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The safety of new vaccines under development as well as existing vaccines is a key priority for national and international public health agencies. A number of countries have implemented universal childhood varicella vaccination programmes over the past 30 years. However, strategies differ in terms of the number of doses, type of vaccine(s) recommended, age at vaccination and interval between doses for a two-dose schedule. An overview of reviews was undertaken to assess the existing systematic review evidence of the safety of varicella vaccination strategies. The review was restricted to immunocompetent children aged 9 months to 6 years inclusive. A comprehensive search of databases, registries and grey literature was conducted up to 2 February 2022. Two reviewers independently screened, extracted data and assessed the methodological quality of included reviews. Overlap of included reviews was also assessed. A total of 17 reviews, incorporating both the monovalent varicella only and quadrivalent measles-mumps-rubella-varicella (MMRV) vaccines were included in the overview; six assessed the safety of one-dose strategies, four assessed the safety of two-dose strategies and 14 reviews did not specify the dosing strategy. The evidence suggests that mild local and systemic reactions are relatively common with varicella vaccination. Febrile seizures are also possible adverse effects of both the monovalent and quadrivalent MMRV vaccine, but serious adverse reactions are rare. While most reviews contained methodological flaws, and analysis by vaccine type and dosing strategy was restricted due to lack of detail in reporting of the reviews, there was clear and consistent evidence from a substantial evidence base, comprising 34 randomised controlled trials and 62 other primary studies/reviews, that varicella vaccination is safe.
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Varicela , Niño , Humanos , Lactante , Vacuna contra la Varicela/efectos adversos , Herpesvirus Humano 3 , Vacunación , Anticuerpos AntiviralesRESUMEN
A number of countries have implemented universal childhood varicella vaccination programmes over the past 30 years. However, strategies differ in terms of dosing schedule (one- or two-dose), type of vaccine(s) recommended (monovalent, quadrivalent measles-mumps-rubella-varicella, or both), age at vaccination, and dosing interval for a two-dose schedule. An overview of reviews was undertaken to assess the existing systematic review evidence of the clinical efficacy/effectiveness of alternative varicella vaccination strategies. A comprehensive search of databases, registries and grey literature was conducted up to 2 February 2022. Two reviewers independently screened, extracted data and assessed the methodological quality of included reviews. A total of 20 reviews were included in the overview; 17 assessed the efficacy/effectiveness of one-dose strategies and 10 assessed the efficacy/effectiveness of two-dose strategies. Although the quality of most reviews was deemed 'critically low', there was clear and consistent evidence that vaccination is very effective at reducing varicella. While the analysis was restricted due to lack of detail in reporting of the reviews, the evidence suggests that two-dose strategies are more efficacious/effective than one-dose strategies in preventing varicella of any severity, but that both strategies have similar high efficacy/effectiveness in preventing moderate or severe varicella. Based on this evidence in this overview of reviews, a key consideration for policymakers on the possible introduction of a childhood varicella vaccination programme and the choice between a one- or two-dose strategy, will be whether the objective of a programme is to prevent varicella of any severity or to prevent moderate to severe varicella.
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Varicela , Niño , Humanos , Lactante , Varicela/epidemiología , Varicela/prevención & control , Vacuna contra la Varicela , Herpesvirus Humano 3 , Vacuna contra el Sarampión-Parotiditis-Rubéola , Resultado del Tratamiento , Vacunación , Vacunas Combinadas , Revisiones Sistemáticas como AsuntoRESUMEN
Rapid antigen detection tests (RADTs) offer advantages over gold-standard reverse transcription polymerase chain reaction (RT-PCR) tests in that they are cheaper and provide faster results, thus enabling prompt isolation of positive SARS-CoV-2 cases and quarantine of close contacts. The aim of this study was to collate and synthesise empirical evidence on the effectiveness of rapid antigen testing for the screening (including serial testing) and surveillance of asymptomatic individuals to limit the transmission of SARS-CoV-2. A rapid review was undertaken in MEDLINE (EBSCO), EMBASE (OVID), Cochrane Library, Europe PMC and Google Scholar up until 19 July 2021, supplemented by a grey literature search. Of the identified 1222 records, 19 reports referring to 16 studies were included. Eight included studies examined the effectiveness of RADTs for population-level screening, four for pre-event screening and four for serial testing (schools, a prison, a university sports programme and in care homes). Overall, there is uncertainty regarding the effectiveness of rapid antigen testing for the screening of asymptomatic individuals to limit the transmission of SARS-CoV-2. This uncertainty is due to the inconsistent results, the relatively low number of studies identified, the predominantly observational and/or uncontrolled nature of the study designs used, and concerns regarding methodological quality. Given this uncertainty, more real-world research evidence in relevant settings, which is of good quality and timely, as well as economic evaluation, is required to inform public policy on the widespread use of RADTs in asymptomatic individuals.
