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Biomedical subjects

James A Hadley

Publications and source records attributed to James A Hadley.

At least 19 recordsLinked to original sources
PubMed2006

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.

Chronic Disease↗
PubMed2006

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 STUDY DESIGN AND METHODS: Meta-analysis of the previous literature, unpublished data, and a prospective trial supported by the Sinus & Allergy Health Partnership.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 Inclusion for both the unpublished and prospective trial as well as prior published literature in the meta-analysis required the studies to compare EDMM versus MST in the acute setting of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 Additional data from unpublished studies and the prospective trial were combined.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.

Endoscopy↗
PubMed2006

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.

Chronic Disease↗
PubMed2006

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.

Acute Disease↗
PubMed2006

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.

Acute Disease↗
PubMed2005

The Cooperative Outcomes Group for ENT: a multicenter prospective cohort study on the effectiveness of medical and surgical treatment for patients with chronic rhinosinusitis.

OBJECTIVE: To assess outcomes for patients with chronic rhinosinusitis. STUDY DESIGN AND SETTING: Prospective, multicenter study; 31 otolaryngologists enrolled 276 adult patients with chronic rhinosinusitis; patients completed surveys at 3-month intervals, and physicians provided clinical and treatment data. The primary outcome measure was the Chronic Sinusitis Survey-Duration (CSS-D). RESULTS: One hundred seventeen adult patients completed 12-month follow-up. Most patients reported sinus symptoms lasting longer than 3 years (74%). Patients showed significant improvement (group P < 0.0001) in the CSS-D score at each follow-up interval. Baseline CSS-D ( P < 0.0001), surgical intervention ( P < 0.003), and Lund-McKay score ( P < 0.04) were predictive of clinical success in regression analysis. CONCLUSIONS: Patients referred to an otolaryngologist have a severe sinus illness. Treatment by an otolaryngologist was associated with significant improvement in sinus-related symptoms. SIGNIFICANCE: The study demonstrated the feasibility of multicenter outcome studies in chronic rhinosinusitis and generated testable hypotheses for future investigation. EBM RATING: C.

Adult↗
PubMed2005

The Cooperative Outcomes Group for ENT: a multicenter prospective cohort study on the outcomes of tympanostomy tubes for children with otitis media.

OBJECTIVE: Outcomes for patients with otitis media were assessed in this prospective, multicenter study. STUDY DESIGN AND SETTING: Thirty-one otolaryngologists enrolled 272 pediatric patients with otitis media; caregivers completed surveys at 3-month intervals, and clinical and treatment data was also collected. The Otitis Media 6 (OM-6) was the primary outcome measure. RESULTS: One hundred seventy-seven patients (mean age 2.0 years) completed 3-month follow-up. One hundred thirty-seven patients underwent tympanostomy tube placement. Large improvements in disease-specific quality of life (QOL) were seen up to 9 months of follow-up. Baseline OM-6 score was the best predictor of clinical success in regression modeling. CONCLUSIONS: Patients referred to an otolaryngologist for treatment of otitis media see large improvements in disease-specific QOL regardless of treatment rendered. SIGNIFICANCE: The study demonstrates the feasibility of multicenter outcomes studies and confirms appropriate triage of patients with otitis media into surgical versus medical interventions. EBM RATING: C.

Child↗
PubMed2005

Value of short-course antimicrobial therapy in acute bacterial rhinosinusitis.

Traditional approaches to antimicrobial management of acute bacterial rhinosinusitis (ABRS) focus on courses of therapy of at least 10 days duration. The rationale for this length of therapy originated from studies in tonsillopharyngitis. Short-course antibiotic therapy for ABRS with 3-5 days of azithromycin has proved equally effective. Potential added benefits of short-course therapy include improved compliance, fewer adverse events as well as reduced risk of treatment failure, bacterial resistance and cost. Single-dose therapy is now possible with a novel microsphere formulation of azithromycin, which permits administration of a higher 2.0 g oral dose. This has proved as effective and well tolerated as 10 days levofioxacin 500 mg/day in patients with uncomplicated ABRS. High single-dose therapy has the potential to maximize adherence to prescribed therapy and thus to help in the battle to control rising antibiotic resistance among respiratory pathogens.

Acute Disease↗
PubMed2005

Esophageal coin with an unusual radiographic appearance.

