Paediatric European Risperidone Studies (PERS): context, rationale, objectives, strategy, and challenges.
Ontology highlight
ABSTRACT:
SUBMITTER: Glennon J
PROVIDER: S-EPMC4246122 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:In the absence of national standards for scholarly requirements, paediatric resident training varies significantly across Canadian programs. This variability may contribute to significant differences in trainee experiences and productivity. A panel of coordinators of paediatric resident research programs from across Canada met in 2014, to share experiences and identify barriers to successful resident scholarly activity. A survey of all programs was completed in 2015. A scoping review and series of meetings led to the development of a proposed list of expectations, timelines for successful completion and consequences for not completing a scholarly project. We propose a harmonized list of scholarly competencies and activities for paediatric residents in Canada to accomplish before completing their training. We also propose that programs implement standardized timelines and consequences in the event that a resident does not meet their program's scholarly expectations.
| S-EPMC6462126 | biostudies-literature
Project description:Successful implementation reflects the interplay between intervention, implementation strategy, and context. Hybrid effectiveness-implementation studies allow investigators to assess the effects of both intervention and implementation strategy, though the role of context as a third independent variable (IV) is incompletely specified. Our objective is to expand the hybrid typology to include mixtures of all three types of IVs: intervention, implementation strategy, and context. We propose to use I to represent the IV of intervention, IS to represent implementation strategy, and C to represent context. Primary IVs are written first and in upper case. Secondary IVs are written after a forward slash and in lower case; co-primary IVs are written after a dash and in upper case. The expanded framework specifies nine two-variable hybrid types: I/is, I-IS, IS/i, IS/c, IS-C, C/is, C/i, I-C, and I/c. We describe four in detail: I/is, IS/c, IS-C, and C/is. We also specify seven three-variable hybrid types. We argue that many studies already meet our definitions of two- or three-variable hybrids. Our proposal builds from the typology proposed by Curran et al. (1), but offers a more complete specification of hybrid study types. We need studies that measure the implementation-related effects of variations in contextual determinants, both to advance the science and to optimize intervention delivery in the real world. Prototypical implementation studies that evaluate the effectiveness of an implementation strategy, in isolation from its context, risk perpetuating the gap between evidence and practice, as they will not generate context-specific knowledge around implementation, scale-up, and de-implementation.
| S-EPMC6857476 | biostudies-literature
Project description:ImportancePregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads.MethodsRECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators.DiscussionRECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero.Clinical trials.gov identifierClinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.
| S-EPMC10734909 | biostudies-literature
Project description:The Paris Agreement promotes forest management as a pathway towards halting climate warming through the reduction of carbon dioxide (CO2) emissions1. However, the climate benefits from carbon sequestration through forest management may be reinforced, counteracted or even offset by concurrent management-induced changes in surface albedo, land-surface roughness, emissions of biogenic volatile organic compounds, transpiration and sensible heat flux2-4. Consequently, forest management could offset CO2 emissions without halting global temperature rise. It therefore remains to be confirmed whether commonly proposed sustainable European forest-management portfolios would comply with the Paris Agreement-that is, whether they can reduce the growth rate of atmospheric CO2, reduce the radiative imbalance at the top of the atmosphere, and neither increase the near-surface air temperature nor decrease precipitation by the end of the twenty-first century. Here we show that the portfolio made up of management systems that locally maximize the carbon sink through carbon sequestration, wood use and product and energy substitution reduces the growth rate of atmospheric CO2, but does not meet any of the other criteria. The portfolios that maximize the carbon sink or forest albedo pass only one-different in each case-criterion. Managing the European forests with the objective of reducing near-surface air temperature, on the other hand, will also reduce the atmospheric CO2 growth rate, thus meeting two of the four criteria. Trade-off are thus unavoidable when using European forests to meet climate objectives. Furthermore, our results demonstrate that if present-day forest cover is sustained, the additional climate benefits achieved through forest management would be modest and local, rather than global. On the basis of these findings, we argue that Europe should not rely on forest management to mitigate climate change. The modest climate effects from changes in forest management imply, however, that if adaptation to future climate were to require large-scale changes in species composition and silvicultural systems over Europe5,6, the forests could be adapted to climate change with neither positive nor negative climate effects.
| S-EPMC6277009 | biostudies-literature
Project description:ImportanceSARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis.MethodsRECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms.DiscussionRECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options.RegistrationNCT05172024.
