This chapter contains sections titled: The Rise of Nanomedicine Diagnostics and Medical Records Treatment Moving Forward.

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable (...) at larger scales. Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

River water pollution by wastewater can cause significant negative impact on the aquatic sustainability. Hence, accurate modeling of this complicated system and its cost-effective treatment and reuse decision is very important because this optimization process is related to economic expenditure, societal health, and environmental deterioration. In order to optimize this complex system, we may consider three treatment or reuse options such as microscreening filtration, nitrification, and fertilization-oriented irrigation on top of two existing options such as settling (...) and biological oxidation. The objective of this environmental optimization is to minimize the economic expenditure of life cycle costs while satisfying the public health standard in terms of groundwater quality and the environmental standard in terms of river water quality. Particularly, this study improves existing optimization model by pinpointing the critical deficit location of dissolved oxygen sag curve by using analytic differentiation. Also, the proposed formulation considers more practical constraints such as maximal size of irrigation area and minimal amount of filtration treatment process. The results obtained by using an evolutionary algorithm, named a parameter-setting-free harmony search algorithm, show that the proposed model successfully finds optimal solutions while conveniently locating the critical deficit point. (shrink)

The goals of vascular composite allotransplantation for hand are to maximize functional status and psychosocial wellbeing and to improve quality of life. Candidates are carefully vetted by transplant programs through an extensive evaluation process to exclude those patients with contraindications and to select those that are most likely to attain functional or quality of life benefit from transplant. Patient choice for any treatment, however, requires that candidates be able to understand the risks, benefits, and alternatives before choosing to proceed. (...) This study aimed to understand patients’ knowledge and perceptions about treatment options for hand loss, including hand transplant. This study will be used to inform a standardized education approach and develop conversation aids for use by clinicians and patients throughout the treatment decision process. Ten individuals who had experienced hand amputation or had congenital limb loss were interviewed to better understand previous and current decisions about treatment, experiences in adjusting to their treatment, and perceptions about hand VCA. From this qualitative interview data, four findings emerged: knowledge and education around VCA as a treatment option; adaptation of individuals with limb loss; fear of risk associated with transplantation; issues of aging and overuse injuries to existing limbs. Results suggests that there is opportunity for expanding education about all treatment options for patients with new loss, long-term loss, and congenital limb loss. Establishing a baseline of knowledge about all options–prosthetics, rehabilitative strategies, and VCA—can help patients evaluate their values and goals of treatment. Issues associated with aging, including overuse and injury, and adaptability over the life course should be included in considerations about treatment choices. Data indicate the need for routinely assessing patient preferences about treatment choice so patients can plan for their future as they adapt and age and as technology for treatments change. To assure that thorough information is provided for current and future decision-making, education about treatment choices and selection procedures for VCA should be standardized. (shrink)

Background Stroke is a worldwide problem with a limited number of approved treatments. Obtaining informed consent for acute stroke therapy is complicated by the breadth of information that must be communicated in a short period of time, the hectic nature of the emergency environment, the possible lack of understanding by the patient and/or family, and the critically time-sensitive nature of treatment for stroke. Complicating matters even further, patients are often unable to consent for themselves, placing the burden on surrogates (...) to infer patients’ wishes regarding treatment, and potentially limiting acute treatment by practitioners. Innovation An advance directive for acute stroke therapy was created, entitled COAST (Coordinating Options for Acute Stroke Therapy). This clinical initiative is being piloted at a large comprehensive stroke center, including the development of the advance directive form, integration of the form with electronic medical records, training healthcare providers, and outreach to patients. Conclusions COAST is an advance directive for stroke designed to make stroke care more efficient, optimize patients’ autonomy, improve the quality of healthcare, and streamline the ethical management of complex care decisions in acute stroke. The inherent benefit of COAST is in providing patients and their families with more information regarding stroke and its treatment options, allowing them to take a more active role in their care. (shrink)

IntroductionA symptom cluster is very common among oncological patients: cancer-related fatigue, emotional distress, sleep difficulties, pain, and cognitive difficulties. Clinical applications of interventions based on non-ordinary states of consciousness, mostly hypnosis and meditation, are starting to be investigated in oncology settings. They revealed encouraging results in terms of improvements of these symptoms. However, these studies often focused on breast cancer patients, with methodological limitations. Another non-ordinary state of consciousness may also have therapeutic applications in oncology: self-induced cognitive trance. It seems (...) to differ from hypnosis and meditation, as it involves the body more directly. Thus, investigating its clinical applications, along with hypnosis and meditation interventions, could improve available therapeutic options in oncology. This article details the study protocol of a preference-based longitudinal controlled superiority trial aiming to assess the effectiveness of 3 group interventions to improve oncological patients’ quality of life, and more specifically CRF, emotional distress, sleep, pain, and cognitive difficulties.Methods and analysisA power analysis required a total sample of 160 patients. Main inclusion criteria are: cancer diagnosis, active treatments completed for less than a year, no practice of hypnosis, meditation, or SICT, and presence of at least one of these four symptoms: fatigue, sleep difficulties, depression, or anxiety. Each participant will choose the intervention in which they want to participate. To test the effectiveness of the interventions, data will be collected by questionnaires and neurobiological measures and directly from the medical record at four time points: before inclusion in the study ; immediately after the intervention; and at 3- and 12-month follow-up. The longitudinal data in each group will then be measured.DiscussionIn addition to standard cancer therapies, there is a growing interest from patients in complementary approaches, such as hypnosis, meditation, and SICT. The results of this study will be useful to increase knowledge about short- and long-term effectiveness of 3 group interventions for CRF, emotional distress, sleep, pain, and cognitive difficulties in patients with different cancers.Clinical Trial RegistrationClinicalTrials.gov/. Retrospectively registered on the 29th of April 2021. url: https://clinicaltrials.gov/ct2/show/NCT04873661. (shrink)

Developmental Dyslexia significantly interferes with children’s academic, personal, social, and emotional functioning. Nevertheless, therapeutic options need to be further validated and tested in randomized controlled clinical trials. The use of transcranial direct current stimulation has been gaining ground in recent years as a new intervention option for DD. However, there are still open questions regarding the most suitable tDCS protocol for young people with DD. The current crossover study tested the effectiveness of a short and intensive tDCS protocol, including (...) the long-term effects, as well as the influence of age and neuropsychological processes at baseline on reading improvements. Twenty-four children and adolescents with DD were randomly assigned to receive active tDCS during the first slot and sham tDCS during the second slot or vice versa. Five consecutive daily sessions of left anodal/right cathodal tDCS set at 1 mA for 20 min were administered over the parieto-occipital regions. Reading measures and neuropsychological measures were collected before, immediately after, 1 week and 1 month later the treatment. Our results showed that only the active tDCS condition improved non-word reading speed immediately after and 1 month later the end of the treatment compared with baseline. In addition, the improvement in non-word reading speed was significantly correlated with age and with neuropsychological measures at baseline but only in the active tDCS condition. The current crossover study contributed to enforce previous effects of tDCS, including long-term effects, on non-word reading speed and to understand the effect of age and neuropsychological processes on reading outcomes. Our findings showed that tDCS could be a low-cost and easy-to-implement treatment option with long-term effects for children and adolescents with DD. (shrink)

The Internet has quickly gained popularity as a major source of health-related information, but its impact is unclear. Here, we investigate the extent to which advocacy websites for three neurodevelopmental disorders—cerebral palsy (CP), autism spectrum disorder (ASD) and fetal alcohol spectrum disorder (FASD)—inform stakeholders about treatment options, and discuss the ethical challenges inherent in providing such information online. We identified major advocacy websites for each disorder and assessed website accountability, the number, attributes, and accessibility of treatments described, and (...) the valence of treatment information. With the exception of FASD websites, we found that advocacy websites provide a plethora of information about a wide variety of readily available products and services. Treatment information is primarily targeted at families and is overwhelmingly encouraging, regardless of the type or conventionality of treatments. Many websites acknowledge corporate sponsors. While the majority do not overtly advertise or endorse specific brands, they also do not prominently display disclaimers about the nature and intent of treatment information. Thus, while advocacy websites are organized to serve as information clearinghouses, they implicitly appear to provide endorsement of selected treatments and services. We conclude with recommendations for new partnerships between government-funded health organizations, advocacy and investigators to make more transparent the role of online information in informing treatment options and improving the evaluation of information. (shrink)

The Treatment Escalation Plan (TEP) was introduced into our trust in an attempt to improve patient involvement and experience of their treatment in hospital and to embrace and clarify a wider remit of treatment options than the Do Not Resuscitate (DNR) order currently offers. Our experience suggests that the patient and family are rarely engaged in DNR discussions. This is acutely relevant considering that the Mental Capacity Act (MCA) now obliges these discussions to take place. The (...) TEP is a form that the doctor completes, ideally with the competent patient or close relative, documenting what treatment options would be appropriate if that patient were to become acutely unwell. Ventilation of the lungs, cardiac resuscitation, renal replacement therapy, intravenous fluids and antibiotics are all discussed. The study evaluated patient and relative experiences with the TEP. 55 patients or their relatives were interviewed regarding their experience of the TEP and thoughts regarding the process. 96% of patients and relatives evaluated thought that the TEP was a good idea. Free text comments were all positive and only 34% of patients claimed to feel anxious when completing the form. Following this study, the TEP has been expanded hospital wide and into the community within our trust. Discussions are currently taking place in hospitals within our region to introduce the TEP form into other local trusts. (shrink)

