Data stewardship in FTLD research: Investigator and research participant views.

INTRODUCTION: Federal policies and guidelines have expanded the return of individual results to participants and expectations for data sharing between investigators and through repositories. Here, we report investigators' and study participants' views and experiences with data stewardship practices within frontotemporal lobal degeneration (FTLD) research, which reveal unique ethical challenges. METHODS: Semi-structured interviews with (1) investigators conducting FTLD research that includes genetic data collection and/or analysis and (2) participants enrolled in a single site longitudinal FTLD study. RESULTS: Analysis of the interviews identified three meta themes: perspectives on data sharing, experiences with enrollment and participation, and data management and security as mechanisms for participant protections. DISCUSSION: This study identified a set of preliminary gaps and needs regarding data stewardship within FTLD research. The results offer initial insights on ethical challenges to data stewardship aimed at informing future guidelines and policies.

Creating an Unprotected Class: Addressing Legal Risks in the Era of Biologically-Defined Alzheimer's Disease.

Background: Documentation of preclinical biomarker tests for Alzheimer's disease (AD) in the medical record may expose patients to employment and insurance discrimination risks. There is a gap in research describing clinicians' approaches to documenting biomarker results. Objective: To evaluate discrimination risks faced by patients undergoing biomarker testing for AD through a qualitative analysis of clinician documentation practices. Methods: Semi-structured interviews using hypothetical patient scenarios. The qualitative analysis focused on interviewees' responses related to documentation and disclosure of results. Results: We collected and analyzed 17 interviews with dementia experts; and identified three approaches to documenting biomarkers as: an association with active AD, noninformative, and an increased susceptibility for AD. Those who associated biomarkers with active disease were more likely to favor disclosure to employers and insurers, which could increase discrimination risks. Conclusions: This study demonstrates the variety of documentation and disclosure practices likely to emerge for preclinical AD biomarker tests and highlights a need for guidelines in this area.

Out-of-Pocket Expenses for Long-Term Care by Dementia Status and Residential Setting among US Older Adults.

OBJECTIVE: To examine long-term care out-of-pocket payments by dementia status and residential setting. DESIGN: Compare monthly out-of-pocket long-term care expenses paid to facilities and helpers, total monthly out-of-pocket long-term expenses and as a percentage of monthly income by dementia status and residential status (community, residential facility, and nursing home). SETTING AND PARTICIPANTS: US Nationwide, 2019 National Health and Aging Trends Study (NHATS) respondents aged ≥70 years. METHODS: We analyzed respondent-level data from the nationally representative 2019 NHATS. Weighted descriptive statistics were calculated for long-term care payments by source and summarized by dementia status and the respondent's residential status. RESULTS: Among 4505 respondents aged ≥70 years, 1750 (38.8%) had possible or probable dementia and 2755 (61.2%) had no dementia. The median monthly out-of-pocket long-term care expenses for persons with dementia was $1465 for those living in nursing homes, and $2925 for those living in other residential facilities, much higher than those with dementia living in the community ($260). Although these are similar to the median out-of-pocket payments for persons without dementia by setting, those with dementia were at greater risk of facing catastrophic out-of-pocket expenses for long-term care than those without dementia, with the 75th percentile value of out-of-pocket payment at $4566 among dementia adults living in non-nursing home residential care facilities, and $7500 for those in nursing homes, compared to $3694 and $3100 among those without dementia. At median, these expenses accounted for 100% of monthly income of respondents with dementia living in facilities. CONCLUSIONS AND IMPLICATIONS: Persons with dementia living in facilities often face substantial financial burdens from high out-of-pocket long-term care expenses. Policies that provide sufficient financial assistance are needed to address long-term care-related financial burdens experienced by older adults and their families, especially for those with dementia.

Crime, Incarceration, and Dementia: An Aging Criminal System.

Dementia within the criminal system, from arrest through incarceration, has been largely ignored. While the health system has begun grappling with the chronic conditions that will accompany an aging society, the criminal system has yet to meaningfully respond. Dementia is a clinical syndrome characterized by impairment in cognitive domains (memory, executive function, visuospatial). Additionally, dementia often includes behavioral symptoms that increase the likelihood that an individual's actions may violate social norms and in some circumstances be deemed criminal. Prior studies have established criminal behavior as a trend among individuals living with dementia. Yet, the criminal system has yet to establish protections for individuals who commit a crime while impaired by dementia. This paper will report on an empirical study to evaluate the treatment of persons with dementia within the criminal justice system. We will report on interviews with attorneys (n=15) regarding their experience and perspective on the treatment of persons with dementia post-arrest. In the paper, we will explore topics identified through these interviews including pre-trial release, competency, placement (housing), criminal liability determination, sentencing, and post-conviction release. We will highlight key findings including the lack of a systematic screening process for dementia post-arrest, placement is a significant challenge, attorneys' lack of training on dementia to be able to understand how the disease could impact decision-making, and the two legal mechanisms available to divert miss the mark given their focus on psychiatric populations. We will use these data and findings to argue for a research and policy agenda to address a gap in legal policies to appropriately manage persons with dementia post-arrest.

