Pharmacogenomics-Based Point-of-Care Clinical Decision Support Significantly Alters Drug Prescribing.

Changes in behavior are necessary to apply genomic discoveries to practice. We prospectively studied medication changes made by providers representing eight different medicine specialty clinics whose patients had submitted to preemptive pharmacogenomic genotyping. An institutional clinical decision support (CDS) system provided pharmacogenomic results using traffic light alerts: green = genomically favorable, yellow = genomic caution, red = high risk. The influence of pharmacogenomic alerts on prescribing behaviors was the primary endpoint. In all, 2,279 outpatient encounters were analyzed. Independent of other potential prescribing mediators, medications with high pharmacogenomic risk were changed significantly more often than prescription drugs lacking pharmacogenomic information (odds ratio (OR) = 26.2 (9.0-75.3), P < 0.0001). Medications with cautionary pharmacogenomic information were also changed more frequently (OR = 2.4 (1.7-3.5), P < 0.0001). No pharmacogenomically high-risk medications were prescribed during the entire study when physicians consulted the CDS tool. Pharmacogenomic information improved prescribing in patterns aimed at reducing patient risk, demonstrating that enhanced prescription decision-making is achievable through clinical integration of genomic medicine.

Patient Perceptions of Care as Influenced by a Large Institutional Pharmacogenomic Implementation Program.

Despite growing clinical use of genomic information, patient perceptions of genomic-based care are poorly understood. We prospectively studied patient-physician pairs who participated in an institutional pharmacogenomic implementation program. Trust/privacy/empathy/medical decision-making (MDM)/personalized care dimensions were assessed through patient surveys after clinic visits at which physicians had access to preemptive pharmacogenomic results (Likert scale, 1 = minimum/5 = maximum; mean [SD]). From 2012-2015, 1,261 surveys were issued to 507 patients, with 792 (62.8%) returned. Privacy, empathy, MDM, and personalized care scores were significantly higher after visits when physicians considered pharmacogenomic results. Importantly, personalized care scores were significantly higher after physicians used pharmacogenomic information to guide medication changes (4.0 [1.4] vs. 3.0 [1.6]; P < 0.001) compared with prescribing visits without genomic guidance. Multivariable modeling controlling for clinical factors confirmed personalized care scores were more favorable after visits with genomic-influenced prescribing (odds ratio [OR] = 3.26; 95% confidence interval [CI] = (1.31-8.14); P < 0.05). Physicians seem to individualize care when utilizing pharmacogenomic results and this decision-making augmentation is perceived positively by patients.

Clinical impact of treatment timing for chronic hepatitis C infection: a decision model.

Recent advances in the treatment of hepatitis C virus (HCV) infection have led to the availability of both highly efficacious interferon-containing and interferon-sparing regimens. However, the use of such therapies faces restrictions due to high costs. For patients who are medically eligible to receive interferon, the choice between the two will likely be impacted by preferences surrounding interferon, severity of disease, coverage policies and out-of-pocket costs. We developed a decision model to quantify the trade-offs between immediate, interferon-containing therapy and delayed, interferon-free therapy for patients with chronic, genotype 1 HCV infection. We projected the quality-adjusted life expectancy stratified by the presence or absence of cirrhosis for four strategies: (i) no treatment; (ii) immediate, one-time treatment with an interferon-containing regimen; (iii) immediate treatment as above with the opportunity for retreatment in patients who fail to achieve sustained virologic response with interferon-free therapy in 1 year; and (iv) delayed therapy with interferon-free therapy in 1 year. When compared to one-time immediate treatment with the interferon-containing regimen, delayed treatment with the interferon-free regimen in 1 year resulted in longer life expectancy, with a 0.2 quality-adjusted life year (QALY) increase in noncirrhotic patients, and a 1.1 QALY increase in patients with cirrhosis. This superiority in health benefits was lost when wait time for interferon-free therapy was greater than 3-3.2 years. In this modelling analysis, interferon-free therapy resulted in superior health benefits compared to immediate therapy with interferon until wait time exceeded 3-3.2 years. Such data can inform decision-making regarding treatment initiation for HCV as healthcare financing evolves.

Nonprofit biomedical companies.