Current management of people with prolonged disorders of consciousness is failing patients, families and society. The causes include a general lack of concern, knowledge and expertise; a legal and professional framework which impedes timely and appropriate decision-making and/or enactment of the decision; and the exclusive focus on the patient, with no legitimate means to consider the broader consequences of healthcare decisions. This article argues that a clinical pathway based on the principles of the English Mental Capacity Act 2005 and using (...) time-limited treatment trials could greatly improve patient management and reduce stress on families. There needs to be early and continuing use of formal best interests meetings, starting between 7 and 21 days after onset of unconsciousness. The treatment options need to evolve as the clinical state and prognosis becomes more certain. A formal discussion of treatment withdrawal should occur when the upper bound of predicted recovery falls below a level the patient would have considered acceptable, and it should always be discussed when the condition is considered permanent. Any decision to stop treatment should be contingent on a formal second opinion from an independent expert who should review the clinical situation and expected prognosis, but not the best interests decision. The article also asks how, if at all, the adverse effects on the family and the resource implications of long-term care of people left in a prolonged state of unconsciousness should be incorporated in the process. (shrink)

Infertility is recognized as a major problem of modern society. Assisted Reproductive Technology is the one of many available treatment options to cure infertility. However, the efficiency of the ART treatment is still inadequate. Therefore, the procedure’s quality is constantly improving and there is a need to determine statistical predictors as well as contributing factors to the successful treatment. There is a concern over the application of adequate statistical analysis to clinical data: should classic statistical (...) methods be used or would it be more appropriate to apply advanced data mining technologies? By comparing two statistical models, Multivariable Logistic Regression analysis and Artificial Neural Network it has been demonstrated that Multivariable Logistic Regression analysis is more suitable for theoretical interest but the Artificial Neural Network method is more useful in clinical prediction. (shrink)

Total knee arthroplasty (TKA) is a commonly implemented elective surgical treatment for end-stage osteoarthritis of the knee, demonstrating high success rates when assessed by objective medical outcomes. However, a considerable proportion of TKA patients report significant dissatisfaction postoperatively, related to enduring pain, functional limitations, and diminished quality of life. In this conceptual analysis, we highlight the importance of assessing patient-centred outcomes routinely in clinical practice, as these measures provide important information regarding whether surgery and postoperative rehabilitation interventions have effectively (...) remediated patients’ real-world “quality of life” experiences. We propose a novel precision medicine approach to improving patient-centred TKA outcomes through the development of a multivariate machine-learning model. The primary aim of this model is to predict individual postoperative recovery trajectories. Uniquely, this model will be developed using an interdisciplinary methodology involving non-linear analysis of the unique contributions of a range of preoperative risk and resilience factors to patient-centred TKA outcomes. Of particular importance to the model’s predictive power is the inclusion of a comprehensive assessment of modifiable psychological risk and resilience factors that have demonstrated relationships with TKA and other conditions in some studies. Despite the potential for patient psychological factors to limit recovery, they are typically not routinely assessed preoperatively in this patient group, and thus can be overlooked in rehabilitative referral and intervention decision-making. This represents a research-to-practice gap that may contribute to adverse patient-centred outcomes. Incorporating psychological risk and resilience factors into a multivariate prediction model could improve the detection of patients at risk of sub-optimal outcomes following TKA. This could provide surgeons and rehabilitation providers with a simplified tool to inform postoperative referral and intervention decision-making related to a range of interdisciplinary domains outside their usual purview. The proposed approach could facilitate the development and provision of more targeted rehabilitative interventions on the basis of identified individual needs. The roles of several modifiable psychological risk and resilience factors in recovery are summarised, and intervention options are briefly presented. While focusing on rehabilitation following TKA, we advocate for the broader utilisation of multivariate prediction models to inform individually-tailored interventions targeting a range of health conditions. (shrink)

Nanomedicine has the potential to transform medical therapy and diagnosis. Its technologies predict improved drug delivery systems with site-specific treatment, precise new surgical techniques that would reduce patient trauma and treatment cause, and even cellular repair that would make age-related conditions such as Alzheimer’s disease a thing of the past. Currently, nanomedicine products are reaching the world market with an annual growth rate of twenty-five percent. However, like any emerging new technology, along with doomsday scenarios of (...) nanoparticles gone amuck, nanomedicine raises serious ethical, moral, and social issues that may potentially limit its technological developments. In this essay, I briefly evaluate some of these issues, and argue that ethical and epistemic issues should be considered prior to research and development. By examining three crucial epistemic challenges in nanomedicine—toxicity, nanodrugs and drug delivery systems, and clinical trials—I argue that by implementing a multi-criterion decision analysis framework as outlined by Linkov, Satterstorm and Corey, these challenges can bridge the knowledge gap between R&D and the introduction of nanomedicine technologies into the market. (shrink)

Background Obtaining informed consent in the clinical setting is an important yet challenging aspect of providing safe and collaborative care to patients. While the medical profession has defined best practices for obtaining informed consent, it is unclear whether these standards meet the expressed needs of patients, their families as well as healthcare providers. The authors sought to address this gap by comparing the responses of these three groups with a standardised informed consent paradigm. Methods Piloting a web-based ‘reverse’ simulation paradigm, (...) participants viewed a video showing a standardised doctor engaging in an informed consent discussion. The scenario depicted a simulated patient with psychotic symptoms who is prescribed an atypical antipsychotic medication. 107 participants accessed the simulation online and completed a web-based debriefing survey. Results Survey responses from patients, family members and healthcare providers indicated disparities in information retention, perception of the doctor's performance and priorities for required elements of the consent process. Conclusions To enhance existing informed consent best practices, steps should be taken to improve patient retention of critical information. Adverse events should be described in the short-term and long-term along with preventative measures, and alternative psychosocial and pharmacological treatment options should be reviewed. Information about treatment should include when the medication takes therapeutic effect and how to safely maintain the treatment. The reverse simulation design is a model that can discern gaps in clinical practice, which can be used to improve patient care. (shrink)

Background:Women's health has received renewed attention in the last few years including health rehabilitation options for women affected by breast cancer. Dancing has often been regarded as one attractive option for supporting women's well-being and health, but research with women recovering from breast cancer is still in its infancy. Dancing with Health is multi-site pilot study that aimed to evaluate a dance programme for women in recovery from breast cancer across five European countries.Methods:A standardized 32 h dance protocol introduced (...) a range of Latin American dances presented within a sports and exercise framework with influences from dance movement therapy. Fifty-four women (M age 53.51; SD 7.99) participated in the study who had a breast cancer diagnosis 6 weeks, no indication of metastasis, or scheduled surgery/chemotherapy/radiation treatment for the duration of the intervention. Primary outcome data was collected for anthropometric and fitness measures next to cancer-related quality of life.T-tests and Wilcoxon signed ranked tests were used to establish differences pre and post intervention. Cohen's d was also calculated to determine the effect size of the intervention.Results:Statistically significant changes were found for: (i) weight, right and left forearm circumference and hip; (ii) 6 min walking, right and left handgrip, sit-to-stand and sit-and-reach; (iii) the EORTC-QLQ C30 summary score as well as the subscales of emotional and social functioning and symptoms. In all cases the direction of change was positive, while Cohen's d calculated showed that the effect of the intervention for these parameters ranged from intermediate to large.Conclusion:Changes on the above anthropometric, fitness and quality of life measures suggest that the intervention was of value to the participating women recovering from breast cancer. Results also advocate collaborative efforts across countries to further research. (shrink)

This book exploits the power of phenomenological methods to access and describe lived moral experiences of pain and suffering for patients, their families and the wider community. Creating new fields of communication for patients, their family members and health professionals in shared decision making processes, this book builds on knowledge about suffering to help and guide correct action in preventing and relieving chronic pain and improving systems of care. It offers a new phenomenology for understanding moral experience in serious (...) illness and suffering, and its implication for policy, practice and research. A series of applied chapters, looking at individual experiences of suffering and care experiences, present some areas of ethical inquiry, including: pain and suffering maternal care ethics evaluation and moral deliberation about treatment options decision-making and moral agency end-of-life experiences of care. Exploring how moral phenomenology could provide fruitful alternatives to traditional frameworks in bioethics, this is an important addition to the literature. It will be of interest to scholars and students of bioethics and phenomenological methods in the health and human services. (shrink)

Within the ethics and science literature surrounding uterus transplantation (UTx), emphasis is often placed on the extent to which UTx might improve upon, or offer additional benefits when compared to, existing ‘treatment options’ for women with absolute uterine factor infertility, such as adoption and gestational surrogacy. Within this literature UTx is often positioned as superior to surrogacy because it can deliver things that surrogacy cannot (such as the experience of gestation). Yet, in addition to claims that UTx is (...) superior in the aforementioned sense it is also often assumed (either implicitly or explicitly) that UTx is less fraught with ethical difficulties and thus should be considered a less morally problematic option. This article seeks to examine this assumption. Given that much UTx research has been performed in Sweden, a country where surrogacy is effectively although not currently explicitly forbidden, we do this through an analysis of the arguments underpinning a 2016 Swedish white paper which considered amending existing policy such that altruistic surrogacy arrangements would be permitted. By applying the white paper’s arguments for a restrictive position on altruistic surrogacy to the case of UTx using living altruistic donors we find that such arguments, if they hold in the case of surrogacy, apply similarly to UTx. We thus suggest that, for reasons of consistency, a similar stance should be taken towards the moral and legal permissibility of these two practices. (shrink)