Geriatricians' Perspectives on the Multiple Dimensions of Utility of Genetic Testing for Alzheimer's Disease: A Qualitative Study.

BACKGROUND: Research advancements in Alzheimer's disease (AD) raise opportunities for genetic testing to improve diagnostic and risk assessment. Despite emerging developments, it is unclear how geriatricians perceive the potential clinical and personal utility of genetic testing for their patients. Geriatricians' perspectives are essential to understanding potential ethical, policy, and clinical challenges. OBJECTIVE: In this paper, we report on geriatricians' perspectives on the utility of genetic testing for AD. METHODS: Semi-structured interviews with California geriatricians within different practices settings to collect and characterize their perspectives on genetic testing for AD. We used an adapted grounded theory approach to analyze recorded and transcribed interviews. RESULTS: We identified geriatricians' (n = 10) perspectives on the clinical and personal utility of testing, alongside their views on clinical care approaches for older adults. Geriatricians perceived minimal clinical utility of genetic testing for AD, though that may change with the availability of disease-modifying therapies. Yet, they recognized the potential personal utility of testing (e.g., assisting with future financial planning). Finally, geriatricians expressed concerns regarding patients' anxiety from learning about genetic status, particularly through direct-to-consumer (DTC) testing. CONCLUSION: Our data highlight that the decision to order genetic testing requires clinical and ethical considerations, including balancing limited clinical utility with the potential personal utility. Although DTC testing is available, geriatricians perceive that they have an important role in managing the decision to test and interpreting the results. Further research is needed to inform policy and ethical guidelines to support geriatricians' critical role to counsel patients considering clinical and DTC genetic testing.

Private payer coverage policies for ApoE-e4 genetic testing.

PURPOSE: ApoE-e4 has a well-established connection to late-onset Alzheimer disease (AD) and is available clinically. Yet, there have been no analyses of payer coverage policies for ApoE. Our objective was to analyze private payer coverage policies for ApoE genetic testing, examine the rationales, and describe supporting evidence referenced by policies. METHODS: We searched for policies from the eight largest private payers (by member numbers) covering ApoE testing for late-onset AD. We implemented content analysis methods to evaluate policies for coverage decisions and rationales. RESULTS: Seven payers had policies with positions on ApoE testing. Five explicitly state they do not cover ApoE and two apply generic preauthorization criteria. Rationales supporting coverage decisions include: reference to guidelines or national standards, inadequate data supporting testing, characterizing testing as investigational, or that testing would not alter patients' clinical management. CONCLUSION: Seven of the eight largest private payers' coverage policies reflect standards that discourage ApoE testing due to a lack of clinical utility. As the field advances, ApoE testing may have an important clinical role, particularly considering that disease-modifying therapies are under evaluation by the US Food and Drug Administration. These types of field advancements may not be consistent with private payers' policies and may cause payers to reevaluate existing coverage policies.

The Proactive Patient: Long-Term Care Insurance Discrimination Risks of Alzheimer's Disease Biomarkers.

Previously diagnosed by symptoms alone, Alzheimer's disease is now also defined by measures of amyloid and tau, referred to as "biomarkers." Biomarkers are detectible up to twenty years before symptoms present and open the door to predicting the risk of Alzheimer's disease. While these biomarkers provide information that can help individuals and families plan for long-term care services and supports, insurers could also use this information to discriminate against those who are more likely to need such services. In this article, we evaluate whether state laws prohibit long-term care insurers from making discriminatory or unfair underwriting and coverage decisions based Alzheimer's disease biomarkers status. We report data demonstrating that current state laws do not provide meaningful protections from discrimination by long-term care insurers based on biomarker information.

Authorship policies of scientific journals.

We analysed the authorship policies of a random sample of 600 journals from the Journal Citation Reports database. 62.5% of the journals we sampled had an authorship policy. Having an authorship policy was positively associated with impact factor. Journals from the biomedical sciences and social sciences/humanities were more likely to have an authorship policy than journals from the physical sciences, engineering or mathematical sciences. Among journals with a policy, the most frequent type of policy was guidance on criteria for authorship (99.7%); followed by guidance on acknowledgments (97.3%); requiring that authors make substantial contributions to the research (94.7%); requiring that authors be accountable for the research as a whole (84.8%); guidance on changes in authorship (77.9%); requiring that authors give final approval to the manuscript (77.6%); requiring that authors draft or critically revise the manuscript (71.7%); providing guidance on corporate authorship (58.9%); prohibiting gift, guest or ghost authorship (31.7%); requiring authors to describe their contributions (5.3%); limiting the number of authors for some types of articles (4.0%) and requiring authors to be accountable for their part in the research (1.1%). None of the policies addressed equal contribution statements. Journals that do not have authorship policies should consider adopting or developing ones.