Ethics Education in Health Sciences Should Engage Contentious Social Issues: Here Is Why and How.

Teaching ethics is crucial to health sciences education. Doing it well requires a willingness to engage contentious social issues. Those issues introduce conflict and risk, but avoiding them ignores moral diversity and renders the work of ethics education irrelevant. Therefore, when (not if) contentious issues and moral differences arise, they must be acknowledged and can be addressed with humility, collegiality, and openness to support learning. Faculty must risk moments when not everyone will "feel safe," so the candor implied in psychological safety can emerge. The deliberative and social work of ethics education involves generous listening, wading into difference, and wondering together if our beliefs and arguments are as sound as we once thought. By forecasting the need for candid engagement with contentious issues and moral difference, establishing ground rules, and bolstering due process structures for faculty and students, a riskier and more relevant ethics pedagogy can emerge. Doing so will prepare everyone for the moral diversity they can expect in our common life and in practice.

Coping Mechanisms for Financial Toxicity Among Patients With Metastatic Prostate Cancer: A Survey-based Assessment.

PURPOSE: Assessments of financial toxicity among patients with metastatic prostate cancer are lacking. Using patient surveys, we sought to identify coping mechanisms and assess characteristics associated with lower financial toxicity. MATERIALS AND METHODS: Surveys were administered to all patients seen at a single center's Advanced Prostate Cancer Clinic over a 3-month period. Surveys included the COST-FACIT (COmprehensive Score for Financial Toxicity) and coping mechanism questionnaires. Patients with metastatic disease (lymph nodes, bone, visceral) were included for analysis. Coping mechanisms were compared between patients experiencing low (COST-FACIT >24) vs high (COST-FACIT ≤24) financial toxicity using Fisher's exact test. Multivariable linear regression was used to evaluate characteristics associated with lower financial toxicity. RESULTS: Overall, 281 patients met inclusion criteria of which 79 reported high financial toxicity. In multivariable analysis, characteristics associated with lower financial toxicity included older age (estimate: 0.36, 95%CI: 0.21-0.52), applying for patient assistance programs (estimate: 4.42, 95%CI: 1.72-7.11), and an annual income of at least $100,000 (estimate: 7.81, 95%CI: 0.97, 14.66). Patients with high financial toxicity were more likely to decrease spending on basic goods (35% vs 2.5%, P < .001) and leisure activities (59% vs 15%, P > .001), as well as use savings (62% vs 17%, P < .001) to pay for their treatment. CONCLUSIONS: In this cross-sectional study, patients with metastatic prostate cancer and high financial toxicity were more likely to decrease spending on basic goods and leisure activities and use savings to pay for care. Understanding the impact of financial toxicity on patients' lives is crucial to inform shared decision-making and interventions designed to mitigate financial toxicity in this population.

Lessons learned from conducting the first cancer care delivery trial in the Alliance for Clinical Trials in Oncology (Alliance A191402CD).

INTRODUCTION: Testing healthcare delivery interventions in rigorous clinical trials is a critical step in improving patient care, but conducting multisite randomized clinical trials to test the effect of care delivery interventions has unique challenges and requires foresight and planning. METHODS: We conducted the first care delivery trial (A191402CD) in the Alliance for Clinical Trials in Oncology, a National Cancer Institute Community Oncology Research Program research base, which tested the effectiveness of two different decision aids for supporting shared decision-making about prostate cancer treatment. Our experience illustrates the kind of challenges that confront care delivery researchers as they seek to test interventions to improve the experiences of patients. RESULTS: Lessons learned include the following: cluster-randomized designs introduce complexity; workflow disruption can discourage site participation; evidence-based methods may not always be sufficient. CONCLUSION: We conclude with the following recommendations: assessing feasibility requires special rigor; relationships and interpersonal dynamics must be leveraged. Our experiences may inform future care delivery research.

Ethics Education in U.S. Allopathic Medical Schools: A National Survey of Medical School Deans and Ethics Course Directors.

