RESUMO
Since 2022, Europe has had 4 cases of extensively drug-resistant Neisseria gonorrhoeae, sequence type 16406, that is resistant to ceftriaxone and highly resistant to azithromycin. We report 2 new cases from France in 2023 involving strains genetically related to the 4 cases from Europe as well as isolates from Cambodia.
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Antibacterianos , Farmacorresistência Bacteriana Múltipla , Gonorreia , Neisseria gonorrhoeae , Neisseria gonorrhoeae/efeitos dos fármacos , Neisseria gonorrhoeae/genética , Neisseria gonorrhoeae/isolamento & purificação , Humanos , Gonorreia/tratamento farmacológico , Gonorreia/microbiologia , Gonorreia/epidemiologia , França/epidemiologia , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Masculino , Farmacorresistência Bacteriana Múltipla/genética , Testes de Sensibilidade Microbiana , Adulto , Feminino , Azitromicina/farmacologia , Azitromicina/uso terapêutico , Ceftriaxona/farmacologia , Ceftriaxona/uso terapêuticoRESUMO
BackgroundDuring the 2022 mpox outbreak in Europe, primarily affecting men who have sex with men, a limited number of cases among children and adolescents were identified. Paediatric cases from outbreaks in endemic countries have been associated with a higher likelihood of severe illness. Detailed clinical case descriptions and interventions in school settings before 2022 are limited.AimTo describe clinical characteristics of mpox cases among children (<â¯15 years) and adolescents (15-17 years) in the greater Paris area in France, and infection control measures in schools.MethodsWe describe all notified laboratory-confirmed and non-laboratory-confirmed cases among children and adolescents identified from May 2022 to July 2023, including demographic and clinical characterisation and infection control measures in school settings, i.e. contact tracing, contact vaccination, secondary attack rate and post-exposure vaccination uptake.ResultsNineteen cases were notified (13 children, 6 adolescents). Four adolescent cases reported sexual contact before symptom onset. Ten child cases were secondary cases of adult patients; three cases were cryptic, with vesicles on hands, arms and/or legs and one case additionally presented with genitoanal lesions. Five cases attended school during their infectious period, with 160 at-risk contacts identified, and one secondary case. Five at-risk contacts were vaccinated following exposure.ConclusionCases among children and adolescents are infrequent but require a careful approach to identify the source of infection and ensure infection control measures. We advocate a 'contact warning' strategy vs 'contact tracing' in order to prevent alarm and stigma. Low post-exposure vaccination rates are expected.
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Busca de Comunicante , Surtos de Doenças , Instituições Acadêmicas , Humanos , Adolescente , Masculino , Criança , Feminino , Surtos de Doenças/prevenção & controle , Paris/epidemiologia , Vacinação/estatística & dados numéricos , Homossexualidade Masculina/estatística & dados numéricos , Seguimentos , Infecções Meningocócicas/prevenção & controle , Infecções Meningocócicas/epidemiologiaRESUMO
During the summer of 2023, the European Region experienced a limited resurgence of mpox cases following the substantial outbreak in 2022. This increase was characterised by asynchronous and bimodal increases, with countries experiencing peaks at different times. The demographic profile of cases during the resurgence was largely consistent with those reported previously. All available sequences from the European Region belonged to clade IIb. Sustained efforts are crucial to control and eventually eliminate mpox in the European Region.
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Surtos de Doenças , Filogenia , Humanos , Europa (Continente)/epidemiologia , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Adolescente , Adulto Jovem , Criança , Idoso , Vigilância da População , Pré-Escolar , IncidênciaRESUMO
We report two extensively drug-resistant (XDR) Neisseria gonorrhoeae (NG) isolates combining high-level resistance to azithromycin and resistance to ceftriaxone, obtained in France from two heterosexual patients, one of whom returned from Cambodia. Whole genome sequencing identified MLST ST16406, the mosaic penA-60.001 which caused ceftriaxone resistance in the internationally spreading FC428 clone, and the A2059G mutation in the 23S rRNA gene. The NG isolates F93 and F94 were related to XDR isolates detected in Austria and the United Kingdom in 2022.
