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1.
BMJ Open ; 11(9): e052842, 2021 09 30.
Artículo en Inglés | MEDLINE | ID: mdl-34593505

RESUMEN

INTRODUCTION: There is considerable variability in symptoms and severity of COVID-19 among patients infected by the SARS-CoV-2 virus. Linking host and virus genome sequence information to antibody response and biological information may identify patient or viral characteristics associated with poor and favourable outcomes. This study aims to (1) identify characteristics of the antibody response that result in maintained immune response and better outcomes, (2) determine the impact of genetic differences on infection severity and immune response, (3) determine the impact of viral lineage on antibody response and patient outcomes and (4) evaluate patient-reported outcomes of receiving host genome, antibody and viral lineage results. METHODS AND ANALYSIS: A prospective, observational cohort study is being conducted among adult patients with COVID-19 in the Greater Toronto Area. Blood samples are collected at baseline (during infection) and 1, 6 and 12 months after diagnosis. Serial antibody titres, isotype, antigen target and viral neutralisation will be assessed. Clinical data will be collected from chart reviews and patient surveys. Host genomes and T-cell and B-cell receptors will be sequenced. Viral genomes will be sequenced to identify viral lineage. Regression models will be used to test associations between antibody response, physiological response, genetic markers and patient outcomes. Pathogenic genomic variants related to disease severity, or negative outcomes will be identified and genome wide association will be conducted. Immune repertoire diversity during infection will be correlated with severity of COVID-19 symptoms and human leucocyte antigen-type associated with SARS-CoV-2 infection. Participants can learn their genome sequencing, antibody and viral sequencing results; patient-reported outcomes of receiving this information will be assessed through surveys and qualitative interviews. ETHICS AND DISSEMINATION: This study was approved by Clinical Trials Ontario Streamlined Ethics Review System (CTO Project ID: 3302) and the research ethics boards at participating hospitals. Study findings will be disseminated through peer-reviewed publications, conference presentations and end-users.


Asunto(s)
COVID-19 , Estudio de Asociación del Genoma Completo , Humanos , Estudios Observacionales como Asunto , Estudios Prospectivos , SARS-CoV-2 , Índice de Severidad de la Enfermedad
2.
Medicine (Baltimore) ; 100(40): e27368, 2021 Oct 08.
Artículo en Inglés | MEDLINE | ID: mdl-34622837

RESUMEN

BACKGROUND: Biological therapy is effective for the treatment of psoriasis and psoriatic arthritis; however, adverse effects related to immunosuppression, such as viral infections, have been reported. Amongst these infections, herpes zoster (HZ) is common. OBJECTIVE: To evaluate the risk of HZ in psoriasis and psoriatic arthritis patients treated with biological therapy. DATA SOURCES: A comprehensive literature search of PubMed, Embase, and Web of Science was performed using certain keywords until October 9, 2020. Nine studies were included after a detailed assessment. STUDY ELIGIBILITY CRITERIA: The eligibility criteria included randomized controlled trials (RCTs) and observational studies of patients with psoriasis or psoriatic arthritis treated with biological therapies; compared with non-biological therapies, non-biological systemic therapies, or controls; with the incidence of HZ reported in case and control groups. The Cochrane risk of bias tool and Newcastle-Ottawa scale were used to assess the quality of the RCTs and observational studies, respectively. Data were extracted from 9 eligible studies and then analyzed using Stata software (Version 12.0). RESULTS: The risk of HZ in biological therapies was higher than that in non-biological (odds ratios [OR]: 1.48; 95% confidence interval [CI]: 1.18-1.86; I2 = 0%) and non-biological systemic (OR: 1.32; 95% CI: 1.02-1.71; I2 = 0%) therapies. Furthermore, the risk of HZ associated with tumor necrosis factor-α inhibitors increased significantly (OR: 1.50; 95% CI: 1.11-2.02; I2 = 0%). Notably, infliximab (OR: 2.43; 95% CI: 1.31-4.50; I2 = 0%) and etanercept (OR: 1.65; 95% CI: 1.07-2.56; I2 = 0%) increased the risk of HZ, while adalimumab (OR: 1.21; 95% CI: 0.64-2.30; I2 = 0%), ustekinumab (OR: 2.20; 95% CI: 0.89-5.44; I2 = 0%), alefacept (OR: 1.46; 95% CI: 0.20-10.47; I2 = 0%), and efalizumab (OR: 1.58; 95% CI: 0.22-11.34; I2 = 0%) did not. LIMITATIONS: Few RCTs have reported HZ incidents; thus, our results require confirmation via large-scale RCTs. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: Biological therapies, especially tumor necrosis factor-α inhibitors, may lead to the risk of HZ in psoriasis and psoriatic arthritis patients. Amongst these agents, infliximab and etanercept have been shown to significantly increase the risk of HZ. Additionally, younger age and female sex may be risk factors. SYSTEMATIC REVIEW REGISTRATION NUMBER: INPLASY202110027.