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COVID-19 , SARS-CoV-2 , COVID-19/diagnóstico , Prueba de COVID-19 , Humanos , Tamizaje Masivo , Estudios Observacionales como Asunto , CuarentenaRESUMEN
The aim of this rapid review was to determine the effectiveness of pharmacological interventions (excluding vaccines) to prevent coronavirus disease 2019 (Covid-19) or reduce the severity of disease. A systematic search of published peer-reviewed articles and non-peer-reviewed pre-prints was undertaken from 1 January 2020 to 17 August 2021. Four randomised controlled trials (RCTs) and one non-RCT were included; three trials (two RCTs and one non-RCT) tested ivermectin with or without carrageenan. While all reported some potential protective effect of ivermectin, these trials had a high risk of bias and the certainty of evidence was deemed to be 'very low'. One RCT tested bamlanivimab compared to placebo and reported a significantly reduced incidence of Covid-19 in the intervention group; this trial had a low risk of bias however the certainty of evidence was deemed 'very low'. The fifth RCT tested casirivimab plus imdevimab versus placebo and reported that the combination of monoclonal antibodies significantly reduced the incidence of symptomatic and asymptomatic SARS-CoV-2 infection, viral load, duration of symptomatic disease and the duration of a high viral load; this trial was deemed to have a low risk of bias, and the certainty of evidence was 'low'. The designations 'low' and 'very low' regarding the certainty of evidence indicate that the estimate of effect is uncertain and therefore is unsuitable for informing decision-making. At the time of writing, there is insufficient high quality evidence to support the use of pharmacological interventions to prevent Covid-19.
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Tratamiento Farmacológico de COVID-19 , COVID-19 , Anticuerpos Monoclonales Humanizados , Anticuerpos Neutralizantes , COVID-19/prevención & control , Humanos , Ivermectina/uso terapéutico , SARS-CoV-2RESUMEN
Mass gatherings play an important role in society, but since the onset of the Covid-19 pandemic, they have generally been restricted in order to mitigate transmission of SARS-CoV-2. The aim of this study was to summarise the evidence regarding the effectiveness of public health measures at preventing the transmission of SARS-CoV-2 at mass gatherings, and hence inform guidance on the organisation of these events. A rapid review was undertaken in Cochrane, Embase (OVID), Medline (OVID), Google, Web of Science and Europe PMC from 1 January 2020 to 3 June 2021. Of the identified 1,624 citations, 14 articles referring to 11 unique studies were included. This rapid review found evidence from 11 studies (involving approximately 30,482 participants) that implementing a range of measures may reduce the risk of SARS-CoV-2 transmission at mass gatherings; however, it is unlikely that this risk can be eliminated entirely. All studies adopted a layered mitigation approach involving multiple measures, which may be more effective than relying on any single measure. The number and intensity of measures implemented varied across studies, with most implementing resource intense measures. Importantly, all included studies were only of 'fair' to 'poor' quality. In conclusion, there is currently limited evidence on the effectiveness of measures to prevent SARS-CoV-2 transmission at mass gatherings. As mass gatherings recommence, continued adoption of known mitigation measures is required to limit the risk of transmission, as well as ongoing research and surveillance to monitor the potential impact of these events on the wider population and healthcare system.
