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1.
Can J Neurol Sci ; 49(2): 161-167, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-33766159

RESUMO

Recent evidence shows that subcutaneous immunoglobulin (SCIG) is as efficacious as intravenous immunoglobulin (IVIG) and has a better safety profile and acceptance rate among patients with neuromuscular disorders who require maintenance IVIG treatment. Awareness of the practical aspects of patient selection, enrollment, dose calculation, administration, and follow-up would help physicians coordinate a smooth and seamless transition from IVIG to SCIG. SCIG is ideally offered to patients having intolerable side effects during IVIG or wearing-off effect and in those keen for treatment autonomy. The weekly dose of SCIG is calculated by multiplying the maintenance dose of IVIG by the dose adjustment factor and dividing by the interval between IVIG in weeks and is initiated 1 week after the last dose of IVIG. The physician places the order for the SCIG and the clinic nurse or the physician refers the patient to the home care nursing program for further education and training. The necessary supplies are dispatched to the patient who would also collect the SCIG from the transfusion center of the nearest hospital. The patient is educated on assembling and administering the infusion, and home visits are continued until the patient or caregiver is confident. Regular follow-up with the patient is maintained to assess treatment response and side effects if any. With a smooth transition, most patients have excellent tolerance to SCIG and in our experience seldom request switching back to IVIG. Transitioning patients from IVIG to SCIG offers several advantages and thus, in general, is preferable for multiple stakeholders.


Assuntos
Imunoglobulinas Intravenosas , Doenças Neuromusculares , Administração Intravenosa , Cuidadores , Humanos , Imunização Passiva , Imunoglobulinas Intravenosas/uso terapêutico , Doenças Neuromusculares/tratamento farmacológico
2.
Muscle Nerve ; 62(5): 637-641, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32785949

RESUMO

BACKGROUND: We aimed to determine the safety and tolerance of higher rates of infusion of intravenous immunoglobulin (IVIG) in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). METHODS: Patients began infusions with 10% IVIG at the standard rate of 0.08 mL/kg/min. If tolerated, infusion rates were incrementally increased to 0.14 mL/kg/min. We considered the frequency of infusions with adverse events (AEs) as the primary outcome. RESULTS: Nineteen of 25 patients safely tolerated the maximum rate of 0.14 mL/kg/min. We observed 25 treatment-related AEs (TAEs) over 13 infusions at standard or transitional rates, across seven patients. We observed no TAEs associated with the maximum infusion rate. CONCLUSIONS: We found that 10% IVIG can be safely administered at a high infusion rate (0.14 ml/kg/min) in most CIDP patients, reducing the treatment time and burden on healthcare resources.


Assuntos
Imunoglobulinas Intravenosas/administração & dosagem , Imunoglobulinas Intravenosas/efeitos adversos , Polirradiculoneuropatia Desmielinizante Inflamatória Crônica/tratamento farmacológico , Idoso , Feminino , Humanos , Infusões Intravenosas/efeitos adversos , Infusões Intravenosas/métodos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Resultado do Tratamento
3.
Dev World Bioeth ; 20(2): 86-95, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31115148

RESUMO

A powerful feature of global health research is data-sharing with regions which bear the heaviest burden of disease. It offers novel opportunities for aggregating data to address critical global health challenges in ways higher than relying on individual studies. Yet there exist important stratifiers of the capacity to share data, particularly across the Global North-South divide. Systemic challenges that characterize sub-Saharan Africa and disadvantage the region's scientific productivity threaten the burgeoning data-sharing culture too. Like all endeavors requiring equal commitments under unequal circumstances, a strong ethical impetus is needed to help reduce inequities and imbalances to encourage adherence. This article discusses mandatory data-sharing in relation to peculiar challenges faced by sub-Saharan African scientists to suggest ethical principles for rethinking and reframing solutions. We propose six principles which mirror guidelines from the Institute of Medicine and encapsulate principles from the Emanuel Framework, Nairobi Data Sharing Principles, and the COHRED guidelines.


Assuntos
Pesquisa Biomédica/ética , Países em Desenvolvimento , Disseminação de Informação , África Subsaariana , Países Desenvolvidos , Ética em Pesquisa , Saúde Global , Recursos em Saúde , Humanos , Recompensa , Justiça Social
4.
BMC Med Ethics ; 19(1): 6, 2018 02 07.
Artigo em Inglês | MEDLINE | ID: mdl-29415709

