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2.
J Trauma Nurs ; 28(3): 203-208, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1216691

RESUMEN

BACKGROUND: The American College of Surgeons (ACS), Committee on Trauma, trauma center verification process is designed to help hospitals improve trauma care. Due to the COVID-19 pandemic social distancing restrictions, performing virtual site visits was piloted. OBJECTIVE: The purpose of this article is to describe the first pilot ACS pediatric trauma center virtual reverification visit performed in the United States. METHODS: This is a descriptive review of a 2020 pilot virtual Level I pediatric trauma center reverification visit. In-person site visit checklists were altered to adjust to the virtual format. All documents, prereview questionnaire, patient charts, and resource documents were prepared electronically. Collaboration with the departments of information technology, clinical education and informatics, and the general counsel's office prepared the infrastructure to allow reviewers access to protected health information. RESULTS: Multiple hospital departments collaborated to facilitate the transition to an electronic format. Organized virtual meeting room scheduling, communications, and coordination between the ACS staff, the reviewers, and the various hospital departments resulted in a successful virtual visit. CONCLUSION: Lessons learned and opportunities for improvement were identified for this first-ever pilot virtual pediatric trauma center reverification site visit. Once the information technology logistic questions were answered, allowing reviewers protected health information access, the general program and document preparation for a virtual trauma reverification site visit was similar to an in-person site visit. Although the review day agenda was similar, execution challenges were identified.


Asunto(s)
Certificación/normas , Guías como Asunto , Unidades de Cuidado Intensivo Pediátrico/normas , Centros Traumatológicos/normas , Realidad Virtual , Adolescente , Niño , Preescolar , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Proyectos Piloto , Encuestas y Cuestionarios , Estados Unidos
3.
Am J Nurs ; 121(4): 65-68, 2021 04 01.
Artículo en Inglés | MEDLINE | ID: covidwho-1209640

RESUMEN

This article is one in a series in which contributing authors discuss how the United Nations (UN) Sustainable Development Goals (SDGs) are linked to everyday clinical issues; national public health emergencies; and other nursing issues, such as leadership, shared governance, and advocacy. The 2030 Agenda for Sustainable Development, a 15-year plan of action to achieve the goals, was unanimously adopted by all UN member states in September 2015 and took effect on January 1, 2016. The Agenda consists of 17 SDGs addressing social, economic, and environmental determinants of health and 169 associated targets focused on five themes: people, planet, peace, prosperity, and partnership. The SDGs build on the work of the UN Millennium Development Goals, which were in effect from 2000 to 2015. The current article highlights SDGs 5 (gender equality), 8 (decent work and economic growth), and 17 (partnerships for the goals), along with the advocacy of these goals by Sigma Theta Tau International Honor Society of Nursing in the UN system.


Asunto(s)
Equidad de Género , Salud Global/normas , Guías como Asunto , Atención de Enfermería/normas , Objetivos Organizacionales , Salud Pública/normas , Desarrollo Sostenible , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Naciones Unidas
5.
Indian J Med Ethics ; VI(2): 1-12, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206596

RESUMEN

On January 14, 2021, a WHO Ad Hoc expert group published an article in the highly influential The New England Journal of Medicine, titled: "Placebo-Controlled Trials of Covid-19 Vaccines - Why We Still Need Them" justifying the use of placebo in further trials of Covid-19 vaccines, even after purported efficacious vaccines have become available. Medical research involving human beings ought to conform strictly to principles, rules and procedures established since the Nuremberg Code (1947), especially as elaborated in the Declaration of Helsinki (2013) and the WHO/CIOMS Guidelines (2016). The NEJM article forms part of an observable trend of moral backsliding that needs to be recorded. In this paper, considering traditional medical research ethics under the impact of the Covid-19 pandemic and its ramifications and effects, and with a particular focus on the highly vulnerable populations and countries of sub-Saharan Africa, I make some relevant remarks. My arguments here are anchored in my observations as a moral philosopher though limited by my lack of expertise in any of the branches of medical science.


