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1.
Sci Rep ; 14(1): 2279, 2024 01 27.
Artigo em Inglês | MEDLINE | ID: mdl-38280894

RESUMO

Time-based prospective memory (TBPM) involves remembering to perform actions at specific times in the future. Several studies suggest that monetary consequences improve prospective remembering; however, the effect of monetary consequences on strategic time monitoring (i.e., clock-checking behaviour) in TBPM is still unknown. The present study investigated how the monetary costs on clock-checking affected TBPM accuracy and strategic time monitoring. Participants performed an ongoing lexical decision task while carrying out a TBPM task every two minutes. Motivational incentives were manipulated across three experimental conditions: a single-cost condition in which missed TBPM responses led to monetary deductions, a double-cost condition in which both missed responses and time monitoring led to monetary deductions, and a control condition with no monetary deductions. Overall, the findings indicated that monetary costs on clock-checking prompted more parsimonious strategic time monitoring behaviour, which negatively impacted TBPM accuracy. These results emphasize the importance of weighing the motivational aspects involved in strategic monitoring, shedding light on the complex relationship between clock-checking behaviour, its consequences, and TBPM performance.


Assuntos
Memória Episódica , Percepção do Tempo , Humanos , Tempo , Cognição , Percepção do Tempo/fisiologia , Motivação
2.
Curr Opin Psychol ; 55: 101765, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38103277

RESUMO

A better understanding of age-related differences in judgment and decision making is important from both theoretical and applied perspectives. In this review, we focus on value-based decisions across adulthood and specifically on how loss aversion (a relatively stronger weight of losses than gains on decisions) and the relative motivational impact of gains and losses may change with aging. In doing so, we will also cover recent findings about the effects of gain or loss incentives on performance in cognitive tasks that involve attention, learning, and remembering. We point out open questions and critical moderating variables for future theorizing and research.


Assuntos
Tomada de Decisões , Julgamento , Adulto , Humanos , Motivação , Aprendizagem , Envelhecimento
3.
BMC Psychiatry ; 23(1): 722, 2023 10 06.
Artigo em Inglês | MEDLINE | ID: mdl-37803337

RESUMO

BACKGROUND: Prospective memory is important for our health and independence but declines with age. Hence, interventions to enhance prospective memory, for example by providing an incentive, may promote healthy ageing. The neuroanatomical correlates of prospective memory and the processing of incentive-related prospective memory changes in older adults are not fully understood. In an fMRI study, we will therefore test whether incentives improve prospective memory in older adults and how prospective memory is processed in the brain in general, and when incentives are provided. Since goals and interests change across adulthood, avoiding losses is becoming more important for older adults than achieving gains. We therefore posit that loss-related incentives will enhance prospective memory, which will be subserved by increased prefrontal and midbrain activity. METHODS: We will include n = 60 healthy older adults (60-75 years of age) in a randomized, single-blind, and parallel-group study. We will acquire 7T fMRI data in an incentive group and a control group (n = 30 each, stratified by education, age, and sex). Before and after fMRI, all participants will complete questionnaires and cognitive tests to assess possible confounders (e.g., income, personality traits, sensitivity to reward or punishment). DISCUSSION: The results of this study will clarify whether loss-related incentives can enhance prospective memory and how any enhancement is processed in the brain. In addition, we will determine how prospective memory is processed in the brain in general. The results of our study will be an important step towards a better understanding of how prospective memory changes when we get older and for developing interventions to counteract cognitive decline.


