RESUMEN
The field of participatory research with children developed largely thanks to shared learning between different cultures, places, and disciplines. However, grand narratives and power relationships in academia inherited from colonialism and imperialism can threaten to obstruct the transformative value of this approach. In this article, we present the case of Think Big, a multinational collaboration for participatory research with children that involved adult and child coresearchers from Australia, Chile, Colombia, and the United Kingdom. Our aim was to explore how this project helped build solidarities between adult researchers from different countries and disciplines. We applied a methodology of diffraction to explore the processes and outcomes of this collaboration and presented our insights using the metaphor of a tree to explain the roots (knowledges and frameworks), trunk (ongoing collaboration and communication between the teams from different countries), branches (local projects), and fruits (research outcomes) of our work. Based on our experience, we proposed that multinational collaborations for participatory research offer important opportunities for adult researchers to collaborate with children to generate more democratic knowledge about their lives and to generate more egalitarian relationships between adult researchers from different places and backgrounds. However, it is important to anticipate that multinational collaborations are more likely to be affected by social and political upheavals, and language barriers must be overcome to decentralize academia. Also, the organizations involved in these collaborations need to develop strategies that facilitate funding, ethics clearance, and international research agreements.
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Investigación Participativa Basada en la Comunidad , Investigadores , Adulto , Niño , Comunicación , Humanos , Conocimiento , Estudios LongitudinalesRESUMEN
OBJECTIVES: To identify differences and similarities in HbA1c levels and patterns regarding age and gender in eight high-income countries. SUBJECTS: 66 071 children and adolescents below18 years of age with type 1 diabetes for at least 3 months and at least one HbA1c measurement during the study period. METHODS: Pediatric Diabetes Quality Registry data from Austria, Denmark, England, Germany, Norway, Sweden, the United States, and Wales were collected between 2013 and 2014. HbA1c, gender, age, and duration were used in the analysis. RESULTS: Distribution of gender and age groups was similar in the eight participating countries. The mean HbA1c varied from 60 to 73 mmol/mol (7.6%-8.8%) between the countries. The increase in HbA1c between the youngest (0-9 years) to the oldest (15-17 years) age group was close to 8 mmol/mol (0.7%) in all countries (P < .001). Females had a 1 mmol/mol (0.1%) higher mean HbA1c than boys (P < .001) in seven out of eight countries. CONCLUSIONS: In spite of large differences in the mean HbA1c between countries, a remarkable similarity in the increase of HbA1c from childhood to adolescence was found.
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Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/epidemiología , Hemoglobina Glucada/análisis , Adolescente , Austria/epidemiología , Benchmarking , Niño , Preescolar , Países Desarrollados/estadística & datos numéricos , Inglaterra/epidemiología , Femenino , Alemania/epidemiología , Hemoglobina Glucada/metabolismo , Humanos , Renta , Lactante , Recién Nacido , Internacionalidad , Masculino , Noruega/epidemiología , Sistema de Registros/estadística & datos numéricos , Suecia/epidemiología , Estados Unidos/epidemiología , Gales/epidemiologíaRESUMEN
OBJECTIVE: A systematic review and meta-analysis was conducted to investigate if glycemic control measured by glycated hemoglobin (HbA1c) levels near diagnosis are predictive of future glycemic outcomes and vascular complications in childhood onset type 1 diabetes (T1D). METHODS: Evidence was gathered using electronic databases (MEDLINE, EMBASE, Web of Science, CINAHL, Scopus, and Cochrane Library up to February 2017) and snowballing techniques. Studies investigating the association between the exposure "early glycemic control" and main outcome: "tracking of early control" and secondary outcome: risk of future complications; in children and young people aged 0 to 19 years at baseline; were systematically double-reviewed, quality assessed, and outcome data extracted for synthesis and meta-analysis. FINDINGS: Five studies (N = 4227 participants) were eligible. HbA1c levels were sub-optimal throughout the study period but tended to stabilize in a "track" by 6 months after T1D diagnosis. The group with low HbA1c <53 mmol/mol (<7%) at baseline had lower long-term HbA1c levels than the higher HbA1c group. The estimated standardized mean difference between the sub groups showed a reduction of HbA1c levels on average by 1.6% (range -0.95% to -2.28%) from baseline. Only one study investigated the association between early glycemic control and development of vascular complications in childhood onset T1D. INTERPRETATIONS: Glycemic control after the first few months of childhood onset T1D, remains stable but sub-optimal for a decade. The low and high HbA1c levels at baseline seem to "track" in their respective tracks during the 10-year follow-up, however, the initial difference between groups narrows over time. PROSPERO: CRD42015024546 http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015024546.
