Cultivating quality awareness in corona times.

The Covid-19 pandemic is a tragedy for those who have been hard hit worldwide. At the same time, it is also a test of concepts and practices of what good care is and requires, and how quality of care can be accounted for. In this paper, we present our Care-Ethical Model of Quality Enquiry (CEMQUE) and apply it to the case of residential care for older people in the Netherlands during the Covid-19 pandemic. Instead of thinking about care in healthcare and social welfare as a set of separate care acts, we think about care as a complex practice of relational caring, crossed by other practices. Instead of thinking about professional caregivers as functionaries obeying external rules, we think about them as practically wise professionals. Instead of thinking about developing external quality criteria and systems, we think about cultivating (self-)reflective quality awareness. Instead of abstracting from societal forces that make care possible but also limit it, we acknowledge them and find ways to deal with them. Based on these critical insights, the CEMQUE model can be helpful to describe, interrogate, evaluate, and improve existing care practices. It has four entries: (i) the care receiver considered from their humanness, (ii) the caregiver considered from their solicitude, (iii) the care facility considered from its habitability and (iv) the societal, institutional and scholarly context considered from the perspective of the good life, justice and decency. The crux is enabling all these different entries with all their different aspects to be taken into account. In Corona times this turns out to be more crucial than ever.

Toward an accelerated adoption of data-driven findings in medicine : Research, skepticism, and the need to speed up public visibility of data-driven findings.

To accelerate the adoption of a new method with a high potential to replace or extend an existing, presumably less accurate, medical scoring system, evaluation should begin days after the new concept is presented publicly, not years or even decades later. Metaphorically speaking, as chameleons capable of quickly changing colors to help their bodies adjust to changes in temperature or light, health-care decision makers should be capable of more quickly evaluating new data-driven insights and tools and should integrate the highest performing ones into national and international care systems. Doing so is essential, because it will truly save the lives of many individuals.

[Accessing the sensitive part of the Being before us]. / Accéder à la part sensible de l'Être qui nous fait face.

The acceleration of the standardisation of care and the dominance of the quality approach, since the 1990s, have brought significant changes to nursing practices, the different therapeutic approaches and the 'place' of caregivers with regard to the patient. In this context of modern psychiatry which must comply with all kinds of recommendations, what is the situation of the patient suffering from psychosis, who would previously have been supported over the long term in a psychopathological process? The encounter, envisaged as an opening, is placed at the heart of the therapeutic relationship.

From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies.

Our goals are to (1) set forth and defend a multiprinciple system for selecting individuals who meet trial eligibility criteria to participate in early phase clinical trials testing chimeric antigen receptor (CAR T-cell) for acute lymphoblastic leukaemia when demand for participation exceeds spaces available in a trial; (2) show the relevance of these selection criteria to other breakthrough experimental therapies; (3) argue that distinct distributive justice criteria apply to breakthrough experimental therapies, standard research and healthcare and (4) argue that as evidence of benefit increases, the emphasis of justice in research shifts from protecting subjects from harm to ensuring fair access to benefits.

Iranian nurses perspectives on assessment of safe care: an exploratory study.

AIM: To explore the perspectives and experiences of nurse instructors and clinical nurses regarding the assessment of safe nursing care and its components in clinical practice. BACKGROUND: Safe nursing care is a key aspect of risk management in the healthcare system. The assessment of safe nursing care and identification of its components are primary steps to establish patient safety and risk management and enhance the quality of care in clinical practice. METHODS: This was an interview study, with qualitative content analysis. Semi-structured interviews were conducted with 16 nurse instructors and clinical nurses including nurse managers chosen by purposive sampling based on theoretical saturation. Data collection and analysis were carried out simultaneously until data saturation was reached. RESULTS: Data analysis led to the extraction of four main themes: holistic assessment of safe nursing care; team working and assessment of safe nursing care; ethical issues; and challenges of safe nursing care assessment. CONCLUSION: Identifying these four components in the assessment of safe nursing care offers a contribution to the understanding of the elements of safe care assessment and the potential for improved patient safety. IMPLICATIONS FOR NURSING MANAGEMENT: Safe care management requires the accurate and reliable assessment of safe nursing care and the need for strategies for reporting actual or potential unsafe care and errors to ensure patient safety.