Assuntos
Memória Episódica , Motivação , Humanos , Idoso , Adulto , Imageamento por Ressonância Magnética , Método Simples-Cego , Encéfalo/diagnóstico por imagem , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Microb Ecol ; 86(4): 3097-3110, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37878053

RESUMO

Drylands comprise one-third of Earth's terrestrial surface area and support over two billion people. Most drylands are projected to experience altered rainfall regimes, including changes in total amounts and fewer but larger rainfall events interspersed by longer periods without rain. This transition will have ecosystem-wide impacts but the long-term effects on microbial communities remain poorly quantified. We assessed belowground effects of altered rainfall regimes (+ 65% and -65% relative to ambient) at six sites in arid and semi-arid Australia over a period of three years (2016-2019) coinciding with a significant natural drought event (2017-2019). Microbial communities differed significantly among semi-arid and arid sites and across years associated with variation in abiotic factors, such as pH and carbon content, along with rainfall. Rainfall treatments induced shifts in microbial community composition only at a subset of the sites (Milparinka and Quilpie). However, differential abundance analyses revealed that several taxa, including Acidobacteria, TM7, Gemmatimonadates and Chytridiomycota, were more abundant in the wettest year (2016) and that their relative abundance decreased in drier years. By contrast, the relative abundance of oligotrophic taxa such as Actinobacteria, Alpha-proteobacteria, Planctomycetes, and Ascomycota and Basidiomycota, increased during the prolonged drought. Interestingly, fungi were shown to be more sensitive to the prolonged drought and to rainfall treatment than bacteria with Basidiomycota mostly dominant in the reduced rainfall treatment. Moreover, correlation network analyses showed more positive associations among stress-tolerant dominant taxa following the drought (i.e., 2019 compared with 2016). Our result indicates that such stress-tolerant taxa play an important role in how whole communities respond to changes in aridity. Such knowledge provides a better understanding of microbial responses to predicted increases in rainfall variability and the impact on the functioning of semi-arid and arid ecosystems.


Assuntos
Quitridiomicetos , Microbiota , Humanos , Ecossistema , Secas , Microbiologia do Solo , Austrália , Solo/química , Bactérias/genética
5.
J Gerontol B Psychol Sci Soc Sci ; 78(1): 51-61, 2023 01 28.
Artigo em Inglês | MEDLINE | ID: mdl-35972470

RESUMO

OBJECTIVES: This research addresses how younger and older adults' decisions and evaluations of gains and losses are affected by the way in which monetary incentives are provided. We compared 2 common incentive schemes in decision making: pay one (only a single decision is incentivized) and pay all (incentives across all decisions are accumulated). METHOD: Younger adults (18-36 years; n = 147) and older adults (60-89 years; n = 139) participated in either a pay-one or pay-all condition and made binary choices between two-outcome monetary lotteries in gain, loss, and mixed domains. We analyzed participants' decision quality, risk taking, and psychometric test scores. Computational modeling of cumulative prospect theory served to measure sensitivity to outcomes and probabilities, loss aversion, and choice sensitivity. RESULTS: Decision quality and risk aversion were higher in the gain than mixed or loss domain, but unaffected by age. Loss aversion was higher, and choice sensitivity was lower in older than younger adults. In the pay-one condition, the value functions were more strongly curved, and choice sensitivity was higher than in the pay-all condition. DISCUSSION: An opportunity of accumulating incentives has similar portfolio effects on younger and older adults' decisions. In general, people appear to decide less cautiously in pay-all than pay-one scenarios. The impact of different incentive schemes should be carefully considered in aging and decision research.


Assuntos
Envelhecimento , Motivação , Humanos , Idoso , Adulto , Probabilidade , Afeto , Tomada de Decisões , Assunção de Riscos
6.
Acta Paediatr ; 112(1): 63-68, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-36177808

