.02 for the French version. The Comparative Fit Index (CFI) was closer to 1 for both versions. CFA models for both the Creole and French versions fit the data adequately. Discussion: Overall, our findings provided evidence that both the Creole and French versions of EQ-5D-5L are suitable for assessing HRQOL in diabetes patients in Reunion Island. However, further research could be done to investigate French-Creole differences concerning the perception of health status, and a cultural adaptation of the French version will be considered.

Feasibility and acceptance of self-hypnosis to reduce chronic stress levels on family in-home caregivers of elderly people: protocol for the POSSAID pilot, randomised, wait-list controlled trial.

INTRODUCTION: Family members who care for elderly people experience high levels of chronic stress because of the intensive assistance they provide permanently to those who are losing their autonomy. Often considered a burden, this stress causes serious consequences to their health and worsens their quality of life (QoL). Reducing caregivers' chronic stress via self-hypnosis protocols may be an effective treatment. The objective is to evaluate the feasibility and acceptance of self-hypnosis protocols taught by hypnotherapy-trained nurses to reduce the chronic stress of in-family caregivers. METHODS AND ANALYSIS: This study is a prospective, monocentric, non-blinded, parallel, pilot, randomised waitlist-controlled trial that will be conducted at the University Hospital of Reunion Island. Sixty participants will be randomly allocated to one of two groups: a self-hypnosis group (intervention) or a waitlist control group. After an 8-week training programme, intervention participants will practice self-hypnosis for ten minutes/day over 8 weeks and subsequently be followed up for 16 weeks thereafter. The primary outcome is to assess the feasibility of a 16-week self-hypnosis protocol for in-family caregivers. Secondary outcomes include the evaluation of the effects of practising self-hypnosis among in-family caregivers of elderly people concerning their stress levels, sleep disorders, levels of fatigue, and QoL at 2, 4 and 8 months on an exploratory basis. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Ethics Committee CPP Ile de France VI-Groupe Hospitalier Pitié Salpêtrière on 14 April 2021 (ID RCB: 2021-A00009-32). All participants will receive information about the trial in verbal and written forms. They will give an oral consent which is notified in a dedicated research file prior before enrolment. Results will be published in peer-reviewed journals as well as presented and disseminated at conferences. TRIAL REGISTRATION NUMBER: NCT04909970.

Diabetes incidence in subjects with PREDIABetes from ReUNion Island: the PREDIABRUN observational cohort study protocol.

INTRODUCTION: Improved knowledge of prediabetic subjects' profile and their risk of developing type 2 diabetes mellitus (T2DM) would enhance secondary prevention. The primary objective is to describe factors associated with incident T2DM in subjects with pre-diabetes diagnosed in primary care. METHODS AND ANALYSIS: The study is based on Reunion Island, a French overseas region that experiences a particularly high disease burden of T2DM. This is an observational, non-randomised prospective cohort study conducted in primary care in which private general practitioner (GP) investigators recruit participants with pre-diabetes from their practices regardless of the initial motive for consultation. Pre-diabetes is defined by WHO criteria, that is, fasting plasma glucose between 1.10 g/L and 1.25 g/L and/or plasma glucose 2 hours after ingestion of 75 g of glucose (2-hour post load plasma glucose) between 1.40 g/L and 1.99 g/L. The design is based on an annual follow-up by the GP (according to French National Health Authority recommendations) with collection of clinical and laboratory data and specific lifestyle questionnaires answered by telephone at three time points: inclusion, and at 2-year and 5-year follow-up visits. Follow-up clinical and laboratory data are collected by the investigating GP as part of the study, and study-specific laboratory collections (serum, DNA and urine) will be obtained 2 and 5 years after inclusion. The primary outcome is transition to T2DM. ETHICS AND DISSEMINATION: This protocol has been approved by the research ethics committee of Saint Etienne (CPP Saint Etienne reference number: 2019-03). Enrolment began in August 2019. Results will be disseminated in at least three papers published in peer-reviewed medical journals, one oral communication and a large-scale communication to the local population and healthcare policymakers. TRIAL REGISTRATION NUMBER: NCT04463160 and ID-RCB 2018-A03106-49.

