Showing papers by "Stacie M. Jones published in 2007"

Clinical practice guideline: Adult sinusitis

Abstract: Objective This guideline provides evidence-based recommendations on managing sinusitis, defined as symptomatic inflammation of the paranasal sinuses. Sinusitis affects 1 in 7 adults in the United States, resulting in about 31 million individuals diagnosed each year. Since sinusitis almost always involves the nasal cavity, the term rhinosinusitis is preferred. The guideline target patient is aged 18 years or older with uncomplicated rhinosinusitis, evaluated in any setting in which an adult with rhinosinusitis would be identified, monitored, or managed. This guideline is intended for all clinicians who are likely to diagnose and manage adults with sinusitis. Purpose The primary purpose of this guideline is to improve diagnostic accuracy for adult rhinosinusitis, reduce inappropriate antibiotic use, reduce inappropriate use of radiographic imaging, and promote appropriate use of ancillary tests that include nasal endoscopy, computed tomography, and testing for allergy and immune function. In creating this guideline the American Academy of Otolaryngology–Head and Neck Surgery Foundation selected a panel representing the fields of allergy, emergency medicine, family medicine, health insurance, immunology, infectious disease, internal medicine, medical informatics, nursing, otolaryngology–head and neck surgery, pulmonology, and radiology. Results The panel made strong recommendations that 1) clinicians should distinguish presumed acute bacterial rhinosinusitis (ABRS) from acute rhinosinusitis caused by viral upper respiratory infections and noninfectious conditions, and a clinician should diagnose ABRS when (a) symptoms or signs of acute rhinosinusitis are present 10 days or more beyond the onset of upper respiratory symptoms, or (b) symptoms or signs of acute rhinosinusitis worsen within 10 days after an initial improvement (double worsening), and 2) the management of ABRS should include an assessment of pain, with analgesic treatment based on the severity of pain. The panel made a recommendation against radiographic imaging for patients who meet diagnostic criteria for acute rhinosinusitis, unless a complication or alternative diagnosis is suspected. The panel made recommendations that 1) if a decision is made to treat ABRS with an antibiotic agent, the clinician should prescribe amoxicillin as first-line therapy for most adults, 2) if the patient worsens or fails to improve with the initial management option by 7 days, the clinician should reassess the patient to confirm ABRS, exclude other causes of illness, and detect complications, 3) clinicians should distinguish chronic rhinosinusitis (CRS) and recurrent acute rhinosinusitis from isolated episodes of ABRS and other causes of sinonasal symptoms, 4) clinicians should assess the patient with CRS or recurrent acute rhinosinusitis for factors that modify management, such as allergic rhinitis, cystic fibrosis, immunocompromised state, ciliary dyskinesia, and anatomic variation, 5) the clinician should corroborate a diagnosis and/or investigate for underlying causes of CRS and recurrent acute rhinosinusitis, 6) the clinician should obtain computed tomography of the paranasal sinuses in diagnosing or evaluating a patient with CRS or recurrent acute rhinosinusitis, and 7) clinicians should educate/counsel patients with CRS or recurrent acute rhinosinusitis regarding control measures. The panel offered as options that 1) clinicians may prescribe symptomatic relief in managing viral rhinosinusitis, 2) clinicians may prescribe symptomatic relief in managing ABRS, 3) observation without use of antibiotics is an option for selected adults with uncomplicated ABRS who have mild illness (mild pain and temperature <38.3°C or 101°F) and assurance of follow-up, 4) the clinician may obtain nasal endoscopy in diagnosing or evaluating a patient with CRS or recurrent acute rhinosinusitis, and 5) the clinician may obtain testing for allergy and immune function in evaluating a patient with CRS or recurrent acute rhinosinusitis. Disclaimer This clinical practice guideline is not intended as a sole source of guidance for managing adults with rhinosinusitis. Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. It is not intended to replace clinical judgment or establish a protocol for all individuals with this condition, and may not provide the only appropriate approach to diagnosing and managing this problem.