RESUMO

AIM: The aim of this study was to assess the resuscitators' opinions of the usefulness and clinical value of using a respiratory function monitor (RFM) when resuscitating extremely preterm infants with positive pressure ventilation. METHODS: The link to an online survey was sent to 106 resuscitators from six countries who were involved in a multicentre trial that compared the percentage of inflations within a predefined target range with and without the RFM. The resuscitators were asked to assess the usefulness and clinical value of the RFM. The survey was online for 4 months after the trial ended in May 2019. RESULTS: The survey was completed by 74 (70%) resuscitators of which 99% considered the RFM to be helpful during neonatal resuscitation and 92% indicated that it influenced their decision-making. The majority (76%) indicated that using the RFM improved their practice and made resuscitation more effective, even when the RFM was not available. Inadequate training was the key issue that limited the effectiveness of the RFM: 45% felt insufficiently trained, and 78% felt more training in using and interpreting the RFM would have been beneficial. CONCLUSION: Resuscitators considered the RFM to be helpful to guide neonatal resuscitation, but sufficient training was required to achieve the maximum benefit.


Assuntos
Recém-Nascido Prematuro , Ressuscitação , Recém-Nascido , Humanos
7.
Sci Rep ; 12(1): 8940, 2022 05 27.
Artigo em Inglês | MEDLINE | ID: mdl-35624305

RESUMO

Head development is a surrogate for brain development in infants and is related to neurocognitive outcome. There is only limited knowledge on early extra-uterine head shape and size assessment in very preterm infants. Here, 26 very preterm infants with a mean gestational age of 29.1 ± 2.2 weeks and a mean birth weight of 1273.8 ± 427.7 g underwent serial stereophotogrammetric 3D head imaging in weekly intervals from birth to term-equivalent age. The main outcome was the longitudinal assessment of the 'physiological' preterm head development with cephalometric size (head circumference, cranial volume) and shape parameters (cranial index, cranial vault asymmetry index) according to chronological and postmenstrual age (PMA). Potential clinical risk factors for the development of an abnormal low cranial index (dolichocephaly) were analysed. In serial measurements of 26 infants, the estimated head volume (95% confidence interval) increased from 244 (226-263) cm3 at 28 weeks PMA to 705 (688-721) cm3 at 40 weeks PMA. Moderate or severe dolichocephaly occurred in 21/26 infants (80.8%). Cranial index decreased over time (72.4%; 70.7-74 95% confidence interval). Brachycephaly and plagiocephaly were uncommon. No risk factors for severe dolichocephaly were identified. Our study shows that early detection of head shape and size anomalies utilizing 3D stereophotogrammetry is feasible and safe even in very preterm infants < 1500 g and/or < 32 weeks. 3D stereophotogrammetry could be used for timely identification of infants at risk for head shape anomalies. No specific risk factors for head shape anomalies were identified, especially not mode and duration of respiratory support.


Assuntos
Craniossinostoses , Doenças do Prematuro , Craniossinostoses/diagnóstico , Feminino , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Fotogrametria
8.
J Exp Psychol Gen ; 151(6): 1358-1376, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34843371

RESUMO

A central tenet of the adaptive-memory framework is that memory has not merely evolved to help us relive the past but to prepare us for the future. In reciprocal social exchange, for instance, people must learn from previous experiences to approach cooperators and to avoid cheaters. In this sense, adaptive memory is inherently prospective. The present research is the first to test this central assumption of the adaptive-memory framework. In Experiments 1 and 2, participants played a Prisoner's Dilemma game and encountered cheating, cooperating, and neutral partners. The faces of these partners later reappeared during an event-based prospective-memory task. Participants showed better prospective-memory performance for cooperator and cheater faces than for neutral control faces. Multinomial processing-tree modeling served to separate the prospective component (remembering that an action needs to be performed) from the retrospective component (recognizing the target faces) of prospective memory. Superior prospective-memory performance for cooperator and cheater faces was attributable to a stronger prospective component, whereas the retrospective component remained unaffected. Experiment 3 showed that emotional descriptions of targets were ineffective in increasing prospective memory, suggesting that emotional valence alone cannot account for the prospective-memory advantage found in Experiments 1 and 2. The results suggest that cooperating with someone or being cheated by someone has a strong impact on future-oriented cognition. Enhanced prospective memory for cooperator and cheater faces may have an important function for maintaining reciprocal relationships and for avoiding cheaters. (PsycInfo Database Record (c) 2022 APA, all rights reserved).


