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Frequent ultra-processed food (UPF) consumption is consistently associated with poor health outcomes. Little is known about UPF intake during early childhood and its effects on growth. We assessed UPF in relation to child anthropometry, bone maturation, and their nutrition profiles in a rural Ecuadorian community. Covariate-adjusted regression models estimated relationships between UPF intake from a 24-hour Food Frequency Questionnaire and three outcomes: linear growth, weight status and bone maturation. Nutrient Profiling Models (NPM) evaluated a convenience sample of UPF (n 28) consumed by children in the community. In this cohort (n 125; mean age = 33·92 (sd 1·75) months), 92·8 % consumed some form of UPF the previous day. On average, children consuming UPF four to twelve times per day (highest tertile) had lower height-for-age z-scores than those with none or a single instance of UPF intake (lowest tertile) (ß = -0·43 [se 0·18]; P = 0·02). Adjusted stunting odds were significantly higher in the highest tertile relative to the lowest tertile (OR: 3·07, 95 % CI 1·11, 9·09). Children in the highest tertile had significantly higher bone age z-scores (BAZ) on average compared with the lowest tertile (ß = 0·58 [se 0·25]; P = 0·03). Intake of savoury UPF was negatively associated with weight-for-height z-scores (ß = -0·30 [se 0·14]; P = 0·04) but positively associated with BAZ (ß = 0·77 [se 0·23]; P < 0·001). NPM indicated the availability of unhealthy UPF to children, with excessive amounts of saturated fats, free sugars and sodium. Findings suggest that frequent UPF intake during early childhood may be linked to stunted growth (after controlling for bone age and additional covariates), despite paradoxical associations with bone maturation.
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Dieta , Alimento Processado , Humanos , Criança , Pré-Escolar , Adulto , Equador , Fast Foods , Manipulação de Alimentos , AntropometriaRESUMO
Introduction: Coronavirus disease 2019 (COVID-19) has widened patient care gaps and created gaps in medical student clinical training. The care gaps are often most obvious in primary care medicine clinics (PCMCs) where residents and medical students care for a vulnerable population. Materials and Methods: We designed an outpatient telehealth program to support and monitor PCMC patients who had been diagnosed or were suspected to have COVID-19 and were confined to their homes due to public health mandated isolation. To support the program, we recruited medical student volunteers. We recruited patients from our institution's primary care clinic who were recently diagnosed with COVID-19 and were currently not hospitalized. Feasibility of the home monitoring program (HMP) was assessed and mortality data for all patients were collected. Results: Over 800 monitoring phone calls were placed during the 8-month study period to 296 patients, with an average of 2.79 calls per patient. A total of 30 medical students participated. A total of four patients died during the study period. Conclusions: Our institution was able to rapidly design and implement a COVID-19 HMP integrated with our primary care clinic to ensure continued access to care during a pandemic.
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COVID-19 , Estudantes de Medicina , Telemedicina , COVID-19/epidemiologia , Humanos , Pandemias , TelefoneRESUMO
Background Stunted growth and development is a serious global public health problem. A limited number of field measures exist that can be used to evaluate stunting and its underlying biologic mechanisms. Purpose To assess bone age using tablet-based US in young children living in a rural community in Ecuador, where stunting is prevalent, and to evaluate the associations between bone age, anthropometry, and diet. Materials and Methods From June through August 2017, tablet-based US was used to assess bone age in young children within their homes in rural Cotopaxi, Ecuador. Bone age z scores (BAZs) were assigned using the standards of Greulich and Pyle. Anthropometric data were collected using international protocols; z scores were generated from World Health Organization Child Growth Standards. Groups were compared using the Student t test. Univariate analyses and generalized linear regression modeling were applied to test the association between bone age and anthropometry, adjusting for covariates including age, sex, dietary intake, and morbidities. Results A total of 128 children (mean age, 33.9 months ± 1.8 [standard deviation]; 59 girls, 69 boys) were evaluated. Mean BAZ was -1.20 ± 1.16. Mean BAZ was lower in children with stunted growth (-1.42 ± 1.18) than in children without stunted growth (-0.98 ± 1.10, P = .04). In adjusted analysis, BAZ was associated with the following variables: height-for-age z score (ß coefficient, 0.26; 95% confidence interval [CI]: 0.05, 0.46; P = .01), female sex (ß coefficient, 0.51; 95% CI: 0.15, 0.88; P = .006), number of times eggs were consumed in the previous 24 hours (ß coefficient, 0.22; 95% CI: 0.05, 0.38; P = .009), number of times savory or salty snacks were consumed in the previous 24 hours (ß coefficient, 0.42; 95% CI: 0.15, 0.68; P = .002), and ownership of pig livestock, which was a binary variable (ß coefficient, -0.46; 95% CI: -0.82, -0.09; P = .01). Conclusion Bone age determined using tablet-based US was lower in children who had stunted growth and was associated with diet in a cohort of children living in rural Ecuador. © RSNA, 2020 See also the editorial by Dillman and Ayyala in this issue.