The Patient Preference Predictor (PPP) is intended to improve treatment decision making for incapacitated patients. The PPP would collect information about the treatment preferences of people with different demographic and other characteristics. It could be used to indicate which treatment option an individual patient would be most likely to prefer, based on data about the preferences of people who resemble the patient. The PPP could be incorporated into existing US law governing treatment for incapacitated patients, although (...) it is unclear whether it would be classified as evidence of a specific patient’s preferences or those of a reasonable person sharing certain characteristics with the patient. Ethical concerns about the quality and significance of PPP choices could influence legal decision makers’ views of the PPP. (shrink)

Professional control in the selection of treatment options for patients is changing. In light of social and legal developments emphasising patient choice and autonomy, and restricting medical paternalism and judicial deference, this article examines how far patients and families can demand NHS treatment in England and Wales. It considers situations where the patient is an adult with capacity, an adult lacking capacity and a child. In all three cases, there is judicial support for professional autonomy, but there (...) are also inconsistencies that have potential to elevate the importance of patient and family preferences. In combination, they may be perceived by healthcare professionals as an obligation to follow patient preferences, even where doing so conflicts with other professional obligations. It is argued that a more nuanced approach to shared decision-making could help clarify the boundaries of decision-making responsibility. (shrink)

BackgroundPrognostic uncertainty is a challenge for physicians in the neuro intensive care field. Questions about whether continued life-sustaining treatment is in a patient’s best interests arise in different phases after a severe traumatic brain injury. In-depth information about how physicians deal with ethical issues in different contexts is lacking. The purpose of this study was to seek insight into clinicians’ strategies concerning unresolved prognostic uncertainty and their ethical reasoning on the issue of limitation of life-sustaining treatment in patients (...) with minimal or no signs of neurological improvement after severe traumatic brain injury in the later trauma hospital phase.MethodsInterviews with 18 physicians working in a neurointensive care unit in a large Norwegian trauma hospital, followed by a qualitative thematic analysis focused on physicians’ strategies related to treatment-limiting decision-making.ResultsA divide between proactive and wait-and-see strategies emerged. Notwithstanding the hospital’s strong team culture, inter-physician variability with regard to ethical reasoning and preferred strategies was exposed. All the physicians emphasized the importance of team—family interactions. Nevertheless, their strategies differed: (1) The proactive physicians were open to consider limitations of life-sustaining treatment when the prognosis was grim. They initiated ethical discussions, took leadership in clarification and deliberation processes regarding goals and options, saw themselves as guides for the families and believed in the necessity to prepare families for both best-case and worst-case scenarios. (2) The “wait-and-see” physicians preferred open-ended treatment (no limitations). Neurologically injured patients need time to uncover their true recovery potential, they argued. They often avoided talking to the family about dying or other worst-case scenarios during this phase.ConclusionsDepending on the individual physician in charge, ethical issues may rest unresolved or not addressed in the later trauma hospital phase. Nevertheless, team collaboration serves to mitigate inter-physician variability. There are problems and pitfalls to be aware of related to both proactive and wait-and-see approaches. The timing of best-interest discussions and treatment-limiting decisions remain challenging after severe traumatic brain injury. Routines for timely and open discussions with families about the range of ethically reasonable options need to be strengthened. (shrink)

Over the past two decades we have seen dramatic improvements in the efficacy, safety and availibity of antiretroviral therapy (ART). In the USA and Europe, life expectancy in people living with HIV disease approaches that of the HIV-uninfected.1 Even in regions hardest hit by the HIV epidemic, effective HIV therapy has reversed more than a decade of HIV-related decreased survival. Despite these advances in ART, motivations to pursue HIV cure remain strong due to the toxicity, adherence challenges, cost and access (...) to care issues associated with HIV therapy, as well as the persistant stigma associated with having HIV infection. Further and renewed motivation comes from a single case of HIV cure after stem cell transplantation for acute leukaemia. Given the tremendous improvements in ART, it is important to assess how effective and safe an HIV cure would need to be in order to be a viable option compared to ART. We argue that this should be done prior to the availability of a cure to provide realistic goals for researchers and policy makers. One methodology that has been increasingly popular over the past decade is the use of mathematical simulation modelling to assess the clinical impact, cost-effectiveness and clinical role of different treatment strategies in HIV disease, as well as in medicine broadly.2 Such models provide a framework and approach for using the best available data at any point in time, and assessing the potential impact of emerging innovations. Further, unlike individual trials focused on a single endpoint, these models can integrate multiple data sources to project beyond the timeline or outcomes of individual studies and project long-term outcomes in many domains, including virologic, immunologic, clinical and cost.3 Mathematical models have particular value in their ability to assess uncertainty in clinical care. Examples include parameters determined in …. (shrink)

Surgical Informed Consent has long been recognized as an important component of modern medicine. The ultimate goals of SIC are to improve clients’ understanding of the intended procedure, increase client satisfaction, maintain trust between clients and health providers, and ultimately minimize litigation issues related to surgical procedures. The purpose of the current study is to assess the comprehensiveness of the SIC process for women undergoing obstetric and gynecologic surgeries. A hospital-based cross-sectional study was undertaken at Hawassa University Comprehensive Specialized Hospital (...) in November and December, 2016. A total of 230 women who underwent obstetric and/or gynecologic surgeries were interviewed immediately after their hospital discharge to assess their experience of the SIC process. Thirteen components of SIC were used based on international recommendations, including the Royal College of Surgeon’s standards of informed consent practices for surgical procedures. Descriptive summaries are presented in tables and figures. Forty percent of respondents were aged between 25 and 29 years. Nearly a quarter had no formal education. More than half of respondents had undergone an emergency surgical procedure. Only 18.4% of respondents reported that the surgeon performing the operation had offered SIC, while 36.6% of respondents could not recall who had offered SIC. All except one respondent provided written consent to undergo a surgical procedure. However, 8.3% of respondents received SIC service while already on the operation table for their procedure. Only 73.9% of respondents were informed about the availability of alternative treatment options. Additionally, a majority of respondents were not informed about the type of anesthesia to be used and related complications. Only 54.2% of respondents reported that they had been offered at least six of the 13 SIC components used by the investigators. There is gap in the provision of comprehensive and standardized pre-operative counseling for obstetric and gynecologic surgeries in the study hospital. This has a detrimental effect on the overall quality of care clients receive, specifically in terms of client expectations and information needs. (shrink)

This is a paper on the philosophical clinical psychology of PTSD. How best to improve our treatment plans for the disorder is the primary imperative in the clinical literature. Our failure to properly treat those suffering from PTSD up until now could be either the result of merely a problem in practice or, more seriously, a problem in principle. In this essay, I explore three possible accounts consistent with the supposition that what we have here is a problem in (...) principle. I call the first the “Somatic” hypothesis; the second, the “Memorial”; and the third, a “Rilkean” hypothesis of PTSD, which is inspired by the recent work of M. Rowlands. The first two have been more-or-less articulated previously; the third is introduced here for the first time. The primary argument of this essay is abductive: I argue in favor of a Rilkean Memory hypothesis of PTSD by comparing it to the other two accounts and showing that it possesses greater theoretical virtue than they do. I then conclude the essay by noting certain limitations with the account here sketched, nonetheless suggesting that this hypothesis can open up new avenues of clinical research and treatment options for the disorder. (shrink)

Euthanasia and assisted suicide have been legally possible in the Netherlands since 2001, provided that statutory due care criteria are met, including: voluntary and well-considered request; unbearable suffering without prospect of improvement; informing the patient; lack of a reasonable alternative; independent second physician’s opinion. ‘Unbearable suffering’ must have a medical basis, either somatic or psychiatric, but there is no requirement of limited life expectancy. All EAS cases must be reported and are scrutinised by regional review committees. The purpose of this (...) study was to investigate whether any particular difficulties arise when the EAS due care criteria are applied to patients with an intellectual disability and/or autism spectrum disorder. The 416 case summaries available on the RTE website were searched for intellectual disability and autism spectrum disorder. Direct content analysis was used on these nine cases. Assessment of decisional capacity was mentioned in eight cases, but few details given; in two cases, there had been uncertainty or disagreement about capacity. Two patients had progressive somatic conditions. For most, suffering was due to an inability to cope with changing circumstances or increasing dependency; in several cases, suffering was described in terms of characteristics of living with an autism spectrum disorder, rather than an acquired medical condition. Some physicians struggled to understand the patient’s perspective. Treatment refusal was a common theme, leading physicians to conclude that EAS was the only remaining option. There was a lack of detail on social circumstances and how patients were informed about their prognosis. Autonomy and decisional capacity are highly complex for patients with intellectual disabilities and difficult to assess; capacity tests in these cases did not appear sufficiently stringent. Assessment of suffering is particularly difficult for patients who have experienced life-long disability. The sometimes brief time frames and limited number of physician-patient meetings may not be sufficient to make a decision as serious as EAS. The Dutch EAS due care criteria are not easily applied to people with intellectual disabilities and/or autism spectrum disorder, and do not appear to act as adequate safeguards. (shrink)

