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INTRODUCTION: Acute kidney injury (AKI) requiring treatment with renal replacement therapy (RRT) is a common complication after admission to an intensive care unit (ICU) and is associated with significant morbidity and mortality. However, the prevalence of RRT use and the associated outcomes in critically patients across the globe are not well described. Therefore, we describe the epidemiology and outcomes of patients receiving RRT for AKI in ICUs across several large health system jurisdictions. METHODS: Retrospective cohort analysis using nationally representative and comparable databases from seven health jurisdictions in Australia, Brazil, Canada, Denmark, New Zealand, Scotland, and the USA between 2006 and 2023, depending on data availability of each dataset. Patients with a history of end-stage kidney disease receiving chronic RRT and patients with a history of renal transplant were excluded. RESULTS: A total of 4,104,480 patients in the ICU cohort and 3,520,516 patients in the mechanical ventilation cohort were included. Overall, 156,403 (3.8%) patients in the ICU cohort and 240,824 (6.8%) patients in the mechanical ventilation cohort were treated with RRT for AKI. In the ICU cohort, the proportion of patients treated with RRT was lowest in Australia and Brazil (3.3%) and highest in Scotland (9.2%). The in-hospital mortality for critically ill patients treated with RRT was almost fourfold higher (57.1%) than those not receiving RRT (16.8%). The mortality of patients treated with RRT varied across the health jurisdictions from 37 to 65%. CONCLUSION: The outcomes of patients who receive RRT in ICUs throughout the world vary widely. Our research suggests that differences in access to and provision of this therapy are contributing factors.
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More severe atopic dermatitis and psoriasis are associated with a higher cumulative impact on quality of life, multimorbidity and healthcare costs. Proactive, early intervention in those most at risk of severe disease may reduce this cumulative burden and modify the disease trajectory to limit progression. The lack of reliable biomarkers for this at-risk group represents a barrier to such a paradigm shift in practice. To expedite discovery and validation, the BIOMarkers in Atopic Dermatitis and Psoriasis (BIOMAP) consortium (a large-scale European, interdisciplinary research initiative) has curated clinical and molecular data across diverse study designs and sources including cross-sectional and cohort studies (small-scale studies through to large multicentre registries), clinical trials, electronic health records and large-scale population-based biobanks. We map all dataset disease severity instruments and measures to three key domains (symptoms, inflammatory activity and disease course), and describe important codependencies and relationships across variables and domains. We prioritize definitions for more severe disease with reference to international consensus, reference standards and/or expert opinion. Key factors to consider when analysing datasets across these diverse study types include explicit early consideration of biomarker purpose and clinical context, candidate biomarkers associated with disease severity at a particular point in time and over time and how they are related, taking the stage of biomarker development into account when selecting disease severity measures for analyses, and validating biomarker associations with disease severity outcomes using both physician- and patient-reported measures and across domains. The outputs from this exercise will ensure coherence and focus across the BIOMAP consortium so that mechanistic insights and biomarkers are clinically relevant, patient-centric and more generalizable to current and future research efforts.
Atopic dermatitis (AD), and psoriasis are long-term skin conditions that can significantly affect people's lives, especially when symptoms are severe. Approximately 10% of adults and 20% of children are affected by AD, while psoriasis affects around 5% of people in the UK. Both conditions are associated with debilitating physical symptoms (such as itch) and have been linked to depression and anxiety. Biomarkers are naturally occurring chemicals in the human body and have potential to enhance the longer-term management of AD and psoriasis. Currently, there are no routinely used biomarkers that can identify people who experience or will go on to develop severe AD and psoriasis. For this reason, research is under way to understand which biomarkers are linked to severity. In this study, a multidisciplinary team of skin researchers from across Europe, along with patient groups, discussed the complexities of studying severity-related biomarkers. We identified a number of severity measurement approaches and there were recommendations for future biomarker research, including (i) considering multiple measures as no single measure can encompass all aspects of severity, (ii) exploring severity measures recorded by both healthcare professionals and patients, as each may capture different aspects, and (iii) accounting for influencing factors, such as different treatment approaches, that may impact AD and psoriasis severity, which make it challenging to compare findings across studies. Overall, we anticipate that the insights gained from these discussions will increase the likelihood of biomarkers being effectively applied in real-world settings, to ultimately improve outcomes for people with AD and psoriasis.