Assuntos
Memória Episódica , Emoções , Humanos , Rememoração Mental , Dilema do Prisioneiro , Estudos Retrospectivos
9.
PLOS Glob Public Health ; 2(5): e0000411, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36962219

RESUMO

Incomplete and absent doses in routine childhood vaccinations are of major concern. Health systems in low- and middle-income countries (LMIC), in particular, often struggle to enable full vaccination of children, which affects their immunity against communicable diseases. Data on child vaccination cards from a cross-sectional primary survey with 1,967 households were used to assess the vaccination status. The association of timely postnatal care (PNC) and the place of delivery with any-dose (at least one dose of each vaccine) and full vaccination of children between 10-20 months in Bihar, India, was investigated. Bivariate and multivariable logistic regression models were used. The vaccines included targeted tuberculosis, hepatitis B, polio, diphtheria/pertussis/tetanus (DPT) and measles. Moreover predictors for perinatal health care uptake were analysed by multivariable logistic regression. Of the 1,011 children with card verification, 47.9% were fully vaccinated. Timely PNC was positively associated with full vaccination (adjusted odds ratio (aOR) 1.48, 95% confidence interval (CI) 1.06-2.08) and with the administration of at least one dose (any-dose) of polio vaccine (aOR 3.37 95% CI 1.79-6.36), hepatitis B/pentavalent vaccine (aOR 2.11 95% CI 1.24-3.59), and DPT/pentavalent vaccine (aOR 2.29 95% CI 1.35-3.88). Additionally, delivery in a public health care facility was positively associated with at least one dose of hepatitis B/pentavalent vaccine administration (aOR 4.86 95% CI 2.97-7.95). Predictors for timely PNC were institutional delivery (public and private) (aOR 2.7 95% CI 1.96-3.72, aOR 2.38 95% CI 1.56-3.64), at least one ANC visit (aOR 1.59 95% CI 1.18-2.15), wealth quintile (Middle aOR 1.57 95% CI 1.02-2.41, Richer aOR 1.51 95% CI 1.01-2.25, Richest aOR 2.06 95% CI 1.28-3.31) and household size (aOR 0.95 95% CI 0.92-0.99). The findings indicate a correlation between childhood vaccination and timely postnatal care. Further, delivery in a public facility correlates with the administration of at least one dose of hepatitis B vaccine and thus impedes zero-dose vaccination. Increasing uptake of timely PNC, encouraging institutional delivery, and improving vaccination services before discharge of health facilities may lead to improved vaccination rates among children.

10.
Cogn Emot ; 35(8): 1652-1669, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34637692

RESUMO

Motivational and emotional changes across adulthood have a profound impact on cognition. In this registered report, we conducted an experimental investigation of motivational influence on remembering intentions after a delay (prospective memory; PM) in younger, middle-aged, and older adults, using gain- and loss-framing manipulations. The present study examined for the first time whether motivational framing in a PM task has different effects on younger and older adults' PM performance (N = 180; age range: 18-85 years) in a controlled laboratory setting. Based on lifespan theories of motivation, we assumed that the prevention of losses becomes more relevant with increasing age: We expected that older adults show relatively higher PM performance in a task with loss-related consequences following PM failure than in a task in which successful PM leads to gains. The opposite pattern of performance was expected for younger adults. The findings suggest that the relevance of reward and positive gain-related consequences for successful remembering appears to decrease with age. As hypothesised, a motivational framing × age interaction indicated that age differences in memory performance were smaller with loss-related than gain-related consequences, supporting a loss-prevention view on motivated cognition.


