Ensuring Safe Practice by Late Career Physicians: Institutional Policies and Implementation Experiences.

BACKGROUND: Late career physicians (LCPs; physicians working beyond age 65 to 75 years) may be at higher risk for delivering unsafe care. To oversee LCPs, some health care organizations (HCOs) have adopted LCP policies requiring cognitive, physical, and practice performance screening assessments. Despite recent controversies, little is known about the content and implementation of such policies. OBJECTIVE: To characterize key features of LCP policies and the perspectives of medical leaders responsible for policy development and implementation. DESIGN: Mixed-methods study using content analysis and key informant interviews. SETTING: 29 U.S. HCOs with LCP policies active in 2020. PARTICIPANTS: 21 purposively sampled interviewees in physician leadership roles at 18 HCOs. MEASUREMENTS: Descriptive statistics of policy features and content analysis of interviews. RESULTS: Although policies had many commonalities-mandatory universal screening at a trigger age around 70 years, a strategy of screening followed by in-depth assessment of positive results, and commitment to patient safety as the key motive-they varied substantially in the testing required, funding, processes after a positive screening result, and decision making around concerning results. Policies prioritized institutional discretion in interpreting and responding to test results; many lacked clear language about appeals or other procedural protections for physicians. Leaders were generally satisfied with policies but reported preemptive retirements as physicians approached the screening age and cautioned that substantial investment in cultivating physicians' buy-in was required for successful rollout. LIMITATIONS: Sampled policies and interviews may not be representative of all HCOs. The analysis excluded the experiences of HCOs that tried and failed to implement LCP screening. CONCLUSION: Policies about LCPs are considered successful by institutional leaders. Policy variations and early adopters' implementation experiences highlight opportunities to improve physician acceptance and program rigor. PRIMARY FUNDING SOURCE: The Greenwall Foundation.

AAAAI Position Statement on Changing Electronic Health Record Allergy Documentation to "Alerts" to Lead to Easily Understood, Actionable Labels.

The term "allergy" is inaccurate for the vast majority of the contents in the current allergy fields of electronic health records (EHRs). While EHRs have transformed access to health information and streamlined the delivery of care, their ability to reliably indicate medications, vaccines, or foods that mandate avoidance versus preferences or mild intolerances, is suboptimal. The current systems are reactive instead of being proactive and frequently fail to communicate the appropriate course of action. This Position Statement of the American Academy of Allergy, Asthma and Immunology (AAAAI) advocates for a change in terminology. The section of the EHR currently labeled "allergies" should be renamed "alerts." The term "alert" accurately captures the purpose of this section without incorrectly assigning an allergic mechanism, and prioritizes easily understood and actionable labels. This change has the potential to simultaneously improve patient safety and care. This shift will be the first step in the transformation of the alerts section of the EHR. This document provides a framework for categorizing what should be included in this section. Enacting these changes will require EHR and clinical decision support vendors, healthcare and data standard regulators, allergists, and the larger health care community to work together to bring about these important advances.

Biologics in Aspirin-Exacerbated Respiratory Disease and Allergic Bronchopulmonary Aspergillosis.

Biologic medications have dramatically altered the landscape for treatment of allergic conditions including aspirin-exacerbated respiratory disease (AERD) and allergic bronchopulmonary aspergillosis (ABPA). Biologics should be considered for patients who are refractory to first line therapies for ABPA. Biologics should be discussed with patients with AERD. Variable responses to different biologics indicate that there may be various endotypes of AERD and ABPA, similar to asthma. Alternative biologics may be considered in patients who fail to respond to initial treatment.

A Standard Approach to Project-Based Learning in a Clinical Informatics Fellowship.

