Evidence-Based, Ethical Decision-Making: Using Simulation to Teach the Application of Evidence and Ethics in Practice.

BACKGROUND: Evidence-based practice and ethics should not be taught as isolated concepts. Instead, it is imperative to prepare students with the knowledge needed to practice ethical, evidence-based decision-making in health care. PURPOSE: The purpose of this project was to describe how a mock hospital ethics committee meeting impacted students' learning about the use of evidence to support ethical decision-making in health care. METHOD: A mock hospital ethics committee was convened for 121 students from schools of nursing, social work, law, and medicine. RESULTS: Thematic content analysis showed a positive impact on nursing students' learning of ethics, group dynamics, discipline-specific responsibilities, and EBP. LINKING EVIDENCE TO ACTION: This interprofessional education experience showed students how evidence and ethics can be used to guide and support practice priorities, responsibilities, and decisions on resource utilization and treatment to enable optimal outcomes for patients and organizations.

Research in global health emergencies

In January 2020, we published the findings of a two year in-depth inquiry into the ethical issues relating to research in global health emergencies. The inquiry was run by an international working group which gathered evidence and experience from many contributors across the globe. Better evidence about what helps or doesn’t help during an emergency is needed in order to improve the response to global health emergencies. Research conducted during an emergency itself plays a crucial role in obtaining this evidence, and helps support the immediate response, as well as learning for the future. The aim of the report is to identify ways in which research can be undertaken ethically during emergencies, in order to promote the contribution that ethically-conducted research can make to improving current and future emergency preparedness and response. We have made 24 recommendations to ‘duty bearers’ such as research funders, research organisations, governments, and researchers. These are summarised in our call for action. We suggest changes that would align their policies and practices more closely to three core values of fairness, equal respect, and helping reduce suffering. The report presents these values in the form of an ‘ethical compass’ to guide the conduct of the very wide range of people involved in research in global health emergencies.

Free to Choose: A Moral Defense of the Right-to-Try Movement.

The claim that individuals legitimately differ with respect to their values seems to be uncontroversial among bioethicists, yet many bioethicists nevertheless oppose right-to-try laws. This seems to be due in part to a failure to recognize that such laws are intended primarily to be political, not legal, instruments. The right-to-try movement seeks to build political support for increasing access to newly developed drugs outside of clinical trials. Opponents of right-to-try laws claim that increasing access outside of clinical trials would undermine evidence-based medicine. They seek to maximize overall gains to patients by protecting them from adverse drug reactions and ensuring that drugs are more effective on average. In contrast, right-to-try activists have a point that regulatory judgments of drug safety and effectiveness impose one set of trade-offs on all individuals, regardless of their different values. That might be acceptable if determinations of safety and effectiveness were black and white, but that does not seem to be the case. This article argues that judgments of safety and effectiveness are in an important respect normative and reflect the perceived value of those ends relative to others. Such judgments, when universally imposed, harm patients who would readily make do with less knowledge of drug safety and effectiveness in exchange for more time and self-determination. The relevant moral principle is that of respect for individual autonomy. Just as that principle should lead one to substitute collective decisions for individual ones to regulate a natural monopoly, the same principle should lead one to substitute individual decisions for collective ones to avoid a government monopoly on access to newly developed drugs. It is argued that reforms should increase the number of treatment options available to patients outside of clinical trials. The final section of the article discusses ways in which current regulations might be reformed so as to provide more treatment options outside of clinical trials, without undermining evidence-based medicine.

Evidence first, practice second in arthroscopic surgery: use of placebo surgery in randomised controlled trial.

The application of evidence-based medicine helps clinicians avoid unnecessary procedures and decreases unnecessary harm for future patients while sparing economic burdens. Randomised controlled trials (RCTs) most accurately produce best research evidence. In arthroscopic surgery, however, many procedures have been extensively used without supportive evidence verified with RCTs. In this paper, we introduce two procedures (arthroscopic partial menisectomy for degenerative knees and arthroscopic subacromial decompression for subacromial pain syndrome), where over 30 years of procedure usage has continued prior to garnering evidence for the inefficacy of the procedures. The situations are attributed to the fact that clinical trials in arthroscopic surgeries are challenging given the use of placebo controls. A placebo-control RCT can accurately answer research questions about efficacy and safety of surgical procedures; however, the majority of arthroscopic surgeries in practice have not been rigorously tested against placebo surgeries. This is because preparing surgical placebo controls, known as sham surgeries, are ethically controversial. Also considering that high-quality study results often do not change clinical practice due to insufficient knowledge translation, the benefits of such trials may be uncertain to society at large. Additionally, there are a lack of clear guidelines for conducting arthroscopic placebo surgeries in RCTs. We hope that this article helps drive discussion about appropriate use of placebo surgeries in RCTs to produce the best quality evidence in arthroscopic surgery.

