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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.
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Colaboración de las Masas , Internado y Residencia , Errores Médicos , Humanos , Internado y Residencia/métodos , Femenino , Masculino , Colaboración de las Masas/métodos , Adulto , Errores Médicos/prevención & control , Competencia Clínica/estadística & datos numéricos , Competencia Clínica/normas , Método Simple Ciego , Revelación de la Verdad , Medicina Interna/educación , Relaciones Médico-Paciente , RetroalimentaciónRESUMEN
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.
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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.
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Pólipos Nasales , Rinitis , Rinosinusitis , Sinusitis , Adulto , Humanos , Enfermedad Crónica , Fluticasona/uso terapéutico , Pólipos Nasales/tratamiento farmacológico , Pólipos Nasales/inducido químicamente , Ensayos Clínicos Controlados Aleatorios como Asunto , Rinitis/tratamiento farmacológico , Rinitis/inducido químicamente , Sinusitis/tratamiento farmacológico , Sinusitis/inducido químicamente , Esteroides/uso terapéuticoRESUMEN
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.
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Asma Inducida por Aspirina , Pólipos Nasales , Sinusitis , Humanos , Mastocitos/patología , Sinusitis/inducido químicamente , Sinusitis/patología , Inflamación/patología , Aspirina/efectos adversosRESUMEN
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.
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Asma Inducida por Aspirina , Asma , Productos Biológicos , Pólipos Nasales , Trastornos Respiratorios , Rinitis , Sinusitis , Humanos , Aspirina/efectos adversos , Asma Inducida por Aspirina/tratamiento farmacológico , Desensibilización Inmunológica , Sinusitis/terapia , Asma/inducido químicamente , Productos Biológicos/efectos adversos , Pólipos Nasales/terapia , Enfermedad Crónica , Rinitis/terapiaRESUMEN
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.
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Síndrome del Colon Irritable , Trastornos Migrañosos , Polímeros , Humanos , Síndrome del Colon Irritable/dietoterapia , Síndrome del Colon Irritable/complicaciones , Femenino , Trastornos Migrañosos/dietoterapia , Persona de Mediana Edad , Oligosacáridos , Resultado del Tratamiento , Monosacáridos , Disacáridos , Dieta Baja en Carbohidratos/métodos , Dieta FODMAPRESUMEN
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.
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Asma Inducida por Aspirina , Pólipos Nasales , Sinusitis , Humanos , Inmunidad Innata , Linfocitos/metabolismo , Asma Inducida por Aspirina/tratamiento farmacológico , Ácidos Hidroxieicosatetraenoicos/uso terapéutico , Inhibidores de la Ciclooxigenasa/uso terapéutico , Sinusitis/tratamiento farmacológico , Mucosa Nasal/metabolismo , Prostaglandinas , Eicosanoides , Aspirina/efectos adversos , Pólipos Nasales/tratamiento farmacológicoRESUMEN
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.
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OBJECTIVE: To analyze published reports on the efficacy and safety of CSI in CRS and evaluate the clinical implications of current gaps in evidence. Corticosteroid irrigation (CSI) is commonly used for management of chronic rhinosinusitis (CRS) with nasal polyps; however, such use is not approved by the US Food and Drug Administration (FDA). DATA SOURCES: Publications were obtained through PubMed searches through January 2022. STUDY SELECTION: Searches were conducted using 2 terms: "chronic rhinosinusitis" or "nasal polyps" as the first term and "corticosteroid irrigation," "steroid nasal lavage," or "sinus rinse" as the second term. We reviewed relevant, peer-reviewed literature (19 original research [9 controlled, 10 uncontrolled trials], 7 reviews, and 1 meta-analysis) reporting safety and efficacy of CSI in patients with CRS. RESULTS: Studies were difficult to compare because they used a variety of solution volumes (60 mL to 125 mL per nostril), corticosteroid agents (budesonide, betamethasone, mometasone, or fluticasone), corticosteroid doses, preparation protocols (by compounding pharmacy or by patient), and administration (frequency, time of day, body positioning). It is difficult to determine which parameters might substantially influence clinical effects because studies were generally small, showed marginal benefits, and rarely assessed safety. To date, no studies evaluating CSI have shown statistically significant differences in a type-I error-controlled primary end point over any comparator, possibly owing to small sample sizes. CONCLUSION: Designing more robust clinical trials may help determine whether CSI is a valid treatment option. Until more evidence supporting CSI use exists, health care professionals should strongly consider choosing FDA-approved therapies for the treatment of CRS.