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Diabetes Mellitus Tipo 1/tratamiento farmacológico , Angiopatías Diabéticas/prevención & control , Hemoglobina Glucada/metabolismo , Hipoglucemiantes/uso terapéutico , Adolescente , Niño , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/complicaciones , Angiopatías Diabéticas/etiología , HumanosRESUMEN
Early glycemic control is associated with reduced future vascular complications risk in type 1 diabetes (T1D). The aim of this study was to systematically review evidence on the predictors of glycemic control within 12 months of diagnosis of childhood onset T1D. Inclusion criteria for the electronic search were: interventional and observational studies that assessed and quantified an association between the predictor and glycemic control within 12 months of diagnosis of childhood onset T1D. A total of 17 915 articles were identified from 6 databases and 20 studies were finally included in the analysis. Harvest plots and narrative synthesis were used to summarize data from intervention (n = 0), prospective/retrospective cohort (n = 15), and cross-sectional (n = 5) studies. Significant predictors of poorer glycemic control 0 to 3 months after diagnosis were older age and female gender. Non-white ethnicity, diabetes autoantibody positivity, measures of deprivation, and non-private health insurance were potential predictors. Predictors of poorer glycemic control 4 to 12 months after diagnosis were: older age, non-white ethnicity, a single parent family, high hemoglobin A1c (HbA1c) levels at diagnosis, longer T1D duration, and non-intensive insulin therapy. Potential predictors included: family with health issues, clinical factors, and comorbidities at diagnosis. Most significant predictors of poor glycemic control within 12 months of diagnosis of childhood onset T1D are non-modifiable. These factors need to be recognized and addressed through individualized and multidisciplinary diabetes care. Further research is required to confirm the association of potential predictors with early glycemic control.
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Diabetes Mellitus Tipo 1/sangre , Hemoglobina Glucada/metabolismo , Niño , Diabetes Mellitus Tipo 1/epidemiología , Diabetes Mellitus Tipo 1/terapia , Humanos , Factores de RiesgoRESUMEN
We conducted a systematic review and meta-analysis to investigate the associations between menarcheal age and all-cause and cardiovascular death. Medline, Embase, Scopus, and Web of Knowledge were searched for articles published prior to March 2013 reporting on the associations between menarcheal age and death from all causes or from cardiovascular disease (total cardiovascular disease, ischemic heart disease (IHD), and stroke) in adult women. Nine articles were eligible for inclusion; these reported 5 estimates each for death from all causes and total cardiovascular death, 6 estimates for IHD, and 7 estimates for death from stroke. Our meta-analysis showed that each 1-year increase in age at menarche was associated with a 3% lower relative risk of death from all causes (pooled hazard ratio = 0.97, 95% confidence interval: 0.96, 0.98) with low heterogeneity (I(2) = 32.2%). Meta-analysis of 2 cohorts showed a higher risk of death from all causes for women who experienced early menarche (at <12 years of age) versus "not early" menarche (at ≥ 12 years of age) (pooled hazard ratio = 1.23, 95% confidence interval: 1.10, 1.38; I(2) = 0%). An inverse association between age at menarche and death from IHD was observed only among nonsmoking populations or populations with low prevalence of smoking. We found no evidence of association between age at menarche and death from all cardiovascular diseases or stroke. Early menarche was consistently associated with higher risk of death from all causes. Further studies are needed to clarify the role of menarcheal age on cardiovascular outcomes and to investigate the potential modifying role of smoking.
