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Biomedical subjects

R M Rosenfeld

Publications and source records attributed to R M Rosenfeld.

14 recordsLinked to original sources

Third-generation cephalosporins in the treatment of acute pneumococcal otitis media. An animal study.

There is concern that third-generation cephalosporins may not be effective in the treatment of acute otitis media due to Streptococcus pneumoniae. Using the chinchilla animal model, we compared two third-generation cephalosporins, cefixime (Suprax) and ceftibuten (investigational), with ampicillin and saline controls in an investigator-blinded, randomized trial. Whereas the saline controls performed worse than all other groups, no significant differences were detected among the three antibiotics regarding the time required to sterilize the middle ear cleft, or the prevalence of positive cultures after 10 days of therapy. The statistical power of the comparisons of cefixime and ceftibuten with ampicillin were 98% and 67%, respectively. The results of this in vivo animal study fail to support the contention that the two third-generation cephalosporins investigated are not effective in the treatment of pneumococcal acute otitis media. Caution is advised when extrapolating these results to the general clinical setting.

Acoustic Impedance Tests

Predictors of residual-recurrent cholesteatoma in children.

The aggressive nature of childhood cholesteatoma has generated much controversy regarding the optimal management of this challenging disorder. To identify potential predictors of residual-recurrent disease, we studied 232 children (244 ears) treated with 427 surgical procedures between 1973 and 1990. Cause of the primary cholesteatoma was congenital in 43 patients (18%), acquired in 83 (36%), and unknown in 106 (46%). Of 90 patients with residual-recurrent disease, 21 (23%) instances were detected during a second-look surgical exploration. The 3- and 5-year residual-recurrence rates were 48% and 57%, respectively. Development of residual-recurrent disease was associated with ossicular erosion (Cox regression) but not with status of the canal wall (up vs down) during tympanomastoidectomy. This study suggests a need for intense and prolonged postoperative follow-up of children with cholesteatoma, especially those with ossicular erosion.

Adolescent

Should granulomas be excised in children with long-term tracheotomy?

We reviewed 265 rigid bronchoscopies performed in 50 children with tracheotomy-dependent subglottic stenosis (25 congenital, 25 acquired). Granulomas developed in 40 children (80%) and were unrelated to age, sex, race, gastroesophageal reflux, tracheotomy duration, or type of stenosis. The incidence of small to medium, large, and obstructing granulomas at endoscopy was 28%, 6%, and 0%, respectively. Compared with a baseline finding of no granuloma at preceding bronchoscopy, the odds of granuloma recurrence were 3.0 after an unexcised granuloma (95% confidence interval [CI], 1.1 to 8.4), 4.1 after granuloma excision (95% CI, 1.4 to 11.9), and 7.3 after expansion surgery (95% CI, 1.1 to 49.2). Considering the low incidence of large or obstructing granulomas, and the failure of granuloma excision to diminish recurrence, we do not recommend interval excision of nonobstructing granulomas in children with stable tracheotomies.

Bronchoscopy

Meta-analysis of antibiotics for the treatment of otitis media with effusion.

OBJECTIVE: To reconcile conflicting reports of antibiotic efficacy for otitis media with effusion in children. DATA SOURCES: English-language MEDLINE search ("antibiotics" and "otitis" media with effusion") from January 1980 through December 1990. Current Contents 1990, consultation with experts, and references from review articles, textbook chapters, and retrieved reports. STUDY SELECTION: Randomized clinical trials with concurrent controls (placebo or no drug), and children with at least one ear not violated by tympanocentesis. Ten of the initial 82 articles were selected after blind review of the methods sections. DATA EXTRACTION: We independently evaluated each trial using 20 measures of internal and external validity, then extracted treatment and control responses for an end point of all affected ears free of effusion at the first posttreatment assessment. DATA SYNTHESIS: Pooled analysis of 1325 children yielded a rate difference of 22.8% (95% Cl, 10.5 to 35.1) that was minimally affected by interstudy quality differences, and was unlikely to represent publication bias. Variations in trial outcomes were not attributable to chance, study design, or choice of drug, but were inversely related to the control group natural cure rate. Children with chronic bilateral effusions not related to a recent episode of acute otitis media tended to have lower natural cure rates, and a more favorable response to therapy. CONCLUSIONS: Antibiotics have a clinically and statistically significant impact on the resolution of otitis media with effusion. The association between outcome and natural cure rate has important implications for the design and interpretation of future trials.

