Placebo in new Covid-19 vaccine trials: data quality prioritised over participants' rights.

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.

Trials for second generation Covid-19 vaccines: Revisiting the debate over placebo use in developing country clinical trials.

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.

Unblinding in Randomized Controlled Trials: A Research Ethics Case.

A pregnant woman was enrolled in a double-blind randomized controlled trial (RCT) in which participants were randomized to a placebo or a drug being tested to prevent a hypertensive complication. After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy. This case highlights an element of RCT procedure that has received minimal attention-whether to unblind study participants at the end of their participation. Given that unblinding is not standard practice for nonserious adverse events, what actions are justifiable for the investigators to take? To synthesize the information about this case, we used the CASES model, created by the National Center for Ethics in Health Care to analyze ethics cases. Ethical principles that guide research emphasize communication with participants and the importance of reducing harm within the constraints of the scientific goals. Participants may value knowing which drug they received for future health care decision-making. We review information about the benefits and harms of unblinding.

Do pré-natal ao parto: um estudo transversal sobre a influência do acompanhante nas boas práticas obstétricas no Sistema Único de Saúde em Santa Catarina, 2019 / Desde la atención prenatal hasta el parto: un estudio transversal sobre la influencia del acompañante en las buenas prácticas obstétricas el Sistema Único de Salud en Santa Catarina, Brasil, 2019 / From prenatal care to childbirth: a cross-sectional study on the influence of a companion on good obstetric practices in the Brazilian National Health System in Santa Catarina State, 2019

Objetivo: Analisar a associação da presença de acompanhante no pré-natal e parto com a qualidade da assistência recebida por usuárias do Sistema Único de Saúde (SUS). Métodos Estudo transversal com puérperas que realizaram pré-natal e parto pelo SUS em Santa Catarina, Brasil, em 2019, entrevistadas em até 48 horas após o parto. Estimaram-se as razões de prevalências mediante regressão de Poisson. Resultados Entrevistaram-se 3.580 puérperas. No pré-natal, a presença de acompanhante associou-se positivamente ao recebimento de orientações pelos profissionais da saúde (RP=1,27 - IC95% 1,08;1,50) e à construção do plano de parto (RP=1,51 - IC95% 1,15;1,97). No parto, a presença de acompanhante associou-se ao maior recebimento de analgesia (RP=2,89 - IC95% 1,40;5,97), manobra não farmacológica para alívio da dor (RP=1,96 - IC95% 1,44;2,65), escolha da posição para o parto (RP=1,63 - IC95% 1,24;2,16) e menor probabilidade de ser amarrada (RP=0,47 - IC95% 0,35;0,63). Conclusão A presença de acompanhante no pré-natal e parto mostrou-se associada à melhor qualidade da assistência.

Objetivo: Analizar la asociación entre presencia de acompañante durante atención prenatal y parto con la calidad de atención que reciben las usuarias del Sistema Único de Salud (SUS). Métodos Estudio transversal con puérperas que recibieron atención prenatal y parto por el SUS en Santa Catarina, Brasil, en 2019, entrevistadas hasta 48 horas posparto. Las razones de prevalencia se estimaron mediante la regresión de Poisson. Resultados Se entrevistaron 3,580 puérperas. En la atención prenatal, la presencia de acompañante se asoció positivamente a recibir orientación de los profesionales de salud (RP=1,27 - IC95% 1,08; 1,50) y la construcción del plan de parto (RP=1,51 - IC95% 1,15; 1,97). En el momento del parto, se asoció con mayor recepción de analgesia (RP=2,89 - IC95% 1,40;5,97), maniobras no-farmacológicas para alivio del dolor (RP=1,96 - IC95% 1,44;2,65), elección de la posición para el parto (RP=1,63 - IC95% 1,24;2,16) y menor probabilidad de estar atada (RP=0,47 - IC95% 0,35;0,63). Conclusión La presencia de acompañante en la atención prenatal y el parto se asoció con una mejor calidad de la atención.