Enhancing quality and integrity in biomedical research in Africa: an international call for greater focus, investment and standardisation in capacity strengthening for frontline staff.

The integrity of biomedical research depends heavily on the quality of research data collected. In turn, data quality depends on processes of data collection, a task undertaken by frontline research staff in many research programmes in Africa and elsewhere. These frontline research staff often have additional responsibilities including translating and communicating research in local languages, seeking informed consent for study participation and maintaining supportive relationships between research institutions and study participants and wider communities. The level of skills that fieldworkers need to undertake these responsibilities clearly affects the quality of data collected, the ethics of research 'on the ground' and the short and long term acceptability of research.We organised an international workshop in Kenya in July 2014 to discuss the role of frontline staff in scientific research. A total of 25 field managers from 9 African countries and the UK met for 2.5 days to discuss the relationship between data quality and institutional performance management systems and how they affect career progression and supportive supervision policies of research frontline staff.From this workshop, and supporting an expanding literature on the role of fieldworkers in international health research, participants agreed that fieldworkers' roles present them with practical and ethical challenges that their routine training does not adequately prepare them for. We argue that the common and complex challenges facing fieldworkers should in part be addressed through increased investment and collaborative agreements across types of research institutions in Africa. We call for standardization of core elements of training for this critically important cadre of research staff who perform similar roles and encounter similar challenges in many African settings. Although many valuable training elements are offered in institutions, there is a need to develop broader, more grounded and innovative strategies to address complex realities for fieldworkers, and support the integrity and ethics of health research in these settings.

Ethical oversight in quality improvement and quality improvement research: new approaches to promote a learning health care system.

BACKGROUND: Institutional review boards (IRBs) distinguish health care quality improvement (QI) and health care quality improvement research (QIR) based primarily on the rigor of the methods used and the purported generalizability of the knowledge gained. Neither of these criteria holds up upon scrutiny. Rather, this apparently false dichotomy may foster under-protection of participants in QI projects and over-protection of participants within QIR. DISCUSSION: Minimal risk projects should entail minimal oversight including waivers for informed consent for both QI and QIR projects. Minimizing the burdens of conducting QIR, while ensuring minimal safeguards for QI projects, is needed to restore this imbalance in oversight. Potentially, such ethical oversight could be provided by the integration of Institutional Review Boards and Clinical Ethical Committees, using a more integrated and streamlined approach such as a two-step process involving a screening review, followed by a review by committee trained in QIR. Standards for such ethical review and training in these standards, coupled with rapid review cycles, could facilitate an appropriate level of oversight within the context of creating and sustaining learning health care systems. We argue that QI and QIR are not reliably distinguishable. We advocate for approaches that improve protections for QI participants while minimizing over-protection for participants in QIR through reasonable ethical oversight that aligns risk to participants in both QI and QIR with the needs of a learning health care system.

[How to Define Good Health Care: An Ethical Framework for the Evaluation of Health Care for the Chronically Ill]. / Was ist gute Versorgung? Ein ethisches Framework zur Bewertung der Versorgung chronisch Kranker.

In Germany we face an increase in chronic illnesses and a health care system not adjusted to the specific needs of this patient group. Innovative health care management programmes (for example, disease management programmes) might be able to play an important role in overcoming the existing deficits. By developing and implementing such programmes we are, how-ever, implicitly touching upon normative issues, but only rarely are the ethical aspects of these programmes discussed explicitly and evaluated in a systematic way. Against this backdrop, we have developed an ethical framework as a tool for evaluating general health care and innovative programmes for the chronically ill. The framework comprises on the one hand a list of criteria that define good health care in the context of chronic illness. Based on a coherentist conception of ethical justification, we developed 8 criteria (among others "the autonomy of patients concerning therapy, use of data and other life choices have to be promoted and respected") for the context of chronic illness. On the other hand, the framework provides a methodological approach to apply the criteria in 6 steps in order to evaluate a specific programme. Thereby, we want to give orienta-tion to policy makers and practitioners concerning the normative underpinnings of their work and support them in identifying relevant ethical requirements and potential problems at an early stage.