Subject(s)
Biomarkers , Dermatitis, Atopic , Psoriasis , Severity of Illness Index , Humans , Psoriasis/immunology , Psoriasis/diagnosis , Dermatitis, Atopic/diagnosis , Dermatitis, Atopic/immunology , Interdisciplinary ResearchABSTRACT
BACKGROUND: While solidarity practices were important in mitigating the Coronavirus Disease 2019 (COVID-19) pandemic, their limits became evident as the pandemic progressed. Taking a longitudinal approach, this study analyses German residents' changing perceptions of solidarity practices during the COVID-19 pandemic and examines potential reasons for these changes. METHODS: Adults living in Germany were interviewed in April 2020 (n = 46), October 2020 (n = 43) and October 2021 (n = 40) as part of the SolPan Research Commons, a large-scale, international, qualitative, longitudinal study uniquely situated in a major global public health crisis. Interviews were analysed using qualitative content analysis. RESULTS: While solidarity practices were prominently discussed and positively evaluated in April 2020, this initial enthusiasm waned in October 2020 and October 2021. Yet, participants still perceived solidarity as important for managing the pandemic and called for institutionalized forms of solidarity in October 2020 and October 2021. Reasons for these changing perceptions of solidarity included (i) increasing personal and societal costs to act in solidarity, (ii) COVID-19 policies hindering solidarity practices, and (iii) a perceived lack of reciprocity as participants felt that solidarity practices from the state were not matching their individual efforts. CONCLUSIONS: Maintaining solidarity contributes to maximizing public health during a pandemic. Institutionalized forms of solidarity to support those most in need contribute to perceived reciprocity among individuals, which might increase their motivation to act in solidarity. Thus, rather than calling for individual solidarity during times of crisis, authorities should consider implementing sustaining solidarity-based social support systems that go beyond immediate crisis management.
Subject(s)
COVID-19 , Adult , Humans , COVID-19/epidemiology , Longitudinal Studies , Pandemics , Germany/epidemiology , Qualitative ResearchABSTRACT
During the COVID-19 pandemic, national triage guidelines were developed to address the anticipated shortage of life-saving resources, should ICU capacities be overloaded. Rationing and triage imply that in addition to individual patient interests, interests of population health have to be integrated. The transfer of theoretical and empirical knowledge into feasible and useful practice models and their implementation in clinical settings need to be improved. This paper analyzes how triage protocols could translate abstract theories of distributive justice into concrete material and procedural criteria for rationing intensive care resources during a pandemic. We reconstruct the development and implementation of a rationing protocol at a German university hospital: describing the ethical challenge of triage, clarifying the aspirational norms, and summarizing specific norms of fair triage and allocation for developing an institutional policy and practice model and implementing it. We reflect on how critical topics are seen by clinicians and what helped manage the perceived burdens of the triage dilemma. We analyze what can be learned from this debate regarding the difficult issues around triage protocols and their potential implementation into clinical settings. Analyzing the ought-to-is gap of triage, integrating abstract ethical principles into practical concepts, and evaluating those should clarify the benefits and risks of different allocation options. We seek to inform debates on triage concepts and policies to ensure the best possible treatment and fair allocation of resources as well as to help protect patients and professionals in worst-case scenarios.