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Antropometria/métodos , Osso e Ossos/diagnóstico por imagem , Transtornos do Crescimento/diagnóstico por imagem , Estado Nutricional , População Rural/estatística & dados numéricos , Ultrassonografia/métodos , Pré-Escolar , Equador , Feminino , Humanos , Masculino , Estudos ProspectivosRESUMO
The Lulun Project, a randomized controlled trial conducted in 2015, found that one egg per day for 6 months during early complementary feeding reduced stunting by 47% and increased linear growth by 0.63 length-for-age Z (LAZ). This follow-up cohort study (Lulun Project II) aimed to test whether the growth effect remained in the egg intervention group compared with the control group after approximately 2 years. Mothers or caregivers from the Lulun Project were recontacted and recruited for this study. Enumerators collected data on socio-economic and demographic factors, 24-hr frequency of dietary intakes, morbidities, and anthropometric measures of height, weight, and head circumference using World Health Organization protocols. Statistical analyses followed the same analytical plan as Lulun Project, applying generalized linear models and regression modelling to test group differences in height-for-age z (HAZ) from LAZ at Lulun Project endline, and structural equation modelling for mediation. One hundred thirty-five mother-child dyads were included in Lulun II, with 11% losses to follow-up from endline Lulun Project. Growth faltering across all children was evident with HAZ -2.07 ± 0.91 and a stunting prevelance of 50%. Regression modelling showed no difference between egg and control groups for the HAZ outcome and other anthropometric outcomes, and significant declines in HAZ from endline Lulun Project in the egg intervention are compared with control groups. Current dietary egg intake, however, was associated with reduced growth faltering in HAZ from Lulun Project endline to Lulun Project II, independent of group assignment and through mediation, explaining 8.8% of the total effect. Findings suggest the need for a longer intervention period and ongoing nutrition support to young children during early childhood.
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Antropometria/métodos , Estatura , Desenvolvimento Infantil , Dieta/métodos , Ovos , Transtornos do Crescimento/epidemiologia , Peso Corporal , Pré-Escolar , Equador/epidemiologia , Feminino , Seguimentos , Transtornos do Crescimento/prevenção & controle , Humanos , Estudos Longitudinais , MasculinoRESUMO
BACKGROUND: Dietary preferences vary depending on cancer type. The purpose of this study was to report dietary intervention preferences and a study program evaluation from post-treatment head and neck cancer survivors participating in a dietary intervention. METHODS: Between January 2015 and August 2016, 24 head and neck cancer survivors participated in a 12-week randomized clinical dietary intervention trial that promoted weekly consumption of 2.5 cups of cruciferous vegetables and 3.5 cups of green leafy vegetables. At study completion, survivors completed a preferences survey and a study program evaluation to probe interests and improvement aspects for planning future dietary intervention trials. Descriptive statistics (means and frequencies) were generated for multiple choice question responses. Responses to open-ended questions were recorded and grouped based on themes, and verified by quality assurance checks by a second study team member. RESULTS: Twenty-three survivors completed the preferences and evaluation surveys (response rate 96%). Overall, most participants reported a preference for one-on-one telephone counseling from a registered dietitian nutritionist before beginning treatment. Ninety-six percent of participants ranked the overall study program as "very good" to "excellent," and all agreed the objectives of the study were clear, the study staff was helpful and easy to contact, and the registered dietitian nutritionist was knowledgeable. CONCLUSIONS: Future research and dietary intervention planning for head and neck cancer survivors should focus on strategies to promote one-on-one telephone or other distance-based counseling combined with face-to-face visits, according to survivor preference.