Nonprofit biomedical firms are an integrated market-based solution to improve incentives for investment in promising scientific areas that have high social value but minimal potential for profit. We briefly review the current market with an emphasis on the financing of innovative product development and propose ideas for new nonprofit companies centered on the health concerns of developed countries. We conclude with a suggestion that opportunities exist for nonprofit firms focused on cancer diagnostics, given the limitations of current financing incentives and ripe scientific opportunity.

Resident uncertainty in clinical decision making and impact on patient care: a qualitative study.

BACKGROUND: Little is known regarding how internal medicine residents manage uncertainty during decision making and subsequent effects on patient care. The aims of this study were to describe types of uncertainty faced by residents, strategies employed to manage uncertainty and effects on patient care. METHODS: Using critical incident technique, residents were asked to recall important clinical decisions during a recent call night, with probes to identify decisions made during uncertainty. They were also asked to report who they approached for advice. Three authors independently coded transcripts using the constant comparative method. RESULTS: The 42/50 (84%) interviewed residents reported 18 discrete critical incidents. Six categories emerged and mapped to the domains of the Beresford Model of Clinical Uncertainty: technical uncertainty (procedural skills, knowledge of indications); conceptual uncertainty (care transitions, diagnostic decision making and management conflict) and personal uncertainty (goals of care). In managing uncertainty, residents report a "hierarchy of assistance", using colleagues and literature for initial management, followed by senior residents, specialty fellows and, finally, the attending physician. Barriers to seeking the attending physician's input included the existence of a defined hierarchy for assistance and fears of losing autonomy, revealing knowledge gaps, and "being a bother". For 12 of the 18 cases reported, patient care was compromised: delay in procedure or escalation of care (n = 8); procedural complications (n = 2); and cardiac arrest (n = 2). CONCLUSION: Resident uncertainty results in delays of indicated care and, in some cases, patient harm. Despite the presence of a supervisory figure, residents adhere to a hierarchy when seeking advice in clinical matters.

A theoretical framework and competency-based approach to improving handoffs.

BACKGROUND: Once characterised by remarkable continuity of care by a familiar doctor, patient care today is delivered by multiple physicians with varying degrees of knowledge of the patient. Yet, few trainees learn the potential risks of these transitions and the strategies to improve patient care during handoffs. Little is known regarding the mechanisms by which handoffs affect patient care. RESULTS: Building on theoretical constructs from the social sciences and illustrated with a case study of the implementation of a night float service for the inpatient general medicine services at the University of Chicago, a conceptual framework is proposed to describe how handoffs affect both patients and physicians. CONCLUSION: Using this conceptual framework, recommendations are made for formal education based on the core competencies of communication and professionalism. Opportunities to educate trainees in acquiring these skills are described in the context of handoffs of patient care.

Communication failures in patient sign-out and suggestions for improvement: a critical incident analysis.

BACKGROUND: The transfer of care for hospitalized patients between inpatient physicians is routinely mediated through written and verbal communication or "sign-out". This study aims to describe how communication failures during this process can lead to patient harm. METHODS: In interviews employing critical incident technique, first year resident physicians (interns) described (1) any adverse events or near misses due to suboptimal preceding patient sign-out; (2) the worst event due to suboptimal sign-out in which they were involved; and (3) suggestions to improve sign-out. All data were analyzed and categorized using the constant comparative method with independent review by three researchers. RESULTS: Twenty six interns caring for 82 patients were interviewed after receiving sign-out from another intern. Twenty five discrete incidents, all the result of communication failures during the preceding patient sign-out, and 21 worst events were described. Inter-rater agreement for categorization was high (kappa 0.78-1.00). Omitted content (such as medications, active problems, pending tests) or failure-prone communication processes (such as lack of face-to-face discussion) emerged as major categories of failed communication. In nearly all cases these failures led to uncertainty during decisions on patient care. Uncertainty may result in inefficient or suboptimal care such as repeat or unnecessary tests. Interns desired thorough but relevant face-to-face verbal sign-outs that reviewed anticipated issues. They preferred legible, accurate, updated, written sign-out sheets that included standard patient content such as code status or active and anticipated medical problems. CONCLUSION: Communication failures during sign-out often lead to uncertainty in decisions on patient care. These may result in inefficient or suboptimal care leading to patient harm.