Assuntos
Intenção , Memória Episódica , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Envelhecimento , Humanos , Rememoração Mental , Pessoa de Meia-Idade , Motivação , Recompensa , Adulto Jovem
11.
Sci Rep ; 11(1): 21155, 2021 10 27.
Artigo em Inglês | MEDLINE | ID: mdl-34707196

RESUMO

The development of head shape and volume may reflect neurodevelopmental outcome and therefore is of paramount importance in neonatal care. Here, we compare head morphology in 25 very preterm infants with a birth weight of below 1500 g and / or a gestational age (GA) before 32 completed weeks to 25 term infants with a GA of 37-42 weeks at term equivalent age (TEA) and identify possible risk factors for non-synostotic head shape deformities. For three-dimensional head assessments, a portable stereophotogrammetric device was used. The most common and distinct head shape deformity in preterm infants was dolichocephaly. Severity of dolichocephaly correlated with GA and body weight at TEA but not with other factors such as neonatal morbidity, sex or total duration of respiratory support. Head circumference (HC) and cranial volume (CV) were not significantly different between the preterm and term infant group. Digitally measured HC and the CV significantly correlated even in infants with head shape deformities. Our study shows that stereophotogrammetric head assessment is feasible in all preterm and term infants and provides valuable information on volumetry and comprehensive head shape characteristics. In a small sample of preterm infants, body weight at TEA was identified as a specific risk factor for the development of dolichocephaly.


Assuntos
Cabeça/diagnóstico por imagem , Recém-Nascido Prematuro , Fotogrametria/métodos , Feminino , Humanos , Recém-Nascido , Masculino , Fotogrametria/instrumentação , Fotogrametria/normas
12.
Sci Rep ; 11(1): 15318, 2021 07 28.
Artigo em Inglês | MEDLINE | ID: mdl-34321493

RESUMO

Understanding how people of different ages decide in competition is a question of theoretical and practical importance. Using an experimental laboratory approach, this research investigates the ability of younger and older adults to think and act strategically with equal or unequal resources. In zero-sum games of resource allocation, younger adults (19-35 years) and older adults (65-81 years) made strategic decisions in competition against opponents of a similar age (Study 1; N = 120) or different age (Study 2; N = 120). The findings highlight people's ability to make good interpersonal decisions in complex scenarios: Both younger and older adults were aware of their relative strength (in terms of material resources) and allocated their resources adaptively. When competing against opponents of a similar age, people's gains were in line with game-theoretic predictions. However, younger adults made superior strategic allocations and won more frequently when competing against older adults. Measures of fluid cognitive and numerical abilities correlated with strategic behavior in interpersonal competition.


Assuntos
Envelhecimento/psicologia , Comportamento Competitivo/fisiologia , Tomada de Decisões/fisiologia , Jogos Experimentais , Adulto , Afeto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Modelos Psicológicos , Alocação de Recursos , Adulto Jovem
13.
Resuscitation ; 167: 317-325, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34302924

RESUMO

AIM: To determine whether the use of a respiratory function monitor (RFM) during PPV of extremely preterm infants at birth, compared with no RFM, leads to an increase in percentage of inflations with an expiratory tidal volume (Vte) within a predefined target range. METHODS: Unmasked, randomised clinical trial conducted October 2013 - May 2019 in 7 neonatal intensive care units in 6 countries. Very preterm infants (24-27 weeks of gestation) receiving PPV at birth were randomised to have a RFM screen visible or not. The primary outcome was the median proportion of inflations during manual PPV (face mask or intubated) within the target range (Vte 4-8 mL/kg). There were 42 other prespecified monitor measurements and clinical outcomes. RESULTS: Among 288 infants randomised (median (IQR) gestational age 26+2 (25+3-27+1) weeks), a total number of 51,352 inflations were analysed. The median (IQR) percentage of inflations within the target range in the RFM visible group was 30.0 (18.0-42.2)% vs 30.2 (14.8-43.1)% in the RFM non-visible group (p = 0.721). There were no differences in other respiratory function measurements, oxygen saturation, heart rate or FiO2. There were no differences in clinical outcomes, except for the incidence of intraventricular haemorrhage (all grades) and/or cystic periventricular leukomalacia (visible RFM: 26.7% vs non-visible RFM: 39.0%; RR 0.71 (0.68-0.97); p = 0.028). CONCLUSION: In very preterm infants receiving PPV at birth, the use of a RFM, compared to no RFM as guidance for tidal volume delivery, did not increase the percentage of inflations in a predefined target range. TRIAL REGISTRATION: Dutch Trial Register NTR4104, clinicaltrials.gov NCT03256578.


