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AIMS: The purpose of this systematic review and meta-analysis was to investigate the effects of family-based health promotion interventions on child-level risk factors for type 2 diabetes in vulnerable families. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist for systematic reviews formed the methodological framework. CINAHL, Embase, MEDLINE, PsycINFO, and Web of Science were searched on January 12, 2024. The NTP-OHAT Risk of Bias Assessment Tool was used to assess the risk of bias in the individual studies, and meta-analyses were performed. RESULTS: The 4723 studies were identified, and 55 studies met the inclusion criteria. Results showed significant effects on children's body mass index (mean difference [MD], -0.18, 95% CI [-0.33 to -0.03], p = 0.02), body fat percentage (MD, -2.00, 95% CI [-3.31 to -0.69], p = 0.003), daily activity (standardized mean difference [SMD], 0.23, 95% CI [0.01; 0.44], p = 0.04), physical activity self-efficacy (SMD, 0.73, 95% CI [0.36 to 1.10], p < 0.01), intake of snacks (MD, -0.10, 95% CI [-0.17 to -0.04], p = 0.002), and sugar-sweetened beverages (SMD, -0.21, 95% CI [-0.42 to -0.01], p = 0.04). Subgroup analyses suggested that interventions aiming to change child and parent behavior simultaneously have larger effect on fasting glucose and nutrition consumption, and that interventions longer than 26 weeks have larger effects on body composition and physical activity behavior than shorter interventions.
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Diabetes Mellitus Tipo 2 , Promoção da Saúde , Humanos , Diabetes Mellitus Tipo 2/prevenção & controle , Criança , Promoção da Saúde/métodos , Exercício Físico , Obesidade Infantil/prevenção & controle , Índice de Massa CorporalRESUMO
INTRODUCTION: Face-it is a randomized controlled trial for women with recent gestational diabetes mellitus (GDM) and their families designed to evaluate the effect of a health promotion intervention on type 2 diabetes mellitus (T2DM) risk and quality of life. This study examined (1) the penetration and participation rates for the Face-it trial, (2) the characteristics of the participating women and the potential differences in characteristics according to partner participation status, and (3) representativity of the women at baseline. RESEARCH DESIGN AND METHODS: We identified women with GDM during pregnancy and invited them and their partners to a baseline examination 10-14 weeks after delivery. Representativity was assessed by comparing the baseline participants with non-participating women, the general population of women with GDM delivering in Denmark, and populations from other intervention trials. RESULTS: The penetration rate was 38.0% (867/2279) and the participation rate was 32.9% (285/867). The 285 women who attended baseline had a mean age of 32.7 (±4.8) years and body mass index (BMI) of 28.1 (±5.4) kg/m2, and 69.8% had a partner who participated. The women participating with a partner were more often primiparous, born in Denmark (82.8% vs 68.2%), were younger, and more often had a BMI ≤24.9 kg/m2 (35.7% vs 21.2%) compared with women without a partner. Compared with the general population of women with GDM in Denmark, these women broadly had similar degree of heterogeneity, but had higher rates of primiparity and singleton deliveries, and lower rates of preterm delivery and prepregnancy obesity. CONCLUSIONS: The penetration and participation rates were acceptable. We found a high rate of partner participation. Overall, women participating with a partner were comparable with those participating without a partner. Participating women were broadly similar to the general national GDM population, however with prepregnancy obesity, multiparity, preterm delivery, and multiple pregnancy being less represented. TRIAL REGISTRATION NUMBER: NCT03997773.
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Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Nascimento Prematuro , Gravidez , Recém-Nascido , Humanos , Feminino , Adulto , Diabetes Gestacional/epidemiologia , Diabetes Gestacional/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Qualidade de Vida , Obesidade/epidemiologia , Promoção da SaúdeRESUMO
Promoting diet and physical activity is important for women with recent gestational diabetes mellitus (GDM) and their partners to reduce the risk of future type 2 diabetes (T2D). The study aimed to understand how motivation for changing diet and physical activity behaviors among women with recent GDM and their partners was experienced after participation in the Danish Face-it intervention. Fourteen couples' interviews were conducted. Data analysis followed a reflexive thematic analysis. Guided by self-determination theory and interdependence theory, we identified four themes affecting couples' motivation for health behavior change: (1) The need to feel understood after delivery; (2) adjusting health expectations; (3) individual and mutual preferences for health behaviors; and (4) the health threat of future T2D as a cue to action. We found that couples in general perceived the Face-it intervention as useful and motivating. Using couple interviews increased our understanding of how the women and partners influenced each other's perspectives after a GDM-affected pregnancy and thus how targeting couples as opposed to women alone may motivate health behavior change.