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Ceftriaxona , Gonorreia , Humanos , Azitromicina/farmacologia , Ceftriaxona/farmacologia , França , Gonorreia/diagnóstico , Gonorreia/tratamento farmacológico , Tipagem de Sequências Multilocus , Neisseria gonorrhoeae/genéticaRESUMO
BackgroundLocally-acquired mpox cases were rarely reported outside Africa until May 2022, when locally-acquired-mpox cases occurred in various European countries.AimWe describe the mpox epidemic in France, including demographic and behavioural changes among a subset of cases, during its course.MethodsData were retrieved from the enhanced national surveillance system until 30 September 2022. Laboratory-confirmed cases tested positive for monkeypox virus or orthopoxviruses by PCR; non-laboratory-confirmed cases had clinical symptoms and an epidemiological link to a laboratory-confirmed case. A subset of ≥ 15-year-old male cases, notified until 1 August, was interviewed for epidemiological, clinical and sexual behaviour information. Association of symptom-onset month with quantitative outcomes was evaluated by t- or Wilcoxon tests, and with binary outcomes, by Pearson's chi-squared or Fisher exact tests.ResultsA total of 4,856 mpox cases were notified, mostly in Île-de-France region (62%; 3,025/4,855). Cases aged ≥ 15 years were predominantly male (97%; 4,668/4,812), with 37 years (range: 15-81) as mean age. Between May and July, among the subset interviewed, mpox cases increased in regions other than Île-de-France, and mean age rose from 35 (range: 21-64) to 38 years (range: 16-75; p = 0.007). Proportions of cases attending men-who-have-sex-with-men (MSM) meeting venues declined from 60% (55/91) to 46% (164/359; p = 0.012); median number of sexual partners decreased from four (interquartile range (IQR): 1-10) to two (IQR: 1-4; p < 0.001).ConclusionChanges in cases' characteristics during the epidemic, could reflect virus spread from people who were more to less behaviourally vulnerable to mpox between May and July, or MSM reducing numbers of sexual partners as recommended.
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Mpox , Minorias Sexuais e de Gênero , Masculino , Humanos , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Adolescente , Feminino , Homossexualidade Masculina , Comportamento Sexual , Surtos de Doenças , França/epidemiologiaRESUMO
BackgroundSince May 2022, an mpox outbreak affecting primarily men who have sex with men (MSM) has occurred in numerous non-endemic countries worldwide. As MSM frequently reported multiple sexual encounters in this outbreak, reliably determining the time of infection is difficult; consequently, estimation of the incubation period is challenging.AimWe aimed to provide valid and precise estimates of the incubation period distribution of mpox by using cases associated with early outbreak settings where infection likely occurred.MethodsColleagues in European countries were invited to provide information on exposure intervals and date of symptom onset for mpox cases who attended a fetish festival in Antwerp, Belgium, a gay pride festival in Gran Canaria, Spain or a particular club in Berlin, Germany, where early mpox outbreaks occurred. Cases of these outbreaks were pooled; doubly censored models using the log-normal, Weibull and Gamma distributions were fitted to estimate the incubation period distribution.ResultsWe included data on 122 laboratory-confirmed cases from 10 European countries. Depending on the distribution used, the median incubation period ranged between 8 and 9 days, with 5th and 95th percentiles ranging from 2 to 3 and from 20 to 23 days, respectively. The shortest interval that included 50% of incubation periods spanned 8 days (4-11 days).ConclusionCurrent public health management of close contacts should consider that in approximately 5% of cases, the incubation period exceeds the commonly used monitoring period of 21 days.
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Homossexualidade Masculina , Mpox , Humanos , Masculino , Berlim/epidemiologia , Surtos de Doenças , Férias e Feriados , Período de Incubação de Doenças Infecciosas , Mpox/epidemiologia , Minorias Sexuais e de GêneroRESUMO
We report a ceftriaxone-resistant, multidrug-resistant urogenital gonorrhoea case in a heterosexual woman in France, June 2022. The woman was successfully treated with azithromycin 2â¯g. She had unprotected sex with her regular partner, who developed urethritis following travel to Vietnam and Switzerland. Whole genome sequencing of the gonococcal isolate (F92) identified MLST ST1901, NG-STAR CC-199, and the novel mosaic penA-237.001, which caused ceftriaxone resistance. penA-237.001 is 98.7% identical to penA-60.001, reported in various ceftriaxone-resistant strains, including the internationally spreading FC428 clone.
