The Relationship of Paranasal Sinus Opacification to Hospital-Acquired Pneumonia in the Neurologic Intensive Care Unit Patient.

BACKGROUND: The association between intensive care unit (ICU) sinusitis and the development of lower airway infections remains unclear. The objective of this study was to determine the correlation between the development of radiographic sinus opacification and pneumonia in the neurologic ICU setting. METHODS: A retrospective review of head computed tomography or magnetic resonance imaging of 612 patients admitted to the neurocritical care unit at a tertiary care center from April 2013 through April 2014 was performed. Paranasal sinus opacification was measured using Lund-Mackay scores (LMS). A diagnosis of pneumonia was determined by the ICU team from radiographic, laboratory, and pulmonary data. Exclusion criteria included a history of endonasal surgery, sinonasal malignancy, facial fractures, ICU admission less than 3 days, or inadequate imaging. RESULTS: Worsening sinus opacification occurred in 42.6% of patients and pneumonia in 18.5% of patients during ICU admission. Of the patients who developed pneumonia, 71.7% also developed worsening sinus opacification (P < .001). In 80.2% of cases, the sinus opacification developed prior to the diagnosis of pneumonia. The mean highest LMS for patients who developed pneumonia was 4.24 compared to 1.99 in patients who did not develop pneumonia (P < .001). Sinus air-fluid levels or complete sinus opacification occurred in a larger proportion of patients who developed pneumonia (46.9% vs 19.4%, P < .001). Mortality rates for patients with no pneumonia or sinusitis, pneumonia only, sinusitis only, and sinusitis with pneumonia were 7.6%, 15.6%, 18.3%, and 25.9%, respectively (P < .001). CONCLUSIONS: This study finds a strong relationship between worsening sinus opacification in the neurologic ICU patient to the development of hospital-acquired pneumonia and increased mortality.

Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial.

IMPORTANCE: Dupilumab has demonstrated efficacy in patients with asthma and atopic dermatitis, which are both type 2 helper T-cell-mediated diseases. OBJECTIVE: To assess inhibition of interleukins 4 and 13 with dupilumab in patients with chronic sinusitis and nasal polyposis. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled parallel-group study conducted at 13 sites in the United States and Europe between August 2013 and August 2014 in 60 adults with chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids with 16 weeks of follow-up. INTERVENTIONS: Subcutaneous dupilumab (a 600 mg loading dose followed by 300 mg weekly; n = 30) or placebo (n = 30) plus mometasone furoate nasal spray for 16 weeks. MAIN OUTCOMES AND MEASURES: Change in endoscopic nasal polyp score (range, 0-8; higher scores indicate worse status) at 16 weeks (primary end point). Secondary end points included Lund-Mackay computed tomography (CT) score (range, 0-24; higher scores indicate worse status), 22-item SinoNasal Outcome Test score (range, 0-110; higher scores indicating worse quality of life; minimal clinically important difference ≥8.90), sense of smell assessed using the University of Pennsylvania Smell Identification Test (UPSIT) score (range, 0-40; higher scores indicate better status), symptoms, and safety. RESULTS: Among the 60 patients who were randomized (mean [SD] age, 48.4 years [9.4 years]; 34 men [56.7%]; 35 with comorbid asthma), 51 completed the study. The least squares (LS) mean change in nasal polyp score was -0.3 (95% CI, -1.0 to 0.4) with placebo and -1.9 (95% CI, -2.5 to -1.2) with dupilumab (LS mean difference, -1.6 [95% CI, -2.4 to -0.7]; P < .001). The LS mean difference between the 2 groups for the Lund-Mackay CT total score was -8.8 (95% CI, -11.1 to -6.6; P < .001). Significant improvements with dupilumab were also observed for the 22-item SinoNasal Outcome Test (LS mean difference between groups, -18.1 [95% CI, -25.6 to -10.6]; P < .001) and sense of smell assessed by UPSIT (LS mean difference, 14.8 [95% CI, 10.9 to 18.7]; P < .001). The most common adverse events were nasopharyngitis (33% in the placebo group vs 47% in the dupilumab group), injection site reactions (7% vs 40%, respectively), and headache (17% vs 20%). CONCLUSIONS AND RELEVANCE: Among adults with symptomatic chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids, the addition of subcutaneous dupilumab to mometasone furoate nasal spray compared with mometasone alone reduced endoscopic nasal polyp burden after 16 weeks. Further studies are needed to assess longer treatment duration, larger samples, and direct comparison with other medications. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01920893.