A bioethical framework to guide the decision-making process in the care of seriously ill patients.

BACKGROUND: One of the biggest challenges of practicing medicine in the age of informational technology is how to conciliate the overwhelming amount of medical-scientific information with the multiple patients' values of modern pluralistic societies. To organize and optimize the the Decision-Making Process (DMP) of seriously ill patient care, we present a framework to be used by Healthcare Providers. The objective is to align Bioethics, Evidence-based Practice and Person-centered Care. MAIN BODY: The framework divides the DMP into four steps, each with a different but complementary focus, goal and ethical principle. Step 1 focuses exclusively on the disease, having accuracy is its ethical principle. It aims at an accurate and probabilistic estimation of prognosis, absolute risk reduction, relative risk reduction and treatments' burdens. Step 2 focuses on the person, using empathic communication to learn about patient values and what suffering means for the patient. Emphasis is given to learning and active listening, not taking action. Thus, instead beneficence, we trust comprehension and understanding with the suffering of others and respect for others as autonomous moral agents as the ethical principles of Step 2. Step 3 focuses on the healthcare team, having the ethics of situational awareness guiding this step. The goal is, through effective teamwork, to contextualize and link rates and probabilities related to the disease to the learned patient's values, presenting a summary of which treatments the team considers as acceptable, recommended, potentially inappropriate and futile. Finally, Step 4 focuses on provider-patient relationship, seeking shared Goals of Care (GOC), for the best and worst scenario. Through an ethics of deliberation, it aims for a consensus that could ensure that the patient's values will be respected as well as a scientifically acceptable medical practice will be provided. In summary: accuracy, comprehension, understanding, situational awareness and deliberation would be the ethical principles guiding each step. CONCLUSION: Hopefully, by highlighting and naming the different perspectives of knowledge needed in clinical practice, this framework will be valuable as a practical and educational tool, guiding modern medical professionals through the many challenges of providing high quality person-centered care that is both ethical and evidence based.

Rethinking bias and truth in evidence-based health care.

In modern philosophy, the concept of truth has been problematized from different angles, yet in evidence-based health care (EBHC), it continues to operate hidden and almost undisputed through the linked concept of "bias." To prevent unwarranted relativism and make better inferences in clinical practice, clinicians may benefit from a closer analysis of existing assumptions about truth, validity, and reality. In this paper, we give a brief overview of several important theories of truth, notably the ideal limit theorem (which assumes an ultimate and absolute truth towards which scientific inquiry progresses), the dominant way truth is conceptualized in the discourse and practice of EBHC. We draw on Belgian philosopher Isabelle Stengers' work to demonstrate that bias means one thing if one assumes a world of hard facts "out there," waiting to be collected. It means something different if one takes a critical view of the knowledge-power complex in research trials. Bias appears to have both an unproductive aspect and a productive aspect as argued by Stengers and others: Facts are not absolute but result from an interest, or interesse: a bias towards a certain line of questioning that cannot be eliminated. The duality that Stengers' view invokes draws attention to and challenges the assumptions underlying the ideal limit theory of truth in several ways. Most importantly, it casts doubt on the ideal limit theory as it applies to the single case scenario of the clinical encounter, the cornerstone of EBHC. To the extent that the goal of EBHC is to support inferencing in the clinical encounter, then the ideal limit as the sole concept of truth appears to be conceptually insufficient. We contend that EBHC could usefully incorporate a more pluralist understanding of truth and bias and provide an example how this would work out in a clinical scenario.

The spectrum of ethical issues in a Learning Health Care System: a systematic qualitative review.

PURPOSE: To determine systematically the spectrum of ethical issues that is raised for stakeholders in a 'Learning Health Care System' (LHCS). DATA SOURCES: The systematic review was conducted in PubMed and Google Books between the years 2007 and 2015. STUDY SELECTION: The literature search retrieved 1258 publications. Each publication was independently screened by two reviewers for eligibility for inclusion. Ethical issues were defined as arising when a relevant normative principle is not adequately considered or two principles come into conflict. DATA EXTRACTION: A total of 65 publications were included in the final analysis and were analysed using an adapted version of qualitative content analysis. A coding frame was developed inductively from the data, only the highest-level categories were generated deductively for a life-cycle perspective. RESULTS OF DATA SYNTHESIS: A total of 67 distinct ethical issues could be categorized under different phases of the LHCS life-cycle. An overarching theme that was repeatedly raised was the conflict between the current regulatory system and learning health care. CONCLUSION: The implementation of a LHCS can help realize the ethical imperative to continuously improve the quality of health care. However, the implementation of a LHCS can also raise a number of important ethical issues itself. This review highlights the importance for health care leaders and policy makers to balance the need to protect and respect individual participants involved in learning health care activities with the social value of improving health care.