Asunto(s)
Antirreumáticos/efectos adversos , Artritis Psoriásica/tratamiento farmacológico , Factores Biológicos/efectos adversos , Herpes Zóster/inducido químicamente , Adulto , Anciano , Antirreumáticos/administración & dosificación , Factores Biológicos/administración & dosificación , Femenino , Humanos , Inmunosupresión/efectos adversos , Inmunosupresión/métodos , Masculino , Persona de Mediana Edad , Estudios Observacionales como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Riesgo
3.
BMJ Open ; 11(10): e055611, 2021 10 11.
Artículo en Inglés | MEDLINE | ID: mdl-34635537

RESUMEN

INTRODUCTION: Inadequate antibody response to mRNA SARS-CoV-2 vaccination has been described among kidney transplant recipients. Immunosuppression level and specifically, use of antimetabolite in the maintenance immunosuppressive regimen, are associated with inadequate response. In light of the severe consequences of COVID-19 in solid organ transplant recipients, we believe it is justified to examine new vaccination strategies in these patients. METHODS AND ANALYSIS: BECAME is a single-centre, open-label, investigator-initiated randomised controlled, superiority trial, aiming to compare immunosuppression reduction combined with a third BNT162b2 vaccine dose versus third dose alone. The primary outcome will be seropositivity rate against SARS-CoV-2. A sample size of 154 patients was calculated for the seropositivity endpoint assuming 25% seropositivity in the control group and 50% in the intervention group. A sample of participants per arm will be also tested for T-cell response. We also plan to perform a prospective observational study, evaluating seropositivity among ~350 kidney transplant recipients consenting to receive a third vaccine dose, who are not eligible for the randomised controlled trial. ETHICS AND DISSEMINATION: The trial is approved by local ethics committee of Rabin Medical Center (RMC-0192-21). All participants will be required to provide written informed consent. Results of this trial will be published; trial data will be available. Protocol amendments will be submitted to the local ethics committee. TRAIL REGISTRATION NUMBER: NCT04961229.


Asunto(s)
COVID-19 , Trasplante de Riñón , Vacunas , Vacunas contra la COVID-19 , Humanos , Inmunosupresión , Estudios Observacionales como Asunto , ARN Mensajero , Ensayos Clínicos Controlados Aleatorios como Asunto , SARS-CoV-2 , Resultado del Tratamiento
4.
Artículo en Inglés | MEDLINE | ID: mdl-34639362

RESUMEN

The aim of this study was to identify the epidemiological profiles of violence against children, victims, and their aggressors, and their correlations between socioeconomic and demographic factors analyzed before and during the COVID-19 pandemic. This was a cross-sectional, retrospective observational study based on a review of Individual Notification Forms from the Information System for Notifiable Diseases, including child victims of violence, under 18 years, assisted by a pediatric emergency service in Brazil, from 2016-2020. Data were stratified, then statistical analysis was performed using the two-proportion equality test and the Chi-square test, with p < 0.05 and a 95% confidence interval. A total of 609 notifications were analyzed and a prevalence of sexual violence (63.2%) was reported. The prevalent profile of victim was female (76.7%), aged between 2-9 years (38.1%) and 14-18 years (35.6%). The violence occurs in the victim's home (58.9%). The prevalent profile of perpetrator was male (82.4%), young adolescent (59.2%), living as family (64%), mainly the parents (18.4%). No correlation was found between the classified socioeconomic and demographic variables and violence. There was an increase in notifications during the COVID-19 pandemic, compared to the same period in the previous year; self-harm was reported in 59.7% of physical violence in 2020. Prevalence of sexual violence was higher for females, aged between 2-9 and 14-18 years, victimized in their homes, by male offenders, living as family, mainly by their parents. No association was found between child violence and the socioeconomic and demographic.


Asunto(s)
COVID-19 , Pandemias , Adolescente , Brasil/epidemiología , Niño , Preescolar , Estudios Transversales , Femenino , Humanos , Masculino , Estudios Observacionales como Asunto , SARS-CoV-2 , Violencia
5.
BMJ Open ; 11(10): e047296, 2021 10 05.
Artículo en Inglés | MEDLINE | ID: mdl-34610931

