Pregnant at the start of the pandemic: a content analysis of COVID-19-related posts on online pregnancy discussion boards.

BACKGROUND: A growing body of evidence indicates that the COVID-19 pandemic has had detrimental mental health effects for pregnant women. However, little is known about the specific stressors that increased anxiety for pregnant women at the start of the pandemic. The present study aimed to better understand the concerns of pregnant women during the beginning COVID-19 pandemic by analyzing content posted during the month of March 2020 on online pregnancy message boards hosted on WhatToExpect.com. METHODS: All posts published between March 1-31, 2020 on nine different due-date specific WhatToExpect.com message boards were reviewed for COVID-19 relevance. Posts mentioning COVID-19 or its direct effects (e.g., "quarantine" or "stay-at-home order") were included in our final sample. Data were coded by three authors according to a codebook developed inductively by all four authors. Posts were analyzed by overall frequency of appearance, by trimester, and temporally across the month of March 2020. RESULTS: Across the 5,541 posts included in our final sample, the most common topics were fear of COVID-19 exposure, concerns with labor and delivery, navigating social interactions, and disruptions to prenatal care. The most dominant topics by trimester were disruptions to prenatal care (first trimester), fear of COVID-19 exposure (second trimester), and concerns about labor and delivery (third trimester). CONCLUSION: Our findings add to prior literature by demonstrating the salience of social concerns, which was the third largest COVID-19 topic in our sample. Emotional distress was most salient with regard to restrictions on birthing partners, but was apparent in everything from disruptions to pregnancy announcements, to cancelled baby showers, and limitations on newborn visitors. Given that anxiety during pregnancy is associated with worse maternal-fetal health outcomes, in the early stages of future pandemics healthcare providers should focus not only on strictly health-related concerns expressed by pregnant women, but also more broadly on other sources of anxiety that may be impacting the well-being and mental health of their patients.

Neurofeedback as placebo: a case of unintentional deception?

The use of placebo in clinical practice has been the topic of extensive debate in the bioethics literature, with much scholarship focusing on concerns regarding deception. While considerations of placebo without deception have largely centred on open-label placebo, this paper considers a different kind of ethical quandary regarding placebo without an intent to deceive-one where the provider believes a treatment is effective due to a direct physiological mechanism, even though that belief may not be supported by rigorous scientific evidence. This is often the case with complementary and alternative medicine (CAM) techniques and also with some mainstream therapies that have not proven to be better than sham. Using one such CAM technique as a case study-electroencephalography (EEG) neurofeedback for attention-deficit/hyperactivity disorder (ADHD)-this paper explores the ethics of providing therapies that may have some beneficial effect, although one that is likely due to placebo effect. First, we provide background on EEG neurofeedback for ADHD and its evidence base, showing how it has proven to be equivalent to-but not better than-sham neurofeedback. Subsequently, we explore whether offering therapies that are claimed to work via specific physical pathways, but may actually work due to the placebo effect, constitute deception. We suggest that this practice may constitute unintentional deception regarding mechanism of action. Ultimately, we argue that providers have increased information provision obligations when offering treatments that diverge from standard of care and we make recommendations for mitigating unintentional deception.

Trading Vulnerabilities: Living with Parkinson's Disease before and after Deep Brain Stimulation.

Implanted medical devices-for example, cardiac defibrillators, deep brain stimulators, and insulin pumps-offer users the possibility of regaining some control over an increasingly unruly body, the opportunity to become part "cyborg" in service of addressing pressing health needs. We recognize the value and effectiveness of such devices, but call attention to what may be less clear to potential users-that their vulnerabilities may not entirely disappear but instead shift. We explore the kinds of shifting vulnerabilities experienced by people with Parkinson's disease (PD) who receive therapeutic deep brain stimulators to help control their tremors and other symptoms of PD.

Understanding the Scope of Do-It-Yourself Fecal Microbiota Transplant.

