Meeting ethical challenges with authenticity when engaging patients and families in end-of-life and palliative care research: a qualitative study.

BACKGROUND: Delivering high quality, patient- and family-centered care depends upon high quality end-of-life and palliative care (EOLPC) research. Engaging patients and families as advisors, partners, or co-investigators throughout the research lifecycle is widely regarded as critical to ensuring high quality research. Engagement is not only an ethical obligation, it also raises ethical challenges of its own. We conducted a qualitative study to understand ethical challenges and potential solutions when engaging patients and families in EOLPC research. METHODS: We recruited and interviewed 20 clinical investigators and 22 patients or family caregivers through the Palliative Care Research Cooperative Group (PCRC). Interview transcripts were analyzed using constructivist grounded theory methodology. Analysis sought to identify ethical challenges and potential solutions, as well as to synthesize findings into practical recommendations tailored to engaging patients and families in EOLPC research. RESULTS: Our study identified 8 ethical challenges considered unique to the EOLPC research context and 11 potential solutions to these challenges. The most frequently described ethical challenges included the need to minimize burdens of engagement for patients and caregivers, challenges of dealing with death and illness, and paternalism or "gatekeeping" (i.e., withholding the opportunity to participate from patients or caregivers). Investigators and patients or family caregivers conceptualized ethics challenges differently; several issues appeared to fall outside a traditional research ethics paradigm and more into the ethics of relationships. We synthesized these findings into 4 practical recommendations hypothesized to support authentic engagement. CONCLUSIONS: Engaging patients and families in EOLPC research can raise unique ethical challenges. These challenges can be overcome to empower participation, minimize the unique burdens of EOLPC, and promote diversity. Whereas traditional research ethics tend to emphasize protecting research participants who may be vulnerable, an ethics approach based on authentic engagement that explores what it means for investigators and patients or family caregivers to be in a relationship may be needed. Future research is needed to explore this approach and test these recommendations in practice.

A systematic review and meta-analysis of attentional bias toward food in individuals with overweight and obesity.

Attentional bias to food stimuli may contribute to the etiology and/or maintenance of overweight and obesity. We conducted a literature review and meta-analysis per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to identify the effect size associated with attentional bias to palatable food in persons with overweight/obesity across the age spectrum. Included studies measured attentional bias to food stimuli using two reaction-time tasks (dot-probe, emotional Stroop), eye-tracking methodology, and/or event-related potentials. Meta-analysis showed that persons with overweight/obesity did not differ from persons with a healthy weight on any of the following: automatic and maintained attention to food stimuli measured by the dot-probe task (Hedge's gautomatic = -0.355, 95% CI = -0.383, 0.486; and Hedge's gmaintained = 0.006, 95% CI = -0.187, 0.199); attentional bias to food stimuli measured by the emotional Stroop task (Hedge's g = 0.184, 95% CI = -0.283, 0.651); and attentional bias to food images on gaze-direction and gaze-duration bias eye-tracking metrics (Hedge's gdirection = 0.317, 95% CI = -0.096, 0.729; and Hedge's gduration = 0.056, 95% CI = -0.296, 0.407). Systematic review of preliminary event-related potentials research suggested automatic, but not maintained, attention to food images in persons with overweight/obesity. Limitations of past attentional bias research in overweight/obesity, such as poor reliability of measures and lack of consideration of moderators, such as binge eating and degree of overweight/obesity, preclude the ability to draw firm conclusions. We recommend implementation of empirically based methods for improving psychometric properties of attentional bias measures and examination of potential moderators so that the field can understand whether attentional bias to food is truly greater in overweight/obesity.

The Athletes' Relationships with Training scale (ART): A self-report measure of unhealthy training behaviors associated with eating disorders.

OBJECTIVE: Several studies indicate that eating-disorder (ED) psychopathology is elevated in athletes compared to non-athletes. The assessment of excessive exercise among athletes is a challenge because, compared to non-athletes, athletes are required to train at higher intensities and for longer periods of time. However, individuals participating in competitive sports are still susceptible to unhealthy physical-activity patterns. Most ED assessments were developed and normed in non-athlete samples and, therefore, do not capture the nuances of athletes' training experiences. The purpose of the current study was to develop and validate a clinically useful, self-report measure of unhealthy training behaviors and beliefs in athletes, the Athletes' Relationships with Training Scale (ART). METHOD: The initial item pool was administered to N = 267 women collegiate athletes who were participating in an ED prevention program study and N = 65 women athletes who were in ED treatment. RESULTS: Factor analyses indicated the ART had a four-factor structure. Factorial and construct validity of the ART were demonstrated. ART scores significantly predicted health care utilization and differed between athletes with an ED versus athletes without an ED. For athletes in ED treatment, ART scores significantly decreased from treatment admission to discharge. DISCUSSION: The ART showed evidence of strong psychometric properties and clinical utility. The ART could be helpful for clinicians and athletic trainers to help gauge whether athletes are engaging in unhealthy training practices that may warrant clinical attention and for tracking clinical outcomes in athletes with EDs who are receiving treatment.

Ethical challenges in mass drug administration for reducing childhood mortality: a qualitative study.