Prospective observational study of chronic rhinosinusitis: environmental triggers and antibiotic implications.

BACKGROUND: A prolonged course of antibiotic therapy is often initiated for chronic rhinosinusitis (CRS) based on symptomatology. We examined differences in clinical manifestations and underlying conditions in patients with symptoms typical for CRS. CT scan abnormality of the sinuses was the gold standard for diagnosis of CRS. METHODS: We performed a prospective observational study of 125 adults with classic symptoms of CRS undergoing nasal endoscopy and sinus CT. RESULTS: The patients were classified into 2 groups: (1) those with radiographic evidence of sinusitis by CT (Sx + CT) (75) and (2) those with normal CT scans of the sinus (Sx - CT) (50). Decreased smell was significantly more common in Sx + CT than in Sx - CT patients, (P = .003). Paradoxically, headache, facial pain, and sleep disturbance occurred significantly more frequently in patients with Sx - CT than in patients with Sx + CT (P < .05). The absence of mucopurulence on endoscopy proved to be highly specific for Sx - CT patients (100%). On the other hand, sensitivity was low; only 24% of Sx + CT patients demonstrated mucopurulence by endoscopy. Improvement in response to antibiotics was similar between both CRS categories. CONCLUSIONS: Most symptoms considered to be typical for CRS proved to be nonspecific. Interestingly, symptoms that were more severe were significantly more likely to occur in younger patients who were Sx - CT. The efficacy of antibiotic therapy was uncertain. We suggest that objective evidence of mucopurulence assessed by endoscopy or CT should be obtained if antibiotics are to be given for prolonged duration. We recommend a moratorium for the widespread practice of a prolonged course of empiric antibiotics in patients with presumed CRS.

Role of antibiotics in sinusitis.

PURPOSE OF REVIEW: Sinusitis is a leading reason for outpatient antibiotic use, but symptoms are nonspecific. We review potential methods that might enhance the ability to appropriately prescribe antibiotics. RECENT FINDINGS: The evidence base for antibiotic use in acute rhinosinusitis is strongest in studies with stringent entry criteria. In less restrictive studies antibiotics and placebo perform equally. Bacteria from nasopharyngeal swabs in adults correlate with sinus cultures. A recent study showed that antibiotics shortened the duration of acute rhinosinusitis (ARS) symptoms in children. Tellingly, over 2000 children with symptoms were screened to enroll less than 10% who fulfilled the study's stringent criteria. In chronic rhinosinusitis (CRS), two grade 1 studies on efficacy of long-term macrolide therapy showed conflicting results. Odontogenic sinusitis is underappreciated and frequently fails to grow on culture because of presumed difficulty in growing anaerobes. SUMMARY: There is currently no grade 1 evidence to support antibiotic use in CRS; however, studies to date have not been conducted in patients with isolated purulent sinusitis. Future use of cultures to direct antibiotic therapy, such as nasopharyngeal swabs in adults with ARS or endoscopically guided cultures, may aid in targeting antibiotic therapy more effectively.

Dexpramipexole depletes blood and tissue eosinophils in nasal polyps with no change in polyp size.

OBJECTIVE: Chronic rhinosinusitis with nasal polyps (CRSwNP) and eosinophilia is a disease of the upper respiratory tract for which few therapies are available. Because the oral investigational drug dexpramipexole serendipitously decreased blood eosinophils in amyotrophic lateral sclerosis studies, we assessed its safety, eosinophil-lowering activity, and preliminary clinical efficacy in patients with CRSwNP and eosinophilia. METHODS: Sixteen subjects with CRSwNP, absolute eosinophil count (AEC) ≥ 0.300 × 109 /L, and polyp tissue eosinophils were evaluable for efficacy in a 6-month open-label, multi-center study of dexpramipexole 150 mg twice daily. The coprimary endpoints were change in AEC and change in total polyp score (TPS) from baseline to month 6, with additional clinical and histologic endpoints assessed. RESULTS: Thirteen of 16 subjects completed 6 months of dexpramipexole treatment. Geometric mean baseline AEC was 0.525 ± 0.465 eosinophils × 109 /L and decreased to 0.031 ± 0.019 after 6 months of dexpramipexole treatment, a 94% reduction (P < 0.001). Ten of 16 subjects had eosinophil counts reduced to ≤ 0.020 × 109 /L at month 6. In 12 subjects with nasal polyp biopsies at baseline and month 6, tissue eosinophils were reduced from a mean of 168 ± 134 to 5 ± 2 per high-power field (HPF) (P = 0.001), a 97% reduction from baseline. There was no significant reduction in TPS or improvement in other clinical endpoints. Dexpramipexole was well tolerated, with no drug-related serious adverse events. CONCLUSION: Dexpramipexole treatment produced profound eosinophil-lowering in peripheral blood and nasal polyp tissue. Despite the near-elimination of polyp eosinophils, decreased TPS and nasal symptom improvement were not observed. LEVEL OF EVIDENCE: 2 Laryngoscope, 129:E61-E66, 2019.