AbstractPurpose: to characterize ethics course content, structure, resources, pedagogic methods, and opinions among academic administrators and course directors at U.S. medical schools. METHOD: An online questionnaire addressed to academic deans and ethics course directors identified by medical school websites was emailed to 157 Association of American Medical Colleges member medical schools in two successive waves in early 2022. Descriptive statistics were utilized to summarize responses. RESULTS: Representatives from 61 (39%) schools responded. Thirty-two (52%) respondents were course directors; 26 (43%) were deans of academic affairs, medical education, or curriculum; and 3 with other roles also completed the survey (5%). All 61 schools reported some form of formal ethics education during the first year of medical school, with most (n = 54, 89%) reporting a formal mandatory introductory course during preclinical education. Schools primarily utilized lecture and small-group teaching methods. Knowledge-based examinations, attendance, and participation were most commonly used for assessment. A large majority regarded ethics as equally or more important than other foundational courses, but fewer (n = 37, 60%) provided faculty training for teaching ethics. CONCLUSIONS: Despite a response rate of 39 percent, the authors conclude that medical schools include ethics in their curricula in small-group and lecture formats with heterogeneity regarding content taught. Preclinical curricular redesigns must innovate and implement best practices for ensuring sound delivery of ethics content in future curricula. Additional large-scale research is necessary to determine said best practices.

Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD).

BACKGROUND: Decision aids (DAs) can improve knowledge for prostate cancer treatment. However, the relative effects of DAs delivered within the clinical encounter and in more diverse patient populations are unknown. A multicenter cluster randomized controlled trial with a 2×2 factorial design was performed to test the effectiveness of within-visit and previsit DAs for localized prostate cancer, and minority men were oversampled. METHODS: The interventions were delivered in urology practices affiliated with the NCI Community Oncology Research Program Alliance Research Base. The primary outcome was prostate cancer knowledge (percent correct on a 12-item measure) assessed immediately after a urology consultation. RESULTS: Four sites administered the previsit DA (39 patients), 4 sites administered the within-visit DA (44 patients), 3 sites administered both previsit and within-visit DAs (25 patients), and 4 sites provided usual care (50 patients). The median percent correct in prostate cancer knowledge, based on the postvisit knowledge assessment after the intervention delivery, was as follows: 75% for the pre+within-visit DA study arm, 67% for the previsit DA only arm, 58% for the within-visit DA only arm, and 58% for the usual-care arm. Neither the previsit DA nor the within-visit DA had a significant impact on patient knowledge of prostate cancer treatments at the prespecified 2.5% significance level (P = .132 and P = .977, respectively). CONCLUSIONS: DAs for localized prostate cancer treatment provided at 2 different points in the care continuum in a trial that oversampled minority men did not confer measurable gains in prostate cancer knowledge.

Out-of-Pocket Cost Burden Associated With Contemporary Management of Advanced Prostate Cancer Among Commercially Insured Patients.

PURPOSE: Out-of-pocket costs represent an important component of financial toxicity and may impact patients' receipt of care. Herein, we evaluated patient-level factors associated with out-of-pocket costs for contemporary advanced prostate cancer treatment options. MATERIALS AND METHODS: We identified all commercially insured men receiving treatment for advanced prostate cancer between 2007 and 2019 within the OptumLabs Data Warehouse®. Patients were categorized into 3 treatment groups: androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy. The primary outcome was out-of-pocket costs in the first year of treatment. The associations of treatment and patient variables with out-of-pocket costs were assessed using multivariable regression models. All costs were adjusted to reflect 2019 U.S. dollars using the Consumer Price Index. RESULTS: In a cohort of 13,409 men 81% (n = 10,926) received androgen deprivation monotherapy, 6% (n = 832) novel hormonal therapy, and 12% (n = 1,651) nonandrogen systemic therapy. Mean treatment-related out-of-pocket costs in the first year were $165, $4,236, and $994 for androgen deprivation monotherapy, novel hormonal therapy, and nonandrogen systemic therapy, respectively. The adjusted difference in annual treatment-related out-of-pocket costs for novel hormonal therapy and nonandrogen systemic therapy were $2,581 (95% CI: $1,923-$3,240) and $752 (95% CI: $600-$903) higher than androgen deprivation monotherapy, respectively. Patient characteristics associated (P < .05) with higher treatment-related out-of-pocket costs included older age (65-74 years), Black race, lower comorbidity scores, and lower household income. CONCLUSIONS: Patients receiving novel hormonal therapy for advanced prostate cancer had substantially higher treatment-related out-of-pocket costs. In addition to raising awareness among prescribers, these data support the inclusion of treatment associated financial toxicity in shared decision making for advanced prostate cancer and call attention to subgroups of patients particularly vulnerable to financial toxicity.

