Heightism, growth hormone treatment, and social functioning: a holistic approach to a persistent clinical challenge.

PURPOSE OF REVIEW: Use of recombinant human growth hormone (rhGH) treatment to increase height in children with non-growth hormone deficient short stature is becoming more common. Yet, the evidence to support the notion that augmenting height directly leads to increased well being, specifically psychosocial well being, is inconsistent, with high-quality evidence lacking. RECENT FINDINGS: Review of recent studies demonstrates that the association between height augmentation and psychosocial well being is complex. The direct contribution of height to well being may be less than the current model of clinical care of short stature assumes. Rather, the new studies provide evidence to support a role for psychosocial factors, including height-related beliefs, social support, and coping skills, in promoting psychosocial well being, specifically quality of life and self-esteem. SUMMARY: Clinical care of short stature would benefit from incorporating a holistic model of care that considers psychosocial interventions in addition to, or instead of, rhGH treatment.

The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research.

There is growing interest in using embedded research methods, particularly pragmatic clinical trials, to address well-known evidentiary shortcomings afflicting the health care system. Reviews of pragmatic clinical trials published between 2014 and 2019 found that 8.8% were conducted with waivers of informed consent; furthermore, the number of trials where consent is not obtained is increasing with time. From a regulatory perspective, waivers of informed consent are permissible when certain conditions are met, including that the study involves no more than minimal risk, that it could not practicably be carried out without a waiver, and that waiving consent does not violate participants' rights and welfare. Nevertheless, when research is conducted with a waiver of consent, several ethical challenges arise. We must consider how to: address empirical evidence showing that patients and members of the public generally prefer prospective consent, demonstrate respect for persons using tools other than consent, promote public trust and investigator integrity, and ensure an adequate level of participant protections. In this article, we use examples drawn from real pragmatic clinical trials to argue that prospective consultation with representatives of the target study population can address, or at least mitigate, many of the ethical challenges posed by waivers of informed consent. We also consider what consultation might involve to illustrate its feasibility and address potential objections.

Bioethicists Today: Results of the Views in Bioethics Survey.

Bioethicists influence practices and policies in medicine, science, and public health. However, little is known about bioethicists' views. We recently surveyed 824 U.S. bioethicists on a wide range of ethical issues, including topics related to abortion, medical aid in dying, and resource allocation, among others. We also asked bioethicists about their demographic, religious, academic, and professional backgrounds. We find that bioethicists' normative commitments predict their views on bioethical issues. We also find that, in important ways, bioethicists' views do not align with those of the U.S. public: for instance, bioethicists are more likely than members of the public to think abortion is ethically permissible but are less likely to believe compensating organ donors is. Our demographic results indicate the field of bioethics is far less diverse than the U.S. population-less diverse even than other academic disciplines-suggesting far more work needs to be done to build an inclusive field.

A survey study of Alzheimer's stigma among Black adults: intersectionality of Black identity and biomarker diagnosis.

OBJECTIVE: We urgently need to understand Alzheimer's disease (AD) stigma among Black adults. Black communities bear a disproportionate burden of AD, and recent advances in early diagnosis using AD biomarkers may affect stigma associated with AD. The goal of our study is to characterize AD stigma within our cohort of self-identified Black participants and test how AD biomarker test results may affect this stigma. DESIGN: We surveyed a sample of 1,150 self-identified Black adults who were randomized to read a vignette describing a fictional person, who was described as either having a positive or negative biomarker test result. After reading the vignette, participants completed the modified Family Stigma in Alzheimer's Disease Scale (FS-ADS). We compared FS-ADS scores between groups defined by age, gender, and United States Census region. We examined interactions between these groupings and AD biomarker test result. RESULTS: Participants over age 65 had lower scores (lower stigma) on all 7 FS-ADS domains compared to those under 65: structural discrimination, negative severity attributions, negative aesthetic attributions, antipathy, support, pity, and social distance. In the biomarker positive condition, worries about structural discrimination were greater than in the biomarker negative condition and statistically similar in the two age groups (DOR, 0.39 [95%CI, 0.22-0.69]). This pattern of results was similar for negative symptom attributions (DOR, 0.51 [95%CI, 0.28-0.90]). CONCLUSION: While older adults reported less AD stigma than younger adults, AD biomarker testing caused similarly high concerns about structural discrimination and negative severity attributions. Thus, use of AD biomarker diagnosis may increase AD stigma and exacerbate healthcare disparities known to effect AD diagnosis in some Black adults. Advances in AD diagnosis may interact with social and structural factors to differentially affect groups of Black adults.