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Enfermedades Cardiovasculares/mortalidad , Menarquia , Mortalidad , Adolescente , Adulto , Factores de Edad , Anciano , Niño , Femenino , Humanos , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Factores de RiesgoRESUMEN
It is known that SARS-CoV-2 infection can result in gastrointestinal symptoms. For some, these symptoms may persist beyond acute infection, in what is known as 'post-COVID syndrome'. We conducted a systematic review to examine the prevalence of persistent gastrointestinal symptoms and the incidence of new gastrointestinal illnesses following acute SARS-CoV-2 infection. We searched the scientific literature using MedLine, SCOPUS, Europe PubMed Central and medRxiv from December 2019 to July 2023. Two reviewers independently identified 45 eligible articles, which followed participants for various gastrointestinal outcomes after acute SARS-CoV-2 infection. The study quality was assessed using the Joanna Briggs Institute Critical Appraisal Tools. The weighted pooled prevalence for persistent gastrointestinal symptoms of any nature and duration was 10.8% compared with 4.9% in healthy controls. For seven studies at low risk of methodological bias, the symptom prevalence ranged from 0.2% to 24.1%, with a median follow-up time of 18 weeks. We also identified a higher risk for future illnesses such as irritable bowel syndrome, dyspepsia, hepatic and biliary disease, liver disease and autoimmune-mediated illnesses such as inflammatory bowel disease and coeliac disease in historically SARS-CoV-2-exposed individuals. Our review has shown that, from a limited pool of mostly low-quality studies, previous SARS-CoV-2 exposure may be associated with ongoing gastrointestinal symptoms and the development of functional gastrointestinal illness. Furthermore, we show the need for high-quality research to better understand the SARS-CoV-2 association with gastrointestinal illness, particularly as population exposure to enteric infections returns to pre-COVID-19-restriction levels.
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COVID-19 , Enfermedades Inflamatorias del Intestino , Humanos , Incidencia , COVID-19/complicaciones , COVID-19/epidemiología , Prevalencia , SARS-CoV-2RESUMEN
OBJECTIVE: To analyse the impact of voluntary rapid testing for SARS-CoV-2 antigen in Liverpool city on covid-19 related hospital admissions. DESIGN: Synthetic control analysis comparing hospital admissions for small areas in the intervention population with a group of control areas weighted to be similar for past covid-19 related hospital admission rates and sociodemographic factors. SETTING: Liverpool city, UK, 6 November 2020 to 2 January 2021, under the intervention of Covid-SMART (systematic meaningful asymptomatic repeated testing) voluntary, open access supervised self-testing with lateral flow devices, compared with control areas selected from the rest of England. POPULATION: General population of Liverpool (n=498 042) and a synthetic control population from the rest of England. MAIN OUTCOME MEASURE: Weekly covid-19 related hospital admissions for neighbourhoods in England. RESULTS: The introduction of community testing was associated with a 43% (95% confidence interval 29% to 57%) reduction (146 (96 to 192) in total) in covid-19 related hospital admissions in Liverpool compared with the synthetic control population (non-adjacent set of neighbourhoods with aggregate trends in covid-19 hospital admissions similar to Liverpool) for the initial period of intensive testing with military assistance in national lockdown from 6 November to 3 December 2020. A 25% (11% to 35%) reduction (239 (104 to 333) in total) was estimated across the overall intervention period (6 November 2020 to 2 January 2021), involving fewer testing centres, before England's national roll-out of community testing, after adjusting for regional differences in tiers of covid-19 restrictions from 3 December 2020 to 2 January 2021. CONCLUSIONS: The city-wide pilot of community based asymptomatic testing for SARS-CoV-2 was associated with substantially reduced covid-19 related hospital admissions. Large scale asymptomatic rapid testing for SARS-CoV-2 could help reduce transmission and prevent hospital admissions.
