Ellen R. Wald

Rhinosinusitis: Establishing definitions for clinical research and patient care

Background There is a need for more research on all forms of rhinosinusitis. Progress in this area has been hampered by a lack of consensus definitions and the limited number of published clinical trials. Objectives To develop consensus definitions for rhinosinusitis and outline strategies useful in clinical trials. Methods Five national societies, The American Academy of Allergy, Asthma and Immunology; The American Academy of Otolaryngic Allergy; The American Academy of Otolaryngology Head and Neck Surgery; The American College of Allergy, Asthma and Immunology; and the American Rhinologic Society formed an expert panel from multiple disciplines. Over two days, the panel developed definitions for rhinosinusitis and outlined strategies for design of clinical trials. Results Committee members agreed to adopt the term “rhinosinusitis” and reached consensus on definitions and strategies for clinical research on acute presumed bacterial rhinosinusitis, chronic rhinosinusitis without polyposis, chronic rhinosinusitis with polyposis, and classic allergic fungal rhinosinusitis. Symptom and objective criteria, measures for monitoring research progress, and use of symptom scoring tools, quality-of-life instruments, radiologic studies, and rhinoscopic assessment were outlined for each condition. Conclusion The recommendations from this conference should improve accuracy of clinical diagnosis and serve as a starting point for design of rhinosinusitis clinical trials.

Clinical Practice Guideline Tonsillectomy in Children

Objective Tonsillectomy is one of the most common surgical procedures in the United States, with more than 530 000 procedures performed annually in children younger than 15 years. Tonsillectomy is defined as a surgical procedure performed with or without adenoidectomy that completely removes the tonsil including its capsule by dissecting the peritonsillar space between the tonsil capsule and the muscular wall. Depending on the context in which it is used, it may indicate tonsillectomy with adenoidectomy, especially in relation to sleep-disordered breathing. This guideline provides evidence-based recommendations on the preoperative, intraoperative, and postoperative care and management of children 1 to 18 years old under consideration for tonsillectomy. In addition, this guideline is intended for all clinicians in any setting who interact with children 1 to 18 years of age who may be candidates for tonsillectomy. Purpose The primary purpose of this guideline is to provide clinicians with evidence-based guidance in identifying children who are the best candidates for tonsillectomy. Secondary objectives are to optimize the perioperative management of children undergoing tonsillectomy, emphasize the need for evaluation and intervention in special populations, improve counseling and education of families of children who are considering tonsillectomy for their child, highlight the management options for patients with modifying factors, and reduce inappropriate or unnecessary variations in care. Results The panel made a strong recommendation that clinicians should administer a single, intraoperative dose of intravenous dexamethasone to children undergoing tonsillectomy. The panel made a strong recommendation against clinicians routinely administering or prescribing perioperative antibiotics to children undergoing tonsillectomy. The panel made recommendations for (1) watchful waiting for recurrent throat infection if there have been fewer than 7 episodes in the past year or fewer than 5 episodes per year in the past 2 years or fewer than 3 episodes per year in the past 3 years; (2) assessing the child with recurrent throat infection who does not meet criteria in statement 2 for modifying factors that may nonetheless favor tonsillectomy, which may include but are not limited to multiple antibiotic allergy/intolerance, periodic fever, aphthous stomatitis, pharyngitis and adenitis, or history of peritonsillar abscess; (3) asking caregivers of children with sleep-disordered breathing and tonsil hypertrophy about comorbid conditions that might improve after tonsillectomy, including growth retardation, poor school performance, enuresis, and behavioral problems; (4) counseling caregivers about tonsillectomy as a means to improve health in children with abnormal polysomnography who also have tonsil hypertrophy and sleep-disordered breathing; (5) counseling caregivers that sleep-disordered breathing may persist or recur after tonsillectomy and may require further management; (6) advocating for pain management after tonsillectomy and educating caregivers about the importance of managing and reassessing pain; and (7) clinicians who perform tonsillectomy should determine their rate of primary and secondary posttonsillectomy hemorrhage at least annually. The panel offered options to recommend tonsillectomy for recurrent throat infection with a frequency of at least 7 episodes in the past year or at least 5 episodes per year for 2 years or at least 3 episodes per year for 3 years with documentation in the medical record for each episode of sore throat and 1 or more of the following: temperature >38.3°C, cervical adenopathy, tonsillar exudate, or positive test for group A β-hemolytic streptococcus.