RESUMEN

INTRODUCTION: The prevalence of chronic, lifestyle-related diseases is increasing among adults and children from low-income and middle-income countries. Despite the effectiveness of community-based interventions to address this situation, the benefits thereof may disappear in the long term, due to a lack of maintenance, especially among disadvantaged and high-risk populations. The KaziBantu randomised controlled trial conducted in 2019 consisted of two school-based health interventions, KaziKidz and KaziHealth. This study will evaluate the long-term effectiveness and sustainability of these interventions in promoting positive lifestyle changes among children and educators in disadvantaged schools in Nelson Mandela Bay, South Africa, in the context of the COVID-19 pandemic. METHODS AND ANALYSIS: This study has an observational, longitudinal, mixed-methods design. It will follow up educators and children from the KaziBantu study. All 160 educators enrolled in KaziHealth will be invited to participate, while the study will focus on 361 KaziKidz children (aged 10-16 years) identified as having an increased risk for non-communicable diseases. Data collection will take place 1.5 and 2 years postintervention and includes quantitative and qualitative methods, such as anthropometric measurements, clinical assessments, questionnaires, interviews and focus group discussions. Analyses will encompass: prevalence of health parameters; descriptive frequencies of self-reported health behaviours and quality of life; the longitudinal association of these; extent of implementation; personal experiences with the programmes and an impact analysis based on the Reach, Efficacy, Adoption, Implementation, Maintenance framework. DISCUSSION: In settings where resources are scarce, sustainable and effective prevention programmes are needed. The purpose of this protocol is to outline the design of a study to evaluate KaziKidz and KaziHealth under real-world conditions in terms of effectiveness, being long-lasting and becoming institutionalised. We hypothesise that a mixed-methods approach will increase understanding of the interventions' capacity to lead to sustainable favourable health outcomes amid challenging environments, thereby generating evidence for policy. TRIAL REGISTRATION NUMBER: ISRCTN15648510.


Asunto(s)
COVID-19 , Enfermedades no Transmisibles , Niño , Estudios de Cohortes , Humanos , Estudios Observacionales como Asunto , Pandemias , Calidad de Vida , SARS-CoV-2 , Instituciones Académicas
6.
Anticancer Res ; 41(10): 4673-4685, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34593415

RESUMEN

Platinum/paclitaxel-based chemotherapy is able to obtain a clinical response in up to 80% of patients with advanced ovarian carcinoma, but most of them will subsequently develop recurrent disease. Several therapeutic approaches, including prolonged administration of the first-line regimen and the concomitant or sequential addition of a third cytotoxic agent to standard chemotherapy, failed to improve the clinical outcome of patients. In the last years, the implementation of the biological knowledge on ovarian carcinoma and the introduction of bevacizumab (BEV) and poly(ADP-ribose) polymerase inhibitors (PARPi) in first-line treatment have improved patient prognosis. In this review, we have analyzed the randomized clinical trials and real world observational studies on these issues, with the aim to suggest an algorithm for a rational use of BEV and PARPi in patients with newly diagnosed advanced ovarian carcinoma.


Asunto(s)
Bevacizumab/uso terapéutico , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Inhibidores de Puntos de Control Inmunológico/uso terapéutico , Neoplasias Ováricas/tratamiento farmacológico , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Femenino , Humanos , Estudios Observacionales como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto
7.
Phytomedicine ; 92: 153753, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-34610528

RESUMEN

BACKGROUND: Medicinal plants or herbs produce a bounty of bioactive phytochemicals. These phytochemicals can influence a variety of physiological events related to cardiovascular health through multiple underlying mechanisms, such as their role as antioxidative, anti-ischemic, anti-proliferative, hypotensive, anti-thrombotic, and anti-hypercholesterolemic agents. PURPOSE: The purpose of this review is to summarize and connect evidences supporting the use of phytotherapy in the management of some of the most common cardiovascular impairments, molecular mechanisms underlying cardio-protection mediated by herbs, and clinical studies which are positively linked with the use of herbs in cardiovascular biology. Additionally, we also describe several adverse effects associated with some of the herbal plants and their products to provide a balanced set of studies in favor or against phytotherapy in cardiovascular health that may help global discourses on this matter. METHODS: Studies relating to the use of medicinal plants were mined by strategically searching scientific databases including Google Scholar, PubMed and Science Direct. Investigations involving approximately 175 articles including reviews, research articles, meta-analyses, and cross-sectional and observational studies were retrieved and analyzed in line with the stated purpose of this study. RESULTS: A positive correlation between the use of medicinal plants and cardiovascular health was observed. While maintaining cardiovascular physiology, medicinal plants and their derivatives seem to govern a variety of cellular mechanisms involved in vasoconstriction and vasorelaxation, which in turn, are important aspects of cardiovascular homeostasis. Furthermore, a variety of studies including clinical trials, cross-sectional studies, and meta-analyses have also supported the anti-hypertensive and thus, cardio-protective effects, of medicinal plants. Apart from this, evidence is also available for the potential drawbacks of several herbs and their products indicating that the unsupervised use of many herbs may lead to severe health issues. CONCLUSIONS: The cardio-protective outcomes of medicinal plants and their derivatives are supported by ever-increasing studies, while evidences exist for the potential drawbacks of some of the herbs. A balanced view about the use of medicinal plants and their derivative in cardiovascular biology thus needs to be outlined by researchers and the medical community. The novelty and exhaustiveness of the present manuscript is reflected by the detailed outline of the molecular basis of "herbal cardio-protection", active involvement of several herbs in ameliorating the cardiovascular status, adverse effects of medicinal plants, and the clinical studies considering the use of phytotherapy, all on a single platform.