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Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Gravidez , Humanos , Feminino , Motivação , Comportamentos Relacionados com a Saúde , Análise de DadosRESUMO
Previous studies have reported select contaminants of emerging concern (CECs) in limited areas of the Chesapeake Bay (USA), but no comprehensive efforts have been conducted. In this work, 43 antibiotics, 9 hormones, 11 UV filters, and sucralose, were measured in matched water, sediment, and oyster samples from 58 sites. The highest sucralose concentration was 3051 ng L-1 in a subwatershed with 4.43 million liters of wastewater effluent per day (MLD) and 4385 septic systems. Although antibiotic occurrence was generally low in subwatersheds located in less populated areas, 102 ng L-1 ciprofloxacin was detected downstream of 0.58 MLD wastewater effluent and 10 animal feeding operations. Hormones were not regularly detected in water (2%) or oysters (37%), but the high detection frequencies in sediment (74%) were associated with septic systems. UV filters were ubiquitously detected in oysters, and octisalate exhibited the highest concentration (423 ng g-1). Oyster-phase oxybenzone and aqueous-phase sucralose concentrations were significantly correlated to wastewater effluent and septic systems, respectively. Toxicity outcomes were predicted for homosalate and octisalate throughout the Bay, and antimicrobial resistance concerns were noted for the Chester River. The geospatial and co-occurrence relationships constitute crucial advances to understanding CEC occurrence in the Chesapeake Bay and elsewhere.
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Antibacterianos , Baías , Animais , Águas Residuárias , ÁguaRESUMO
AIM: In this study, we investigated healthcare professionals' (HCPs) experiences with delivering home visits and digital coaching in the Face-it health promotion intervention targeting women with recent GDM and their families. Understanding the acceptability and adoption of a health promotion intervention can provide insights into intervention fidelity and future scalability. METHODS: In total, 13 HCPs were interviewed. Data were analysed thematically through an abductive approach using Sekhon et al.'s theoretical framework of acceptability and Greenhalgh et al.'s framework for non-adoption, abandonment, scale-up, spread, and sustainability. RESULTS: Acceptability and adoption of the intervention among HCPs were influenced by (1) skills and technology, (2) values, and (3) organisation. The intervention was experienced as acceptable to HCPs because the dialogue tool, visualising different topics, used in the home visits and digital coaching through the LIVA app were flexible and enabled them to address psychosocial health and personalise goal setting in families. However, delivering asynchronous and non-verbal communication was experienced as straining HCPs' relationship with families, which misaligned with HCPs' values. Establishing a non-judgemental environment was needed to increase intervention acceptability among HCPs towards addressing type 2 diabetes risk after GDM. Increased collaboration between HCPs may have aligned advice and support to families and could have benefitted delivery. CONCLUSIONS: When delivering health promotion to women with prior GDM, flexible intervention components that support psychosocial- and mental health topics may increase acceptability and adoption of the intervention among HCPs. HCPs' skills, values, and organisational factors should be considered prior and during implementation.