BACKGROUND: The Accreditation Council for Graduate Medical Education suggests that Clinical Informatics (CI) fellowship programs foster broad skills, which include collaboration and project management. However, they do not dictate how to best accomplish these learning objectives. OBJECTIVES: This study aimed to describe a standard approach to project-based learning for CI, to share its implementation, and to discuss lessons learned. METHODS: We created a standard approach to project-based learning based on concepts from adult learning theory, the project life cycle framework, the Toyota Production System, and Improvement Science. RESULTS: With this standard approach in place, we learned how best to support fellows in its use. In addition to this approach to supporting needs assessment, risk/change management, implementation, and evaluation/improvement skills, we found the need to develop fellow skills in collaboration, leadership, and time management/managing up. Supported by project-based learning using this standard approach, and with targeted project selection to meet topic-based learning objectives, fellows reached the ability to practice independently in 15 to 21 months. DISCUSSION: Fellows are uniquely positioned to ensure the success of projects due to their increased availability and protected time compared with attendings. They are readily available for project teams to draw upon their expertise with clinical workflows and understanding of technological solutions. Project-based learning addressing organizational priorities complements fellow project management coursework and improves fellows' ability to function successfully in large, complex, and dynamic organizations. Exposing fellows to contemporary problems, then addressing them through projects, provides fellows with up-to-date applied informatics knowledge. CONCLUSION: Project-based learning can ensure that many general CI learning objectives are supported inherently. It reinforces project management teachings, while providing fellows with a marketable project portfolio to aid with future job applications. Having projects tightly aligned with organizational priorities supports ongoing investment in fellowship programs.

Isotype deficiencies (IgG subclass and selective IgA, IgM, IgE deficiencies).

Background: Immunoglobulin G (IgG) subclass deficiencies and isolated IgA, IgM, IgE deficiencies have all been described in the literature with variable prevalence. Methods: These isotype deficiencies have a variable presentation from asymptomatic to recurrent infections resistant to prophylactic antibiotics. Results: Atopic disorders and autoimmune diseases are common comorbidities. IgE deficiency has been associated with impaired vaccine response and an increased risk of malignancy, particularly in patients with no allergic comorbidities and those with non-common variable immunodeficiency (CVID) humoral immunodeficiency, IgM deficiency, IgG2 deficiency, and CD4 lymphopenia. Conclusion: Close monitoring for malignancy should be strongly considered for these patients who are at risk. Treatment is variable and may include antimicrobial therapies for illnesses and prophylactic antibiotics in select patients, and immunoglobulin replacement can be considered for patients with refractory, recurrent infections.

EDS-FLU efficacy in patients with chronic rhinosinusitis with or without prior sinus surgery in ReOpen1 and ReOpen2 randomized controlled trials.

BACKGROUND: The inability of topical medications to reach sinus cavities is a potential reason for lack of efficacy in chronic rhinosinusitis (CRS). One purpose of endoscopic sinus surgery (ESS) is to enable delivery of medications into the sinus cavities. The exhalation delivery system with fluticasone (EDS-FLU; XHANCE) creates unique biomechanics that enable deposition of intranasal corticosteroid into sinuses and sinus drainage pathways but may have differing efficacy in operated versus unoperated sinuses. Two 24-week randomized trials (ReOpen1/2) evaluated EDS-FLU versus EDS-placebo in patients with CRS, stratified by surgical status. METHODS: Surgery-naive (n = 332) and prior-surgery (n = 215) patient groups were analyzed as pooled data from ReOpen1/2. Outcome measures (least-squares mean change from baseline) included combined symptom score (CSS) and congestion score at weeks 4, 8, and 12 and average of percentages of opacified volume (APOV) of ethmoid/maxillary sinuses on CT and Sinonasal Outcome Test 22 (SNOT-22) total score at week 24. RESULTS: Baseline scores suggested moderate-severe disease: mean CSS = 5.8; APOV = 67.2%. EDS-FLU produced significant improvement versus placebo (p < 0.05): CSS (surgery-naive, -0.68 vs. -1.42; prior ESS, -0.70 vs. -1.87); congestion (surgery-naive, -0.24 vs. -0.59; prior ESS, -0.24 vs. -0.69); and SNOT-22 (surgery-naive, -7.56 vs. -18.30; prior ESS, -10.72 vs. -18.74). Similar results were observed for APOV (p < 0.05). No statistically significant difference was observed between surgery subgroups with either EDS-FLU dose. CONCLUSION: EDS-FLU improved symptoms, sinus opacification, and quality of life in patients with CRS with or without prior ESS, suggesting a role for EDS-FLU in both populations.