Older Patients with Advanced Chronic Kidney Disease and Their Perspectives on Prognostic Information: a Qualitative Study.

BACKGROUND: Prognostic information is key to shared decision-making, particularly in life-limiting illness like advanced chronic kidney disease (CKD). OBJECTIVE: To understand the prognostic information preferences expressed by older patients with CKD. DESIGN AND PARTICIPANTS: Qualitative study of 28 consecutively enrolled patients over 65 years of age with non-dialysis dependent CKD stages 3b-5, receiving care in a multi-disciplinary CKD clinic. APPROACH: Semi-structured telephone or in-person interviews to explore patients' preference for and perceived value of individualized prognostic information. Interviews were analyzed using inductive content analysis. KEY RESULTS: We completed interviews with 28 patients (77.7 ± SD 6.8 years, 69% men). Patients varied in their preference for prognostic information and more were interested in their risk of progression to end-stage kidney disease (ESKD) than in life expectancy. Many conflated ESKD risk with risk of death, perceiving a binary choice between dialysis and quick decline and death. Patients expressed that prognostic information would allow them to plan, take care of important business, and think about their treatment options. Patients were accepting of prognostic uncertainty and imagined leveraging it to nurture hope or motivate them to better manage risk factors. They endorsed the desire to receive prognosis of life expectancy even though it may be hard to accept or difficult to talk about but worried it could create helplessness for other patients in their situation. CONCLUSION: Most, but not all, patients were interested in prognostic information and could see its value in motivating behavior change and allowing planning. Some patients expressed concern that information on life expectancy might cause depression and hopelessness. Therefore, prognostic information is most appropriate as part of a clinical conversation that fosters shared decision-making and helps patients consider treatment risks, benefits, and burdens in context of their lives.

Do radiation oncologists and urologists endorse decision aids for active surveillance of low-risk prostate cancer: Results from a national survey.

OBJECTIVE: The degree decision aids (DAs) can promote active surveillance (AS) for prostate cancer (PCa) remains poorly understood. Herein, we surveyed radiation oncologists (RO) and urologists (URO) about their attitudes towards DAs in counselling patients about AS for low-risk PCa. METHODS: We conducted a national survey of RO (n = 915) and URO (n = 940) to assess their attitudes about DAs for AS for patients with low-risk PCa. Respondents were queried about their attitudes towards DAs and proportion of PCa patients managed with AS. Multivariable logistic regression models were used to examine physician characteristics related to attitudes about DAs. RESULTS: The overall response rate was 37.3% (n = 691). Most respondents strongly agreed or agreed that DAs helped patients with low-risk PCa make informed decisions (93.9%) and also increased patient support for AS (86.6%). Having a high volume of their low-risk PCa patients on AS (>15%) was associated with endorsing the statement that use of DAs increased the likelihood of recommending AS (OR: 1.83; 95% CI: 1.00-4.61; p = .05) and being a URO versus a RO (OR: 3.37; 95% CI: 2.46-5.79; p < .001). CONCLUSIONS: Most specialists view DAs as effective tools to facilitate more informed treatment decisions and facilitate greater use of AS in appropriately selected patients.