Prognosis of patients with acute respiratory failure due to the SARS-CoV-2 501Y.V2 variant: a multicenter retrospective matched cohort study.

The aim of this study was to compare the prognosis of patients with acute respiratory failure (ARF) due to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant 501Y.V2 to that of patients with ARF due to the original strain. This retrospective matched cohort study included all consecutive patients who were hospitalized for ARF due to SARS-CoV-2 in Reunion Island University Hospital between March 2020 and March 2021. Twenty-eight in hospital mortality was evaluated before and after matching. A total of 218 patients with ARF due to SARS-CoV-2 were enrolled in the study. Of these, 83 (38.1%) were infected with the 501Y.V2 variant. During intensive care unit stay, 104 (47.7%) patients received invasive mechanical ventilation and 20 (9.2%) patients were supported by venovenous extracorporeal membrane oxygenation. Patients infected with the 501Y.V2 variant were younger (58 [51-68] vs. 67 [56-74] years old, P = 0.003), had less hypertension (54.2% vs 68.1%, P = 0.04), and had less chronic kidney disease (13.3% vs. 31.9%, P = 0.002) than patients infected with the original strain. After controlling for confounding variables (62 matched patients in each group), 28-day mortality was higher in the group of patients infected with the 501Y.V2 variant (30.6%) than in the group of patients infected with the original strain (19.4%, P = 0.04). In Reunion Island, where SARS-CoV-2 incidence remained low until February 2021 and the health care system was never saturated, mortality was higher in patients with ARF infected with the 501Y.V2 variant than in patients infected with the original strain.

Differentiating COVID-19 and dengue from other febrile illnesses in co-epidemics: Development and internal validation of COVIDENGUE scores.

OBJECTIVES: The purpose of this cohort study was to develop two scores able to differentiate coronavirus 2019 (COVID-19) from dengue and other febrile illnesses (OFIs). METHODS: All subjects suspected of COVID-19 who attended the SARS-CoV-2 testing center of Saint-Pierre hospital, Reunion, between March 23 and May 10, 2020, were assessed for identifying predictors of both infectious diseases from a multinomial logistic regression model. Two scores were developed after weighting the odd ratios then validated by bootstrapping. RESULTS: Over 49 days, 80 COVID-19, 60 non-severe dengue and 872 OFIs were diagnosed. The translation of the best fit model yielded two scores composed of 11 criteria: contact with a COVID-19 positive case (+3 points for COVID-19; 0 point for dengue), return from travel abroad within 15 days (+3/-1), previous individual episode of dengue (+1/+3), active smoking (-3/0), body ache (0/+5), cough (0/-2), upper respiratory tract infection symptoms (-1/-1), anosmia (+7/-1), headache (0/+5), retro-orbital pain (-1/+5), and delayed presentation (>3 days) to hospital (+1/0). The area under the receiver operating characteristic curve was 0.79 (95%CI 0.76-0.82) for COVID-19 score and 0.88 (95%CI 0.85-0.90) for dengue score. Calibration was satisfactory for COVID-19 score and excellent for dengue score. For predicting COVID-19, sensitivity was 97% at the 0-point cut-off and specificity 99% at the 10-point cut-off. For predicting dengue, sensitivity was 97% at the 3-point cut-off and specificity 98% at the 11-point cut-off. CONCLUSIONS: COVIDENGUE scores proved discriminant to differentiate COVID-19 and dengue from OFIs in the context of SARS-CoV-2 testing center during a co-epidemic.

Co-infection in patients with hypoxemic pneumonia due to COVID-19 in Reunion Island.