Subject(s)
Pandemics , Triage , Humans , SARS-CoV-2 , Health Care Rationing , Critical Care , Social JusticeABSTRACT
BACKGROUND: Social media platforms are increasingly used to recruit patients for clinical studies. Yet, patients' attitudes regarding social media recruitment are underexplored. OBJECTIVE: This mixed methods study aims to assess predictors of the acceptance of social media recruitment among patients with hepatitis B, a patient population that is considered particularly vulnerable in this context. METHODS: Using a mixed methods approach, the hypotheses for our survey were developed based on a qualitative interview study with 6 patients with hepatitis B and 30 multidisciplinary experts. Thematic analysis was applied to qualitative interview analysis. For the cross-sectional survey, we additionally recruited 195 patients with hepatitis B from 3 clinical centers in Germany. Adult patients capable of judgment with a hepatitis B diagnosis who understood German and visited 1 of the 3 study centers during the data collection period were eligible to participate. Data analysis was conducted using SPSS (version 28; IBM Corp), including descriptive statistics and regression analysis. RESULTS: On the basis of the qualitative interview analysis, we hypothesized that 6 factors were associated with acceptance of social media recruitment: using social media in the context of hepatitis B (hypothesis 1), digital literacy (hypothesis 2), interest in clinical studies (hypothesis 3), trust in nonmedical (hypothesis 4a) and medical (hypothesis 4b) information sources, perceiving the hepatitis B diagnosis as a secret (hypothesis 5a), attitudes toward data privacy in the social media context (hypothesis 5b), and perceived stigma (hypothesis 6). Regression analysis revealed that the higher the social media use for hepatitis B (hypothesis 1), the higher the interest in clinical studies (hypothesis 3), the more trust in nonmedical information sources (hypothesis 4a), and the less secrecy around a hepatitis B diagnosis (hypothesis 5a), the higher the acceptance of social media as a recruitment tool for clinical hepatitis B studies. CONCLUSIONS: This mixed methods study provides the first quantitative insights into social media acceptance for clinical study recruitment among patients with hepatitis B. The study was limited to patients with hepatitis B in Germany but sets out to be a reference point for future studies assessing the attitudes toward and acceptance of social media recruitment for clinical studies. Such empirical inquiries can facilitate the work of researchers designing clinical studies as well as ethics review boards in balancing the risks and benefits of social media recruitment in a context-specific manner.
Subject(s)
Hepatitis B , Patient Selection , Social Media , Humans , Hepatitis B/psychology , Female , Male , Adult , Cross-Sectional Studies , Middle Aged , GermanyABSTRACT
BACKGROUND: The increasing use of social media opens new opportunities for recruiting patients for research studies. However, systematic evaluations indicate that the success of social media recruitment in terms of cost-effectiveness and representativeness depends on the type of study and its purpose. OBJECTIVE: This study aims to explore the practical benefits and challenges of recruiting study participants with social media in the context of clinical and nonclinical studies and provide a summary of expert advice on how to conduct social media-based recruitment. METHODS: We conducted semistructured interviews with 6 patients with hepatitis B who use social media and 30 experts from the following disciplines: (1) social media researchers or social scientists, (2) practical experts for social media recruitment, (3) legal experts, (4) ethics committee members, and (5) clinical researchers. The interview transcripts were analyzed using thematic analysis. RESULTS: We found diverging expert opinions regarding the challenges and benefits of social media recruitment for research studies in four domains: (1) resources needed, (2) representativeness, (3) web-based community building, and (4) privacy considerations. Moreover, the interviewed experts provided practical advice on how to promote a research study via social media. CONCLUSIONS: Even though recruitment strategies should always be sensitive to individual study contexts, a multiplatform approach (recruiting via several different social media platforms) with mixed-methods recruitment (web-based and offline recruitment channels) is the most beneficial recruitment strategy for many research studies. The different recruitment methods complement each other and may contribute to improving the reach of the study, the recruitment accrual, and the representativeness of the sample. However, it is important to assess the context- and project-specific appropriateness and usefulness of social media recruitment before designing the recruitment strategy.
Subject(s)
Social Media , Humans , Patient Selection , Privacy , Qualitative ResearchABSTRACT
OBJECTIVES: Simulation and evaluation of a prioritization protocol at a German university hospital using a convergent parallel mixed methods design. DESIGN: Prospective single-center cohort study with a quantitative analysis of ICU patients and qualitative content analysis of two focus groups with intensivists. SETTING: Five ICUs of internal medicine and anesthesiology at a German university hospital. PATIENTS: Adult critically ill ICU patients ( n = 53). INTERVENTIONS: After training the attending senior ICU physicians ( n = 13) in rationing, an impending ICU congestion was simulated. All ICU patients were rated according to their likelihood to survive their acute illness (good-moderate-unfavorable). From each ICU, the two patients with the most unfavorable prognosis ( n = 10) were evaluated by five prioritization teams for triage. MEASUREMENTS AND MAIN RESULTS: Patients nominated for prioritization visit ( n = 10) had higher Sequential Organ Failure Assessment scores and already a longer stay at the hospital and on the ICU compared with the other patients. The order within this worst prognosis group was not congruent between the five teams. However, an in-hospital mortality of 80% confirmed the reasonable match with the lowest predicted probability of survival. Qualitative data highlighted the tremendous burden of triage and the need for a team-based consensus-oriented decision-making approach to ensure best possible care and to support professionals. Transparent communication within the teams, the hospital, and to the public was seen as essential for prioritization implementation. CONCLUSIONS: To mitigate potential bias and to reduce the emotional burden of triage, a consensus-oriented, interdisciplinary, and collaborative approach should be implemented. Prognostic comparative assessment by intensivists is feasible. The combination of long-term ICU stay and consistently high Sequential Organ Failure Assessment scores resulted in a greater risk for triage in patients. It remains challenging to reliably differentiate between patients with very low chances to survive and requires further conceptual and empirical research.