Environmental controls of allergies.

Environmental controls of allergy remain a cornerstone in the management of patients who have allergic rhinitis. In the past, recommendations for environmental controls were based on common sense and the demonstration that certain methods of environmental control reduce antigen quantity. Reduction of antigen quantity is, however, only an indirect measure of whether an environmental control strategy actually reduces allergic symptoms. This article details current recommendations for reducing antigen exposure based on specific antigen sensitivities. Strategies for reduction of indoor inhalant allergens-dust mites, cockroach, molds, and house pet danders-are presented, as well as techniques for reducing exposure to outdoor inhalant allergens.

Sleep impairment in allergic rhinitis, rhinosinusitis, and nasal polyposis.

Sleep impairment is a significant problem for patients with inflammatory disorders of the upper respiratory tract, such as allergic rhinitis, rhinosinusitis, and nasal polyposis. Nasal congestion, one of the most common and bothersome symptoms of these conditions, is associated with sleep-disordered breathing and is thought to be a key cause of sleep impairment. This review examines sleep impairment associated with allergic rhinitis, rhinosinusitis, and nasal polyposis. It explores the adverse effects of disturbed sleep on patients' quality of life and how these inflammatory nasal conditions can be reduced by therapies that address the underlying problems affecting sleep. Treatment with intranasal corticosteroids has been shown to reduce nasal congestion in inflammatory disorders of the upper respiratory tract. Data on sleep-related end points from clinical trials of intranasal corticosteroids indicate that this reduction is associated with improved sleep, reduced daytime fatigue, and improved quality of life. Further research using measures of sleep as primary end points is warranted, based on the potential of these agents to improve sleep and quality of life in patients with allergic rhinitis, acute rhinosinusitis, and nasal polyposis. Such trials will help to identify the most effective therapies for sleep impairment in these 3 nasal conditions.

Odor provocation test for laryngeal hypersensitivity.

This study was to present an odor provocation/challenge test for laryngeal hypersensitivity in a suspected odor induced dysphonic patient. The second aim was to rule out secondary gain from organic laryngeal hypersensitivity. Two steps were taken for this purpose. First, because the evaluation of hypersensitivity may be affected by the perception of odor, the study investigated laryngeal hypersensitivity during nasal and oral breathing separately to disentangle possible cognitive reactions to odors. Second, a healthy control (HC) participant was used with the identical testing protocol for nasal breathing to minimize unbiased results. The HC's response to nasal breathing of the odors showed no response to all the stimuli. The participant with possible secondary gain issues responded differently to the odors when presented nasally versus orally. Oral breathing showed less severe and less frequent laryngeal hypersensitive reactions. This suggests that laryngeal hypersensitivity was either due to the odor, cognitive information, sensory changes in olfaction leading to psychological conditioning, or for any possible secondary gain. Hence, it is difficult to indicate the precise reason (cause and effect) for the participant's laryngeal hypersensitivity; however, this study describes the first structured, controlled, repeatable, and randomized design to investigate odor induced laryngeal hypersensitivity and decipher possible secondary gain from true laryngeal hypersensitivity.

Eosinophilic bacterial chronic rhinosinusitis.

BACKGROUND: A subset of Chronic Rhinosinusitis (CRS) patients are those with eosinophilic CRS (ECRS). These patients remain the most refractory to medical and surgical intervention, and are thought to reflect an inflammatory process arising from a variety of causes. Recently the role of fungus in ECRS, defined as the presence of fungi in the eosinophilic mucin of CRS, has been proposed as causal in many cases. Other proposed causes of ECRS include bacterial superantigen induction of inflammation and aspirin sensitivity. DESIGN: Retrospective review. METHODS: Histopathology from patients with previously diagnosed ECRS was prospectively re-reviewed for bacterial and fungal presence and correlated with patients' demographic data. The study population was comprised of 55 specimens with ECRS from 34 patients, over a 3-year period from a single investigator at the University of Pittsburgh Medical Center. RESULTS: Histologic presence of bacteria was shown in 34 of 55 (62%) of all ECRS specimens. Specimens with fungal colonization were more often associated with bacterial presence than without bacteria (17 of 22 [77%] vs. 5 of 22 [23%], P < .02). CONCLUSION: Bacteria were present in almost two-thirds of all specimens, and most cases of fungal presence were accompanied by bacterial presence, potentially providing support for bacteria as a source of superantigen. Other possible reasons for the high rate of bacterial and fungal colonization of ECRS include increased pathogen exposure, or failure to eliminate pathogens.