How reactions to a brain scan result differ for adults based on self-identified Black and White race.

INTRODUCTION: How do reactions to a brain scan result differ between Black and White adults? The answer may inform efforts to reduce disparities in Alzheimer's disease (AD) diagnosis and treatment. METHODS: Self-identified Black (n = 1055) and White (n = 1451) adults were randomized to a vignette of a fictional patient at a memory center who was told a brain scan result. Measures of stigma and diagnosis confidence were compared between-groups. RESULTS: Black participants reported more stigma than White participants on four of seven domains in reaction to the patient at a memory center visit. Black participants' confidence in an AD diagnosis informed by a brain scan and other assessments was 72.2 points (95% confidence interval [CI] 70.4 to 73.5), which was lower than the respective rating for White participants [78.1 points (95%CI 77.0 to 79.3)]. DISCUSSION: Equitable access to early AD diagnosis will require public outreach and education that address AD stigma associated with a memory center visit.

What is paradoxical lucidity? The answer begins with its definition.

Paradoxical lucidity in dementia is a clinically significant but understudied phenomenon. A provisional definition was proposed by the 2018 National Institute on Aging expert workshop and published in Alzheimer's and Dementia. However, several conceptual features of this definition remain vague, creating barriers to robust clinical research. Here, we critically analyze the provisional definition and present a refined definition that can be applied in clinical research. The refined definition is based on an analytic process our research group recently undertook to operationalize paradoxical lucidity for our own study protocol. Our goal is to facilitate debate and potentially harmonize interpretations of paradoxical lucidity among research groups.

Putting participants and study partners FIRST when clinical trials end early.

Between 2018 and 2019, multiple clinical trials ended earlier than planned, resulting in calls to improve communication with and support for participants and their study partners ("dyads"). The multidisciplinary Participant Follow-Up Improvement in Research Studies and Trials (Participant FIRST) Work Group met throughout 2021. Its goals were to identify best practices for communicating with and supporting dyads affected by early trial stoppage. The Participant FIRST Work Group identified 17 key recommendations spanning the pre-trial, mid-trial, and post-trial periods. These focus on prospectively allocating sufficient resources for orderly closeout; developing dyad-centered communication plans; helping dyads build and maintain support networks; and, if a trial stops, informing dyads rapidly. Participants and study partners invest time, effort, and hope in their research participation. The research community should take intentional steps toward better communicating with and supporting participants when clinical trials end early. The Participant FIRST recommendations are a practical guide for embarking on that journey.

Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in California.

California has focused on health equity in the state's COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California's 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier's test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 residents must meet an equity metric. California's explicit incorporation of health equity into its reopening plan underscores the interrelated fate of its residents during the COVID-19 pandemic and creates incentives for action. This article evaluates the benefits and challenges of this novel health equity focus, and outlines recommendations for other US states to address disparities in their reopening plans.

The Legality and Ethics of Mandating COVID-19 Vaccination.

In light of ongoing concerns in the US that COVID-19 vaccine uptake is stagnating and that cases remain high amongst the unvaccinated, there is growing interest in increasing uptake by mandating vaccination. COVID-19 vaccine mandates must be understood and assessed in terms of who is requiring vaccination and who is required to be vaccinated. This essay considers the legal and ethical implications of states mandating vaccination for children and adults, as well as of employers mandating vaccines for employees. We conclude that COVID-19 vaccine mandates are legally and ethically permissible.