Oral Versus Initial Intravenous Therapy for Urinary Tract Infections in Young Febrile Children

Background. The standard recommendation for treatment of young, febrile children with urinary tract infection has been hospitalization for intravenous antimicrobials. The availability of potent, oral, third-generation cephalosporins as well as interest in cost containment and avoidance of nosocomial risks prompted evaluation of the safety and efficacy of outpatient therapy. Methods. In a multicenter, randomized clinical trial, we evaluated the efficacy of oral versus initial intravenous therapy in 306 children 1 to 24 months old with fever and urinary tract infection, in terms of short-term clinical outcomes (sterilization of the urine and defervescence) and long-term morbidity (incidence of reinfection and incidence and extent of renal scarring documented at 6 months by99mTc-dimercaptosuccinic acid renal scans). Children received either oral cefixime for 14 days (double dose on day 1) or initial intravenous cefotaxime for 3 days followed by oral cefixime for 11 days. Results. Treatment groups were comparable regarding demographic, clinical, and laboratory characteristics. Bacteremia was present in 3.4% of children treated orally and 5.3% of children treated intravenously. Of the short-term outcomes, 1) repeat urine cultures were sterile within 24 hours in all children, and 2) mean time to defervescence was 25 and 24 hours for children treated orally and intravenously, respectively. Of the long-term outcomes, 1) symptomatic reinfections occurred in 4.6% of children treated orally and 7.2% of children treated intravenously, 2) renal scarring at 6 months was noted in 9.8% children treated orally versus 7.2% of children treated intravenously, and 3) mean extent of scarring was ∼8% in both treatment groups. Mean costs were at least twofold higher for children treated intravenously (

Acute Maxillary Sinusitis in Children

3577 vs

Three-Year Multicenter Surveillance of Pneumococcal Meningitis in Children: Clinical Characteristics, and Outcome Related to Penicillin Susceptibility and Dexamethasone Use

1473) compared with those treated orally. Conclusions. Oral cefixime can be recommended as a safe and effective treatment for children with fever and urinary tract infection. Use of cefixime will result in substantial reductions of health care expenditures.

Frequency and severity of infections in day care

We sought to correlate the clinical, radiographic, and bacteriologic findings in maxillary sinusitis in 30 children who had both upper-respiratory-tract symptoms and abnormal maxillary radiographs. Cough, nasal discharge, and fetid breath were the most common signs, but fever was present inconsistently. Facial pain or swelling and headache were prominent symptoms in older children. Bacterial colony counts of greater than or equal to 10(4) colony-forming units per milliliter were found in 34 of 47 sinus aspirates obtained from 23 children. The most common species recovered were Streptococcus pneumoniae, Haemophilus influenzae, and Branhamella catarrhalis. No anaerobic bacteria were isolated. Viruses were isolated from only two sinus aspirates. There was a poor correlation between the predominant species of bacteria recovered from either the nasopharyngeal or throat culture and the bacteria isolated from the sinus aspirate. This study demonstrates that children with both upper-respiratory-tract symptoms and abnormal sinus radiographs are likely to harbor bacteria in their sinuses, suggesting that such children have bacterial sinusitis.

Urinary tract infections in young febrile children

Objectives. To evaluate the antibiotic susceptibility of Streptococcus pneumoniae isolates obtained from the blood and cerebrospinal fluid of children with meningitis. To describe and compare the clinical and microbiological characteristics, treatment, and outcome of children with meningitis caused by S pneumoniae based on antimicrobial susceptibility of isolates and the administration of dexamethasone. Design and Patients. Children with pneumococcal meningitis were identified from among a group of patients with systemic infections caused by S pneumoniae who were enrolled prospectively in the United States Pediatric Multicenter Pneumococcal Surveillance Study at eight childrens hospitals in the United States. From September 1, 1993 to August 31, 1996, 180 children with 181 episodes of pneumococcal meningitis were identified and data were collected by retrospective chart review. Outcome. Clinical and laboratory characteristics were assessed. All pneumococcal isolates were serotyped and antibiotic susceptibilities for penicillin and ceftriaxone were determined. Clinical presentation, hospital course, and outcome parameters at discharge were compared between children infected with penicillin-susceptible isolates and those with nonsusceptible isolates and for children who did and did not receive dexamethasone. Results. Fourteen (7.7%) of 180 children died; none of the fatalities were because of a documented failure of treatment caused by a resistant strain. Only 1 child, who had mastoiditis and a lymphangioma, experienced a bacteriologic failure with a penicillin-resistant (minimum inhibitory concentration = 2 μg/mL) organism. Of the 166 surviving children, 41 (25%) developed neurologic sequelae (motor deficits) and 48 (32%) of 151 children had unilateral (n = 26) or bilateral (n = 22) moderate to severe hearing loss at discharge. Overall, 12.7% and 6.6% of the pneumococcal isolates were intermediate and resistant to penicillin and 4.4% and 2.8% were intermediate and resistant to ceftriaxone, respectively. Clinical presentation, cerebrospinal fluid indices on admission, and hospital course, morbidity, and mortality rates were similar for patients infected with penicillin- or ceftriaxone-susceptible versus nonsusceptible organisms. However, the relatively small numbers of nonsusceptible isolates and the inclusion of vancomycin in the treatment regimen for the majority of the patients limit the power of this study to detect significant differences in outcome between patients infected with susceptible and nonsusceptible isolates. Nonetheless, our results show that the nonsusceptible organisms do not seem to be intrinsically more virulent. Forty children (22%) received dexamethasone (≥8 doses) initiated before or within 1 hour after the first dose of antibiotics. The incidence of any moderate or severe hearing loss was significantly higher in the dexamethasone group (46%) compared with children not receiving any dexamethasone (23%). The incidence of any neurologic deficits, including hearing loss, also was significantly higher in the dexamethasone group (55% vs 33%). However, children in the dexamethasone group more frequently required intubation and mechanical ventilation and had lower initial concentration of glucose in the cerebrospinal fluid than children who did not receive any dexamethasone. When we controlled for the confounding factor, severity of illness (intubation), the incidence of any deafness and of any neurologic sequelae, including deafness, were no longer significantly different between children who did or did not receive dexamethasone. Conclusions. Children with pneumococcal meningitis caused by penicillin- or ceftriaxone-nonsusceptible organisms and those infected by susceptible strains had similar clinical presentation and outcome. The use of dexamethasone was not associated with a beneficial effect in this retrospective and nonrandomized study. Only a well-designed, prospective, randomized, placebo-controlled study, conducted in centers where optimal supportive care can be provided, will determine the potential benefit, if any, of dexamethasone in patients with pneumococcal meningitis.