| S-EPMC10289397 | biostudies-literature
Project description:ImportanceThe prevalence, pathophysiology, and long-term outcomes of COVID-19 (post-acute sequelae of SARS-CoV-2 [PASC] or "Long COVID") in children and young adults remain unknown. Studies must address the urgent need to define PASC, its mechanisms, and potential treatment targets in children and young adults.ObservationsWe describe the protocol for the Pediatric Observational Cohort Study of the NIH's RE searching COV ID to E nhance R ecovery (RECOVER) Initiative. RECOVER-Pediatrics is an observational meta-cohort study of caregiver-child pairs (birth through 17 years) and young adults (18 through 25 years), recruited from more than 100 sites across the US. This report focuses on two of five cohorts that comprise RECOVER-Pediatrics: 1) a de novo RECOVER prospective cohort of children and young adults with and without previous or current infection; and 2) an extant cohort derived from the Adolescent Brain Cognitive Development (ABCD) study ( n =10,000). The de novo cohort incorporates three tiers of data collection: 1) remote baseline assessments (Tier 1, n=6000); 2) longitudinal follow-up for up to 4 years (Tier 2, n=6000); and 3) a subset of participants, primarily the most severely affected by PASC, who will undergo deep phenotyping to explore PASC pathophysiology (Tier 3, n=600). Youth enrolled in the ABCD study participate in Tier 1. The pediatric protocol was developed as a collaborative partnership of investigators, patients, researchers, clinicians, community partners, and federal partners, intentionally promoting inclusivity and diversity. The protocol is adaptive to facilitate responses to emerging science.Conclusions and relevanceRECOVER-Pediatrics seeks to characterize the clinical course, underlying mechanisms, and long-term effects of PASC from birth through 25 years old. RECOVER-Pediatrics is designed to elucidate the epidemiology, four-year clinical course, and sociodemographic correlates of pediatric PASC. The data and biosamples will allow examination of mechanistic hypotheses and biomarkers, thus providing insights into potential therapeutic interventions.Clinical trialsgov identifierClinical Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT05172011.
| S-EPMC10197716 | biostudies-literature
Project description:A recent article by Luyssaert et al. (Nature 562:259-262, 2018) analyses the climate impact of forest management in the European Union, considering both biogeochemical (i.e., greenhouse gases, GHG) and biophysical (e.g., albedo, transpiration, etc.) effects. Based on their findings, i.e. that additional net overall climate benefits from forest management would be modest, the authors conclude that the EU "should not rely on forest management to mitigate climate change". We first explain that most of the additional EU GHG mitigation effort by 2030 is expected to come from emission reductions and only a very small part from forestry, even when forest bioenergy is allowed for. Nevertheless, the inclusion of forest management in climate change mitigation strategies is key to identifying the country-specific optimal mix, in terms of overall GHG balance, between strategies focused on conserving and/or enhancing the sink and strategies focused on using more wood to reduce emissions in other GHG sectors. Then, while acknowledging the importance that biophysical effects have on the climate, especially at the local and seasonal scale, we argue that the net annual biophysical climate impact of forest management in Europe remains more uncertain than the net CO2 impact. This has not been adequately emphasized by Luyssaert et al. (2018), leading to conclusions on the net overall climate impact of forest management that we consider premature and applied to a partially biased perception of European policy towards forestry and climate change. To avoid further confusion in the debate on how forestry may contribute to mitigating climate change, a more constructive dialogue between the scientific community and policy makers is needed.
| S-EPMC7227057 | biostudies-literature
Project description:BackgroundInfluenza viruses pose significant disease burdens through seasonal outbreaks and unpredictable pandemics. Existing surveillance programs rely heavily on reporting of medically attended influenza (MAI). Continuously monitoring cause-specific school absenteeism may identify local acceleration of seasonal influenza activity. The Oregon Child Absenteeism Due to Respiratory Disease Study (ORCHARDS; Oregon, WI) implements daily school-based monitoring of influenza-like illness-specific student absenteeism (a-ILI) in kindergarten through Grade 12 schools and assesses this approach for early detection of accelerated influenza and other respiratory pathogen transmission in schools and surrounding communities.MethodsStarting in September 2014, ORCHARDS combines automated reporting of daily absenteeism within six schools and home visits to school children with acute respiratory infection (ARI). Demographic, epidemiological, and symptom data are collected along with respiratory specimens. Specimens are tested for influenza and other respiratory viruses. Household members can opt into a supplementary household transmission study. Community comparisons are possible using a pre-existing and highly effective influenza surveillance program, based on MAI at five family medicine clinics in the same geographical area.ResultsOver the first 5 years, a-ILI occurred on 6634 (0.20%) of 3,260,461 student school days. Viral pathogens were detected in 64.5% of 1728 children with ARI who received a home visit. Influenza was the most commonly detected virus, noted in 23.3% of ill students.ConclusionORCHARDS uses a community-based design to detect influenza trends over multiple seasons and to evaluate the utility of absenteeism for early detection of accelerated influenza and other respiratory pathogen transmission in schools and surrounding communities.