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Sobreviventes de Câncer/estatística & dados numéricos , Dieta/métodos , Neoplasias de Cabeça e Pescoço/complicações , Desnutrição/dietoterapia , Desnutrição/etiologia , Avaliação de Programas e Projetos de Saúde/métodos , Adulto , Idoso , Aconselhamento/métodos , Estudos de Viabilidade , Feminino , Preferências Alimentares , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente/estatística & dados numéricos , Projetos Piloto , VerdurasRESUMO
A protocol is established for the high-yielding synthesis of F-BODIPYs involving non-anhydrous reagents and not requiring precautions to exclude moisture. This simple and robust strategy simply requires a second addition of NEt3 and BF3·OEt2, midway through the reaction period. The ratio and amounts of NEt3 and BF3·OEt2 used in each aliquot are critical to success (6 : 9 for each aliquot). The protocol can be completed using bench-dry apparatus, without need to achieve and maintain anhydrous conditions or solvents.
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The United States Food and Drug Administration recently removed the requirement for a General Safety Test (GST) for biologics in the Code of Federal Regulations (21 CFR 610.11). The GST, as well as abnormal toxicity (European Pharmacopeia) and innocuity tests (World Health Organization), were designed to test for extraneous toxic contaminants on each product lot intended for human use. Tests require one-week observations for general health and weight following injection of specified volumes of product batches into guinea pigs and mice. At the volumes specified, dose-related toxicity may result when the product is pharmacologically active in rodents. With vaccines, required doses may be > 3 logs higher than intended human dose on a weight-adjusted basis and if an immune modulatory adjuvant is included, systemic immune hyperactivation may cause toxicity. Herein, using the CpG/alum adjuvant combination we evaluated the different test protocols and showed their unsuitability for this adjuvant combination.
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Produtos Biológicos/normas , Qualidade de Produtos para o Consumidor/legislação & jurisprudência , Qualidade de Produtos para o Consumidor/normas , Aprovação de Drogas/legislação & jurisprudência , Licenciamento/legislação & jurisprudência , Animais , Cobaias , Humanos , Camundongos , Testes de Toxicidade/métodos , Estados Unidos , United States Food and Drug Administration , Organização Mundial da SaúdeRESUMO
OBJECTIVE: We aimed to review gastric dysmotility in critically ill children: 1) its pathophysiology, with a focus on critical care diseases and therapies that affect gastric motility, 2) diagnostic methodologies, and 3) current and future potential therapies. DATA SOURCES: Eligible studies were identified from PubMed and MEDLINE. STUDY SELECTION: Literature search included the following key terms: "gastric emptying," "gastric motility/dysmotility," "gastrointestinal motility/dysmotility," "nutrition intolerance," and "gastric residual volume." DATA EXTRACTION: Studies since 1995 were extracted and reviewed for inclusion by the authors related to the physiology, pathophysiology, diagnostic methodologies, and available therapies for gastric emptying. DATA SYNTHESIS: Delayed gastric emptying, a common presentation of gastric dysmotility, is present in up to 50% of critically ill children. It is associated with the potential for aspiration, ventilator-associated pneumonia, and inadequate delivery of enteral nutrition and may affect the efficacy of enteral medications, all of which may be result in poor patient outcomes. Gastric motility is affected by critical illness and its associated therapies. Currently available diagnostic tools to identify gastric emptying at the bedside have not been systematically studied and applied in this cohort. Gastric residual volume measurement, used as an indirect marker of delayed gastric emptying in PICUs around the world, may be inaccurate. CONCLUSIONS: Gastric dysmotility is common in critically ill children and impacts patient safety and outcomes. However, it is poorly understood, inadequately defined, and current therapies are limited and based on scant evidence. Understanding gastric motility and developing accurate bedside measures and novel therapies for gastric emptying are highly desirable and need to be further investigated.