Assuntos
Respiração com Pressão Positiva , Ressuscitação , Humanos , Lactente , Lactente Extremamente Prematuro , Recém-Nascido , Monitorização Fisiológica , Volume de Ventilação Pulmonar
14.
J Gerontol B Psychol Sci Soc Sci ; 76(4): 711-721, 2021 03 14.
Artigo em Inglês | MEDLINE | ID: mdl-32877530

RESUMO

OBJECTIVES: Changes in motivational orientation across adulthood affect cognitive processes. The purpose of this research was to investigate if and how motivational incentives (gains or losses) affect prospective memory for intended actions in younger, middle-aged, and older adults. METHODS: The consequences of memory hits and misses and the framing of the memory tasks were experimentally manipulated between participants: In a gain-framing condition, participants accumulated rewards, dependent on the proportion of target events to which they responded accurately. In a loss-framing condition, participants received an initial endowment from which losses were deducted, dependent on the proportion of targets they missed. We measured memory accuracy, perceived task importance, and ongoing-task performance. RESULTS: Gains and losses had different effects on memory across age groups: Age × Motivational Valence interactions emerged across two studies. Older adults showed relatively better memory performance to avoid losses than to achieve gains. Moreover, higher age was associated with lower memory performance (Study 1) and slower but more accurate decisions in an ongoing activity (Study 2). DISCUSSION: The findings reveal that motivational incentives and the framing of consequences as gains or losses moderate the relation between age and memory performance. Older adults' memory performance may benefit when messages encourage the avoidance of losses. This may also help to design age-tailored interventions in applied settings (e.g., health-related behavior).


Assuntos
Envelhecimento Cognitivo/psicologia , Tomada de Decisões , Intenção , Memória Episódica , Motivação , Idoso , Pesquisa Comportamental/métodos , Empoderamento , Feminino , Humanos , Masculino , Processos Mentais , Pessoa de Meia-Idade , Tempo de Reação , Recompensa , Análise e Desempenho de Tarefas , Adulto Jovem
15.
Nervenarzt ; 92(1): 50-56, 2021 Jan.
Artigo em Alemão | MEDLINE | ID: mdl-32681216

RESUMO

BACKGROUND: Psychiatric disorders during pregnancy are common. Electroconvulsive therapy (ECT) can be indicated in severely affective or psychotic disorders with the necessity of a rapid response. Currently available review articles greatly differ in the methodology, leading to divergent conclusions concerning the use of ECT during pregnancy. OBJECTIVE: Description of a new clinical case and interdisciplinary treatment suggestions for the safe application of ECT in pregnancy. METHODS: Clinical case report and selective review of the literature with special consideration of existing systematic reviews. RESULTS AND CONCLUSION: This case report shows the potentially high effectiveness and safe administration of ECT in pregnancy for both mother and fetus. The undesired adverse events associated with ECT described in the literature are largely qualitatively congruent with the risks of severe psychotic disorders in pregnancy per se. For a better risk-benefit analysis, larger case control studies would be desirable. Under the premise of a thorough evaluation of the indications, good interdisciplinary coordination and consideration of the specific practical requirements, ECT is a useful therapeutic option in pregnancy.