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COVID-19 , SARS-CoV-2 , COVID-19/epidemiología , COVID-19/prevención & control , Humanos , Reuniones Masivas , Pandemias/prevención & control , Salud PúblicaRESUMEN
MOTIVATION: CircRNAs are covalently closed RNA molecules that are particularly abundant in the brain. While circRNA expression data from the human brain is rapidly accumulating, integration of large-scale datasets remains challenging and time-consuming, and consequently an integrative view of circRNA expression in the human brain is currently lacking. RESULTS: NeuroCirc is a web-based resource that allows interactive exploration of multiple types of circRNA data from the human brain, including large-scale expression datasets, circQTL data and circRNA expression across neuronal differentiation and cellular maturation time-courses. NeuroCirc also allows users to upload their own circRNA expression data and explore it in the integrative platform, thereby supporting circRNA prioritization for experimental validation and functional studies. AVAILABILITY AND IMPLEMENTATION: NeuroCirc is freely available at: https://voineagulab.github.io/NeuroCirc/. The source code and user documentation are available at: https://github.com/Voineagulab/NeuroCirc. SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.
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A key consideration in the Covid-19 pandemic is the dominant modes of transmission of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus. The objective of this review was to synthesise the evidence for the potential airborne transmission of SARS-CoV-2 via aerosols. Systematic literature searches were conducted in PubMed, Embase, Europe PMC and National Health Service UK evidence up to 27 July 2020. A protocol was published and Cochrane guidance for rapid review methodology was adhered to throughout. Twenty-eight studies were identified. Seven out of eight epidemiological studies suggest aerosol transmission may occur, with enclosed environments and poor ventilation noted as possible contextual factors. Ten of the 16 air sampling studies detected SARS-CoV-2 ribonucleic acid; however, only three of these studies attempted to culture the virus with one being successful in a limited number of samples. Two of four virological studies using artificially generated aerosols indicated that SARS-CoV-2 is viable in aerosols. The results of this review indicate there is inconclusive evidence regarding the viability and infectivity of SARS-CoV-2 in aerosols. Epidemiological studies suggest possible transmission, with contextual factors noted. Viral particles have been detected in air sampling studies with some evidence of clinical infectivity, and virological studies indicate these particles may represent live virus, adding further plausibility. However, there is uncertainty as to the nature and impact of aerosol transmission of SARS-CoV-2, and its relative contribution to the Covid-19 pandemic compared with other modes of transmission.
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Aerosoles/análisis , COVID-19/transmisión , ARN Viral/aislamiento & purificación , SARS-CoV-2/fisiología , COVID-19/epidemiología , COVID-19/patología , COVID-19/virología , Humanos , Estudios Retrospectivos , SARS-CoV-2/patogenicidad , IncertidumbreRESUMEN
The collection of nasopharyngeal swabs to test for the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an invasive technique with implications for patients and clinicians. Alternative clinical specimens from the upper respiratory tract may offer benefits in terms of collection, comfort and infection risk. The objective of this review was to synthesise the evidence for detection of SARS-CoV-2 ribonucleic acid (RNA) using reverse transcription polymerase chain reaction (RT-PCR) tested saliva or nasal specimens compared with RT-PCR tested nasopharyngeal specimens. Searches were conducted in PubMed, Embase, Europe PMC and NHS evidence from December 2019 to 20 July 2020. Eighteen studies were identified; 12 for saliva, four for nasal and two included both specimen types. For saliva-based studies, the proportion of saliva samples testing positive relative to all positive samples in each study ranged from 82.9% to 100%; detection in nasopharyngeal specimens ranged from 76.7% to 100%; positive agreement between specimens for overall detection ranged from 65.4% to 100%. For nasal-based studies, the proportion of nasal swabs testing positive relative to all positive samples in each study ranged from 81.9% to 100%; detection in nasopharyngeal specimens ranged from 70% to 100%; positive agreement between specimens for overall detection ranged from 62.3% to 100%. The results indicate an inconsistency in the detection of SARS-CoV-2 RNA in the specimen types included, often with neither the index nor the reference of interest detecting all known cases. Depending on the test environment, these clinical specimens may offer a viable alternative to standard. However, at present the evidence is limited, of variable quality, and relatively inconsistent.