| S-EPMC8818813 | biostudies-literature
Project description:BackgroundThe European Rare Kidney Disease Reference Network (ERKNet) recently established ERKReg, a Web-based registry for all patients with rare kidney diseases. The main objectives of this core registry are to generate epidemiological information, identify current patient cohort for clinical research, explore diagnostic and therapeutic management practices, and monitor treatment performance and patient's outcomes. The registry has a modular design that allows to integrate comprehensive disease-specific registries as extensions to the core database. The diagnosis (Orphacode) and diagnostic information (clinical, imaging, histopathological, biochemical, immunological and genetic) are recorded. Anthropometric, kidney function, and disease-specific management and outcome items informing a set of 61 key performance indicators (KPIs) are obtained annually. Data quality is ensured by automated plausibility checks upon data entry and regular offline database checks prompting queries. Centre KPI statistics and benchmarking are calculated automatically.ResultsWithin the first 24 months since its launch, 7607 patients were enrolled to the registry at 45 pediatric and 12 specialized adult nephrology units from 21 countries. A kidney disease diagnosis had been established in 97.1% of these patients at time of enrolment. While 199 individual disease entities were reported by Orphacode, 50% of the cohort could be classified with 11, 80% with 43 and 95% with 92 codes. Two kidney diagnoses were assigned in 6.5% of patients; 5.9% suffered from syndromic disease. Whereas glomerulopathies (54.8%) and ciliopathies including autosomal dominant polycystic kidney disease (ADPKD) (31.5%) were the predominant disease groups among adults, the pediatric disease spectrum encompassed congenital anomalies of the kidney and urinary tract (CAKUT) (33.7%), glomerulopathies (30.7%), ciliopathies (14.0%), tubulopathies (9.2%), thrombotic microangiopathies (5.6%), and metabolic nephropathies (4.1%). Genetically confirmed diagnoses were reported in 24% of all pediatric and 12% adult patients, whereas glomerulopathies had been confirmed by kidney biopsy in 80.4% adult versus 38.5% pediatric glomerulopathy cases.ConclusionsERKReg is a rapidly growing source of epidemiological information and patient cohorts for clinical research, and an innovative tool to monitor management quality and patient outcomes.
| S-EPMC8173879 | biostudies-literature
Project description:BackgroundEvaluations, using questionnaires, of a two-year long CPD program for on-call consultant paediatricians, showed that the overall objective of the program was largely met. We stipulate that the coherency of the CPD program contributed to the learning. To gains a deeper understanding of the participants learning within and beyond the overall objectives of the program, we decided to conduct an interview study enrolling participants from the first two CPD courses.MethodsNine experienced paediatric consultants were interviewed 1-4 years after completing a coherent two-year long CPD program, focusing on what and how they learned. The interviews were audio-recorded and transcribed as text, analysed, and categorised using qualitative content analysis.ResultsWhat the participants learned: improved medical competences, greater confidence in the role of an on-call consultant, better understanding of the role of an on-call consultant and importance of professional networks. Several categories were outside the overall objective, at personal level: an understanding of one's own and other's competences, taking responsibility for one's own CPD and managing things one does not know. At professional level: more secure as an individual and with colleagues. How it was learned: relevant objectives, preparatory material and case discussions were important. Participants learned by preparing, repeating, reflecting, and participating actively, and by applying what they learned in clinical practice. The participants learned from one other over a period of two years, when they also got to know one another and created networks. A safe learning environment imposed demands and enabled participants to define their competence and learn accordingly.ConclusionsThis study describes what and how on-call consultant paediatricians learned during a coherent two-year long CPD program. The learning took place within and beyond the framework of the overall objectives. The study suggests that evaluation methods based on objectives may be blind to important areas of learning and need to be combined with qualitative methods that examine a broad impact of learning. Taken together, the analysis of what and how the participants learned shows that they were better equipped to work as consultant on call and deal with the things they did not know.
| S-EPMC9749295 | biostudies-literature