Subject(s)
Pandemics , Triage , Adult , Humans , Triage/methods , Prospective Studies , Cohort Studies , Intensive Care UnitsABSTRACT
Machine intelligence already helps medical staff with a number of tasks. Ethical decision-making, however, has not been handed over to computers. In this proof-of-concept study, we show how an algorithm based on Beauchamp and Childress' prima-facie principles could be employed to advise on a range of moral dilemma situations that occur in medical institutions. We explain why we chose fuzzy cognitive maps to set up the advisory system and how we utilized machine learning to train it. We report on the difficult task of operationalizing the principles of beneficence, non-maleficence and patient autonomy, and describe how we selected suitable input parameters that we extracted from a training dataset of clinical cases. The first performance results are promising, but an algorithmic approach to ethics also comes with several weaknesses and limitations. Should one really entrust the sensitive domain of clinical ethics to machine intelligence?
Subject(s)
Ethics, Clinical , Personal Autonomy , Algorithms , Beneficence , HumansABSTRACT
The emergence of ethical concerns surrounding artificial intelligence (AI) has led to an explosion of high-level ethical principles being published by a wide range of public and private organizations. However, there is a need to consider how AI developers can be practically assisted to anticipate, identify and address ethical issues regarding AI technologies. This is particularly important in the development of AI intended for healthcare settings, where applications will often interact directly with patients in various states of vulnerability. In this paper, we propose that an 'embedded ethics' approach, in which ethicists and developers together address ethical issues via an iterative and continuous process from the outset of development, could be an effective means of integrating robust ethical considerations into the practical development of medical AI.
Subject(s)
Artificial Intelligence , Health Facilities , Delivery of Health Care , Humans , Morals , TechnologyABSTRACT
[This corrects the article DOI: 10.2196/31231.].
ABSTRACT
BACKGROUND: The COVID-19 pandemic is a threat to global health and requires collaborative health research efforts across organizations and countries to address it. Although routinely collected digital health data are a valuable source of information for researchers, benefiting from these data requires accessing and sharing the data. Health care organizations focusing on individual risk minimization threaten to undermine COVID-19 research efforts, and it has been argued that there is an ethical obligation to use the European Union's General Data Protection Regulation (GDPR) scientific research exemption during the COVID-19 pandemic to support collaborative health research. OBJECTIVE: This study aims to explore the practices and attitudes of stakeholders in the German federal state of Bavaria regarding the secondary use of health data for research purposes during the COVID-19 pandemic, with a specific focus on the GDPR scientific research exemption. METHODS: Individual semistructured qualitative interviews were conducted between December 2020 and January 2021 with a purposive sample of 17 stakeholders from 3 different groups in Bavaria: researchers involved in COVID-19 research (n=5, 29%), data protection officers (n=6, 35%), and research ethics committee representatives (n=6, 35%). The transcripts were analyzed using conventional content analysis. RESULTS: Participants identified systemic challenges in conducting collaborative secondary-use health data research in Bavaria; secondary health data research generally only happens when patient consent has been obtained, or the data have been fully anonymized. The GDPR research exemption has not played a significant role during the pandemic and is currently seldom and restrictively used. Participants identified 3 key groups of barriers that led to difficulties: the wider ecosystem at many Bavarian health care organizations, legal uncertainty that leads to risk-adverse approaches, and ethical positions that patient consent ought to be obtained whenever possible to respect patient autonomy. To improve health data research in Bavaria and across Germany, participants wanted greater legal certainty regarding the use of pseudonymized data for research purposes without the patient's consent. CONCLUSIONS: The current balance between enabling the positive goals of health data research and avoiding associated data protection risks is heavily skewed toward avoiding risks; so much so that it makes reaching the goals of health data research extremely difficult. This is important, as it is widely recognized that there is an ethical imperative to use health data to improve care. The current approach also creates a problematic conflict with the ambitions of Germany, and the federal state of Bavaria, to be a leader in artificial intelligence. A recent development in the field of German public administration known as norm screening (Normenscreening) could potentially provide a systematic approach to minimize legal barriers. This approach would likely be beneficial to other countries.
