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.

Policies of US Companies Offering Direct-to-Consumer Laboratory Tests.

This qualitative study assesses the practices and policies of companies offering direct-to-consumer laboratory testing in the US.

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.

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.

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.

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.

Brief Report: Financial Incentives and Real-Time Adherence Monitoring to Promote Daily Adherence to HIV Treatment and Viral Suppression Among People Living With HIV: A Pilot Study.

BACKGROUND: Interventions to promote medication adherence and viral suppression are needed among HIV-positive individuals. We aimed to determine the feasibility, acceptability, and preliminary impact of daily financial incentives linked to real-time adherence monitoring among treatment-experienced individuals. METHODS: At an HIV clinic in Philadelphia, we conducted a pilot randomized trial among treatment-experienced HIV-positive adults with unsuppressed viral loads (>400 copies/mL). Participants randomized to the intervention group were eligible for daily lottery-based financial rewards dependent on antiretroviral therapy (ART) adherence, measured by a wireless-enabled electronic pill bottle. Participants also received a financial incentive for achieving viral suppression at 3 months. The control group received the standard of care. We measured acceptance and feasibility through follow-up survey at 3 months, viral suppression at 3 months, and adherence. RESULTS: Among 29 participants, 28 (93%) completed 3-month follow-up, and 24 (83%) completed a 3-month laboratory visit. Electronic pill bottles were highly acceptable to participants, with most strongly agreeing that they worked well, were reliable, and easy to use. Among those who received the intervention, 77% were very satisfied with their experience. Among those who completed the 3-month laboratory visit, viral suppression was achieved by 40% in the intervention group and 29% in the control group. ART adherence ≥80% was achieved by 36% and 25% in the intervention and control groups, respectively. CONCLUSIONS: Daily financial incentives coupled with real-time adherence monitoring are a promising strategy to support ART adherence among HIV-positive individuals who are not virally suppressed. This novel approach warrants testing in a larger trial.

Direct-to-consumer orthodontics: surveying the user experience.

BACKGROUND: The rise of direct-to-consumer (DTC) orthodontics has caused significant controversy among dentists and orthodontists. However, little is known about the actual harms or benefits experienced by users of at-home teeth aligners. METHODS: The authors designed a 24-item online survey to assess users' experiences with at-home aligners. The authors recruited users for 6 months (March-August 2019) on social media platforms (Instagram, Twitter) and online forums related to DTC orthodontics. A total of 470 responses were analyzed. RESULTS: The typical respondent was a white, female millennial (23-38 years old in 2019) who purchased aligners to correct crowding. More than one-half of respondents consulted with a dentist before purchasing aligners. In those interactions, the dentist most often recommended an in-office treatment. Although most respondents (87.5%) were satisfied with DTC treatment, 6.6% had to visit their dentist due to the severity of adverse effects. CONCLUSIONS: Although many respondents would have preferred traditional treatment from a dentist or orthodontist, they opted for DTC aligners because of cost and convenience. PRACTICAL IMPLICATIONS: Rather than warning patients wholesale against at-home aligners, it might be more productive for dentists to have frank discussions with them about the risks and benefits. In parallel to pushing for increased accountability, it might be prudent to consider new ways of coexisting in this altered landscape, such as offering professional oversight of DTC treatments.

Pregnancy and health in the age of the Internet: A content analysis of online "birth club" forums.

BACKGROUND: Although studies report that more than 90% of pregnant women utilize digital sources to supplement their maternal healthcare, little is known about the kinds of information that women seek from their peers during pregnancy. To date, most research has used self-report measures to elucidate how and why women to turn to digital sources during pregnancy. However, given that these measures may differ from actual utilization of online health information, it is important to analyze the online content pregnant women generate. OBJECTIVE: To apply machine learning methods to analyze online pregnancy forums, to better understand how women seek information from a community of online peers during pregnancy. METHODS: Data from seven WhatToExpect.com "birth club" forums (September 2018; January-June 2018) were scraped. Forum posts were collected for a one-year period, which included three trimesters and three months postpartum. Only initial posts from each thread were analyzed (n = 262,238). Automatic natural language processing (NLP) methods captured 50 discussed topics, which were annotated by two independent coders and grouped categorically. RESULTS: The largest topic categories were maternal health (45%), baby-related topics (29%), and people/relationships (10%). While pain was a popular topic all throughout pregnancy, individual topics that were dominant by trimester included miscarriage (first trimester), labor (third trimester), and baby sleeping routine (postpartum period). CONCLUSION: More than just emotional or peer support, pregnant women turn to online forums to discuss their health. Dominant topics, such as labor and miscarriage, suggest unmet informational needs in these domains. With misinformation becoming a growing public health concern, more attention must be directed toward peer-exchange outlets.