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Prueba de COVID-19/métodos , COVID-19/diagnóstico , Mucosa Nasal/virología , Nasofaringe/virología , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa/métodos , Saliva/virología , Manejo de Especímenes/métodos , Humanos , Reproducibilidad de los ResultadosRESUMEN
In this review, we systematically searched and summarized the evidence on the immune response and reinfection rate following SARS-CoV-2 infection. We also retrieved studies on SARS-CoV and MERS-CoV to assess the long-term duration of antibody responses. A protocol based on Cochrane rapid review methodology was adhered to and databases were searched from 1/1/2000 until 26/5/2020. Of 4744 citations retrieved, 102 studies met our inclusion criteria. Seventy-four studies were retrieved on SARS-CoV-2. While the rate and timing of IgM and IgG seroconversion were inconsistent across studies, most seroconverted for IgG within 2 weeks and 100% (N = 62) within 4 weeks. IgG was still detected at the end of follow-up (49-65 days) in all patients (N = 24). Neutralizing antibodies were detected in 92%-100% of patients (up to 53 days). It is not clear if reinfection with SARS-CoV-2 is possible, with studies more suggestive of intermittent detection of residual RNA. Twenty-five studies were retrieved on SARS-CoV. In general, SARS-CoV-specific IgG was maintained for 1-2 years post-infection and declined thereafter, although one study detected IgG up to 12 years post-infection. Neutralizing antibodies were detected up to 17 years in another study. Three studies on MERS-CoV reported that IgG may be detected up to 2 years. In conclusion, limited early data suggest that most patients seroconvert for SARS-CoV-2-specific IgG within 2 weeks. While the long-term duration of antibody responses is unknown, evidence from SARS-CoV studies suggest SARS-CoV-specific IgG is sustained for 1-2 years and declines thereafter.
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COVID-19/inmunología , Infecciones por Coronavirus/inmunología , Coronavirus/inmunología , Inmunidad/inmunología , SARS-CoV-2/inmunología , Anticuerpos Neutralizantes/inmunología , Anticuerpos Antivirales/inmunología , Humanos , Inmunoglobulina G/inmunología , Inmunoglobulina M/inmunologíaRESUMEN
BACKGROUND: Use of restrictive practices (RP) in care settings may sometimes be warranted but can also conflict with human rights. Research to date has focused primarily on physical and chemical RP, however other forms are also used. Better understanding of practice can inform RP reduction. This study describes the incidence of all types of RP use reported from nursing homes in Ireland. METHODS: RP notifications from nursing homes reported in 2020 were extracted from the Database of Statutory Notifications from Social Care in Ireland. The primary outcome measurement was the national incidence of use (frequency of RP/occupancy per 1000 residents) of categories and types of RP. Secondary outcome measurements such as percentage of facilities reporting use and quarterly median incidence of use in these facilities were calculated. RESULTS: Seventy thousand six hundred sixty-three RP uses were notified from 608 facilities (33,219 beds). National incidence of RP use per 1000 residents was, all categories: 2465.1, environmental: 1324.5, physical: 922.5, chemical: 141.1; 'other': 77.0. The most frequently used RPs per category were, environmental: door locks; physical: bedrails; chemical (where drug specified): antipsychotics; 'other': privacy. 90.5% of nursing homes reported using at least one type of RP in the 12-month period. Quarterly incidence of any RP use in these facilities was median 1.642 (IQR: 0.018 to 18.608) per bed. CONCLUSIONS: Nursing homes in Ireland regularly use RP; only 9.5% reported no RP use in the 12-month period. A wide variety of types of RP were reported. Environmental and 'other' (largely psychosocial) RP contributed notably to total RP use and warrant attention alongside the traditional focus on physical and chemical RP. Policy implications include the need for more comprehensive RP definitions.
