How do we teach medical students to protect patients? My initial reaction to the question posed by Taylor and Goodwin was like first glimpsing ‘Jaws’: we’re going to need a bigger boat. The authors’ answer makes two important claims: first, that safety should be ethically sourced by better integration between teaching of safety and ethics; second, that teaching should encourage students to think about organisational failure rather than focusing on individual blame and personal responsibility to whistleblow.1 On the first, (...) they highlight how ethics teaching often sits apart from that on safety. For the second, they use the concept normalisation of deviance, with its contained idea of structural secrecy, to depict organisational failure that is argued as largely immune to whistleblowing. Why wouldn’t these challenges warrant a bigger boat? On their first claim: it is not just for safety, but throughout the curriculum that ethics teaching needs to be integral. Given coming challenges, it should become the cake rather than the icing. Consider, for example, that artificial intelligence stands to transform many knowledge-based professions, medicine among them. Tomorrow’s doctors will have a surfeit of data and automated decision aids at their fingertips. So, as far as they remain necessary, doctors will …. (shrink)

Objectives To conduct an independent evaluation of the first phase of the Health Foundation’s Safer Patients Initiative (SPI), and to identify the net additional effect of SPI and any differences in changes in participating and non-participating NHS hospitals. Design Mixed method evaluation involving five substudies, before and after design. Setting NHS hospitals in the United Kingdom. Participants Four hospitals (one in each country in the UK) participating in the first phase of the SPI (SPI1); 18 control hospitals. (...) Intervention The SPI1 was a compound (multi-component) organisational intervention delivered over 18 months that focused on improving the reliability of specific frontline care processes in designated clinical specialties and promoting organisational and cultural change. Results Senior staff members were knowledgeable and enthusiastic about SPI1. There was a small (0.08 points on a 5 point scale) but significant (P<0.01) effect in favour of the SPI1 hospitals in one of 11 dimensions of the staff questionnaire (organisational climate). Qualitative evidence showed only modest penetration of SPI1 at medical ward level. Although SPI1 was designed to engage staff from the bottom up, it did not usually feel like this to those working on the wards, and questions about legitimacy of some aspects of SPI1 were raised. Of the five components to identify patients at risk of deterioration—monitoring of vital signs (14 items); routine tests (three items); evidence based standards specific to certain diseases (three items); prescribing errors (multiple items from the British National Formulary); and medical history taking (11 items)—there was little net difference between control and SPI1 hospitals, except in relation to quality of monitoring of acute medical patients, which improved on average over time across all hospitals. Recording of respiratory rate increased to a greater degree in SPI1 than in control hospitals; in the second six hours after admission recording increased from 40% (93) to 69% (165) in control hospitals and from 37% (141) to 78% (296) in SPI1 hospitals (odds ratio for “difference in difference” 2.1, 99% confidence interval 1.0 to 4.3; P=0.008). Use of a formal scoring system for patients with pneumonia also increased over time (from 2% (102) to 23% (111) in control hospitals and from 2% (170) to 9% (189) in SPI1 hospitals), which favoured controls and was not significant (0.3, 0.02 to 3.4; P=0.173). There were no improvements in the proportion of prescription errors and no effects that could be attributed to SPI1 in non-targeted generic areas (such as enhanced safety culture). On some measures, the lack of effect could be because compliance was already high at baseline (such as use of steroids in over 85% of cases where indicated), but even when there was more room for improvement (such as in quality of medical history taking), there was no significant additional net effect of SPI1. There were no changes over time or between control and SPI1 hospitals in errors or rates of adverse events in patients in medical wards. Mortality increased from 11% (27) to 16% (39) among controls and decreased from 17% (63) to 13% (49) among SPI1 hospitals, but the risk adjusted difference was not significant (0.5, 0.2 to 1.4; P=0.085). Poor care was a contributing factor in four of the 178 deaths identified by review of case notes. The survey of patients showed no significant differences apart from an increase in perception of cleanliness in favour of SPI1 hospitals. Conclusions The introduction of SPI1 was associated with improvements in one of the types of clinical process studied (monitoring of vital signs) and one measure of staff perceptions of organisational climate. There was no additional effect of SPI1 on other targeted issues nor on other measures of generic organisational strengthening. (shrink)

Patients sometimes visit their general practitioners with more than one concern. This article investigates when and how patients initiate presentations of such additional concerns. The study is conversation analytic in its approach and scope. It is based upon video-recordings of naturally occurring general practice consultations in Denmark. Data suggest that Danish patients relatively frequently initiate presentations of additional concerns and defer such initiations until moments when the parties would otherwise engage in closing down the consultations. Additional concerns (...) are introduced in response to the doctor’s possible pre-closing remarks. The parties, thereafter, employ a set of transitional elements: confirmation, preliminary announcement and ratification. This transition enables the parties to recycle the activities of the visit, to discuss and examine yet another concern. Thus, additional concerns are not presented completely unexpectedly or randomly as commonsense understanding sometimes has it; they are introduced at orderly moments and by means of recognizable methods. (shrink)

Ethical foundations of patient safety -- Vigilance -- Mindfulness -- Compliance -- Humility -- Some theoretical aspects of vigilance and risk acceptability -- Fifty shades of error -- The standard care and medical malpractice law as an ethical achievement -- The present and the future.