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Esvaziamento Gástrico/fisiologia , Gastropatias/diagnóstico , Gastropatias/fisiopatologia , Estômago/fisiopatologia , Glicemia/fisiologia , Criança , Cuidados Críticos , Estado Terminal , Esvaziamento Gástrico/efeitos dos fármacos , Humanos , Hiperglicemia/fisiopatologia , Inflamação/fisiopatologia , Respiração Artificial/efeitos adversos , Gastropatias/terapiaRESUMO
BACKGROUND: Multiple studies have highlighted the inequities minority and Indigenous children face when accessing health care. Health and wellbeing are positively impacted when Indigenous children are educated and receive care in their maternal language. However, less is known about the association between minority or Indigenous language use and child development risks and outcomes. In this study, we provide global estimates of development risks and assess the associations between minority or Indigenous language status and early child development using the ten-item Early Child Development Index (ECDI), a tool widely used for global population assessments in children aged 3-4 years. METHODS: We did a secondary analysis of cross-sectional data from 65 UNICEF Multiple Indicator Cluster Surveys (MICS) containing the ECDI from 2009-19 (waves 4-6). We included individual-level data for children aged 2-4 years (23-60 months) from datasets with ECDI modules, for surveys that captured the language of the respondent, interview, or head of household. The Expanded Graded Intergenerational Disruption Scale was used to classify household languages as dominant versus minority or Indigenous at the country level. Our primary outcome was on-track overall development, defined per UNICEF's guidelines as development being on track for at least three of the four ECDI domains (literacy-numeracy, learning, physical, and socioemotional). We performed logistic regression of pooled, weighted ECDI scores, aggregated by language status and adjusting for the covariables of child sex, child nutritional status (stunting), household wealth, maternal education, developmental support by an adult caregiver, and country-level early child education proportion. Regression analyses were done for all children aged 3-4 years with ECDI results, and separately for children with functional disabilities and ECDI results. FINDINGS: 65 MICS datasets were included. 186 393 children aged 3-4 years had ECDI and language data, corresponding to an estimated represented population of 34 714 992 individuals. Estimated prevalence of on-track overall development as measured by ECDI scores was 65·7% (95% CI 64·2-67·2) for children from a minority or Indigenous language-speaking household, and 76·6% (75·7-77·4) for those from a dominant language-speaking household. After adjustment, dominant language status was associated with increased odds of on-track overall development (adjusted OR 1·54, 95% CI 1·40-1·71), which appeared to be largely driven by significantly increased odds of on-track development in the literacy-numeracy and socioemotional domains. For the represented population aged 2-4 years (n=11 465 601), the estimated prevalence of family-reported functional disability was 3·6% (95% CI 3·0-4·4). For the represented population aged 3-4 years with a functional disability (n=292 691), language status was not associated with on-track overall development (adjusted OR 1·02, 95% CI 0·43-2·45). INTERPRETATION: In a global dataset, children speaking a minority or Indigenous language were less likely to have on-track ECDI scores than those speaking a dominant language. Given the strong positive benefits of speaking an Indigenous language on the health and development of Indigenous children, this disparity is likely to reflect the sociolinguistic marginalisation faced by speakers of minority or Indigenous languages as well as differences in the performance of ECDI in these languages. Global efforts should consider performance of measures and monitor developmental data disaggregated by language status to stimulate efforts to address this disparity. FUNDING: None. TRANSLATIONS: For the Spanish, Kaqchikel and K'iche' translations of the abstract see Supplementary Materials section.