Objective: To analyze association between presence of a companion during prenatal consultations and childbirth and quality of care received by puerperal women using the Brazilian National Health System (SUS). Methods This was a cross-sectional study with puerperal women who underwent prenatal care and delivery on the SUS in Santa Catarina State, Brazil, in 2019, and who were interviewed within 48 hours postpartum. Prevalence ratios were estimated using Poisson regression. Results 3,580 puerperal women were interviewed. In prenatal care, presence of a companion was positively associated with receiving guidance from health professionals (PR=1.27 - 95%CI 1.08;1.50) and building a birth plan (PR=1.51 - 95%CI 1.15;1.97). At delivery, presence of a companion was associated with greater receipt of analgesics (PR=2.89 - 95%CI 1.40;5.97), non-pharmacological pain relief management (PR=1.96 - 95%CI 1.44;2.65), choice of position for delivery (PR=1.63 - 95%CI 1.24;2.16) and less likelihood of being strapped down (PR=0.47 - 95%CI 0.35;0.63). Conclusion Presence of a companion during prenatal care and delivery was associated with better quality of care.

An audit tool for relicensing inspection for private hospitals in eThekwini district, South Africa.

BACKGROUND: South Africa is moving towards National Health Insurance (NHI), which aims to provide access to universal health coverage for all South Africans. The NHI will only accredit and contract eligible health facilities that meet nationally approved quality standards in the public and private sector. Detailed tools for measuring compliance with the National Core Standards (NCS) and Batho Pele principles have been developed and implemented in the public sector. To date and since its implementation in the public sector, very little is known about the national audit tool and the method used to evaluate quality and patient safety standards in private hospitals in eThekwini district. OBJECTIVE: The aim of the study was to develop an audit tool for relicensing inspection of private hospitals in eThekwini district based on the clinical domains of the NCS and Batho Pele principles. METHODOLOGY: An exploratory sequential mixed method research design was used with a qualitative first phase involving 24 nurse managers through purposive sampling. This was followed by a quantitative phase in which a structured questionnaire was administered to 270 nurses who were randomly sampled for the study from 4 hospitals. RESULTS: The results revealed that the NCS and the Batho Pele principles are not fully implemented or evaluated in the selected hospitals in eThekwini district. CONCLUSION: These findings were significant and denoted the need for a standardised clinical audit tool for private hospitals in eThekwini district.

Primary health care, the Declaration of Astana and COVID-19.

Four decades after the Declaration of Alma-Ata, its vision of health for all and strategy of primary health care are still an inspiration to many people. In this article we evaluate the current status of primary health care in the era of the Declaration of Astana, the sustainable development goals, universal health coverage and the coronavirus disease 2019 pandemic. We consider how best to guide greater application of the primary health care strategy, reflecting on tensions that remain between the political vision of primary health care and its implementation in countries. We also consider what is required to support countries to realize the aspirations of primary health care, arguing that national needs and action must dominate over global preoccupations. Changing contexts and realities need to be accommodated. A clear distinction is needed between primary health care as an inspirational vision and set of values for health development, and primary health care as policy and implementation space. To achieve this vision, political action is required. Stakeholders beyond the health sector will often need to lead, which is challenging because the concept of primary health care is poorly understood by other sectors. Efforts on primary health care as policy and implementation space might focus explicitly on primary care and the frontline of service delivery with clear links and support to complementary work on social determinants and building healthy societies. Such efforts can be partial but important implementation solutions to contribute to the much bigger political vision of primary health care.