ABSTRACT: This study aimed to evaluate the incidence of co-infection with different types of pathogens in patients with hypoxemic pneumonia due to coronavirus disease 2019 (COVID-19) in Reunion Island.This observational study using a prospectively collected database of hypoxemic pneumonia due to COVID-19 cases was conducted at Félix Guyon University Hospital in Reunion Island, France.Between 18 March 2020 and 15 April 2020, 156 patients were admitted to our hospital for COVID-19. A total of 36 patients had hypoxemic pneumonia (23.1%) due to COVID-19. Thirty of these cases (83.3%) were imported by travelers returning mainly from metropolitan France and Spain. Patients were screened for co-infection with other pathogens at admission: 31 (86.1%) by multiplex polymerase chain reaction (PCR) and 16 (44.4%) by cytobacteriological examination of sputum culture. Five patients (13.9%) were found to have co-infection: 1 with influenza virus A H1N1 (pdm09) associated with Branhamella catarrhalis, 1 with Streptococcus pneumoniae associated with Haemophilus influenzae, 1 with Human Coronavirus 229E, 1 with Rhinovirus, and 1 with methicillin-susceptible Staphylococcus aureus. Patients with co-infection had higher D-dimer levels than those without co-infection (1.36 [1.34-2.36] µg/mL vs 0.63 [0.51-1.12] µg/mL, P = .05).The incidence of co-infection in our cohort was higher than expected (13.9%). Three co-infections (with influenza virus A(H1N1) pdm09, Streptococcus pneumoniae, and Staphylococcus aureus) required specific treatment. Patients with hypoxemic pneumonia due to COVID-19 should be screened for co-infection using respiratory cultures or multiplex PCR. Whilst our study has a number of limitations, the results from our study suggest that in the absence of screening, patients should be commenced on treatment for co-infection in the presence of an elevated D-dimer.

Clinical Remission and Psychological Management are Major Issues for the Quality of Life in Pediatric Crohn Disease.

OBJECTIVES: Crohn disease (CD) can affect patient's quality of life (QOL) with physical, social, and psychological impacts. This study aimed to investigate the QOL of children with CD and its relationship with patient and disease characteristics. METHODS: Children ages from 10 to 17 years with diagnosed CD for more than 6 months were eligible to this cross-sectional study conducted in 35 French pediatric centers. QOL was assessed by the IMPACT-III questionnaire. Patient and disease characteristics were collected. RESULTS: A total of 218 children (42% of girls) were included at a median age of 14 years (interquartile range [IQR]: 13--16). Median duration of CD was 3.2 years (IQR: 1.7-5.1) and 63% of children were in clinical remission assessed by wPCDAI. Total IMPACT-III score was 62.8 (±11.0). The lowest score was in "emotional functioning" subdomain (mean: 42.8 ±â€Š11.2). Clinical remission was the main independent factor associated with QOL of children with CD (5.74 points higher compared with those "with active disease", 95% confidence interval [CI] 2.77--8.70, P < 0.001). Age of patient at the evaluation was found negatively correlated with QOL (-0.76 per year, 95% CI: -1.47 to -0.06, P = 0.009). Presence of psychological disorders was associated with a lower QOL (-9.6 points lower to those without, 95% CI: -13.34 to -5.86, P < 0.0001). Total IMPACT-III and its subdomains scores were not related to sex, disease duration, or treatments. CONCLUSIONS: These results not only confirm that clinical remission is a major issue for the QOL of patients, but also highlights the importance of psychological care.

A comprehensive strategy for the early treatment of COVID-19 with azithromycin/hydroxychloroquine and/or corticosteroids: Results of a retrospective observational study in the French overseas department of Réunion Island.

BACKGROUND: This study aimed to evaluate the prognosis of COVID-19 patients in Reunion Island, with a particular focus on the management of patients with hypoxemic pneumonia. METHODS: This retrospective observational study was conducted from 11 March to 17 April 2020 at the only hospital authorized to manage patients with COVID-19 in Reunion Island. RESULTS: Over the study period, 164 out of 398 patients (41.2%) infected with COVID-19 were admitted to Félix Guyon University Hospital. Of these, 36 (22%) developed hypoxemic pneumonia. Patients with hypoxemic pneumonia were aged 66 [56-77] years, 69% were male and 33% had hypertension. Ten patients (27.8%) were hospitalized in intensive care unit (ICU). Hydroxychloroquine/azithromycin treatment was associated with a lower ICU admission rate (P=0.008). None of the 6 patients treated with corticosteroids were hospitalized in ICU (P=0.16). There were no deaths at follow up (minimum 80 days). CONCLUSIONS: Despite the risk profile of COVID-19 patients with severe hypoxemic pneumonia, the mortality rate of the disease in Reunion Island was 0%. This may be due to the care bundle used in our hospital (early hospitalisation, treatment with hydroxychloroquine/azithromycin and/or corticosteroids, non-invasive respiratory support, etc).