Esophageal coins are typically seen as radiopaque disks on anteroposterior chest radiographs. This radiographic finding is generally considered classic for identifying "swallowed" coins as being in the esophagus. We report the case of an 11-year-old girl with an esophageal coin seen end-on on an anteroposterior chest radiograph and as a disk consistent with a coin in the lateral view. These findings are typically associated with coin aspiration. Clinicians should be wary of making the diagnosis of foreign body aspiration of coins by relying on single-view radiographic findings alone. When clinically reasonable, we suggest additional imaging to help further localize swallowed coins.

Child↗
PubMed2004

Efficacy and safety of oral telithromycin once daily for 5 days versus moxifloxacin once daily for 10 days in the treatment of acute bacterial rhinosinusitis.

OBJECTIVE: To compare the clinical and bacteriologic efficacy and safety of short-duration treatment with telithromycin given for 5 days with moxifloxacin given for 10 days in adults with acute bacterial rhinosinusitis (ABRS). STUDY DESIGN: In this prospective, double-blind, parallel-group, randomized, multicenter study, adult patients (N = 349) with ABRS were randomized to oral telithromycin (800 mg once daily for 5 days) or to oral moxifloxacin (400 mg once daily for 10 days) and followed for 31 to 36 days. Clinical outcome was determined by the investigator at the posttherapy/test of cure (TOC) visit. Bacteriologic outcome was determined by comparing cultures taken at the pretreatment visit with cultures obtained at the posttherapy/TOC visit. The primary objective was to demonstrate equivalence of clinical cure rates in the per-protocol population between treatment groups at the posttherapy/TOC visit. RESULTS: Clinical success at TOC (primary endpoint) was achieved in 87.4% of patients in the telithromycin group compared with 86.9% for moxifloxacin (per-protocol patients; 0.5% difference between treatment groups; 95% confidence interval [CI], -8.1, 9.2; P = 0.8930). The bacteriologic success rates were 94.1% and 93.9%, respectively (0.2% difference between treatment groups; 95% CI, -14.2, 14.5; P = 0.9734). Overall treatment-emergent adverse events for both drugs (mostly gastrointestinal) were mild to moderate in intensity. CONCLUSION AND SIGNIFICANCE: The clinical and bacteriologic efficacy of telithromycin 800 mg once daily for 5 days was equivalent to that of moxifloxacin 400 mg once daily for 10 days, establishing telithromycin as an important treatment option for ABRS.

Acute Disease↗
PubMed2004

Techniques of intranasal steroid use.

OBJECTIVE: The effectiveness of topical intranasal steroids (INS) sprays for the treatment of allergic and nonallergic rhinitis may be limited by lack of instruction in the optimal spray technique. To determine whether the technique used affects the efficacy and safety of the product, this review of evidence had the goal of identifying and establishing a preferred method of applying INS sprays. STUDY DESIGN: A MEDLINE search of pertinent literature on 7 INS and 1 intranasal antihistamine spray preparations conducted with the use of appropriate search terms, yielded an initial 121 articles, 29 of which were identified as appropriate for review and grading for quality of evidence. RESULTS: The analysis provided no definitive evidence regarding how best to instruct patients to use INS or antihistamine spray devices. CONCLUSIONS: On the basis of a lack of clear evidence regarding instructions to maximize efficacy and safety of these drugs, the panel recommended a 7-step standard technique.

Administration, Intranasal↗
PubMed2003

Cost-effective pharmacotherapy for inhalant allergic rhinitis.

The otolaryngologist is one of the decision leaders for patients who seek to learn more about their problems of respiratory allergy. Although these patients do not have a life-threatening illness, the reduction of quality of life and performance can significantly restrict their overall sense of well being. Patients with allergic rhinitis desire the relief of the bothersome problems without other side effects. Second-generation antihistamines were introduced to reduce the significant impairment brought on by the sedation of the first-generation products. Most physicians prescribe the intranasal corticosteroids as the prescription drug of first choice for most patients with chronic allergic rhinitis. Second-generation H1 receptor antagonists are better for the patient than the first-generation drugs because of the reduced side-effect profile and improved tolerance. Compliance factors certainly need to be addressed with medications that need more than once-daily dosing. Patients with only sporadic problems in season or on limited exposure are best treated with oral antihistamines, topical cromolyn, and short-term decongestant therapy.

Adrenal Cortex Hormones↗