Significant orbital and intracranial complications from balloon sinus dilation as a stand-alone and powered dissector-assisted procedure.

Chronic rhinosinusitis is one of the most common chronic conditions affecting millions of people in the United States every year. Balloon sinus dilation is a minimally invasive intervention that was introduced as a possible alternative to endoscopic sinus surgery (ESS). In select patients, balloon dilation has been advocated as a relatively safe procedure with comparable efficacy to traditional ESS. Over the past 12 months, significant intracranial and intraorbital complications have been observed on five patients who underwent balloon sinus dilation as a stand-alone procedure, as well as what could be termed a power dissector-assisted balloon dilation procedure, obviating the need for a wide sinusotomy or any significant ethmoid surgery, which are typically performed to establish anatomical landmarks before the introduction of power instruments into dependent sinus cavities. Laryngoscope, 2455-2459, 2018.

Skin prick/puncture testing in North America: a call for standards and consistency.

BACKGROUND: Skin prick/puncture testing (SPT) is widely accepted as a safe, dependable, convenient, and cost-effective procedure to detect allergen-specific IgE sensitivity. It is, however, prone to influence by a variety of factors that may significantly alter test outcomes, affect the accuracy of diagnosis, and the effectiveness of subsequent immunotherapy regimens. Proficiency in SPT administration is a key variable that can be routinely measured and documented to improve the predictive value of allergy skin testing. METHODS: Literature surveys were conducted to determine the adherence to repeated calls for development and implementation of proficiency testing standards in the 1990's, the mid-2000's and the 2008 allergy diagnostics practice parameters. RESULTS: Authors publishing clinical research in peer-reviewed journals and conducting workshops at annual scientific meetings have recommended proficiency testing based primarily on its potential to reduce variability, minimize confounding test results, and promote more effective immunotherapeutic treatments. Very few publications of clinical studies, however, appear to report proficiency testing data for SPT performance. Allergen immunotherapy recommendations are updated periodically by the Joint Task Force on Practice Parameters representing the American Academy of Allergy, Asthma and Immunology (AAAAI), the American College of Allergy, Asthma and Immunology (ACAAI), and the Joint Council of Allergy, Asthma and Immunology (JCAAI). CONCLUSIONS: Despite consensus that all staff who perform SPT should meet basic quality assurance standards that demonstrate their SPT proficiency, the gap between recommendations and daily practice persists. By embracing standards, the accuracy of SPT and allergy diagnosis can be optimized, ultimately benefiting patients with allergic disease.

The Allergies, Immunotherapy, and RhinoconjunctivitiS (AIRS) survey: provider practices and beliefs about allergen immunotherapy.

BACKGROUND: The practices and beliefs of the provider specialties that treat allergic rhinoconjunctivitis (ARC) with allergen immunotherapy (AIT) may vary. METHODS: A telephone survey of 500 randomly selected health care practitioners in 7 specialties, conducted in 2012. RESULTS: AIT was provided as a subcutaneous injection (SCIT) by 91% of allergist/immunologists, 54% of otolaryngologists, and 18% to 24% of other specialties. Otolaryngologists were the most frequent providers of sublingual drops of AIT (SLIT; 33%), compared to 2% to 10% of other specialties. AIT was recommended for adults with allergic rhinoconjunctivitis by 100% of allergist/immunologists vs 62% to 84% of the other specialties (p < 0.001). The primary reason for recommending AIT for adults (52%) or children (46%) was that other therapies did not work. Between 48% (nurse practitioners/physician assistants) and 93% (allergist/immunologists) of practitioners always or often decreased symptomatic medications over the course of AIT treatment. Most practitioners in all specialties (82-100%) thought that AIT was appropriate for patients with severe allergy symptoms. Significantly more allergist/immunologists and otolaryngologists than other specialists thought AIT was appropriate for mild allergy symptoms (p < 0.001 and p = 0.004, respectively, vs other specialties). Significantly more allergist/immunologists than other specialists thought that AIT was more effective than symptomatic medications (p < 0.001), could reduce the further development of allergies (p = 0.03), and could prevent the development of asthma. CONCLUSION: SCIT was more frequently provided than SLIT by all the specialties. Otolaryngologists were the most likely to offer SLIT, while very few allergist/immunologists offered SLIT. Allergist/immunologists differed from other specialties in some beliefs about the effectiveness of AIT.