OBJECTIVES: Fecal microbiota transplantation (FMT) has emerged as an effective treatment option for Clostridioides difficile infection (CDI) and is considered an investigational therapy for a number of other diseases. Social media has facilitated widespread exposure of the public to the gut microbiome and FMT, ultimately acting as a catalyst for the Do-It-Yourself (DIY)-FMT movement. The aims of this study were to identify factors that influenced willingness to pursue DIY-FMT including common indications, screening processes, sample preparation, and self-reported efficacy and safety outcomes. METHODS: A twenty-five-point cross-sectional survey was posted online through the websites and social media pages of the Peggy Lillis Foundation, The Fecal Transplant Foundation, and The Power of Poop. Responses were cataloged through the Research Electronic Data Capture tool, and descriptive analyses were performed. RESULTS: Eighty-four respondents completed the survey between January 2018 and February 2019. The majority were female (71%) and white (92%). Most (80%) reported performing FMT on themselves; 87% used Internet resources to assist in the process, and 92% knew their stool donor. Inflammatory bowel disease (35%) and irritable bowel syndrome (29%) were the 2 most common conditions that respondents attempted to treat. Only 12% reported adverse events, whereas 82% reported improvement in their condition. DISCUSSION: DIY-FMT is being used for many indications, including those for which there is little evidence. There was a high self-reported success rate among respondents with few adverse events. There is a need for increased awareness around DIY-FMT and research around this phenomenon, which may impact public health.

My Digital Refuge.

In this narrative medicine essay, a medical ethicist discusses the complexity of juggling the interests of members in online forums dedicated to rare diseases after being blocked upon disclosing her affiliation with a medical school, thus barring her from the support and information she needed to manage her daughter's rare disease.

The Medical Battery in The United States (1870-1920): Electrotherapy at Home and in the Clinic.

This paper focuses on the history of a portable shock-producing electrotherapeutic device known as the medical battery (1870-1920), which provided both direct and alternating current and was thought to cure a wide variety of ailments. The product occupied a unique space at the nexus of medicine, consumerism and quackery: it was simultaneously considered a legitimate device by medical professionals who practiced electrotherapeutics, yet identical versions were sold directly to consumers, often via newspaper advertisements and with cure-all marketing language. Indeed, as I show in this paper, the line between what was considered a medical device and a consumer product was often blurred. Even though medical textbooks and journals never mentioned (much less promoted) the home use of electricity, every reputable electrotherapy instrument manufacturer sold a "family battery" for patients to use on themselves at home. While a handful of physicians spoke out against the use of electricity by the laity-as they felt it undermined the image of electrotherapy as a skilled medical procedure-existing evidence suggests that many physicians were likely recommending the home use of medical electricity to their patients. Taken together, this paper shows how the professional ideals of electrotherapeutics were not always aligned with physicians' actual practices.

The practices of do-it-yourself brain stimulation: implications for ethical considerations and regulatory proposals.

Scientists and neuroethicists have recently drawn attention to the ethical and regulatory issues surrounding the do-it-yourself (DIY) brain stimulation community, which comprises individuals stimulating their own brains with transcranial direct current stimulation (tDCS) for self-improvement. However, to date, existing regulatory proposals and ethical discussions have been put forth without engaging those involved in the DIY tDCS community or attempting to understand the nature of their practices. I argue that to better contend with the growing ethical and safety concerns surrounding DIY tDCS, we need to understand the practices of the community. This study presents the results of a preliminary inquiry into the DIY tDCS community, with a focus on knowledge that is formed, shared and appropriated within it. I show that when making or acquiring a device, DIYers (as some members call themselves) produce a body of knowledge that is completely separate from that of the scientific community, and share it via online forums, blogs, videos and personal communications. However, when applying tDCS, DIYers draw heavily on existing scientific knowledge, posting links to academic journal articles and scientific resources and adopting the standardised electrode placement system used by scientists. Some DIYers co-opt scientific knowledge and modify it by creating their own manuals and guides based on published papers. Finally, I explore how DIYers cope with the methodological limitations inherent in self-experimentation. I conclude by discussing how a deeper understanding of the practices of DIY tDCS has important regulatory and ethical implications.

Ethical issues in direct-to-consumer healthcare: A scoping review.

An increasing number of health products and services are being offered on a direct-to-consumer (DTC) basis. To date, however, scholarship on DTC healthcare products and services has largely proceeded in a domain-specific fashion, with discussions of relevant ethical challenges occurring within specific medical specialties. The present study therefore aimed to provide a scoping review of ethical issues raised in the academic literature across types of DTC healthcare products and services. A systematic search for relevant publications between 2011-2021 was conducted on PubMed and Google Scholar using iteratively developed search terms. The final sample included 86 publications that discussed ethical issues related to DTC healthcare products and services. All publications were coded for ethical issues mentioned, primary DTC product or service discussed, type of study, year of publication, and geographical context. We found that the types of DTC healthcare products and services mentioned in our sample spanned six categories: neurotechnology (34%), testing (20%), in-person services (17%), digital health tools (14%), telemedicine (13%), and physical interventions (2%). Ethical arguments in favor of DTC healthcare included improved access (e.g., financial, geographical; 31%), increased autonomy (29%), and enhanced convenience (16%). Commonly raised ethical concerns included insufficient regulation (72%), questionable efficacy and quality (70%), safety and physical harms (66%), misleading advertising claims (56%), and privacy (34%). Other frequently occurring ethical concerns pertained to financial costs, targeting vulnerable groups, informed consent, and potential burdens on healthcare providers, the healthcare system, and society. Our findings offer insights into the cross-cutting ethical issues associated with DTC healthcare and underscore the need for increased interdisciplinary communication to address the challenges they raise.