Asunto(s)
Plantas Medicinales , Antioxidantes , Estudios Transversales , Estudios Observacionales como Asunto , Fitoquímicos/farmacología , Fitoterapia
8.
J Public Health (Oxf) ; 43(Suppl 2): ii35-ii42, 2021 10 08.
Artículo en Inglés | MEDLINE | ID: mdl-34622290

RESUMEN

BACKGROUND: Common mental disorders (CMD) are among the largest contributors to global maternal morbidity and mortality. Although research on perinatal mental health in India has grown in recent years, important evidence gaps remain, especially regarding CMD. Our study aims to improve understanding of CMD among perinatal and non-perinatal women of reproductive age across two settings in India: Bangalore (Karnataka) and Tanda (Himachal Pradesh). METHODS: The study is embedded within the Maternal and Perinatal Health Research Collaboration India (MaatHRI). This mixed-methods observational study comprises three consecutive phases: (i) focus group discussions and individual interviews to explore women's knowledge and seek feedback on CMD screening tools; (ii) validation of CMD screening tools; and (iii) prospective cohort study to identify CMD incidence, prevalence and risk factors among perinatal and non-perinatal women. Results of the three phases will be analyzed using inductive thematic analysis, psychometric analysis and multivariable regression analysis, respectively. CONCLUSION: Improving understanding, detection and management of CMD among women is key to improving women's health and promoting gender equality. This study will provide evidence of CMD screening tools for perinatal and non-perinatal women in two diverse Indian settings, produce data on CMD prevalence, incidence and risk factors and enhance understanding of the specific contribution of the perinatal state to CMD.


Asunto(s)
Trastornos Mentales , Salud Mental , Estudios de Cohortes , Femenino , Humanos , India/epidemiología , Trastornos Mentales/epidemiología , Estudios Observacionales como Asunto , Embarazo , Estudios Prospectivos
9.
BMJ Open ; 11(9): e045910, 2021 09 30.
Artículo en Inglés | MEDLINE | ID: mdl-34593484

RESUMEN

INTRODUCTION: Paediatric sepsis is a major contributor to morbidity and mortality worldwide. Assessing concern from parents and healthcare professionals to determine disease severity in a child evaluated for sepsis remains a field requiring further investigation. This study aims to determine the diagnostic accuracy of parental and healthcare professional concern in the diagnosis of children evaluated for sepsis. METHODS AND ANALYSIS: This prospective multicentre observational study will be conducted over a 24-month period in the paediatric emergency department (ED) at two tertiary Australian hospitals. A cross-sectional survey design will be used to assess the level of concern in parents, nurses and doctors for children presenting to ED and undergoing assessment for sepsis. The primary outcome is a diagnosis of sepsis, defined as suspected infection plus organ dysfunction at time of survey completion. Secondary outcomes include suspected or proven infection and development of organ dysfunction, defined as a Paediatric Sequential Organ Failure Assessment Score >0, within 48 hours of presentation, paediatric intensive care unit admission, confirmed or probable bacterial infection independent of organ dysfunction, and hospital length of stay. ETHICS AND DISSEMINATION: Ethics approval was obtained from Children's Health Queensland's Human Research Ethics Committee (HREC/17/QRCH/85). Findings will be shared with relevant stakeholders and disseminated via conferences and peer-reviewed journals TRIAL REGISTRATION NUMBER: WHO Universal Trial Number, U1111-1256-4537; ANZCTR number, ACTRN1262000134092.


Asunto(s)
Sepsis , Australia , Niño , Estudios Transversales , Atención a la Salud , Humanos , Estudios Multicéntricos como Asunto , Estudios Observacionales como Asunto , Padres , Estudios Prospectivos , Sepsis/diagnóstico
10.
BMJ Open ; 11(9): e046590, 2021 09 30.
Artículo en Inglés | MEDLINE | ID: mdl-34593486

RESUMEN

INTRODUCTION: Clinically diagnosed pneumonia in children is a leading cause of paediatric hospitalisation and mortality. The aetiology is usually bacterial or viral, but malaria can cause a syndrome indistinguishable from clinical pneumonia. There is no method with high sensitivity to detect a bacterial infection in these patients and, as result, antibiotics are frequently overprescribed. Conversely, unrecognised concomitant bacterial infection in patients with malarial infections occur with omission of antibiotic therapy from patients with bacterial infections. Previously, we identified two combinations of blood proteins with 96% sensitivity and 86% specificity for detecting bacterial disease. The current project aimed to validate and improve these combinations by evaluating additional biomarkers in paediatric patients with clinical pneumonia. Our goal was to describe combinations of a limited number of proteins with high sensitivity and specificity for bacterial infection to be incorporated in future point-of-care tests. Furthermore, we seek to explore signatures to prognosticate clinical pneumonia. METHODS AND ANALYSIS: Patients (n=900) aged 2-59 months presenting with clinical pneumonia at two Gambian hospitals will be enrolled and classified according to criteria for definitive bacterial aetiology (based on microbiological tests and chest radiographs). We will measure proteins at admission using Luminex-based immunoassays in 90 children with definitive and 160 with probable bacterial aetiology, and 160 children classified according to the prognosis of their disease. Previously identified diagnostic signatures will be assessed through accuracy measures. Moreover, we will seek new diagnostic and prognostic signatures through machine learning methods, including support vector machine, penalised regression and classification trees. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Gambia Government/Medical Research Council Unit The Gambia Joint Ethics Committee (protocol 1616) and the institutional review board of Boston University Medical Centre (STUDY00000958). Study results will be disseminated to the staff of the study hospitals, in scientific seminars and meetings, and in publications. TRIAL REGISTRATION NUMBER: H-38462.