Too many patients are injured in the course of medical care. This truth is as distressing now as it was four years ago when it began an article in this journal’s last similar symposium. Many or most injuries seem preventable. Yet today’s systems of care and of oversight of care too often fail to prevent them, despite generations of increasing legal intervention. Few injuries are litigated, even fewer addressed through medical peer review or state disciplinary authorities. The Institute of (...) Medicine’s landmark report To Err Is Human brought patient safety to national attention when released in late 1999. Half a decade later, significant reduction of injury remains a distant prospect, despite some apparent progress. (shrink)

Too many patients are injured in the course of medical care. This truth is as distressing now as it was four years ago when it began an article in this journal’s last similar symposium. Many or most injuries seem preventable. Yet today’s systems of care and of oversight of care too often fail to prevent them, despite generations of increasing legal intervention. Few injuries are litigated, even fewer addressed through medical peer review or state disciplinary authorities. The Institute of (...) Medicine’s landmark report To Err Is Human brought patient safety to national attention when released in late 1999. Half a decade later, significant reduction of injury remains a distant prospect, despite some apparent progress. (shrink)

The ethical obligation to provide a reasonably safe discharge option from the inpatient setting is often confounded by the context of homelessness. Living without the security of stable housing is a known determinant of poor health, often complicating the safety of discharge and causing unnecessary readmission. But clinicians do not have significant control over unjust distributions of resources or inadequate societal investment in social services. While physicians may stretch inpatient stays beyond acute care need in the interest of their (...) class='Hi'>patients who are experiencing homelessness, they must also consider the implications of using an inpatient hospital bed for someone without the attendant level of medical need. Caring for patients in an inpatient setting when they no longer require acute care means fewer beds for acute care patients. And when a patient who is experiencing homelessness declines a medically safer option such as a skilled nursing facility, then clinicians may be faced with the sole option of discharge to the street, which raises troubling questions of nonmaleficence and social justice. Here we investigate the different forms of injustice that play out when patients are discharged to the street, and offer a map of the interwoven ethical responsibilities of clinicians, hospitals, and skilled nursing facilities. (shrink)

Psychiatric patients may try (or express a desire) to injure themselves in hospital in order to cope with overwhelming emotional pain. Some health care practitioners and patients propose allowing a controlled amount of self-injury to occur in inpatient facilities, so as to prevent escalation of distress. Is this approach an example of professional assistance with harm? Or, is the approach more likely to minimise harm, by ensuring safer self-injury? In this article, I argue that health care practitioners (...) who use harm-minimisation can be considered to be helping physical injury to occur, although they do not encourage the act. I consider why there are compelling reasons to believe that a patient who self-injures is not maximally autonomous in relation to that choice. However, I then move onto argue that allowing a degree of self-injury may enable engagement with psychotherapy (enhancing autonomy) and behavioural change. In these circumstances, allowing injury (with precautions) may not be harm, all things considered. (shrink)

Clinical ethics consultations exist to support patients, families and clinicians who are facing ethical or moral challenges related to patient care. They provide a forum for open communication, where all stakeholders are encouraged to express their concerns and articulate their viewpoints. Ethics consultations can be requested by patients, caregivers or members of a patient’s clinical or supportive team. Althoughpatientsand by extension their families (especially in cases of decisional incapacity) are the common denominators in most ethics consultations, these constituents (...) are theleastlikely to request them. At many healthcare organisations in the USA, ethics consultations are overwhelmingly requested by physicians and other clinicians. We believe it is vital that healthcare institutions bridge the knowledge gaps and power imbalances over access to ethics consultation services through augmented policies, procedures and infrastructure. With enhanced education and support, patients and families may use ethics consultation to elevate their voices and prioritise their unique characteristics and preferences in the delivery of their healthcare. Empowering patients and families to request ethics consultation can only strengthen the patient/family–clinician relationship, enhance the shared decision-making model of care and ultimately lead to improved patient-centred care. (shrink)

BackgroundThe high incidence of post-stroke depression during rehabilitation exerts a negative effect on the treatment and functional recovery of patients with stroke and increases the risk of mortality. It is necessary to screen PSD in the rehabilitation stage and thus provide effective intervention strategies. However, existing measurements used to assess PSD in the rehabilitation stage in patients with stroke lack specificity. This study aimed to develop a clinical measure to assess symptoms of PSD in the rehabilitation stage.MethodsThe research (...) team created the initial items through a literature review and semi-structured interviews of patients with stroke. Then, the symptom-related items were estimated by three panels: healthcare professionals, Delphi experts, and patients with stroke in the rehabilitation stage.ResultsThe literature review and semi-structured interview produced 51 symptom-related items including six domains, and the items were reduced to 47 by the healthcare professionals. The symptom-related items were further reduced to 33 items by a two-round Delphi consultation. The initiative coefficients of the two Delphi rounds were 71.4 and 100%, the expert authority coefficients were both 0.85, Kendall’s W were 0.152 and 0.408, and the coefficient of variation were 0.05–0.32 and 0.00–0.18, respectively. The item-level content validity index was 0.53–1.00, the scale-level CVI/universal agreement was 0.26, and the S-CVI/average was 0.85 for the first found Delphi consultation; the I-CVI was 0.67–1.00, the S-CVI/UA was 0.61, and the S-CVI/Ave was 0.97 for the second round Delphi consultation. All content validity indicators have been significantly improved compared with the first round. Using mean ≥ 4 and full score ≥ 0.5, combined with CV ≤ 0.16 as the item criteria, a clinical measure of PSD with 33 items and 6 dimensions was finally formed after two rounds. The patients with stroke made no further revisions after evaluation.ConclusionThe research team developed a specific tool with good content validity to assess the symptoms of PSD in the rehabilitation stage. (shrink)