Egg oral immunotherapy in nonanaphylactic children with egg allergy

Abstract: Background There is no current active treatment for food allergy. Traditional injection immunotherapy has been proved unsafe, and thus there is a need for other forms of immunotherapy. Objective The purpose was to study the safety and immunologic effects of egg oral immunotherapy (OIT). The short-term goal was to desensitize subjects to protect against accidental ingestion reactions. The eventual goal was to induce lasting clinical and immunologic tolerance. Methods Subjects with a history of egg allergy but without a history of anaphylaxis to egg underwent a 24-month egg OIT protocol involving modified rush, build-up, and maintenance phases. Double-blind, placebo-controlled food challenges were performed at study conclusion. Egg-specific IgE and IgG concentrations were followed. Results Seven subjects completed the protocol. Egg-specific IgG concentrations increased significantly, whereas egg-specific IgE concentrations did not significantly change. Three subjects tolerated known or possible accidental egg ingestions while receiving OIT. During double-blind, placebo-controlled food challenges at study conclusion, all tolerated significantly more egg protein than at study onset and than that found in the typical accidental exposure. Two subjects demonstrated oral tolerance. Conclusion This study provides proof of concept that OIT can be safely used for patients with egg allergy without a history of anaphylaxis to egg. Egg OIT does not heighten sensitivity to egg and might protect against reaction on accidental ingestion. Whether OIT will induce clinical oral tolerance cannot be concluded from this initial cohort. Clinical implications Use of allergen-specific OIT to protect subjects with food allergy from reaction on accidental ingestion would represent a significant paradigm change in the treatment of food allergy.

A phase II, randomized, double‑blind, parallel‑group, placebo‑controlled oral food challenge trial of Xolair (omalizumab) in peanut allergy

Abstract: To the Editor: Food allergy is the most common cause of anaphylaxis seen in emergency departments in the United States, and peanut allergy is the most common food provoking fatal or near-fatal reactions. Currently, strict peanut avoidance and ready access to selfinjectable epinephrine are the standard of care. Despite a growing awareness of food allergy, adherence to avoidance diets is very difficult, quality of life is markedly affected, and accidental ingestions remain common. Results from an earlier study suggested that humanized anti-IgE (Hu-901) might be effective for the treatment of food allergy. Hu-901 was not selected for further clinical development; however, omalizumab was approved for marketing in moderate to severe asthma. A phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial was therefore designed to assess the efficacy of omalizumab (Xolair; Genentech, South San Francisco, Calif), which had been approved by the US Food and Drug Administration for treatment of patients with moderate-severe asthma, in reducing the risk of peanut-induced allergic reactions. The study was designed to compare changes in peanut tolerability thresholds in subjects with proven peanut allergy who were treated with either omalizumab or placebo. Although the study intended to randomize 150 subjects, it was stopped early on the basis of the recommendation of the Data Safety Monitoring Committee because of the severity of 2 anaphylactic reactions that occurred during the qualifying oral food challenges (OFCs) before the administration of the study drug. Consequently, only 14 subjects reached the study’s primary endpoint before the discontinuation of the trial. Despite the small number of subjects enrolled, some favorable trends in posttherapy peanut challenge thresholds were noted. The primary objective of this study was to assess the efficacy of omalizumab in reducing the risk of peanut-induced allergic reactions by comparing the amount of peanut tolerated without symptoms before and after treatment. These thresholds were determined by double-blind placebo-controlled food challenge in subjects with peanut allergy treated with omalizumab compared with subjects treated with placebo. The OFC consisted of ingesting encapsulated peanut flour and placebo (wheat) flour on different days (1 day placebo [wheat] flour and 1 day peanut flour, with order determined at random). Doses of flour were 5, 15, 50, 100, and 250 mg during the initial qualification challenge and 5, 15, 50, 100, 250, 500, 1000, 1500, 4000, and 8000 mg during the posttherapy challenge, as tolerated. Subjects were eligible for the study if they were 6 to 75 years of age with histories of an

Sublingual Immunotherapy With Once-Daily Grass Allergen Tablets: A Randomized Controlled Trial in Seasonal Allergic Rhinoconjunctivitis