RESUMO

BACKGROUND: A review of literature published a decade ago noted a significant increase in empirical papers across nine bioethics journals. This study provides an update on the presence of empirical papers in the same nine journals. It first evaluates whether the empirical trend is continuing as noted in the previous study, and second, how it is changing, that is, what are the characteristics of the empirical works published in these nine bioethics journals. METHOD: A review of the same nine journals (Bioethics; Journal of Medical Ethics; Journal of Clinical Ethics; Nursing Ethics; Cambridge Quarterly of Healthcare Ethics; Hastings Center Report; Theoretical Medicine and Bioethics; Christian Bioethics; and Kennedy Institute of Ethics Journal) was conducted for a 12-year period from 2004 to 2015. Data obtained was analysed descriptively and using a non-parametric Chi-square test. RESULTS: Of the total number of original papers (N = 5567) published in the nine bioethics journals, 18.1% (n = 1007) collected and analysed empirical data. Journal of Medical Ethics and Nursing Ethics led the empirical publications, accounting for 89.4% of all empirical papers. The former published significantly more quantitative papers than qualitative, whereas the latter published more qualitative papers. Our analysis reveals no significant difference (χ2 = 2.857; p = 0.091) between the proportion of empirical papers published in 2004-2009 and 2010-2015. However, the increasing empirical trend has continued in these journals with the proportion of empirical papers increasing from 14.9% in 2004 to 17.8% in 2015. CONCLUSIONS: This study presents the current state of affairs regarding empirical research published nine bioethics journals. In the quarter century of data that is available about the nine bioethics journals studied in two reviews, the proportion of empirical publications continues to increase, signifying a trend towards empirical research in bioethics. The growing volume is mainly attributable to two journals: Journal of Medical Ethics and Nursing Ethics. This descriptive study further maps the still developing field of empirical research in bioethics. Additional studies are needed to completely map the nature and extent of empirical research in bioethics to inform the ongoing debate about the value of empirical research for bioethics.


Assuntos
Bibliometria , Bioética/tendências , Pesquisa Biomédica/ética , Pesquisa Empírica , Análise Ética , Ética Clínica , Editoração/tendências , Temas Bioéticos , Ética Médica , Ética em Enfermagem , Ética em Pesquisa , Humanos , Publicações Periódicas como Assunto/tendências
5.
Dev World Bioeth ; 18(4): 331-340, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-28470856

RESUMO

OBJECTIVES: The study uses a qualitative empirical method to define Health Research for Development. This project explores the perspectives of stakeholders in an international health research partnership operating in Ghana and Tanzania. METHODS: We conducted 52 key informant interviews with major stakeholders in an international multicenter partnership between GlaxoSmithKline (GSK, Vaccine Developer) and the global health nonprofit organisation PATH and its Malaria Vaccine Initiative program (PATH/MVI, Funder-Development Partner), (RTS, S) (NCT00866619). The respondents included teams from four clinical research centres (two centres in Ghana and two in Tanzania) and various collaborating partners. This paper analyses responses to the question: What is Health Research for Development? RESULTS: Based on the stakeholders' experience the respondents offered many ways of defining Health Research for Development. The responses fell into four broad themes: i) Equitable Partnerships; ii) System Sustainability; iii) Addressing Local Health Targets, and iv) Regional Commitment to Benefit Sharing. CONCLUSION: Through defining Health Research for Development six key learning points were generated from the four result themes: 1) Ensure there is local research leadership working with the collaborative partnership, and local healthcare system, to align the project agenda and activities with local research and health priorities; 2) Know the country-specific context - map the social, health, legislative and political setting; 3) Define an explicit development component and plan of action in a research project; 4) Address the barriers and opportunities to sustain system capacity. 5) Support decentralised health system decision-making to facilitate the translation pathway; 6) Govern, monitor and evaluate the development components of health research partnerships. Overall, equity and unity between partners are required to deliver health research for development.


Assuntos
Pesquisa Biomédica , Cooperação Internacional , Projetos de Pesquisa , Atitude , Atenção à Saúde , Gana , Saúde Global , Prioridades em Saúde , Humanos , Malária/prevenção & controle , Pesquisa Qualitativa , Participação dos Interessados , Tanzânia , Vacinas
6.
Dev World Bioeth ; 18(2): 98-108, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-28008708

RESUMO

Existing ethics guidelines, influential literature and policies on ethical research generally focus on real-time data collection from humans. They enforce individual rights and liberties, thereby lowering need for aggregate protections. Although dependable, emerging public health research paradigms like research using public health data (RUPD) raise new challenges to their application. Unlike traditional research, RUPD is population-based, aligned to public health activities, and often reliant on pre-collected longitudinal data. These characteristics, when considered in relation to the generally lower protective ethico-legal frameworks of the Global South, including Africa, highlight ethical gaps. Health and demographic surveillance systems are examples of public health programs that accommodate RUPD in these contexts. We set out to explore the perspectives of professionals with a working knowledge of these systems to determine practical ways of appropriating the foundational principles of health research to advance the ever growing opportunities in RUPD. We present their perspectives and in relation to the literature and our ethical analysis, make context relevant recommendations. We further argue for the development of a framework founded on the discussions and recommendations as a minimum base for achieving optimal ethics for optimal RUPD in the Global South.