Assuntos
Eletroconvulsoterapia , Transtornos Psicóticos , Estudos de Casos e Controles , Feminino , Humanos , Gravidez , Transtornos Psicóticos/diagnóstico , Transtornos Psicóticos/terapia , Sugestão
16.
Child Dev ; 92(1): 239-257, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32885842

RESUMO

Younger children's free recall from episodic memory is typically less organized than recall by older children. To investigate if and how repeated learning opportunities help children use organizational strategies that improve recall, the authors analyzed category clustering across four study-test cycles. Seven-year-olds, 10-year-olds, and young adults (N = 150) studied categorically related words for a free-recall task. The cognitive processes underlying recall and clustering were measured with a multinomial model. The modeling revealed that developmental differences emerged particularly in the rate of learning to encode words as categorical clusters. The learning curves showed a common pattern across age groups, indicating developmental invariance. Memory for individual items also contributed to developmental differences and was the only factor driving 7-year-olds' moderate improvements in recall.


Assuntos
Cognição/fisiologia , Memória Episódica , Rememoração Mental/fisiologia , Modelos Psicológicos , Tempo de Reação/fisiologia , Criança , Análise por Conglomerados , Estudos Transversais , Feminino , Humanos , Aprendizagem/fisiologia , Masculino , Estimulação Luminosa/métodos , Adulto Jovem
17.
Pharmaceut Med ; 34(6): 381-386, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33289912

RESUMO

Labelling of pharmaceutical products plays a vital role in the safe and effective use of approved medicinal products. This information may be provided to end-users including patients and/or prescribers, and it needs to be made available in multiple formats including printed forms (patient information leaflets, pack inserts, etc.) or web portals of the product, based on national authority guidelines. The Company Core Data Sheet (CCDS) serves as a key document representing the pharmaceutical company's position on the product and is used as a reference document for national labels. Content from national labels may differ from the CCDS for different reasons including implementation of national authority requirements in the serving market and findings from local markets. In the current article, we discuss the process, challenges and key concepts in creating and maintaining CCDS documents for generic products. We highlight key parameters that are worthy of process improvement in generic products' CCDS updates. In addition, we argue that labelling harmonisation across multiple regions, especially safety section-related information, plays a key role in promoting end-user safety and would help communicate risks. We also strongly believe that the topic is worthy of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) consideration, and propose that this is the key area that requires standardisation and harmonisation.


Assuntos
Indústria Farmacêutica/estatística & dados numéricos , Rotulagem de Medicamentos/estatística & dados numéricos , Medicamentos Genéricos/normas , Manutenção/normas , Tomada de Decisões , Feminino , Fidelidade a Diretrizes/ética , Guias como Assunto , Humanos , Masculino , Marketing/ética , Marketing/tendências , Rotulagem de Produtos/normas , Rotulagem de Produtos/tendências , Segurança , Participação dos Interessados , Resultado do Tratamento
18.
Antibiotics (Basel) ; 9(8)2020 Aug 04.
Artigo em Inglês | MEDLINE | ID: mdl-32759868

RESUMO

Young children are frequently colonized with Clostridioides (C.) difficile. Depending on their resistance patterns, antibiotic treatment can facilitate gastrointestinal spreading in colonized individuals, potentially leading to transmission to others. C. difficile was isolated from stool samples from infants born in two hospitals in Göttingen and Darmstadt, Germany. All isolates were subjected to phenotypic antimicrobial resistance testing, PCR-based screening for toxin genes and mass spectrometry-based exclusion of ribotypes 027 and 176. Within an initial cohort of 324 neonates with a longitudinal survey of C. difficile, 137 strains were isolated from 48 individuals. Antimicrobial resistance was recorded against metronidazole in one (0.7%), erythromycin in 16 (11.7%) and moxifloxacin in 2 (1.5%) of the strains, whereas no resistance was observed against vancomycin (0.0%) or rifampicin (0.0%). Newly observed resistance against erythromycin in children with detection of previously completely sensitive isolates was reported for C. difficile isolates from 2 out of 48 children. In 20 children (42%), non-toxigenic strains were detected, and from 27 children (56%), toxigenic strains were isolated, while both toxigenic and non-toxigenic strains were recorded for 1 child (2%). Ribotypes 027 or 176 were not observed. In conclusion, the German C. difficile strains isolated from the children showed mild to moderate resistance with predominance of macrolide resistance, a substance class which is frequently applied in children. The observed switches to the dominance of macrolide-resistant isolates suggests likely selection of resistant C. difficile strains already in children.