Assuntos
Ceftriaxona , Gonorreia , Humanos , Feminino , Ceftriaxona/farmacologia , Ceftriaxona/uso terapêutico , Neisseria gonorrhoeae , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Tipagem de Sequências Multilocus , Gonorreia/diagnóstico , Gonorreia/tratamento farmacológico , Testes de Sensibilidade Microbiana , Farmacorresistência Bacteriana/genéticaRESUMO
Following the report of a non-travel-associated cluster of monkeypox cases by the United Kingdom in May 2022, 41 countries across the WHO European Region have reported 21,098 cases and two deaths by 23 August 2022. Nowcasting suggests a plateauing in case notifications. Most cases (97%) are MSM, with atypical rash-illness presentation. Spread is mainly through close contact during sexual activities. Few cases are reported among women and children. Targeted interventions of at-risk groups are needed to stop further transmission.
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Exantema , Mpox , Animais , Criança , Surtos de Doenças , Feminino , Humanos , Mpox/diagnóstico , Mpox/epidemiologia , Monkeypox virus , Organização Mundial da SaúdeRESUMO
OBJECTIVE: We aimed to assess the number, the prevalence and the socio-occupational characteristics of the employees who were allowed to benefit from prevention measures due to their exposure to occupational biomechanical factors before and after the modification, by the reform (order n° 2017-1389), of the law dealing with occupational health and safety preventive measures. METHODS: This study was based on the French national survey on occupational exposures (Sumer 2010). Almost 48,000 employees, representative of the French population, were included. Exposure to the four biomechanical factors, initially included in the law and associated with a minimum exposure threshold, were assessed during the employee's interview by the occupational physician. RESULTS: Before the reform, 31.2% of men and 23.6% of women were likely to benefit from measures of prevention due to their exposure to occupational biomechanical factors. Following the reform, 11,6% of men and 13,7% of women employees are still able to benefit from these occupational preventive measures, leading to an overall decrease of 3.3 million of beneficiaries. CONCLUSIONS: Although musculoskeletal disorders (MSD) remain the first cause of recognition as an occupational disease, the exclusion, by the reform, of three biomechanical occupational risk factors of MSDs from the preventives measures in occupational health and safety risk assessment will substantially decrease the number of employees exposed to biomechanical factors that could benefit from these preventive and compensatory occupational measures.
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Fenômenos Biomecânicos/fisiologia , Doenças Musculoesqueléticas/etiologia , Doenças Profissionais/complicações , Exposição Ocupacional , Saúde Ocupacional , Adulto , Feminino , Política de Saúde , Humanos , Masculino , Doenças Musculoesqueléticas/psicologia , Doenças Profissionais/psicologia , Fatores de RiscoRESUMO
BACKGROUND: Carpal tunnel syndrome (CTS) is the most common nerve entrapment neuropathy in the working-age population. The reduction of CTS incidence in the workforce is a priority for policy makers due to the human, social and economic costs. To assess the theoretical impact of workplace-based primary interventions designed to reduce exposure to personal and/or work-related risk factors for CTS. METHODS: Surgical CTS were assessed using regional hospital discharge records for persons aged 20-59 in 2009. Using work-related attributable fractions (AFEs), we estimated the number of work-related CTS (WR-CTS) in high-risk jobs. We simulated three theoretical scenarios of workplace-based primary prevention for jobs at risk: a mono-component work-centered intervention reducing the incidence of WR-CTS arbitrarily by 10% (10%-WI), and multicomponent global interventions reducing the incidence of all surgical CTS by 5% and 10% by targeting personal and work risk factors. RESULTS: A limited proportion of CTS were work-related in the region's population. WR-CTS were concentrated in nine jobs at high risk of CTS, amounting to 1603 [1137-2212] CTS, of which 906 [450-1522] were WR-CTS. The 10%-WI, 5%-GI and 10%-GI hypothetically prevented 90 [46-153], 81 [58-111] and 159 [114-223] CTS, respectively. The 10%-GI had the greatest impact regardless of the job. The impact of the 10%-WI interventions was high only in jobs at highest risk and AFEs (e.g. food industry jobs). The 10%-WI and 5%-GI had a similar impact for moderate-risk jobs (e.g. healthcare jobs). CONCLUSION: The impact of simulated workplace-based interventions suggests that prevention efforts to reduce exposure to work-related risk factors should focus on high-risk jobs. Reducing CTS rates will also require integrated strategies to reduce personal risk factors, particularly in jobs with low levels of work-related risk of CTS.