Schizophrenia is a serious mental illness characterized by a disconnection between brain regions. Transcranial magnetic stimulation is a non-invasive brain intervention technique that can be used as a new and safe treatment option for patients with schizophrenia with drug-refractory symptoms, such as negative symptoms and cognitive impairment. However, the therapeutic effects of transcranial magnetic stimulation remain unclear and would be investigated using non-invasive tools, such as functional connectivity. A longitudinal design was adopted to investigate the alteration in FC dynamics (...) using a dynamic functional connectivity approach in patients with schizophrenia following high-frequency repeated transcranial magnetic stimulation with the target at the left dorsolateral prefrontal cortex. Two groups of schizophrenia inpatients were recruited. One group received a 4-week high-frequency rTMS together with antipsychotic drugs, while the other group only received antipsychotic drugs. Resting-state functional magnetic resonance imaging and psychiatric symptoms were obtained from the patients with schizophrenia twice at baseline and after 4-week treatment. The dynamics was evaluated using voxel- and region-wise FC temporal variability resulting from fMRI data. The pattern classification technique was used to verify the clinical application value of FC temporal variability. For the voxel-wise FC temporary variability, the repeated measures ANCOVA analysis showed significant treatment × time interaction effects on the FC temporary variability between the left DLPFC and several regions, including the thalamus, cerebellum, precuneus, and precentral gyrus, which are mainly located within the cortico-thalamo-cerebellar circuit. For the ROI-wise FC temporary variability, our results found a significant interaction effect on the FC among CTCC. rTMS intervention led to a reduced FC temporary variability. In addition, higher alteration in FC temporal variability between left DLPFC and right posterior parietal thalamus predicted a higher remission ratio of negative symptom scores, indicating that the decrease of FC temporal variability between the brain regions was associated with the remission of schizophrenia severity. The support vector regression results suggested that the baseline pattern of FC temporary variability between the regions in CTCC could predict the efficacy of high-frequency rTMS intervention on negative symptoms in schizophrenia. These findings confirm the potential relationship between the reduction in whole-brain functional dynamics induced by high-frequency rTMS and the improvement in psychiatric scores, suggesting that high-frequency rTMS affects psychiatric symptoms by coordinating the heterogeneity of activity between the brain regions. Future studies would examine the clinical utility of using functional dynamics patterns between specific brain regions as a biomarker to predict the treatment response of high-frequency rTMS. (shrink)

One main goal of argumentation theory is to evaluate arguments and to determine whether they should be accepted or rejected. When there is no clear answer, a third option, being undecided, has to be taken into account. Indecision is often not considered explicitly, but rather taken to be a collection of all unclear or troubling cases. However, current philosophy makes a strong point for taking indecision itself to be a proper object of consideration. This paper aims at revealing parallels between (...) the findings concerning indecision in philosophy and the treatment of indecision in argumentation theory. By investigating what philosophical forms and norms of indecision are involved in argumentation theory, we can improve our understanding of the different uncertain evidential situations in argumentation theory. (shrink)

Due to improvements in medicine, the figures of patients with disorders of consciousness (DoC) are increasing. Diagnostics of DoC and prognostication of rehabilitation outcome is challenging but necessary to evaluate recovery potential and to decide on treatment options. Such decisions should be made by doctors and patients’ surrogates based on medico-ethical principles. Meeting information needs and communicating effectively with caregivers as the patients´ most common surrogate-decision makers is crucial, and challenging when novel tech-nologies are introduced. This qualitative study (...) aims to explore information needs of informal DoC caregivers, how they manage the obtained information and their perceptions and experiences with caregiver-physician communication in facilities that implemented innovative neurodiagnostics studies. In 2021, we conducted semi-structured interviews with nine caregivers of clinically stable DoC patients in two rehabilitation centers in Italy and Germany. Participants were selected based on consecutive purposeful sampling. Caregivers were recruited at the facilities after written informed consent. All interviews were recorded, transcribed verbatim and translated. For analysis, we used reflexive thematic analysis according to Braun & Clarke (2006). Caregivers experienced the conversations emotionally, generally based on the value of the information provided. They reported to seek positive information, comfort and empathy with-in the communication of results of examinations. They needed detailed information to gain a deep understanding and a clear picture of their loved-one’s condition. The results suggest a mismatch between the perspectives of caregivers and the perspectives of medical profession-als, and stress the need for more elaborate approaches to the communication of results of neu-rodiagnostics studies. (shrink)

Childbearing is an increasingly complicated matter, which has evolved significantly over the past several decades. Treatment options for infertility have expanded. Prenatal testing and treatment have led to an evolution in obstetrical decision-making, wherein the risks and benefits to the fetus and future child are better understood and more strongly considered in medical management of the pregnant woman. Obstetrics appears to be increasingly interventional; one in three babies in the United States is now born by cesarean section. (...) Neonatal intensive care has markedly improved outcomes for premature babies. A pregnant woman may now be presented with many options— obstetrician or midwife, home or hospital delivery, choices among prenatal testing and monitoring, early induction of labor, cesarean delivery. Health care professionals face similar decisions with regard to what they recommend and the boundaries of safe and responsible care they should make available. Preterm Babies, Fetal Patients, and Childbearing Choices, by John D. Lantos and Diane S. Lauderdale, provides an excellent overview of the available information relevant to these questions. (shrink)

BackgroundThe transplantation of porcine islet cells provides a new potential therapy to treat patients with type 1 diabetes mellitus (T1DM). Compared to other biomedical technologies, xenotransplantation stands out in terms of its involvement of animals as graft sources, as well as the possible transmission of infectious diseases. As these aspects are especially relevant for potential xenotransplantation recipients, it is important to assess their opinion regarding this technology, in particular in terms of the requirements that should be met in the informed (...) consent process for xenotransplantation.MethodsWe conducted qualitative interviews with seven T1DM patients to assess their information needs prior to xenotransplantation. Before the interview, the participants received a model informed consent form for a clinical trial with porcine islet cells transplantation. The interviews were transcribed and analysed using qualitative content analysis.ResultsIn the interviews, we identified several requirements that are crucial for patients with T1DM in order to consider xenotransplantation as a potential treatment option: therapy-related requirements, professional care and supervision, successful behaviour and attitude management, improving quality of life, and managing control/self-determination challenges. Regarding the informed consent form, several of the participants’ questions remained open and should be addressed in more detail. The interviewees stressed the importance of personal consultations.ConclusionsTo become a sustainable therapeutic option, patients especially expected an improved diabetes control and a reduction of diabetes-related burdens. Health-related aspects prove to be pivotal for diabetic patients when considering porcine islet cell transplantation. The use of pigs as source for organ retrievals was not considered as problematic. (shrink)

Rationale, aims and objectives: Appropriate use of diagnostic and treatment modalities are essential for rational use of resources. The aim of this study is to evaluate the use of diagnostic modalities and different treatment options and their economic impacts following an acute ankle distortion resulting from an occupational accident. We evaluated the type-of-treatment impact on the victims' course of recovery as well as its impact on the associated accident costs. Research was carried out in Belgium. Methods: (...) An ankle distortion victims' database consisting of 200 cases of (Belgian) occupational accidents during the period 2005-2007 was analysed. Results: Patients who were prescribed immobilization or the use of adjuvant support or physical therapy (118 cases) were not employed during a period of 37 days on average, with a mean total cost of 3140.14 Euros caused by the ankle sprain. Patients without any adjuvant therapy (82 cases) were characterized by an unemployment rate of 15 days on average, and a total cost of 1077.86 Euros. Cast immobilization, although its application is not supported by evidence-based literature, was still applied in 36% of the population studied and resulted in the longest average absence of work of 42 days with an obvious significant increase in medical and total costs. Conclusions: Our results show a high rate of inappropriate use of cast immobilizations for ankle distortions. From an economic point of view and for the same clinical endpoint (being full resumption of the occupational activities), simple conventional treatment, consisting of rest, ice, compression and elevation at diagnosis with allowance of early weight bearing in the further clinical course, leads to the quickest full resumption of activities in combination with the lowest medical costs, if compared with any other kind of treatment. (shrink)