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Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Gravidez , Humanos , Feminino , Diabetes Gestacional/prevenção & controle , Diabetes Mellitus Tipo 2/prevenção & controle , Pesquisa Qualitativa , Pessoal de Saúde/psicologia , Promoção da Saúde , Atenção à SaúdeRESUMO
Participatory methodologies have become imperative when developing health promotion programmes. However, the concrete adoption of co-creation and its implications for intervention development are less reported. This article aims to convey how fidelity and adaptation were balanced in a structured intervention design by co-creating intervention components with various stakeholders. The intervention was part of the Face-it programme, which was initiated to prevent diabetes and increase the quality of life in women with prior diabetes during pregnancy by supporting the entire family's health practices. We relied on participatory methods, e.g. workshops using design games, role play and family interviews, as well as ethnographic fieldwork. Stakeholders comprised women with prior gestational diabetes mellitus and their families as intervention receivers and healthcare professionals, e.g. obstetricians, midwives and health visitors as potential intervention deliverers to shape intervention content. We used Bammer's stakeholder participation spectrum in research to describe how different stakeholders were engaged and with what implications for the intervention components. This article shows how an iterative co-creation process was (i) achieved through diverse involvement practices across stakeholder groups; and (ii) upheld both premises of the structured design (fidelity) and flexibility (adaptation) in developing intervention content and delivery. When adopting co-creation as a strategy for intervention development, we recommend using various engagement practices according to the role of stakeholders in the intervention and available resources to create ownership and sustainable intervention content.
This article argues that by involving stakeholders in intervention development differently according to their available resources, and intervention roles, we can optimize co-creation processes and thus increase the likelihood of intervention sustainability. We describe how co-creation was pursued by involving multiple stakeholders comprising: families where the mother previously had a pregnancy-related diabetes (target group); healthcare professionals working with women with diabetes in pregnancy, including health visitors (intervention deliverers). We engaged in co-creation through workshops using design games, in-depth interviews and ethnographic fieldwork to understand families' experiences with gestational diabetes and how these experiences can be used to facilitate health practices after birth. Also, we negotiated intervention content and delivery with health visitors, which optimized feedback processes to adapt intervention content and strengthened the health visitors' ownership towards delivering the intervention as intended. By using Bammer's stakeholder-participation-spectrum in research, we show how we tailored co-creation to the target group, intervention deliverers and other key stakeholders in intervention development. Further, we suggest collaborating and empowering intervention deliverers as part of the solution in balancing the underlying premises of a structured design with the social dynamics learned from the intervention deliverers and the target group.
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Promoção da Saúde , Qualidade de Vida , Atenção à Saúde , Feminino , Pessoal de Saúde , Humanos , Gravidez , Participação dos InteressadosRESUMO
In this systematic review and realist synthesis, we aimed to identify strategies to improve dietary and physical activity behaviors for parents with small children. A systematic literature search was conducted in MEDLINE, Embase, CINAHL, and PsycINFO in July 2021. Included studies had to: (i) target one or both parents with at least one child (0-3 years), (ii) aim to improve diet and physical activity, and (iii) report on diet and physical activity outcomes. Intervention context, delivery, and outcomes were extracted, and behavior change techniques were coded. A program theory was developed, and context-mechanism-outcome configurations were identified. In total, 17 interventions reported in 28 studies (19 effectiveness studies; nine protocols) were included. Nine interventions showed small improvements: in diet (n = 5), physical activity (n = 2), or both (n = 2) in mothers. The realist synthesis revealed three strategies to improve health behaviors: (1) using knowledge and role modelling to improve family dynamics, (2) providing various home-based activities to change home environment, and (3) offering flexible delivery, for example, phone or website-based to increase social support. Future interventions for parents with small children should consider involving the whole family, focusing on home-based and practical components, and offering various delivery modes. The protocol for the systematic review and realist synthesis was registered in Research Registry (registration ID: reviewregistry860) March 30th, 2020.