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Desenvolvimento Infantil , Povos Indígenas , Idioma , Grupos Minoritários , Humanos , Estudos Transversais , Fatores Socioeconômicos , Inquéritos e Questionários , Pré-EscolarRESUMO
Background: An increasing proportion of the population in the United States have limited English proficiency (LEP). Hospitals that receive federal funding must offer interpreter services. However, access is often lacking for patients. Patients with LEP are at higher risk for adverse events, and the Emergency Department is a particularly high-risk environment for these events. Methods: This quality improvement initiative took place from April 2021 to August 2022 in an urban, tertiary care Pediatric Emergency Department. A driver diagram informed four Plan-Do-Study-Act cycles, and data were collected through medical record review, patient surveys, and staff surveys. We tracked outcomes using run and control chart data. Results: During the study period, the proportion of patients with LEP reporting "always" having an interpreter was unchanged (no centerline shift-control chart rules). Documentation of interpreter use for encounters with patients with LEP improved. Preferred language documentation and documentation of the need for an interpreter in the electronic medical record showed no change. Process measure data for staff-reported use of professional interpreters significantly increased, and the use of ad hoc interpreters decreased significantly. Length of stay did not change for English or LEP patients. Conclusions: This quality improvement initiative improved appropriate documentation of LEP and decreased use of nonqualified interpreters, although no change occurred in the proportion of patients who reported always having an interpreter. Patient satisfaction was unaffected.
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A 14-Year-Old Girl with Dyspnea and Chest PainA 14-year-old girl presented for evaluation of shortness of breath and chest pain after recent travel to the Caribbean. How do you approach the evaluation, and what is the diagnosis?
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Dor no Peito , Dispneia , Feminino , Humanos , Adolescente , Tórax , Diagnóstico Diferencial , Região do CaribeRESUMO
Importance: Many US children and adolescents with mental and behavioral health (MBH) conditions do not access MBH services. One contributing factor is limited insurance coverage, which is influenced by state MBH insurance parity legislation. Objective: To investigate the association of patient-level factors and the comprehensiveness of state MBH insurance legislation with perceived poor access to MBH care and perceived inadequate MBH insurance coverage for US children and adolescents. Design, Setting, and Participants: This retrospective cross-sectional study was conducted using responses by caregivers of children and adolescents aged 6 to 17 years with MBH conditions in the National Survey of Children's Health and State Mental Health Insurance Laws Dataset from 2016 to 2019. Data analyses were conducted from May 2022 to January 2024. Exposure: MBH insurance legislation comprehensiveness defined by State Mental Health Insurance Laws Dataset (SMHILD) scores (range, 0-7). Main Outcomes and Measures: Perceived poor access to MBH care and perceived inadequacy of MBH insurance were assessed. Multivariable regression models adjusted for individual-level characteristics. Results: There were 29â¯876 caregivers of children and adolescents with MBH conditions during the study period representing 14â¯292â¯300 youths nationally (7â¯816â¯727 aged 12-17 years [54.7%]; 8â¯455â¯171 male [59.2%]; 292â¯543 Asian [2.0%], 2â¯076â¯442 Black [14.5%], and 9â¯942â¯088 White [69.6%%]; 3â¯202â¯525 Hispanic [22.4%]). A total of 3193 caregivers representing 1â¯770â¯492 children and adolescents (12.4%) perceived poor access to MBH care, and 3517 caregivers representing 1â¯643â¯260 of 13â¯175â¯295 children and adolescents (12.5%) perceived inadequate MBH insurance coverage. In multivariable models, there were higher odds of perceived poor access to MBH care among caregivers of Black (adjusted odds ratio [aOR], 1.35; 95% CI, 1.04-1.75) and Asian (aOR, 1.69; 95% CI, 1.01-2.84) compared with White children and adolescents. As exposures to adverse childhood experiences (ACEs) increased, the odds of perceived poor access to MBH care increased (aORs ranged from 1.68; 95%, CI 1.32-2.13 for 1 ACE to 4.28; 95% CI, 3.17-5.77 for ≥4 ACEs compared with no ACEs). Compared with living in states with the least comprehensive MBH insurance legislation (SMHILD score, 0-2), living in states with the most comprehensive legislation (SMHILD score, 5-7) was associated with lower odds of perceived poor access to MBH care (aOR, 0.79; 95% CI, 0.63-0.99), while living in states with moderately comprehensive legislation (score, 4) was associated with higher odds of perceived inadequate MBH insurance coverage (aOR, 1.23; 95% CI, 1.01-1.49). Conclusions and Relevance: In this study, living in states with the most comprehensive MBH insurance legislation was associated with lower odds of perceived poor access to MBH care among caregivers for children and adolescents with MBH conditions. This finding suggests that advocacy for comprehensive mental health parity legislation may promote improved child and adolescent access to MBH services.
