[French version of The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, in a French law context]. / Version française des recommandations de la déclaration d'Ottawa sur la conception et la conduite éthique d'essais randomisés en clusters, dans le contexte législatif français.

INTRODUCTION: There is growing evidence on the ethical challenges raised by cluster randomized trials. This specificity is not reflected in the legal texts regulating research, which creates difficulties for researchers implementing these experimental designs. The Ottawa Statement (Weijer et al. 2012) aims to provide detailed guidance on the ethical design, conduct and assessment of cluster trials. More broadly aims to help research stakeholders and decision-makers to make informed ethical decisions regarding the particularity of these experimental designs. It seems that this international statement, written in English, is not sufficiently accessible to all of the French professionals involved in health research. The aim of this article is to provide these professionals with a contextualized and illustrated French translation of the "Ottawa statement". METHOD: . The "complex design" working group of the RECaP network (Research in Clinical Epidemiology and Public Health), carried out this work. A first version was discussed by the authors in several meetings. It was completed by contextual explanations and examples of French studies currently conducted by the authors. The final version was obtained by consensus and validated by the group. RESULTS: . This work reports 15 recommendations grouped into 7 key questions: How to justify cluster design? How to submit an article to an ethics committee? How to identify research participants? How and when to obtain informed consent? Who are the gatekeepers? How to assess benefits and harm? How to protect vulnerable participants? Each of these recommendations is specific to cluster trials. The recommendations are explained and detailed through concrete examples. CONCLUSION: Without interfering with current French laws, this work provides a framework for the organization, conduct and ethical assessment of cluster randomized trials in France. In the present-day context, it is essential that all concerned groups can base their decisions on recommendations in line with the elementary principles of health research ethics.

Individual and contextual risk factors for chikungunya virus infection: the SEROCHIK cross-sectional population-based study.

The purpose of the study was to weigh the community burden of chikungunya determinants on Reunion island. Risk factors were investigated within a subset of 2101 adult persons from a population-based cross-sectional serosurvey, using Poisson regression models for dichotomous outcomes. Design-based risk ratios and population attributable fractions (PAF) were generated distinguishing individual and contextual (i.e. that affect individuals collectively) determinants. The disease burden attributable to contextual determinants was twice that of individual determinants (overall PAF value 89.5% vs. 44.1%). In a model regrouping both categories of determinants, the independent risk factors were by decreasing PAF values: an interaction term between the reporting of a chikungunya history in the neighbourhood and individual house (PAF 45.9%), a maximal temperature of the month preceding the infection higher than 28.5 °C (PAF 25.7%), a socio-economically disadvantaged neighbourhood (PAF 19.0%), altitude of dwelling (PAF 13.1%), cumulated rainfalls of the month preceding the infection higher than 65 mm (PAF 12.6%), occupational inactivity (PAF 11.6%), poor knowledge on chikungunya transmission (PAF 7.3%) and obesity/overweight (PAF 5.2%). Taken together, these covariates and their underlying causative factors uncovered 80.8% of chikungunya at population level. Our findings lend support to a major role of contextual risk factors in chikungunya virus outbreaks.

Rheumatism and chronic fatigue, the two facets of post-chikungunya disease: the TELECHIK cohort study on Reunion island.

Prolonged fatigue is increasingly reported among chikungunya virus (CHIKV)-infected populations. We investigated the relationships between CHIKV exposure, long-lasting rheumatic musculoskeletal pain (LRMSP) and chronic fatigue. 1094 participants (512 CHIKV seropositive and 582 seronegative) of the TELECHIK population-based cohort were analysed considering the duration of the manifestations throughout an average 2-year follow-up. Weighted prevalence rates and prevalence ratios for LRMSP, idiopathic chronic fatigue (ICF), and chronic fatigue syndrome (CFS)-like illness, both latter syndromes adapted from Centers for Disease Control (CDC)-1994/Fukuda criteria, were compared. Population attributable fractions (PAF) were estimated to assess the contribution of CHIKV infection to each of the three phenotypes. Among 362 adult subjects who had reported either rheumatic pain or fatigue at the onset of the infection, weighted prevalence rates of LRMSP, ICF and CFS-like illness were respectively of 32.9%, 38.7% and 23.9%, and of 8.7%, 8.5% and 7.4% among initially asymptomatic peers (P < 0.01, respectively). Each of the three outcomes was highly attributable to chikungunya (PAF of 43.2%, 36.2% and 41.0%, respectively). In the sub-cohort of CHIKV-infected subjects, LRMSP, ICF and CFS-like illness, which overlapped in 70%, accounted for 53% of the chronic manifestations. In addition to rheumatic disease, chronic fatigue could be considered in caring for patients with chronic chikungunya disease.