Development and oversight of ethical health promotion quality assurance and evaluation activities involving human participants.

ISSUE ADDRESSED: This paper considers the role of ethics and ethics review processes in the development of health promotion quality assurance and evaluation activities involving human participants. CONTENT: The Australian National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research and associated documents provide the framework for the ethical conduct and independent review of research (including quality assurance and evaluation) involving humans in Australia. Identifying the level of risk to which participants may be exposed by participation in quality assurance and evaluation activities is essential for health promotion workers undertaking such activities. Organisations can establish processes other than review by a Human Research Ethics Committee for negligible and low risk research activities. Health promotion quality assurance and evaluation activities often involve negligible and low risk to participants. Seven triggers that indicate the need for ethics review of quality assurance and evaluation activities and a procedural checklist for developing ethical quality assurance and evaluation activities are provided. CONCLUSION: Health promotion workers should be familiar with the NHMRC's National Statement on Ethical Conduct in Human Research. When ethical considerations underpin the planning and conduct of all quality assurance and evaluation from the very beginning, the activity is the better for it, independent 'ethics approval' can mostly be secured without much trouble and workers' frustration levels are reduced. So what? Health promotion quality assurance and evaluation activities must be ethically justified. Health promotion workers should be familiar with the NHMRC's National Statement on Ethical Conduct in Human Research and should use it when developing health promotion quality assurance and evaluation activities.

[Today's jobs in the healthcare sector are comparable to other professions]. / Gesundheitsberufe sind heute Berufe wie andere auch.

By applying current standards of job descriptions and performance profiles in the healthcare sector, this article focuses on the issue whether there are fundamental differences between physicians and other healthcare professionals compared to other professions. There are special requirements for physicians, such as a university degree, but the same also holds true for other professions. The increasing economization of the healthcare sector in recent years has led to a situation where differences in the standards for healthcare professionals when compared to other occupations are no longer apparent. Medical directors at university hospitals also have to conform to standards that are applied to executive managers in other businesses. Besides the obvious professional skills, communication with patients and collaborators, knowledge of economics and leadership competence are also mandatory. This does not exclude the impression that physicians and nurses subjectively see in their profession more than just a job but truly a vocation.

[Healthcare occupations are "different"]. / Gesundheitsberufe sind "anders"

Healthcare requires careful coordination of several occupations. In order to attain the best possible result, including effectiveness and cost-efficiency, the specific expertise of each of these occupations must be clearly defined. Healthcare occupations, physicians and nurses, are indeed professions as opposed to mere "jobs". They are concerned with living but ill human beings and not with things. Reliance on a personal capacity of judgment is a decisive aspect of professions. Healthcare professionals perform best if they are granted specific independence relative to their work.

Research across the disciplines: a road map for quality criteria in empirical ethics research.

BACKGROUND: Research in the field of Empirical Ethics (EE) uses a broad variety of empirical methodologies, such as surveys, interviews and observation, developed in disciplines such as sociology, anthropology, and psychology. Whereas these empirical disciplines see themselves as purely descriptive, EE also aims at normative reflection. Currently there is literature about the quality of empirical research in ethics, but little or no reflection on specific methodological aspects that must be considered when conducting interdisciplinary empirical ethics. Furthermore, poor methodology in an EE study results in misleading ethical analyses, evaluations or recommendations. This not only deprives the study of scientific and social value, but also risks ethical misjudgement. DISCUSSION: While empirical and normative-ethical research projects have quality criteria in their own right, we focus on the specific quality criteria for EE research. We develop a tentative list of quality criteria--a "road map"--tailored to interdisciplinary research in EE, to guide assessments of research quality. These quality criteria fall into the categories of primary research question, theoretical framework and methods, relevance, interdisciplinary research practice and research ethics and scientific ethos. SUMMARY: EE research is an important and innovative development in bioethics. However, a lack of standards has led to concerns about and even rejection of EE by various scholars. Our suggested orientation list of criteria, presented in the form of reflective questions, cannot be considered definitive, but serves as a tool to provoke systematic reflection during the planning and composition of an EE research study. These criteria need to be tested in different EE research settings and further refined.