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Comportamentos Relacionados com a Saúde , Promoção da Saúde , Terapia Comportamental , Criança , Exercício Físico , Promoção da Saúde/métodos , Humanos , PaisRESUMO
BACKGROUND: Women with prior gestational diabetes mellitus (GDM) are at high risk of developing type 2 diabetes; however, this risk can be reduced by engaging in positive health behaviours e.g. healthy diet and regular physical activity. As such behaviours are difficult to obtain and maintain there is a need to develop sustainable behavioural interventions following GDM. We aimed to report the process of systematically developing a health promotion intervention to increase quality of life and reduce diabetes risk among women with prior GDM and their families. We distil general lessons about developing complex interventions through co-production and discuss our extensions to intervention development frameworks. METHODS: The development process draws on the Medical Research Council UK Development of complex interventions in primary care framework and an adaptation of a three-stage framework proposed by Hawkins et al. From May 2017 to May 2019, we iteratively developed the Face-it intervention in four stages: 1) Evidence review, qualitative research and stakeholder consultations; 2) Co-production of the intervention content; 3) Prototyping, feasibility- and pilot-testing and 4) Core outcome development. In all stages, we involved stakeholders from three study sites. RESULTS: During stage 1, we identified the target areas for health promotion in families where the mother had prior GDM, including applying a broad understanding of health and a multilevel and multi-determinant approach. We pinpointed municipal health visitors as deliverers and the potential of using digital technology. In stage 2, we tested intervention content and delivery methods. A health pedagogic dialogue tool and a digital health app were co-adapted as the main intervention components. In stage 3, the intervention content and delivery were further adapted in the local context of the three study sites. Suggestions for intervention manuals were refined to optimise flexibility, delivery, sequencing of activities and from this, specific training manuals were developed. Finally, at stage 4, all stakeholders were involved in developing realistic and relevant evaluation outcomes. CONCLUSIONS: This comprehensive description of the development of the Face-it intervention provides an example of how to co-produce and prototype a complex intervention balancing evidence and local conditions. The thorough, four-stage development is expected to create ownership and feasibility among intervention participants, deliverers and local stakeholders. TRIAL REGISTRATION: ClinicalTrials.gov NCT03997773 , registered retrospectively on 25 June 2019.
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Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Diabetes Gestacional/prevenção & controle , Feminino , Promoção da Saúde , Humanos , Gravidez , Qualidade de Vida , Estudos RetrospectivosRESUMO
Gestational diabetes mellitus (GDM) increases the risk of adverse outcomes during and after pregnancy, including a long-term risk of type 2 diabetes. Women with GDM are treated by numerous healthcare professionals during pregnancy and describe a lack of preventive care after pregnancy. We aim to investigate healthcare professionals' perspectives on the cross-sectoral treatment pathway for women with GDM-during and after pregnancy. A qualitative study was conducted using systematic text condensation. Nine healthcare professionals (two general practitioners, four midwives, two obstetricians and one diabetes nurse) were interviewed and eight health visitors participated in two focus group discussions., Three major themes emerged: (1) "professional identities", which were identified across healthcare professionals and shaped care practices; (2) "unclear guidelines on type 2 diabetes prevention after GDM", which contributed to uncertainty about tasks and responsibilities during and after pregnancy; and (3) "cross-sectoral collaboration", which relied heavily on knowledge transfers between hospitals, general practice and the local municipality. The findings implicate that clear, transparent guidelines for all sectors should be prioritized to strengthen cross-sectoral care to women with GDM during and after pregnancy. As a result, strong cross-sectoral care throughout the GDM care pathway may improve maternal health by supporting healthy behaviors, facilitate weight loss and reduce the risk of subsequent GDM and early onset diabetes.
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Estrogenic hormones and organic ultraviolet-filters (UV-filters) have attracted increased attention as endocrine disrupting chemicals (EDCs) due to their potent estrogenicity and widespread occurrence in the environment. This study investigated the accumulation of three estrogenic hormones and five UV-filters in red swamp crayfish (Procambarus clarkii). Exposure experiments were conducted for 42 days with a mixture of EDCs at two environmentally-relevant design concentrations (i.e., 500 and 5000 ng L-1). The aqueous-phase EDC concentrations decreased over time and were re-established every two days. Within 14 days of exposure, the five UV-filters were measured at 2.2 to 265 ng g-1 (dry weight) in crayfish tail tissue. Only one estrogenic hormone, 17ß-estradiol, was detected in the crayfish at 10.4-13.5 ng g-1. No apparent changes were observed for EDC concentrations in the tail tissue over the next four weeks of exposure. The apparent bioaccumulation factors for the EDCs ranged from 23 L (kg tail tissue, dry weight)-1 for 4-methylbenzylidene camphor to 1050 L (kg tail tissue, dry weight)-1 for 2-ethylhexyl-4-methoxycinnamate. EDC input was stopped after 42 days, and the more hydrophobic UV-filters (i.e., octocrylene, 2-ethylhexyl-4-methoxycinnamate, homosalate) were found to be persistent throughout a 14-d elimination period. A lyticase-assisted yeast estrogen screen demonstrated that the residual estrogenic activity of water samples aligned with (or was lower than) predictions from targeted chemical analysis. These results suggest that the transformation products did not contribute significant estrogenicity, although further analysis of endocrine disruption outcomes in crayfish is recommended.