Assuntos
Síndrome do Túnel Carpal/prevenção & controle , Doenças Profissionais/prevenção & controle , Saúde Ocupacional , Prevenção Primária , Adulto , Síndrome do Túnel Carpal/epidemiologia , Feminino , França/epidemiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Modelos Teóricos , Doenças Profissionais/epidemiologia , Avaliação de Programas e Projetos de Saúde , Fatores de Risco , Adulto JovemRESUMO
OBJECTIVES: This study aimed at exploring the cross-sectional and prospective associations between psychosocial work factors and sleep problems. METHODS: The study population consisted of a national representative sample of the French working population (SIP survey). The sample sizes were 7506 and 3555 for the cross-sectional and prospective analyses. Sleep problems were defined by either sleep disturbances or insufficient sleep duration at least several times a week. Psychosocial work factors included classical (job strain model factors) and emergent factors (recognition, insecurity, role/ethical conflict, emotional demands, work-life imbalance, etc.). Occupational factors related to working time/hours and physical work environment were also included as well as covariates related to factors outside work. Statistical analyses were performed using weighted Poisson regression analysis. RESULTS: In the cross-sectional analyses, psychological demands, low social support, low recognition, emotional demands, perception of danger, work-life imbalance and night work were found to be associated with sleep problems. In the prospective analyses, psychological demands and night work were predictive of sleep problems. Using a less conservative method, more factors were found to be associated with sleep problems. Dose-response associations were observed, showing that the more frequent the exposure to these factors, the higher the risk of sleep problems. No effect of repeated exposure was found on sleep problems. CONCLUSION: Classical and emergent psychosocial work factors were associated with sleep problems. More prospective studies and prevention policies may be needed.
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Doenças Profissionais/epidemiologia , Transtornos do Sono-Vigília/epidemiologia , Estresse Psicológico/epidemiologia , Adulto , Idoso , Estudos Transversais , Emoções , Feminino , França/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Profissionais/psicologia , Prevalência , Estudos Prospectivos , Análise de Regressão , Fatores de Risco , Transtornos do Sono-Vigília/psicologia , Apoio Social , Estresse Psicológico/psicologia , Tolerância ao Trabalho Programado/psicologia , Carga de Trabalho/psicologia , Local de Trabalho/psicologia , Adulto JovemRESUMO
OBJECTIVES: The aim was to estimate the effect of reported history of smallpox vaccination prior to 1980 on clinical expression of mpox. METHODS: We included all confirmed mpox cases identified by the national mpox surveillance system in France between May and July 2022. Cases tested positive for monkeypox virus or orthopoxviruses by PCR. Cases were interviewed by phone using a questionnaire documenting demographics, symptoms and exposures. To estimate the effect of smallpox vaccination on the presence of marked mpox symptoms (association of fever, lymphadenopathy and extensive mucocutaneous lesions), we estimated prevalence ratios (PRs) and 95% CIs using Poisson regression models with robust standard errors. RESULTS: There were 1888 confirmed mpox cases with date of symptom onset between 7 May and 31 July 2022. Overall, 7% (93/1394) presented marked mpox symptoms. Among patients who provided information about their vaccination status, 14% (207/1469) reported smallpox vaccination prior to 1980. The proportion of cases with marked symptoms was 2% (3/170) among those reporting smallpox vaccination prior to 1980 and 8% (76/974) among those who reported no vaccination. The proportion of marked symptoms was four times lower among cases reporting previous smallpox vaccination than in cases reporting no vaccination (PR, 0.24; 95% CI: 0.08-0.76). There was no evidence of an effect of smallpox vaccination on development of complications (PR, 0.65; 95% CI: 0.35-1.22) or hospitalization due to mpox (PR, 0.64; 95% CI: 0.23-1.80). DISCUSSION: Our results suggest that smallpox vaccination during childhood attenuated the clinical expression of monkeypox virus infection, but there was no evidence of an effect on complications or hospitalization.