[Corruption and health care system]. / Korupcija i zdravstveni sustav.

Corruption is a global problem that takes special place in health care system. A large number of participants in the health care system and numerous interactions among them provide an opportunity for various forms of corruption, be it bribery, theft, bureaucratic corruption or incorrect information. Even though it is difficult to measure the amount of corruption in medicine, there are tools that allow forming of the frames for possible interventions.

[Informed consent with special emphasis on Croatia]. / Pristanak obavijestenog pacijenta s posebnim osvrtom na Hrvatsku.

Respecting the informed consent and its implementation is one of the fundamental components of high-quality health care. This article discusses the informed consent with an overview of Croatian and international legal documents and scientific studies dealing with this issue. Based on the review of the literature it can be concluded that this is an important issue that contains several key components that should be observed and investigated. It is necessary to evaluate the purposefulness and quality of the implementation of the informed consent, to systematically examine respect of the patients' right to information regarding the medical procedure during treatment, to explore decision-making model in the physician-patient encounter in Croatian hospitals, to determine the content and amount of information shared between physicians and patients, to determine the content and readability of consent forms and written patient information on the medical procedure. In order to assure higher quality of the implementation of the informed consent it is necessary to define by law a list of medical procedures that require written consent and to uniform consent forms for the same medical procedures country-wide.

Universal antiretroviral therapy for HIV infection: should US treatment guidelines be applied to resource-limited settings?

US treatment guidelines now recommend antiretroviral therapy (ART) for all persons infected with human immunodeficiency virus (HIV), regardless of CD4 count, both for the benefit of infected individuals and to prevent HIV transmission. In an effort to meet the critical goal of treating all HIV-infected persons worldwide, there is movement toward extrapolating these guidelines and the data supporting them to resource-limited settings. While economic and practical barriers to universal ART are widely recognized, there has been little discussion of the ethical considerations resulting from global disparities in the safety and efficacy of universal ART in these settings. We argue that the risk-benefit considerations for initiating ART are not the same worldwide due to limitations in the ART regimens used, laboratory monitoring, and consistent availability of ART, which raises ethical questions about universally applying US guidelines in resource-limited settings at the present time.

Existence and functionality of emergency obstetric care services at district level in Kenya: theoretical coverage versus reality.

BACKGROUND: The knowledge on emergency obstetric care (EmOC) is limited in Kenya, where only partial data from sub-national studies exist. The EmOC process indicators have also not been integrated into routine health management information system to monitor progress in safe motherhood interventions both at national and lower levels of the health system. In a country with a high maternal mortality burden, the implication is that decision makers are unaware of the extent of need for life-saving care and, therefore, where to intervene. The objective of the study was to assess the actual existence and functionality of EmOC services at district level. METHODS: This was a facility-based cross-sectional study. Data were collected from 40 health facilities offering delivery services in Malindi District, Kenya. Data presented are part of the "Response to accountable priority setting for trust in health systems" (REACT) study, in which EmOC was one of the service areas selected to assess fairness and legitimacy of priority setting in health care. The main outcome measures in this study were the number of facilities providing EmOC, their geographical distribution, and caesarean section rates in relation to World Health Organization (WHO) recommendations. RESULTS: Among the 40 facilities assessed, 29 were government owned, seven were private and four were voluntary organisations. The ratio of EmOC facilities to population size was met (6.2/500,000), compared to the recommended 5/500,000. However, using the strict WHO definition, none of the facilities met the EmOC requirements, since assisted delivery, by vacuum or forceps was not provided in any facility. Rural-urban inequities in geographical distribution of facilities were observed. The facilities were not providing sufficient life-saving care as measured by caesarean section rates, which were below recommended levels (3.7% in 2008 and 4.5% in 2009). The rates were lower in the rural than in urban areas (2.1% vs. 6.8%; p < 0.001 ) in 2008 and (2.7% vs. 7.7%; p < 0.001) in 2009. CONCLUSIONS: The gaps in existence and functionality of EmOC services revealed in this study may point to the health system conditions contributing to lack of improvements in maternal survival in Kenya. As such, the findings bear considerable implications for policy and local priority setting.