Quarante ans après la Déclaration d'Alma-Ata, sa vision en matière de santé universelle et sa stratégie de soins de santé primaires demeurent une inspiration pour de nombreuses personnes. Dans cet article, nous évaluons l'état actuel des soins de santé primaires à l'ère de la Déclaration d'Astana, des objectifs de développement durable, de la couverture maladie universelle et de la pandémie de maladie à coronavirus 2019 (COVID-19). Nous tentons de déterminer quel est le meilleur moyen de favoriser une application plus vaste de la stratégie de soins de santé primaires, en tenant compte des tensions qui subsistent entre la vision politique des soins de santé primaires et leur mise en œuvre dans les différents pays. Nous identifions également les éléments qui aident les pays à concrétiser les aspirations liées aux soins de santé primaires, et affirmons que les besoins et actions à l'échelle nationale doivent primer sur les préoccupations internationales. L'évolution des contextes et des réalités doit être prise en considération. Il est impératif d'opérer une nette distinction entre les soins de santé primaires comme source d'inspiration et ensemble de valeurs guidant le développement sanitaire d'une part, et comme espace politique et de mise en œuvre de l'autre. Pour y parvenir, des actes politiques sont indispensables. Des intervenants n'appartenant pas au secteur de la santé devront souvent prendre l'initiative, ce qui représente un défi car le concept des soins de santé primaires suscite l'incompréhension dans les autres secteurs. Les efforts en matière d'espace politique et de mise en œuvre pourraient se concentrer explicitement sur les soins de santé primaires et la première ligne des prestations de service, avec des liens clairement établis et un soutien aux travaux complémentaires consacrés aux déterminants sociaux et à la création d'une société saine. De tels efforts peuvent offrir des solutions partielles mais essentielles à l'élaboration d'une vision politique bien plus large des soins de santé primaires.

Cuatro décadas después de la Declaración de Almá Atá, su visión de la salud para todos y su estrategia de atención primaria de salud siguen siendo una inspiración para muchas personas. En este artículo se evalúa el estado actual de la atención primaria de salud en la era de la Declaración de Astaná, los objetivos de desarrollo sostenible, la cobertura sanitaria universal y la pandemia de la enfermedad por coronavirus de 2019. Se analiza la mejor manera de orientar una mayor aplicación de la estrategia de atención primaria de salud al estudiar las tensiones que subsisten entre la visión política de la atención primaria de salud y su aplicación en los países. También se analiza lo que se requiere para ayudar a los países a materializar las aspiraciones de la atención primaria de salud al argumentar que las necesidades y las medidas nacionales deben prevalecer sobre las preocupaciones mundiales. Se deben tener en cuenta los contextos y las realidades cambiantes. Hay que establecer una clara diferencia entre la atención primaria de salud como visión inspiradora y conjunto de valores para el desarrollo de la salud, y la atención primaria de salud como entorno normativo y de aplicación. Por consiguiente, se requiere la adopción de medidas políticas para hacer realidad esta visión. Con frecuencia, las partes interesadas que no pertenecen al sector sanitario tendrán que tomar la iniciativa, lo que supone un reto porque el concepto de atención primaria de salud no se comprende bien en otros sectores. Los esfuerzos relacionados con la atención primaria como entorno normativo y de aplicación se podrían centrar de manera explícita en la atención primaria y en la prestación de servicios de primera línea a través de vínculos claros y el apoyo a la labor complementaria sobre los determinantes sociales y la construcción de sociedades sanas. Esos esfuerzos pueden ser soluciones parciales pero importantes de aplicación para contribuir a la visión política mucho más amplia de la atención primaria de salud.

A Matter of Justice: "Fat" Is Not Necessarily a Bad Word.

This essay argues that the discrimination that fat patients face is an issue of health justice. Insofar as this is the case, bioethicists and health care providers should not only care about it but also work to dismantle the systematic, institutional, social, and individual factors that are contributing to it to ensure that fat patients receive high-quality health care, free of stigma and discrimination. The essay discusses a variety of ways in which fat patients are discriminated against and considers the false assumptions that fuel such discrimination. It concludes by considering the structural and social issues that contribute to fatness and pushes health care providers to abandon the assumption that being fat is an individual moral failing. Ultimately, the paper argues, "fat" is not necessarily a bad word, nor one that health care providers should avoid.

Developing a Patient Charter for People Living With Conditions, Diseases, or Traumas Involving the Skin [Formula: see text].