ABSTRACT I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments. INTRODUCTION In contrast to the classic model of randomized-control trials, often with a large number of (...) subjects enrolled, precision medicine attempts to optimize therapeutic outcomes by focusing on the individual.[i] A recent publication highlights the strengths and weakness of both traditional evidence-based medicine and precision medicine.[ii] Plus, it outlines a tension in the shift from evidence-based medicine’s inductive reasoning style (the collection of data to postulate general theories) to precision medicine’s abductive reasoning style (the generation of an idea from the limited data available).[iii] The paper’s main example is the application of precision medicine for the treatment of cancer.[iv] I argue that this examination and appreciation for the shift to abductive reasoning should be extended to the intersection of neuroscience and novel brain-computer interfaces too. As the name suggests, brain-computer interfaces are a significant advancement in neurotechnology that directly connects someone’s brain to external or implanted devices.[v] Among the various kinds of brain-computer interfaces, adaptive deep brain stimulation devices require numerous personalized adjustments to their settings during the implantation and computation stages in order to provide adequate relief to patients with treatment-resistant disorders. What makes these devices unique is how adaptive deep brain stimulation integrates a sensory component to initiate the stimulation. While not commonly at the level of sophistication as self-supervising or generative large language models,[vi] they currently allow for a semi-autonomous form of neuromodulation. This paper highlights the implications of applying abductive reasoning to personalized implantable neurotechnologies. Then, it explores whether abductive reasoning is sufficient to justify insurance coverage for devices absent widespread clinical trials, which are better applied to one-size-fits-all treatments.[vii] ANALYSIS I. The State of Precision Medicine in Oncology and the Epistemological Shift While a thorough overview of precision medicine for the treatment of cancer is beyond the scope of this article, its practice can be roughly summarized as identifying clinically significant characteristics a patient possesses (e.g., genetic traits) to land on a specialized treatment option that, theoretically, should benefit the patient the most.[viii] However, in such a practice of stratification patients fall into smaller and smaller populations and the quality of evidence that can be applied to anyone outside these decreases in turn.[ix] As inductive logic helps to articulate, the greater the number of patients that respond to a particular therapy the higher the probability of its efficacy. By straying from this logical framework, precision medicine opens the treatment of cancer to more uncertainty about the validity of these approaches to the resulting disease subcategories.[x] Thus, while contemporary medical practices explicitly describe some treatments as “personalized”, they ought not be viewed as inherently better founded than other therapies.[xi] A relevant contemporary case of precision medicine out of Norway focuses on the care of a patient with cancer between the ventricles of the heart and esophagus, which had failed to respond to the standard regimen of therapies over four years.[xii] In a last-ditch effort, the patient elected to pay out-of-pocket for an experimental immunotherapy (nivolumab) at a private hospital. He experienced marked improvements and a reduction in the size of the tumor. Understandably, the patient tried to pursue further rounds of nivolumab at a public hospital. However, the hospital initially declined to pay for it given the “lack of evidence from randomised clinical trials for this drug relating to this [patient’s] condition.”[xiii] In rebuttal to this claim, the patient countered that he was actually similar to a subpopulation of patients who responded in “open‐label, single arm, phase 2 studies on another immune therapy drug” (pembrolizumab).[xiv] Given this interpretation of the prior studies and the patient’s response, further rounds of nivolumab were approved. Had the patient not had improvements in the tumor’s size following a round of nivolumab, then pembrolizumab’s prior empirical evidence in isolation would have been insufficient, inductively speaking, to justify his continued use of nivolumab.[xv] The case demonstrates a shift in reasoning from the traditional induction to abduction. The phenomenon of ‘cancer improvement’ is considered causally linked to nivolumab and its underlying physiological mechanisms.[xvi] However, “the weakness of abductions is that there may always be some other better, unknown explanation for an effect. The patient may for example belong to a special subgroup that spontaneously improves, or the change may be a placebo effect. This does not mean, however, that abductive inferences cannot be strong or reasonable, in the sense that they can make a conclusion probable.”[xvii] To demonstrate the limitations of relying on the abductive standard in isolation, commentators have pointed out that side effects in precision medicine are hard to rule out as being related to the initial intervention itself unless trends from a group of patients are taken into consideration.[xviii] As artificial intelligence (AI) assists the development of precision medicine for oncology, this uncertainty ought to be taken into consideration. The implementation of AI has been crucial to the development of precision medicine by providing a way to combine large patient datasets or a single patient with a large number of unique variables with machine learning to recommend matches based on statistics and probability of success upon which practitioners can base medical recommendations.[xix] The AI is usually not establishing a causal relationship[xx] – it is predicting. So, as AI bleeds into medical devices, like brain-computer interfaces, the same cautions about using abductive reasoning alone should be carried over. II. Responsive Neurostimulation, AI, and Personalized Medicine Like precision medicine in cancer treatment, computer-brain interface technology similarly focuses on the individual patient through personalized settings. In order to properly expose the intersection of AI, precision medicine, abductive reasoning, and implantable neurotechnologies, the descriptions of adaptive deep brain stimulation systems need to deepen.[xxi] As a broad summary of adaptive deep brain stimulation, to provide a patient with the therapeutic stimulation, a neural signal, typically referred to as a local field potential,[xxii] must first be detected and then interpreted by the device. The main adaptive deep brain stimulation device with premarket approval, the NeuroPace Responsive Neurostimulation system, is used to treat epilepsy by detecting and storing “programmer-defined phenomena.”[xxiii] Providers can optimize the detection settings of the device to align with the patient’s unique electrographic seizures as well as personalize the reacting stimulation’s parameters.[xxiv] The provider adjusts the technology based on trial and error. One day machine learning algorithms will be able to regularly aid this process in myriad ways, such as by identifying the specific stimulation settings a patient may respond to ahead of time based on their electrophysiological signatures.[xxv] Either way, with AI or programmers, adaptive neurostimulation technologies are individualized and therefore operate in line with precision medicine rather than standard treatments based on large clinical trials. Contemporary neurostimulation devices are not usually sophisticated enough to be prominent in AI discussions where the topics of neural networks, deep learning, generative models, and self-attention dominate the conversation. However, implantable high-density electrocorticography arrays (a much more sensitive version than adaptive deep brain stimulation systems use) have been used in combination with neural networks to help patients with neurologic deficits from a prior stroke “speak” through a virtual avatar.[xxvi] In some experimental situations, algorithms are optimizing stimulation parameters with increasing levels of independence.[xxvii] An example of neurostimulation that is analogous to the use of nivolumab in Norway surrounds a patient in the United States who was experiencing both treatment-resistant OCD and temporal lobe epilepsy.[xxviii]Given the refractory nature of her epilepsy, implantation of an adaptive deep brain stimulation system was indicated. As a form of experimental therapy, her treatment-resistant OCD was also indicated for the off-label use of an adaptive deep brain stimulation set-up. Another deep brain stimulation lead, other than the one implanted for epilepsy, was placed in the patient’s right nucleus accumbens and ventral pallidum region given the correlation these nuclei had with OCD symptoms in prior research. Following this, the patient underwent “1) ambulatory, patient-initiated magnet-swipe storage of data during moments of obsessive thoughts; (2) lab-based, naturalistic provocation of OCD-related distress (naturalistic provocation task); and (3) lab-based, VR [virtual reality] provocation of OCD-related distress (VR provocation task).”[xxix] Such signals were used to identify when to deliver the therapeutic stimulation in order to counter the OCD symptoms. Thankfully, following the procedure and calibration the patient exhibited marked improvements in their OCD symptoms and recently shared her results publicly.[xxx] In both cases, there is a similar level of abductive justification for the efficacy of the delivered therapy. In the case study in which the patient was treated with adaptive deep brain stimulation, they at least had their neural activity tested in various settings to determine the optimum parameters for treatment to avoid them being based on guesswork. Additionally, the adaptive deep brain stimulation lead was already placed before the calibration trials were conducted, meaning that the patient had already taken on the bulk of the procedural risk before the efficacy could be determined. Such an efficacy test could have been replicated in the first patient’s cancer treatment, had it been biopsied and tested against the remaining immunotherapies in vitro. Yet, in the case of cancer with few options, one previous dose of a drug that appeared to work on the patient may justify further doses. However, as the Norwegian case presents, corroboration with known responses to a similar drug (from a clinical trial) could be helpful to validate the treatment strategy. (It should be noted that both patients were resigned to these last resort options regardless of the efficacy of treatment.) There are some elements of inductive logic seen with adaptive deep brain stimulation research in general. For example, abductively the focus could be that patient X’s stimulation parameters are different from patient Y’s and patient Z’s. In contrast, when grouped as subjects who obtained personalized stimulation, patients X, Y, and Z demonstrate an inductive aspect to this approach’s safety and/or efficacy. The OCD case holds plenty of abductive characteristics in line with precision medicine’s approach to treating cancer and as more individuals try the method, there will be additional data. With the gradual integration of AI into brain-computer interfaces in the name of efficacy, this reliance on abduction will continue, if not grow, over time. Moving forward, if a responsive deep brain stimulation treatment is novel and individualized (like the dose of nivolumab) and there is some other suggestion of efficacy (like clinical similarities to other patients in the literature), then it may justify insurance coverage for the investigative intervention, absent other unrelated reasons to deny it. III. Ethical Implications and Next Steps While AI’s use in oncology and neurology is not yet as prominent as its use in other fields (e.g., radiology), it appears to be on the horizon for both.[xxxi] AI can be found in both the functioning of the neurotechnologies as well as the implementation of precision medicine. The increasing use of AI may serve to further individualize both oncologic and neurological therapies. Given these implications and the handful of publications cited in this article, it is important to have a nuanced evaluation of how these treatments, which heavily rely on abductive justification, ought to be managed. The just use an abductive approach may be difficult as AI infused precision medicine is further pursued. At baseline, such technology relies on a level of advanced technology literacy among the general public and could exclude populations who lack access to basic technological infrastructure or know-how from participation.[xxxii] Even among nations with adequate infrastructure, as more patients seek out implantable neurotechnologies, which require robust healthcare resources, the market will favor patient populations that can afford this complex care.[xxxiii] If patients already have the means to pay for an initial dose/use of a precision medicine product out of pocket, should insurance providers be required to cover subsequent treatments?[xxxiv] That is, if a first dose of a cancer drug or a deep brain stimulator over its initial battery life is successful, patients may feel justified in having the costs of further treatments covered. The Norwegian patient’s experience implies there is a precedent for the idea that some public insurance companies ought to cover successful cancer therapies, however, insurance companies may not all see themselves as obligated to cover neurotechnologies that rely on personalized settings or that are based on precision/abductive research more than on clinical trials. CONCLUSION The fact that the cases outlined above rely on abductive style of reasoning implies that there may not be as strong a justification for coverage by insurance, as they are both experimental and individualized, when compared to the more traditional large clinical trials in which groups have the same or a standardized protocol (settings/doses). If a study is examining the efficacy of a treatment with a large cohort of patients or with different experimental groups/phases, insurance companies may conclude that the resulting symptom improvements are more likely to be coming from the devices themselves. A preference for inductive justification may take priority when ruling in favor of funding someone’s continued use of an implantable neurostimulator. There are further nuances to this discussion surrounding the classifications of these interventions as research versus clinical care that warrant future exploration, since such a distinction is more of a scale[xxxv] than binary and could have significant impacts on the “right-to-try” approach to experimental therapies in the United States.[xxxvi] Namely, given the inherent limitations of conducting large cohort trials for deep brain stimulation interventions on patients with neuropsychiatric disorders, surgically innovative frameworks that blend abductive and inductive methodologies, like with sham stimulation phases, have traditionally been used.[xxxvii] Similarly, for adaptive brain-computer interface systems, if there are no large clinical trials and instead only publications that demonstrate that something similar worked for someone else, then, in addition to the evidence that the first treatment/dose worked for the patient in question, the balance of reasoning would be valid and arguably justify insurance coverage. As precision approaches to neurotechnology become more common, frameworks for evaluating efficacy will be crucial both for insurance coverage and for clinical decision making. ACKNOWLEDGEMENT This article was originally written as an assignment for Dr. Francis Shen’s “Bioethics & AI” course at Harvard’s Center for Bioethics. I would like to thank Dr. Shen for his comments as well as my colleagues in the Lázaro-Muñoz Lab for their feedback. - [i] Jonathan Kimmelman and Ian Tannock, “The Paradox of Precision Medicine,” Nature Reviews. Clinical Oncology 15, no. 6 (June 2018): 341–42, https://doi.org/10.1038/s41571-018-0016-0. [ii] Henrik Vogt and Bjørn Hofmann, “How Precision Medicine Changes Medical Epistemology: A Formative Case from Norway,” Journal of Evaluation in Clinical Practice 28, no. 6 (December 2022): 1205–12, https://doi.org/10.1111/jep.13649. [iii] David Barrett and Ahtisham Younas, “Induction, Deduction and Abduction,” Evidence-Based Nursing 27, no. 1 (January 1, 2024): 6–7, https://doi.org/10.1136/ebnurs-2023-103873. [iv] Vogt and Hofmann, “How Precision Medicine Changes Medical Epistemology,” 1208. [v] Wireko Andrew Awuah et al., “Bridging Minds and Machines: The Recent Advances of Brain-Computer Interfaces in Neurological and Neurosurgical Applications,” World Neurosurgery, May 22, 2024, S1878-8750(24)00867-2, https://doi.org/10.1016/j.wneu.2024.05.104. [vi] Mark Riedl, “A Very Gentle Introduction to Large Language Models without the Hype,” Medium (blog), May 25, 2023, https://mark-riedl.medium.com/a-very-gentle-introduction-to-large-language-models-without-the-hype-5 f67941fa59e. [vii] David E. Burdette and Barbara E. Swartz, “Chapter 4 - Responsive Neurostimulation,” in Neurostimulation for Epilepsy, ed. Vikram R. Rao (Academic Press, 2023), 97–132, https://doi.org/10.1016/B978-0-323-91702-5.00002-5. [viii] Kimmelman and Tannock, 2018. [ix] Kimmelman and Tannock, 2018. [x] Simon Lohse, “Mapping Uncertainty in Precision Medicine: A Systematic Scoping Review,” Journal of Evaluation in Clinical Practice 29, no. 3 (April 2023): 554–64, https://doi.org/10.1111/jep.13789. [xi] Kimmelman and Tannock, “The Paradox of Precision Medicine.” [xii] Vogt and Hofmann, 1206. [xiii] Vogt and Hofmann, 1206. [xiv] Vogt and Hofmann, 1206. [xv] Vogt and Hofmann, 1207. [xvi] Vogt and Hofmann, 1207. [xvii] Vogt and Hofmann, 1207. [xviii] Vogt and Hofmann, 1210. [xix] Mehar Sahu et al., “Chapter Three - Artificial Intelligence and Machine Learning in Precision Medicine: A Paradigm Shift in Big Data Analysis,” in Progress in Molecular Biology and Translational Science, ed. David B. Teplow, vol. 190, 1 vols., Precision Medicine (Academic Press, 2022), 57–100, https://doi.org/10.1016/bs.pmbts.2022.03.002. [xx] Stefan Feuerriegel et al., “Causal Machine Learning for Predicting Treatment Outcomes,” Nature Medicine 30, no. 4 (April 2024): 958–68, https://doi.org/10.1038/s41591-024-02902-1. [xxi] Sunderland Baker et al., “Ethical Considerations in Closed Loop Deep Brain Stimulation,” Deep Brain Stimulation 3 (October 1, 2023): 8–15, https://doi.org/10.1016/j.jdbs.2023.11.001. [xxii] David Haslacher et al., “AI for Brain-Computer Interfaces,” 2024, 7, https://doi.org/10.1016/bs.dnb.2024.02.003. [xxiii] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 103–4; “Premarket Approval (PMA),” https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100026. [xxiv] Burdette and Swartz, “Chapter 4 - Responsive Neurostimulation,” 104. [xxv] Burdette and Swartz, 126. [xxvi] Sean L. Metzger et al., “A High-Performance Neuroprosthesis for Speech Decoding and Avatar Control,” Nature 620, no. 7976 (August 2023): 1037–46, https://doi.org/10.1038/s41586-023-06443-4. [xxvii] Hao Fang and Yuxiao Yang, “Predictive Neuromodulation of Cingulo-Frontal Neural Dynamics in Major Depressive Disorder Using a Brain-Computer Interface System: A Simulation Study,” Frontiers in Computational Neuroscience 17 (March 6, 2023), https://doi.org/10.3389/fncom.2023.1119685; Mahsa Malekmohammadi et al., “Kinematic Adaptive Deep Brain Stimulation for Resting Tremor in Parkinson’s Disease,” Movement Disorders 31, no. 3 (2016): 426–28, https://doi.org/10.1002/mds.26482. [xxviii] Young-Hoon Nho et al., “Responsive Deep Brain Stimulation Guided by Ventral Striatal Electrophysiology of Obsession Durably Ameliorates Compulsion,” Neuron 0, no. 0 (October 20, 2023), https://doi.org/10.1016/j.neuron.2023.09.034. [xxix] Nho et al. [xxx] Nho et al.; Erik Robinson, “Brain Implant at OHSU Successfully Controls Both Seizures and OCD,” OHSU News, accessed March 3, 2024, https://news.ohsu.edu/2023/10/25/brain-implant-at-ohsu-successfully-controls-both-seizures-and-ocd. [xxxi] Awuah et al., “Bridging Minds and Machines”; Haslacher et al., “AI for Brain-Computer Interfaces.” [xxxii] Awuah et al., “Bridging Minds and Machines.” [xxxiii] Sara Green, Barbara Prainsack, and Maya Sabatello, “The Roots of (in)Equity in Precision Medicine: Gaps in the Discourse,” Personalized Medicine 21, no. 1 (January 2024): 5–9, https://doi.org/10.2217/pme-2023-0097. [xxxiv] Green, Prainsack, and Sabatello, 7. [xxxv] Robyn Bluhm and Kirstin Borgerson, “An Epistemic Argument for Research-Practice Integration in Medicine,” The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 43, no. 4 (July 9, 2018): 469–84, https://doi.org/10.1093/jmp/jhy009. [xxxvi] Vijay Mahant, “‘Right-to-Try’ Experimental Drugs: An Overview,” Journal of Translational Medicine 18 (June 23, 2020): 253, https://doi.org/10.1186/s12967-020-02427-4. [xxxvii] Michael S. Okun et al., “Deep Brain Stimulation in the Internal Capsule and Nucleus Accumbens Region: Responses Observed during Active and Sham Programming,” Journal of Neurology, Neurosurgery & Psychiatry 78, no. 3 (March 1, 2007): 310–14, https://doi.org/10.1136/jnnp.2006.095315. (shrink)

