Pride and Prejudice during the COVID-19 Pandemic: The Misfortune of Inappropriate Clinical Trial Design.

Coronavirus Disease 2019 (COVID-19) is a rapidly evolving global pandemic for which more than a thousand clinical trials have been registered to secure therapeutic effectiveness, expeditiously. Most of these are single-center non-randomized studies rather than multi-center, randomized controlled trials. Single-arm trials have several limitations and may be conducted when spontaneous improvement is not anticipated, small placebo effect exists, and randomization to a placebo is not ethical. In an emergency where saving lives takes precedence, it is ethical to conduct trials with any scientifically proven design, however, safety must not be compromised. A phase II or III trial can be conducted directly in a pandemic with appropriate checkpoints and stopping rules. COVID-19 has two management paradigms- antivirals, or treatment of its complications. Simultaneous assessment of two different treatments can be done using 2 × 2 factorial schema. World Health Organization's SOLIDARITY trial is a classic example of the global research protocol which can evaluate the preferred treatment to combat COVID-19 pandemic. Short of that, a trial design must incorporate the practicality of the intervention used, and an appropriate primary endpoint which should ideally be a clinical outcome. Collaboration between institutions is needed more than ever to successfully execute and accrue in randomized trials.

[Safe management of COVID-19 dead bodies in sub-Saharan Africa: could families be allowed to bury their dead?] / Gestion sécurisée des dépouilles de personnes décédées de la COVID-19 en Afrique sub-Saharienne: et si on laissait les familles enterrer leurs morts?

Sub-Saharan African countries have been hit by the Coronavirus 2019 pandemic (COVID-19) since March 2020. Besides the resulting health and economic disasters is the psycho-socio-cultural problem related with the management of corpses of people dead from the disease, which might hinder the implementation of the response strategy. In Cameroon for instance, the current corpse management policy is very disputed. In fact, although they were recently made more flexible, the restrictions applied to burials still ban any transfer of dead bodies between cities. In light of the African cultural considerations of dead persons, the disputes observed between the families and the health personnel, the legislation and the available scientific evidence, this article analyses the risks and benefits of allowing families to bury their relatives. It thereafter suggests solutions that reconcile dignity (by allowing families to bury their dead relatives in their homes) and safety (by ensuring a sealed handling and the surveillance by a judiciary police officer). Applying these solutions could improve the population's trust towards the health system, and positively contribute to COVID-19 case prevention, identification and management.

Covid-19: Ethical Challenges for Nurses.

The Covid-19 pandemic has highlighted many of the difficult ethical issues that health care professionals confront in caring for patients and families. The decisions such workers face on the front lines are fraught with uncertainty for all stakeholders. Our focus is on the implications for nurses, who are the largest global health care workforce but whose perspectives are not always fully considered. This essay discusses three overarching ethical issues that create a myriad of concerns and will likely affect nurses globally in unique ways: the safety of nurses, patients, colleagues, and families; the allocation of scarce resources; and the changing nature of nurses' relationships with patients and families. We urge policy-makers to ensure that nurses' voices and perspectives are integrated into both local and global decision-making so as to minimize the structural injustices many nurses have faced to date. Finally, we urge nurses to seek sources of support throughout this pandemic.

The influence of organizational culture, climate and commitment on speaking up about medical errors.

AIM: Speaking up about medical errors is an essential behaviour for nurses in pursuit of their goal of maintaining patient safety. This study was designed to understand how a hospital's culture and climate can impact a nurse's active behaviour in this important health care activity. BACKGROUND: Research shows that while medical errors happen frequently, there is great variability on whether these errors are reported. As such, organizational culture, climate and commitment as well as employee perceptions associated with the reporting process were investigated to determine their impact on participants' intentions to speak up about medical errors. METHODS: Focus groups and one-on-one interviews were used to collect these data and were analysed using content analysis. RESULTS/KEY ISSUES: Nurses in the hospital perceive and understand both the benefits and barriers to reporting medical errors. Commonly reported benefits include patient safety, promoting education and awareness, and the improvement of internal processes or systems. Barriers include an inefficient reporting system and organizational influences such as perceived consequences and unequal status/position of the individual who made the error and the person reporting the error. Participants are aware that the organization believes that the responsibility to report medical errors falls to everyone. CONCLUSIONS: Results indicate that the organization's existing culture does not facilitate the reporting of medical errors and that the organizational climate interferes with the reporting process. Lastly, organizational commitment is not related to the perception of importance given to the reporting of medical errors by the hospital. IMPLICATIONS FOR NURSING MANAGEMENT: Nurses and nurse managers are an essential part of any hospital. In their role, they can effect change on the organization's culture and climate, but often do not realize the connection between organizational culture and patient safety. Results indicate that promoting organizational commitment to speaking up through the creation of a positive organizational culture can both promote speaking up about medical errors and increase patient safety.

