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Abstract Ethical issues arise in the context of implementation science that may differ from those encountered in other research settings. This report, developed out of a workshop convened by the Center for Translation Research and Implementation Science within the United States National Heart, Lung, and Blood Institute, identifies six key themes that are important to the assessment of ethical dimensions of implementation science. First, addressing ethical challenges in implementation science does not require new ethical principles, commitments, or regulations. However, it does require understanding of the specific contexts arising in implementation research related to both study design and the intervention being implemented. Second, implementation research involves many different types of people in research, including patients, clinicians, administrators, the social networks of any of these, and the general population. These individuals play different roles that may entail different ethical considerations, obligations, and vulnerabilities. Third, the appropriateness of and need for informed consent in implementation research is connected to the role of the subject/participant, the nature of the intervention, and the design of the study. Even where traditional “full” consent processes are unnecessary or inappropriate, communication and engagement are critical. Similarly, even when research is exempt and informed consent unnecessary, Data Safety and Monitoring Board oversight of implementation studies may be advisable to ensure quality, address unexpected consequences, and identify overwhelming evidence of benefit. Fourth, implementation science is often explicitly designed to encourage specific behaviors and discourage others. There is a need for clarity regarding when efforts at behavioral change enhance or threaten autonomy and how to protect participants whose autonomy is threatened. Fifth, there is significant overlap between implementation science and quality improvement, and the ideal regulatory oversight structure for implementation science remains unclear. It is critical to encourage learning and growth while assuring appropriate protections. Sixth, implementation research takes place across a range of social and cultural contexts. Engagement and collaboration with stakeholders in designing and executing implementation trials and studies- especially when vulnerabilities exist- is essential. Attention to these themes will help ensure that implementation science fulfills its goal of advancing the practice of health care within a sound ethical framework.

Abstract Background Values are broadly understood to have implications for how individuals make decisions and cope with serious illness stressors, yet it remains uncertain how patients and their family and friend caregivers discuss, reflect upon, and act on their values in the post-left ventricular assist device (LVAD) implantation context. This study aimed to explore the values elicitation experiences of patients with an LVAD in the post-implantation period. Methods Qualitative descriptive study of LVAD recipients. Socio-demographics and patient resource use were analyzed using descriptive statistics and semi-structured interview data using thematic analysis. Adult (> 18 years) patients with an LVAD receiving care at an outpatient clinic in the Southeastern United States. Results Interviewed patients (n = 27) were 30–76 years, 59% male, 67% non-Hispanic Black, 70% married/living with a partner, and 70% urban-dwelling. Three broad themes of patient values elicitation experiences emerged: 1) LVAD implantation prompts deep reflection about life and what is important, 2) patient values are communicated in various circumstances to convey personal goals and priorities to caregivers and clinicians, and 3) patients leverage their values for strength and guidance in navigating life post-LVAD implantation. LVAD implantation was an impactful experience often leading to reevaluation of patients’ values; these values became instrumental to making health decisions and coping with stressors during the post-LVAD implantation period. Patient values arose within broad, informal exchanges and focused, decision-making conversations with their caregiver and the healthcare team. Conclusions Clinicians should consider assessing the values of patients post-implantation to facilitate shared understanding of their goals/priorities and identify potential changes in their coping.

A potential contributor to the suboptimal rates of guideline directed medical therapy (GDMT) prescribing for heart failure with reduced ejection fraction (HFrEF) is the burden of multimorbidity in patients with HFrEF. We examined the effect of multimorbidity on GDMT prescription in the EPIC-HF trial, finding that multimorbidity was associated with decreased likelihood of GDMT intensification. Further study is needed to guide treatment in high-risk, multimorbid patients with HFrEF.

Objectives: We explored the perspectives of older veterans in Gerofit, a Department of Veteran Affairs (VA) supervised clinical exercise program, to understand the factors associated with participation and how the program supported personal health goals. Methods: Twenty semistructured interviews were conducted with active and inactive Gerofit participants. We used a hybrid inductive and deductive approach to thematic analysis of transcripts, with the latter informed by the Health Action Process Approach model of behavior change. Results: Active and inactive participants differed in their perspectives about how Gerofit impacted their progress toward meeting personal health goals. Active participants noted program features (e.g., schedule, staffing) as facilitators and suggested greater self-efficacy about program participation compared to inactive participants. Both groups perceived the camaraderie with other veterans as a facilitator. Conclusions: Exercise program features, including camaraderie, are important factors that affect the ability of older veterans to participate in exercise and achieve personal health goals.

Background: Caregivers face challenges (including competing desires to prevent injury, respect autonomy, and avoid conflict) when addressing firearm access by community-dwelling persons with Alzheimer disease and related dementias (ADRD)., Objective: To test the effect of the online Safety in Dementia (SiD) decision aid on caregivers' decision making about firearm access for people with ADRD., Design: Prospective 2-group randomized trial with longitudinal follow-up. (ClinicalTrials.gov: NCT05173922)., Setting: United States., Participants: English- or Spanish-speaking caregivers (aged ≥18 years) of community-dwelling adults with ADRD and firearm access., Intervention: SiD versus a web-based information control., Measurements: The primary outcome was preparation for decision making about firearm access. The secondary outcome at follow-up was self-reported action to reduce access., Results: Among 500 participants enrolled between June 2022 and February 2024, the mean age was 47 years, 69% identified as female, half were the adult child or stepchild of the person with ADRD, and 99% chose study participation in English. Participant characteristics were similar by study group. For the primary outcome, SiD significantly increased preparation for decision making versus the control (69.8 vs. 64.8 out of 100; mean difference, 4.80 [95% CI, 0.53 to 9.07]; P = 0.024). There was no significant effect on actions to reduce firearm access at 2 weeks or 2 months., Limitation: The results may not be generalizable to non-English-speaking populations., Conclusion: The online SiD decision aid increased preparation for decision making about firearm access in this sample of ADRD caregivers in the United States. Use of such resources in clinical or community settings may support caregivers and people with ADRD in avoiding firearm injury or death., Primary Funding Source: National Institute on Aging, National Institutes of Health., Competing Interests: Disclosures: All relevant financial relationships have been mitigated. Disclosures are available with the article online.

Introduction: We developed a patient decision aid to enhance patient participation in amputation level decision making when there is a choice between a transmetatarsal or transtibial amputation., Methods: In accordance with International Patient Decision Aid Standards, we developed an amputation level patient decision aid for patients who are being considered for either a transmetatarsal or transtibial amputation, incorporating qualitative literature data, quantitative literature data, qualitative provider and patient interviews, expert panel input and iterative patient feedback., Results: The rapid qualitative literature review and qualitative interviews identified five domains outcome priority domains important to patients facing amputation secondary to chronic limb threatening ischemia: 1) the ability to walk, 2) healing and risk for reamputation, 3) rehabilitation program intensity, 4) ease of prosthetic use, and 5) limb length after amputation. The rapid quantitative review identified only two domains with adequate evidence comparing differences in outcomes between the two amputation levels: mobility and reamputation. Patient, surgeon, rehabilitation and decision aid expert feedback allowed us to integrate critical facets of the decision including addressing the emotional context of loss of limb, fear and anxiety as an obstacle to decision making, shaping the decision in the context of remaining life years, and how to facilitate patient knowledge of value tradeoffs., Conclusions: Amputation level choice is associated with significant outcome trade-offs. The AMPDECIDE patient decision aid can facilitate acknowledgment of patient fears, enhance knowledge of amputation level outcomes, assist patients in determining their personal outcome priorities, and facilitate shared amputation level decision making., (Published by Elsevier Inc.)