ObjectiveThis study aimed to analyze the hearing improvement and prognosis factors of idiopathic sudden sensorineural hearing loss in different ages with initial total hearing loss.MethodsWe reviewed the medical records of 5,711 hospitalized patients with ISSNHL from 2016 to 2021 in our center. All of the patients had been treated with uniform combination drug therapy. After excluding the patients with initial partial hearing loss and those diagnosed with clear etiology, 188 patients were enrolled in this study and (...) divided into six age groups. In all groups, decreases in pure-tone average 1 month posttreatment, effective rate, and clinical characteristics were analyzed.ResultsAmong the 188 enrolled patients, 86% had vertigo. Complete recovery was seen in 0.5% of patients, and marked recovery was seen in 43% of patients. The mean 1 month posttreatment PTAs were as follows: 18–30 years: 80 ± 7.5 dB; 31–40 years: 100 ± 9.0 dB; 41–50 years: 99 ± 8.3 dB; 51–60 years: 101 ± 8.6 dB; 61–70 years: 96 ± 9.6 dB; and ≥ 71 years: 88 ± 13.0 dB. Compared with the other groups, the 18–30- years group showed better recovery of hearing threshold in five frequencies, and the recovery of hearing threshold at 0.25 and 0.5 Hz was better than the recovery at 1, 2, and 4 kHz. According to the results of the chi-square test statistical analysis, vertigo and comorbidities were associated with a poor prognosis of ISSNHL.ConclusionIn summary, the treatment outcomes of patients with ISSNHL with initial total hearing loss were poor. There was a significant age-related difference with respect to marked recovery 1 month posttreatment, and the 18–30- years group showed better recovery than the other age groups. (shrink)

The aim of the study was to explore heterogeneity of change in state affect following the introduction of insulin therapy in patients with type 2 diabetes. State affect was assessed twice among 305 patients: just before the introduction of insulin therapy and at 1-month follow-up. Latent class growth modeling showed that negative affect increased in 78% of the sample, whereas positive affect improved in only 17% of the participants. On the basis of cross-tabulation of these changes a 4-class (...) model of emotional response to the new treatment was obtained. The largest subgroup of participants manifested “threat response”, i.e. moderate-stable PA with increase in NA. Participants in the “challenge response” subgroup showed increases in both NA and PA. The third class characterized by “no response”, had low-stable NA and moderate-stable PA. The smallest “stress response” subgroup showed increase in NA and high-stable PA. Gender, age and education level were significant covariates of group membership. Thus, the findings revealed heterogeneous emotional response to the new treatment, which may be of clinical relevance for improving diabetic patients’ adjustment through a more individual, person-centered approach. (shrink)

In this article, an ethical analysis of an educational programme on renal replacement therapy options for patients and their social network is presented. The two main spearheads of this approach are: (1) offering an educational programme on all renal replacement therapy options ahead of treatment requirement and (2) a home-based approach involving the family and friends of the patient. Arguments are offered for the ethical justification of this approach by considering the viewpoint of the various stakeholders involved. Finally, reflecting (...) on these ethical considerations, essential conditions for carrying out such a programme are outlined. The goal is to develop an ethically justified and responsible educational programme. (shrink)

Placebo-controlled trials are controversial when individuals might be denied existing beneficial medical interventions. In the case of malaria, most patients die in rural villages without healthcare facilities. An artesunate suppository that can be given by minimally skilled persons might be of value when patients suddenly become too ill for oral treatment but are several hours from a facility that can give injectable treatment for severe disease. In such situations, by default, no treatment is (or can be) given until (...) the patient reaches a facility, making the placebo control design clinically relevant; alternative bioequivalence designs at the facility would misrepresent reality and risk incorrect conclusions. We describe the ethical issues underpinning a placebo-controlled trial in severe malaria. To protect patients and minimise risk, all patients were referred immediately to hospital so that each had a higher chance of prompt treatment through participation. There was no difference between artesunate and placebo in patients who reached clinic rapidly; among those who could not, a single artesunate suppository significantly reduced death or permanent disability, a finding of direct and indirect benefit to patients in participating villages and elsewhere. (shrink)

Designing and manufacturing medical devices for specific patients is becoming increasingly feasible with developments in 3D printing and 3D imaging software. This raises the question of how patient-specific devices can be evaluated, since our ‘gold standard’ method for evaluation, the randomised controlled trial, requires that an intervention is standardised across a number of individuals in an experimental group. I distinguish several senses of patient-specific device, and focus the discussion on understanding the problem of variations between instances of an intervention (...) for RCT evaluation. I argue that, despite initial appearances, it is theoretically possible to use RCTs to evaluate some patient-specific medical devices. However, the argument reveals significant difficulties for ensuring the validity of such trials, with implications for how we should think about methods of evidence gathering and regulatory approaches for these technologies. (shrink)

Major concerns about privacy have limited health professionals’ usage of popular social networking sites such as Facebook. However, the landscape of social media is changing in favor of more sophisticated privacy controls that enable users to more carefully manage public and private information. This evolution in technology makes it potentially less hazardous for health professionals to consider accepting colleagues and patients into their online networks, and invites medicine to think constructively about how social media may add value to contemporary (...) healthcare. (shrink)

IntroductionInternational sharing of health data opens the door to the study of the so-called ‘Big Data’, which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a ‘social license’ is identifying the views patients and the public may hold with regard to data sharing for health research.MethodsWe performed a narrative review of the empirical evidence addressing (...) patients’ and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed, Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients’ and public attitudes were extracted from selected references and thematically categorised.ResultsTwenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread—though conditional—support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability.ConclusionsOur results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests. (shrink)