Filling Voice Promotion Gaps in Healthcare through a Comparative Analysis of Error Reporting and Learning Systems and Open Communication and Disclosure Policies in the United States and Germany.

Voice in healthcare is crucial because of its ability to improve organizational performance and prevent medical errors. This paper contends that a comparative analysis of voice promotion in the American and German healthcare industries can strengthen a culture of safety in both countries. It provides a brief introduction to the concept of voice in healthcare, including its impact on safety culture, barriers to voice, and the dual influences of confidentiality and transparency on voice promotion policies. It then examines the theoretical basis, practical workings, and legal aspects of voluntary error reporting and error disclosure as avenues for exercising voice in the U.S. and Germany. Finally, it identifies transferable practices that can remedy shortcomings in each country's voice promotion policy.

Using Participatory Action Research to Develop a Working Model That Enhances Psychiatric Nurses' Professionalism: The Architecture of Stability.

Ward rules in psychiatric care aim to promote safety for both patients and staff. Simultaneously, ward rules are associated with increased patient violence, leading to neither a safe work environment nor a safe caring environment. Although ward rules are routinely used, few studies have explicitly accounted for their impact. To describe the process of a team development project considering ward rule issues, and to develop a working model to empower staff in their daily in-patient psychiatric nursing practices. The design of this study is explorative and descriptive. Participatory action research methodology was applied to understand ward rules. Data consists of audio-recorded group discussions, observations and field notes, together creating a data set of 556 text pages. More than 100 specific ward rules were identified. In this process, the word rules was relinquished in favor of adopting the term principles, since rules are inconsistent with a caring ideology. A linguistic transition led to the development of a framework embracing the (1) Principle of Safety, (2) Principle of Structure and (3) Principle of Interplay. The principles were linked to normative guidelines and applied ethical theories: deontology, consequentialism and ethics of care. The work model reminded staff about the principles, empowered their professional decision-making, decreased collegial conflicts because of increased acceptance for individual decisions, and, in general, improved well-being at work. Furthermore, the work model also empowered staff to find support for their decisions based on principles that are grounded in the ethics of totality.

An exemplum and its road safety morals.

With the design of an existing bike-lane in mind I discuss several general issues: accident causation and its linkage to the formulation of prevention strategies; the myopia afflicting major studies of causation and their misleading 'the-driver-did-it' message; the question of who is responsible for what in the management of road safety; and the difficult position in which the professionals find themselves when the 'State' does not embrace its responsibility to road safety. I think that were the public aware of this state of affairs in North America it might insist on change.

Recomendaciones para la respuesta institucional a un evento adverso / Recommendations for institutional response to an adverse event