Promoting Ethical Payment in Human Infection Challenge Studies.

To prepare for potential human infection challenge studies (HICS) involving SARS-CoV-2, we convened a multidisciplinary working group to address ethical questions regarding whether and how much SARS-CoV-2 HICS participants should be paid. Because the goals of paying HICS participants, as well as the relevant ethical concerns, are the same as those arising for other types of clinical research, the same basic framework for ethical payment can apply. This framework divides payment into reimbursement, compensation, and incentives, focusing on fairness and promoting adequate recruitment and retention as counterweights to concerns about undue inducement. Within the basic framework, several factors are especially salient for HICS, and for SARS-CoV-2 HICS in particular, including the nature of participant confinement, anticipated discomfort, risks and uncertainty, participant motivations, and trust. These factors are reflected in a payment worksheet created to help sponsors, researchers, and ethics reviewers systematically develop and assess ethically justifiable payment amounts.

Paying Participants in COVID-19 Trials.

Trials are in development and underway to examine potential interventions for treatment and prophylaxis of coronavirus disease 2019 (COVID-19). How should we think about offering payment to participants in these trials? Payment for research participation is ethically contentious even under ideal circumstances. Here, we review 3 functions of research payment-reimbursement, compensation, and incentive-and identify heightened and novel ethical concerns in the context of a global pandemic. We argue that COVID-19 trial participants should usually be offered reimbursement for research-related expenses, and compensation for their time and effort, as for other types of research under usual circumstances. Given increased risk of undue influence against pandemic background conditions, incentive payment should be avoided unless essential to recruitment and retention in important trials whose social value outweighs this risk. Where essential, however, incentives can be ethically permissible, so long as reasonable efforts are made to minimize the possibility of undue influence.

Making the case for completion bonuses in clinical trials.

Attrition is a serious problem in many clinical trials. The practice of offering completion bonuses-financial incentives offered to participants on the condition that they remain in a trial until they reach a prespecified study endpoint-is one means of addressing attrition. Despite their practical appeal, however, completion bonuses remain ethically controversial due to concern that they will coerce or unduly influence participants to not exercise their right to withdraw from a trial. Although this interaction with the right to withdraw does render completion bonuses conceptually distinct from other incentive payments offered to research participants, we argue here that completion bonuses are never coercive and, in the context of effective institutional review board oversight, are unlikely to be unduly influential. Nonetheless, because completion bonuses may in some cases still encourage unreasonable continued participation in a study, additional safeguards are appropriate. Rejecting completion bonuses entirely is, however, unnecessary and would problematically fail to address the significant ethical problems associated with participant attrition.

When Is It Ethical for Physician-Investigators to Seek Consent From Their Own Patients?

Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about "dual-role" consent reflects the view that distinct normative commitments govern physician-patient and investigator-participant relationships, and that blurring the research-care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the physician-investigator; that it can compromise the voluntariness of the patient-participant's consent; and that it promotes therapeutic misconceptions. Although these concerns have merit in some circumstances, they are not dispositive in all cases. Rather, their force-and the ethical acceptability of dual-role consent-varies with features of the particular study. As research participation more closely approximates usual care, it becomes increasingly acceptable, or even preferable, for physicians to seek consent for research from their own patients. It is time for a more nuanced approach to dual-role consent.

Oversight of Patient-Centered Outcomes Research: Recommendations From a Delphi Panel.

A key aim of patient-centered outcomes research (PCOR) is to generate data that are important to patients by deliberately and extensively involving them in all aspects of research, from design to dissemination. However, certain elements of PCOR raise challenging and potentially novel ethical and regulatory issues for institutional review boards and oversight bodies. These challenges stem primarily from the engagement of patients in roles other than research subject, such as advisors, study personnel, and co-investigators, which gives rise to questions about appropriate levels of protection, training, and education, as well as identifying and managing conflicts of interest. This article presents and discusses recommendations from a Delphi expert panel that was convened to address these and other PCOR-related oversight challenges.