Anti-Bacterial Agents

Clinical research in otolaryngology journals.

In an era of cost-effectiveness and quality control, the need for sound clinical research as a basis for health care decisions has intensified. To identify trends in clinical research, a survey of 1831 articles in four otolaryngology journals spanning a 20-year period was performed. Clinical research comprised 77% of all articles and has steadily increased in volume. Significant trends have occurred toward multiple authorship, more female first authors, and a declining proportion of articles with grant support. In 1989, a total of 224 articles (40%) employed analytic or experimental study designs vs only 64 articles (18%) in 1969. Descriptive studies and review articles have declined in prevalence. These findings suggest that over the past two decades, clinical research in otolaryngology journals has increased in both quantity and quality.

Bibliometrics

Systemic steroids for otitis media with effusion in children.

The role of oral steroids in the treatment of otitis media with effusion in children is the subject of ongoing debate. To critically evaluate the existing evidence, we performed a formal meta-analysis of six randomized clinical trials (n = 264 children) selected from 14 articles and abstracts. Children receiving steroids for 7 to 14 days were 3.6 times more likely than placebo-treated control subjects to have both ears free of effusion at the end of therapy (95% confidence interval, 2.2 to 4.1). This finding was essentially unchanged when the studies were weighted by a quality score, or stratified by use of concurrent antibiotic. The presence of significant heterogeneity among these studies suggests that additional trials will be needed to identify the specific subset(s) of children most likely to benefit from steroid therapy.

Adolescent

Biostatistics in otolaryngology journals.

Clinical research depends on biostatistics to form meaningful inferences from uncertain data. We performed a cross-sectional analysis of clinical research in otolaryngology journals to identify trends in statistical usage and determine the statistical aptitude expected of journal readers. Statistical content and study design were assessed for 1262 articles from 1969, 1979, and 1989. General trends toward an increasing use of inferential statistics and stronger study designs were observed. The number of analytic and experimental studies employing inferential statistics has risen from 20 (31%) in 1969 to 145 (65%) in 1989. Although familiarity with only five statistical techniques gave access to 90% of current articles, this study suggests that the level of statistical expertise demanded of both researchers and readers will continue to increase.

Bibliometrics

Fourth branchial pouch sinus: diagnosis and treatment.

The fourth branchial pouch sinus (FBPS) is a rare translaryngeal anomaly with diverse manifestations, including neonatal stridor and recurrent deep neck infection. Review of the world literature reveals 23 reports of sinuses consistent with fourth pouch origin. We present two additional cases, including the only example of a right-sided FBPS. Retrograde excision, beginning at the piriform apex, ensures complete removal of the tract and protection of the recurrent nerve. The posterior border of the thyroid ala must be resected or retracted for adequate exposure. Failure to remove the translaryngeal portion of the tract almost guarantees recurrence.

Adolescent

Tonsillectomy and adenoidectomy: changing trends.

A review of 1,722 tonsil and adenoid procedures performed between 1978 and 1986 is presented. Each year there has been a progressive decrease in the number of procedures performed; the incidence of adenoidectomy has declined particularly. Although infection remains the predominant indication for surgery, there has been a dramatic rise in obstructive sleep apnea as a significant indication, from 0% in 1978 to 19% in 1986. At present, this trend promises to continue as physicians become increasingly aware of the prevalence and seriousness of adenotonsillar hypertrophy as a cause of sleep apnea, particularly in the general pediatric population.

Adenoidectomy