Abstract.The United Kingdom Department of Health initiative on “The Expert Patient” (2001) reflects recent trends in political philosophy, ethics and health services research. The overall objective of the initiative is to encourage patients, particularly those suffering from chronic conditions to become more actively involved in decisions concerning their treatment. In doing so there would be (perhaps) an expectation of better patient compliance and (arguably) a resultant improvement in quality of life. Despite these anticipated beneficial influences on health (...) outcomes, there may be a danger that such initiatives are being carried along by the general swell of enthusiasm for recognising and facilitating the claims of disadvantaged or discriminated against groups. What more attractive than that patients should be “liberated” from what might be seen as the oppression of medical paternalism? To a great extent the potential for success of the Expert Patient venture turns on:(a) whether and to what extent a patient can be considered truly to be an expert and (b) full acceptance by the medical and heath care professions of allowing patients a more equitable and positive role.Whilst clearly the patient is an expert in the hermeneutic sense – it is they and they alone who experience their illness – there is nevertheless a risk of confusing experience with expertise. Experience limited to an individual does not of itself give rise to the generalisations that underlie reliable clinical treatment. Neither do the vast majority of patients possess the physiological and pharmacological knowledge to fully appreciate the biological nature of their illness nor the basis, risks or limitations of therapeutic measures. Might the notion of “The Expert Patient” as informed co-decision maker become a well-meaning but rather vacuous aspiration similar to that of informed consent? Even worse, could patient “empowerment” have a deleterious effect? The paper reviews some of the major issues and concludes that the expert patient initiative could have benefits for both patients and health professionals if operated on the basis of concordance: an informed collaborative alliance that optimises the potential benefits of medical care. (shrink)

This debate article explores how smart technologies may create a double-edged sword for patient safety and effective therapeutic relationships. Increasing utilization of health monitoring devices by patients will likely become an important aspect of self-care and preventive medicine. It may also help to enhance accurate symptom reports, diagnoses, and prompt referral to specialist care where appropriate. However, the development, marketing, and use of such technology raise significant ethical implications for therapeutic relationships and patient safety. Drawing on lessons learned from (...) other direct-to-consumer health products such as genetic testing, this article explores how smart technology can also pose regulatory challenges and encourage overutilization of healthcare services. In order for smart technology to promote safer care and effective therapeutic encounters, the technology and its utilization must be safe. This article argues for unified regulatory guidelines and better education for both healthcare providers and patients regarding the benefits and risks of these devices. (shrink)

Count Me In (CMI) was launched in 2015 as a patient-driven research initiative aimed at accelerating the study of cancer genomics through direct participant engagement, electronic consent and open-access data sharing. It is an example of a large-scale direct-to-patient (DTP) research project which has since enrolled thousands of individuals. Within the broad scope of ‘citizen science’, DTP genomics research is defined here as a specific form of ‘top-down’ research endeavour developed and overseen by institutions within the traditional human subjects (...) research context; in novel ways, it engages and recruits patients with defined diseases, consents them for medical information and biospecimens sharing, and stores and disseminates genomic information. Importantly, these projects simultaneously aim to empower participants in the research process while increasing sample size, particularly in rare disease states. Using CMI as a case study, this paper discusses how DTP genomics research raises new questions in the context of traditional human subjects research ethics, including issues surrounding participant selection, remote consent, privacy and return of results. It aims to demonstrate how current research ethics frameworks may be insufficient in this context, and that institutions, institutional review boards and investigators should be aware of these gaps and their role in ensuring the conduct of ethical, novel forms of research together with participants. Ultimately, a broader question is raised of whether the rhetoric of participatory genomics research advocates for an ethic of personal and social duty for contributing to the advancement of generalisable knowledge about health and disease. (shrink)

The increasing gap between organ supply and demand has opened the door for illegal organ sale, trafficking of human organs, tissues and cells, as well as transplant tourism. Currently, underprivileged and vulnerable populations in resource-poor countries are a major source of organs for rich patient-tourists who can afford to purchase organs at home or abroad. This paper presents a summary of international initiatives, such as World Health Organization’s Principle Guidelines, The Declaration of Istanbul, Asian Task Force Recommendations, as well as (...) UNESCO’s and the United Nation’s initiatives against trafficking of human organs, tissues, cells, and transplant tourism. Beyond the summary, it calls for more practical measures to be taken to implement the existing guidelines and recommendations, in order to prevent exploitation of the poor as organ providers. The paper suggests that an international legally binding agreement in criminalizing organ trafficking would be a step forward to bring a change in the global picture of organ trafficking and transplant tourism. (shrink)

