Key person ethical decision-making and substandard drugs rejection intentions.
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ABSTRACT:
SUBMITTER: Ren X
PROVIDER: S-EPMC7081989 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Ethical evaluation of projects involving animal testing is mandatory within the EU and other countries. However, the evaluation process has been subject to criticism, e.g., that the committees are not balanced or democratic enough and that the utilitarian weighting of harm and benefit that is normally prescribed is difficult to carry out in practice. In this study, members of Swedish Animal Ethics Committees (AECs) completed a survey aiming to further investigate the decision-making process. We found that researchers and animal laypersons make significantly different ethical judgments, and hold disparate views on which ethical aspects are the most relevant. Researchers were significantly more content than laypersons with the functioning of the committees, indicating that the ethical model used suited their preferences better. We argue that in order to secure a democratic and proper ethical evaluation, the expectations of a scientific discourse must be acknowledged, while giving room for different viewpoints. Further, to fulfil the purpose of the project evaluations and meet public concern, the functions of the different AEC member categories need to be clarified. We suggest that one way of achieving a more thorough, balanced and inclusive ethical evaluation is to allow for more than one model of ethical reasoning.
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Project description:Evidence from well-designed clinical trials may guide clinicians, reduce regional variation, and lead to improved outcomes. Many physicians choose to ignore evidence-based practice guidelines. Using unproven therapies outside of a randomized trial slows recruitment in clinical trials that could yield information on clinical and economic efficacy. Using acute stroke therapy as an illustration, we present an ethical hierarchy for therapeutic decision making during medical emergencies. First, physicians should offer standard care. If no standard care option exists, the physician should consider enrollment in a randomized clinical trial. If no trial is appropriate, the physician should consider a nonrandomized registry, or consensus-based guidelines. Finally, only after considering the first 3 options, the physician should use best judgment based on previous personal experience and any published case series or anecdotes. Given the paucity of quality randomized clinical trial data for most medical decisions, the "best judgment" option will be used most frequently. Nevertheless, such a hierarchy is needed because of the limited time during medical emergencies for consideration of general principles of clinical decision making. There should be general agreement in advance as to the hierarchy to follow in selecting treatment for critically ill patients. Were more clinicians to follow this hierarchy, and choose to participate in clinical trials, the generation of new knowledge would accelerate, yielding rigorous data supporting or refuting the efficacy and safety of new interventions more quickly, thus benefiting far more patients over time.
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Project description:BackgroundEthical decision-making confidence develops from clinical expertise and is a core competency for nurse leaders. No tool exists to measure confidence levels in nurse leaders based upon an ethical decision-making framework.AimsThe objective of this research was to compare ethical decision-making among nurse leaders in the U.S. and three German-speaking countries in Europe by developing and testing a newly constructed Ethical Decision-Making Confidence (EDMC) scale.MethodsThe cross-sectional survey included 18 theory-derived questions on ethical decision-making confidence which were used to develop the scale.ParticipantsA convenience sample of nurse leaders from the U.S. and three German-speaking countries in Europe who self-identified as holding a leadership position.Ethical considerationsEthical approval was given by the IRB Board of a U.S. university. Participation in the survey implied voluntary consent.ResultsThe scale's item structure dimensionality and subscale's reliability were analyzed and compared between nurse leaders from all four countries. A principal component analysis (PCA) produced a 15-item bi-dimensional EDMC scale yielding a skill-related (9-item) and a behavior-related (6-item) confidence dimension. EDMC subscales showed good-to-excellent internal consistency. In both subscales, U.S. nurse leaders rated their mean EDMC score higher than their German-speaking counterparts in Europe.DiscussionThis exploratory study is the first of its kind to focus on nurse leaders' confidence regarding ethical decision-making in an international context. An overarching factor structure was identified, which is shared by the two samples of nurse leaders and to examine (sub)scales' psychometric properties.ConclusionThis newly developed scale is an effective tool for measuring ethical decision-making confidence in nurse leaders. The promising results of this study should be replicated to ensure validity and reliability of the EDMC scale measuring skill-related and behavior-related concepts and include nurse leaders from various cultural, social, and demographic groups.