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Acessibilidade aos Serviços de Saúde , Cobertura do Seguro , Serviços de Saúde Mental , Humanos , Criança , Adolescente , Acessibilidade aos Serviços de Saúde/legislação & jurisprudência , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Estudos Transversais , Masculino , Feminino , Estados Unidos , Cobertura do Seguro/estatística & dados numéricos , Cobertura do Seguro/legislação & jurisprudência , Estudos Retrospectivos , Serviços de Saúde Mental/legislação & jurisprudência , Serviços de Saúde Mental/estatística & dados numéricos , Seguro Saúde/estatística & dados numéricos , Seguro Saúde/legislação & jurisprudência , Transtornos MentaisRESUMO
BACKGROUND: Hfq is an RNA chaperone protein that has been broadly implicated in sRNA function in bacteria. Here we describe the construction and characterization of a null allele of the gene that encodes the RNA chaperone Hfq in Shewanella oneidensis strain MR-1, a dissimilatory metal reducing bacterium. RESULTS: Loss of hfq in S. oneidensis results in a variety of mutant phenotypes, all of which are fully complemented by addition of a plasmid-borne copy of the wild type hfq gene. Aerobic cultures of the hfq∆ mutant grow more slowly through exponential phase than wild type cultures, and hfq∆ cultures reach a terminal cell density in stationary phase that is ~2/3 of that observed in wild type cultures. We have observed a similar growth phenotype when the hfq∆ mutant is cultured under anaerobic conditions with fumarate as the terminal electron acceptor, and we have found that the hfq∆ mutant is defective in Cr(VI) reduction. Finally, the hfq∆ mutant exhibits a striking loss of colony forming units in extended stationary phase and is highly sensitive to oxidative stress induced by H2O2 or methyl viologen (paraquat). CONCLUSIONS: The hfq mutant in S. oneidensis exhibits pleiotropic phenotypes, including a defect in metal reduction. Our results also suggest that hfq mutant phenotypes in S. oneidensis may be at least partially due to increased sensitivity to oxidative stress.
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Fator Proteico 1 do Hospedeiro/deficiência , Fator Proteico 1 do Hospedeiro/metabolismo , Viabilidade Microbiana , Shewanella/crescimento & desenvolvimento , Shewanella/genética , Aerobiose , Anaerobiose , Carga Bacteriana , Cromo/metabolismo , Contagem de Colônia Microbiana , Deleção de Genes , Teste de Complementação Genética , Fator Proteico 1 do Hospedeiro/genética , Oxirredução , Estresse Oxidativo , Shewanella/fisiologiaRESUMO
The COVID-19 pandemic disrupted medical education worldwide, leading medical students to organize response initiatives. This paper summarizes the Washington University Medical Student COVID-19 Response (WUMS-CR) and shares lessons to guide future initiatives. We used a three-principle framework of community needs assessment, faculty mentorship, and partnership with pre-existing organizations to address needs in St. Louis, including contact tracing and childcare. In total, over 12,000 h were volunteered across 15+ projects. Overall, student response initiatives should use appropriate frameworks to guide projects and should capitalize on volunteer participation, speed and flexibility, and the diversity of student interests and skills for maximal impact.