Microarray analysis of allergic fungal sinusitis and eosinophilic mucin rhinosinusitis.

OBJECTIVE: Our goal was to determine and compare the differential gene expression in allergic fungal sinusitis (AFS) and eosinophilic mucin rhinosinusitis (EMRS). STUDY DESIGN AND SETTING: We conducted a complementary DNA microarray analysis of prospectively gathered tissue from a tertiary rhinology practice. RESULTS: Compared to normal subjects, 38 genes or potential genes were differentially expressed in AFS patients, while 10 genes were differentially expressed in EMRS patients. Four genes differentially expressed in EMRS were not differentially expressed in AFS: cathepsin B, sialyltransferase 1, GM2 ganglioside activator protein, and S100 calcium binding protein. These genes mediate lysosomal activity and are known to have differential expression in inflammatory and neoplastic states. CONCLUSIONS: EMRS and AFS show some similarities in gene expression profiles using microarray analysis. Significant differences in gene expression in both EMRS and AFS patients compared with normal subjects provide early clues to the pathophysiology of EMRS and AFS. SIGNIFICANCE: This study demonstrates that complementary DNA microarray analysis is a feasible tool for studying different disease subclassifications and is the first to study these subclasses in chronic rhinosinusitis.

The impact of endoscopic cultures on care in rhinosinusitis.

OBJECTIVES: The objectives of this retrospective, observational study were primarily to analyze endoscopically guided culture results (EGCRs) from an office setting in patients with subclassifications of chronic rhinosinusitis (CRS) and to determine the frequency EGCR-altered patient management; and secondarily to determine whether purulent secretions are more likely to be positive for a bacterial pathogen. METHODS: Consecutive symptomatic patients with nasal secretions not currently on antibiotics were cultured endoscopically. Patients were classified as chronic rhinosinusitis (CRS; n = 41) or acute exacerbation of chronic rhinosinusitis (AECRS; n = 27). Initial therapy was individualized and 32 of 68 (47%) had an antibiotic initiated before availability of the EGCR. Patients were reassessed 2 to 4 days later, and therapy was continued or altered based on clinical course and EGCR. RESULTS: EGCRs were positive in 41 of 68 (60.2%) of all patients. Incidence of positive cultures was not statistically different between CRS (21 of 41 [51%]) and AECRS (20 of 27 [74%]) patients. Initial therapy was changed in 45 of 68 (66%) patients. In 35 of 68 (51.4%), the change was directed by EGCR; in 11 of 77 (14.2%), the change was unsubstantiated by EGCR, and in no cases was an antibiotic initiated inappropriate to EGCR. The frequency of pathogens in the subgroups of CRS and AECRS, respectively, were Staphylococcus aureus (9 of 41 [22%]; 9 of 27 [33%]), acute pathogens (6 of 41 [14.6%], 7 of 27 [25.9%]), and Pseudomonas aeruginosa (5 of 41 [12%], 5 of 27 [18.5%]) and were not statistically different between subgroups. Purulent cultures were not significantly more likely to be Gram stain-positive than nonpurulent cultures (12 of 34 [35%] compared with 6 of 34 [17.6%], respectively; P = .1). Purulent cultures were more likely to be culture-positive (25 of 34 [73.5%]) compared with nonpurulent secretions (17 of 34 [50%]; P < .05). AECRS was significantly more likely to be purulent (21 of 27 cases) compared with CRS (13 of 41 cases, P < .001). CONCLUSION: EGCR directed a change in therapy in 35 of 68 (51.4%) patients with CRS. The pathogens isolated from CRS and AECRS were similar and predominately S. aureus, acute pathogens, and P. aeruginosa. Purulent secretions are more frequently bacteriologically positive than nonpurulent secretions and more common in AECRS than CRS.

Acute bacterial rhinosinusitis: a review of U.S. treatment guidelines.