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Disruptores Endócrinos , Poluentes Químicos da Água , Animais , Astacoidea , Bioacumulação , Estrogênios , Alimentos Marinhos , Poluentes Químicos da Água/análiseRESUMO
BACKGROUND: Gestational diabetes mellitus (GDM) is associated with an increased risk of future diabetes in both mother, father and offspring. More knowledge is needed about how to effectively reduce the risk of diabetes through sustained behavioural interventions in these families. The Face-it intervention is a complex health promotion intervention embedded in multi-level supportive environments. The aim of the intervention is to reduce type 2 diabetes risk and increase quality of life among families in the first year following a GDM-affected pregnancy by promoting physical activity, healthy dietary behaviours and breastfeeding through a focus on social support, motivation, self-efficacy, risk perception and health literacy. METHODS: This national multicentre study is a two-arm randomised controlled trial including 460 women with GDM in a ratio of 2 (intervention):1 (usual care). The Face-it intervention consists of three main components: 1) additional visits from municipal health visitors, 2) digital health coaching tailored to family needs and 3) a structured cross-sectoral communication system in the health care system. The intervention runs from 3 to 12 months after delivery. The primary outcome is maternal body mass index at 12 months after delivery as a proxy for diabetes risk. The women will be examined at baseline and at follow-up, and this examination will include blood tests, oral glucose tolerance test (OGTT), anthropometrics, blood pressure, self-reported diet and physical activity, breastfeeding, quality of life, health literacy, physical and mental health status, risk perception and social support. Aside from those data collected for OGTT and breastfeeding and offspring parameters, the same data will be collected for partners. Data on offspring anthropometry will also be collected. Information on pregnancy- and birth-related outcomes will be derived from the medical records of the woman and child. DISCUSSION: This randomised controlled trial seeks to demonstrate whether the Face-it intervention, addressing the individual, family and health care system levels, is superior to usual care in reducing diabetes risk for mothers and their families. Coupled with a process evaluation and an economic analysis, the study will provide evidence for policymakers and health services about health promotion among families affected by GDM and the potential for reducing risk of type 2 diabetes and associated conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03997773. Registered June 25, 2019 - Retrospectively registered.
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Diabetes Mellitus Tipo 2/prevenção & controle , Diabetes Gestacional/reabilitação , Relações Familiares , Promoção da Saúde/métodos , Qualidade de Vida , Adulto , Aleitamento Materno/psicologia , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/fisiopatologia , Diabetes Gestacional/fisiopatologia , Feminino , Seguimentos , Teste de Tolerância a Glucose , Letramento em Saúde , Estilo de Vida Saudável/fisiologia , Humanos , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Motivação , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Comportamento de Redução do Risco , Apoio Social , Resultado do TratamentoRESUMO
Globally, the occurrence of contaminants of emerging concern (CECs) in the environment has raised critical questions on ecological and human health, but few efforts have focused on the Chesapeake Bay, the largest estuary in the United States. Here, 43 antibiotics, 3 estrogenic hormones, and 5 ultraviolet-filters (UV-filters), which are active ingredients in a variety of personal care products, were measured in water, sediment, and oyster tissue from 14 sites along the Eastern Shore of the Chesapeake Bay in Maryland. Fluoroquinolone, macrolide, and sulfonamide antibiotics were detected in water samples. As both human- and animal-labeled antibiotics were found, wastewater effluent and agricultural runoff were identified as potential sources. The highest aqueous-phase concentrations were recorded for norfloxacin (94.1â¯ng/L), enrofloxacin (17.8â¯ng/L), sulfamethoxazole (14.8â¯ng/L), and clarithromycin (9.7â¯ng/L). Estrone and four UV-filters, namely 2-ethylhexyl-4-methoxycinnamate, benzophenone-3, homosalate, and octocrylene, were frequently detected in Chesapeake Bay water (93-100%), sediment (100%), and oyster tissue (79-100%). High sediment-phase concentrations of estrone (58.4â¯ng/g) and 17ß-estradiol (11.5â¯ng/g) were detected at the mouth of the Manokin River. Homosalate and benzophenone-3 were present at concentrations as high as 187.9 and 113.7â¯ng/L in water, 74.2 and 10.8â¯ng/g in sediment, and 158.3 and 118.0â¯ng/g in oyster tissue, respectively. These results demonstrate the ubiquitous presence of CECs in the Chesapeake Bay, confirm UV-filter bioaccumulation in oysters, and suggest the need for improved CEC removal during municipal wastewater treatment and agricultural waste management within the Chesapeake Bay watershed.