Responsibilities, Strategies, and Practice Factors in Clinical Cost Conversations: a US Physician Survey.

BACKGROUND: Physicians play a key role in mitigating and managing costs in healthcare which are rising. OBJECTIVE: Conduct a cross-sectional survey in 2017, comparing results to a 2012 survey to understand US physicians' evolving attitudes and strategies concerning healthcare costs. PARTICIPANTS: Random sample of 1200 US physicians from the AMA Masterfile. MEASURES: Physician views on responsibility for costs of care, enthusiasm for cost-saving strategies, cost-consciousness scale, and practice strategies on addressing cost. KEY RESULTS: Among 1200 physicians surveyed in 2017, 489 responded (41%). In 2017, slightly more physicians reported that physicians have a major responsibility for addressing healthcare costs (32% vs. 27%, p = 0.03). In 2017, more physicians attributed "major responsibility" for addressing healthcare costs to pharmaceutical companies (68% vs. 56%, p < 0.001) and hospital and health systems (63% vs. 56%%, p = 0.008) in contrast to 2012. Fewer respondents in 2017 attributed major responsibility for addressing costs to trial lawyers (53% vs. 59%, p = 0.007) and patients (42% vs. 52%, p < 0.0001) as compared to 2012. Physician enthusiasm for patient-focused cost-containment strategies like high deductible health plans and higher co-pays (62% vs. 42%, p < 0.0001 and 62% vs. 39%, p < 0.0001, not enthusiastic, respectively) declined. Physicians reported that when they discussed cost, it resulted in a change in disease management 56% of the time. Cost-consciousness within surveyed physicians had not changed meaningfully in 2017 since 2012 (31.7 vs. 31.2). Most physicians continued to agree that decision support tools showing costs would be helpful in their practice (> 70%). After adjusting for specialty, political affiliation, practice setting, age, and gender, only democratic/independent affiliation remained a significant predictor of cost-consciousness. CONCLUSIONS AND RELEVANCE: US physicians increasingly attribute responsibility for rising healthcare costs to organizations and express less enthusiasm for strategies that increase patient out-of-pocket cost. Interventions that focus on physician knowledge and communication strategies regarding cost of care may be helpful.

Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot trial.

INTRODUCTION: Chemotherapy-induced peripheral neuropathy (CIPN) is a prominent clinical problem, with limited effective therapies. Preliminary non-randomized clinical trial data support that Scrambler Therapy is helpful in this situation. METHODS: Patients were eligible if they had CIPN symptoms for at least 3 months and CIPN-related tingling or pain at least 4/10 in severity during the week prior to registration. They were randomized to receive Scrambler Therapy versus transcutaneous electrical nerve stimulation (TENS) for 2 weeks. Patient-reported outcomes (PROs) were utilized to measure efficacy and toxicity daily for 2 weeks during therapy and then weekly for 8 additional weeks. RESULTS: This study accrued 50 patients, 25 to each of the 2 study arms; 46 patients were evaluable. There were twice as many Scrambler-treated patients who had at least a 50% documented improvement during the 2 treatment weeks, from their baseline pain, tingling, and numbness scores, when compared with the TENS-treated patients (from 36 to 56% compared with 16-28% for each symptom). Global Impression of Change scores for "neuropathy symptoms," pain, and quality of life were similarly improved during the treatment weeks. Patients in the Scrambler group were more likely than those in the TENS group to recommend their treatment to other patients, during both the 2-week treatment period and the 8-week follow-up period (p < 0.0001). Minimal toxicity was observed. CONCLUSIONS: The results from this pilot trial were positive, supporting the conduct of further investigations regarding the use of Scrambler Therapy for treating CIPN.

Myths and social structure: The unbearable necessity of mythology in medical education.