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COVID-19 , Humanos , COVID-19/diagnóstico , COVID-19/epidemiología , SARS-CoV-2 , Control de Enfermedades Transmisibles , Hospitalización , HospitalesRESUMEN
BACKGROUND: The prevalences of obstructive and restrictive spirometric phenotypes, and their relation to early-life risk factors from childhood to young adulthood remain poorly understood. The aim was to explore these phenotypes and associations with well-known respiratory risk factors across ages and populations in European cohorts. METHODS: We studied 49â334 participants from 14 population-based cohorts in different age groups (≤10, >10-15, >15-20, >20-25â
years, and overall, 5-25â
years). The obstructive phenotype was defined as forced expiratory volume in 1â
s (FEV1)/forced vital capacity (FVC) z-score less than the lower limit of normal (LLN), whereas the restrictive phenotype was defined as FEV1/FVC z-score ≥LLN, and FVC z-score
RESUMEN
BACKGROUND: Healthcare workers' (HCW) seasonal influenza vaccination (SIV) is critical to prevent nosocomial influenza. However, HCW vaccination rates remain unacceptably low in many European institutions. A two-year three-step initiative was implemented at a tertiary-care pediatric hospital with 750 beds in Athens, Greece with the aim of increasing SIV among HCW. METHODS: Α cross-sectional anonymous survey of HCWs was conducted during the 2015-16 influenza season with the aim to evaluate attitudes, knowledge, and specific barriers and facilitators for SIV. Stratified analysis was used to identify factors associated with no prior history of influenza vaccination. Multifaceted interventions were implemented in the 2016-2017 season. These included 1) education around influenza disease and SIV, and 2) communication of availability and opportunity (time and place) of SIV. Interventions were designed to target HCWs with the lowest SIV rates in the previous three years. RESULTS: We achieved a 67% response rate, with 363 respondents (106 doctors, 145 nurses, 101 other hospital staff; 11 did not provide their profession). Most (64%) had not been vaccinated in the previous three years; only 14% received the vaccine annually. Non-vaccination rates were significantly higher among nurses (76%) and cleaning and food-service workers (73%) compared to doctors (40%) (P < 0.001). Protection of self, family, patients and colleagues were the most common motivations. Concerns about the safety and effectiveness of the vaccine, the belief that one does not belong to a high-risk group were the most common barriers. The interventions led to an increase in SIV uptake by the HCWs in the hospital, from 19% to 31%. CONCLUSIONS: In a country with very low reported rates of vaccination among HCWs, a simple, low-cost, tailor-made intervention strategy can lead to an increase in SIV uptake. Stratifying data according to vaccination history may reveal a diversity of targets for improvement that might otherwise be missed.
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Vacunas contra la Influenza , Gripe Humana , Actitud del Personal de Salud , Niño , Estudios Transversales , Grecia , Personal de Salud , Hospitales Pediátricos , Humanos , Gripe Humana/prevención & control , Estaciones del Año , Encuestas y Cuestionarios , VacunaciónRESUMEN
OBJECTIVE: International studies on childhood type 1 diabetes (T1D) have focused on whole-country mean HbA1c levels, thereby concealing potential variations within countries. We aimed to explore the variations in HbA1c across and within eight high-income countries to best inform international benchmarking and policy recommendations. RESEARCH DESIGN AND METHODS: Data were collected between 2013 and 2014 from 64,666 children with T1D who were <18 years of age across 528 centers in Germany, Austria, England, Wales, U.S., Sweden, Denmark, and Norway. We used fixed- and random-effects models adjusted for age, sex, diabetes duration, and minority status to describe differences between center means and to calculate the proportion of total variation in HbA1c levels that is attributable to between-center differences (intraclass correlation [ICC]). We also explored the association between within-center variation and children's glycemic control. RESULTS: Sweden had the lowest mean HbA1c (59 mmol/mol [7.6%]) and together with Norway and Denmark showed the lowest between-center variations (ICC ≤4%). Germany and Austria had the next lowest mean HbA1c (61-62 mmol/mol [7.7-7.8%]) but showed the largest center variations (ICC â¼15%). Centers in England, Wales, and the U.S. showed low-to-moderate variation around high mean values. In pooled analysis, differences between counties remained significant after adjustment for children characteristics and center effects (P value <0.001). Across all countries, children attending centers with more variable glycemic results had higher HbA1c levels (5.6 mmol/mol [0.5%] per 5 mmol/mol [0.5%] increase in center SD of HbA1c values of all children attending a specific center). CONCLUSIONS: At similar average levels of HbA1c, countries display different levels of center variation. The distribution of glycemic achievement within countries should be considered in developing informed policies that drive quality improvement.