Background: In the USA, the Food and Drug Administration waiver of informed consent permits certain emergency research only if community consultation occurs. However, uncertainty exists regarding how to define the community or their representatives.Objective: To collect data on the actual preferences and values of a group—those at risk for stroke—most directly affected by the waiver of informed consent for emergency research.Design: Face to face focused interviews were conducted with 12 patients who were hospitalised with a stroke diagnosis in the (...) previous year. The interviews were audiotaped and a transcript based method was used for their analysis.Results: All 12 participants felt “that it was important that new treatments for stroke be developed”, but they were initially confused about the distinction between “research for stroke” and “emergency research for stroke”. However, after explanation, most expressed willingness to participate in the latter. In the absence of a surrogate to give informed consent in a stroke emergency situation, the majority said they would want the physician to “go ahead and enrol them in the trial”.Conclusions: This study is the first to identify the values and concerns of individuals most directly affected by stroke emergency research. Further interviews and focus groups are needed to develop and test a validated questionnaire on the preferences and values surrounding emergency research for stroke. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 11.2 (2001) 115-116 [Access article in PDF] The Ethics of Medical Mistakes: Historical, Legal, and Institutional Perspectives Introduction In late 1999, the Institute of Medicine (IOM) released its report on medical errors, To Err is Human: Building a Safer Health System. The report estimated almost 50,000 deaths per year nationally due to medical mistakes, making it a leading cause of death. IOM speculated (...) that more than half of the deaths related to medical error are preventable. The IOM report shocked the public and medical professionals alike, sparking a national discussion of how to make the health care system safer. This multifaceted issue has profound implications for all aspects of health care, from the very personal--e.g., the relationship of caregiver and patient--to the societal--e.g., a nation's responsibility to its citizens.On 15 May 2000, the University of Pittsburgh Medical Center hosted an ethics conference devoted to the topic of medical mistakes. The goal was to bring together experts from various disciplines, before an audience of both providers and patients, to discuss medical mistakes and their implications. In this issue of the Kennedy Institute of Ethics Journal, we present selected papers resulting from that conference. These papers reflect not only the original oral presentations, but also much of the discussion those presentations generated. Three key perspectives on the ethics of medical mistakes are offered: historical, legal, and institutional.Rosa Lynn Pinkus offers a revealing historical perspective on the ethics of medical mistakes. In analyzing the history of mistake reporting in neurosurgery, she shows how the notion of a mistake developed only as the notion of a standard of practice emerged. Although much of managed care is directed toward systematically fostering a standard of care, this pursuit is relatively new in health care. One might speculate that as more standards are created, mistakes--defined as deviations from standard practice--must increase. If deviation from standard practice is overly castigated, however, then needed innovation in practice may be stifled. Interestingly, as Pinkus discusses, medical malpractice suits quickly followed the emergence of practice standards, driving the initial open reporting of mistakes underground. [End Page 115]Taking up the issue of medical malpractice, Thomas May and Mark Aulisio consider the ramifications of the current malpractice system for mistake prevention. The current system, they argue, while failing to adequately achieve its purported goals of deterring medical mistakes and compensating victims, itself creates a climate that deters the open reporting of mistakes by engendering fear and shame in clinicians. According to May and Aulisio, this failure to report medical mistakes openly has serious ramifications. Chief among these is the inability to do root cause analysis of mistakes, and then, where possible, to implement safeguards to minimize the occurrence of future mistakes. Ultimately, both the prevention of medical mistakes and the goals of malpractice litigation itself will be better served if substantial malpractice reform is undertaken.Andy Thurman argues that even in the current climate institutions ought to have a policy (and practice) of admitting to and openly reporting medical mistakes. Thurman argues that doing so not only is the right thing to do, but is also in the interest of institutions. Interestingly, he contends that failing to admit and openly report mistakes is both at odds with the mission of health care institutions and puts them at higher risk of litigation, and liability. In light of this, Thurman then suggests an institutional process for handling medical mistakes.Michael DeVita concedes that disclosing mistakes is widely supported by the health professionals' principles of ethics, but argues that there are a number of factors that conspire to make doing so a very difficult task. In analyzing an index case, DeVita contends that platitudes about being honest are not nearly enough to foster honest behavior and that policies that offer specific guidance on handling unfavorable events are needed in health care institutions.Finally, we conclude with the policy on disclosure of unfavorable events (this terminology is chosen because it includes both iatrogenic and natural diseases and conditions) that resulted from... (shrink)

The Patient Protection and Affordable Care Act (ACA) sets in motion a wide range of programs that substantially affected the health system in the United States and signify a moderate but important regulatory shift in the role of the federal government in public health. This article briefly addresses two interesting policy paradoxes about the ACA. First, while the legislation primarily addresses health care financing and insurance and establishes only a few initiatives directly targeting public health, the ACA nevertheless has the (...) potential to produce extensive public health benefits across the United States population by improving access to health care and services and reducing cost. Essentially, the ACA does not take the explicit form of a public health law but instead strives to advance public health indirectly through its effects. Second, while the ACA does not establish a right to health — or even a right to health insurance — in the United States, it does set in motion a number of significant structural and normative changes to United States law that comport with the attainment of the right to health. Most significantly, key provisions of the bill are designed to improve availability, accessibility, acceptability, and quality of conditions necessary for health, and to prompt the government to respect, protect, and fulfill these conditions. These developments mean that, to a degree, the United States essentially has undertaken the same types of legal and policy steps that a country would be required to take to uphold the right to health without actually recognizing the right to health in any formal or legally binding way.Despite these dual paradoxes and the upside potential for public health improvements resulting from the ACA, the public health impact of the law remains uncertain and will be decided by numerous subsequent regulatory and implementation decisions. The ACA authorizes multiple federal agencies to engage in rulemaking, a process that will largely dictate the systemic and health impacts that will become its legacy. This reality opens up ample opportunity to bolster public health aspects and interpretations of the law, and to simultaneously augment the corresponding components of the right to health. (shrink)

This book is a collection of papers presented at an interdisciplinary workshop at the Calgary Institute for the Humanities in May 1980. The three broad issues covered are: the physician-patient relationship, the allocation of responsibility among doctors and nurses, and the political and social framework of the health care system. The first set of essays is concerned with the moral and legal aspects of the physician-patient relationship. The link between knowledge and power is examined as well as the moral dilemmas (...) posed by medical technology. These initial essays would alone justify this publ. (shrink)