Abstract: Durham SR, Yang WH, Pedersen MR, Johansen N, Rak S. J Allergy Clin Immunol . 2006;117:802–809 PURPOSE OF THE STUDY. To examine the efficacy and safety of sublingual immunotherapy (SLIT) in seasonal allergic rhinoconjunctivitis using timothy-grass–allergen tablets. STUDY POPULATION. The study included 855 patients aged 18 to 65 from 55 centers in Canada and Europe with seasonal allergic rhinoconjunctivitis induced by grass pollen. METHODS. A double-blind, randomized, parallel-group, placebo-controlled trial was conducted during 2002–2003. Patients had a history of allergic rhinoconjunctivitis during grass-pollen season for at least 2 years with a positive skin-prick–test result and serum-specific immunoglobulin E (IgE) to Phleum pratense . Individuals were randomly assigned to receive placebo or 2500, 25 000, or 75 000 SQ-T sublingual tablets administered daily. Daily diaries of symptoms (0–3) and rescue-medication use from pre–through post–grass-pollen season were kept, and a rhinoconjunctivitis quality-of-life (QoL) questionnaire was completed. Well days were calculated as those with a symptom score of ≤2 and no rescue-medication use. RESULTS. A total of 790 (92%) participants completed the trial that included a mean duration of treatment of 18 weeks. Treatment with 75 000 SQ-T tabs revealed an improvement in symptom score (16%; P = .0710) and medication score (28%; P = .0470) when compared with placebo. The QoL score and number of well days also revealed improvement of 17% ( P = .006) and 18% ( P = .041), respectively. The 2 lower doses did not demonstrate significant change from placebo. Preseason treatment for 8 weeks with the 75 000 SQ-T dose showed an increased improvement of symptom score (21%; P = .002) and medication score (29%; P = .012) compared with placebo. In the 75 000 SQ-T group, specific IgG to P pratense was increased after 8 weeks of treatment and tripled posttreatment. Specific IgE levels increased after treatment initialized but remained unchanged thereafter. Therapy was well tolerated with only mild-to-moderate symptoms (consisting of primarily oral pruritis and throat irritation) noted in 53% of the patients. CONCLUSIONS. Grass-pollen SLIT has a dose-dependent efficacy, is well tolerated, and provides improved QoL for patients with seasonal allergic rhinoconjunctivitis. REVIEWER COMMENTS. SLIT for grass-pollen allergy holds promise as an alternative future therapy to subcutaneous immunotherapy that is attractive on many levels. Grass-pollen SLIT may have broader coverage range because of improved accessibility and more convenient administration, less discomfort than injections, and decreased risk of IgE-mediated severe systemic reactions. Preseason coverage with SLIT may improve symptoms and reduce medication requirements for treatment of seasonal allergic rhinoconjunctivitis.

Systematic review of antimicrobial therapy in patients with acute rhinosinusitis.

Abstract: Objective To estimate the natural history of acute rhinosinusitis and the impact of antimicrobial therapy on clinical outcomes. Data Sources MEDLINE and Cochrane Trial Registry through February 2007 combined with manual review of retrieved article bibliographies. Review Methods Systematic review and random-effects meta-analysis of double-blind, randomized, controlled trials comparing placebo vs oral antimicrobial for initial therapy of uncomplicated acute rhinosinusitis in patients aged 12 years or older. Results Thirteen trials met inclusion criteria and had data suitable for pooling. Clinical cure occurred in 8% of patients who received placebo after 3 to 5 days, rising to 35% by 7 to 12 days and 45% by 14 to 15 days. Antimicrobials increased cure rates at 7 to 12 days, with an absolute rate difference of 15% (95% CI, 4%-25%). Clinical improvement occurred in 30% of patients who received placebo after 3 to 5 days, rising to 73% by 7 to 12 days and 14 to 15 days. Antimicrobials increased improvement rates at 7 to 12 days by 14% (95% CI, 1%-28%) and at 14 to 15 days by 7% (95% CI, 2%-13%). Diarrhea and adverse events were about 80% more common in patients who received antimicrobials ( P Conclusions Over 70% of patients with acute rhinosinusitis are improved after 7 days, with or without antimicrobial therapy. About 7 patients must be treated to achieve one additional positive outcome at 7 to 12 days above and beyond spontaneous resolution. Generalizability of results is limited because nearly all trials involved a primary care setting and some trials excluded patients with severe illness.