Asunto(s)
Neumonía Bacteriana , África del Sur del Sahara , Antibacterianos/uso terapéutico , Biomarcadores , Niño , Humanos , Estudios Observacionales como Asunto , Neumonía Bacteriana/diagnóstico , Neumonía Bacteriana/tratamiento farmacológico , Pronóstico
11.
Biomed Res Int ; 2021: 1901772, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34568488

RESUMEN

Background: Although vaccine rollout for COVID-19 has been effective in some countries, there is still an urgent need to reduce disease transmission and severity. We recently carried out a meta-analysis and found that pre- and in-hospital use of statins may improve COVID-19 mortality outcomes. Here, we provide an updated meta-analysis in an attempt to validate these results and increase the statistical power of these potentially important findings. Methods: The meta-analysis investigated the effect of observational and randomized clinical studies on intensive care unit (ICU) admission, tracheal intubation, and death outcomes in COVID-19 cases involving statin treatment, by searching the scientific literature up to April 23, 2021. Statistical analysis and random effect modeling were performed to assess the combined effects of the updated and previous findings on the outcome measures. Findings. The updated literature search led to the identification of 23 additional studies on statin use in COVID-19 patients. Analysis of the combined studies (n = 47; 3,238,508 subjects) showed no significant effect of statin treatment on ICU admission and all-cause mortality but a significant reduction in tracheal intubation (OR = 0.73, 95% CI: 0.54-0.99, p = 0.04, n = 10 studies). The further analysis showed that death outcomes were significantly reduced in the patients who received statins during hospitalization (OR = 0.54, 95% CI: 0.50-0.58, p < 0.001, n = 7 studies), with no such effect of statin therapy before hospital admission (OR = 1.06, 95% CI = 0.82-1.37, p = 0.670, n = 29 studies). Conclusion: Taken together, this updated meta-analysis extends and confirms the findings of our previous study, suggesting that in-hospital statin use leads to significant reduction of all-cause mortality in COVID-19 cases. Considering these results, statin therapy during hospitalization, while indicated, should be recommended.


Asunto(s)
COVID-19/tratamiento farmacológico , Hospitalización/tendencias , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Intubación Intratraqueal/tendencias , COVID-19/mortalidad , Causas de Muerte/tendencias , Hospitalización/estadística & datos numéricos , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/farmacología , Unidades de Cuidados Intensivos , Intubación Intratraqueal/estadística & datos numéricos , Modelos Estadísticos , Estudios Observacionales como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Análisis de Supervivencia , Resultado del Tratamiento
12.
Pediatr Emerg Care ; 37(10): 528-532, 2021 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-34570081

RESUMEN

OBJECTIVE: Because of the abundance of complications associated with peri-intubation hypoxia, maintaining adequate oxygen saturation during endotracheal intubation (ETI) is of great concern. In addition to standard preoxygenation techniques, apneic oxygenation (AO), the continuous flow of passive oxygenation, is a potential tool that can be used to eliminate hypoxia during ETI. Although scarcely studied in the pediatric population, AO has proven effective in reducing the incidence of hypoxia in adult patients with minimal side effects. The objective of this study is to evaluate the use of apneic oxygenation in pediatric patients and to determine its efficacy in preventing or delaying oxygen desaturation during the apneic period of ETI. METHODS: This literature review examines 4 studies that evaluate the practice of AO in pediatric patients. A total of 712 patients across 3 randomized control trials and 1 observational study were assigned to either a control group that did not receive any form of AO, a group that did not receive 100% fraction of inspired oxygen (FiO2), or an intervention group where various methods of AO were delivered. RESULTS: Each AO method that provided 100% FiO2 saw a significantly longer time until initial desaturation when compared with those that did not receive any form of AO or those not receiving 100% FiO2. CONCLUSIONS: The findings in this study confirm that the practice of AO is not only efficacious in increasing the time until initial desaturation but also reduces the overall incidence of hypoxia during laryngoscopy in children.