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Crassostrea/química , Exposição Ambiental , Contaminação de Alimentos/análise , Sedimentos Geológicos/análise , Alimentos Marinhos/análise , Poluentes Químicos da Água/análise , Animais , Antibacterianos/análise , Antibacterianos/metabolismo , Monitoramento Ambiental , Estrogênios/análise , Estrogênios/metabolismo , Maryland , Protetores Solares/análise , Protetores Solares/metabolismo , Poluentes Químicos da Água/metabolismoRESUMO
Women with prior gestational diabetes mellitus (GDM) have a seven-fold increased risk of developing Type 2 diabetes. There are currently no systematic initiatives in Denmark to ensure prevention of Type 2 diabetes in this target group. To address the missed opportunity, we suggest applying complex intervention research and participatory methods to develop a coherent healthcare pathway during pregnancy and post-partum, which systematically supports women with prior GDM and their families as well as strengthens their capacity to make healthy choices in everyday life.
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Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Dinamarca , Feminino , Nível de Saúde , Humanos , Período Pós-Parto , Gravidez , Fatores de RiscoRESUMO
Ultraviolet-filters (UV-filters) and estrogens have attracted increased attention as contaminants of emerging concern (CECs) due to their widespread occurrence in the environment. Most of these CECs are hydrophobic and have the potential to accumulate in aquatic organisms. To date, co-analysis of UV-filters and estrogens has not been reported due, in part, to the complex environmental matrices. Here, a multi-residue method has been developed for simultaneous determination of five UV-filters and three estrogens in tissue from aquatic and marine organisms. The procedure involved a modified Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) extraction with a novel reverse-solid-phase extraction (reverse-SPE) cleanup in place of dispersive-SPE, followed by liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis. The tissue mass, acetonitrile content, and salt conditions for QuEChERS extraction, along with the reverse-SPE cartridge material and elution conditions, were thoroughly investigated and optimized. Five UV-filters (i.e., 3-(4-methylbenzylidene) camphor, benzophenone-3, ethylhexylmethoxycinnamate, homosalate, and octocrylene) and three estrogens (i.e., estrone, 17ß-estradiol, and 17α-ethinylestradiol) were simultaneously analyzed by taking advantage of wrong-way-round ionization in LC-MS/MS. The optimized analytical protocol exhibited good recoveries (>80%) for target compounds and enabled their detection at concentrations as low as 0.2ng/g in 50mg tissue samples. The method was applied to determine concentrations of target analytes in four invertebrates (i.e., Orconectes virilis, Procambarus clarkii, Crassostrea virginica, and Ischadium recurvum). All eight target analytes were detected at least once in the tissue samples, with the highest concentration being 399ng/g of homosalate in O. virilis. These results highlight the ubiquitous bioaccumulation of CECs in aquatic and marine invertebrates.