Crowdsourced Feedback to Improve Resident Physician Error Disclosure Skills: A Randomized Clinical Trial.

Importance: Residents must prepare for effective communication with patients after medical errors. The video-based communication assessment (VCA) is software that plays video of a patient scenario, asks the physician to record what they would say, engages crowdsourced laypeople to rate audio recordings of physician responses, and presents feedback to physicians. Objective: To evaluate the effectiveness of VCA feedback in resident error disclosure skill training. Design, Setting, and Participants: This single-blinded, randomized clinical trial was conducted from July 2022 to May 2023 at 7 US internal medicine and family medicine residencies (10 total sites). Participants were second-year residents attending required teaching conferences. Data analysis was performed from July to December 2023. Intervention: Residents completed 2 VCA cases at time 1 and were randomized to the intervention, an individual feedback report provided in the VCA application after 2 weeks, or to control, in which feedback was not provided until after time 2. Residents completed 2 additional VCA cases after 4 weeks (time 2). Main Outcomes and Measures: Panels of crowdsourced laypeople rated recordings of residents disclosing simulated medical errors to create scores on a 5-point scale. Reports included learning points derived from layperson comments. Mean time 2 ratings were compared to test the hypothesis that residents who had access to feedback on their time 1 performance would score higher at time 2 than those without feedback access. Residents were surveyed about demographic characteristics, disclosure experience, and feedback use. The intervention's effect was examined using analysis of covariance. Results: A total of 146 residents (87 [60.0%] aged 25-29 years; 60 female [41.0%]) completed the time 1 VCA, and 103 (70.5%) completed the time 2 VCA (53 randomized to intervention and 50 randomized to control); of those, 28 (54.9%) reported reviewing their feedback. Analysis of covariance found a significant main effect of feedback between intervention and control groups at time 2 (mean [SD] score, 3.26 [0.45] vs 3.14 [0.39]; difference, 0.12; 95% CI, 0.08-0.48; P = .01). In post hoc comparisons restricted to residents without prior disclosure experience, intervention residents scored higher than those in the control group at time 2 (mean [SD] score, 3.33 [0.43] vs 3.09 [0.44]; difference, 0.24; 95% CI, 0.01-0.48; P = .007). Worse performance at time 1 was associated with increased likelihood of dropping out before time 2 (odds ratio, 2.89; 95% CI, 1.06-7.84; P = .04). Conclusions and Relevance: In this randomized clinical trial, self-directed review of crowdsourced feedback was associated with higher ratings of internal medicine and family medicine residents' error disclosure skill, particularly for those without real-life error disclosure experience, suggesting that such feedback may be an effective way for residency programs to address their requirement to prepare trainees for communicating with patients after medical harm. Trial Registration: ClinicalTrials.gov Identifier: NCT06234085.

Mast Cells in Aspirin-Exacerbated Respiratory Disease.

PURPOSE OF REVIEW: Aspirin-exacerbated respiratory disease (AERD) is a syndrome of high type 2 inflammation and is known to critically involve mast cell activation. The mast cell is an important cell in the baseline inflammatory processes in the upper and lower airway by maintaining and amplifying type 2 inflammation. But it also is prominent in the hypersensitivity reaction to COX-1 inhibition which defines this condition. RECENT FINDINGS: Recent work highlights the mast cell as a focal point in AERD pathogenesis. Using AERD as a specific model of both high type 2 asthma and chronic sinusitis, the role of mast cell activity can be better understood in other aspects of airway inflammation. Further dissecting out the mechanism of COX-1-mediated mast cell activation in AERD will be an important next phase in our understanding of NSAID-induced hypersensitivity as well as AERD pathophysiology.

Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials (ReOpen1 and ReOpen2).