[Perceived morbidity and community burden of chikungunya in La Reunion]. / Morbidité perçue et impact communautaire du chikungunya a l'île de La Réunion: enquête de cohorte en population TELECHIK.

BACKGROUND: Persistence of clinical manifestations, especially polyarthralgia and fatigue, is a characteristic feature of chikungunya virus (CHIK-v) infection. The purpose of this study was to measure the impact of prolonged or late-onset manifestations of CHIK-v infection on the self-perceived health of people on Reunion Island. METHODS: This retrospective cohort survey, dubbed TELECHIK survey, was conducted eighteen months after the end of the chikungunya outbreak on a representative random sample from the SEROCHIK population-based survey conducted on Reunion Island. A total of 1094 subjects whose CHIK-v specific IgG antibody status had been documented were interviewed about current symptoms. RESULTS: Analysis of data showed 45% of CHIK+ vs 14% of CHIK- subjects reporting musculoskeletal pain (P < 0.001), 56% vs. 44% reporting fatigue (P = 0.003), 77% vs. 53% reporting cerebral manifestations (P < 0.001), 51% vs. 34% reporting sensorineural impairments (P < 0.001), 18% vs. 13% reporting digestive complaints (P = 0.06), and 38% vs. 32% reporting skin involvement (P = 0.13). The mean delay between infection and interview was two years (range, 15-34 months). Analysis of data after correction for age, gender, body mass index and comorbidity indicated that rheumatic pain, fatigue, cerebral manifestations and sensorineural impairments were more likely in CHIK+ than CHIK- subjects but the likelihood of digestive and skin manifestations was the same. CONCLUSION: With a mean delay of two years after infection, 45% to 77% of CHIK+ subjects reported prolonged or late-onset symptoms attributable to CHIK-v. These results indicate that persistent manifestations of chikungunya infection have a heavy impact on rheumatologic, neurological and sensorineural health.

Quarterly individual outpatients lifestyle counseling after initial inpatients education on type 2 diabetes: the REDIA Prev-2 randomized controlled trial in Reunion Island.

AIMS: This study aimed to describe the 1-year evolution of type 2 diabetes (T2D) patients who attended inpatients education, and to assess whether quarterly outpatients counseling visits by nurses and dietitians can improve metabolic control and health-related behaviours. METHODS: Following in-hospital educational sessions, 398 adult T2D patients were randomized to either attend quarterly individual lifestyle counseling visits by a nurse and a dietitian (intervention group), or receive the usual care (control group). Primary (HbA(1c)) and secondary endpoints (fasting blood glucose, lipids, body mass index, waist circumference, fat mass, blood pressure, diet, physical activity) were assessed at baseline and at 12 months. RESULTS: HbA(1c) changes from baseline to 12 months were -1.74±2.64% (P<0.0001) for the intervention group and -2.02±2.57% (P<0.0001) for the control group. There was no statistically significant difference between the intervention group (n=153) and the controls (n=166) for any of the clinical and biological outcomes. In both groups, total energy and fat intakes decreased significantly from baseline levels. Also, no difference was found between the groups for any dietary outcome. A slight enhancement in sports activity was observed in the intervention group, but the difference between the two groups did not reach statistical significance, and no difference was found concerning any other physical activity scores. CONCLUSION: In this study of adults with T2D, patients significantly improved their metabolic control, and dietary and exercise habits, 1 year after receiving intensive inpatients education, whereas subsequent quarterly outpatients counseling visits with nurses and dietitians have not demonstrated any superiority compared with the usual care.