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Pólipos Nasales , Rinitis , Sinusitis , Humanos , Rinitis/tratamiento farmacológico , Corticoesteroides/uso terapéutico , Pólipos Nasales/tratamiento farmacológico , Esteroides/uso terapéutico , Lavado Nasal (Proceso) , Sinusitis/tratamiento farmacológico , Enfermedad CrónicaRESUMEN
BACKGROUND: US residents require practice and feedback to meet Accreditation Council for Graduate Medical Education mandates and patient expectations for effective communication after harmful errors. Current instructional approaches rely heavily on lectures, rarely provide individualized feedback to residents about communication skills, and may not assure that residents acquire the skills desired by patients. The Video-based Communication Assessment (VCA) app is a novel tool for simulating communication scenarios for practice and obtaining crowdsourced assessments and feedback on physicians' communication skills. We previously established that crowdsourced laypeople can reliably assess residents' error disclosure skills with the VCA app. However, its efficacy for error disclosure training has not been tested. OBJECTIVE: We aimed to evaluate the efficacy of using VCA practice and feedback as a stand-alone intervention for the development of residents' error disclosure skills. METHODS: We conducted a pre-post study in 2020 with pathology, obstetrics and gynecology, and internal medicine residents at an academic medical center in the United States. At baseline, residents each completed 2 specialty-specific VCA cases depicting medical errors. Audio responses were rated by at least 8 crowdsourced laypeople using 6 items on a 5-point scale. At 4 weeks, residents received numerical and written feedback derived from layperson ratings and then completed 2 additional cases. Residents were randomly assigned cases at baseline and after feedback assessments to avoid ordinal effects. Ratings were aggregated to create overall assessment scores for each resident at baseline and after feedback. Residents completed a survey of demographic characteristics. We used a 2×3 split-plot ANOVA to test the effects of time (pre-post) and specialty on communication ratings. RESULTS: In total, 48 residents completed 2 cases at time 1, received a feedback report at 4 weeks, and completed 2 more cases. The mean ratings of residents' communication were higher at time 2 versus time 1 (3.75 vs 3.53; P<.001). Residents with prior error disclosure experience performed better at time 1 compared to those without such experience (ratings: mean 3.63 vs mean 3.46; P=.02). No differences in communication ratings based on specialty or years in training were detected. Residents' communication was rated higher for angry cases versus sad cases (mean 3.69 vs mean 3.58; P=.01). Less than half of all residents (27/62, 44%) reported prior experience with disclosing medical harm to patients; experience differed significantly among specialties (P<.001) and was lowest for pathology (1/17, 6%). CONCLUSIONS: Residents at all training levels can potentially improve error disclosure skills with VCA practice and feedback. Error disclosure curricula should prepare residents for responding to various patient affects. Simulated error disclosure may particularly benefit trainees in diagnostic specialties, such as pathology, with infrequent real-life error disclosure practice opportunities. Future research should examine the effectiveness, feasibility, and acceptability of VCA within a longitudinal error disclosure curriculum.
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The allergy section of the electronic health record (EHR) is ideally reviewed and updated by health care workers during routine outpatient visits, emergency room visits, inpatient hospitalizations, and surgical procedures. This EHR section has the potential to help proactively and comprehensively avoid exposures to drugs, contact irritants, foods, and other agents for which, based on an individual's medical history and/or genetics, there is increased risk for adverse outcomes with future exposures. Because clinical decisions are made and clinical decision support is triggered based on allergy details from the EHR, the allergy module needs to provide meaningful, accurate, timely, and comprehensive allergy information. Although the allergy section of the EHR must meet these requirements to guide appropriate clinical decisions and treatment plans, current EHR allergy modules have not achieved this standard. We urge EHR vendors to collaborate with allergists to optimize and modernize allergy documentation. A work group within the Adverse Reactions to Drugs, Biologicals, and Latex Committee of the American Academy of Allergy, Asthma & Immunology was formed to create recommendations for allergy documentation in the EHR. Whereas it is recognized that the term "allergy" is often used incorrectly because most adverse drug reactions (ADRs) are not true immune-mediated hypersensitivity reactions, "allergy" in this article includes allergies and hypersensitivities as well as side effects and intolerances. Our primary objective is to provide guidance for the current state of allergy documentation in the EHR. This guidance includes clarification of the definition of specific ADR types, reconciliation of confirmed ADRs, and removal of disproved or erroneous ADRs. This document includes a proposal for the creation, education, and implementation of a drug allergy labeling system that may allow for more accurate EHR documentation for improved patient safety.