Detection of Pulmonary Embolism in Returning Travelers with Hypoxemic Pneumonia due to COVID-19 in Reunion Island.

The aim of this study was to evaluate the occurrence of pulmonary embolism in returning travelers with hypoxemic pneumonia due to COVID-19. All returning travelers to Reunion Island with hypoxemic pneumonia due to COVID-19 underwent computed tomography pulmonary angiography (CTPA) and were included in the cohort. Thirty-five patients were returning travelers with hypoxemic pneumonia due to COVID-19 and had recently returned from one of the countries most affected by the COVID-19 outbreak (mainly from France and Comoros archipelago). Five patients (14.3%) were found to have pulmonary embolism and two (5.9%) were incidentally found to have deep vein thrombosis on CTPA. Patients with pulmonary embolism or deep vein thrombosis had higher D-dimer levels than those without pulmonary embolism or deep vein thrombosis (P = 0.04). Returning travelers with hypoxemic pneumonia due to COVID-19 should be systematically screened for pulmonary embolism.

Trends in initiation of direct oral anticoagulant therapies for atrial fibrillation in a national population-based cross-sectional study in the French health insurance databases.

OBJECTIVE: Unlike several other national health agencies, French health authorities recommended that the newer direct oral anticoagulant (DOAC) agents only be prescribed as second choice for the treatment of newly diagnosed non-valvular atrial fibrillation (NVAF), with vitamin K antagonists (VKA) remaining the first choice. We investigated the patterns of use of DOACs versus VKA in the treatment of NVAF in France over the first 5 years of DOAC availability. We also identified the changes in patient characteristics of those who initiated DOAC treatment over this time period. METHODS: Based on the French National Health Administrative Database, we constituted a population-based cohort of all patients who were newly treated for NVAF between January 2011 and December 2015. Trends in drug use were described as the percentage of patients initiating each drug at the time of treatment initiation. A multivariate analysis using logistic regression model was performed to identify independent sociodemographic and clinical predictors of initial anticoagulant choice. RESULTS: The cohort comprised 814 446 patients who had received a new anticoagulant treatment for NVAF. The proportion of patients using DOACs as initial anticoagulant therapy reached 54% 3 months after the Health Ministry approved the reimbursement of dabigatran for NVAF, and 61% by the end of 2015, versus VKA use. In the multivariate analysis, we found that DOAC initiators were younger and healthier overall than VKA initiators, and this tendency was reinforced over the 2011-2014 period. DOACs were more frequently prescribed by cardiologists in 2012 and after (adjusted OR in 2012: 2.47; 95% CI 2.40 to 2.54). CONCLUSION: Despite recommendations from health authorities, DOACs have been rapidly and massively adopted as initial therapy for NVAF in France. Observational studies should account for the fact that patients selected to initiate DOAC treatment are healthier overall, as failure to do so may bias the risk-benefit assessment of DOACs.

Factors associated with the level of CD4 cell counts at HIV diagnosis in a French cohort: a quantile regression approach.

The consensus definition of late presentation for human immunodeficiency virus patient based on a CD4 threshold of 350 cells/mm3 has limitations concerning risk factors identification since there is growing biomedical justification for earlier initiation of treatment. The objective was to overcome this problem by simultaneously determining factors associated with different levels of CD4 counts at the time of diagnosis. Between January 2000 and July 2014, 1179 patients with a first human immunodeficiency virus diagnosis and entering care in a French human immunodeficiency virus reference center were enrolled. Factors associated with each 5 percentile from 5th to 95th quantile of CD4 counts at diagnosis were simultaneously studied in a multivariable quantile regression model. At each of the quantiles, the factors identified as negatively associated with CD4 count at diagnosis were older age, male sex , foreign patients, hepatitis B virus or hepatitis C virus co-infection, employment status, non-MSM transmission, heterosexual transmission, suburban and rural's place of residence and earlier period of diagnosis. Association with CD4 count was not uniformly significant, most factors being significant for some quantiles. The only significant determinant for all quantiles was being born in a foreign country. These results are particularly helpful in the context of human immunodeficiency virus clinical care, management and prevention.