Embodying performance excellence in medicine: Can The Six Viewpoints help?

Performance excellence in healthcare relies on skilled situational awareness, but there is no comprehensive framework articulating what within a situation requires awareness. Envisioning medicine as a performing artform, we introduce Mary Overlie's The Six Viewpoints-a comprehensive, yet flexible, conceptual framework used in the performing arts world, for teaching, learning, and creating, for over 50 years. We imagine The Viewpoints could serve as a framework to help improve verbal and non-verbal communication and collaboration on medical teams and between providers and their patients. We call on health professions educators to experiment with The Viewpoints to determine how they could be adapted to support performance excellence in the medical arena.

Who will receive the last ventilator: why COVID-19 policies should not prioritise healthcare workers.

Policies promoted and adopted for allocating ventilators during the COVID-19 pandemic have often prioritised healthcare workers or other essential workers. While the need for such policies has so far been largely averted, renewed stress on health systems from continuing surges, as well as the experience of allocating another scarce resource-vaccination-counsel revisiting the justifications for such prioritisation. Prioritising healthcare workers may have intuitive appeal, but the ethical justifications for doing so and the potential harms that could follow require careful analysis. Ethical justifications commonly offered for healthcare worker prioritisation for ventilators rest on two social value criteria: (1) instrumental value, also known as the 'multiplier effect', which may preserve the ability of healthcare workers to help others, and (2) reciprocity, which rewards past usefulness or sacrifice. We argue that these justifications are insufficient to over-ride the common moral commitment to value each person's life equally. Institutional policies prioritising healthcare workers over other patients also violate other ethical norms of the healthcare professions, including the commitment to put patients first. Furthermore, policy decisions to prioritise healthcare workers for ventilators could engender or deepen existing distrust of the clinicians, hospitals and health systems where those policies exist, even if they are never invoked.

Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders.

BACKGROUND: Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited. METHODS: In this five-site, open-label, randomized trial, we compared a 24-week course of extended-release naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78. RESULTS: A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extended-release naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P=0.91). The rates of other prespecified secondary outcome measures--self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration--were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P=0.02). CONCLUSIONS: In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation. (Funded by the National Institute on Drug Abuse; ClinicalTrials.gov number, NCT00781898.).

U.S. physician knowledge of the FDA-approved indications and evidence base for commonly prescribed drugs: results of a national survey.

PURPOSE: The Food and Drug Administration (FDA) regulates prescription drug marketing, not prescribing. However, off-label use is common, often lacks supporting evidence, and may expose patients to unwarranted risk. We sought to determine physicians' knowledge of the FDA-approved indications of commonly prescribed drugs, and to assess whether physicians' belief that an indication is FDA-approved increases with level of evidence supporting such use. METHODS: We conducted a national random sample mail survey of 599 primary care physicians and 600 psychiatrists from November 2007 to August 2008. Physicians were presented with 14 drug-indication pairs (e.g., gabapentin [Neurontin] for diabetic neuropathy) that varied in their FDA-approval status and levels of supporting evidence. RESULTS: The adjusted response rate was 47%, respondents were similar to non-respondents, and physicians commonly prescribed the drugs examined. The average respondent accurately identified the FDA-approval status of just over half of the drug-indication pairs queried (mean 55%; median 57%). Accuracy increased modestly (mean 60%, median 63%) when limited to drugs the respondent reported having prescribed during the previous 12 months. There was a strong association between physicians' belief that an indication was FDA-approved and greater evidence supporting efficacy for that use (Spearman's rho 0.74, p < 0.001). However, 41% of physicians believed at least one drug-indication pair with uncertain or no supporting evidence (e.g., quetiapine [Seroquel] for dementia with agitation) was FDA approved. CONCLUSIONS: These findings highlight a pressing need for more effective methods to inform physicians about the evidence base, or lack thereof, for drugs they prescribe off label.

The CREATE Act: increasing costs associated with the biotech industry?

A new law intended to promote collaborative research may end up costing the biotech industry more and inhibiting innovation.

Minding the Form That Transforms: Using Kegan's Model of Adult Development to Understand Personal and Professional Identity Formation in Medicine.