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INTRODUCTION: Bull-related injuries are commonly observed in rural areas of India as result of the animal's use in sporting events as well as for agricultural purposes. These patients need early resuscitation due to complications from severe injuries. Previous work examining the epidemiology of bull-related injuries is limited, with most studies focusing on injuries in Spain and Latin America. There is scant literature examining the prevalence of such injuries in India. The objective of this study was to evaluate the demographic and clinical characteristics of bull-related injuries at a hospital in Tamil Nadu, India. METHODS: This was a prospective, observational study of patients who presented to an emergency department (ED) in Madurai, India, with a reported history of bull-related injuries between June 2017 and March 2019. We recorded information about patient demographics, location of injury, disposition, initial Injury Severity Score (ISS), and transport time. RESULTS: Our sample included a total of 42 patients. Almost a third of patients who presented were between the ages of 20-30 years (31%, n = 13), and most were male (86%, n = 36). Approximately 59% of patients (n = 25) had provoked injuries, occurring as a result of active participation during sporting activities. Injuries to the trunk were most common (55%, n = 23), followed by injuries to the perineum (19%, n = 19). The majority of patients (59.5%) had penetrating injuries (n = 25), The mean ISS was 10.1 (standard deviation 6.3). Five (12%) patients had a complication after injury including intra-abdominal abscess formation, peritonitis, and sepsis. Two patients died as a result of septicemia from peritonitis. CONCLUSION: Bull-related injuries may result in significant morbidity and mortality. Education of the population about the dangers of bull injuries from sporting events and the need for early transportation to the ED have the potential for significant reduction in morbidity and mortality.
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Serviço Hospitalar de Emergência/estatística & dados numéricos , Ferimentos Penetrantes/epidemiologia , Adulto , Animais , Bovinos , Feminino , Humanos , Índia/epidemiologia , Escala de Gravidade do Ferimento , Masculino , Prevalência , Estudos Prospectivos , Estudos Retrospectivos , Ferimentos Penetrantes/terapia , Adulto JovemRESUMO
Trumenba (MenB-FHbp; bivalent rLP2086), the first meningococcal serogroup B vaccine approved in the United States and subsequently approved in Europe, Canada, and Australia, is well-characterized. Pfizer devised a control strategy approach by using a simplified control strategy wheel for Trumenba based on International Council for Harmonisation (ICH) Q8 (R2), Q9, Q10, and Q11 guidelines, which provide complementary guidance on pharmaceutical development, quality risk management, quality systems, and development and manufacture of drug substances, respectively. These guidelines ensure product quality using a scientific and risk-based approach. Trumenba contains two factor H binding proteins (FHbps), one from each of the two FHbp subfamilies (A and B), adsorbed onto aluminum phosphate. Trumenba manufacturing processes are complicated by the recombinant protein expression of Subfamily A and B proteins and the nature of the drug product (suspension in syringes); the latter also introduces challenges in controlling product critical quality attributes during the development process. In such complex systems, the control strategy is critical to ensuring consistent desired product quality; it also supports the regulatory requirement of continued improvement through continuous process verification and aids regulatory filing. This article describes Pfizer's approach toward robust control strategy development, built on product and process understanding, and links control strategy to regulatory document sections and flow of controls. Specifically, an approach is presented on product quality attribute criticality determination based on safety and efficacy and on an understanding of process parameter criticality. This was achieved by studying the impact of the approach on product quality attributes to define process parameter and in-process controls. This approach is further explained through Trumenba case studies, highlighting specific quality attributes and the associated controls implemented, and provides a holistic view of controls employed for both drug substance and drug product.