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Estruturas Animais/química , Cromatografia Líquida/métodos , Estrogênios/química , Estrogênios/isolamento & purificação , Invertebrados/química , Extração em Fase Sólida/métodos , Espectrometria de Massas em Tandem/métodos , AnimaisRESUMO
BACKGROUND: The evidence on selective serotonin reuptake inhibitors (SSRIs) for major depressive disorder is unclear. METHODS: Our objective was to conduct a systematic review assessing the effects of SSRIs versus placebo, 'active' placebo, or no intervention in adult participants with major depressive disorder. We searched for eligible randomised clinical trials in The Cochrane Library's CENTRAL, PubMed, EMBASE, PsycLIT, PsycINFO, Science Citation Index Expanded, clinical trial registers of Europe and USA, websites of pharmaceutical companies, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency until January 2016. All data were extracted by at least two independent investigators. We used Cochrane systematic review methodology, Trial Sequential Analysis, and calculation of Bayes factor. An eight-step procedure was followed to assess if thresholds for statistical and clinical significance were crossed. Primary outcomes were reduction of depressive symptoms, remission, and adverse events. Secondary outcomes were suicides, suicide attempts, suicide ideation, and quality of life. RESULTS: A total of 131 randomised placebo-controlled trials enrolling a total of 27,422 participants were included. None of the trials used 'active' placebo or no intervention as control intervention. All trials had high risk of bias. SSRIs significantly reduced the Hamilton Depression Rating Scale (HDRS) at end of treatment (mean difference -1.94 HDRS points; 95% CI -2.50 to -1.37; P < 0.00001; 49 trials; Trial Sequential Analysis-adjusted CI -2.70 to -1.18); Bayes factor below predefined threshold (2.01*10-23). The effect estimate, however, was below our predefined threshold for clinical significance of 3 HDRS points. SSRIs significantly decreased the risk of no remission (RR 0.88; 95% CI 0.84 to 0.91; P < 0.00001; 34 trials; Trial Sequential Analysis adjusted CI 0.83 to 0.92); Bayes factor (1426.81) did not confirm the effect). SSRIs significantly increased the risks of serious adverse events (OR 1.37; 95% CI 1.08 to 1.75; P = 0.009; 44 trials; Trial Sequential Analysis-adjusted CI 1.03 to 1.89). This corresponds to 31/1000 SSRI participants will experience a serious adverse event compared with 22/1000 control participants. SSRIs also significantly increased the number of non-serious adverse events. There were almost no data on suicidal behaviour, quality of life, and long-term effects. CONCLUSIONS: SSRIs might have statistically significant effects on depressive symptoms, but all trials were at high risk of bias and the clinical significance seems questionable. SSRIs significantly increase the risk of both serious and non-serious adverse events. The potential small beneficial effects seem to be outweighed by harmful effects. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42013004420.
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Antidepressivos de Segunda Geração/uso terapêutico , Transtorno Depressivo/tratamento farmacológico , Qualidade de Vida , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Adulto , Humanos , Placebos , Ideação SuicidaRESUMO
In Europe, the one-year prevalence of migraine is 14.9% and migraine is on the top-10 list of leading causes of years lost to disability. Sleep disturbances and irregular daily routines are considered triggers of migraine and these factors are well-known consequences of shift work. We studied the association between treatment-seeking migraine and shift work, categorised as fixed evening work, fixed night work and variable working hours with and without night work in a Danish working population of 5872 participants. When compared with fixed day workers, only participants with fixed evening work were found to have significantly increased odds of reporting treatment-seeking migraine after adjustment for socio-demographic and behavioural covariates (OR = 1.56; 95% CI 1.05-2.32). Participants with seniority of 10 years or more notably accounted for this association. Due to the cross-sectional design, selection mechanisms may have biased the results. Practitioner Summary: The study showed higher odds of treatment-seeking migraine among evening workers even when taking a range of potential confounders into account. Due to the cross-sectional design, we cannot draw any causal inferences, but potential mechanisms underlying the present study are discussed, with an emphasis on possible selection into evening work.