Subject(s)
COVID-19 , Artificial Intelligence , Attitude , COVID-19/epidemiology , COVID-19/prevention & control , Ecosystem , Humans , Pandemics/prevention & control , Qualitative ResearchABSTRACT
BACKGROUND: Social media recruitment for clinical studies holds the promise of being a cost-effective way of attracting traditionally marginalized populations and promoting patient engagement with researchers and a particular study. However, using social media for recruiting clinical study participants also poses a range of ethical issues. OBJECTIVE: This study aims to provide a comprehensive overview of the ethical benefits and risks to be considered for social media recruitment in clinical studies and develop practical recommendations on how to implement these considerations. METHODS: On the basis of established principles of clinical ethics and research ethics, we reviewed the conceptual and empirical literature for ethical benefits and challenges related to social media recruitment. From these, we derived a conceptual framework to evaluate the eligibility of social media use for recruitment for a specific clinical study. RESULTS: We identified three eligibility criteria for social media recruitment for clinical studies: information and consent, risks for target groups, and recruitment effectiveness. These criteria can be used to evaluate the implementation of a social media recruitment strategy at its planning stage. We have discussed the practical implications of these criteria for researchers. CONCLUSIONS: The ethical challenges related to social media recruitment are context sensitive. Therefore, social media recruitment should be planned rigorously, taking into account the target group, the appropriateness of social media as a recruitment channel, and the resources available to execute the strategy.
Subject(s)
Social Media , Ethical Analysis , Ethics, Research , Humans , Research PersonnelABSTRACT
BACKGROUND: Since the approval of the digital care law (Digitale-Versorgung-Gesetz-DVG) on 19.12.2019, physicians have been able to prescribe digital health applications (DHA). Patients are now entitled to such applications. The present article sets out to clarify how physicians should integrate DHAs into patient care and the ethical responsibilities they have in this process. METHODS: Based on an adapted principle-oriented case analysis, three hypothetical case scenarios are discussed. The argumentative-analytical approach is based on four established principles of medical ethics (following Beauchamp and Childress), namely autonomy, beneficence, non-maleficence and justice, as well as on the Model Professional Code of Conduct for Physicians working in Germany (MBO-Ä). RESULTS: When prescribing DHAs, physicians need to give patients additional information on the specific risks that result from such applications. Special attention must be paid to patients' digital health literacy. Furthermore, DHAs should not replace personal contact, but complement and support guideline-based treatment. To enable patients to use DHAs more independently, we recommend an 'app anamnesis'. CONCLUSION: Beauchamp's and Childress's principles as well as the MBO-Ä are instructive for handling DHAs in patient care. The Dos and Don'ts presented must be complemented by further guidance providing orientation for physicians on how to integrate DHAs in patient care in a responsible way.
Subject(s)
Ethics, Medical , Social Justice , Beneficence , Germany , Humans , Personal Autonomy , PrescriptionsABSTRACT
BACKGROUND: In the COVID-19 pandemic, Switzerland introduced broad nationwide face mask mandates only by October 2020, later than other Western European countries. This study aims to assess the underlying values and considerations of individuals to wear face masks in the absence of face mask mandates in the COVID-19 pandemic in German-speaking Switzerland. METHODS: As part of the "Solidarity in times of a pandemic" (SolPan) research commons, we interviewed 31 participants living in the German-speaking part of Switzerland in April 2020 and 25 of them again in October 2020. Qualitative inductive thematic analysis was applied for data analysis and interpretation. Public health ethics principles guided the interpretation and organization of findings. RESULTS: Five themes were identified: Trust and governmental policy; perceived benefits of mask-wearing; perceived risks of mask-wearing; social exclusion and prejudice; and decision-making in the absence of mandates. In light of increasing infection rates in October 2020, many participants started to consider the benefits higher than the risks and were willing to accept face mask mandates in that context, despite earlier reservations. CONCLUSIONS: The absence of face mask mandates underline individual autonomy but may also suppress personal responsibility due to social influence. Face masks are only temporarily acceptable in liberal Western societies and face mask mandates should be enforced only when epidemiologically necessary.