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Antipsicóticos , Casas de Salud , Humanos , Incidencia , Irlanda/epidemiología , Restricción FísicaRESUMEN
OBJECTIVES: Psychotropic medications are commonly inappropriately prescribed for people with dementia (PwD) residing in nursing homes. This population is often multi-morbid, receiving multiple medications and therefore at an increased risk of mortality. This overview aimed to collate all synthesised quantitative, qualitative, and mixed-method evidence pertaining to the effectiveness of interventions aimed at reducing inappropriate psychotropic prescribing for nursing home residents with dementia; the perceived barriers and facilitators to the implementation of these interventions; and the attitudes and experiences of stakeholders toward prescribing. Method: An overview of reviews was conducted (PROSPERO protocol registration CRD42020187288). Five databases were systematically searched from January 2010 through June 2020, supplemented by grey literature searching. Reviews presenting evidence pertaining to either randomised controlled trials (RCT) aiming to reduce inappropriate prescribing or qualitative/mixed method studies of stakeholder views, were included. RESULTS: Of 273 records identified, 11 systematic reviews were included. The quality of reviews ranged from critically low to moderate. There was mixed evidence for the use of education-only interventions. Multicomponent interventions (typically staff education combined with organisational and structural components), medication review, and interventions aimed at cultural change were evidenced as effective compared to care as usual. Stakeholders cited the importance of multidisciplinary collaboration and targeting organisational climate in changing psychotropic prescribing behaviours. CONCLUSIONS: The inappropriate use of psychotropic medications in nursing homes for PwD is a complex issue with many contextual factors. The evidence suggests a comprehensive approach, targeting organisational climate and multidisciplinary collaboration, along with staff education and training, may be an effective strategy.
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Demencia , Casas de Salud , Demencia/tratamiento farmacológico , Humanos , Prescripción Inadecuada/prevención & control , Psicotrópicos/uso terapéutico , Literatura de Revisión como AsuntoRESUMEN
BackgroundThe role of children in the transmission of SARS-CoV-2 during the early pandemic was unclear.AimWe aimed to review studies on the transmission of SARS-CoV-2 by children during the early pandemic.MethodsWe searched MEDLINE, Embase, the Cochrane Library, Europe PubMed Central and the preprint servers medRxiv and bioRxiv from 30 December 2019 to 10 August 2020. We assessed the quality of included studies using a series of questions adapted from related tools. We provide a narrative synthesis of the results.ResultsWe identified 28 studies from 17 countries. Ten of 19 studies on household and close contact transmission reported low rates of child-to-adult or child-to-child transmission. Six studies investigated transmission of SARS-CoV-2 in educational settings, with three studies reporting 183 cases from 14,003 close contacts who may have contracted COVID-19 from children index cases at their schools. Three mathematical modelling studies estimated that children were less likely to infect others than adults. All studies were of low to moderate quality.ConclusionsDuring the early pandemic, it appeared that children were not substantially contributing to household transmission of SARS-CoV-2. School-based studies indicated that transmission rates in this setting were low. Large-scale studies of transmission chains using data collected from contact tracing and serological studies detecting past evidence of infection would be needed to verify our findings.
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COVID-19 , SARS-CoV-2 , Trazado de Contacto , Humanos , Pandemias , Instituciones AcadémicasRESUMEN
PURPOSE OF THE STUDY: Understanding self-directed learning (SDL) when using point of care information systems (POCIS) can inform educational providers of the usefulness of the system for continuing medical education (CME). Sen's capability approach can offer a unique perspective to understand SDL, which considers the extent to which individual valued learning needs can be achieved. The aim of the study was to pilot the use of a questionnaire informed by the capability approach for understanding SDL when using POCIS in the context of CME. METHODS: A semi-structured questionnaire aligned to the capability approach (Capability Approach for SDL with POCIS Questionnaire - CA-SPQ) in the context of CME was developed and implemented with 200 users of a POCIS (BMJ Best Practice). RESULTS: The response rate was 92 and 78% of users considered that their valued outcomes were achieved and that they could apply their new learning to practice. The questionnaire had high content, face, and construct validity. CONCLUSION: The CA-SPQ can offer a practical instrument to provide data and useful information for understanding SDL, when using POCIS in the context of CME. It also has the potential for adaptation to other areas of medical education.