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Desenvolvimento de Medicamentos/tendências , Indústria Farmacêutica/tendências , Meningite Meningocócica/prevenção & controle , Vacinas Meningocócicas/administração & dosagem , Vacinas Meningocócicas/síntese química , Neisseria meningitidis Sorogrupo B/efeitos dos fármacos , Desenvolvimento de Medicamentos/métodos , Desenvolvimento de Medicamentos/normas , Indústria Farmacêutica/métodos , Indústria Farmacêutica/normas , Humanos , Meningite Meningocócica/epidemiologia , Vacinas Meningocócicas/normas , Neisseria meningitidis Sorogrupo B/fisiologiaRESUMO
PURPOSE OF REVIEW: This review summarizes a selection of epidemiologic research assessing the associations between carbohydrate intake and cancer incidence and survival. Evidence for plausible biological mechanisms is also considered. RECENT FINDINGS: The mechanistic paradigm explaining the relationship between carbohydrates and cancer risk has been contested by numerous observational studies. Carbohydrates have conventionally been ascribed a deleterious role in the field of cancer research due to previous preclinical findings. A breadth of studies suggests that complex carbohydrate intake is inversely associated with risk of a number of cancer types. Data from studies assessing simple carbohydrates and cancer risk are mixed. Furthermore, recommendations for subsequent studies are framed.
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Carboidratos da Dieta/efeitos adversos , Neoplasias/epidemiologia , Neoplasias/etiologia , Fibras na Dieta , Glucose/metabolismo , Índice Glicêmico , Humanos , Incidência , Neoplasias/prevenção & controle , Fatores de RiscoAssuntos
Aleitamento Materno , Fórmulas Infantis , Lactente , Humanos , Feminino , Alimentos FormuladosRESUMO
BACKGROUND: Higher intakes of cruciferous vegetables (CVs) and green leafy vegetables (GLVs) in observational studies are associated with improvements in survival and cancer-related biomarkers in patients diagnosed with head and neck cancer (HNC). These results have yet to be corroborated in a randomized clinical trial (RCT). OBJECTIVE: Determine the feasibility of implementing a 12-week RCT to increase CV and GLV intake in posttreatment HNC survivors. DESIGN AND PARTICIPANTS: This was a two-arm RCT conducted among 24 posttreatment HNC survivors. Survivors were recruited from a southeastern, National Cancer Institute-designated Comprehensive Cancer Center between January 2015 and September 2016. INTERVENTION: There were two groups: (1) an experimental group (n=12) receiving weekly 15- to 30-minute telephone dietary counseling from a registered dietitian nutritionist stressing 2.5 cups per week CVs and 3.5 cups per week GLVs, and (2) an attention control group (n=12) receiving weekly 15- to 30-minute telephone dietary counseling from a registered dietitian nutritionist focusing on general healthy eating for cancer survivors. Participants completed a baseline survey, three 24-hour dietary recalls, phlebotomy, and anthropometric measures prior to randomization and at the end of the 12-week study period. The experimental group also completed weekly vegetable record recalls. MAIN OUTCOME MEASURES: Primary outcomes included feasibility, recruitment, retention, adherence, and safety. Secondary outcomes included inflammatory markers and carotenoids. STATISTICAL ANALYSES PERFORMED: Descriptive statistics were generated for demographic, epidemiological, and clinical variables as well as the primary feasibility outcomes. Between- and within-group comparisons of mean serum cytokine and carotenoid levels were performed using appropriate statistical tests depending on their respective distributions for the purpose of generating preliminary effect sizes. RESULTS: Overall, 350 incident HNC cases were screened for eligibility, and 98 were eligible for study participation. Reasons for ineligibility and exclusion included deceased (n=93); wrong or inactive telephone numbers, or unable to be reached, or lost to follow-up (n=93); not meeting inclusion criteria (n=39); and too ill to participate (n=27). Of the 98 eligible HNC cases, 24 agreed to participate, for an enrollment rate of 25%. The most common reason for nonparticipation was distance (n=48), as participants were asked to report for two on-site assignments. The retention rate was 96%. Mean intervention adherence rates for weekly goals were 67% CV, 74% GLV, and 71% overall. Completion rate of weekly counseling calls was 90%. The experimental group reported an overall mean increase of 5.5 cups GLV and 3.5 cups CV per week from baseline intake, respectively. No significant between- or within-arm differences were observed for inflammatory markers or carotenoids. CONCLUSION: A posttreatment intervention aimed at increasing CV and GLV intake in HNC survivors is feasible. A larger RCT is needed to assess the efficacy of this intervention on disease outcomes.