Subject(s)
COVID-19 , Pandemics , Humans , Masks , SARS-CoV-2 , Switzerland/epidemiologyABSTRACT
BACKGROUND: The workplace has been identified as a priority setting for health promotion. There are potential advantages of systematically integrating Occupational Health Management (OHM) and Corporate Social Responsibility (CSR). However, OHM and CSR are usually overseen by different management branches with different sets of values, and there is a lack of empirical research regarding interfaces between OHM and CSR. Germany offers a particularly useful setting due to legislation requiring health to be promoted in the workplace. This study aims to examine key stakeholders' views and experiences regarding interfaces between OHM and CSR in German companies. METHODS: Individual semi-structured qualitative interviews were conducted with a sample of 77 German stakeholders from three different groups: experts in occupational health and corporate social responsibility from various companies (n = 35), business partners (n = 19), and various non-business partners (n = 23). Transcripts were analysed using qualitative content analysis. RESULTS: Participants identified several areas in which OHM and CSR are already interacting at strategic, structural and cultural levels, but also highlighted several barriers that undermine a more meaningful interaction. Participants reported difficulties in articulating the underlying ethical values relevant to both OHM and CSR at the strategic level. Several structural barriers were also highlighted, including a lack of resources (both financial and knowledge), and OHM and CSR departments not being fully developed or undertaken at entirely different operational levels. Finally, the missing practical implementation of corporate philosophy was identified as a critical cultural barrier to interfaces between OHM and CSR, with existing guidelines and companies' philosophies that already connect OHM and CSR not being embraced by employees and managers. CONCLUSIONS: There is already significant overlap in the focus of OHM and CSR, at the structural, strategic and cultural levels in many German companies. The potential is there, both in theory and practice, for the systematic combination of OHM and CSR. The insights from this study will be useful to ensure that closer integration between both management branches is set up in a socially sustainable and ethical manner.
Subject(s)
Occupational Health , Germany , Humans , Organizations , Social Responsibility , WorkplaceABSTRACT
BACKGROUND: The EU's 2006 Paediatric Regulation aims to support authorisation of medicine for children, thus effectively increasing paediatric research. It is ethically imperative to simultaneously establish procedures that protect children's rights. METHOD: This study endeavours (a) to evaluate whether a template consent form designed by the Standing Working Group of the German-Research-Ethics-Committees (AKEK) adequately informs adolescents about research participation, and (b) to investigate associated phenomena like therapeutic misconception and motives for research participation. In March 2016 a questionnaire study was conducted among 279 pupils (mean age 13.1 years) of a secondary school in northern Germany. RESULTS: A majority of participants showed a general good understanding of foundational research ethics concepts as understood from the AKEK consent form. Nevertheless, our data also suggests possible susceptibility to therapeutic misconception. Own health concerns and pro-social considerations were found to be significant motivational factors for participating in research, while anticipation of pain lessens likelihood of participation. Advice from trusted others is an important decisional influence, too. Furthermore, data security was found to be a relevant aspect of adolescents' decision-making process. CONCLUSION: Bearing in mind adolescents' generally good understanding, we infer the lack of knowledge about medical research in general to be one source of therapeutic misconception. To further improve the quality of consent we propose a multi-staged approach whereby general research education is completed before an individual becomes a patient or potential participant. To the best of our knowledge this is the first German questionnaire-study addressing issues of informed consent in a large under-age sample.
Subject(s)
Informed Consent , Motivation , Adolescent , Child , Consent Forms , Ethics, Research , Germany , HumansABSTRACT
BACKGROUND: Critical Incident Reporting Systems (CIRS) provide a well-proven method to identify clinical risks in hospitals. All professions can report critical incidents anonymously, low-threshold, and without sanctions. Reported cases are processed to preventive measures that improve patient and staff safety. Clinical ethics consultations offer support for ethical conflicts but are dependent on the interaction with staff and management to be effective. The aim of this study was to investigate the rationale of integrating an ethical focus into CIRS. METHODS: A six-step approach combined the analysis of CIRS databases, potential cases, literature on clinical and organizational ethics, cases from ethics consultations, and experts' experience to construct a framework for CIRS cases with ethical relevance and map the categories with principles of biomedical ethics. RESULTS: Four main categories of critical incidents with ethical relevance were derived: (1) patient-related communication; (2) consent, autonomy, and patient interest; (3) conflicting economic and medical interests; (4) staff communication and corporate culture. Each category was refined with different subcategories and mapped with case examples and exemplary related ethical principles to demonstrate ethical relevance. CONCLUSION: The developed framework for CIRS cases with its ethical dimensions demonstrates the relevance of integrating ethics into the concept of risk-, quality-, and organizational management. It may also support clinical ethics consultations' presence and effectiveness. The proposed enhancement could contribute to hospitals' ethical infrastructure and may increase ethical behavior, patient safety, and employee satisfaction.