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Educación a Distancia , Sistemas de Atención de Punto , Humanos , Educación Médica Continua , Aprendizaje , Sistemas de InformaciónRESUMEN
There is increased emphasis on adopting positive health and aging policy goals for heterogeneous older populations, and recognition of the role that participatory research approaches can play in supporting their implementation. However, questions remain about how to represent the marginalized experiences of some older populations within such processes. With a focus on older Irish ethnic Travelers and older homeless adults as two vulnerable populations in Ireland, this article presents and critically discusses a participatory approach developed to integrate marginalized older adult perspectives on positive health and aging in a multistakeholder research and development process. The qualitative methodology is first detailed, incorporating methods that harness collaboratively derived views and individual narratives (e.g., focus groups; consultation forums; in-depth interviews). Critical reflections on research implementation and specific considerations relevant to these populations are presented (e.g., trust building; one-to-one facilitation), with lessons then drawn for the design of multistakeholder participatory approaches with marginalized older populations.
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Personas con Mala Vivienda , Anciano , Envejecimiento , Investigación Participativa Basada en la Comunidad/métodos , Grupos Focales , Humanos , Confianza , Poblaciones VulnerablesRESUMEN
SUMMARY: TDAview is an online tool for topological data analysis (TDA) and visualization. It implements the Mapper algorithm for TDA and provides extensive graph visualization options. TDAview is a user-friendly tool that allows biologists and clinicians without programming knowledge to harness the power of TDA. TDAview supports an analysis and visualization mode in which a Mapper graph is constructed based on user-specified parameters, followed by graph visualization. It can also be used in a visualization only mode in which TDAview is used for visualizing the data properties of a Mapper graph generated using other open-source software. The graph visualization options allow data exploration by graphical display of metadata variable values for nodes and edges, as well as the generation of publishable figures. TDAview can handle large datasets, with tens of thousands of data points, and thus has a wide range of applications for high-dimensional data, including the construction of topology-based gene co-expression networks. AVAILABILITY AND IMPLEMENTATION: TDAview is a free online tool available at https://voineagulab.github.io/TDAview/. The source code, usage documentation and example data are available at TDAview GitHub repository: https://github.com/Voineagulab/TDAview.
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Análisis de Datos , Programas Informáticos , Algoritmos , Documentación , MetadatosRESUMEN
Growing demand for accountability, transparency, and efficiency in health professions education is expected to drive increased demand for, and use of, cost and value analyses. In this AMEE Guide, we introduce key concepts, methods, and literature that will enable novices in economics to conduct simple cost and value analyses, hold informed discussions with economic specialists, and undertake further learning on more advanced economic topics. The practical structure for conducting analyses provided in this guide will enable researchers to produce robust results that are meaningful and useful for improving educational practice. Key steps include defining the economic research question, identifying an appropriate economic study design, carefully identifying cost ingredients, quantifying, and pricing the ingredients consumed, and conducting sensitivity analyses to explore uncertainties in the results.