Alzheimer's in the modern age: Ethical challenges in the use of digital monitoring to identify cognitive changes.

Pushes toward earlier detection of Alzheimer's disease (AD)-related cognitive changes are creating interest in leveraging technologies, like cellphones, that are already widespread and well-equipped for data collection to facilitate digital monitoring for AD. Studies are ongoing to identify and validate potential "digital biomarkers" that might indicate someone has or is at risk of developing AD dementia. Digital biomarkers for AD have potential as a tool in aiding more timely diagnosis, though more robust research is needed to support their validity and utility. While there are grounds for optimism, leveraging digital monitoring and informatics for cognitive changes also poses ethical challenges, related to topics such as algorithmic bias, consent, and data privacy and security. As we confront the modern era of Alzheimer's disease, individuals, companies, regulators and policymakers alike must prepare for a future in which our day-to-day interactions with technology in our daily life may identify AD-related cognitive changes.

To Counsel or Not to Counsel: Physician Attitudes and Experiences with Do-It-Yourself (DIY) Fecal Microbiota Transplant (FMT).

BACKGROUND: In the early 2010s, a phenomenon known as do-it-yourself (DIY) fecal microbiota transplant (FMT) emerged as lay individuals began self-administering FMTs at home. Although prior research indicates that many individuals who perform DIY FMT have sought advice from healthcare providers, to date there has been no investigation of physicians' experiences with DIY FMT. The objective of this qualitative study was to examine the attitudes of physicians who offer FMT regarding the practice of DIY FMT and to assess how they navigated the ethical challenges of patient requests for DIY FMT. METHODS: We recruited physicians listed on two patient-created online databases of FMT providers. All physicians who indicated having been approached for advice about DIY FMT were included in the study. Semi-structured interviews with physicians explored their attitudes toward and experiences with DIY FMT. RESULTS: Of 18 physicians interviewed, one reported having provided counsel in response to an initial patient inquiry about DIY FMT, 2 indicated they explicitly advised against DIY FMT and refused to provide advice, and 15 fell in a middle category of discouraging DIY FMT and discussing reasons why. Among the physicians in this third category, four reported that they had changed their approach to providing counsel in response to a patient telling them they were going to perform DIY FMT anyway. CONCLUSIONS: Physicians in our study employed a wide range of strategies for promoting safety in the DIY FMT context, from explicitly advising against the procedure to the provision of guidance aimed at mitigating potential harms. While there has been increasing attention to the practices of DIY medicine, this study underscores the need for greater attention to the ethically complex situations that physicians face when patients request guidance for unapproved at-home treatments.

Post-trial access to implantable neural devices: an exploratory international survey.

Objectives: Clinical trials of innovative neural implants are rapidly increasing and diversifying, but little is known about participants' post-trial access to the device and ongoing clinical care. This exploratory study examines common practices in the planning and coordination of post-trial access to neurosurgical devices. We also explore the perspectives of trial investigators on the barriers to post-trial access and ongoing care, as well as ethical questions related to the responsibilities of key stakeholder groups. Design setting and participants: Trial investigators (n=66) completed a survey on post-trial access in the most recent investigational trial of a surgically implanted neural device they had conducted. Survey respondents predominantly specialized in neurosurgery, neurology and psychiatry, with a mean of 14.8 years of experience working with implantable neural devices. Main outcome measures: Outcomes of interest included rates of device explantation during or at the conclusion of the trial (pre-follow-up) and whether plans for post-trial access were described in the study protocol. Outcomes also included investigators' greatest 'barrier' and 'facilitator' to providing research participants with post-trial access to functional implants and perspectives on current arrangements for the sharing of post-trial responsibilities among key stakeholders. Results: Trial investigators reported either 'all' (64%) or 'most' (33%) trial participants had remained implanted after the end of the trial, with 'infection' and 'non-response' the most common reasons for explantation. When asked to describe the main barriers to facilitating post-trial access, investigators described limited funding, scarcity of expertise and specialist clinical infrastructure and difficulties maintaining stakeholder relationships. Notwithstanding these barriers, investigators overwhelmingly (95%) agreed there is an ethical obligation to provide post-trial access when participants individually benefit during the trial. Conclusions: On occasions when devices were explanted during or at the end of the trial, this was done out of concern for the safety and well-being of participants. Further research into common practices in the post-trial phase is needed and essential to ethical and pragmatic discussions regarding stakeholder responsibilities.