Acute bacterial rhinosinusitis (ABRS) is a common complication of viral upper respiratory tract infections and is associated with a significant socioeconomic burden. Guidelines for the diagnosis and management of ABRS have been produced in association with a number of societies in the United States; these guidelines aim to promote the rational selection of antibiotic therapy to optimize clinical outcomes while minimizing the potential for selection of antibiotic resistance. This article provides an overview of current U.S. guidelines for the treatment of ABRS, focusing on the impact of antibiotic resistance on treatment options.

Endoscopically directed middle meatal cultures versus maxillary sinus taps in acute bacterial maxillary rhinosinusitis: a meta-analysis.

OBJECTIVE: The aim of this study was to verify the correlation of endoscopically directed middle meatal (EDMM) cultures with maxillary sinus tap and culture (MST) in acute bacterial rhinosinusitis (ABRS). STUDY DESIGN AND METHODS: Meta-analysis of the previous literature, unpublished data, and a prospective trial supported by the Sinus & Allergy Health Partnership. EDMM and MST cultures were obtained and their results compared. Inclusion for both the unpublished and prospective trial as well as prior published literature in the meta-analysis required the studies to compare EDMM versus MST in the acute setting of bacterial rhinosinusitis with both symptomatic and radiologic evidence of ABRS. RESULTS: Three articles and 1 national presentation were identified for inclusion. Additional data from unpublished studies and the prospective trial were combined. The pooled data consisted of 126 patients with 131 culture pairs. For known pathogenic bacteria for ABRS and in comparison to MST, EDMM had a sensitivity of 80.9%, a specificity of 90.5%, a positive predictive value of 82.6%, a negative predictive value of 89.4%, and an overall accuracy of 87.0% (95% confidence interval, 81.3%-92.8%); 70.5% (12/17) of false positive culture pairs were of known pathogens for ABRS that would not be expected to be contaminants. CONCLUSIONS AND SIGNIFICANCE: This meta-analysis shows that EDMM is a highly sensitive and accurate culture method for acute ABRS and may be more sensitive than MST given the presence of pathogenic bacteria not found on antral lavage. EDMM is a viable, and possibly preferred, culture method for determining antimicrobial efficacy and bacterial resistance patterns. EBM RATING: A-1a.

Rhinosinusitis: Developing guidance for clinical trials.

The Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication, "Rhinosinusitis: Establishing definitions for clinical research and patient care" and provides templates for clinical trials in antimicrobial, anti-inflammatory, and symptom-relieving therapies for the following: (1) acute presumed bacterial rhinosinusitis, (2) chronic rhinosinusitis (CRS) without nasal polyps, (3) CRS with nasal polyps, and (4) classic allergic fungal rhinosinusitis. In addition to the templates for clinical trials and proposed study designs, the Rhinosinusitis Initiative has developed 6 appendices, which address (1) health outcomes, (2) nasal endoscopy and staging of CRS, (3) radiologic imaging, (4) microbiology, (5) laboratory measures, and (6) biostatistical methods.

Predictive factors in patients undergoing endoscopic sinus surgery for odontogenic sinusitis.

BACKGROUND: Odontogenic sinusitis (OS) presents a therapeutic dilemma. Evidence is lacking whether dental treatment alone is sufficient or whether patients will eventually require endoscopic sinus surgery (ESS). Our aim was to identify predictors of OS patients undergoing ESS. METHODS: Retrospective review performed of OS patients (n = 43) analyzing multiple factors including age, sex, symptoms, prior dental procedures, treatment, diabetes, immunosuppression, smoking history, retained dental hardware, oral-antral fistula (OAF), and Lund-Mackay scores (LMSs). Descriptive statistics, Wilcoxon rank sum, and logistic regression analyses were performed. RESULTS: Common presenting symptoms included facial pressure, discolored nasal drainage, and foul smell/taste. Half of patients presented either after a recent dental procedure or with dental complaints. Forty-eight percent required ESS after failing medical and dental therapy alone. Total LMS was significantly higher in the group undergoing ESS (8.3 vs 3.7; p = 0.0003). Multivariate analysis showed 2 significant predictors of undergoing ESS: (1) OMC involvement (OR 37.3, p = 0.003) and prior dental procedure (OR 7.4, p = 0.03). All patients with OAF or retained dental hardware required ESS. CONCLUSION: Forty-eight percent of patients who presented with OS underwent ESS for symptom control and prevention of complications. Patients who underwent ESS had significantly higher total LMS than those who did not. In multivariate analysis, prior dental procedures and OMC involvement significantly increased the likelihood of requiring ESS.