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Proyectos de Investigación , Investigadores , Empleos en Salud , HumanosRESUMEN
BACKGROUND: The use of levothyroxine to treat subclinical hypothyroidism is controversial. We aimed to determine whether levothyroxine provided clinical benefits in older persons with this condition. METHODS: We conducted a double-blind, randomized, placebo-controlled, parallel-group trial involving 737 adults who were at least 65 years of age and who had persisting subclinical hypothyroidism (thyrotropin level, 4.60 to 19.99 mIU per liter; free thyroxine level within the reference range). A total of 368 patients were assigned to receive levothyroxine (at a starting dose of 50 µg daily, or 25 µg if the body weight was <50 kg or the patient had coronary heart disease), with dose adjustment according to the thyrotropin level; 369 patients were assigned to receive placebo with mock dose adjustment. The two primary outcomes were the change in the Hypothyroid Symptoms score and Tiredness score on a thyroid-related quality-of-life questionnaire at 1 year (range of each scale is 0 to 100, with higher scores indicating more symptoms or tiredness, respectively; minimum clinically important difference, 9 points). RESULTS: The mean age of the patients was 74.4 years, and 396 patients (53.7%) were women. The mean (±SD) thyrotropin level was 6.40±2.01 mIU per liter at baseline; at 1 year, this level had decreased to 5.48 mIU per liter in the placebo group, as compared with 3.63 mIU per liter in the levothyroxine group (P<0.001), at a median dose of 50 µg. We found no differences in the mean change at 1 year in the Hypothyroid Symptoms score (0.2±15.3 in the placebo group and 0.2±14.4 in the levothyroxine group; between-group difference, 0.0; 95% confidence interval [CI], -2.0 to 2.1) or the Tiredness score (3.2±17.7 and 3.8±18.4, respectively; between-group difference, 0.4; 95% CI, -2.1 to 2.9). No beneficial effects of levothyroxine were seen on secondary-outcome measures. There was no significant excess of serious adverse events prespecified as being of special interest. CONCLUSIONS: Levothyroxine provided no apparent benefits in older persons with subclinical hypothyroidism. (Funded by European Union FP7 and others; TRUST ClinicalTrials.gov number, NCT01660126 .).
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Hipotiroidismo/tratamiento farmacológico , Tiroxina/administración & dosificación , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Fatiga/etiología , Femenino , Humanos , Hipotiroidismo/complicaciones , Análisis de Intención de Tratar , Masculino , Calidad de Vida , Tirotropina/sangre , Tiroxina/efectos adversos , Tiroxina/sangre , Insuficiencia del TratamientoRESUMEN
PURPOSE: The purpose of this study was to explore the knowledge, attitudes and practices of health professionals working in clinical trials, to pharmacovigilance and adverse drug reaction (ADR) reporting. METHODS: A mixed methods study comprising an online questionnaire disseminated from September to November 2018, three semi-structured interviews and four focus groups. The qualitative components were conducted with a random sample of questionnaire participants who had provided their contact details (n = 24). The qualitative interviews were conducted at a location convenient to the participant's place of work between October and December 2018. RESULTS: One hundred forty-eight participants completed the questionnaire. Study coordinators/project managers represented the largest group of participants ( 28.6%, n = 38). Poor knowledge or understanding of ADR reporting was the most frequently cited barrier to ADR reporting (75%, n = 93). The most common enabler to reporting was having a clear understanding of an ADR definition (85.7%, n = 108). Focus group and interview participants described having limited staff as a barrier to reporting an ADR. They welcomed the prospect of pharmacovigilance training and indicated that face-to-face training would be preferred to provision of online training. CONCLUSION: This study highlights key factors that influence the reporting of ADRs in clinical trials. Although the findings are specifically related to the clinical trial environment in Ireland, they may provide a useful platform for optimising the future conduct of trials. This research suggests that ADR reporting may be improved through provision of enhanced pharmacovigilance training to clinical trial staff.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Conocimientos, Actitudes y Práctica en Salud , Farmacovigilancia , Ensayos Clínicos como Asunto/métodos , Femenino , Grupos Focales , Personal de Salud/estadística & datos numéricos , Humanos , Entrevistas como Asunto , Irlanda , Masculino , Encuestas y CuestionariosRESUMEN
CONTEXT: High-quality research into education costs can inform better decision making. Improvements to cost research can be guided by information about the research questions, methods and reporting of studies evaluating costs in health professions education (HPE). Our objective was to appraise the overall state of the field and evaluate temporal trends in the methods and reporting quality of cost evaluations in HPE research. METHODS: We searched the MEDLINE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), EMBASE, Business Source Complete and ERIC (Education Resources Information Centre) databases on 31 July 2017. To evaluate trends over time, we sampled research reports at 5-year intervals (2001, 2006, 2011 and 2016). All original research studies in HPE that reported a cost outcome were included. The Medical Education Research Study Quality Instrument (MERSQI) and the BMJ economic checklist were used to appraise methodological and reporting quality, respectively. Trends in quality over time were analysed. RESULTS: A total of 78 studies were included, of which 16 were published in 2001, 15 in 2006, 20 in 2011 and 27 in 2016. The region most commonly represented was the USA (n = 43). The profession most commonly referred to was that of the physician (n = 46). The mean ± standard deviation (SD) MERSQI score was 10.9 ± 2.6 out of 18, with no significant change over time (p = 0.55). The mean ± SD BMJ score was 13.5 ± 7.1 out of 35, with no significant change over time (p = 0.39). A total of 49 (63%) studies stated a cost-related research question, 23 (29%) stated the type of cost evaluation used, and 31 (40%) described the method of estimating resource quantities and unit costs. A total of 16 studies compared two or more interventions and reported both cost and learning outcomes. CONCLUSIONS: The absolute number of cost evaluations in HPE is increasing. However, there are shortcomings in the quality of methodology and reporting, and these are not improving over time.