Deep brain stimulation (DBS) of the globus pallidus interna and subthalamic nucleus has restored some degree of motor control in many patients in advanced stages of Parkinson’s disease. DBS has also been used to treat dystonia, essential tremor (progressive neurological condition causing trembling), chronic pain, obsessive-compulsive disorder, Tourette’s syndrome, major depressive disorder, obesity, cerebral palsy, and the minimally conscious state. Although the underlying mechanisms of the technique are still not clear, DBS can modulate underactive or overactive neural circuits and restore (...) disrupted communication between and among groups of neurons in interacting regions of the brain. This can control and relieve many symptoms associated with a range of neurological and psychiatric disorders.But the procedures of implanting and stimulating the electrodes are brain-invasive and entail significant risks. Some patients receiving DBS have experienced intracerebral hemorrhage, infection, cognitive disturbances such as impulsive behavior, and affective disturbances such as mania. It is not known whether continuous electrical stimulation of the brain would reshape synaptic connectivity and permanently alter neural circuits in ways that may not be salutary. The risk of these effects indicates that DBS should be used only when a patient’s condition is refractory to all other interventions and when there is a high probability that the technique will benefit the patient and improve his or her quality of life. If a patient’s quality of life is poor and all other treatment options have been exhausted, then the likelihood of benefit can justify physicians’ exposing patients to some risk. The clinical and ethical significance of the risk in DBS underscores the obligation of physicians to obtain fully informed consent from patients undergoing the procedure. (shrink)