ACR Appropriateness Criteria Headache.

Most patients presenting with uncomplicated, nontraumatic, primary headache do not require imaging. When history, physical, or neurologic examination elicits "red flags" or critical features of the headache, then further investigation with imaging may be warranted to exclude a secondary cause. Imaging procedures may be diagnostically useful for patients with headaches that are: associated with trauma; new, worse, or abrupt onset; thunderclap; radiating to the neck; due to trigeminal autonomic cephalgia; persistent and positional; and temporal in older individuals. Pregnant patients, immunocompromised individuals, cancer patients, and patients with papilledema or systemic illnesses, including hypercoagulable disorders may benefit from imaging. Unlike most headaches, those associated with cough, exertion, or sexual activity usually require neuroimaging with MRI of the brain with and without contrast to exclude potentially underlying pathology before a primary headache syndrome is diagnosed. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every 2 years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer-reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances in which evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

Ocular and nasal allergy symptom burden in America: the Allergies, Immunotherapy, and RhinoconjunctivitiS (AIRS) surveys.

Previous nationwide surveys of allergies in the United States have focused on nasal symptoms, but ocular symptoms are also relevant. This study determines the effects of ocular and nasal allergies on patients' lives. Telephone surveys of randomly selected U.S. households (the patient survey) and health care providers (provider survey) were conducted in the United States in 2012. Study participants were 2765 people ≥5 years of age who had ever been diagnosed with nasal or ocular allergies and 500 health care providers in seven specialties. Respondents to the patient survey reported a bimodal seasonal distribution of allergy symptoms, with peaks in March to May and September. Nasal congestion was the most common of the symptoms rated as "extremely bothersome" (39% of respondents), followed by red, itchy eyes (34%; p = 0.84 for difference in extreme bothersomeness of nasal and ocular symptoms). Twenty-nine percent of respondents reported that their or their child's daily life was impacted "a lot" when allergy symptoms were at their worst. Workers rated their mean productivity at 29% lower when allergy symptoms were at their worst (p < 0.001 compared with no symptoms). Providers reported that itchy eyes was the symptom causing most patients to seek medical treatment by pediatricians (73%), ophthalmologist/optometrists (72%), and nurse practitioners or physician assistants (62%), whereas nasal congestion was the symptom causing most patients to seek treatment from otolaryngologists (85%), allergist/immunologists (79%), and family medicine practitioners (64%). Ocular and nasal allergy symptoms substantially affected patients' lives and were comparable in their impact.

Comorbidities and allergic rhinitis: not just a runny nose.

Allergic rhinitis is rarely found in isolation and should be considered in the context of upper and lower airway disease. People with AR are at greater risk of suffering asthma, rhinosinusitis, and other related upper airway conditions. Most people with both nasal allergies and asthma report that their asthma gets better when their nasal allergies are under control. People with AR are more than twice as likely to suffer problems sleeping due to their nasal allergy symptoms.

Otoscopic signs of otitis media.