Use of Research Interfaces for Psychophysical Studies With Cochlear-Implant Users.

A growing number of laboratories are using research interfaces to conduct experiments with cochlear-implant (CI) users. Because these interfaces bypass a subject's clinical sound processor, several concerns exist regarding safety and stimulation levels. Here we suggest best-practice approaches for how to safely and ethically perform this type of research and highlight areas of limited knowledge where further research is needed to help clarify safety limits. The article is designed to provide an introductory level of technical detail about the devices and the effects of electrical stimulation on perception and neurophysiology. From this, we summarize what should be the best practices in the field, based on the literature and our experience. Findings from the review of the literature suggest that there are three main safety concerns: (a) to prevent biological or neural damage, (b) to avoid presentation of uncomfortably loud sounds, and (c) to ensure that subjects have control over stimulus presentation. Researchers must pay close attention to the software-hardware interface to ensure that the three main safety concerns are closely monitored. An important area for future research will be the determination of the amount of biological damage that can occur from electrical stimulation from a CI placed in the cochlea, not in direct contact with neural tissue. As technology used in research with CIs evolve, some of these approaches may change. However, the three main safety principles outlined here are not anticipated to undergo change with technological advances.

Determinants of acceptance of end-of-life interventions: a comparison between withdrawing life-prolonging treatment and euthanasia in Austria.

BACKGROUND: End-of-life decisions remain a hotly debated issue in many European countries and the acceptance in the general population can act as an important anchor point in these discussions. Previous studies on determinants of the acceptance of end-of-life interventions in the general population have not systematically assessed whether determinants differ between withdrawal of life-prolonging treatment (WLPT) and euthanasia (EUT). METHODS: A large, representative survey of the Austrian adult population conducted in 2014 (n = 1,971) included items on WLPT and EUT. We constructed the following categorical outcome: (1) rejection of both WLPT and EUT, (2) approval of WLPT but rejection of EUT, and (3) approval of both WLPT and EUT. The influence of socio-demographics, personal experiences, and religious and socio-cultural orientations on the three levels of approval were assessed via multinomial logistic regression analysis. RESULTS: Higher education and stronger socio-cultural liberal orientations increased the likelihood of approving both WLPT and EUT; personal experience with end-of-life care increased only the likelihood of approval of WLPT; and religiosity decreased approval of EUT only. CONCLUSION: This study found evidence for both shared (education, liberalism) and different (religiosity, care experiences) determinants for the acceptance of WLPT and EUT.

The practice of OTC counseling by community pharmacists in Parana, Brazil / La práctica del asesoramiento en OTC por farmacéuticos comunitarios de Paraná, Brasil

Background: In order to provide appropriate advice to the patient at the time of dispensing and over-the-counter (OTC) medication counseling, community pharmacists need access to current and reliable information about medicines. Brazilian pharmacists have assumed new functions such as prescribing medication, in a dependent model, based in protocols. Objective: To examine the practice of community pharmacists in a Brazilian State, focusing on OTC recommendation. Method: A cross-sectional survey of community pharmacists in a state of Brazil was conducted from October 2013 to January 2014, with data collection through a pre-piloted self-administered anonymous survey via Survey Monkey® platform. Following ethical approval, the online instrument was sent to 8,885 pharmacists registered in Parana State, Brazil, focusing on professionals working in community pharmacies. The questionnaire assessed the community pharmacy setting, the search for information, the knowledge of the evidencebased practice, the important factors to consider when recommending an OTC medicine, and the pharmacist prescribing. Responses were imported into SPSS® (version 22.0) for analysis. Nonparametric tests were used to assess the association between responses and demographic information with a significance level less than 5% (p<0.05). Results: Of the pharmacists, 97.4% dispensed medications and counseled patients for a median of six hours per day. Product's efficacy (97%) and adverse effects (62.3%) were the most important factors taken into account when counseling a nonprescription medicine. Few pharmacists knew the meaning of terms related to evidence-based health. Most respondents agreed that pharmacists have the necessary training to prescribe. Conclusion: Over-the-counter medication counseling is a daily practice among Brazilian pharmacists. Learning needs exist for community pharmacists in relation to evidence-based practice. Thus, sources of information with good evidence could be used daily by community pharmacists, especially as regards nonprescription medication counseling (AU)