BACKGROUND: Mass drug administration (MDA) of medications to entire at-risk communities or populations has shown promise in the control and elimination of global infectious diseases. MDA of the broad-spectrum antibiotic azithromycin has demonstrated the potential to reduce childhood mortality in children at risk of premature death in some global settings. However, MDA of antibiotics raises complex ethical challenges, including weighing near-term benefits against longer-term risks-particularly the development of antimicrobial resistance that could diminish antibiotic effectiveness for current or future generations. The aim of this study was to understand how key actors involved in MDA perceive the ethical challenges of MDA. METHODS: We conducted 35 semi-structured interviews from December 2020-February 2022 with investigators, funders, bioethicists, research ethics committee members, industry representatives, and others from both high-income countries (HICs) and low- and middle-income countries (LMICs). Interview participants were identified via one of seven MDA studies purposively chosen to represent diversity in terms of use of the antibiotic azithromycin; use of a primary mortality endpoint; and whether the study occurred in a high child mortality country. Data were analyzed using constructivist grounded theory methodology. RESULTS: The most frequently discussed ethical challenges related to meaningful community engagement, how to weigh risks and benefits, and the need to target MDA We developed a concept map of how participants considered ethical issues in MDA for child mortality; it emphasizes MDA's place alongside other public health interventions, empowerment, and equity. Concerns over an ethical double standard in weighing risks and benefits emerged as a unifying theme, albeit one that participants interpreted in radically different ways. Some thought MDA for reducing child mortality was ethically obligatory; others suggested it was impermissible. CONCLUSIONS: Ethical challenges raised by MDA of antibiotics for childhood mortality-which span socio-cultural issues, the environment, and effects on future generations-require consideration beyond traditional clinical trial review. The appropriate role of MDA also requires attention to concerns over ethical double standards and power dynamics in global health that affect how we view antibiotic use in HICs versus LMICs. Our findings suggest the need to develop additional, comprehensive guidance on managing ethical challenges in MDA.

Referrals, access, and equity of monoclonal antibodies for outpatient COVID-19: A qualitative study of clinician perspectives.

Neutralizing monoclonal antibody treatments for non-hospitalized patients with COVID-19 have been available since November 2020. However, they have been underutilized and access has been inequitable. To understand, from the clinician perspective, the factors facilitating or hindering monoclonal antibody referrals, patient access, and equity to inform development of clinician-focused messages, materials, and processes for improving access to therapeutics for COVID-19 in Colorado. We interviewed 38 frontline clinicians with experience caring for patients with COVID-19 in outpatient settings. Clinicians were purposely sampled for diversity to understand perspectives across geography (i.e., urban versus rural), practice setting, specialty, and self-reported knowledge about monoclonal antibodies. Interviews were conducted between June and September 2021, lasted 21 to 62 minutes, and were audio recorded and transcribed verbatim. Interview transcripts were then analyzed using rapid qualitative analysis to identify thematic content and to compare themes across practice settings and other variables. Clinicians perceived monoclonal antibodies to be highly effective and were unconcerned about their emergency use status; hence, these factors were not perceived to hinder patient referrals. However, some barriers to access - including complex and changing logistics for referring, as well as the time and facilities needed for an infusion - inhibited widespread use. Clinicians in small, independent, and rural practices experienced unique challenges, such as lack of awareness of their patients' COVID-19 test results, disconnect from treatment distribution systems, and patients who faced long travel times to obtain treatment. Many clinicians held a persistent belief that monoclonal antibodies were in short supply; this belief hindered referrals, even when monoclonal antibody doses were not scarce. Across practice settings, the most important facilitator for access to monoclonal antibodies was linkage of COVID-19 testing and treatment within care delivery. Although clinicians viewed monoclonal antibodies as safe and effective treatments for COVID-19, individual- and system-level barriers inhibited referrals, particular in some practice settings. Subcutaneous or oral formulations may overcome certain barriers to access, but simplifying patient access by linking testing with delivery of treatments that reduce morbidity and mortality will be critical for the ongoing response to COVID-19 and in future pandemics.

Barriers to metabolic bariatric surgery in adolescents: results of a qualitative study.

BACKGROUND: It is estimated that 4.5 million youth in the United States have severe obesity (SO). Metabolic and bariatric surgery (MBS) is the most effective and longitudinally durable treatment for adolescents with SO, but only an estimated 1600 adolescents undergo the procedure annually. OBJECTIVE: To understand patients' perceptions and experiences with the barriers to MBS as an adolescent. SETTING: This research was conducted at Children's Hospital Colorado, an urban academic medical center, and the University of Colorado Anschutz School of Medicine and Sanford Research, a rural medical center. METHODS: We conducted 14 qualitative interviews with individuals who received MBS between the ages of 19 and 25 years in the last 5 years regarding the barriers to MBS they experienced as an adolescent. A formal qualitative analysis was conducted using the constant comparative techniques of grounded theory generally guided by Anderson's behavioral model of health service use. RESULTS: We identified 3 principal groups of barriers related to (1) a lack of information that MBS was an option and the absence of discussions about MBS with medical providers while an adolescent, (2) a lack of access to MBS primarily related to insurance coverage, costs, and family-related issues, and (3) a general stigma around MBS as a treatment for obesity. CONCLUSION: This study suggests that the primary barriers to MBS for adolescents with SO are related to a general lack of information about MBS, social stigma, and access issues related to costs that decrease or limit access.