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Glucemia/metabolismo , Países Desarrollados , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/epidemiología , Renta/estadística & datos numéricos , Adolescente , Austria/epidemiología , Niño , Estudios Transversales , Dinamarca/epidemiología , Países Desarrollados/economía , Países Desarrollados/estadística & datos numéricos , Diabetes Mellitus Tipo 1/economía , Inglaterra/epidemiología , Femenino , Alemania/epidemiología , Hemoglobina Glucada/análisis , Hemoglobina Glucada/metabolismo , Humanos , Masculino , Grupos Minoritarios/estadística & datos numéricos , Noruega/epidemiología , Suecia/epidemiología , Gales/epidemiologíaRESUMEN
AIMS: To synthesise evidence from UK-based randomised trials of psycho-educational interventions in children and young people (CYP) with Type 1 Diabetes (T1D) to inform the evidence-base for adoption of such interventions into the NHS. METHODS: We searched Medline, Embase, Cochrane, PsycINFO, CINAHL, and Web of Science up to March 2016. Two reviewers independently selected UK-based randomised trials comparing psycho-educational interventions for improving management of T1D for CYP with a control group of usual care or attention control. The main outcome was glycaemic control measured by percentage of glycated haemoglobin (HbA1c); secondary outcomes included psychosocial functioning, diabetes knowledge, adverse and other clinical outcomes. A narrative synthesis and meta-analysis were conducted. Pooled effect sizes of standardised mean difference (SMD) were calculated. RESULTS: Ten eligible trials of three educational and seven psycho-educational interventions were identified. Most interventions were delivered by non-psychologists and targeted adolescents with more than one year duration of diabetes. Meta-analysis of nine of these trials (N = 1,838 participants) showed a non-significant reduction in HbA1c attributable to the intervention (pooled SMD = -0.06, 95% CI: -0.21 to 0.09). Psycho-educational interventions aiming to increase children's self-efficacy had a moderate, beneficial effect (SMD = 0.50, 95% CI: 0.13 to 0.87). No benefits on diabetes knowledge and other indicators of psychosocial functioning were identified. CONCLUSIONS: There is insufficient evidence to recommend the use of particular psycho-educational programme for CYP with T1D in the UK. Further trials with sufficient power and reporting standards are needed. Future trials could consider active involvement of psychological specialists in the delivery of psychologically informed interventions and implementation of psycho-educational interventions earlier in the course of the disease. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015010701.
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Diabetes Mellitus Tipo 1/terapia , Educación del Paciente como Asunto/normas , Adolescente , Adulto , Niño , Diabetes Mellitus Tipo 1/psicología , Medicina Basada en la Evidencia , Femenino , Humanos , Masculino , Educación del Paciente como Asunto/métodos , Psicoterapia/métodos , Psicoterapia/normas , Ensayos Clínicos Controlados Aleatorios como Asunto , Reino Unido , Adulto JovenRESUMEN
Gastrointestinal (GI) models that mimic physiological conditions in vitro are important tools for developing and optimizing biopharmaceutical formulations. Oral administration of live attenuated bacterial vaccines (LBV) can safely and effectively promote mucosal immunity but new formulations are required that provide controlled release of optimal numbers of viable bacterial cells, which must survive gastrointestinal transit overcoming various antimicrobial barriers. Here, we use a gastro-small intestine gut model of human GI conditions to study the survival and release kinetics of two oral LBV formulations: the licensed typhoid fever vaccine Vivotif comprising enteric coated capsules; and an experimental formulation of the model vaccine Salmonella Typhimurium SL3261 dried directly onto cast enteric polymer films and laminated to form a polymer film laminate (PFL). Neither formulation released significant numbers of viable cells when tested in the complete gastro-small intestine model. The poor performance in delivering viable cells could be attributed to a combination of acid and bile toxicity plus incomplete release of cells for Vivotif capsules, and to bile toxicity alone for PFL. To achieve effective protection from intestinal bile in addition to effective acid resistance, bile adsorbent resins were incorporated into the PFL to produce a new formulation, termed BR-PFL. Efficient and complete release of 4.4×10(7) live cells per dose was achieved from BR-PFL at distal intestinal pH, with release kinetics controlled by the composition of the enteric polymer film, and no loss in viability observed in any stage of the GI model. Use of this in vitro GI model thereby allowed rational design of an oral LBV formulation to maximize viable cell release.