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Vacina Antivariólica , Vacinação , Humanos , França/epidemiologia , Masculino , Feminino , Adulto , Adulto Jovem , Adolescente , Pessoa de Meia-Idade , Criança , Vacinação/estatística & dados numéricos , Mpox/epidemiologia , Pré-Escolar , Idoso , Lactente , Monkeypox virus/genética , Prevalência , Orthopoxvirus/genética , Varíola/epidemiologia , Varíola/prevenção & controleRESUMO
BACKGROUND: Exploratory study to investigate whether co-exposure to physical wrist stressors and chemicals is associated with carpal tunnel syndrome (CTS) in French male farmers and agricultural workers. METHODS: Cross-sectional study of 711 men aged 30-65 years and working as either farmers or agricultural workers in 2009-2010 within a cohort covered by the French Agricultural Workers' and Farmers' Mutual Benefit Fund. CTS and exposure to physical wrist stressors and chemicals were assessed using a self-administered questionnaire. Associations between CTS and personal/medical factors, exposure to physical wrist stressors, exposure to chemicals, and co-exposure to physical wrist stressors and chemicals were studied using multivariate logistic regression models. RESULTS: Forty-four men {5.6% [95% confidence interval (CI) 4.0-7.7]} reported that they had suffered from unilateral/bilateral CTS during the last 12 months. CTS was associated with age, current smoking [odds ratio (OR) = 2.1 (1.0-4.5)], and exposure to physical wrist stressors [OR = 2.6 (1.1-5.9)]. An association was found between CTS and co-exposure to physical wrist stressors and chemicals [OR = 3.3 (0.8-14.3), p = 0.044] in comparison with the no-exposure group. CONCLUSIONS: This exploratory study shows an association of CTS with exposure to biomechanical wrist stressors in male farmers and agricultural workers and suggests an association of CTS with co-exposure to physical wrist stressors and chemicals. Owing to the limitations of the study, this result must be confirmed by a prospective study with objective assessments of the outcome and exposure before drawing conclusions on the possible synergistic effects of mechanical stressors and chemicals on the impairment of the median nerve.
RESUMO
Objectives: To compare the data of the French workers' compensation system (WCS) and three surveillance networks, and to determine the possibility of identifying the industry sectors most in need of programs for prevention of low-back pain (LBP). Methods: This study compared four databases and two types of indicators in a west central region of France: ⢠surveillance of musculoskeletal symptoms in the working population [LBP and disc-related sciatica (DRS) indicators; Cosali study] ⢠surveillance of uncompensated work-related diseases (LBP and DRS indicators) ⢠surveillance of lumbar disc surgery (LDS) in the general population (DRS indicator) ⢠French WCS (disc herniation with radiculopathy caused by vibration or handling of materials; DRS indicator) People aged 20-59 were studied. The prevention index (PI) was used to rank industry sectors according to the number of cases and the prevalence/incidence rate. Results: Construction and manufacturing were the first sectors in terms of PI for men in all databases and indicators. Moreover, transport and agriculture were not consistently highlighted. For women, manufacturing was the leading sector (except for the LDS study: health sector), followed by the health sector. Specific epidemiologic surveillance networks (LDS and Cosali studies) provided ranking of the greatest number of sectors out of the 17 classified. For DRS indicators, the LDS study classified 13 sectors for both genders, and for LBP indicators, the Cosali study ranked 8 and 7 sectors in men and women, respectively. Conclusions: The results showed the complementarity of the four surveillance programs. A multi-component surveillance system allowed detection of industry sectors most in need of prevention programs.