19.
Am J Clin Nutr ; 112(5): 1219-1227, 2020 11 11.
Artigo em Inglês | MEDLINE | ID: mdl-32710779

RESUMO

BACKGROUND: Despite ongoing debate about the health impact of probiotics, rigorous evidence assessing the use of probiotics in routine preterm newborn care is lacking. OBJECTIVES: We aimed to estimate the causal effect of routine probiotics supplementation on moderately preterm newborns' anthropometric development (weight-for-age and height-for-age z scores) and risk of late-onset sepsis. METHODS: This study used a regression discontinuity analysis based on hospital guidelines that recommended routine probiotics supplementation for neonates born before 34 completed weeks of gestation. Data for this study came from electronic medical records of a level III neonatal care center in Germany and were collected between 2013 and 2019. Newborns born between 30 to 38 completed weeks of gestation without severe congenital defects were eligible for inclusion. Outcomes were weight-for-age and height-for-age z scores at discharge as well as late-onset sepsis. RESULTS: Study participants included 1734 preterm neonates. The results showed no significant intention-to-treat effect on weight-for-age (effect: -0.033 SD; 95% CI: -0.220, 0.155), length-for-age (-0.133 SD; 95% CI: -0.380, 0.114), or late-onset sepsis probability (-1.175 percentage points; 95% CI: -6.556, 4.205). There was no evidence for significant effects of probiotics for any of the study's endpoints on those complying with the hospital guidelines (local average treatment effect). CONCLUSIONS: Routine treatment of moderately preterm newborns with probiotics is unlikely to improve anthropometric outcomes. Complier-level analysis suggested that this finding was not simply driven by a lack of physician compliance with hospital guidelines but by an overall absence of large health effects from the treatment itself. Moreover, overall sepsis risk was low and did not change significantly as a result of probiotics supplementation. The findings of this study therefore do not support the routine use of probiotics for improving growth or preventing late-onset sepsis in moderately preterm neonates.


Assuntos
Suplementos Nutricionais , Fenômenos Fisiológicos da Nutrição do Lactente , Recém-Nascido Prematuro , Probióticos/administração & dosagem , Peso Corporal , Humanos , Recém-Nascido , Lacunas da Prática Profissional , Fatores de Risco , Sepse/prevenção & controle
20.
Child Dev ; 91(2): 417-438, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-30644533

RESUMO

Value-based decisions often involve comparisons between benefits and costs that must be retrieved from memory. To investigate the development of value-based decisions, 9- to 10-year olds (N = 30), 11- to 12-year olds (N = 30), and young adults (N = 30) first learned to associate gain and loss magnitudes with symbols. In a subsequent decision task, participants rapidly evaluated objects that consisted of combinations of these symbols. All age groups achieved high decision performance and were sensitive to gain-loss magnitudes, suggesting that required core cognitive abilities are developed early. A cognitive-modeling analysis of performance revealed that children were less efficient in object evaluation (drift rate) and had longer nondecision times than adults. Developmental differences, which emerged particularly for objects of high positive net value, were linked to mnemonic and numerical abilities.


Assuntos
Aprendizagem por Associação/fisiologia , Tomada de Decisões/fisiologia , Desenvolvimento Humano/fisiologia , Memória/fisiologia , Adulto , Criança , Feminino , Humanos , Masculino , Adulto Jovem
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