BACKGROUND: Chronic rhinosinusitis (CRS) is a prevalent inflammatory disease. No medications are Food and Drug Administration-approved for the most common form, CRS without nasal polyps (also called "chronic sinusitis"). Novel biomechanics of the exhalation delivery system deliver fluticasone (EDS-FLU; XHANCE) to sinonasal areas above the inferior turbinate, especially sinus drainage pathways not reached by standard-delivery nasal sprays. OBJECTIVE: Assess EDS-FLU efficacy for CRS (irrespective of nasal polyps). METHODS: Two randomized, EDS-placebo-controlled trials in adults with CRS irrespective of polyps (ReOpen1) or exclusively without polyps (ReOpen2) were conducted at 120 sites in 13 countries. Patients received EDS-FLU 1 or 2 sprays/nostril, or EDS-placebo, twice daily for 24 weeks. Coprimary measures were composite symptom score through week 4 and ethmoid/maxillary sinus percent opacification by computed tomography at week 24. RESULTS: ReOpen1 (N = 332) composite symptom score least-squares mean change for EDS-FLU 1 or 2 sprays/nostril versus EDS-placebo was -1.58 and -1.60 versus -0.62 (P < .001, P < .001); ReOpen2 (N = 223), -1.54 and -1.74 versus -0.81 (P = .011, P = .001). In ReOpen1, sinus opacification least-squares mean change for EDS-FLU 1 or 2 sprays/nostril versus EDS-placebo was -5.58 and -6.20 versus -1.60 (P = .045, P = .018), and in ReOpen2, -7.00 and -5.14 versus +1.19 (P < .001, P = .009). Acute disease exacerbations were reduced by 56% to 66% with EDS-FLU versus EDS-placebo (P = .001). There were significant, and similar magnitude, symptom reductions in patients using standard-delivery nasal steroid products just before entering the study (P < .001). Adverse events were similar to standard-delivery intranasal steroids. CONCLUSIONS: EDS-FLU is the first nonsurgical treatment demonstrated to reduce symptoms, intrasinus opacification, and exacerbations in replicate randomized clinical trials in CRS, regardless of polyp status.

Should Biologics Be Used Before Aspirin Desensitization in Aspirin-Exacerbated Respiratory Disease?

There has been a paradigm shift in the management of aspirin-exacerbated respiratory disease (AERD). It started in 2015 when the first biologic was Food and Drug Administration (FDA) approved for severe eosinophilic asthma. Thus, there emerged a new era in the treatment of patients with type 2-mediated airway diseases. This has led to an increasing number of options for patients, undoubtably a great thing, but has left clinicians without a clear answer for how to balance the therapies that exist for AERD, what to recommend for treatment, and how to best assess the benefits and risks of each therapy. This paper aims to explore these benefits and risks, and to provide a roadmap for future studies.

Case Report: Initial Successful Treatment of Migraine and Irritable Bowel Syndrome With a Low-FODMAP Diet.

OBJECTIVE: Migraine and irritable bowel syndrome (IBS) can be difficult-to-treat comorbidities that may be driven by underlying gut-brain axis dysfunction. This report describes utilization of a low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet (LFD) in a patient with refractory migraine and co-occurring IBS. METHODS: After unremarkable physical and neurological examinations, a 57-year-old woman with IBS and chronic migraine was started on a LFD under the guidance of a registered dietician. Psychometrically validated surveys administered at baseline and initial follow-up assessed patient-reported outcomes related to migraine and IBS symptoms. RESULTS: At baseline, the patient reported 80/90 migraine days with average pain of 8/10, a Migraine Disability Assessment (MIDAS) score of 33, and Headache Impact Test-6 (HIT-6) score of 64, the latter 2 scores indicating severe disability. Baseline IBS symptom severity was noted at 9/10. Within 1 week on a LFD, the patient's IBS symptoms and migraines improved in both frequency and intensity of episodes. After 5 weeks on a LFD elimination, the patient's clinical improvement continued and she reported significant reduction in migraines, with average pain of 1/10 and IBS severity of 3/10. The patient also improved from severe to minimal levels of disability on validated measures (MIDAS, HIT-6, and IBS Patient Global Impression of Change). CONCLUSION: This is the first case report detailing successful initial treatment of migraine and co-occurring IBS utilizing a dietician-guided LFD. There are a number of important reasons for potential improvement in these gut-brain axis disorders which are reviewed as well as an implication for long-term management and food reintroduction. Larger, randomized trials evaluating a LFD in diverse individuals with migraine and co-occurring IBS are warranted to help confirm these results.