Assuntos
Dor Lombar/epidemiologia , Doenças Profissionais/epidemiologia , Ciática/epidemiologia , Adulto , Bases de Dados Factuais , Monitoramento Epidemiológico , Feminino , França , Humanos , Indústrias/estatística & dados numéricos , Deslocamento do Disco Intervertebral/epidemiologia , Masculino , Pessoa de Meia-Idade , Vibração/efeitos adversos , Adulto JovemRESUMO
Evidence from literature is mixed regarding a possible association of maternal gestational diabetes mellitus (GDM) and overweight in the offspring. Sexual dimorphism, or sex disparities in the pathogenesis linking GDM exposure to overweight, could be at play. The objective of this study was to investigate the association between GDM and child overweight at 5-7 years. Six hundred pairs (1:1) of Reunionese liveborn singletons selected from a hospital-based birth registry, matched for sex, gestational age, and birth period, underwent a prospective in-home follow-up and were analyzed with respect to their exposure to GDM. The primary outcome was child overweight at 5-7 years, as defined by the International Obesity Task Force. The association between GDM exposure and child overweight was estimated by the odds ratio (OR) using conditional logistic regression models. For the subset of children exposed to GDM with available maternal glycemic data, we analyzed the relationship between maternal glycemic levels during pregnancy and child body mass index (BMI) at 5-7 years with a linear regression model. In light of the significant interaction between sex and GDM, all statistical analyses were then stratified by sex. After controlling for pre-pregnancy BMI and maternal sociodemographic characteristics, the risk of overweight increased with exposure to GDM for boys (adjusted OR: 2.34; 95% confidence interval = 1.26-4.34, P = 0.007) but not for girls (adjusted OR: 0.56; 95%CI = 0.28-1.10, P = 0.093). Consistent with this, the linear increase of boys' BMI at 5-7 years with maternal blood glucose levels during pregnancy, in the exposed group, displayed a dose-response relationship. Our findings indicate that exposure to GDM is a risk factor for childhood overweight in boys but not in girls, which adds to the growing body of evidence suggesting greater sensitivity of male offspring to intrauterine hyperglycemia.
Assuntos
Diabetes Gestacional/epidemiologia , Obesidade Infantil/epidemiologia , Caracteres Sexuais , Índice de Massa Corporal , Criança , Pré-Escolar , Diabetes Gestacional/sangue , Feminino , Seguimentos , Humanos , Modelos Lineares , Modelos Logísticos , Masculino , Razão de Chances , Gravidez , Estudos Prospectivos , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Fatores SocioeconômicosRESUMO
Objective The aim of this study was to describe time trends of incidence/prevalence of carpal tunnel syndrome (CTS), one of the most common musculoskeletal disorders, in a French region over an 8-year period. Methods Three independent data sources were analyzed for the population of the Pays de la Loire region aged 20-59 between 2004 and 2011: hospital discharge records for "surgically treated CTS" (SURG-CTS), the social insurance data on "CTS compensated for as an occupational disease" (OD-CTS), and the regional surveillance program of "work-related diseases" (WRD-CTS). Case counts were analyzed using negative binomial regression models and cubic spline curves with year as the main covariate. Results The annual incidence rates of SURG-CTS decreased from 3.35 to 2.98 per 1000 person-years over the 8-year period, with an overall declining trend [-2.00%, 95% confidence interval (95% CI) -3.07- -0.91%), P<0.001]. The annual incidence rate of OD-CTS per 1000 person-years decreased (from 1.52 to 1.01) between 2004 and 2007 and increased after 2007 (from 1.45 to 2.34), with an overall gain of 54% during the study period. The prevalence rate of WRD-CTS decreased from 5.04 (95% CI 3.90-6.13) to 3.08 (95% CI 2.11-4.06) per 1000 employed person-years, with a non-significant trend between 2004 and 2011. Conclusion The study showed declining rates of SURG-CTS and WRD-CTS in the population of working age between 2004 and 2011, contrasting with increasing rate of OD-CTS after 2007. More research and surveillance data are needed to assess whether and to what extent the declining rates of CTS are actually attributable to improvement in working conditions and/or to non-occupational factors.
Assuntos
Síndrome do Túnel Carpal/epidemiologia , Armazenamento e Recuperação da Informação/tendências , Doenças Musculoesqueléticas/epidemiologia , Doenças Profissionais/epidemiologia , Adulto , Síndrome do Túnel Carpal/cirurgia , Feminino , França/epidemiologia , Humanos , Incidência , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de RiscoRESUMO
OBJECTIVES: To assess the reporting of the unequal randomization ratio in reports of trials with this design and to identify the justification for the design. STUDY DESIGN AND SETTING: Systematic review of reports of trials with unequal randomization. We selected all original reports of two parallel-group randomized controlled trials with unequal randomization, which were published in 2009 and 2010 in core clinical journals in MEDLINE on the basis of the abstract (and full text, if necessary). Additional information was collected by an author survey. RESULTS: We retrieved 106 reports (prevalence, 4.7%). The randomization ratio was not stated in 8.5% of reports and 51.9% of abstracts. Sample size calculation was reported in 70 reports, with unequal randomization not taken into account in 25.7% (n = 18). Justification for unequal randomization was not reported in 77.4% (n = 82) of reports. Combining information from reports and author surveys, we had justification for 41 trials. The main justification was safety issues for 20 trials. In 11 of those latter 20 reports, adverse events were not fully reported. CONCLUSION: A better reporting of the randomization ratio, sample size calculation, and justification to unequal randomization could help readers appraise the quality and risk of bias of such trials.
