Use of At-Home Medical Tests Among Older US Adults: A Nationally Representative Survey.

The availability of direct-to-consumer, at-home medical tests has grown over the last decade, but it is unknown how frequently older adults purchase at-home tests, how they perceive such tests, and how interested they are in using at-home tests in the future. We conducted a cross-sectional, nationally representative survey of non-institutionalized US adults aged 50 to 80 about their previous use of, perceptions of, and future intentions to use at-home medical tests. We found that nearly half of older adults (48.

Discordant Care and Decision Quality: Patients' Reasons for Not Receiving Their Initial Test of Choice in Colorectal Cancer Screening.

Background: Concordance between a person's values and the test or treatment they ultimately receive is widely considered to be an essential outcome for good decision quality. There is little research, however, on why patients receive "discordant" care. A large, randomized trial of decision aids for colorectal cancer (CRC) screening provided an opportunity to assess why some patients received a different test than the one they preferred at an earlier time point.

Returning Clinically Relevant Research Results to Participants: Guidelines for Investigators and the IRB.

In 2019, the revised Common Rule required informed consent documents for research to include a statement about whether clinically relevant research results would be returned to research participants. While there are national discussions regarding the return of results, these do not provide specific guidance about how institutional review boards (IRBs) should address this issue. Through a year-long process involving IRB staff and leadership, science and bioethics faculty members, community IRB members, and others, Indiana University's human research protection program created a framework that offers a clear categorization of types of results for researchers to consider returning, provides language for informed consent documents, and describes an active but intentionally limited role for the IRB.

Measuring the Impact of Quantitative Information on Patient Understanding: Approaches for Assessing the Adequacy of Patient Knowledge about Colorectal Cancer Screening.

Unlabelled: Guidelines recommend that decision aids disclose quantitative information to patients considering colorectal cancer (CRC) screening, but the impact on patient knowledge and decision making is limited. An important challenge for assessing any disclosure involves determining when an individual has "adequate knowledge" to make a decision. We analyzed data from a trial that randomized 213 patients to view a decision aid about CRC screening that contained verbal information (qualitative arm) versus one containing verbal plus quantitative information (quantitative arm).

Privacy Risks in Microbiome Research: Public Perspectives before and during a Global Pandemic.

We assessed public perspectives of microbiome research privacy risks before and after a nationwide emergency was declared in the United States regarding the Covid-19 pandemic. From January to July of 2020, we conducted an online survey of perceived privacy risks of microbiome research among U.S.

Biobank Participants' Attitudes toward Requiring Understanding for Biobank Consent.

Biobank participants often do not understand the information they are provided during the informed consent process. Ethicists and other stakeholders have disagreed, however, on the appropriate response to these failures in understanding. This paper describes an attempt to address this issue by conducting knowledge tests with 22 recent biobank enrollees, followed by in-depth, semistructured interviews about the goal of understanding in biobank consent.

Biobank Participants' Attitudes Toward Data Sharing and Privacy: The Role of Trust in Reducing Perceived Risks.

Biobank participants are often unaware of possible uses of their genetic and health information, despite explicit descriptions of those uses in consent forms. To explore why this misunderstanding persists, we conducted semi-structured interviews and knowledge tests with 22 participants who had recently enrolled in a research biobank. Results indicated that participants lacked understanding of privacy and data-sharing topics but were mostly unconcerned about associated risks.

Hybrid theories, psychological plausibility, and the human/animal divide.

A hybrid theory is any moral theory according to which different classes of individuals ought to be treated according to different principles. We argue that some hybrid theories are able to meet standards of psychological plausibility, by which we mean that it's feasible for ordinary human beings to understand and act in accord with them. Insofar as psychological plausibility is a theoretical virtue, then, such hybrid theories deserve more serious consideration.

Collecting Biospecimens and Obtaining Biobank Consent From Patients in an Academic Health Care Setting: Practical and Ethical Considerations.

Academic health centers and health systems increasingly ask patients to enroll in research biobanks as part of standard care, raising important practical and ethical questions for integrating biobank consent processes into health care settings. This article aims to assist academic health centers and health systems considering implementing these integrated consent processes by outlining the 5 main issues-and the key practical and ethical considerations for each issue-that Indiana University Health and the Indiana Biobank faced when integrating biobank consent into their health system, as well as the key obstacles encountered. The 5 main issues to consider include the specimen to collect (leftover, new collection, or add-ons to clinical tests), whether to use opt-in or opt-out consent, where to approach patients, how to effectively use digital tools for consent, and how to appropriately simplify consent information.

Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues.

Research biobanks that enroll minors face important practical, ethical, and regulatory challenges in reconsenting participants when they reach the age of 18. Federal regulations governing research in the United States provide minimal guidance and allow for a range of practices, including waiving the requirement to obtain reconsent. Some commentators have argued that institutional review boards should indeed grant such waivers, given the low risks of biobank-based research and the impracticality of contacting all participants when they turn 18.

Layperson Views about the Design and Evaluation of Decision Aids: A Public Deliberation.

Purpose: We carried out the first public deliberation to elicit lay input regarding guidelines for the design and evaluation of decision aids, focusing on the example of colorectal ("colon") cancer screening.

Methods: A random, demographically stratified sample of 28 laypeople convened for 4 days, during which they were informed about key issues regarding colon cancer, screening tests, risk communication, and decision aids. Participants then deliberated in small and large group sessions about the following: 1) What information should be included in all decision aids for colon screening? 2) What risk information should be in a decision aid and how should risk information be presented? 3) What makes a screening decision a good one (reasonable or legitimate)? 4) What makes a decision aid and the advice it provides trustworthy? With the help of a trained facilitator, the deliberants formulated recommendations, and a vote was held on each to identify support and alternative views.

Conflicting roles for humans in learning health systems and AI-enabled healthcare.

The goals of learning health systems (LHS) and of AI in medicine overlap in many respects. Both require significant improvements in data sharing and IT infrastructure, aim to provide more personalized care for patients, and strive to break down traditional barriers between research and care. However, the defining features of LHS and AI diverge when it comes to the people involved in medicine, both patients and providers.

Expanded FDA regulation of health and wellness apps.

This paper argues that the Food and Drug Administration's (FDA) policy for health and wellness apps is ethically problematic. Currently, the FDA does not regulate health and wellness apps that are not intended for medical use. As a result of this hands-off policy, preventing harm to consumers is left primarily to developers and app marketplaces.

International Travel for Living Donor Kidney Donation: A Proposal for Focused Screening of Vulnerable Groups.

As the gap between organ donors and patients on the recipient waiting list grows, residents of the United States who are in need of kidney transplantation occasionally contract with living donors from outside the United States. Those donors then travel to the United States to undergo living donor kidney donation at US transplant centers. This practice is not limited to the United States and occurs with some regularity around the world.

Anticipatory Waivers of Consent for Pediatric Biobanking.

As pediatric biobank research grows, additional guidance will be needed about whether researchers should always obtain consent from participants when they reach the legal age of majority. Biobanks struggle with a range of practical and ethical issues related to this question. We propose a framework for the use of anticipatory waivers of consent that is empirically rooted in research that shows that children and adolescents are often developmentally capable of meaningful deliberation about the risks and benefits of participation in research.

Impact of including quantitative information in a decision aid for colorectal cancer screening: A randomized controlled trial.

Objective: Guidelines recommend that decision aids provide quantitative information about risks and benefits of available options. Impact of providing this information is unknown.

Methods: Randomized trial comparing two decision aids about colorectal cancer (CRC) screening with colonoscopy or fecal immunochemical test (FIT).

How illuminates four themes of the Adolescent End of Life Narrative.

Adolescents who face life-limiting illness have unique developmental features and strong personal preferences around end of life (EOL) care. Understanding and documenting those preferences can be enhanced by practising narrative medicine. This paper aims to identify a new form of narrative, the Adolescent End of Life Narrative, and recognise four central themes.

Decreased body mass index in the preclinical stage of autosomal dominant Alzheimer's disease.

The relationship between body-mass index (BMI) and Alzheimer´s disease (AD) has been extensively investigated. However, BMI alterations in preclinical individuals with autosomal dominant AD (ADAD) have not yet been investigated. We analyzed cross-sectional data from 230 asymptomatic members of families with ADAD participating in the Dominantly Inherited Alzheimer Network (DIAN) study including 120 preclinical mutation carriers (MCs) and 110 asymptomatic non-carriers (NCs).

Providing Quantitative Information and a Nudge to Undergo Stool Testing in a Colorectal Cancer Screening Decision Aid: A Randomized Clinical Trial.

Background: Guidelines recommend that patient decision aids should provide quantitative information about probabilities of potential outcomes, but the impact of this information is unknown. Behavioral economics suggests that patients confused by quantitative information could benefit from a "nudge" towards one option. We conducted a pilot randomized trial to estimate the effect sizes of presenting quantitative information and a nudge.