Relationship of body mass index with asthma indicators in Head Start children

Abstract: Objective To examine the relationship of body mass index (BMI) and asthma indicators on children with asthma in a Head Start (HS) program. Methods In this cross-sectional study (November 18, 2000, to December 12, 2003) of children aged 3 to 5 years with asthma, we compared the BMI data of HS asthmatic patients (n = 213) with the data of peer control subjects from a sample (n = 816) of the National Health and Nutrition Examination Survey aged 3 to 5 years and with children in prekindergarten in Arkansas public schools (n = 1,024). Parental reports of asthma symptoms, health care use, medication use, school days missed, and quality of life were used as indicators of asthma morbidity. Categorical analysis and χ 2 tests were performed to examine the relationship between BMI and asthma morbidity. Results The prevalence of overweight (≥95th percentile) was significantly higher in HS children with asthma compared with the National Health and Nutrition Examination Survey children ( P P = .05). Compared with HS asthmatic children with a BMI less than the 85 th percentile, HS asthmatic patients with a BMI of the 85th percentile or greater reported significantly more school days missed ( P = .02), lifetime hospitalizations ( P = .04), emergency department visits ( P = .02), and activity limitations ( P = .03) and fewer oral corticosteroid bursts ( P = .04). There was also a trend for more daytime symptoms ( P = .05) and lower quality of life ( P = .06). No differences were observed in rescue ( P = .28) or controller ( P = .47) medications, environmental tobacco smoke exposure ( P = .47), positive allergy test results ( P = .85), and nighttime symptoms ( P > .99). Conclusions Having an increased BMI was associated with more asthma morbidity in this group of HS asthmatic patients. Despite the lack of a clear explanation for the link between asthma and BMI, our data suggest that an increased BMI significantly affects the well-being of young asthmatic patients and should be further addressed.

Asthma Control Test: Reliability, Validity, and Responsiveness in Patients Not Previously Followed by Asthma Specialists

Abstract: Schatz M, Sorkness CA, Li JT, et al. J Allergy Clin Immunol . 2006;117:549–556 PURPOSE OF THE STUDY. To evaluate the validity and reliability of the asthma-control test (ACT) and assess its responsiveness to changes in asthma control over time in a sample of patients who were new to the care of an asthma specialist. STUDY POPULATION. Participants were asthmatic subjects ( N = 313) aged ≥12 years who had not consulted an asthma specialist within 5 years and had a previous diagnosis of asthma. METHODS. This prospective trial was conducted in 6 asthma specialty practices. Participants were evaluated at 2 physician office visits (a baseline visit and a follow-up visit separated by 4–12 weeks) in which they completed the ACT, the Asthma Control Questionnaire (ACQ), and prebronchodilator measurements of forced expiratory volume in 1 second (FEV 1 ). The ACT is a 5-item patient-administered survey for assessing asthma control. Each of the 5 questions is given a score from 1 to 5. Responses from the ACT are summed to yield a score that ranges from 5 (poor control) to 25 (complete control). Asthma specialists, who were blinded to the ACT and ACQ results, rated asthma control on a 5-point Likert scale (not completely controlled to completely controlled) based on history, physical examination, FEV 1 scores, and National Asthma Education and Prevention Program–defined goals for asthma control. Reliability, validity, and responsiveness were all tested via comparison of the ACT results to the specialists’ evaluation, the ACQ scores, and the FEV 1 scores. RESULTS. Participants ( N = 313) had a mean age of 35 years (12–84 years). At baseline, specialists rated asthma control as well controlled or completely controlled (48%), somewhat controlled (29%), and not controlled (23%). The reliability of the ACT was tested by internal consistency and test-retest methods. The internal consistency was .85 for the initial visit ( n = 313) and .79 for the follow-up visit ( n = 248). The test-retest assessment among 86 patients with the same specialist rating for asthma was .77. The criterion validity was based on comparisons between the ACT scores at the baseline visit and the specialists’ assessment as well as the ACQ scores and FEV 1 values. All of these comparisons were found to be statistically significant. The discriminant validity was measured in 3 ways: the asthma specialists’ rating, percent predicted value of FEV 1 , and treatment recommendation of the asthma specialists. As predicted, patients with low ACT scores correlated with diagnoses of poorer control by asthma specialists. Patients with low FEV 1 scores also scored lower on the ACT, and patients who required an increase in their therapy had lower scores on this questionnaire. The responsiveness of the ACT was also measured by assessing the changes in scores between the initial and follow-up visits. Moderate correlations existed between the ACT and the asthma specialist9s score, whereas changes in the ACT and ACQ were found to be highly consistent. Changes in FEV 1 and ACT were only minimally correlated. An ACT score of ≤19 identified patients with poorly controlled asthma (71% sensitivity; 71% specificity). CONCLUSIONS. The ACT was reliable, valid, and responsive to changes in asthma control over time in a sample of patients who were new to the care of an asthma specialist. REVIEWER COMMENTS. These authors have further shown the value of the ACT in assessing asthma control in the practice of asthma specialists. In a day when physicians are pressed for time when evaluating patients, it is important to find effective tools that are reliable, valid, responsive, and practical to assist in patient evaluations. Additional work is needed to assess the usefulness of the ACT within primary care, where it may prove to be even more valuable in assessing asthma control.