Asunto(s)
Investigación Biomédica/normas , /prevención & control , Ética Médica , Ética en Investigación , Guías como Asunto , Placebos/normas , Humanos , Pandemias , Organización Mundial de la Salud
6.
Indian J Med Ethics ; VI(2): 1-14, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206595

RESUMEN

The world is currently facing another severe pandemic, Covid-19, just four decades after the start of AIDS, and the still increasing incidence of HIV infection continues to be one of the greatest global health challenges. The way the latter was confronted is of fundamental importance for a serious discussion on global health, ethics and human rights, and this experience could and can still be applied to Covid-19. The Covid-19 pandemic has specific characteristics and these will be discussed, in relation to vaccine research and especially to the global right to equal access to products proven to be safe and effective. The article focusses primarily on issues related to Covid-19 vaccines, especially the appropriate use and limits on placebo, the right to post-trial access to placebo arm participants, and the use of an active control for subsequent Phase-3 trials after the approval of other safe and efficacious vaccines. Most importantly, it will emphasise that access to Covid-19 vaccines is a human right, which presupposes the establishment of appropriate ethical standards to ensure universal, equal, and affordable access to healthcare and to vaccines for all, and the imperative need for suspension of patents for products developed for Covid-19. It will consider the role of social determinants that contribute to the severity of Covid-19 and that must be addressed to effectively curb the current syndemic.


Asunto(s)
Investigación Biomédica/normas , /prevención & control , Guías como Asunto , Accesibilidad a los Servicios de Salud/ética , Accesibilidad a los Servicios de Salud/normas , Placebos/normas , Ética Médica , Derechos Humanos , Humanos , Pandemias
7.
Indian J Med Ethics ; VI(2): 1-6, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206594

RESUMEN

The WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation makes recommendations on the use of placebo controlled trials in ongoing and future Covid-19 vaccine research. These recommendations unequivocally prioritise data quality over participants' rights and safety. Participants in trials of vaccines which have received emergency use listing or authorisation would be refused available vaccines. Placebo-controlled trials that would be impossible to conduct in rich countries would be permitted in poor countries. If these suggestions are implemented, the major beneficiary will be the vaccine industry.


Asunto(s)
/normas , Ética Médica , Derechos del Paciente/ética , Derechos del Paciente/normas , Placebos/normas , Adulto , Anciano , Anciano de 80 o más Años , Investigación Biomédica , Exactitud de los Datos , Femenino , Guías como Asunto , Humanos , Masculino , Persona de Mediana Edad , Pandemias
8.
Indian J Med Ethics ; VI(2): 1-10, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206593

RESUMEN

This article compares the current debate over the use of placebos in developing country clinical trials of second generation Covid-19 vaccines with the debates over previous paradigmatic cases raising similar issues. Compared to the earlier zidovudine and Surfaxin trials, Covid-19 vaccine trials are likely to confer lower risk to placebo groups and to offer a greater number and variety of alternative study designs. However, turning to the developing world to conduct studies that would be unacceptable in developed countries, simply on the ground that Covid-19 vaccines are generally unavailable in developing countries, is not ethically justifiable. This is so whether the justification is rooted in total absence of vaccine in a given country or in developing country vaccine prioritisation practices, because at root both derive from economic, not scientific conditions. However, the advent of variants that may create genuine uncertainty as to comparator vaccine effectiveness could justify a placebo control, depending on vaccine characteristics, variant prevalence, the degree of variant resistance, and the acceptability of immune-bridging studies. These factors must be considered together in the necessary case-by-case assessment of the ethical justification for any proposed trial.


Asunto(s)
/normas , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/normas , Ética Médica , Derechos del Paciente/normas , Placebos/normas , Adulto , Anciano , Anciano de 80 o más Años , Países en Desarrollo , Femenino , Guías como Asunto , Humanos , Masculino , Persona de Mediana Edad , Pandemias , Factores de Riesgo
9.
Indian J Med Ethics ; VI(2): 1-7, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206592

RESUMEN

Vaccines preventing Covid-19 have been approved in several countries. Is it still ethically acceptable to use placebo controls during the development of other vaccine options? If two of the most influential international guidelines of biomedical research are consulted, the Declaration of Helsinki and the CIOMS-guidelines, the answer is "no". We discuss the implications for ongoing vaccine research, and how placebo controls might be justified nevertheless. However, the ethical conflict remains highly problematic. We suggest that such ethical dilemmas should be avoided in the future by the introduction of a new system of global governance. Once vaccines are approved, a global regulation should oblige producers to provide the necessary amount of vaccine doses for the control groups of ongoing vaccine research.


Asunto(s)
/normas , Ensayos Clínicos como Asunto/normas , Ética Médica , Guías como Asunto , Cooperación Internacional , Placebos/normas , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pandemias
10.
Indian J Med Ethics ; VI(2): 1-10, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206590

RESUMEN

Covid-19 vaccines are a critical tool for controlling the pandemic. While safe and effective vaccines have been developed, research is expected to continue for many years regarding the optimal implementation of existing vaccines in specific settings, and the development of second-generation vaccines that may offer advantages in terms of either efficacy or ease of implementation. Given this context, some commentators have argued that new Covid vaccine trials should be able to use placebo controls, and that existing studies should be able to continue with blinded participants in order to collect high quality, unbiased data. Using international ethics guidance documents, this paper argues against placebo controls, given the existence of proven effective interventions, and against protracted blinding once safety and efficacy milestones have been met. Instead, it advocates for study designs that allow for direct comparison between approved and experimental vaccines, which facilitates both data collection and greater access to vaccines.