Asunto(s)
Intubación Intratraqueal , Laringoscopía , Apnea/terapia , Niño , Humanos , Hipoxia/etiología , Hipoxia/prevención & control , Estudios Observacionales como Asunto , Oxígeno , Terapia por Inhalación de Oxígeno , Ensayos Clínicos Controlados Aleatorios como Asunto , Respiración Artificial
14.
Int J Public Health ; 66: 1604149, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34557062

RESUMEN

Objectives: Global environmental challenges demand sustainable behaviours and policies to protect human and planetary health. We aimed to summarize the evidence about the factors related to Sustainable Food Consumption (SFC) behaviours of university students, and to propose an operational categorization of SFC behaviours. Methods: Seven databases were searched for observational studies evaluating Sustainable Food Consumption (SFC) among university students and that reported at least one behavioural outcome measure. Qualitative synthesis was conducted, and PRISMA guidelines for reporting were followed. Results: Out of 4,479 unique references identified, 40 studies were selected. All studies examined personal factors, while 11 out of 40 also measured social or situational factors. Except for food waste, females had higher levels of SFC behaviours, but situational factors moderated this association. Knowledge and attitudes showed mixed results. Overall, sustainable food consumers reported healthier lifestyles. Conclusions: Healthy lifestyle of sustainable food consumers suggests possible synergies between human health and sustainability in terms of motivations for food choice. Moderation effects of social and situational factors on personal factors reveal opportunities to design and examine the effects of choice architecture interventions.


Asunto(s)
Conducta Alimentaria , Estudiantes , Humanos , Estudios Observacionales como Asunto , Estudiantes/psicología , Estudiantes/estadística & datos numéricos , Universidades
15.
BMC Fam Pract ; 22(1): 173, 2021 09 02.
Artículo en Inglés | MEDLINE | ID: mdl-34474667

RESUMEN

BACKGROUND: A SARS-CoV-2 infection can lead from asymptomatic through to critical disease in a dynamic and unpredictable course within a few days. The challenge in outpatient monitoring the highly contagious COVID-19 disease during the ongoing pandemic is to filter severe courses followed by admission to hospital with the aim of preventing an overburdening of clinics. However, little is known of the effect of risk factors on the course of the infection of outpatient patients. To support general practices in managing high risk patients, we designed a COVID-19 surveillance and care tool (CovidCare). It includes an initial assessment of yet known risk factors and symptoms and a continuous telephone monitoring of signs and symptoms. This study aims to investigate the effects of different risk factors on the course of the COVID-19 disease, utilisation of different health care services and to gain insights into the utilisation of CovidCare in general practices. METHODS: We will conduct a multi-centered prospective, longitudinal non-controlled observational trial of COVID-19 patients in general practices. Overall, 700 GPs who participate in general-practice centered care by the AOK Baden-Württemberg (large German sickness fund) are eligible and will be invited for study participation, including adult, outpatient COVID-19 patients (or urgent suspicion and ≥ 50 years) with at least one additional known risk factor, who participate in general-practice centered care. The primary outcome is hospitalisation due to COVID-19. Secondary outcomes are diagnosis of pneumonia, utilisation of palliative care, mortality rate, anxiety and identification of predictive risk factors. Quantitative data analysis will focus on valid descriptive figures and mixed regression models. The accompanying process evaluation is based on interviews and questionnaires from general practice staff and patients. The analysis of the process evaluation is descriptive and explorative. DISCUSSION: The use of the COVID-19 surveillance and care tool is expected to encourage the provision of structured quality of care during the ongoing pandemic. This trial will provide an understanding of the COVID-19-disease and the effect of several risk factors on the course of the disease and health care utilisation. The results can be used for a better management of the COVID-19 pandemic and its consequences. TRIAL REGISTRATION: German Clinical Trials Register DRKS00022054 .


Asunto(s)
COVID-19 , Medicina General , Adulto , Humanos , Persona de Mediana Edad , Estudios Observacionales como Asunto , Pandemias , Estudios Prospectivos , SARS-CoV-2 , Resultado del Tratamiento
16.
JAMA ; 326(11): 1045-1056, 2021 09 21.
Artículo en Inglés | MEDLINE | ID: mdl-34546296