Lower serum 15-HETE level predicts nasal ILC2 accumulation during COX-1 inhibition in AERD.

BACKGROUND: Aspirin-exacerbated respiratory disease (AERD) is associated with high levels of cysteinyl leukotrienes, prostaglandin D2, and low levels of prostaglandin E2. Further, 15-hydroxyeicosatetraenoic acid (15-HETE) levels may have predictive value in therapeutic outcomes of aspirin desensitization. Accumulation of nasal group 2 innate lymphoid cells (ILC2s) has been demonstrated during COX-1 inhibition in AERD, although the relationships between tissue ILC2 accumulation, reaction symptom severity, and novel lipid biomarkers are unknown. OBJECTIVE: We sought to determine whether novel lipid mediators are predictive of nasal ILC2 accumulation and symptom scores during COX-1 inhibitor challenge in patients with AERD. METHODS: Blood and nasal scraping samples from patients with AERD were collected at baseline and COX-1 inhibitor reaction and then processed for flow cytometry for nasal ILC2s and serum for lipidomic analysis. RESULTS: Eight patients with AERD who were undergoing aspirin desensitization were recruited. Of the 161 eicosanoids tested, 42 serum mediators were detected. Baseline levels of 15-HETE were negatively correlated with the change in numbers of airway ILC2s (r = -0.6667; P = .0428). Docosahexaenoic acid epoxygenase metabolite 19,20-dihydroxy-4Z,7Z,10Z,13Z,16Z-docosapentaenoic acid (19,20-diHDPA) was positively correlated with both changes in airway ILC2s (r = 0.7143; P = .0305) and clinical symptom scores (r = 0.5000; P = .0081). CONCLUSION: Low levels of baseline 15-HETE predicted a greater accumulation of airway ILC2s in patients with AERD who were receiving COX-1 inhibition. Further, increases in the cytochrome P pathway metabolite 19,20-dihydroxy-4Z,7Z,10Z,13Z,16Z-docosapentaenoic acid (19,20-diHDPA) were associated with increased symptoms and nasal ILC2 accumulation. Future studies to assess how these mediators might control ILC2s may improve the understanding of AERD pathogenesis.

Evaluation of an experiential training program in patient-centered outcomes and comparative effectiveness research for diverse researcher communities and health care organizations.

Background/Objective: The goal of the Patient-Centered Outcomes Research Partnership was to prepare health care professionals and researchers to conduct patient-centered outcomes and comparative effectiveness research (CER). Substantial evidence gaps, heterogeneous health care systems, and decision-making challenges in the USA underscore the need for evidence-based strategies. Methods: We engaged five community-based health care organizations that serve diverse and underrepresented patient populations from Hawai'i to Minnesota. Each partner nominated two in-house scholars to participate in the 2-year program. The program focused on seven competencies pertinent to patient-centered outcomes and CER. It combined in-person and experiential learning with asynchronous, online education, and created adaptive, pragmatic learning opportunities and a Summer Institute. Metrics included the Clinical Research Appraisal Inventory (CRAI), a tool designed to assess research self-efficacy and clinical research skills across 10 domains. Results: We trained 31 scholars in 3 cohorts. Mean scores in nine domains of the CRAI improved; greater improvement was observed from the beginning to the midpoint than from the midpoint to conclusion of the program. Across all three cohorts, mean scores on 52 items (100%) increased (p ≤ 0.01), and 91% of scholars reported the program improved their skills moderately/significantly. Satisfaction with the program was high (91%). Conclusions: Investigators that conduct patient-centered outcomes and CER must know how to collaborate with regional health care systems to identify priorities; pose questions; design, conduct, and disseminate observational and experimental research; and transform knowledge into practical clinical applications. Training programs such as ours can facilitate such collaborations.