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Transtornos de Enxaqueca/epidemiologia , Doenças Profissionais/epidemiologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Tolerância ao Trabalho Programado , Adolescente , Adulto , Estudos Transversais , Dinamarca/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/psicologia , Transtornos de Enxaqueca/terapia , Doenças Profissionais/psicologia , Doenças Profissionais/terapia , Razão de Chances , Adulto JovemRESUMO
Finite element models are frequently used to study lumbar spinal biomechanics. Deterministic models are used to reflect a certain configuration, including the means of geometrical and material properties, while probabilistic models account for the inherent variability in the population. Because model parameters are generally uncertain, their predictive power is frequently questioned. In the present study, we determined the sensitivities of spinal forces and motions to material parameters of intervertebral discs, vertebrae, and ligaments and to lumbar morphology. We performed 1200 model simulations using a generic model of the human lumbar spine loaded under pure moments. Coefficients of determination and of variation were determined for all parameter and response combinations. Material properties of the vertebrae displayed the least impact on results, whereas those of the discs and morphology impacted most. The most affected results were the axial compression forces in the vertebral body and in several ligaments during flexion and the facet-joint forces during extension. Intervertebral rotations were considerably affected only when several parameters were varied simultaneously. Results can be used to decide which model parameters require careful consideration in deterministic models and which parameters might be omitted in probabilistic studies. Findings allow quantitative estimation of a model׳s precision.
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Disco Intervertebral/fisiologia , Ligamentos/fisiologia , Vértebras Lombares/fisiologia , Modelos Biológicos , Articulação Zigapofisária/fisiologia , Fenômenos Biomecânicos , Análise de Elementos Finitos , Humanos , Região Lombossacral , Pressão , Amplitude de Movimento ArticularRESUMO
OBJECTIVES: An increasingly important concern for clinicians who care for patients at the end of life is their spiritual well-being and sense of meaning and purpose in life. In response to the need for short-term interventions to address spiritual well-being, we developed Meaning Centered Group Psychotherapy (MCGP) to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives, even as they approach the end of life. METHODS: Patients with advanced (stage III or IV) solid tumor cancers (N=90) were randomly assigned to either MCGP or a supportive group psychotherapy (SGP). Patients were assessed before and after completing the 8-week intervention, and again 2 months after completion. Outcome assessment included measures of spiritual well-being, meaning, hopelessness, desire for death, optimism/pessimism, anxiety, depression and overall quality of life. RESULTS: MCGP resulted in significantly greater improvements in spiritual well-being and a sense of meaning. Treatment gains were even more substantial (based on effect size estimates) at the second follow-up assessment. Improvements in anxiety and desire for death were also significant (and increased over time). There was no significant improvement on any of these variables for patients participating in SGP. CONCLUSIONS: MCGP appears to be a potentially beneficial intervention for patients' emotional and spiritual suffering at the end of life. Further research, with larger samples, is clearly needed to better understand the potential benefits of this novel intervention.
Assuntos
Adaptação Psicológica , Linfoma não Hodgkin/psicologia , Neoplasias/psicologia , Psicoterapia de Grupo , Adulto , Idoso , Idoso de 80 Anos ou mais , Atitude Frente a Morte , Emoções , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Neoplasias/patologia , Cidade de Nova Iorque , Cuidados Paliativos/psicologia , Cooperação do Paciente/psicologia , Satisfação do Paciente , Projetos Piloto , Grupos de Autoajuda , Espiritualidade , Assistência Terminal/psicologia , Adulto JovemRESUMO
Despite the importance and complexity of evaluating decision-making capacity at the end of life, little research has focused on terminally ill patients' decision-making ability. The purpose of this study was to explore the decision-making capacity of elderly, terminally ill patients and the psychological and physical factors that affect decision making. Decision-making capacity and cognitive abilities were assessed using four measures: the Hopkins Competency Assessment Kit, the Bechara Gambling Task, the Concept Assessment Kit, and the Mini Mental Status Exam. In addition, symptoms of depression, level of physical functioning, and extent of physical symptoms were evaluated in order to identify correlates of decision-making ability. Two samples were compared: elderly, terminally ill patients with cancer (n = 43) and elderly, physically healthy adults living in supportive community residence (n = 35). Results revealed significantly poorer decision-making abilities among the terminal ill sample compared with healthy comparisons, but no association between demographic variables (e.g., age, race, or education) or clinical variables (depression or physical symptoms) and decision making. Implications for evaluating decision-making capacity are addressed.