RESUMEN

Importance: Mediation analyses of randomized trials and observational studies can generate evidence about the mechanisms by which interventions and exposures may influence health outcomes. Publications of mediation analyses are increasing, but the quality of their reporting is suboptimal. Objective: To develop international, consensus-based guidance for the reporting of mediation analyses of randomized trials and observational studies (A Guideline for Reporting Mediation Analyses; AGReMA). Design, Setting, and Participants: The AGReMA statement was developed using the Enhancing Quality and Transparency of Health Research (EQUATOR) methodological framework for developing reporting guidelines. The guideline development process included (1) an overview of systematic reviews to assess the need for a reporting guideline; (2) review of systematic reviews of relevant evidence on reporting mediation analyses; (3) conducting a Delphi survey with panel members that included methodologists, statisticians, clinical trialists, epidemiologists, psychologists, applied clinical researchers, clinicians, implementation scientists, evidence synthesis experts, representatives from the EQUATOR Network, and journal editors (n = 19; June-November 2019); (4) having a consensus meeting (n = 15; April 28-29, 2020); and (5) conducting a 4-week external review and pilot test that included methodologists and potential users of AGReMA (n = 21; November 2020). Results: A previously reported overview of 54 systematic reviews of mediation studies demonstrated the need for a reporting guideline. Thirty-three potential reporting items were identified from 3 systematic reviews of mediation studies. Over 3 rounds, the Delphi panelists ranked the importance of these items, provided 60 qualitative comments for item refinement and prioritization, and suggested new items for consideration. All items were reviewed during a 2-day consensus meeting and participants agreed on a 25-item AGReMA statement for studies in which mediation analyses are the primary focus and a 9-item short-form AGReMA statement for studies in which mediation analyses are a secondary focus. These checklists were externally reviewed and pilot tested by 21 expert methodologists and potential users, which led to minor adjustments and consolidation of the checklists. Conclusions and Relevance: The AGReMA statement provides recommendations for reporting primary and secondary mediation analyses of randomized trials and observational studies. Improved reporting of studies that use mediation analyses could facilitate peer review and help produce publications that are complete, accurate, transparent, and reproducible.


Asunto(s)
Guías como Asunto , Análisis de Mediación , Estudios Observacionales como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Lista de Verificación , Técnica Delfos , Humanos , Revisión por Pares , Revisiones Sistemáticas como Asunto
17.
BMJ Open ; 11(9): e050833, 2021 09 02.
Artículo en Inglés | MEDLINE | ID: mdl-34475182

RESUMEN

INTRODUCTION: Diabetic foot disease is a common condition globally and is over-represented in indigenous populations. The propensity for patients with diabetic foot disease to undergo minor or major limb amputation is a concern. Diabetic foot disease and lower limb amputation are debilitating for patients and have a substantial financial impact on health services. The purpose of this multicentre study is to prospectively report the presentation, management and outcomes of diabetic foot disease, to validate existing scoring systems and assess long term outcomes for these patients particularly in relation to major limb amputation. METHODS AND ANALYSIS: This is a multisite, international, prospective observational study, being undertaken at Waikato Hospital, New Zealand (NZ); Sir Charles Gairdner Hospital, the Royal Adelaide Hospital and the Queen Elizabeth Hospital, Australia. Consecutive participants with diabetic foot disease that meet inclusion criteria and agree to participate will be recruited from multidisciplinary team diabetic foot clinic, vascular clinic, dialysis and admission to hospital. Follow-up of participants will occur at 1, 3, 6 and 12 months. At recruitment and follow-up reviews, information about service details, demographic and clinical history, wound data and discharge information will be recorded. The primary outcomes are the time to wound healing, major amputation, overall mortality and amputation-free survival at 12 months. This study started in NZ in August 2020 and will commence in Australian sites in early 2021. ETHICS AND DISSEMINATION: New Zealand Central Health and Disability Ethics Committee (20/CEN/122), Waikato DHB Research Department (RDO020044), Quality Improvement HoD Sir Charles Gairdner Hospital (39715) and the Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (13928). Results will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12621000337875).


Asunto(s)
Diabetes Mellitus , Pie Diabético , Australia/epidemiología , Pie Diabético/epidemiología , Pie Diabético/cirugía , Humanos , Estudios Multicéntricos como Asunto , Nueva Zelanda/epidemiología , Estudios Observacionales como Asunto , Diálisis Renal , Temefós
18.
Environ Int ; 157: 106852, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34500362

RESUMEN

BACKGROUND: Applications emitting radiofrequency electromagnetic fields (RF-EMF; 100 kHz to 300 GHz) are widely used for communication (e.g. mobile phones), in medicine (diathermy) and in industry (RF heaters). Concern has been raised that RF-EMF exposure affects health related quality of life, because a part of the population reports to experience a variety of symptoms related to low exposure levels below regulatory limits. OBJECTIVES: To systematically review the effects of longer-term or repeated local and whole human body RF-EMF exposure on the occurrence of symptoms evaluating migraine, tinnitus, headaches, sleep disturbances and composite symptom scores as primary outcomes. METHODS: We will follow the WHO handbook for guideline development. For the development of the systematic review protocol we considered handbook for conducting systematic reviews for health effects evaluations from the National Toxicology Program-Office of Health Assessment and Translation (NTP-OHAT) and COSTER (Recommendations for the conduct of systematic reviews in toxicology and environmental health research). ELIGIBILITY CRITERIA: Peer-reviewed epidemiological studies in the general population or workers aiming to investigate the association between local or whole-body RF-EMF exposure for at least one week and symptoms are eligible for inclusion. Only cohort, case-control and panel studies will be included. INFORMATION SOURCES: We will search the scientific literature databases Medline, Web of Science, PsycInfo, Cochrane Library, Epistemonikos and Embase, using a predefined search strategy. This search will be supplemented by a search in the EMF-Portal and checks of reference lists of relevant papers and reviews. STUDY APPRAISAL AND SYNTHESIS METHOD: Data from included papers will be extracted according to predefined forms. Findings will be summarized in tables, graphical displays and in a narrative synthesis of the available evidence, complemented with meta-analyses. We will separately review effects of local, far field and occupational exposure. RISK OF BIAS: The internal validity of included studies will be assessed using the NTP-OHAT Risk of Bias Rating Tool for Human and Animal Studies, elaborated to observational RF-EMF studies. EVIDENCE APPRAISAL: To rate certainty of the evidence, we will use the OHAT GRADE-based approach for epidemiological studies. FRAMEWORK AND FUNDING: This protocol concerns one of the ten different systematic reviews considered in a larger systematic review of the World Health Organization to assess potential health effects of exposure to RF-EMF in the general and working population. REGISTRATION: PROSPERO CRD42021239432.