[Determinants of group B streptococcus maternal colonization and factors related to its vertical perinatal transmission: case-control study]. / Déterminants de la colonisation maternelle à streptocoque B et facteurs associés à sa transmission verticale périnatale: étude cas-témoins.

OBJECTIVES: To investigate the determinants of Group B streptococcus (GBS) maternal colonization, as well as factors associated with its vertical transmission. PATIENTS AND METHODS: Case-control study on all singletons pregnancies delivered beyond at least 24 weeks of amenorrhoea in Southern Reunion maternities for which GBS screening was known. Multiple logistic regression analysis using 2004-2007 dataset of South Reunion birth registers. RESULTS: Out of 17,430 women delivered between 1st January 2004 and 31st December 2007, 2911 (16.7%) carried GBS. In a model adjusted on antenatal care, risk groups for GBS carriage were the women indigenous from another island of the Indian Ocean than Reunion (OR: 1.29, CI95%: 1.05-1.57) and obese women (body mass index ≥ 30, OR: 1.19, CI95%: 1.03-1.18). Protective factors included birthplace in mainland France (OR: 0.82, CI95%: 0.69-0.97) and underweight (OR: 0.81; CI95%: 0.69-0. 95). In a model controlling for a composite obstetrical variable delineating the protective roles of C-section and antibioprophylaxis as well as the putative role of meconium-stained fluids (thin, thick or fetid), all previously found in our setting, three key factors were independently associated with GBS vertical mother-to-child transmission: obesity (OR: 1.48, CI95%: 1.05-2.09), fetal tachycardia (OR: 4.92, CI95%: 2.79-8.68) and late preterm birth (35 to 36 wks, OR: 2.14, CI95%: 1.32-3.45). CONCLUSION: These findings strengthen the putative roles of corpulence and ethnicity in GBS acquisition previously found in the United States, while confirming an authentic role of obesity in its vertical transmission, independently of other classical cofactors lighted by our study.

[Early onset neonatal infections in the South of the Reunion Island: Incidence and use of 2002 ANAES risk criteria]. / Infection bactérienne néonatale précoce dans le sud de la Réunion: incidence et application des critères de risque Anaes 2002.

OBJECTIVES: The aim of this study was to describe the incidence of early onset neonatal infections (EONI) in the southern part of the Reunion Island, and to study the application of ANAES criteria. PATIENTS AND METHODS: A cross-sectional study was made of data collected for all live births having occurred between 1st January 2001 and 31st December 2004. RESULTS: Four hundred and thirty-seven in 16,071 neonates (out of 21,231 live births) presented with a certain or probable EONI, accounting for a regional rate of 20 per thousand (CI95 % 18-23 per thousand). Among 437 EONIs, group B streptococcus (GBS) was reported in 70.5% of the cases (n=308), Gram negative bacteria in 19.9% (n=87), of which nearly two thirds of Escherichia coli (n=56). Applying ANAES criteria led to identify 380 EONIs among 437 proven infections (sensitivity: 87%, specificity: 26%). A logistic regression analysis identified eight EONI predictors for the 7015 neonates for whom the mother GBS screening was documented: GBS positive vaginal culture (OR 4.2; CI95% 3.3-5.4), unexplained preterm birth less than 35 weeks (OR 5.7; CI95% 3.7-8.7), prolonged rupture of membranes greater than or equal to 18 hours (OR 2.1; CI95% 1.4-3.0), maternal fever greater than or equal to 37.8 degrees C (OR 3.2; CI95% 2.3-4.5), fetal tachycardia greater than or equal to 160 ppm (OR 2.7; CI95% 1.8-4.0), and thin (OR 1.6; CI95% 1.2-2.1) or thick meconium-stained amniotic fluid (OR 3.0; CI95% 2.1-4.5) or fetid fluid (OR 14.8; CI95% 4.2-51.8). CONCLUSION: The incidence of EONIS far exceeded that observed in metropolitan France, and the ANAES criteria lack sensitivity and specificity.