BACKGROUND: Studies have shown disparities in the perception of skin disease burden between patients and physicians, with patients often feeling that the severity, emotional impact, and social repercussions of their skin condition are underestimated. Although physician's professional behavior is guided by documents such as the Hippocratic Oath, there are no patient-driven principles to guide healthcare interactions involving skin concerns. OBJECTIVE: To develop a concise and practical charter for patients based on their perceptions of unmet needs with the goals of helping patients express their needs and exercise their rights to accessing and utilizing the healthcare system for conditions, diseases, or traumas involving the skin. METHODS: An initial literature review examined healthcare delivery concerns of patients with skin conditions. Results were used to draft a charter that was reviewed by a Canadian patient focus group representing various skin condition advocacy groups. A revised charter was reviewed by Canadian dermatologists before being formally approved by the Canadian Skin Patient Alliance Board and endorsed by the Canadian Dermatology Association. RESULTS: The Patient Charter comprises 8 principles for providing and receiving professional services for the skin in the healthcare setting. CONCLUSIONS: This Patient Charter provides direct insights into patient priorities and will be used as an educational and advocacy tool in healthcare, occupational, and social settings. The intended goal is for the Patient Charter to empower patients and to educate health professions, government, industry, and society at large. Accordingly, the charter will be disseminated through print materials, informational videos, and social media campaigns.

Humanizing birth in Tanzania: a qualitative study on the (mis) treatment of women during childbirth from the perspective of mothers and fathers.

BACKGROUND: While there has been a trend for greater number of women to deliver at health facilities across Tanzania, mothers and their family members continue to face mistreatment with respectful maternity care during childbirth being violated. The objective of this study was to describe the experience of mothers and fathers in relation to (mis) treatment during childbirth in Tanzania. METHODS: Using a qualitative descriptive design, 12 semi-structured interviews and four focus group discussions were held with mothers and fathers who were attending a postnatal clinic in the Lake Zone region of Tanzania. Mothers' age ranged from 20 to 45 years whereas fathers' age ranged from 25 to 60 years. Data were analyzed using a priori coding based on Bohren's et al. typology of the mistreatment of women during childbirth. RESULTS: Mothers reported facing mistreatment and disrespectful maternity care through verbal abuse (harsh or rude language and judgmental or accusatory comments), failure to meet professional standards of care (refused pain relief, unconsented surgical operations, neglect, abandonment or long delays, and skilled attendant absent at time of delivery), poor rapport between women and providers (poor communication, lack of supportive care, denied husbands presence at birth, denied mobility, denied safe traditional practices, no respect for their preferred birth positions), and health system conditions and constraints (poor physical condition of facilities, supply constraints, bribery and extortion, unclear fee structures). Despite some poor care, some mothers also reported positive birthing experiences and respectful maternity care by having a skilled attendant assistance at delivery, having good communication from nurses, receiving supportive care from nurses and privacy during delivery. CONCLUSION: Despite the increasing number of deliveries occurring in the hospital, there continue to be challenges in providing respectful maternity care. Humanizing birth care in Tanzania continues to have a long way to go, however, there is evidence that changes are occurring as mothers notice and report positive changes in delivery care practices.

Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine.

Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of patients and society as a whole. Given these concerns, how should we control and oversee innovative practice, and in particular, how should we coordinate innovative practice and clinical research? In this article, I argue that an ethical approach overseeing innovative practice must encourage the early transition to rigorous clinical research without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients.

Protecting privacy to protect mental health: the new ethical imperative.

Confidentiality is a central bioethical principle governing the provider-patient relationship. Dating back to Hippocrates, new laws have interpreted it for the age of precision medicine and electronic medical records. This is where the discussion of privacy and technology often ends in the scientific health literature when Internet-related technologies have made privacy a much more complex challenge with broad psychological and clinical implications. Beyond the recognised moral duty to protect patients' health information, clinicians should now advocate a basic right to privacy as a means to safeguard psychological health. The article reviews empirical research into the functions of privacy, the implications for psychological development and the resigned sentiment taking hold regarding the ability to control personal data. The article concludes with a call for legislative, educational and research steps to readjust the equilibrium between the individual and 'Big Data'.

Chemotherapy and Supportive Care Agents as Essential Medicines for Children With Cancer.