The formation of a physician's professional identity is a dynamic process shaped by and intertwined with the development of that person's larger adult identity. Constructive-developmentalist Robert Kegan's model of adult development describes four mental lenses used for meaning-making and the trajectory through which they transform over time. These lenses determine the way people take in and integrate complex influences into forming their adult identities.When people use a particular lens to construct meaning, Kegan describes them as being "subject" to that lens: The lens "has them," and they are unaware of the ways it shapes their world. Transformations occur when individuals are able to take a lens to which they were subject and regard it objectively. Kegan's lenses that are relevant to medical educators are called instrumental-focused on rules and rewards; socialized-attending to social norms and expectations; self-authoring-seeking to build internal values; and self-transforming-seeing gaps in one's closely held value systems and being open to those of others.When individuals have difficulty facing current challenges, they begin to grow a more complex lens. Subsequent lenses bring the ability to deal with more complexity but also bring their own challenges. Familiarity with Kegan's model can help educators provide more effective support to groups of learners as well as individuals, support learners' transformational growth through the challenging situations inherent in medical education, and supply a common language for many important areas of medical education, including competencies and entrustable professional activities, remediation, leadership development, and curriculum planning.

Using Instrument-Guided Team Reflection and Debriefing to Cultivate Teamwork Knowledge, Skills, and Attitudes in Pre-Clerkship Learning Teams.

Drawing on the science of teamwork and the science of learning, we designed an instrument-guided team reflection and debriefing activity to foster teamwork knowledge, skills, and attitudes (KSAs) in medical students. We then embedded this activity within and between a biweekly series of pre-clerkship Team-Based Learning sessions with the goal of encouraging medical students to cultivate a practical and metacognitive appreciation of eight foundational teamwork KSAs that are applicable to both healthcare teams and classroom learning teams. On evaluations, 144 learners from a class of 156 reported increased appreciation for and team improvement with these teamwork KSAs.

Stroke genetic research and adults with impaired decision-making capacity: a survey of IRB and investigator practices.

BACKGROUND AND PURPOSE: In stroke and other brain disorders, severely affected phenotypes often impair decision-making capacity. Severity is in part under genomic control. Therefore, scientifically valid research into genetic risk may require inclusion of such impaired individuals. U.S. Federal regulations do not detail rules governing enrollment of adults with impaired decision-making capacity into genetic research. Rather, policy and practice are locally determined. This study was conducted to obtain data on how investigators and IRBs handle surrogate authorization to enroll probands into a genetic study where some may lack capacity because of ischemic stroke. METHODS: Sequential surveys of sites from an ongoing North American study investigating genetic risks for ischemic stroke (2003: 49 sites, response rate=100%; 2007: 53 sites; response rate=91%) assessed whether and how investigators enroll adults with impaired decision-making capacity and determined frequency of IRB approval for enrollment by surrogate authorization. RESULTS: Approximately 40% of sites report that their IRBs do not approve surrogate authorization to enroll stroke patients-43% (21/49) in 2003 and 35% (17/48) in 2007. Thirty-three percent of sites report evaluating eligible adults who lacked capacity to provide their own informed consent; 18% (9/49) in 2003 and 15% (7/48) in 2007 have enrolled these individuals. Surrogate enrollment is the most common method used. Most sites have not enrolled any individual lacking capacity to give his or her own consent. CONCLUSIONS: Our study suggests that enrollment by surrogate authorization into stroke genetic research is often not approved by IRBs, and even when allowed is frequently not used. For disorders like stroke, this situation has significant implications for scientific validity.

Impact of restricting enrollment in stroke genetics research to adults able to provide informed consent.

BACKGROUND AND PURPOSE: The extent of potential consent bias in observational studies elucidating genetic and environmental contributions to ischemic stroke is largely unknown. The purpose of this study was to assess differences in stroke cohort characteristics between those who provided informed consent and those whose enrollment was authorized by surrogate decision makers. METHODS: The Ischemic Stroke Genetics Study (ISGS) is a prospective, 5-center, case-control study of first-ever ischemic stroke. Demographic, clinical, and stroke characteristics were compared between cases enrolled by self versus by surrogate. Data from one site that limits enrollment only to those able to self-consent were also analyzed to compare those who enrolled with those not able to consent. RESULTS: Overall, 10% (54 of 517) were enrolled using surrogate authorization. Self-consented and surrogate-authorized cases did not differ significantly in age, sex, or conventional risk factors. Surrogate-authorized cases had significantly more severe stroke deficits, larger infarcts, and infarcts localizing to left supratentorial regions. Similarly, at the site restricting enrollment, stroke severity and characteristics differed between self-consented individuals and those otherwise eligible but unable to provide consent. CONCLUSIONS: Failure to permit surrogate authorization in genetic studies of ischemic stroke may skew enrollment toward less severe strokes caused by smaller infarcts. This potential consent bias may undermine the ability to identify genetic determinants of risk and severity and suggests that surrogate enrollment in these studies can be ethically justifiable.