Assuntos
Países em Desenvolvimento , Ética em Pesquisa , Disseminação de Informação/ética , Saúde Pública , Pesquisa , África , Análise Ética , Saúde Global , Humanos , Ética Baseada em Princípios
7.
Dev World Bioeth ; 18(4): 394-405, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-28745008

RESUMO

Data-sharing is a desired default in the field of public health and a source of much ethical deliberation. Sharing data potentially contributes the largest, most efficient source of scientific data, but is fraught with contextual challenges which make stakeholders, particularly those in under-resourced contexts hesitant or slow to share. Relatively little empirical research has engaged stakeholders in discussing the issue. This study sought to explore relevant experiences, contextual, and subjective explanations around the topic to provide a rich and detailed presentation of what it means to different stakeholders and contexts to share data and how that can guide practice and ethical guidance. A qualitative design involving interviews was undertaken with professionals working in public health institutions endowed with data (HDSS), ethics committees, and advisory agencies which help shape health research in Africa. A descriptive form of thematic analysis was used to summarize results into six key themes: (1) The role of HDSSs in research using public health data and data-sharing; (2) Ownership and funding are critical factors influencing data-sharing; (3) Other factors discourage data-sharing; (4) Promoting and sustaining data-sharing; (5) Ethical guidance structures; and (6) Establishing effective guidance. The themes reveal factors regarding the willingness or not to share and an intricate ethical system that current discourse could reflect. Many of the concerns resonate with the literature, but a whole other gamut of people and process issues; commitments, investments, careers, and the right ethical guidance are needed to realize a sustainable goal of reaching 'share' as a default.


Assuntos
Acesso à Informação/ética , Atitude , Pesquisa Biomédica/ética , Recursos em Saúde , Disseminação de Informação/ética , Saúde Pública/ética , Participação dos Interessados , África , Temas Bioéticos , Coleta de Dados , Países em Desenvolvimento , Comissão de Ética , Ética em Pesquisa , Organização do Financiamento , Humanos , Propriedade , Pesquisa Qualitativa
8.
Medsurg Nurs ; 25(3): 145-52, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27522840

RESUMO

Present financial consequences imposed by the Affordable Care Act, along with practice challenges to address rates of 30-day readmission among patients with heart failure, emphasize the need for effective interventions. Healthcare workers must identify effective interventions to reduce readmission of patients with heart failure while providing high-quality care.


Assuntos
Insuficiência Cardíaca/epidemiologia , Readmissão do Paciente , Humanos , Medicare , Patient Protection and Affordable Care Act , Estados Unidos
9.
J Empir Res Hum Res Ethics ; 13(3): 258-269, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29756531

RESUMO

This study explores stakeholder experiences and perspectives on end-of-trial obligations at the close of a phase II/III Pediatric Malaria Vaccine Trial (PMVT) [GSK/PATH-MVI RTS, S) (NCT00866619]. We conducted 52 key informant interviews with major stakeholders of an international multicentre PMVT in Ghana and Tanzania. The responses fell into four main themes: (a) Communicating End-of-Trial, (b) Maintaining Health Care Services, (c) Dissemination of Results, and (d) Post-Trial Access. Interviewee responses shared important practical experiences and insights that complement current thinking in the literature on research ethics guidance: (a) accompany end-of-trial communication with information on personal and family health care responsibilities, (b) establish public health indicators to measure the impact of research on a health care system,


Assuntos
Atitude , Pesquisa Biomédica/ética , Atenção à Saúde , Vacinas Antimaláricas , Malária/prevenção & controle , Obrigações Morais , Participação dos Interessados , Criança , Comunicação , Ética em Pesquisa , Gana , Serviços de Saúde , Humanos , Disseminação de Informação , Pediatria , Saúde Pública , Tanzânia
10.
J Empir Res Hum Res Ethics ; 13(1): 26-41, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29179625

RESUMO

This study explores ethical issues raised in providing medical care to participants and communities of low-resource settings involved in a Phase II/III pediatric malaria vaccine trial (PMVT). We conducted 52 key informant interviews with major stakeholders of an international multi-center PMVT (GSK/PATH-MVI RTS,S) (NCT00866619) in Ghana and Tanzania. Based on their stakeholder experiences, the responses fell into three main themes: (a) undue inducement, (b) community disparities, and (c) broad therapeutic misconceptions. The study identified the critical ethical aspects, from the perspectives of stakeholders, of delivering health care during a PMVT. The study showed that integrating research into health care services needs to be addressed in a manner that upholds the favorable risk-benefit ratio of research and attends to the health needs of local populations. The implementation of research should aim to improve local standards of care through building a collaborative agenda with local institutions and systems of health.


Assuntos
Pesquisa Biomédica/ética , Atenção à Saúde/ética , Ética Clínica , Serviços de Saúde/ética , Vacinas Antimaláricas , Malária/prevenção & controle , Mal-Entendido Terapêutico , Atitude , Pré-Escolar , Países em Desenvolvimento , Ética em Pesquisa , Gana , Recursos em Saúde , Humanos , Lactente , Motivação , Pediatria/ética , Pobreza , Projetos de Pesquisa , Características de Residência , Participação dos Interessados , Tanzânia
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