BACKGROUND: Lack of agreed-upon diagnostic criteria for acute otitis media (AOM) has led to inconsistencies in clinical care, misleading research results, and misguided educational efforts. The objective of this study was to examine findings that expert otoscopists use when diagnosing AOM. METHODS: A group of experienced otoscopists examined 783 children presenting for primary care. In addition, endoscopic still images of the tympanic membranes (TMs) were obtained. A random sample of 135 of these images was sent for review to a group of 7 independent physicians who were expert otoscopists. We examined the findings that both groups of observers used to distinguish between AOM, otitis media with effusion (OME), and no effusion. RESULTS: Among both groups of observers, bulging of the TM was the finding judged best to differentiate AOM from OME: 96% of ears and 93% of ear image evaluations assigned a diagnosis of AOM by members of the 2 groups were reported as showing bulging of the TM, compared with 0% and 3%, respectively, of ears and ear image evaluations assigned a diagnosis of OME. Opacification of the TM was the finding that best differentiated OME from no effusion. CONCLUSIONS: We describe findings that are used by experienced otoscopists to diagnose AOM and OME. The findings point to the advisability under most circumstances of restricting antimicrobial treatment for AOM to children who have TM bulging, and they call into question clinical trials of the treatment of AOM in which TM bulging has not been a required element for participation.

Moxifloxacin five-day therapy versus placebo in acute bacterial rhinosinusitis.

OBJECTIVES: To evaluate the efficacy and safety of moxifloxacin in the treatment of acute bacterial rhinosinusitis (ABRS). STUDY DESIGN: Prospective, multicenter, randomized, double-blind, phase III trial. METHODS: Patients with ABRS defined by clinical, radiologic, and bacteriologic criteria were recruited to the study. Study treatments were 400 mg of oral moxifloxacin or a matching placebo daily for 5 days. The primary end point was clinical response at test-of-cure, 1 to 3 days after the end of therapy in the modified intent-to-treat (mITT) population (patients with positive culture for one of five prespecified pathogens). Secondary efficacy variables included patient-reported symptom improvement measured using the Sino-Nasal Outcome Test-16 (SNOT-16), and concomitant medication use. RESULTS: The mITT population consisted of 118 patients (moxifloxacin, n = 73; placebo, n = 45). Clinical success rates were numerically higher for moxifloxacin (78.1%, 57/73) versus placebo (66.7%, 30/45); (P = .189). Significantly greater mean reductions in SNOT-16 scores occurred in moxifloxacin- versus placebo-treated patients (-17.54 vs. -12.83; P = .032). Overall concomitant medication use was lower in moxifloxacin versus placebo patients (38.4%, 28/73 vs. 55.6%, 25/45 respectively). Premature discontinuation due to insufficient therapeutic effect was significantly lower in moxifloxacin- versus placebo-treated patients (8.2%, 6/73 vs. 22.2%, 10/45; P = .031). The rate of treatment-emergent adverse events in the ITT population was similar between arms (moxifloxacin 38.2%, 96/251; placebo 40.7%, 50/123). CONCLUSIONS: Although moxifloxacin 5-day therapy for ABRS was not statistically superior to placebo for the primary end point, patients who received moxifloxacin had significantly greater improvements in health outcomes and used fewer concomitant medicines than patients treated with placebo, while experiencing no increase in adverse events.

Managing rhinitis: Strategies for improved patient outcomes.

Allergic rhinitis affects more than 40 million Americans, with estimated costs reaching $5.3 billion annually. The global impact includes negative effects on quality of life (QOL), sleep, diminished work productivity, and exacerbation of comorbid conditions. An accurate diagnosis of allergic or nonallergic rhinitis is needed before selecting optimal treatment, which can include antihistamines, decongestants, intranasal corticosteroids, immunotherapy, and anticholinergics. It is also important to understand that pharmacologic properties of these different interventions may affect patient satisfaction, compliance, and overall clinical response. This article reviews currently available therapies for allergic rhinitis with a focus on improving patient outcomes.

Cephalosporin use in treatment of patients with penicillin allergies.