Asunto(s)
Investigación Biomédica/normas , /prevención & control , Guías como Asunto , Derechos Humanos , Seguridad del Paciente/normas , Placebos/normas , Ética Médica , Humanos , Pandemias
11.
Indian J Med Ethics ; VI(2): 1-7, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206589

RESUMEN

Recently the WHO Ad Hoc Expert Group proposed that it is ethical to continue placebo-controlled Covid-19 vaccine trials in countries where vaccines are not available even if this vaccine is marketed and being used elsewhere. The reason for this proposal is the usual scientific argument claiming that these trials are the most efficient method to obtain reliable results, and individuals in these countries will continue to get the local standard of care, meaning no vaccination, and thus participants are not being left worse off. We refute this argument on two counts. First the global equity and justice issue, that the scarcity of vaccines in most countries is created by the rich nations that have hoarded vaccines. Second, the science versus research ethics issue, that there are valid scientific methods like non-inferiority trials which can give reliable results, and that applying a standard of care imposed by rich nations is both unethical and possibly exploitative. Thus, we feel that the WHO Ad Hoc Expert Group is wrong in proposing to continue placebo-controlled Covid-19 vaccine trials.


Asunto(s)
/normas , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/normas , Ética Médica , Derechos Humanos , Placebos/normas , Guías como Asunto , Humanos , Pandemias
12.
Indian J Med Ethics ; VI(2): 1-4, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206588

RESUMEN

The initial trials of SARS-CoV-2 vaccines were randomised control trials (RCT) with a placebo as control. The use of a placebo was ethically justified because, as with any new and emerging infectious disease, there was no known vaccine. There are now at least eight vaccines that have been shown to be effective and approved for emergency use, so the use of a placebo in the control group is no longer ethically justified. This article discusses why ethical guidelines should be continually evaluated in a changing landscape and why trust is so important.


Asunto(s)
Investigación Biomédica/ética , Investigación Biomédica/normas , /prevención & control , Ética Médica , Guías como Asunto , Placebos/normas , Humanos , Pandemias , Estados Unidos
13.
Indian J Med Ethics ; VI(2): 1-8, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206587

RESUMEN

A World Health Organization (WHO) Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation recently recommended placebo-controlled trials (PCT) of Covid-19 vaccines. PCTs are ethically acceptable when there is no proven effective and safe treatment for a certain condition. However, there are already some vaccines that have been approved and which have high levels of efficacy and safety. Any new vaccine under development must be tested against the most effective vaccines available. PCTs go against the participants' best interests, by putting them in a position of disadvantage while taking part in a trial, compared with people who are not in the trial and who could get vaccinated. Particularly in high-income countries, many people are getting vaccinated. This means that, following a recent trend in clinical trials, PCTs would have to be conducted in low- and middle-income countries, where there a number of advantages for drug companies, but where fatality rates of Covid-19 are, in many cases, much higher. For this and other reasons having to do with equal rights, participants in control groups should be protected with the most effective vaccines available.


Asunto(s)
Investigación Biomédica/ética , Investigación Biomédica/normas , /prevención & control , Ética Médica , Guías como Asunto , Placebos/normas , Humanos , Pandemias
14.
Indian J Med Ethics ; VI(2): 1-7, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206586

RESUMEN

Thanks to an impressive R&D effort, three vaccines for Covid-19 have been conditionally approved by stringent regulators as of February 2021, and sixteen have entered the WHO evaluation process. However, they all need to keep on being evaluated in clinical trials. The WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine suggested that countries with limited or no access to an effective vaccine could ethically permit placebo-controlled trials, even if effective vaccines were already being marketed elsewhere. Here, I argue that inclusion in a placebo-controlled trial is ethically sound for those who would be in any case ineligible for vaccination outside the trial, and as long as the access to the vaccine outside the trial depends on a transparent and just allocation framework. Conversely, carrying out placebo-controlled studies in countries where vaccines are not (or are insufficiently) available because of unequal global allocation, would be unethical, as an ethical strategy cannot be built on an unethical premise.