Asunto(s)
Lista de Verificación , Análisis Costo-Beneficio , Empleos en Salud , Calidad de la Atención de Salud , Proyectos de Investigación , Educación Médica , Empleos en Salud/educación , Empleos en Salud/tendencias , HumanosRESUMEN
BACKGROUND: E-Learning has taken a firm place in postgraduate medical education. Whereas 10 years ago it was promising, it now has a definite niche and is clearly here to stay. However, evaluating the effect of postgraduate medical e-learning (PGMeL) and improving upon it can be complicated. While the learning aims of e-learning are evaluated, there are no instruments to evaluate the instructional design of PGMeL. Such an evaluation instrument may be developed by following the Association for Medical Education in Europe (AMEE) 7-step process. The first 5 steps of this process were previously performed by literature reviews, focus group discussion, and an international Delphi study. OBJECTIVE: This study will continue with steps 6 and 7 and answer the research question: Is a content-validated PGMeL evaluation survey useful, understandable, and of added value for creators of e-learning? METHODS: There are five phases in this study: creating a survey from 37 items (phase A); testing readability and question interpretation (phase B); adjusting, rewriting, and translating surveys (phase C); gathering completed surveys from three PGMeL modules (phase D); and holding focus group discussions with the e-learning authors (phase E). Phase E was carried out by presenting the results of the evaluations from phase D, followed by a group discussion. There are four groups of participants in this study. Groups A and B are experienced end users of PGMeL and participated in phase B. Group C are users who undertook e-learning and were asked to complete the survey in phase D. Group D are the authors of the e-learning modules described above. RESULTS: From a list of 36 items, we developed a postgraduate Medical E-Learning Evaluation Survey (MEES). Seven residents participated in the phase B group discussion: 4 items were interpreted differently, 3 were not readable, and 2 items were double. The items from phase B were rewritten and, after adjustment, understood correctly. The MEES was translated into Dutch and again pilot-tested. All items were clear and were understood correctly. The MEES version used for the evaluation contained 3 positive domains (motivation, learning enhancers, and real-world translation) and 2 negative domains (barriers and learning discouragers), with 36 items in those domains, 5 Likert scale questions of 1 to 10, and 5 open questions asking participants to give their own comments in each domain. Three e-learning modules were evaluated from July to November 2018. There were a total of 158 responses from a Dutch module, a European OB/GYN (obstetrics and gynecology) module, and a surgical module offered worldwide. Finally, 3 focus group discussions took place with a total of 10 participants. Usefulness was much appreciated, understandability was good, and added value was high. Four items needed additional explanation by the authors, and a Creators' Manual was written at their request. CONCLUSIONS: The MEES is the first survey to evaluate the instructional design of PGMeL and was constructed following all 7 steps of the AMEE. This study completes the design of the survey and shows its usefulness and added value to the authors. It finishes with a final, publicly available survey that includes a Creators' Manual. We briefly discuss the number of responses needed and conclude that more is better; in the end, however, one has to work with what is available. The next steps would be to see whether improvement can be measured by using the MEES and continue to work on the end understandability in different languages and cultural groups.