CONTEXT: Myth busting engages scholars in the critical examination of commonly accepted but poorly evidenced claims with the goal of instilling quality and trust in knowledge making. The debunking of such knowledge "myths" and associated misguided practices purportedly serves to avert resources and attention from wasteful and dangerous scholarship. We address the myth that "all myths in medical education deserve to be busted". METHODS: Using a critical narrative approach, we searched the medical education literature for orientations to myths and myth busting, and reviewed this literature analytically drawing from the sociology of science and Merton's concepts of manifest and latent functions. The results of this analysis are presented in the form of a narrative that deploys the articles reviewed to explore the utility of myth busting for medical education reform and begins with a brief exploration of the etymology of "myth" and how meaning making is related to symbols, practices and storytelling. RESULTS: Our analysis revealed the important function of myths in the social practice of medical education and practice. A deconstruction of five salient examples of the contemporary myth in medical education (the myth of the "ideal candidate", the myth of "cut-throats", the myth of "cadaver stories", the myth of "learning styles", and the myth of "patient information leaflets") demonstrates that myths continue to have material effects even after they have been busted. CONCLUSIONS: Our analysis makes evident that myth busting disrupts, renegotiates and reconstitutes socio-epistemic relationships rather than simply correcting falsehoods. We also argue that myths play important and inescapable roles in the social practice of medical education and the negotiation of values, and in constructing the conditions for group change and transformation. Imperatives related to humanism, compassion and patient engagement offer a healthy humanising counter-mythologising that we suggest must survive any contemporary myth-busting endeavour aimed at improving medical education practice.

Curare Aude-Caring for Patients, with Them.

We reflect on Dr. Iserson's article in this journal, in which he suggests that clinicians must "shove" patients towards appropriate care. While recognizing that overt clinical guidance is part of care, we suggest that its use should be tempered by the guidance's responsiveness to the human and emotional experience of each patient.

A Multicenter Comparison of Complementary and Alternative Medicine (CAM) Discussions in Oncology Care: The Role of Time, Patient-Centeredness, and Practice Context.

BACKGROUND: Little is known about how complementary and alternative medicine (CAM) is discussed in cancer care across varied settings in the U.S. METHODS: In two practices affiliated with one academic medical center in southern California (SoCal), and one in the upper Midwest (UM), we audio-recorded patient-clinician interactions in medical oncology outpatient practices. We counted the frequency and duration of CAM-related conversations. We coded recordings using the Roter Interaction Analysis System. We used chi-square tests for bivariate analysis of categorical variables and generalized linear models for continuous variables to examine associations between dialogue characteristics, practice setting, and population characteristics with the occurrence of CAM discussion in each setting followed by multivariate models adjusting for clinician clustering. RESULTS: Sixty-one clinicians and 529 patients participated. Sixty-two of 529 (12%) interactions included CAM discussions, with significantly more observed in the SoCal university practice than in the other settings. Visits that included CAM were on average 6 minutes longer, with CAM content lasting an average of 78 seconds. In bivariate tests of association, conversations containing CAM included more psychosocial statements from both clinicians and patients, higher patient-centeredness, more positive patient and clinician affect, and greater patient engagement. In a multivariable model including significant bivariate terms, conversations containing CAM were independently associated with higher patient-centeredness, slightly longer visits, and being at the SoCal university site. CONCLUSION: The frequency of CAM-related discussion in oncology varied substantially across sites. Visits that included CAM discussion were longer and more patient centered. IMPLICATIONS FOR PRACTICE: The Institute of Medicine and the American Society of Clinical Oncology have called for more open discussions of complementary and alternative medicine (CAM). But little is known about the role population characteristics and care contexts may play in the frequency and nature of those discussions. The present data characterizing actual conversations in practice complements a much larger literature based on patient and clinician self-report about CAM disclosure and use. It was found that CAM discussions in academic oncology visits varied significantly by practice context, that the majority were initiated by the patient, and that they may occur more when visit time exists for lifestyle, self-care, and psychosocial concerns.

Perceptions of Barriers Towards Active Surveillance for Low-Risk Prostate Cancer: Results From a National Survey of Radiation Oncologists and Urologists.