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Vacunas Bacterianas/química , Mucosa Gástrica/metabolismo , Intestino Delgado/metabolismo , Vacunas Tifoides-Paratifoides/química , Vacunas Atenuadas/química , Administración Oral , Vacunas Bacterianas/administración & dosificación , Bilis/metabolismo , Cápsulas/química , Química Farmacéutica/métodos , Humanos , Concentración de Iones de Hidrógeno , Modelos Biológicos , Polímeros/química , Vacunas Tifoides-Paratifoides/administración & dosificación , Vacunas Atenuadas/administración & dosificaciónRESUMEN
Wheat Distillers' Dried Grains with Solubles (DDGS) and in-process samples were used for protein extraction. Prolamins were the predominant protein components in the samples. The absence of extractable α- and γ-gliadins in DDGS indicated protein aggregation during the drum drying processing stage. Prolamin extraction was performed using 70% (v/v) ethanol or alkaline-ethanol solution in the presence of reducing agent. DDGS extracts had relatively low protein contents (14-44.9%, w/w), regardless of the condition applied. The wet solids were the most suitable raw material for protein extraction, with recovery yields of â¼ 55% (w/w) and protein content of â¼ 58% (w/w) in 70% (v/v) ethanol. Protein extracts from wet solids were significantly rich in glutamic acid and proline. Mass balance calculations demonstrated the high carbohydrate content (â¼ 50%, w/w) of solid residues. Overall, the feasibility of utilising in-process samples of DDGS for protein extraction with commercial potential was demonstrated.
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Estructuras de las Plantas/química , Proteínas/química , Triticum/químicaRESUMEN
OBJECTIVE: The European Paediatric Life Support (EPLS) provider course aims at training doctors and nurses in the efficient and prompt management of cardiopulmonary arrest in children. EPLS is a 2-day European Resuscitation Council course, involving the teaching of theoretical knowledge and practical skills. The aim of the study was to evaluate the retention of theoretical knowledge and certain skills of EPLS providers 4 months after the course. MATERIALS AND METHODS: In total, 80 doctors and nurses who attended three EPLS provider courses, from May 2012 to December 2012, were asked to participate in the study and only 50 responded positively. Demographic data (age, sex, occupation) of the participants were collected. The European Resuscitation Council-approved EPLS written test was used to assess theoretical knowledge right after the course and after 4 months. The retention of certain skills (airway opening, bag-mask ventilation, chest compressions) was also examined. RESULTS: The theoretical knowledge decreased significantly (P<0.001) 4 months after the course. Age, sex and occupational status (medical or nursing profession) had no effect in theoretical knowledge retention. Interestingly, certain skills such as the application of airway opening manoeuvres and effective bag-mask ventilation were retained 4 months after the course, whereas chest compression skill retention significantly declined (P=0.012). CONCLUSION: According to our findings, theoretical knowledge of the EPLS course uniformly declines, irrespective of the provider characteristics, whereas retention of certain skills is evident 4 months after the course.
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Reanimación Cardiopulmonar/educación , Competencia Clínica , Cuidados para Prolongación de la Vida/métodos , Pediatría/educación , Retención en Psicología/fisiología , Adulto , Evaluación Educacional , Servicios Médicos de Urgencia/métodos , Femenino , Grecia , Humanos , Masculino , Paro Cardíaco Extrahospitalario/terapia , Medición de Riesgo , Factores de TiempoRESUMEN
We present a novel but simple enteric coated sphere formulation containing probiotic bacteria (Lactobacillus casei). Oral delivery of live bacterial cells (LBC) requires live cells to survive firstly manufacturing processes and secondly GI microbicidal defenses including gastric acid. We incorporated live L. casei directly in the granulation liquid, followed by granulation, extrusion, spheronization, drying and spray coating to produce dried live probiotic spheres. A blend of MCC, calcium-crosslinked alginate, and lactose was developed that gave improved live cell survival during manufacturing, and gave excellent protection from gastric acid plus rapid release in intestinal conditions. No significant loss of viability was observed in all steps except drying, which resulted in approximately 1 log loss of viable cells. Eudragit coating was used to protect dried live cells from acid, and microcrystalline cellulose (MCC) was combined with sodium alginate to achieve efficient sphere disintegration leading to rapid and complete bacterial cell release in intestinal conditions. Viability and release of L. casei was evaluated in vitro in simulated GI conditions. Uncoated spheres gave partial acid protection, but enteric coated spheres effectively protected dried probiotic LBC from acid for 2h, and subsequently released all viable cells within 1h of transfer into simulated intestinal fluid.