_Initiating Psychoanalysis_ presents an international collection of papers brought together by the Working Party on Initiating Psychoanalysis of the European Psychoanalytic Federation and addresses the specific clinical and technical issues involved in launching the processes that are at the core of psychoanalysis and psychoanalytic treatment. Expert contributors provide introductions and commentaries on a selection of psychoanalytic papers, including one by Freud himself, which refer to beginning psychoanalytic treatment in a wide range of settings. Divided into four main sections, areas of (...) discussion include: historical and conceptual developments in the field practical, technical and ethical considerations unconscious transference and counter-transference dynamics of initial interviews internal factors that can help or hinder psychoanalysts in their work to initiate psychoanalysis. This book will be helpful to all psychoanalytical practitioners in thinking about their work in first interviews with prospective patients, as well as psychoanalysts and psychotherapists at all levels of experience, who will be able to use this book to enrich their own practice. (shrink)

Abstract.This paper responds to the Expert Patient initiative by questioning its over-reliance on instrumental forms of reasoning. It will be suggested that expertise of the patient suffering from chronic illness should not be exclusively seen in terms of a model of technical knowledge derived from the natural sciences, but should rather include an awareness of the hermeneutic skills that the patient needs in order to make sense of their illness and the impact that the illness has upon their sense (...) of self-identity. By appealing to MacIntyre’s concepts of “virtue” and “practice”, as well as Frank’s notion of the “wounded story-teller”, it will be argued that chronic illness can be constituted as a practice, by building a culture of honest and courageous story-telling about the experience of chronic suffering. The building of such a practice will renew the cultural resources available to the patient, the physician and the rest of the community in understanding illness and patient-hood. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Semi-Personal Story from a Ukrainian NGO Professional (or a Semi-Professional Story from a Ukrainian Person) Living through the WarYuliya NogovitsynaI live in Kyiv with my husband and two daughters. On 24 February 2022, my husband woke me up at 5 am tapping me on the shoulder and saying, “Yulia, wake up. There are bombings outside. The war started”. [End Page 160]That day was our younger daughter’s birthday. She (...) turned six. We had planned a birthday party for her with friends, cake, candles and birthday gifts. Instead, we had to move both daughters to the bathroom where there are no windows so that broken glass did not hurt them if a missile hit.I am the Program Director at Tabletochki Charity Foundation, Ukraine’s largest childhood cancer NGO (https://tabletochki.org/en/). For 11 years before the war, we have been fostering childhood cancer care in Ukraine—through our direct assistance to families, support of pediatric oncology units, professional development of medical personnel, and advocacy.The Russian invasion of Ukraine in February 2022 dramatically changed the healthcare system landscape in Ukraine. The physical threat, treatment disruption, exposure of immunosuppressed patients to improper conditions in bomb shelters and cellars, interruption in supplies, infrastructure damage, logistics failure, and funding constraints have been among the most manifested immediate and deferred implications of the war for the health-care system in Ukraine.That said, the biggest professional challenge was uncertainty and inability to plan. You have nothing to rely on in developing at least a short-term strategy. This may sound speculative and unimportant—who bothers about uncertainty when there is a physical threat to your life? But this is a wrong perception—uncertainty paralyzes and disables long before a bullet or missile reaches you.War also brings the collapse of relationships, partnerships, and coalitions. It depletes and limits resources, whether human, financial, or emotional. Scarce resources make hospitals, healthcare professionals, and NGOs compete for patients, donors, and financing. The war and the external threat unite only for a short period of emergency response. Once the situation transitions to a protracted conflict, people and institutions start fighting for their own survival.My family stayed in Ukraine but moved to Lviv, a city in Western Ukraine, which turned into an evacuation hub for children with cancer. More than 1,000 children with cancer were evacuated and referred for treatment abroad through the SAFER Ukraine collaborative initiative by St. Jude Global, Tabletochki, West-Ukrainian Specialized Children’s Medical Center (WUSCMC), and other international and local partners.During the first months of the war, we worked hand-in-hand day and night to bring critically ill children to safety and treatment. We sent evacuation convoys from Lviv to Poland twice a week, the largest one with 71 families, included four buses and 11 ambulances. We slept 4-5 hours per day. Within two weeks, my hands and legs were trembling from constant tension, concentration, and tiredness.And even this extremely fast-responding and effective evacuation may be questioned. We have been facing an ethical dilemma—whether the safety needs of the existing patients prevail over the needs of future patients in diagnostics and treatment in Ukraine. We discussed more than once whether we should stop evacuation and referral of children to European hospitals to sustain the Ukrainian childhood cancer care system and prevent it from degradation. It is very uncomfortable to confront such questions. Could our heroic efforts to evacuate as many Ukrainian children with cancer as possible turn into an evil for future patients to come? By evacuating patients, we left pediatric oncology units empty, without work for Ukrainian pediatric oncologists, and the usual pathways for diagnostics and treatment were disrupted. A healthcare system without patients is like a cardiovascular system without blood.My family returned to Kyiv in August 2022 for our daughters to continue their schooling. There were (and still are) only five to seven kids in a class; other children left Ukraine or switched to online studies. My husband and I decided that our children will attend school offline—despite the regular missile attacks. This is a private school; we pay for it. In such a way... (shrink)

Two potentially lifesaving protocols, emergency preservation and resuscitation and uncontrolled donation after circulatory determination of death, currently implemented in some U.S. emergency departments, have similar eligibility criteria and initial technical procedures, but critically different goals. Both follow unsuccessful cardiopulmonary resuscitation and induce hypothermia to “buy time”: one in trauma patients suffering cardiac arrest, to enable surgical repair, and the other in patients who unexpectedly die in the ED, to enable organ donation. This article argues that to fulfill patient-focused (...) fiduciary obligations and maintain community trust, institutions implementing both protocols should adopt and publicize policies to guide ED physicians to utilize either protocol for particular patients, in order to address the appearance of conflict of interest arising from the protocols' similarities. It concludes by analyzing ethical implications of incentives that may influence institutions to develop the expertise required for uDCDD but not EPR. (shrink)