Sinus opacification in the intensive care unit patient.

OBJECTIVES/HYPOTHESIS: The significance of sinus opacification in intensive care unit (ICU) patients remains uncertain. Our objectives were to determine the baseline incidence and risk factors associated with the development of radiographic sinus abnormalities in the ICU population. METHODS: A retrospective study of head computed tomography scan or magnetic resonance imaging from April 2013 through April 2014 of 612 neurologic ICU patients at the University of Pittsburgh Medical Center Presbyterian Hospital, Pittsburgh, Pennsylvania, was performed. Images were scored by the Lund-Mackay system (LMS). Exclusion criteria included prior sinus or skull base surgery, history of sinonasal malignancy, facial fractures, ICU admission less than 3 days, or inadequate imaging. RESULTS: At the time of admission, 40.7% of patients had a LMS greater than zero (mean 2.2). Worsening sinus opacification occurred in 42.6% of patients (mean highest LMS 4.6) during ICU admission. There was a peak between days 8 and 10, during which 65% of scans exhibited worsening opacification compared to baseline. On multivariate analysis, risk factors associated with increased sinus opacification (higher LMS) included the presence of an endotracheal tube (odds ration [OR] 3.28, P < .001) or nasogastric tube (OR 3.34, P < .001) and increased length of stay (OR 2.50, P < .001). Age greater than 60 was found to be protective for the development of worsening sinus opacification (OR 0.57, P = .007). CONCLUSION: Using serial imaging and comparison control groups, this study finds that there is a high baseline incidence of sinus opacification in the ICU population. Prolonged length of stay, younger age, and presence of nasogastric or endotracheal tubes all corresponded to worsening LMS. LEVEL OF EVIDENCE: 4. Laryngoscope, 126:2433-2438, 2016.

Powered instrumentation and tissue effects in the nose and paranasal sinuses.

PURPOSE OF REVIEW: The technologic cornerstones of endoscopic sinus surgery initially rested on the endoscope and CT scanning. In the mid-1990s, the advent of powered instrumentation, in particular the microdebrider, advanced the surgeon's ability to treat polypoid disease, sinus and nasal disease in a bleeding field, choanal atresia, antral choanal polyps, and inferior turbinate hypertrophy. This review evaluates both positive and negative tissue effects secondary to powered instrumentation. RECENT FINDINGS: Recent reports of deleterious outcomes with powered instrumentation require a reevaluation of the role of powered instrumentation and consideration of factors that lead to injury. The rapidity of injury makes the powered instrument especially dangerous in inexperienced hands. One third of participants in a recent survey were unaware that powered instruments could be involved in orbital injury and half were unaware that cranial injuries could be secondary to powered instrumentation. SUMMARY: Microdebriders will continue to advance the field of endoscopic surgery, providing clearer operative fields and causing less tissue trauma in experienced hands. However, the severity of complications, including the potential for rapidly aspirating orbital and cerebral contents when laminae are violated, must be appreciated and respected.

Impact of quality improvement measures on the delivery of allergy immunotherapy: a 2-year follow-up.

BACKGROUND: Anaphylaxis is the most serious potential complication from allergy treatment with subcutaneous immunotherapy (SCIT). Quality measures were developed with the goal to decrease the incidence of complications resulting from SCIT and improve the safety of care provided. METHODS: The incidence and characteristics of anaphylaxis episodes resulting from SCIT was measured between 2008 and 2012 prior to implementation of quality measures including vial verification, vial testing, and standardized training across 6 allergy delivery sites. Errors and anaphylaxis rates were then tracked prospectively over a 2-year period after implementation of these process measures. RESULTS: From 2008 to 2012 there were 9 episodes of anaphylaxis or 0.02% of injections/year. Eight patients had sufficient information from which to derive meaningful data. Patient identification error led to anaphylaxis in 2 patients, dosing error in 2, and compounding error in 1 patient. In 2 patients, anaphylaxis occurred with advancement during pollen season, and in 1 patient no clear reason could be identified although she had asthma as a risk factor. After implementation of quality improvement measures the anaphylaxis rate fell to 0 of 8948 injections for years 2013 and 2014. CONCLUSION: Errors in the mixing and administration of allergy serum comprised the majority of identifiable factors that led to anaphylaxis. Implementation of quality measures, including vial verification and vial testing, can improve safety and decrease anaphylaxis rates in the delivery of allergy immunotherapy.