Can heroin addicts give consent to research on trials in which heroin is prescribed to them? Analyses of addicts and informed consent have been objects of debate in several articles. Informed consent requires the agent not only to be competent but also to give consent voluntarily. This has been questioned because of alleged features of heroin addiction. Until recently the discussion has focused on heroin addicts' desires for heroin, whether these are irresistible and thus pose a problem for giving consent. (...) Still, in light of empirical evidence, there seems to be a consensus more or less that the problem is not whether the addicts can resist their desire for heroin. A recent article concentrates specifically on heroin addicts' false assumptions of options and voluntariness. We argue that the prevailing framing of the options in this discussion in terms of heroin and access to it is problematic. The way in which the options are typically laid out suggests an assumption that participation in the research is allegedly based on the addicts' views on using the drug. We argue that this way of presenting the options is, first, a mismatch to the studies carried out and, second, symptomatic of potential misconceptions about heroin addiction and addicts. Furthermore, we also suggest that the account of voluntariness needs to be realistic in order for subjects to be able to give consent voluntarily in actual situations, and for medical research to carry out studies on improving outcomes in addiction treatment in an ethical way. (shrink)

In a recent paper, Yeo argues that the framing of treatment options by physicians in the contexts of patient’s decision-making conflicts with a physician’s duty of disclosure. I argue that this conclusion is drawn too quickly, as it is questionable whether the empirical research on which Yeo relies is applicable to the framing of treatment options. This means that Yeo’s main assumption is undermined, and we should hold off on concluding that the framing of treatment (...) options is misleading. (shrink)

Taking post-traumatic stress disorder (PTSD) as an example, we present a concept for transdisciplinary cooperation between life sciences and humanities. PTSD is defined as a long-term persisting anxiety disorder after severe psychological traumata. Initially recognized in war veterans, PTSD also appears in victims of crime and violence or survivors of natural catastrophes, e.g., earthquakes. We consider PTSD as a prototype topic to realize transdisciplinary projects, because this disease is multifacetted from different points of view. Based on physiological and molecular biological (...) research to understand the causes of this disease, conventional academic medicine (to Western medicine) and pharmacology can offer a panel of drugs for treatment, albeit only with limited success. Hence, other treatment options are indispensable. Chinese medicine is frequently regarded as alternative to complement Western medicine. In fact, Chinese medicine offers a large array of both pharmacological and non-pharmacological treatments for PTSD patients. Narrative therapy represents a non-pharmacological approach combating PTSD both in Western medicine as well as in Chinese medicine to improve quality of life of affected patients. Narratives on traumatic experiences form a new genre of life writing in Asian American literature, whose excitement is considerably fueled by the tension between fictitious and very personal narratives taken from reality. Systematic academic reflections on narratives from PTSD patients in the field of Asian American studies may support the improvement of narrative therapy in medical practice. Chinese medicine has a strong philosophical background and may, therefore, serve as junction between life sciences with their strong rational and reductionistic way to generate new knowledge and more holistic approaches in traditional medicines and humanities. In this regard, Chinese medicine may represent a missing link between life science and life writing. (shrink)

As innovations in the field of vascular composite allotransplantation (VCA) progress, whole-eye transplantation (WET) is poised to transition from non-human mammalian models to living human recipients. Present treatment options for vision loss are generally considered suboptimal, and attendant concerns ranging from aesthetics and prosthesis maintenance to social stigma may be mitigated by WET. Potential benefits to WET recipients may also include partial vision restoration, psychosocial benefits related to identity and social integration, improvements in physical comfort and function, and (...) reduced surgical risk associated with a biologic eye compared to a prosthesis. Perioperative and postoperative risks of WET are expected to be comparable to those of facial transplantation (FT), and may be similarly mitigated by immunosuppressive protocols, adequate psychosocial support, and a thorough selection process for both the recipient and donor. To minimize the risks associated with immunosuppressive medications, the first attempts in human recipients will likely be performed in conjunction with a FT. If first-in-human attempts at combined FT-WET prove successful and the biologic eye survives, this opens the door for further advancement in the field of vision restoration by means of a viable surgical option. This analysis integrates recent innovations in WET research with the existing discourse on the ethics of surgical innovation and offers preliminary guidance to VCA programs considering undertaking WET in human recipients. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Appreciating Anorexia:Decisional Capacity and the Role of ValuesThomas Grisso (bio) and Paul S. Appelbaum (bio)Keywordscompetence, consent, anorexia, appreciation, decision makingTan and her colleagues (2006) reported that persons with anorexia nervosa typically manifest no difficulty satisfying the criteria for abilities associated with competence to consent to or refuse treatment. Their results led them to conclude that these patients generally had no problem grasping the nature of anorexia and its (...) possible consequences (understanding), typically did not have difficulty processing information when making treatment decisions (reasoning), and usually neither denied that they had a disorder nor manifested distorted beliefs about the potential consequences of treatment for the disorder.Nevertheless, these authors found, some anorexia patients said that they knew they might die and that they would rather die than suffer the alternative consequences (e.g., loss of identity, feeling of being disgusting). They point out that these beliefs, suggesting questionable competence, were not identified by the usual criteria for competence to consent to treatment. Therefore, they propose that we should consider a modification of the criteria for competence to consent to treatment. They argue for inclusion of "pathological values" as the basis for a finding of incompetence. Their notion of a pathological value (as we summarize it based on their Discussion) includes (a) a personal value (b) on which treatment refusal is based, that (c) is not authentic, and (d) is due to a mental disorder.Second, Tan and colleagues were concerned that the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), currently used widely to assess competence to consent to treatment, did not seem to take values into account when examining deficits related to lack of appreciation or reasoning. They point out that most patients with anorexia nervosa in their study had "pathological values" that influenced their thinking about treatment, yet they did not obtain poor scores on the instrument's appreciation scale, which assesses whether patients deny that they have the illness or offer reasons for accepting or refusing treatment that are based on delusional premises or a serious distortion of reality. Moreover, almost all of the anorexia patients in the study obtained adequate scores on reasoning, which examines the ability to process options and consequences when weighing a treatment decision. [End Page 293]Reasons for Caution in Altering Criteria for CompetenceA fundamental step in considering Tan and her co-worker's proposal is to examine whether it is necessary to add a concept of "pathological values" to the legal construct of competence to consent to treatment. Modifying the legal doctrine of consent is important if that is needed to improve its validity or reliability. But modifications of the doctrine would have considerable costs, including a long process of producing logical and empirical evidence for its necessity, developing methods to assess the new concept, and then a process of debate, persuasion, and education to change laws, ethical guidelines, and medical training. Moreover, principles of theory building urge parsimony. A theory should employ no more concepts or assumptions than are required to account for the phenomena that the theory seeks to organize or explain. So one must be sure that modifications are truly necessary before adding complexity to the theory of decisional competence.In addition, there is an inherent danger in altering a concept like competence to consent to treatment on the basis of the study of any one mental disorder. It is not at all clear how the modification might influence findings of competence when applied to other disorders. Using a study of patients with anorexia nervosa as the impetus for changing the competence concept runs this risk. For example, anorexia is one of a class of mental disorders that is characterized by a failure to abstain from behavior (here, limiting food intake and other behaviors designed to reduce weight) that has negative consequences for the person. Other conditions in this category might include substance abuse disorders and impulse control disorders (e.g., pathological gambling). Even if one concludes that revised criteria for competence would reduce false-positive findings of competence in this group of disorders, one would have to consider carefully its impact on the full range of disabling mental conditions.Moreover, the sensitivity... (shrink)

In this paper, the public view of nanotechnology and its applications in medicine, agriculture and industry is evaluated in the mega cities of Iran. Data from 683 individuals in public places provided the first civic perception of nanotechnology in Iran. Quantitative statistical analysis on positive or negative points of view demonstrated that Iranian people had general positive opinions on nanotechnology and its application in medicine. They believed that nanomedicine can significantly improve the current methods used in disease treatments, especially (...) for cancer therapy. In general, the responders believed that they would easily accept the use of nanotechnology products and would like increased financial support of the government on nanomedicine and nanotechnology research fields and they showed little anxiety about the possible risks. According to our statistical analysis, three individual characteristics age, education level and career had a direct correlation with the knowledge level of Iranian people on nanotechnology in the mega cities of Iran. (shrink)