Neuroenhancement for sale: assessing the website claims of neurofeedback providers in the United States.

Although electroencephalographic (EEG) neurofeedback is a technique that has been in existence for many decades, it has remained controversial, largely due to questions about efficacy. Yet neurofeedback is being widely offered to the public, often at great expense. To date, however, there has not been empirical data on which providers are utilizing neurofeedback, what they are offering it for, and how they are advertising the technique. The present study aimed to fill that gap by systematically analyzing the websites of neurofeedback practitioners in the United States. To that end, we obtained data from four directories of neurofeedback providers, extracting practitioner names, geographical locations, professional training, and website URLs. Only websites offering neurofeedback services (N=371) were included in the next step, wherein two coders independently coded the websites based on a codebook developed from preliminary analyses. We found that nearly all websites (97.0%) contained claims about at least one clinical indication, most commonly anxiety, ADHD/ADD, and depression; however, only 36.0% of providers had either a medical degree (MD) or a doctoral-level degree in psychology. The majority of websites advertised neurofeedback for cognitive (90.0%) or performance (67.9%) enhancement, and roughly three-quarters utilized language related to complementary and alternative medicine (CAM). In sum, there is a considerable divergence between the scientific literature on neurofeedback and the marketing of neurofeedback services to the general public, raising concerns regarding the misrepresentation of services and misleading advertising claims.

Medical Student Exposure to Integrated Behavioral Health.

OBJECTIVE: Integrated behavioral health (IBH) allows for effective care delivery for patients with mental health and behavioral health disorders in primary care settings. This study assesses the state of exposure current medical students have to the IBH model in family medicine clerkships, in order to augment the readiness of students to participate in IBH as developing professionals. METHODS: Clerkship directors at US and Canadian medical schools with a required family medicine run course (n = 141) were asked to estimate the percentage of students exposed to IBH in their clerkships, as part of the Council of Academic Family Medicine Educational Research Alliance (CERA) 2016 survey. RESULTS: The response rate was 86% (n = 118). Forty-four percent of clerkship directors reported that 0-20% of students are exposed to the IBH model in their clerkships. A comparison of schools with low and high exposure showed no significant differences among clerkship characteristics. CONCLUSIONS: A majority of medical students in the USA and Canada are not exposed to IBH models during their primary care clerkship. Larger systematic studies are needed to elucidate the steps necessary to prepare graduating medical students to collaborate in IBH models.

Discovery of 6-phenylpyrimido[4,5-b][1,4]oxazines as potent and selective acyl CoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitors with in vivo efficacy in rodents.

The discovery and optimization of a series of acyl CoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitors based on a pyrimido[4,5-b][1,4]oxazine scaffold is described. The SAR of a moderately potent HTS hit was investigated resulting in the discovery of phenylcyclohexylacetic acid 1, which displayed good DGAT1 inhibitory activity, selectivity, and PK properties. During preclinical toxicity studies a metabolite of 1 was observed that was responsible for elevating the levels of liver enzymes ALT and AST. Subsequently, analogues were synthesized to preclude the formation of the toxic metabolite. This effort resulted in the discovery of spiroindane 42, which displayed significantly improved DGAT1 inhibition compared to 1. Spiroindane 42 was well tolerated in rodents in vivo, demonstrated efficacy in an oral triglyceride uptake study in mice, and had an acceptable safety profile in preclinical toxicity studies.

Synthesis and optimization of arylsulfonylpiperazines as a novel class of inhibitors of 11 beta-hydroxysteroid dehydrogenase type 1 (11 beta-HSD1).

The synthesis and SAR of a series of arylsulfonylpiperazine inhibitors of 11beta-HSD1 are described. Optimization rapidly led to potent, selective, and orally bioavailable inhibitors demonstrating efficacy in a cynomolgus monkey ex vivo enzyme inhibition model.

Discovery of novel, potent benzamide inhibitors of 11beta-hydroxysteroid dehydrogenase type 1 (11beta-HSD1) exhibiting oral activity in an enzyme inhibition ex vivo model.

We report the discovery of potent benzamide inhibitors of 11beta-hydroxysteroid dehydrogenase (11beta-HSD1). The optimization and correlation of in vitro and in vivo metabolic stability will be described. Through modifications to our initial lead 2, we discovered pyridyl compound 13. This compound has a favorable pharmacokinetic profile across three species and showed a dose-dependent decrease in adipose 11beta-HSD1 activity in a monkey ex vivo pharmacodynamic model.