Asunto(s)
Trastornos Migrañosos , Acúfeno , Animales , Campos Electromagnéticos/efectos adversos , Humanos , Trastornos Migrañosos/epidemiología , Estudios Observacionales como Asunto , Calidad de Vida , Revisiones Sistemáticas como Asunto
19.
J Nephrol ; 34(5): 1641-1649, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-34559398

RESUMEN

BACKGROUND: Hypertensive disorders of pregnancy are associated with chronic kidney disease. Early detection of renal dysfunction enables implementation of strategies to prevent progression. International guidelines recommend review at 6-8 weeks postpartum to identify persistent hypertension and abnormal renal function, but evidence for the efficacy of this review is limited. METHODS: All women attending a specialist fetal-maternal medicine clinic for hypertensive disorders of pregnancy (pre-eclampsia, chronic hypertension, gestational hypertension) were invited for a 6-8 weeks postpartum review of their blood pressure and renal function in order to establish the prevalence and independent predictors of renal dysfunction. Renal dysfunction was defined as low estimated Glomerular Filtration Rate (eGFR < 60 ml/min/1.73 m2) or proteinuria (24-h protein excretion > 150 mg or urinary albumin-to-creatinine ratio > 3 mg/mmol). All women attending a specialist clinic for hypertensive disorders were invited for a 6-8 weeks postpartum review of their blood pressure and renal function. Demographics, pregnancy and renal outcomes were prospectively collected. RESULTS: Between 2013 and 2019, 740 of 1050 (70.4%) women who had a pregnancy complicated by a hypertensive disorder attended their 6-8 weeks postpartum visit. Renal dysfunction was present in 32% of the total cohort and in 46% and 22% of women with and without pre-eclampsia, respectively. Multivariate logistic regression demonstrated that independent predictors were pre-eclampsia, chronic hypertension, highest measured antenatal serum creatinine, highest measured antenatal 24-h urinary protein, and blood pressure ≥ 140/90 mmHg at the postnatal visit. CONCLUSIONS: Renal dysfunction was present in one in three women with hypertensive disorders of pregnancy at 6-8 weeks postpartum. This includes women with gestational hypertension and chronic hypertension without superimposed pre-eclampsia, and thus these women should also be offered postnatal review.


Asunto(s)
Hipertensión Inducida en el Embarazo , Hipertensión , Enfermedades Renales , Preeclampsia , Presión Sanguínea , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/epidemiología , Hipertensión Inducida en el Embarazo/diagnóstico , Hipertensión Inducida en el Embarazo/epidemiología , Estudios Observacionales como Asunto , Preeclampsia/diagnóstico , Preeclampsia/epidemiología , Embarazo , Estudios Prospectivos
20.
J Coll Physicians Surg Pak ; 31(9): 1099-1101, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34500529

RESUMEN

The levothyroxine absorption test for the assessment of pseudo-malabsorption in patients with refractory hypothyroidism has not been standardised. The aim of this observational study was to describe a protocol for levothyroxine (LT-4) absorption test in patients with refractory hypothyroidism, to report possible side effects and to emphasise the importance of pseudo-malabsorption in the differential diagnosis. The results of 10 patients, who underwent LT-4 absorption tests because thyroid stimulating hormone suppression could not be achieved despite the need for LT-4 >3 mcg/kg/day, were retrospectively analysed. When compared with basal free T4 (fT4), a statistically significant increase in fT4 was observed after the first hour (p=0.012). fT4 reached its peak level and plateau at the 4th hour. The fT4 peak level increased 3.25 times compared to baseline. The shorter LT-4 absorption test with low doses may provide an alternative method to the commonly used longer protocols with higher doses to rule out malabsorption. Key Words: Levothyroxine absorption test, Pseudo-malabsorption, Resistant hypothyroidism.


Asunto(s)
Hipotiroidismo , Tiroxina , Humanos , Hipotiroidismo/diagnóstico , Hipotiroidismo/tratamiento farmacológico , Estudios Observacionales como Asunto , Estudios Retrospectivos , Pruebas de Función de la Tiroides , Tirotropina
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