Health researchers working in low-resource settings routinely encounter serious unmet health needs for which research participants have, at best, limited treatment options through the local health system (Taylor, Merritt, and Mullany 2011). A recent case discussion features a study conducted in Bamako, Mali (Dickert and Wendler 2009). The study objective was to see whether children with severe malaria develop pulmonary hypertension in order to improve the general understanding of morbidity and mortality associated with malaria. In the study team's (...) interactions with participating children, they encountered not only malaria but also "eye infections, upper respiratory tract illnesses, rashes, pericardial effusions," .. (shrink)

Patients have the right to refuse their treatment; however, this refusal should be informed. We evaluated the quality of the informed refusal process in Iranian hospitals from patients' viewpoints. To this end, we developed a questionnaire that covered four key aspects of the informed refusal process including; information disclosure, voluntariness, comprehension, and provider-patient relationship. A total of 284 patients who refused their treatment from 12 teaching hospitals in the Isfahan Province, Iran, were recruited and surveyed to produce a (...) convenience sample. Patients' perceptions about the informed refusal process were scored and the mean scores of the four components were calculated. The findings showed that the practice of information disclosure was perceived to be moderate, however, comprehension, voluntariness and provider–patient relationship were perceived to be relatively good. We found that patients, who refused their care before any treatment had commenced, reported a lower quality of information disclosure and voluntariness. Patients informed by nurses and those who had not had a previous related admission, reported lower scores for comprehension and relationship. In conclusion, the process of obtaining informed refusal was relatively satisfactory except for levels of information disclosure. To improve current practices, Iranian patients need to be better informed about; different treatment options, consequences of treatment refusal, costs of not continuing treatment and follow-ups after refusal. Developing more informative refusal forms is needed. (shrink)

Next SectionAccess to medicines, vaccination and care in resource-poor settings is threatened by the emigration of physicians and other health workers. In entire regions of the developing world, low physician density exacerbates child and maternal mortality and hinders treatment of HIV/AIDS. This article invites philosophers to help identify ethical and effective responses to medical brain drain. It reviews existing proposals and their limitations. It makes a case that, in resource-poor countries, ’locally relevant medical training’—teaching primarily locally endemic diseases and (...) practice in scarcity conditions, training in rural communities and admitting rural students preferentially—could help improve retention. Locally relevant training would arguably diminish medical brain drain in five ways. It would (i) make graduates less attractive for Western employers, (ii) align graduates’ expectations with actual practice, diminishing ‘burn-out’, (iii) enhance the professional prestige of local practice, (iv) hold rotations in, and recruit applicants from, rural areas, which is known to improve retention there, and (v) create local career development options that attract practitioners to stay. Such educational reform may raise worries about poor-quality care, breach of the freedom of education and occupation, breach of the freedom of movement, unequal distribution of opportunities among students, hypocrisy and resistance from influential actors. We address these worries. (shrink)

The exponential growth of genetic knowledge and precision medicine research raises hopes for improved prevention, diagnosis, and treatment options for children with behavioral and psychiatric conditions. Although well-intended, this prospect also raise the possibility — and concern — that behavioral, including psychiatric genetic data would be increasingly used — or misused — outside the clinical context, such as educational settings. Indeed, there are ongoing calls to endorse a “personalized education” model that would tailor educational interventions to children's behavioral (...) and psychiatric genetic makeup. This article explores the justifications for, and prospects and pitfalls of such endeavors. It considers the scientific challenges and highlights the ethical, legal, and social issues that will likely arise should behavioral genetic data become available and are routinely incorporated in student education records. These include: when to disclose students' behavioral and psychiatric genetic profile; whose genomic privacy is protected and by whom; and how students' genetic data may affect education-related decisions. I argue that the introduction of behavioral genetics in schools may overshadow the need to address underlying structural and environmental factors that increase the risk for psychiatric conditions of all students, and that the unregulated use of student behavioral genetic profiles may lead to unintended consequences that are detrimental for individuals, families and communities. Relevant stakeholders — from parents and students to health professionals, educators, and policy-makers — ought to consider these issues before we forge ahead with a genomically informed education system. (shrink)

Preoperative informed consent is a legal and ethical requirement that ensures patients understand a procedure, its associated risks and benefits, alternative treatment options, and potential complications to make an informed decision about their care. This cross‐sectional study evaluated the informed consent process for major orthopaedic surgeries at a tertiary hospital in Nigeria. A self‐administered questionnaire was used to collect data from 120 adult participants. Results showed that many patients do not read the consent form before signing it, and (...) surgeons do not adequately explain the alternatives to surgery, potential risks, and available anaesthetic options. Higher‐educated patients are more likely to read the consent form. Surgeons performed well in explaining the nature of the condition and prognosis, the procedure's potential benefits, and answering patients' questions. The study emphasises the need to improve the informed consent process to ensure patients understand and can make rational decisions about their healthcare. (shrink)

German legislation demands that decisions about the treatment of mentally incompetent patients require an ‘informed consent’. If this was not given by the patient him-/herself before he/she became incompetent, it has to be sought by the physician from a guardian, who has to be formally legitimized before. Additionally this surrogate has to seek the permission of a Court of Guardianship (Vormundschaftsgericht), if he/she intends to consent to interventions, which pose significant risks to the health or the life of the (...) person under his/her care. This includes ‘end-of-life decisions’. Deviations from this procedure are only allowed in acute emergencies or cases of ‘medical futility’. On the basis of epidemiological and demographical data it can be shown that the vast majority of surrogate decisions on incompetent patients in Germany is not covered by legally valid consent. Moreover, the data suggests that if consent were to be requested according to the legal regulations, both the legal and medical system could realistically never cope with the practical consequences of this. Additionally, empiric research has revealed serious deficits concerning medical ‘end of life-decisions’ and practical performance in palliative care. As a consequence a multidisciplinary discussion has developed in Germany about the reform of present legislation with respect to key-issues like• the assessment of mental competence• the options for exercising patient self-determination via advance directives and durable powers of attorney• the improvement of palliative care facilities,• the clarification of formal procedures for surrogate decision-making in health care and towards the end of life• and the possibilities and their limitations of controlling these decision-making processes ‘externally’ (e.g., by Guardianship Courts or committees).The authors discuss those proposals, which clearly dominate the present debate: They all aim to comply with the scientific basis of German law, jurisdiction and the European traditions of philosophy of health care and bioethics. (shrink)

Deep brain stimulation is a well-established therapy for the motor symptoms of Parkinson’s disease, but there remains an opportunity to improve symptom relief. The temporal pattern of stimulation is a new parameter to consider in DBS therapy, and we compared the effectiveness of Temporally Optimized Patterned Stimulation to standard DBS at reducing the motor symptoms of PD. Twenty-six subjects with DBS for PD received three different patterns of stimulation while on medication and using stimulation parameters optimized for standard DBS. Side (...) effects and motor symptoms were assessed after 30 min of stimulation with each pattern. Subjects experienced similar types of side effects with TOPS and standard DBS, and TOPS were well-tolerated by a majority of the subjects. On average, the most effective TOPS was as effective as standard DBS at reducing the motor symptoms of PD. In some subjects a TOPS pattern was the most effective pattern. Finally, the TOPS pattern with low average frequency was found to be as effective or more effective in about half the subjects while substantially reducing estimated stimulation energy use. TOPS DBS may provide a new programing option to improve DBS therapy for PD by improving symptom reduction and/or increasing energy efficiency. Optimizing stimulation parameters specifically for TOPS DBS may demonstrate further clinical benefit of TOPS DBS in treating the motor symptoms of Parkinson’s disease. (shrink)

Moral enhancement is a topic that has sparked much current interest in the world of bioethics. The possibility of making people ‘better,’ not just in the conventional enhancement sense of improving health and other desirable qualities and capacities, but by making them somehow more moral, more decent, altogether better people, has attracted attention from both advocates 1 2 and sceptics 3 alike. The concept of moral enhancement, however, is fraught with difficult questions, theoretical and practical. What does it actually (...) mean to be ‘more moral’? How would moral enhancement be defined and would it necessarily, as some have claimed, make the world a better or safer place? How would or could such enhancement be achieved safely and without undue constraint on personal liberty and autonomy? On this subject, a recent paper by Crockett et al 4 investigating the effects of the neurotransmitter serotonin on moral decision-making provides an intriguing scientific basis for examining what might or might not constitute moral enhancement. The study involved treatment with citalopram, a drug that increases the action of serotonin in the brain, and subsequent analysis of participants' decision-making behaviour in two different situations involving moral dilemmas: the well-known ‘Trolley Problem’ 5 and the ‘Ultimatum Game’. 6 The researchers found that citalopram promoted what they call ‘prosocial behaviour’, increasing the participants' aversion to causing direct harm to others: in the first scenario, they were less likely to select the option that required killing one in order to save five, and in the second, less likely to reject unfair offers at the expense of others. The Crockett study is fascinating both for its insight into human behaviour and because it appears to demonstrate that, at least on some accounts of moral behaviour, serotonin may in fact be a …. (shrink)