Subject(s)
Patient Safety , Risk Management , Communication , Hospitals , HumansABSTRACT
BACKGROUND: The main German-speaking countries (Germany, Austria, and Switzerland) have implemented digital contact tracing apps to assist the authorities with COVID-19 containment strategies. Low user rates for these apps can affect contact tracing and, thus, its usefulness in controlling the spread of the novel coronavirus. OBJECTIVE: This study aimed to assess the early perceptions of people living in the German-speaking countries and compare them with the frames portrayed in the newspapers during the first wave of the COVID-19 pandemic. METHODS: We conducted qualitative interviews with 159 participants of the SolPan project. Of those, 110 participants discussed contact tracing apps and were included in this study. We analyzed articles regarding contact tracing apps from 12 newspapers in the German-speaking countries. RESULTS: Study participants perceived and newspaper coverage in all German-speaking countries framed contact tracing apps as governmental surveillance tools and embedded them in a broader context of technological surveillance. Participants identified trust in authorities, respect of individual privacy, voluntariness, and temporary use of contact tracing apps as prerequisites for democratic compatibility. Newspapers commonly referenced the use of such apps in Asian countries, emphasizing the differences in privacy regulation among these countries. CONCLUSIONS: The uptake of digital contact tracing apps in German-speaking countries may be undermined due to privacy risks that are not compensated by potential benefits and are rooted in a deeper skepticism towards digital tools. When authorities plan to implement new digital tools and practices in the future, they should be very transparent and proactive in communicating their objectives and the role of the technology-and how it differs from other, possibly similar, tools. It is also important to publicly address ethical, legal, and social issues related to such technologies prior to their launch.
Subject(s)
COVID-19/epidemiology , Contact Tracing/methods , Mobile Applications , Adolescent , Adult , Aged , Germany/epidemiology , Humans , Middle Aged , Perception , SARS-CoV-2/isolation & purification , Young AdultABSTRACT
BACKGROUND AND METHOD: People have a right to physical and mental integrity in all spheres of life. They also have the right to autonomous actions and informed decisions regarding their health. To ensure this, informed consent has been the ethico-legal gold standard in medicine for some years now. The registration for measures of behavioural prevention, in contrast, is mainly conducted through forms focussing on data protection, with little attention to full informed consent of future participants. In this article, we discuss the ethical challenges that arise when employees consent to health-promoting measures. We then examine whether the instrument of informed consent can be translated to the context of behavioural prevention. RESULTS: Informed consent can be transferred to the corporate context in an altered version. Of particular importance is not only the handling of health-related data, but also the appropriate disclosure of all essential information as well as voluntary participation. CONCLUSIONS: The adjusted version of informed consent in behavioural prevention ought to be developed further, resulting in a matrix of criteria that define conditions under which the informed consent can be applied to single measures of behavioural prevention.
Subject(s)
Informed Consent , Morals , Germany , HumansABSTRACT
There is growing interest in contact tracing apps (CT apps) for pandemic management. It is crucial to consider ethical requirements before, while, and after implementing such apps. In this paper, we illustrate the complexity and multiplicity of the ethical considerations by presenting an ethical framework for a responsible design and implementation of CT apps. Using this framework as a starting point, we briefly highlight the interconnection of social and political contexts, available measures of pandemic management, and a multi-layer assessment of CT apps. We will discuss some trade-offs that arise from this perspective. We then suggest that public trust is of major importance for population uptake of contact tracing apps. Hasty, ill-prepared or badly communicated implementations of CT apps will likely undermine public trust, and as such, risk impeding general effectiveness.