In resource-rich countries, 5-year survival rates for children with cancer approach 85%. This impressive statistic is largely the result of integrating research with clinical care. At the core of this endeavor are multiagent combination chemotherapy and supportive care agents (CASCA). Most CASCAs belong to the class of sterile injectable drugs, which make up the backbone of many proven and life-saving pediatric oncology regimens. There are few if any alternative agents available to treat most life-threatening childhood cancers. In the United States, shortages of CASCAs are now commonplace. The consequences of drug shortages are far reaching. Beyond the economic costs, these shortages directly affect patients' lives, and this is especially true for children with cancer. Drug shortages in general and shortages of CASCAs specifically result in increased medication errors, delayed administration of life-saving therapy, inferior outcomes, and patient deaths. One way to mitigate drug shortages is to adopt an essential medicines list and ensure that these medications remain in adequate supply at all times. We argue for creation of a CASCA-specific essential medicines list for childhood cancer and provide ethical and policy-based reasoning for this approach. We recognize that such a call has implications beyond pediatric cancer, in that children with other serious disease should have an equal claim to access to guaranteed evidence-based medicines. We provide these arguments as an example of what should be claimed for medical indications that are deemed essential to preserve life and function.

Health care reform in Iran: Implications for nurses' moral distress, patient rights, satisfaction and turnover intention.

AIM: The aim of the present study was to assess the implications of Iran's recent health care reforms on nurses' experience of moral distress, their perceptions of the respect for patient rights and the relationship of these variables to job and income dissatisfaction and turnover intention. BACKGROUND: Health systems around the world are reforming themselves to adapt to meeting the future needs of increasing patient care to an ever-growing population. METHODS: This was a cross-sectional correlational study. The participants were 276 nurses at six large private and public hospitals in Tehran, Iran. FINDINGS: Negative correlations were reported between turnover intention and respecting patient rights (r = -0.560, p < 0.001), satisfaction with job (r = -0.710, p < 0.001) and satisfaction with income (r = -0.226, p < 0.001). The correlation between moral distress intensity (r = 0.626, p < 0.001) and frequency (r = 0.701, p < 0.001) was positive with turnover intention. CONCLUSIONS: Moral distress was significantly correlated to poor respect for patient rights, poor job satisfaction and income satisfaction and was a major predictor of turnover intention. IMPLICATIONS FOR NURSING MANAGEMENT: Health system reform must take into account the concomitant increasing workload and its negative impact in order to ensure that reform does not lead to unintentional detrimental outcomes of increased moral distress, decreased satisfaction and increased turnover rates among nursing personnel.

On the violation of hospitalized patients' rights: A qualitative study.

BACKGROUND:: Nurses have always been known as an advocate for the rights of patients. The recognition of what is perceived as the violation of patients' rights can help nurses to understand patients' concerns and priorities. Thus, it helps nurses play their supportive roles more effectively. OBJECTIVE:: The aim of this study was to explore different dimensions of the violation of patients' rights. RESEARCH DESIGN:: Data were collected utilizing unstructured interviews and field notes. Data analysis was conducted using the qualitative content analysis approach. Prolonged engagement, maximum variation sampling, and member check were among the factors which enriched the research. PARTICIPANTS AND RESEARCH CONTEXT:: The sample consisted of 18 patients and 11 members of their families. They were purposively selected from two hospitals in Tehran during 2009-2012. ETHICAL CONSIDERATIONS:: The research was approved by the Ethics Committee of the university and hospitals. FINDING:: The patients' rights were violated in a variety of ways. There were three main dimensions to this issue: (a) care recession including deprivation of the caregiver's presence and the delay/lack of needed responses; (b) receiving mechanical care including superficiality, lack of emotion, and failure to understand the situation; and (c) being disrespected including humility and aggression. CONCLUSION:: The patients and their families consider any shortcomings in relation to the patient and the quality of care as the violation of the rights. The findings of the study imply sensitizing managers toward providing appropriate conditions as well as educating nurses to observe patients' rights. It is suggested that the processes leading to the violation of patients' rights be discovered and prevented in the future.