OBJECTIVE: To review the evidence that supports the use of certain cephalosporins in penicillin-allergic patients. DATA SOURCES: Published articles were identified through Medline and EMBASE (1960-2007) using the search terms penicillin and allergy and cephalosporin and cross-reactivity. Additional sources were identified from the authors' personal collection and the reference bibliographies. STUDY SELECTION: The articles found in the search were limited to the English language and screened for relevance. Review articles and republication of results were excluded. A total of 44 articles reported evidence of cross-reactivity between cephalosporins and penicillins in human and animal studies. Additional references provided background and perspective. DATA SYNTHESIS: Physicians may now prescribe certain cephalosporins in patients with a history of a nonserious, non-life-threatening penicillin reaction. Exclusions include type I anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, and other potentially life-threatening responses to medication. Recent reports demonstrate that a considerable body of literature describing the cross-reactivity between cephalosporins and penicillin was established based on nonallergic adverse reactions or in vitro studies rather than on clinically relevant immune-mediated reactions. Oral rechallenge and skin testing data support the relationship of the beta-lactam side-chain structures of these drugs as a predictor of cross-reactivity. CONCLUSION: Recent data suggest that the incidence of cross-reactivity among penicillins and cephalosporins is lower than historically reported. Pharmacists should be aware that cephalosporin cross-reactivity in a penicillin-allergic patient is not necessarily a class effect. Dispensing should be evaluated based on the type of allergic manifestations and the drug prescribed.

Cutting edge: anti-tumor necrosis factor therapy in rheumatoid arthritis inhibits memory B lymphocytes via effects on lymphoid germinal centers and follicular dendritic cell networks.

Rheumatoid arthritis (RA) is mediated by a proinflammatory cytokine network with TNF at its apex. Accordingly, drugs that block TNF have demonstrated significant efficacy in the treatment of RA. A great deal of experimental evidence also strongly implicates B cells in the pathogenesis of RA. Yet, it remains unclear whether these two important players and the therapies that target them are mechanistically linked. In this study we demonstrate that RA patients on anti-TNF (etanercept) display a paucity of follicular dendritic cell networks and germinal center (GC) structures accompanied by a reduction in CD38+ GC B cells and peripheral blood memory B cell lymphopenia compared with healthy controls and RA patients on methotrexate. This study provides initial evidence in humans to support the notion that anti-TNF treatment disrupts GC reactions at least in part via effects on follicular dendritic cells.

Patient and physician perspectives on the attributes of nasal allergy medications.

Allergic rhinitis (AR) often requires regular prophylactic use of allergy medications for the effective long-term management of nasal symptoms. However, patient adherence to AR treatment is frequently poor. The Allergies in America survey of nasal allergy sufferers assessed 2500 adults diagnosed with AR. Four hundred healthcare professionals also participated in this survey. Participants were interviewed about their perceptions of the effectiveness and tolerability of AR medications and the relationship of these parameters to patient satisfaction with therapy. Only 15% of nasal allergy sufferers reported that their intranasal corticosteroid (INCS) provided complete symptom relief, and 48% of patients indicated that their INCS did not provide 24-hour symptom relief. Healthcare professionals agreed that intranasal corticosteroids do not provide complete 24-hour symptom relief. The most commonly reported adverse effects of all nasal allergy medications were a drying feeling (47%), dripping down the throat (41%), drowsiness (37%), bad taste (32%), burning (17%), and headaches (16%). Many patients indicated that these adverse effects were moderately or extremely bothersome. Thirty-two percent and 25% of patients, respectively, discontinued treatment because their nasal allergy medications did not provide 24-hour symptom relief or were associated with bothersome adverse effects. Patients and healthcare professionals do not believe that INCSs provide complete 24-hour symptom relief. In general, allergy medications also are perceived as conferring unpleasant adverse effects. Lack of efficacy and bothersome adverse effects contribute to lack of satisfaction with treatment and treatment discontinuation in patients with AR.

Intranasal corticosteroids in the treatment of allergic rhinitis.