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Project description:Visitation restrictions in hospitals during the COVID-19 (coronavirus disease 2019) pandemic led to great psychological burden for patients, their relatives and employees. For hospitals, they represent a complex organizational challenge with respect to ethics. The present recommendations are intended to support decision-making at the meso- and microlevels.
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Project description:ImportancePhysicians endorse deprescribing of risky or unnecessary medications for older adults (aged ≥65 years) with dementia, but there is a lack of information on what influences decisions to deprescribe in this population.ObjectiveTo understand how physicians make decisions to deprescribe for older adults with moderate dementia and ethical and pragmatic concerns influencing those decisions.Design, setting, and participantsA cross-sectional national mailed survey study of a random sample of 3000 primary care physicians from the American Medical Association Physician Masterfile who care for older adults was conducted from January 15 to December 31, 2021.Main outcomes and measuresThe study randomized participants to consider 2 clinical scenarios in which a physician may decide to deprescribe a medication for older adults with moderate dementia: 1 in which the medication could cause an adverse drug event if continued and the other in which there is no evidence of benefit. Participants ranked 9 factors related to possible ethical and pragmatic concerns through best-worst scaling methods (from greatest barrier to smallest barrier to deprescribing). Conditional logit regression quantified the relative importance for each factor as a barrier to deprescribing.ResultsA total of 890 physicians (35.0%) returned surveys; 511 (57.4%) were male, and the mean (SD) years since graduation was 26.0 (11.7). Most physicians had a primary specialty in family practice (50.4% [449 of 890]) and internal medicine (43.5% [387 of 890]). A total of 689 surveys were sufficiently complete to analyze. In both clinical scenarios, the 2 greatest barriers to deprescribing were (1) the patient or family reporting symptomatic benefit from the medication (beneficence and autonomy) and (2) the medication having been prescribed by another physician (autonomy and nonmaleficence). The least influential factor was ease of paying for the medication (justice).Conclusions and relevanceFindings from this national survey study of primary care physicians suggests that understanding ethical aspects of physician decision-making can inform clinician education about medication management and deprescribing decisions for older adults with moderate dementia.
| S-EPMC10548310 | biostudies-literature
Project description:Ethical standards in audiology have been continuously improved and discussed, leading to the elaboration of specific regulatory guidelines for the profession. However, in the field of auditory rehabilitation, audiologists are still faced with circumstances that question their ethical principles, usually associated with the support of the hearing aids industry. The study explores the decision-making process and ethical concerns in auditory rehabilitation as they relate to the practice of audiology in Portugal. An online questionnaire constructed by the authors was used and sent to the email addresses of a list of audiologists, registered with the Portuguese Association of Audiologists. The questionnaire was answered by 93 audiologists with clinical experience in auditory rehabilitation for more than one year. The collected data demonstrated that audiometric results and clinical experience are the most important factors for decision-making in auditory rehabilitation practice. Moreover, incentives from the employers or manufacturers were identified as the main cause of ethical dilemmas. This study highlights the ethical concerns regarding the clinical practice of auditory rehabilitation in Portugal, revealing that the decision-making process is complex and, specifically in this field, the current practice may not be adequate for effective compliance with professional ethical standards.
| S-EPMC9028603 | biostudies-literature
Project description:Ethical decision making in disaster and emergency management requires more than good intentions; it also asks for careful consideration and an explicit, systematic approach. The decisions made by leaders and the effects they have in a disaster must carry the confidence of the community to which they serve. Such decisions are critical in settings where resources are scarce; when decisions are perceived as unjust, the consequences may erode public trust, result in moral injury to staff, and cause community division. To understand how decisions in these settings are informed by ethics, a systematic literature review was conducted to determine what ethical guidance informs decision making in disaster and emergency management. This study found evidence of ethical guidance to inform decision making in disaster management in the humanitarian system, based on humanitarian principles. Evidence of the application of an ethical framework to guide or reference decision making was varied or absent in other emergency management agencies or systems. Development and validation of ethical frameworks to support decision making in disaster management practice is recommended.