Molecular and serological diagnosis of Chikungunya virus infection.

INTRODUCTION: In 2005-2006, during the Chikungunya virus outbreak in La Réunion (Indian Ocean), we urgently established the molecular and serological methods for the diagnosis of Chikungunya virus (CHIKV) from various types of samples. METHODS: CHIKV RNA was detected using a highly sensitive real-time RT PCR assay. A co-extracted and co-amplified internal control RNA was used to identify RT PCR inhibitors. Depending on their nature samples were pretreated before nucleic acid extraction. Viral loads were measured using a synthetic RNA calibrator. CHIKV immunoglobulin (Ig) G and M antibodies were detected by ELISA either from sera or from blood absorbed on filter paper. RESULTS: CHIKV RNA was found in various types of samples such as plasma, cerebrospinal fluid, and placenta, but was not found in some samples including maternal milk and synovial samples. Detection of IgG from filter paper absorbed blood is specific and sensitive. Routine data showed that maternally transferred IgG and naturally acquired IgM persist at least 12 and 18 months, respectively. DISCUSSION: The techniques enabled the diagnosis of chikungunya in known and newly described forms of the disease. They are used for routine diagnosis and large scale surveys.

Trends and sociocultural factors for childhood overweight in La Reunion Island.

OBJECTIVE: To examine time trends (study 1) and sociocultural factors associated with childhood overweight (study 2) in La Reunion Island. DESIGN: Study 1: a longitudinal analysis of anthropometric data available from health services in the town of Saint-Pierre. Study 2: a case - control study. SUBJECTS: Study 1: 1753 children born between 1977 and 1996. Study 2: 101 six-year old overweight children sex-matched with 101 non-overweight children. MEASUREMENTS: Study 1: overweight at birth (birth weight>4 kg) and at age 4 and 6 using French references and references from the International Obesity Task Force. Study 2: parental and perinatal data, child's lifestyle and representation of food, all collected from the mother. RESULTS: Study 1: a dramatic increase in the prevalence rate of overweight at 4 and at 6 is observed, more severe in girls. Study 2: multivariate logistic regressions showed that mother's overweight was the only variable significantly associated with overweight in both the sexes. The other associated factors were related to sociocultural and family features and sedentarity. Logistic probability functions derived from these data are proposed as a tool for detection of at risk families. CONCLUSION: Our results show the need for a targeted prevention of overweight. We offer a proposal based on education and behaviour modification in La Reunion Island.

Health perceptions of diabetic patients in the REDIA study.

AIM: To explore the beliefs and perceptions of type 2 diabetic patients in La Réunion where the disease is highly prevalent (17.5% among 30-69 yr old subjects) with a strong link to the metabolic syndrome and nutritional habits. METHODS: Two sets of data were analysed. An 80-item questionnaire explored the perceptions of causal factors, knowledge of complications and therapeutic issues in 331 known diabetic patients included in the REDIA study. The data were completed by semi-structured interviews of 40 diabetic patients in a hospital setting. RESULTS: Perceived causal factors of diabetes are mainly sugar excess, heredity and stress or life events. Weight excess and lack of physical activity are virtually never mentioned as causes. Diabetes is predominantly perceived as potentially acute, with risk of coma and death. Its chronic and progressive nature is not appreciated, and chronic complications are not well understood, especially in poorly educated people. Only 33% of males and 42% of females are willing to change their nutritional habits and the role of fats is largely underestimated (30.2%) although 90% consider physical activity as an effective course of action. Most patients are tardy in the way that they adopt medical recommendations and treatment in the course of the disease. CONCLUSION: These results highlight the discrepancy between medical knowledge and patients' perceptions, especially concerning etiological issues and complications. Lifestyle and therapeutic recommendations are not well understood. Educational activities need to consider the knowledge issues and understanding by patients early in the course of chronic diseases like diabetes.