Antecedentes: Para proporcionar asesoramiento adecuado al paciente en la dispensación de medicamentos over-the-counter (OTC), los farmacéuticos comunitarios necesitan acceso a información actual y fiable sobre medicamentos. Los farmacéuticos brasileños han asumido nuevas funciones, tales como la prescripción de la medicación, en un modelo independiente basado en protocolos. Objetivo: Examinar la práctica de los farmacéuticos comunitarios en un estado de Brasil, centrándose en las recomendaciones de OTC. Métodos: Se realizó un estudio transversal de farmacéuticos comunitarios en un estado de Brasil entre octubre 2013 y enero 2014, con recogida de datos mediante un cuestionario auto-administrado, pre-pilotado y anónimo en una plataforma Survey Monkey®. Después de la aprobación ética, se envió el instrumento online a 8.885 farmacéuticos registrados en el estado de Paraná (Brasil), centrándose en los profesionales que trabajan en farmacia comunitaria. El cuestionario evaluaba el establecimiento de la farmacia comunitaria, la busca de información, el conocimiento de las prácticas basadas en la evidencia, los factores importantes a considerar cuando se recomienda un medicamento OTC, y la prescripción del farmacéutico. Las respuestas se importaron a SPSS® (versión 22.0) para su análisis. Se usaron pruebas no paramétricas para evaluar la asociación entre respuestas y la información demográfica con un nivel de significancia de menos del 5% (p<0,05). Resultados: El 97,4% de los farmacéuticos dispensaba medicamentos y aconsejaba a pacientes durante una mediana de seis horas por día. Los factores más importantes a tener en cuenta cuando se aconsejaba un medicamento sin receta eran la eficacia del producto (97%) y los efectos adversos (62,3%). Pocos farmacéuticos conocían el significado de los términos relacionados con la práctica basada en la evidencia. La mayoría de los respondentes estaban de acuerdo con que los farmacéuticos tienen la formación necesaria para prescribir medicamentos. Conclusión: El asesoramiento en medicamentos overthe- counter es una práctica diaria entre los farmacéuticos brasileños. Existen necesidades formativas de los farmacéuticos comunitarios en relación a la práctica basada en la evidencia. Así, los farmacéuticos comunitarios podrían usar a diario las fuentes de información con buena evidencia, especialmente relativas al asesoramiento de medicación sin receta (AU)

Specific Techniques Vs. Common Factors? Psychotherapy Integration and its Role in Ethical Practice.

Important change in competent practice in psychological therapy is increasingly being influenced by evidence-based practice. This paper explores major issues related to the evidence-based literature with regard to specific techniques and common factors. Increasing evidence that support common factors provides validity for the psychotherapy integration movement. This movement is explored in relation to the three waves of behavior therapy that indicate an increasing integration of a wide range of therapies. The discussion concludes with implications for therapists who wish to adopt an ethical and evidence-based approach.

Enseñar bioética a estudiantes de medicina mediante el aprendizaje basado en problemas (ABP) / Teaching bioethics to students of medicine with problema-based learning (PBL)

Se describe la implantación de la asignatura de Bioética en una Facultad de Medicina con el objetivo de dotar a los 73 alumnos de quinto curso de competencias para manejar conflictos éticos en su práctica profesional. El método docente utilizado principalmente fue el aprendizaje basado en problemas. Se describen las competencias y objetivos docentes marcados. El diseño de la asignatura consistió en un seminario teórico (2 horas), un taller práctico (2 horas), cuatro casos de aprendizaje basado en problemas (ABP) (24 horas en total) y un taller de dramatizaciones (Role Playing) (2 horas). El seminario se orientó a la adquisición de conocimientos teóricos básicos sobre bioética. Los casos ABP facilitaron la valoración crítica, la obtención de conocimiento, y su aplicación. Los Role Playing se encaminaron a la demostración práctica de las competencias adquiridas en un entorno simulado. Se realizó una evaluación continuada de los alumnos durante su trabajo en los casos ABP (40% de la nota), y una evaluación final de la asignatura mediante un examen (60% de la nota). Los alumnos evaluaron la asignatura y al profesorado de forma anónima, siendo los resultados positivos (8,5/10)

We present the experience of the introduction of the subject of bioethics in a medical school in order to give to the 73 students of 5th degree skills to handle ethical conflicts in their practice. The main teaching method used was problem-based learning (PBL). Skills objectives are described. The course was structured with a theoretical seminar (2 hours of duration), a workshop (2 hours of duration), 4 cases of PBL (24 hours of duration in total) and a role playing workshop (2 hours of duration). The seminar was aimed at the acquisition of theoretical knowledge. The PBL cases provided critical appraisal, obtaining knowledge, and application. The Role Playing set out for the practical demonstration of skills acquired in a simulated environment. A continuous assessment of students was performed throughout their practice on the PBL cases (40% of the final score) and also a final evaluation of the course was carried out via exam (60% of the final score). Students completed a course and faculty evaluation anonymously, which came out with positive results (median score of 8.5/10)