PURPOSE: The reasons for low clinical adoption of active surveillance (AS) for low-risk prostate cancer (PCa) remain poorly understood. Thus, we conducted a national survey of radiation oncologists (ROs) and urologists (UROs) to elucidate perceived barriers to AS for low-risk PCa. METHODS: In 2017, we undertook a four-wave mail survey of 1855 ROs and UROs. The survey instrument assessed attitudes about possible barriers towards AS for low-risk PCa. We used Pearson Chi square and multivariable logistic regression analyses to identify physician characteristics associated with attitudes about AS. RESULTS: We received 691 completed surveys for an overall response rate of 37.3%. A majority of respondents indicated that they felt comfortable recommending AS (90.0%), agreed that high-level evidence supports it (82.3%), and considered AS equally effective for survival compared with surgery and radiation therapy (84.4%). UROs were less likely to agree that patients were not interested in AS for low-risk PCa compared with ROs (16.5 vs. 48.9%; adjusted odds ratio [OR] 0.18, p < 0.001). Similarly, UROs were less likely to concur patients avoid AS because of repeat prostate biopsies than ROs (36.3 vs. 55.4%; adjusted OR 0.41, p < 0.001). ROs and UROs were more likely to agree that patients preferred treatments delivered by the respondent's specialty. CONCLUSIONS: Physician perceptions of patient lack of interest in AS, need for repeat prostate biopsies, and biases of patient treatment preferences in favor of their own specialty treatments represent key barriers to AS. Shared decision making may be a meaningful approach to engaging patients in conversations about treatment decisions.

A national survey of radiation oncologists and urologists on prediction tools and nomograms for localized prostate cancer.

PURPOSE: Although prediction tools for prostate cancer (PCa) are essential for high-quality treatment decision-making, little is known about the degree of confidence in existing tools and whether they are used in clinical practice from radiation oncologists (RO) and urologists (URO). Herein, we performed a national survey of specialists about perceived attitudes and use of prediction tools. METHODS: In 2017, we invited 940 URO and 911 RO in a national survey to query their confidence in and use of the D'Amico criteria, Kattan Nomogram, and CAPRA score. The statistical analysis involved bivariate association and multivariable logistic regression analyses to identify physician characteristics (age, gender, race, practice affiliation, specialty, access to robotic surgery, ownership of linear accelerator and number of prostate cancer per week) associated with survey responses and use of active surveillance (AS) for low-risk PCa. RESULTS: Overall, 691 (37.3%) specialists completed the surveys. Two-thirds (range 65.6-68.4%) of respondents reported being "somewhat confident", but only a fifth selected "very confident" for each prediction tool (18.0-20.1%). 19.1% of specialists in the survey reported not using any prediction tools in clinical practice, which was higher amongst URO than RO (23.9 vs. 13.4%; p < 0.001). Respondents who reported not using prediction tools were also associated with low utilization of AS in their low-risk PCa patients (adjusted OR 2.47; p = 0.01). CONCLUSIONS: While a majority of RO and URO view existing prediction tools for localized PCa with some degree of confidence, a fifth of specialists reported not using any such tools in clinical practice. Lack of using such tools was associated with low utilization of AS for low-risk PCa.

Noninvasive Ventilation in Patients With Do-Not-Intubate and Comfort-Measures-Only Orders: A Systematic Review and Meta-Analysis.