Treatment of Acute Otitis Media in Children under 2 Years of Age

This study was undertaken to compare prospectively the frequency, nature, and severity of infections experienced by children in three types of child care arrangements: home care, group care (two to six children), and day care (seven or more children). Children were enrolled at birth and observed for 12 to 18 months. At entry there were 159 children in home care, 40 in group care, and 45 in day care. The families were telephoned every 2 weeks to record on a standardized form the type and severity of illnesses experienced during the previous interval. Severe illnesses were defined by high fever, duration exceeding 10 days, or physician visit. Children remaining in their original child care group for at least 1 year were compared with regard to the frequency and severity of illness. Children in group care and day care were more likely than children in home care to experience at least six respiratory infections, more than 60 days of illness, and more than four severe illnesses (P less than 0.01). Similarly, life table analyses showed that children in home care had fewer episodes of infection than did children in day care (P less than 0.01). Although no children were hospitalized because of acute infections during the first year of study, hospitalization for myringotomy and tube placement occurred in 21% of children in day care and 3% of children in home care (P less than 0.01).

Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial

UTI is a common and important clinical problem in infants and young children, with a prevalence of 5.3% among febrile infants seen in our Emergency Department. White females with rectal temperature > or = 39 degrees C are at particularly high risk (prevalence, 17%). Several studies have highlighted the limitations of the standard urinalysis for identifying UTI in infants and young children and have recommended performance of both urinalysis and urine culture. Alternative methods such as dipstick urinalysis, although attractive because of ease of performance, are inadequate as a screen for UTI. Hemocytometer WBC counts of an uncentrifuged urine specimen can be performed in an office or hospital-based laboratory with minimal training. Performance of Gram-stained smears, however, is most appropriate for the hospital-based laboratory. In the hospital setting where both tests can readily be performed, the positive predictive value of the combination of pyuria and bacteriuria (85%) allows prompt institution of antimicrobial therapy before culture results are available, whereas the lower positive predictive value of the single finding of either pyuria or bacteriuria (40%) justifies delaying treatment decisions until culture results are available. In the office setting where hemocytometer counts can easily be performed, culturing only specimens with pyuria and those of children presumptively treated with antimicrobials will result in the identification of almost all patients with true UTI, sparing large health care expenditures. Although the urine culture is traditionally regarded as the gold standard of UTI, positive urine cultures may occur secondary to contamination or in cases of ABU, leading to a false diagnosis of UTI. In contrast we found pyuria to be a reliable marker to discriminate infection from colonization of the urinary tract. The sustained absence of an inflammatory response, on repeat UA within 24 h, constitutes strong evidence that infection is absent. Management of ABU is controversial; many experts recommend withholding antibiotics because eradication of low virulence organisms may be followed by colonization with more virulent species that cause pyelonephritis. Preliminary results of our ongoing treatment trial suggest that management of young febrile children with UTI as outpatients receiving oral cefixime is as efficacious as inpatient management with intravenous cefotaxime. Results of renal ultrasound and DMSA scan at the time of infection have not modified management in any patient. Accordingly selective rather than routine performance of ultrasound is recommended. A voiding cystourethrogram at 1 month and a DMSA scan 6 months later have been valuable in identifying patients with vesicoureteral reflux and renal scarring, respectively. Among patients initially identified as having acute pyelonephritis, the incidence of renal scarring at 6 months has been substantially more frequent (approximately 40%) than we had expected. However, the long term implications of small scars identified with renal scintigraphy remain to be determined.

Clinical Practice Guideline for the Diagnosis and Management of Acute Bacterial Sinusitis in Children Aged 1 to 18 Years

BACKGROUND Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media. METHODS We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure. RESULTS Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P=0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae. CONCLUSIONS Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00377260.).