Neuromodulation for the treatment of Prader-Willi syndrome - A systematic review.

Prader-Willi syndrome (PWS) is a complex, genetic disorder characterized by multisystem involvement, including hyperphagia, maladaptive behaviors and endocrinological derangements. Recent developments in advanced neuroimaging have led to a growing understanding of PWS as a neural circuit disorder, as well as subsequent interests in the application of neuromodulatory therapies. Various non-invasive and invasive device-based neuromodulation methods, including vagus nerve stimulation (VNS), transcranial direct current stimulation (tDCS), repetitive transcranial magnetic stimulation (rTMS), and deep brain stimulation (DBS) have all been reported to be potentially promising treatments for addressing the major symptoms of PWS. In this systematic literature review, we summarize the recent literature that investigated these therapies, discuss the underlying circuits which may underpin symptom manifestations, and cover future directions of the field. Through our comprehensive search, there were a total of 47 patients who had undergone device-based neuromodulation therapy for PWS. Two articles described VNS, 4 tDCS, 1 rTMS and 2 DBS, targeting different symptoms of PWS, including aberrant behavior, hyperphagia and weight. Multi-center and multi-country efforts will be required to advance the field given the low prevalence of PWS. Finally, given the potentially vulnerable population, neuroethical considerations and dialogue should guide the field.

Translational Neuroethics: A Vision for a More Integrated, Inclusive, and Impactful Field.

As early-career neuroethicists, we come to the field of neuroethics at a unique moment: we are well-situated to consider nearly two decades of neuroethics scholarship and identify challenges that have persisted across time. But we are also looking squarely ahead, embarking on the next generation of exciting and productive neuroethics scholarship. In this article, we both reflect backwards and turn our gaze forward. First, we highlight criticisms of neuroethics, both from scholars within the field and outside it, that have focused on speculation and lack of skepticism; the dearth of consideration of broader social issues such as justice and equality, both with regard to who speaks for neuroethics as a field and who benefits from its recommendations and findings; and the insufficient focus on the practical impact of our ethical work. Second, we embrace the concept of "translational neuroethics" to outline a vision for neuroethics that is integrated, inclusive, and impactful. Integration can help us identify more pertinent, real-world issues, and move away from speculation; inclusivity can help ensure that the questions we attend to are not merely relevant to a single subgroup but aim toward just distribution of benefits; and impact can help us think beyond guidelines and recommendations to focus on implementation. Our goal is for this call to action to help shape neuroethics into a discipline that develops rigorous research agendas through relationships with interdisciplinary partners, that is broadly inclusive and attends to issues beyond novel neurotechnologies, and that is devoted to the translation of scholarship into practice.

Navigating biosafety concerns within COVID-19 do-it-yourself (DIY) science: an ethnographic and interview study.

Non-establishment or do-it-yourself (DIY) science involves individuals who may not have formal training conducting experiments outside of institutional settings. While prior scholarship has examined the motivations and values of those involved in the subset of DIY science known as "DIY biology," little research has addressed how these individuals navigate ethical issues in practice. The present study therefore aimed to understand how DIY biologists identify, approach, and resolve one particular ethical issue-biosafety-in their work. We conducted a digital ethnography of Just One Giant Lab (JOGL), the primary hub for DIY biology during the COVID-19 pandemic, and subsequently conducted interviews with individuals involved with JOGL. We found that JOGL was the first global DIY biology initiative to create a Biosafety Advisory Board and develop formal biosafety guidelines that applied to different groups in multiple locations. There was disagreement, however, regarding whether the Board should have an advisory role or provide mandatory oversight. We found that JOGL practiced ethical gatekeeping of projects that fell outside the limits defined by the Board. Our findings show that the DIY biology community recognized biosafety issues and tried to build infrastructure to facilitate the safe conduct of research. Supplementary Information: The online version contains supplementary material available at 10.1057/s41292-023-00301-2.

Mapping the Landscape of Do-it-Yourself Medicine.