Introducción. La respuesta institucional tras un evento adverso (EA) es determinante para la recuperación del paciente y el restablecimiento de la confianza en el sistema sanitario, así como para el restablecimiento psicológico de los profesionales implicados. Objetivos. Diseño de un marco de recomendaciones que sirvan de orientación para que servicios asistenciales, instituciones y organizaciones sanitarias favorezcan un abordaje sistemático de los EA. Metodología. A partir de una revisión no sistemática de la literatura, un grupo reducido de expertos elaboró un borrador inicial que fue enviado a los autores, quienes sugirieron cambios en estructura, contenido, referencias y estilo en versiones sucesivas hasta elaborar un manuscrito final aceptado por todos los participantes. Resultados. La respuesta al EA debería incluir la estabilización clínica del paciente, un plan terapéutico para mitigar los daños, la custodia y/o retirada del material o productos sanitarios implicados; la comunicación al paciente y los familiares de lo acaecido; el apoyo y sustitución de los profesionales afectados si se precisa; la notificación a los responsables asistenciales y de la dirección; la documentación de todo lo concerniente al EA; y el inicio de la investigación y análisis. Además de restaurar la la confianza y la recuperación de paciente, familiares y profesionales, el propósito último de la respuesta a un EA debe ser la mejora de los procesos asistenciales para evitar su repetición, primando su evaluación como errores de sistema, y el aprendizaje y mejora a partir de su análisis (AU)

Introduction. The organizational response after an Adverse Event (AE) is critical for the patient recovery and trust restoration in the health system. It is also crucial for the involved caregiver psychological recovery. Objective. To design a frame of recommendations to help the healthcare services, institutions and organizations to provide a systematic approach to an AE. Methods. A reduced group of authors performed a non-systematic review of the literature and developed an initial draft. The draft was sent to the rest of authors, who suggested modifications in structure, content, references and style throughout successive manuscript versions until a final one was accepted. Results. AE response includes the patient's clinical stabilization and a therapeutic plan to mitigate harm, the safeguard of used materials or health products involved, the appropriate disclosure to patient and family, the support of affected staff and their replacement if needed, the report to appropriate clinical and management heads, the event circumstances documentation and the starting of the AE investigation and analysis. Besides the professional, family and patient's trust and health recovery, the ultimate target of a correct AE response is the improvement of healthcare processes to prevent its repetition considering the AE as a system failure and learning and improving through its analysis (AU)

What is the role of individual accountability in patient safety? A multi-site ethnographic study.

An enduring debate concerns how responsibility for patient safety should be distributed between organisational systems and individual professionals. Though rule-based, calculus-like approaches intended to support a 'just culture' have become popular, they perpetuate an asocial and atomised account. In this article, we use insights from practice theory--which sees organisational phenomena as accomplished in everyday actions, with individual agency and structural conditions as a mutually constitutive, dynamic duality--along with contributions from the political science and ethics literature as a starting point for analysis. Presenting ethnographic data from five hospitals, three in one high-income country and two in low-income countries, we offer an empirically informed, normative rethinking of the role of personal accountability, identifying the collective nature of the healthcare enterprise and the extent to which patient safety depends on contributions from many hands. We show that moral responsibility for actions and behaviours is an irreducible element of professional practice, but that individuals are not somehow 'outside' and separate from 'systems': they create, modify and are subject to the social forces that are an inescapable feature of any organisational system; each element acts on the other. Our work illustrates starkly the structuring effects of the broader institutional and socioeconomic context on opportunities to 'be good'. These findings imply that one of the key responsibilities of organisations and wider institutions in relation to patient safety is the fostering of the conditions of moral community.

Strategies for Navigating Common Ethical Dilemmas Encountered by Operational Radiation Safety Professionals.

Because operational radiation safety professionals can encounter ethical dilemmas in the course of their work, codes of ethics and professional standards of conduct are maintained by the Health Physics Society (HPS) and the American Academy of Health Physics (AAHP). While these works provide valuable guidance, they do not operationalize the types of ethical dilemmas radiation safety practitioners might encounter. For example, consider the ethical conundrum of "dual loyalty," defined as the situation in which an individual holds simultaneous obligations to two or more parties. In the case of radiation safety, practicing professionals hold obligations to the workers being protected and to the leaders of the organization. If these obligations are in conflict, serious difficulties can arise. The conundrum of dual loyalty is described and a strategy for reducing its effect is discussed. Two other common ethical issues; "confidentiality" and "organizational dissent" are similarly presented. A foundation from which to launch an ongoing dialogue about ethical issues within the radiation safety profession is also proposed.

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

BACKGROUND: International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. METHODS: It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. RESULTS: In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. DISCUSSIONS: Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. CONCLUSION: Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.