National recommendations for enhancing the conduct of ethical health research with human participants in post-disaster situations.

The intricacies and time- sensitivity of conducting high- quality and clinically relevant health-related human subject research in post-disaster situations challenges traditional approaches to ensuring optimal protection that study participants are protected from exploitation and harm. This article briefly reviews the ethics and guidelines for conducting research in post-disaster periods and offers recommendations to improve human subjects research conducted in situations defined by the National Response Framework as 'disasters' and 'emergencies.'

Relapse to opioid use disorder after inpatient treatment: Protective effect of injection naltrexone.

BACKGROUND: Opioid use disorder is often treated with short term hospitalization and medically supervised withdrawal from opioids followed by counseling alone without medication assisted treatment (MAT). More evidence is needed to confirm the expectation that the rate of relapse would be high after short term inpatient treatment and withdrawal from opioids without follow-up MAT. OBJECTIVE/METHODS: To examine relapse to opioid use disorder in a randomized, multi-site effectiveness trial of extended-release injection naltrexone (XR-NTX) vs community-based treatment as usual (TAU) without medication, as a function of the type of clinical service where treatment was initiated-short-term inpatient (N=59), long-term inpatient (N=48), or outpatient (N=201). Inpatients typically were admitted to treatment actively using opioids and had completed withdrawal from opioids before study entry. Outpatients typically presented already abstinent for varying periods of time. RESULTS: One month after randomization, relapse rates on TAU by setting were: short-term inpatient: 63%; long term inpatient: 14%; outpatient: 28%. On XR-NTX relapse rates after one month were low (<12%) across all three settings. At the end of the 6 month trial, relapse rates on TAU were high across all treatment-initiation settings (short term inpatient 77%; long term inpatient 59%; outpatient 61%), while XR-NTX exerted a modest protective effect against relapse across settings (short term inpatient: 59%; long term inpatient 46%; outpatient 38%). CONCLUSIONS: Short term inpatient treatment is associated with a high rate of relapse among patients with opioid use disorder. These findings support the recommendation that medically supervised withdrawal from opioids should be followed by medication assisted treatment.

Do patient characteristics moderate the effect of extended-release naltrexone (XR-NTX) for opioid use disorder?

BACKGROUND: Extended release naltrexone (XR-NTX) injected intramuscularly monthly has been shown to reduce relapse in persons with opioid use disorder. Baseline factors, including patients' demographics, comorbidities and lifestyle, may help identify patients who will benefit most or least from XR-NTX treatment. METHODS: Potential moderators of XR-NTX's effect were examined in the largest North American randomized open-label effectiveness trial of XR-NTX. Relapse status (Yes/No) at 6-month follow-up was regressed on treatment group (XR-NTX, N=153; or Treatment-as-Usual [TAU], N=155), baseline covariates, and their two-way interaction to identify moderator effects. Baseline covariates included age, gender, summary scores for depression, suicidal thoughts, drug abuse risk, substance use, medical, psychiatric and employment status, socialization, legal and family/social issues, history of abuse and quality of life measures. RESULTS: Alcohol use to intoxication in the 30days before randomization was a significant moderator: during the treatment phase, those who reported being recently intoxicated before randomization to XR-NTX relapsed to opioids at a rate (56%) similar to TAU (58%), while those without alcohol intoxication in the prior 30days had a lower rate of opioid relapse (41% vs. 65%, respectively, P<0.04). CONCLUSIONS: XR-NTX appeared to work equally well across subgroups with diverse demographic, addiction, mental health and environmental characteristics, with the possible exception of working better among those without recent alcohol intoxication. These findings should be reassuring to practitioners increasingly using XR-NTX as medical addiction therapy in diverse and often vulnerable populations.