| S-EPMC10548018 | biostudies-literature
Project description:BackgroundThe four principles of Beauchamp and Childress--autonomy, non-maleficence, beneficence and justice--have been extremely influential in the field of medical ethics, and are fundamental for understanding the current approach to ethical assessment in health care. This study tests whether these principles can be quantitatively measured on an individual level, and then subsequently if they are used in the decision making process when individuals are faced with ethical dilemmas.MethodsThe Analytic Hierarchy Process was used as a tool for the measurement of the principles. Four scenarios, which involved conflicts between the medical ethical principles, were presented to participants who then made judgments about the ethicality of the action in the scenario, and their intentions to act in the same manner if they were in the situation.ResultsIndividual preferences for these medical ethical principles can be measured using the Analytic Hierarchy Process. This technique provides a useful tool in which to highlight individual medical ethical values. On average, individuals have a significant preference for non-maleficence over the other principles, however, and perhaps counter-intuitively, this preference does not seem to relate to applied ethical judgements in specific ethical dilemmas.ConclusionsPeople state they value these medical ethical principles but they do not actually seem to use them directly in the decision making process. The reasons for this are explained through the lack of a behavioural model to account for the relevant situational factors not captured by the principles. The limitations of the principles in predicting ethical decision making are discussed.
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Project description:BackgroundThe UN Convention on the Rights of Persons with Disabilities, and the reformed guardianship law in Germany, require that persons with a disability, including people with dementia in Alzheimer's disease (PwAD), are supported in making self-determined decisions. This support is achieved through communication. While content-related communication is a deficit of PwAD, relational aspects of communication are a resource. Research in supported decision-making (SDM) has investigated the effectiveness of different content-related support strategies for PwAD but has only succeeded in improving understanding, which, although one criterion of capacity to consent, is not sufficient to ensure overall capacity to consent. The aim of the 'spatial intervention study' of the DECIDE project is to examine an innovative resource-oriented SDM approach that focuses on relational aspects. We hypothesise that talking to PwAD in their familiar home setting (as opposed to a clinical setting) will reduce the complexity of the decision-making process and enhance overall capacity to consent.MethodsPeople with a suspected or confirmed diagnosis of dementia in Alzheimer's disease will be recruited from two memory clinics (N = 80). We will use a randomised crossover design to investigate the intervention effect of the decision-making place on capacity to consent. Besides reasoning capacity, which is part of overall capacity to consent and will be the primary outcome, various secondary outcomes (e.g., other aspects of capacity to consent, subjective task complexity, decisional conflict) and suspected moderating or mediating variables (e.g., meaning of home, demographic characteristics) will be assessed.DiscussionThe results of the study will be used to develop a new SDM strategy that is based on relational resources for PwAD. If a change in location achieves the anticipated improvement in capacity to consent, future research should focus on implementing this SDM strategy in a cost-effective manner in clinical practice.Trial registrationDRKS00030799 .
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Project description:"Values-based decision-making" frameworks and models are widely described in the literature in various disciplines, including healthcare settings. However, there is a paucity of literature on the application of systematic methods or models in the biopharmaceutical research and development (R&D) field of drugs, vaccines, and immunotherapeutics. In this report, we describe our model that uses company values along with framing questions in a five-step process to guide ethical decisions in the vaccines R&D context. The model uniquely supports practical prospective decision-making: employees are engaged as moral agents applying values and principles to guide their decision in a specific situation. We illustrate, by way of case studies, how the model is being used in practice. The consistent application of company values during decision-making calls upon employees to use their judgment, therefore reducing the need for the organization to systematically generate written instructions. Finally, we report on preliminary results of model adoption by teams within our organization, discuss its limitations and likely future contribution. We applied our model within a vaccines R&D context and believe its use can be extended to other areas where business-related decisions impact patients.
| S-EPMC7482740 | biostudies-literature