Faculty Opinions recommendation of FDA Briefing Document: Moderna COVID-19 Vaccine.

Background Nursing education has evolved in line with societal needs, and simulation-based learning (SBL) is increasingly being used to bridge the gap between practice and education. Previous literature reviews have demonstrated the effectiveness of using SBL in nursing education. However, there is a need to explore how and why it works to expand the theoretical foundation of SBL. Objective This review aims to understand how, why, and in what circumstances the use of simulation affects learning as part of the bachelor’s program in nursing. Methods A realist review will be conducted in accordance with the realist template for a systematic review. In particular, we will identify and explore the underlying assumption of how SBL is supposed to work, that is, identify and explore program theories of SBL. The review will be carried out as an iterative process of searching, appraising, and synthesizing the evidence to uncover theoretical concepts that explain the causal effects of SBL. In the final section of the review, we will involve stakeholders in the Norwegian community in a web-based Delphi survey to ensure that the emerging theoretical framework derived from the published literature aligns with stakeholders’ experience in practice. Results We have performed an initial literature search, whereas quality appraisal and data extraction are ongoing processes. Conclusions The Norwegian Centre for Research Data (project number 60415) has approved the study. The final outcome of the review is anticipated to extend the theoretical foundation for using simulation as an integrated component of the bachelor’s program in nursing. Furthermore, the findings will be used to produce a briefing document containing guidance for national stakeholders in the community of simulation-based nursing education. Finally, the review findings will be disseminated in a peer-reviewed journal as well as national and international conferences. International Registered Report Identifier (IRRID) DERR1-10.2196/16363

Download Full-text

Public Benefit: the challenge for development-led archaeology in the UK

Internet Archaeology ◽

10.11141/ia.57.1 ◽

2021 ◽

Author(s):

Sadie Watson

Keyword(s):

Best Practice ◽

Theoretical Concept ◽

The Public ◽

Public Benefit ◽

Development Control ◽

Research And Innovation ◽

Archaeological Work ◽

Briefing Document ◽

The Uk ◽

New Research

The challenge of providing public benefit from development control archaeology has been a concern across Europe after both the Valletta and Faro conventions encouraged the view that the public must be the key beneficiaries of archaeological work, and since then the theoretical concept of public benefit has become well recognised across our profession. However, it seems to me that the archaeological sector does not yet provide this in a meaningful way or know how to maximise the public benefit potential of our work; indeed, this is acknowledged at the highest levels (e.g. British Academy 2017, 33). The EAC established their Working Group on 'Making the Case' to investigate examples of best practice and provide a practical toolkit for the better articulation of public benefit arising from development-led archaeology (EAC 2019). In the UK the Chartered Institute for Archaeologists has published a briefing document that outlines the potential for public benefit offered by archaeology (CIfA 2020). This dovetails well with a new research project, funded by United Kingdom Research and Innovation (UKRI) and hosted at Museum of London Archaeology (MOLA), intended to ensure that public benefit is at the heart of decision-making throughout the development control sector in the UK (MOLA 2019). This article provides an introduction to the rationale behind this project and outlines how the project ambitions could be achieved through a careful navigation through the complex structures of development programmes' procurement and management.

Download Full-text

The Jonglei Canal - Earthscan Briefing Document #8

SSRN Electronic Journal ◽

10.2139/ssrn.4001392 ◽

1978 ◽

Author(s):

Arnold Michael Muller

Keyword(s):

Briefing Document

Download Full-text

Adverse Events Following COVID-19 Vaccine in Patients Previously Injected with Facial Filler: Scoping Review and Case Report

Applied Sciences ◽

10.3390/app112210888 ◽

2021 ◽

Vol 11 (22) ◽

pp. 10888

Author(s):

Raffaele Rauso ◽

Giorgio Lo Giudice ◽

Nicola Zerbinati ◽

Giovanni Francesco Nicoletti ◽

Romolo Fragola ◽

...

Keyword(s):

Adverse Event ◽

Case Report ◽

Adverse Events ◽

Scoping Review ◽

Selection Process ◽

Adverse Event Rate ◽

Cochrane Library ◽

Low Molecular Weight ◽

Facial Filler ◽

Briefing Document

The “Vaccines and Related Biological Products Advisory Committee 17 December 2020 Meeting Briefing Document”, formulated by the FDA, reported three cases of swelling in areas previously injected with HA filler, introducing the possible relationship between a COVID-19 vaccine and adverse events in areas previously injected with HA fillers. The aim of this research is to report a case of an adverse event following a COVID-19 vaccine in a patient previously injected with facial filler. Furthermore, a scoping review on the same topic was performed. The research was carried out on the electronic databases PubMed, Cochrane Library, Web of Science, Google Scholar and Scopus. The selection process identified four articles as eligible for inclusion in the review. Nineteen patients, including the described case report, who experienced an adverse event following a COVID-19 vaccine in areas previously injected with facial filler were identified. Adverse events following a COVID-19 vaccine in patients previously injected with facial filler appear to be rare. A high BDDE cross-linking rate and/or a low-molecular-weight hyaluronic acid filler may have a higher tardive adverse event rate when triggered.

Download Full-text

Pimavanserin (Nuplazid™) for the treatment of Parkinson disease psychosis: A review of the literature

Mental Health Clinician ◽

10.9740/mhc.2017.09.230 ◽

2017 ◽

Vol 7 (5) ◽

pp. 230-234 ◽

Cited By ~ 3

Author(s):

Katie T. B. Touma ◽

Daniel C. Touma

Keyword(s):

Parkinson Disease ◽

Clinical Utility ◽

Psychotic Symptoms ◽

Controlled Trials ◽

Agonist Activity ◽

Review Of The Literature ◽

Additional Information ◽

Randomized Controlled ◽

Receptor Profile ◽

Briefing Document

Abstract Introduction: Pimavanserin (Nuplazid™) is an atypical antipsychotic currently indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis. The antipsychotic effects of this new agent are believed to occur via selective inverse agonist activity at serotonin 5-HT2a receptors. Methods: Study authors completed a literature review of 2 published randomized controlled trials of pimavanserin for the treatment of Parkinson disease psychosis. The Food and Drug Administration Briefing Document by the Psychopharmacologic Drugs Advisory Committee for the review of pimavanserin dated March 29, 2016, was reviewed for additional information on 2 unpublished trials. Results: Pimavanserin has demonstrated no worsening of motor symptoms of Parkinson disease, but only 1 of 4 trials has shown consistent statistically significant improvements in psychotic symptoms compared with placebo. Discussion: Options for the treatment of Parkinson disease psychosis are limited. The selective receptor profile of pimavanserin offers advantages for tolerability. Further studies are warranted to better provide clinicians and patients with information regarding the clinical utility of this agent.

Download Full-text