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Editoração/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Humanos , Tamanho da AmostraRESUMO
PURPOSE: Sudden cardiac death (SCD) is a major public health concern, but data regarding epidemiology of this disease in Western European countries are outdated. This study reports the first results from a large registry of SCD. METHODS: A population-based registry was established in May 2011 using multiple sources to collect every case of SCD in Paris and its suburbs, covering a population of 6.6 million. Utstein variables were recorded. Pre-hospital and in-hospital data were considered, and the main outcome was survival at hospital discharge. Neurologic status at discharge was established as well. RESULTS: Of the 6,165 cases of SCD recorded over 2 years, 3,816 had a resuscitation attempt and represent the study population. Most patients were male (69%), the SCD occurred at home (72%) with bystanders in 80% of cases, and cardiopulmonary resuscitation (CPR) was performed in 45% of cases. Initial rhythm was shockable in 26% of cases. A total of 1,332 patients (35%) were admitted alive to hospital. Among hospitalized patients, 58% had a coronary angiogram, and the same proportion had therapeutic hypothermia. Finally, 279 patients (7.5%) were discharged alive, of whom 96% had a favorable neurological outcome. In multivariate analysis, bystander CPR (OR 2.1, 95% CI 1.5-3.1) and initial shockable rhythm (OR 11.5, 95% CI 7.6-17.3) were positively associated with survival at hospital discharge, whereas age (OR 0.97 per year, 95% CI 0.96-0.98), longer response time (OR 0.93 per minute, 95% CI 0.89-0.97), occurrence at home (OR 0.4, 95% CI 0.3-0.6), and epinephrine dose greater than 3 mg (OR 0.05, 95% CI 0.03-0.08) were inversely associated with survival. CONCLUSION: Despite being conducted in the therapeutic hypothermia and early coronary angiogram era, hospital discharge survival rate of resuscitated SCD remains poor. The current registry suggests ways to improve pre-hospital and in-hospital care of these patients.
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Reanimação Cardiopulmonar/mortalidade , Morte Súbita Cardíaca/epidemiologia , Parada Cardíaca Extra-Hospitalar/mortalidade , Sistema de Registros , Idoso , Estudos de Coortes , Serviços Médicos de Emergência/estatística & dados numéricos , Feminino , Humanos , Pacientes Internados/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Paris/epidemiologia , Prognóstico , Taxa de Sobrevida/tendênciasRESUMO
BACKGROUND: Social inequalities in mental disorders have been described, but studies that explain these inequalities are lacking, especially those using diagnostic interviews. This study investigates the contribution of various explanatory factors to the association between educational level and major depression and generalised anxiety disorder in Irish men and women. METHODS: The study population comprised a national random sample of 5771 women and 4207 men aged 18 or more in Ireland (SLÁN 2007 survey). Major depression and generalised anxiety disorder were measured using a standardised diagnostic interview (CIDI-SF). Four groups of explanatory factors were explored: material, psychosocial, and behavioural factors, and chronic disease. RESULTS: For both genders, low educational level increased the risk of both mental disorders. Material factors, especially no private health insurance, but also no car, housing tenure, insufficient food budget, and unemployment (for men), made the highest contribution (stronger for men than for women) in explaining the association between education and both mental disorders. Psychosocial (especially formal social participation, social support and marital status) and behavioural factors (smoking and physical activity for both genders, and alcohol and drug use for men) and chronic disease made low independent contributions in explaining the association between education and both mental disorders. LIMITATIONS: Given the cross-sectional study design, no causal conclusion could be drawn. CONCLUSIONS: Targeting various material, psychosocial, and behavioural factors, as well as chronic diseases may help to reduce educational differences in depression and anxiety in the general population.