Surgical patients' and nurses' opinions and expectations about privacy in care.

The purpose of this study was to determine the opinions and expectations of patients and nurses about privacy during a hospital admission for surgery. The study explored what enables and maintains privacy from the perspective of Turkish surgical patients and nurses. The study included 102 adult patients having surgery and 47 nurses caring for them. Data were collected via semistructured questionnaire by face-to-face interviews. The results showed that patients were mostly satisfied by the respect shown to their privacy by the nurses but were less confident of the confidentiality of their personal data. It was found that patients have expectations regarding nursing approaches and attitudes about acknowledging and respecting patient autonomy and confidentiality. It is remarkable that while nurses focused on the physical dimension of privacy, patients focused on informational and psychosocial dimensions of privacy, as well as its physical dimension.

Exploring ethical aspects of elective surgery patients' decision-making experiences.

The practice of respecting patients' autonomy is rooted in the healthcare professionals' empathy for patients' situations, without which appropriate supports to the patients during the informed consent process may be remarkably moderated. The purpose of this study was to explore elective surgery patients' experiences during their decision-making process. This research was conducted using a phenomenological approach, and the data analysis was guided by Colaizzi's method. A total of 17 participants were recruited from a hospital in southern Taiwan. Two major themes emerged from the analyses: (a) a voluntary yet necessary alternative--to undergo a surgery and (b) alternatives compelled by the unalterable decision--the surgery. It was concluded that unless healthcare professionals can empathize with the distressed situation of their patients who are facing elective surgery, the practice of informed consent may become merely a routine. Nurses can be the best advocates for patients and facilitators to enhance communication between patients and healthcare personnel.

Simulated patient studies: an ethical analysis.

CONTEXT: In connection with health care reform, the U.S. Department of Health and Human Services commissioned a "mystery shopper," or simulated patient study, to measure access to primary care. But the study was shelved because of public controversy over "government spying" on doctors. Opponents of the study also raised ethical concerns about the use of deception with human subjects without soliciting their informed consent. METHODS: We undertook an ethical analysis of the use of simulated patient techniques in health services research, with a particular focus on research measuring access to care. Using a case study, we explored relevant methodological considerations and ethical principles relating to deceptive research without informed consent, as well as U.S. federal regulations permitting exceptions to consent. FINDINGS: Several relevant considerations both favor and oppose soliciting consent for simulated patient studies. Making research participation conditional on informed consent protects the autonomy of research subjects and shields them from unreasonable exposure to research risks. However, scientific validity is also an important ethical principle of human subjects research, as the net risks to subjects must be justified by the value to society of the knowledge to be gained. The use of simulated patients to monitor access is a naturalistic and scientifically sound experimental design that can answer important policy-relevant questions, with minimal risks to human subjects. As interaction between researchers and subjects increases, however, so does the need for consent. CONCLUSIONS: As long as adequate protections of confidentiality of research data are in place, minimally intrusive simulated patient research that gathers policy-relevant data on the health system without the consent of individuals working in that system can be ethically justified when the risks and burdens to research subjects are minimal and the research has the potential to generate socially valuable knowledge.