Asunto(s)
/normas , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/normas , Ética Médica , Guías como Asunto , Placebos/normas , Humanos , Pandemias
15.
Indian J Med Ethics ; VI(2): 1-2, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206585

RESUMEN

The government of India imposed a strict nationwide lockdown on March 24, 2020, to arrest the spread of Covid-19 (1). Abiding by the government regulations, several educational institutions including those in healthcare, postponed or cancelled several academic activities to curb the spread of the virus (2). Considering the high risk of infection transmission, several academic research projects involving human participants were paused. This has posed serious challenges in managing academic tasks such as teaching and learning activities related to research, participant examination and follow-up, field work for data collection, face-to-face discussion with colleagues, students and supervisors. Many academic healthcare research activities involve human subjects as research participants; but because of the lockdown, final year post-graduate students may not be able to complete their research projects within the stipulated time frame. Healthcare students are in a vulnerable situation because of the pressure to submit their research projects for the successful completion of the courses. Given this situation, it is probable that students may resort to unethical or fraudulent research activities such as data manipulation or fabrication to complete their research projects before the existing deadline. Such research, if published in the future, can damage the credibility and validity of the scientific evidence.

.


Asunto(s)
Investigación Biomédica/estadística & datos numéricos , Investigación Biomédica/normas , Control de Enfermedades Transmisibles/normas , Guías como Asunto , Pandemias/prevención & control , Cuarentena/normas , Adulto , Femenino , Humanos , India/epidemiología , Masculino , Persona de Mediana Edad , Adulto Joven
16.
Indian J Med Ethics ; VI(2): 1-6, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206583

RESUMEN

The ongoing Covid-19 pandemic, starting in China in late 2019, has spread to every corner of the world, and thrown up several important ethical challenges. The rising numbers of infected persons and of death rates are keeping the health systems of most countries on their toes. However, the heightened focus on infection prevention and control have left several aspects of peoples' social life unaddressed. The stringent lockdowns in many countries including India, the mandatory public health measures, such as quarantine, isolation and contact tracing, have left a deep impact on the lives of the people.


Asunto(s)
/prevención & control , Control de Enfermedades Transmisibles/normas , Trazado de Contacto/estadística & datos numéricos , Política de Salud , Pandemias/prevención & control , Salud Pública , Cuarentena/normas , Adulto , Anciano , Anciano de 80 o más Años , China , Control de Enfermedades Transmisibles/estadística & datos numéricos , Femenino , Guías como Asunto , Humanos , India , Masculino , Persona de Mediana Edad
17.
Indian J Med Ethics ; VI(2): 1-3, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1206578

RESUMEN

The Covid-19 pandemic has affected dental practice globally. Proximity with patients and predominance of aerosol-generating procedures has raised concerns regarding the safety of dentists and patients alike. The near-total, yet inevitable, suspension of dental practice has raised several ethical issues.


Asunto(s)
Odontología/normas , Ética Odontológica , Guías como Asunto , Pandemias , Humanos , Encuestas y Cuestionarios
19.
Nurs Res ; 70(3): 215-221, 2021.
Artículo en Inglés | MEDLINE | ID: covidwho-1199586

RESUMEN

BACKGROUND: Methodological guidelines are required to ensure both the rigor and feasibility of just-in-time, qualitative research addressing the human experience and response to the COVID-19 pandemic and major public health crises. OBJECTIVES: This article presents methodological guidelines for just-in-time qualitative research based on our current, pandemic-relevant research. METHODS: The processes followed while conducting two longitudinal, online qualitative studies addressing the lived experience and response to the COVID-19 pandemic were analyzed. Methodological challenges faced were then identified, and specific design and implementation guidelines were developed. The ways in which these guidelines can be applied to conduct just-in-time research during the COVID-19 pandemic and future public health crises were further delineated using examples from our pandemic-relevant research. RESULTS: Six guidelines were identified: (a) capitalize on fast track review and reporting processes; (b) prioritize accessibility during sample specification and selection; (c) optimize recruitment and retention strategies; (d) maximize current and future data use through strategic research design; (e) tailor data collection to participants' characteristics, preferences, and priorities; and (f) incorporate timeline mapping of personal and contemporaneous phenomena. DISCUSSION: Public health measures taken to slow disease spread during the current COVID-19 pandemic and future public health crises may slow the pace of research and make its implementation all the more challenging. However, just-in-time qualitative research advances our understanding of the human experience and response to the COVID-19 and major public health crises. It also complements existing behavioral theory and research. The guidelines presented may assist researchers to initiate necessary qualitative research more rapidly, with fewer logistic challenges, and with methodological rigor. They may also help expand research on groups experiencing collateral effects of the pandemic and major public health crisis. Lastly, the guidelines may support the development of more robust data for alternate analysis at a later date.


Asunto(s)
Guías como Asunto , Investigación Cualitativa , Proyectos de Investigación , Humanos
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