OBJECTIVES: To assess the effectiveness of noninvasive ventilation in patients with acute respiratory failure and do-not-intubate or comfort-measures-only orders. DATA SOURCES: MEDLINE, EMBASE, CINAHL, Scopus, and Web of Science from inception to January 1, 2017. STUDY SELECTION: Studies of all design types that enrolled patients in the ICU or hospital ward who received noninvasive ventilation and had preset do-not-intubate or comfort-measures-only orders. DATA EXTRACTION: Data abstraction followed Meta-analysis of Observational Studies in Epidemiology guidelines. Data quality was assessed using a modified Newcastle-Ottawa Scale. DATA SYNTHESIS: Twenty-seven studies evaluating 2,020 patients with do-not-intubate orders and three studies evaluating 200 patients with comfort-measures-only orders were included. In patients with do-not-intubate orders, the pooled survival was 56% (95% CI, 49-64%) at hospital discharge and 32% (95% CI, 21-45%) at 1 year. Hospital survival was 68% for chronic obstructive pulmonary disease, 68% for pulmonary edema, 41% for pneumonia, and 37% for patients with malignancy. Survival was comparable for patients treated in a hospital ward versus an ICU. Quality of life of survivors was not reduced compared with baseline, although few studies evaluated this. No studies evaluated quality of dying in nonsurvivors. In patients with comfort-measures-only orders, a single study showed that noninvasive ventilation was associated with mild reductions in dyspnea and opioid requirements. CONCLUSIONS: A large proportion of patients with do-not-intubate orders who received noninvasive ventilation survived to hospital discharge and at 1 year, with limited data showing no decrease in quality of life in survivors. Provision of noninvasive ventilation in a well-equipped hospital ward may be a viable alternative to the ICU for selected patients. Crucial questions regarding quality of life in survivors, quality of death in nonsurvivors, and the impact of noninvasive ventilation in patients with comfort-measures-only orders remain largely unanswered.

Ethical Issues in the Design and Implementation of Population Health Programs.

Spurred on by recent health care reforms and the Triple Aim's goals of improving population health outcomes, reducing health care costs, and improving the patient experience of care, emphasis on population health is increasing throughout medicine. Population health has the potential to improve patient care and health outcomes for individual patients. However, specific population health activities may not be in every patient's best interest in every circumstance, which can create ethical tensions for individual physicians and other health care professionals. Because individual medical professionals remain committed primarily to the best interests of individual patients, physicians have a unique role to play in ensuring population health supports this ethical obligation. Using widely recognized principles of medical ethics-nonmaleficence/beneficence, respect for persons, and justice-this article describes the ethical issues that may arise in contemporary population health programs and how to manage them. Attending to these principles will improve the design and implementation of population health programs and help maintain trust in the medical profession.

The comparative effectiveness of decision aids in diverse populations with early stage prostate cancer: a study protocol for a cluster-randomized controlled trial in the NCI Community Oncology Research Program (NCORP), Alliance A191402CD.

BACKGROUND: Treatments for localized prostate cancer present challenging tradeoffs in the face of uncertain treatment benefits. These options are best weighed in a process of shared decision-making with the patient's healthcare team. Minority men experience disparities in prostate cancer outcomes, possibly due in part to a lack of optimal communication during treatment selection. Decision aids facilitate shared decision-making, improve knowledge of treatment options, may increase satisfaction with treatment choice, and likely facilitate long-term quality of life. METHODS/DESIGN: This study will compare the effect of two evidence-based decision aids on patient knowledge and on quality of life measured one year after treatment, oversampling minority men. One decision aid will be administered prior to specialist consultation, preparing patients for a treatment discussion. The other decision aid will be administered within the consultation to facilitate transparent, preference-sensitive, and evidence-informed deliberations. The study will utilize a four-arm, block-randomized design to test whether each decision aid alone (Arms 1 and 2) or in combination (Arm 3) can improve patient knowledge and quality of life compared to usual care (Arm 4). The study, funded by the National Cancer Institute's Community Oncology Research Program (NCORP), will be deployed within select institutions that have demonstrated capacity to recruit minority populations into urologic oncology trials. DISCUSSION: Upon completion of the trial, we will have 1) tested the effectiveness of two evidence-based decision aids in enhancing patients' knowledge of options for prostate cancer therapy and 2) estimated whether decision aids may improve patient quality of life one year after initial treatment choice. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03103321 . The trial registration date (on ClinicalTrials.gov) was April 6, 2017.