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Lacticaseibacillus casei , Probióticos/administración & dosificación , Resinas Acrílicas/química , Alginatos/química , Cloruro de Calcio/química , Celulosa/química , Jugo Gástrico , Ácido Glucurónico/química , Ácidos Hexurónicos/química , Secreciones Intestinales , Lactosa/químicaRESUMEN
BACKGROUND: Landmark studies in adult-onset type 1 diabetes (T1D) populations indicate that improved glycaemic control through use of intensive insulin therapy is strongly associated with reduced risk for the development of diabetes-related complications and mortality in later years. However, it is unclear whether these associations can be extrapolated to childhood-onset T1D, given the influence of other important biological and psychosocial determinants of glycaemic control, particularly during adolescence. The aims of the review are (1) to investigate the impact of early glycaemic control (within the first 2 years after diagnosis) on subsequent glycaemic trends and risk of complications during the life course of childhood-onset T1D and (2) to identify the predictors of early glycaemic control in children and young people (0-25 years). METHODS: The methods used in this study are systematic identification, review and mapping of quantitative (intervention and observational) and qualitative literature; assessing the effect and predictors of early glycaemic control in T1D (diagnosed ≤18 years) on risk or prevalence of later complications. An iterated search strategy, with no language or period restrictions, was applied to identify studies from six electronic databases. This will be supplemented by hand-searching (reference lists and contacting authors of studies meeting the inclusion criteria). Studies assessing glycaemic control within the first 2 years of diagnosis in children (at baseline) will be quality-assessed against predefined criteria and mapped descriptively to future health outcomes. Extracted data will be analysed and synthesised using narrative and forest plots or harvest plots for quantitative evidence and thematic analyses for qualitative studies. To get a deeper understanding of the predictors of early glycaemic control in reducing complications in childhood and adult life, we will integrate qualitative and quantitative evidence using mixed methods or parallel synthesis approach. DISCUSSION: These linked reviews will be the first to systematically investigate the effects of early glycaemic control and integrate both the quantitative and qualitative evidence on predictors of early glycaemic control in childhood-onset T1D in reducing future diabetes complications. This will help identify and map current research and inform development of effective future interventions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015024546.
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Glucemia/metabolismo , Complicaciones de la Diabetes/prevención & control , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Insulina/uso terapéutico , Edad de Inicio , Niño , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/complicaciones , Humanos , Proyectos de Investigación , Revisiones Sistemáticas como AsuntoRESUMEN
Live bacterial cells (LBCs) are administered orally as attenuated vaccines to deliver biopharmaceutical agents and as probiotics to improve gastrointestinal (GI) health. However, LBCs present unique formulation challenges and must survive GI antimicrobial defenses including gastric acid after administration. We present a simple new formulation concept, termed polymer film laminate (PFL). LBCs are ambient dried onto cast acid-resistant enteric polymer films that are then laminated together to produce a solid oral dosage form. LBC of a model live bacterial vaccine and a probiotic were dried directly onto a cast film of enteric polymer. The effectiveness at protecting dried cells in a simulated gastric fluid (SGF, pH 2.0) depended on the composition of enteric polymer film used, with a blend of ethylcellulose plus Eudragit L100 55 providing greater protection from acid than Eudragit alone. However, although PFL made from blended polymer films completely released low-molecular-weight dye into intestinal conditions (pH 7.0), they failed to release LBCs. In contrast, PFL made from Eudragit alone successfully protected dried probiotic or vaccine LBC from SGF for 2 h, and subsequently released all viable cells within 60 min of transfer into simulated intestinal fluid. Release kinetics could be controlled by modifying the lamination method.