Since the introduction of drugs to prevent vertical transmission of HIV, the purpose of and approach to HIV testing of pregnant women has increasingly become an area of major controversy. In recent years, many strategies to increase the uptake of HIV testing have focused on offering HIV tests to women in pregnancy-related services. New global guidance issued by the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) specifically notes these services as an entry point for (...) provider-initiated HIV testing and counseling (PITC). The guidance constitutes a useful first step towards a framework within which PITC sensitive to health, human rights and ethical concerns can be provided to pregnant women in health facilities. However, a number of issues will require further attention as implementation moves forward. It is incumbent on all those involved in the scale up of PITC to ensure that it promotes long-term connection with relevant health services and does not result simply in increased testing with no concrete benefits being accrued by the women being tested. Within health services, this will require significant attention to informed consent, pre- and post-test counseling, patient confidentiality, referrals and access to appropriate services, as well as reduction of stigma and discrimination. Beyond health services, efforts will be needed to address larger societal, legal, policy and contextual issues. The health and human rights of pregnant women must be a primary consideration in how HIV testing is implemented; they can benefit greatly from PITC but only if it is carried out appropriately. (shrink)

Health innovation is mainly envisioned in direct connection to medical research institutions or pharmaceutical and technology companies. Yet, these types of innovation often do not meet the needs and expectations of individuals affected by health conditions. With the emergence of digital health technologies and social media, we can observe a shift, which involves people living with illness modifying and improving medical and health devices outside of the formal research and development sector, figuring both as users and innovators. This patient‐led innovation (...) has been celebrated in innovation studies and economics as a “bottom‐up” type of innovation. In this article, we take a closer look at open‐source patient‐led innovation in the context of type 1 diabetes care. In our inquiry, we pay particular attention to the social and ethical dimensions of this innovation, building on empirical material. Upon exploring the notion of patient‐led innovation and its socio‐political context through the lens of intersectional and global health justice, we argue that a proactive strategy is needed to ensure that open‐source patient‐led innovation will be more globally accessible, center the health needs of the most underserved populations, as well as facilitate equitable and just health benefits. To support this aim, we provide a range of examples of different initiatives addressing the persistent inequalities that have so far inhibited patient‐led innovation from more fully materializing its innovative potential. (shrink)

Background In this qualitative analysis we aimed to explore addiction physicians’ perspectives on safer injection education for people who inject drugs, especially: (1) on possible means of introducing safer injection education in the medical environment, (2) on the compatibility of safer injection education with each physician’s core values and goals, and (3) on possible reasons for the ethical dilemma in safer injection education. Methods We conducted semi-structured interviews with eleven physicians practicing addiction medicine in France in (...) clinical and harm reduction settings. Results All participants were in favor of educational interventions for people who inject drugs. Nonetheless, these interventions varied from simple advice to injection supervision and they were seen as less acceptable when they concerned the practical and material aspects of injection. Some participants found that physicians practicing in clinical settings, where patients consult mostly to stop their drug use, should not practice safer injection education. On the contrary, other participants claimed that safer injection education was essential in all settings and was not a choice but rather a duty for addiction physicians. The ethical dilemma of such intervention when delivered by medical staff was viewed as a complex phenomenon, related to the representations of intravenous drug use and to societal expectations from physicians. Conclusion Physicians’ views on safer injection education for people who inject drugs reveal an emotionally charged subject related to the structural organization of addiction management in France. Such education is marked by an arduous history of harm reduction policies in France. IRB registration: #00011928. (shrink)