Personal Control Over Decisions to Participate in Research by Persons With Histories of Both Substance Use Disorders and Criminal Justice Supervision.

Individuals must feel free to exert personal control over decisions regarding research participation. We present an examination of participants' perceived personal control over, as well as reported pressures and threats from others, influencing their decision to join a study assessing the effectiveness of extended-release naltrexone in preventing opioid dependence relapse. Most participants endorsed a strong sense of control over the decision; few reported pressures or threats. Although few in number, participants' brief narrative descriptions of the pressures and threats are illuminating and provide context for their perceptions of personal control. Based on this work, we propose a useful set of tools to help ascertain participants' sense of personal control in joining research.

Cost-effectiveness of extended release naltrexone to prevent relapse among criminal justice-involved individuals with a history of opioid use disorder.

BACKGROUND AND AIMS: Criminal justice-involved individuals are highly susceptible to opioid relapse and overdose-related deaths. In a recent randomized trial, we demonstrated the effectiveness of extended-release naltrexone (XR-NTX; Vivitrol® ) in preventing opioid relapse among criminal justice-involved US adults with a history of opioid use disorder. The cost of XR-NTX may be a significant barrier to adoption. Thus, it is important to account for improved quality of life and downstream cost-offsets. Our aims were to (1) estimate the incremental cost per quality-adjusted life-year (QALY) gained for XR-NTX versus treatment as usual (TAU) and evaluate it relative to generally accepted value thresholds; and (2) estimate the incremental cost per additional year of opioid abstinence. DESIGN: Economic evaluation of the aforementioned trial from the taxpayer perspective. Participants were randomized to 25 weeks of XR-NTX injections or TAU; follow-up occurred at 52 and 78 weeks. SETTING: Five study sites in the US Northeast corridor. PARTICIPANTS: A total of 308 participants were randomized to XR-NTX (n = 153) or TAU (n = 155). MEASUREMENTS: Incremental costs relative to incremental economic and clinical effectiveness measures, QALYs and abstinent years, respectively. FINDINGS: The 25-week cost per QALY and abstinent-year figures were $162 150 and $46 329, respectively. The 78-week figures were $76 400/QALY and $16 371/abstinent year. At 25 weeks, we can be 10% certain that XR-NTX is cost-effective at a value threshold of $100 000/QALY and 62% certain at $200 000/QALY. At 78 weeks, the cost-effectiveness probabilities are 59% at $100 000/QALY and 76% at $200 000/QALY. We can be 95% confident that the intervention would be considered 'good value' at $90 000/abstinent year at 25 weeks and $500/abstinent year at 78 weeks. CONCLUSIONS: While extended-release naltrexone appears to be effective in increasing both quality-adjusted life-years (QALYs) and abstinence, it does not appear to be cost-effective using generally accepted value thresholds for QALYs, due to the high price of the injection.

Assessing informed consent in an opioid relapse prevention study with adults under current or recent criminal justice supervision.

Concerns persist that individuals with substance use disorders who are under community criminal justice supervision experience circumstances that might compromise their provision of valid, informed consent for research participation. These concerns include the possibilities that desire to obtain access to treatment might lead individuals to ignore important information about research participation, including information about risks, or that cognitive impairment associated with substance use might interfere with attending to important information. We report results from a consent quiz (CQ) administered in a multisite randomized clinical trial of long-acting naltrexone to prevent relapse to opioid use disorder among adults under community criminal justice supervision-a treatment option difficult to access by this population of individuals. Participants were required to answer all 11 items correctly before randomization. On average, participants answered 9.8 items correctly (89%) at baseline first attempt (n=306). At week 21 (n=212), participants scored 87% (9.5 items correct) without review. Performance was equivalent to, or better than, published results from other populations on a basic consent quiz instrument across multiple content domains. The consent quiz is an efficient method to screen for adequate knowledge of consent information as part of the informed consent process. Clinical researchers who are concerned about these issues should consider using a consent quiz with corrected feedback to enhance the informed consent process. Overall, while primarily useful as an educational tool, employing a CQ as part of the gateway to participation in research may be particularly important as the field continues to advance and tests novel experimental treatments with significant risks and uncertain potential for benefit.