The practice of medicine is typically conceptualized as remaining within the boundaries of a hospital or clinic. However, in recent years, patients have been able to gain access to information about medical research as it is ongoing. As a result, there has been a rise in do-it-yourself (DIY) medicine, where individuals treat themselves for medical conditions outside of clinical settings, often mimicking experimental therapies that remain inaccessible to the wider public. For example, in DIY brain stimulation, individuals suffering from depression build at-home electrical headsets using nine-volt batteries, mimicking an experimental neuroscience technique used in scientific laboratories. In DIY fecal transplantation, those with intestinal disorders like C. Difficile and inflammatory bowel disease transplant stool from donors into themselves with the aid of blenders and enemas. In the open Artificial Pancreas System movement, diabetes patients hacked together an artificial pancreas system from their glucose monitors and insulin pumps, years before such a system was approved by the United States Food and Drug Administration (US FDA). To date, scholarship on DIY medicine has largely been relegated to specific medical domains (e.g., neurology, gastroenterology, infectious disease). In this paper, however, I recognize DIY medicine as a cross-cutting phenomenon that has emerged independently across medical domains but shares common features. I map the varieties of DIY medicine across these domains and suggest that four key factors lead to their creation, growth, and uptake. In doing so, this essay sheds light on an understudied area of biomedical citizen science that is likely to grow substantially in the coming decades.

Opportunity Cost or Opportunity Lost: An Empirical Assessment of Ethical Concerns and Attitudes of EEG Neurofeedback Users.

Background: Electroencephalography (EEG) neurofeedback is a type of biofeedback that purportedly teaches users how to control their brainwaves. Although neurofeedback is currently offered by thousands of providers worldwide, its provision is contested, as its effectiveness beyond a placebo effect is unproven. While scholars have voiced numerous ethical concerns about neurofeedback-regarding opportunity cost, physical and psychological harms, financial cost, and informed consent-to date these concerns have remained theoretical. This pilot study aimed to provide insights on whether these issues were supported by empirical data from the experiences of neurofeedback users. Methods: Semi-structured telephone interviews were conducted with individuals who had used EEG neurofeedback for themselves and/or for a child. Results: The majority of respondents (N = 36) were female (75%), white (92%), and of higher socioeconomic status relative to the U.S. population. Among adult users (n = 33), most (78.8%) resorted to neurofeedback after having tried other therapies and were satisfied with treatment (81.8%). The majority paid for neurofeedback out-of-pocket (72.7%) and considered it to be good value for money (84.8%). More than half (57.6%) considered neurofeedback to be a scientifically well-established therapy. However, of those, 78.9%were using neurofeedback for indications not adequately supported by scientific evidence. Conclusion: Concerns regarding opportunity cost, physical and psychological harms, and financial cost are not substantiated by our findings. Our results partially support concerns regarding insufficient understanding of limitations. This study underlines the disconnect between some of the theoretical concerns raised by scholars regarding the use of non-validated therapies and the lived experiences of users.

Ethical Issues in Intraoperative Neuroscience Research: Assessing Subjects' Recall of Informed Consent and Motivations for Participation.

BackgroundAn increasing number of studies utilize intracranial electrophysiology in human subjects to advance basic neuroscience knowledge. However, the use of neurosurgical patients as human research subjects raises important ethical considerations, particularly regarding informed consent and undue influence, as well as subjects' motivations for participation. Yet a thorough empirical examination of these issues in a participant population has been lacking. The present study therefore aimed to empirically investigate ethical concerns regarding informed consent and voluntariness in Parkinson's disease patients undergoing deep brain stimulator (DBS) placement who participated in an intraoperative neuroscience study.MethodsTwo semi-structured 30-minute interviews were conducted preoperatively and postoperatively via telephone. Interviews assessed participants' motivations for participation in the parent intraoperative study, recall of information presented during the informed consent process, and participants' postoperative reflections on the research study.ResultsTwenty-two participants (mean age = 60.9) completed preoperative interviews at a mean of 7.8 days following informed consent and a mean of 5.2 days prior to DBS surgery. Twenty participants completed postoperative interviews at a mean of 5 weeks following surgery. All participants cited altruism or advancing medical science as "very important" or "important" in their decision to participate in the study. Only 22.7% (n = 5) correctly recalled one of the two risks of the study. Correct recall of other aspects of the informed consent was poor (36.4% for study purpose; 50.0% for study protocol; 36.4% for study benefits). All correctly understood that the study would not confer a direct therapeutic benefit to them.ConclusionEven though research coordinators were properly trained and the informed consent was administered according to protocol, participants demonstrated poor retention of study information. While intraoperative studies that aim to advance neuroscience knowledge represent a unique opportunity to gain fundamental scientific knowledge, improved standards for the informed consent process can help facilitate their ethical implementation.