Background Decisions regarding Cardio-Pulmonary Resuscitation (CPR) and Do Not Attempt Resuscitation (DNAR) orders remain demanding, as does including patients in the process. Objectives To explore physicians’ justification for CPR/DNAR orders and decisions regarding patient inclusion, as well as their reports of how they initiated discussions with patients. Methods We administered a face-to-face survey to residents in charge of 206 patients including DNAR and CPR orders, with or without patient inclusion. Results Justifications were provided for 59% of DNAR (...) orders and included severe comorbidity, patients and families’ resuscitation preferences, patients’ age, or poor prognosis or quality of life. Reasons to include patients in CPR/DNAR decisions were provided in 96% and 84% of cases, and were based on respect for autonomy, clinical assessment of the situation as not too severe, and the view that such inclusion was required. Reasons for not including patients were offered in 84% of cases for CPR and in 70% for DNAR. They included absent decision-making capacity, a clinical situation viewed as good (CPR) or offering little hope of recovery (DNAR), barriers to communication, or concern that discussions could be emotionally difficult or superfluous. Decisions made earlier in the patient's management were infrequently viewed as requiring revision. Residents reported a variety of introductions to discussions with patients. Conclusions These results provide better understanding of reasons for CPR/DNAR decisions, reasons for patient inclusion or lack thereof, and ways in which such inclusion is initiated. They also point to potential side-effects of implementing CPR/DNAR recommendations without in-depth and practical training. This should be part of a regular audit and follow-up process for such recommendations. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Patient Self-Determination ActElizabeth Leibold McCloskey (bio)What are the ethics of extending the length of life? We know that we cannot artificially end life (Thou Shalt not Kill), but how about artificially extending life? Is that always good, sometimes good?... In ethics, is keeping people alive the highest good? Should our priority be to keep people breathing?... What does basic religious ethics say about this?(John C. Danforth, letter to (...) the author, 19 August 1989)The Patient Self-Determination Act, signed into law as part of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) last November, marks the first time that Congress has passed legislation concerning the ethics of life-sustaining medical treatment. The bill was spearheaded by Senator John C. Danforth (RMO), who has a special interest in this area. An Episcopal priest, Danforth was formerly an assistant chaplain at New York's Memorial Sloan-Kettering Cancer Center and now sits as a senior member of the Senate Finance Committee, which oversees Medicare and Medicaid. Although Senator Danforth's legislative initiative was not a result of the Cruzan case, it was in his state of Missouri that the U.S. Supreme Court case involving removal of Nancy Cruzan's feeding tube arose (Cruzan v. Director of Missouri Department of Health, U.S. Supreme Court, 58 LW 4916, 26 June 1990). From his unique vantage point, he felt it was time to craft a legislative response to some of the difficult issues surrounding prolongation of life.The short answer to Senator Danforth's questions about when to artificially extend life is simple enough: people must be free to determine that for themselves. Common law and common sense dictate such a conclusion; living will and health care proxy statutes, enacted in almost every state, codify that right. The Catholic moral tradition teaches that one is not morally obligated to use extraordinary means to prolong life, a tradition shared both by the mainline Protestant and the reform and conservative Jewish community. Yet most people are unaware of their fundamental legal right to make such decisions, and as court cases from Quinlan (In re Quinlin, 137 N.J. Super. 227, 1975) to Cruzan demonstrate, few know [End Page 163] how to make arrangements for this right to be exercised if they become incapacitated.Meanwhile, health care practices are often driven by a denial of death. When Senator Danforth and Senator Daniel Patrick Moynihan (D-NY) introduced the bill on October 17, 1989, Senator Danforth said:More and more it is arguable that we play God by subjecting people to unwanted and sometimes unnecessary treatment, treatment that unnaturally prolongs the dying process. Our health care system has become obsessed with extending life, at times neglecting the caring component of medicine and trampling on the rights of patients.(Congressional Record 1989, 135:5.13566)The American Hospital Association estimates that 70 percent of deaths now occur after a determination to withhold or withdraw medical treatment. Many of those decisions are made without the benefit of an incapacitated patient's views, yet a Harvard study revealed that 95 percent of the population would like to prepare in advance for such decisions. Only 4 percent of hospitals have a systematic method of asking patients if they have an advance directive. Family members confront painful choices in the face of uncertainty about their loved one's wishes and it can be even more painful when a family knows the patient's desires but providers and the courts act otherwise because clear evidence is lacking.The Patient Self-Determination Act is rooted in the belief that people should be given information that enables them to specify the extent of medical treatment they wish to receive should they become incapacitated. The public should be educated about applicable state laws that protect the individual's right to make such choices through the use of an advance directive.The Act moves toward that goal by promoting knowledge of state laws. It requires every hospital, nursing home, home health agency, hospice, and health maintenance organization that participates in Medicaid or Medicare to routinely give all adult patients information about advance directives. Patients will also be given information on the... (shrink)

Research documents that many chronic non-malignant pain patients experience existential, spiritual and religious needs; however, research knowledge is missing on if and how physicians approach these needs. We conducted a systematic review to explore the extent to which physicians address these needs in their communication with chronic non-malignant pain patients and to explore the facilitators and challenges of this communication. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, searching Embase, Medline, Scopus and PsycINFO. The (...) quality of the included articles was assessed based on design-specific screening tools. We included four of 2337 screened articles and found the quality to be good. Physicians’ communication about existential, spiritual and religious needs was given low priority and depended on the patients’ own initiative, except when clinicians were interested in holistic care. Patient dissatisfaction with the physician’s attention to these needs was related to higher pain and depression. Physicians’ challenges for addressing these needs were their tendency to prioritize physiological aspects and close further elaboration of existential needs when addressed by the patients. The main facilitator was the individual physician’s willingness to listen with openness and empathy to the patients’ existential concerns. A tentative conclusion is that physicians rarely meet the existential, spiritual and religious needs of their chronic non-malignant pain patients. This might be due to higher priority of physical aspects, lack of time and a lack of knowledge about the importance of and training in the ability to address these needs. Further research is needed on physicians’ communication about existential, spiritual and religious needs and on their training in here. (shrink)

BackgroundAcute myocardial infarction (AMI) research is challenging as it requires enrollment of acutely ill patients. Patients are generally in a suboptimal state for providing informed consent. Patients’ understanding to verbal assents have not been previously examined in AMI research. Patients Acceptance and Comprehension to Written and Verbal Consent (PAC–VC) compared patients’ understanding and attitudes to verbal and written consents in AMI RCTs.MethodsPAC–VC recruited patients from 3 AMI trials using both verbal N = 12 and (...) written N = 6 consents. We compared patients’ understanding using two survey questionnaires. The first questionnaire used open-ended questions with multiple choice answers. The second questionnaire used a 5-point Likert scale to measure patients understanding and attitudes to the consent process. Overall answers average scores were categorized into three groups: Adequate understanding (71–100) %, Partial understanding (41–70)% and Inadequate understanding (0–40)%.ResultsResponses showed patients with verbal assent had adequate understanding to most components of informed consent, close to those of written consent. Most patients did not read written information entirely and believed that it is not important to make a final decision. Patients favoured to have written information be part of the consent but not necessarily presented during the initial consent process. Patients felt less pressured in the verbal assent arm than those of written consent.ConclusionPatients had adequate understanding to most components of verbal assent and comparable to those of written consent. Utilizing verbal assents in the acute care setting should be further assessed in larger trials. (shrink)