Intranasal corticosteroids (INCSs) have been established as the first-line treatment of moderate to severe allergic rhinitis (AR). Compared with other monotherapies, INCSs are most effective at controlling underlying allergic inflammation and providing symptom relief. Although currently available INCSs show comparable efficacy in controlling nasal symptoms of AR, onset and duration of action are thought to be somewhat variable among the INCSs. The low frequency of side effects suggests that, at recommended doses, INCSs are safe for the treatment of AR. However, concerns remain regarding the long-term systemic side effects associated with INCS therapy. Recent clinical studies have indicated that ciclesonide provides effective relief from nasal symptoms of AR and may have a rapid onset of action. Moreover, the results of two clinical trials, including a 52-week study, have suggested that intranasal ciclesonide does not cause cortisol suppression. Furthermore, intranasal ciclesonide does not have an additive effect on the hypothalamic-pituitary-adrenal-axis function when administered in combination with inhaled corticosteroids (ICSs), indicating that intranasal ciclesonide can be used in combination with an ICS in patients with asthma and comorbid AR. Therefore, intranasal ciclesonide appears to provide an additional treatment option for patients with AR.

Oral beta-lactams in the treatment of acute bacterial rhinosinusitis.

Acute bacterial rhinosinusitis (ABRS) is a well-known complication of viral upper respiratory tract infection and is associated with a significant socioeconomic burden. Difficulties in diagnosis, a substantial spontaneous resolution rate, and growing concerns regarding antimicrobial resistance make the proper management of ABRS quite challenging. Treatment guidelines have been developed, taking into account the major bacterial pathogens, rates of antimicrobial resistance, spontaneous resolution rates, and pharmacokinetic and pharmacodynamic considerations. Optimal choices for initial treatment of ABRS in patients without prior antibacterial exposure include the oral beta-lactam agents amoxicillin/clavulanate, cefdinir, cefpodoxime, and cefuroxime. Clinicians are encouraged to consider the local pathogen distribution and rates of antibacterial resistance in selecting therapy for ABRS.

Faropenem medoxomil: a treatment option in acute bacterial rhinosinusitis.

Faropenem medoxomil is the first oral penem in a new class of beta-lactam antibiotics. Faropenem medoxomil has excellent in vitro activity against Streptococcus pneumoniae, Haemophilus influenzae and other key pathogens implicated in acute bacterial rhinosinusitis. Clinical studies have demonstrated that, in the treatment of acute bacterial rhinosinusitis in adults, 7 days of treatment with faropenem medoxomil is as clinically and bacteriologically effective as 10 days of treatment with cefuroxime axetil. One study showed faropenem medoxomil to be superior to cefuroxime axetil. Overall, the safety profile of faropenem medoxomil is similar to that of most comparators. Specifically, the minimal impact of faropenem medoxomil on the gastrointestinal flora leads to less diarrhea and other adverse events than coamoxicillin-clavulanate. Faropenem medoxomil has almost no drug-drug interactions and little requirement for dosage adjustments in the typical acute rhinosinusitis population.

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.

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.

The efficacy of cefdinir in acute bacterial rhinosinusitis.

Acute bacterial rhinosinusitis is a common infection resulting in substantial morbidity. Cefdinir, an oral cephalosporin, has extended-spectrum, bactericidal activity against common acute bacterial rhinosinusitis pathogens, including Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. Cefdinir shows rapid oral absorption and good respiratory tissue penetration, and may be administered once daily. In randomised clinical trials, cefdinir showed efficacy similar to that of other recommended regimens in the treatment of acute bacterial rhinosinusitis, namely amoxicillin/clavulanate and levofloxacin. Cefdinir is well tolerated and has shown a low propensity to suppress the normal commensal flora. Cefdinir oral suspension is rated highly by children in terms of its taste and smell. As the only once-daily beta-lactam currently recommended by acute bacterial rhinosinusitis guidelines (for first-line use in patients with mild acute bacterial rhinosinusitis and no recent antibacterial use), cefdinir offers a convenient and attractive treatment option.