randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen...
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3. Van Woensel JB, van Aalderen WM. Treatment for bronchiolitis: the
story continues. Lancet 2002;360:101-2.
4. Nelson R. Bronchiolitis drugs lack convincing evidence of efficacy. Lancet
2003;361:939.
5. Garrison MM, Christakis DA, Harvey E, Cummings P, Davis RL.
Systemic corticosteroids in infant bronchiolitis: a meta-analysis. Pediatrics
2000;105:e44.
6. Goebel J, Estrada B, Quinonez J, Nagji N, Sanford D, Boerth RC.
Prednisolone plus albuterol versus albuterol alone in mild to moderate
bronchiolitis. Clin Pediatr 2000;39:213-20.
7. Schuh S, Coates AL, Binnie R, Allin T, Goia C, Corey M, et al. Efficacy
of oral dexamethasone in outpatients with acute bronchiolitis. J Pediatr
2002;140:27-32.
Evidence assessment of the accuracy of methodsof diagnosing middle ear effusion in childrenwith otitis media with effusion
TakataGS,Chan LS,MorphewT,Mangione-Smith R,Morton SC, Shekelle P.
Pediatrics 2003;112:1379-87
Context Recommendations for diagnosing otitis media with
effusion (OME) have largely been based on limited evidence
and expert opinion.
Objective To assess the accuracy of methods of diagnosing
middle ear effusion in children with OME.
Design Systematic review of diagnostic studies.
Study identification The authors searched Medline (1966-
January 2000), the Cochrane Library (through January 2000),
and Embase (1980-January 2000) and identified additional
articles from reference lists in proceedings, published articles,
reports, and guidelines.
Study selection 52 studies of varying quality were selected
for analysis.
Results Among 8 diagnostic methods, pneumatic otoscopy
had the best apparent performance with a sensitivity of 94%
(95% CI, 92-96) and a specificity of 80% (95% CI, 75-86), with
corresponding likelihood ratios of 4.7 for a positive test and
0.08 for a negative test. However, examiner qualifications were
reported inconsistently, and training was not specified.
Conclusions Pneumatic otoscopy was found to do as well as
or better than tympanometry and acoustic reflectometry.
Comment Takata and colleagues conducted a detailed
assessment of the evidence for various diagnostic methods of
identifying otitis media with effusion (OME) in children 12
years of age and younger. They established reasonable criteria
to both conduct a literature search (through January 2000)
and assess study quality. Fifty-two studies (1% of 4879 initial
titles and abstracts) were ultimately selected for final assess-
ment. Comparisons with three or more studies were subjected
to meta-analyses. The authors did not assess combined
diagnostic methods or algorithms. No study was excluded,
however, on the basis of study quality. It would have been
interesting to also have seen the data when studies deemed to
have been of poor quality, relative to this analysis, were
excluded. In the pneumatic otoscopy comparison, five of the
seven studies were considered to have been of adequate to high
quality. The authors concluded that pneumatic otoscopy and
professional tympanometry had the highest pooled sensitivity,
compared with myringotomy, the ‘‘gold standard.’’ Pneumatic
otoscopy optimized both pooled sensitivity (94%) and speci-
ficity (80%).
Additional information on the assessment of each of the
various diagnostic methods by age of the child would have been
useful because otitis media occurs most frequently in infants
and younger children. Moreover, the difficulty of accurately
performing and interpreting these diagnostic modalities in-
creases in very young age groups. Age distributions could not
provided, however, due to limitations of the available data. In
addition, specific data were not available regarding the degree
of expertise of the otoscopists in each of the selected studies.
One wonders how representative their skills are compared
with those of pediatric practitioners. This report raises
a number of other challenging questions. How much training
will be required to achieve such a degree of otoscopic
proficiency? How best can this training be provided? What
level of otoscopic proficiency should be considered to be
satisfactory at the end of a formal training process?
The authors are to be commended for undertaking this
prodigious study. Their report provides support for the recom-
mendations, based at the time on limited scientific evidence
and strong panel consensus, of the 1994 AHCPR (now AHRQ)
OME Guideline promoting the use of pneumatic otoscopy. In
skilled hands, pneumatic otoscopy provides a powerful and
relatively inexpensive diagnostic modality.
Phillip H. Kaleida, MDProfessor of Pediatrics, Division of General Academic Pediatrics
Children’s Hospital of PittsburghPittsburgh, PA 15213-2583
138 Clinical Research Abstracts for Pediatricians
Randomized clinical trial of docusate,triethanolamine polypeptide, and irrigation incerumen removal in children
Whatley VN, Dodds CL, Paul RI. Arch Pediatr Adolesc Med
2003;157:1177-80
Context The efficacy of the variety of ceruminolytic agents
used in clinical practice in children is not very well studied.
Objectives To evaluate the efficacy of triethanolamine
polypeptide and docusate as ceruminolytic agents in children
with cerumen impaction.
Design Randomized controlled trial.
Setting Urban tertiary care children’s hospital emergency
department and general pediatric clinic.
Participants 92 children aged 6 months to 5 years who
presented as a convenience sample to either of the study sites
with cerumen impaction.
The Journal of Pediatrics � July 2004
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ALSO NOTED
Valvular dysfunction and carotid, subclavian, andcoronary artery disease in survivors of Hodgkinlymphoma treated with radiation therapy
Hull MC, Morris CG, Pepine CJ, Mendenhall NP. JAMA 2003;290:2831-7
This is an important study of survivors of Hodgkin’s
lymphoma designed to estimate the incidence and risk factors
for three potential radiation treatment-related complications:
coronary and noncoronary atherosclerotic vascular disease
and clinically important valvular disease. The authors docu-
ment a high rate of valve surgery (observed:expected ratio
8.42; 95% CI, 3.20-13.65) and coronary revascularization
procedures (1.63; 95% CI, 0.98-2.28) 10 to 20 years after the
radiation treatments. The coronary disease seems to be
associated with the radiation dose received and other
traditional coronary disease risk factors.
Intervention Children were computer randomized to receive
1-mL instillation of triethanolamine polypeptide, docusate, or
saline placebo. The study drug was left in place for 15 minutes,
then flushed with a standardized amount and technique of
warm tap water up to two times.
Main outcome measures Percentage of children in each
group that had complete visualization of the tympanic
membrane (light reflex, ossicles, and mobility).
Results Groups were similar in age, race, sex, ear enrolled,
wax consistency, and degree of obstruction. There was no
statistical difference in the percentage of children who had
complete resolution of cerumen impaction (docusate 53%,
triethanolamine polypeptide 43%, and placebo 68%).
Conclusion There was no difference between either of the
two drugs used or placebo in alleviating cerumen impaction in
children.
Comment Earache is the fourth most common complaint of
children who present to a pediatrician. The diagnosis of the
various ear disorders requires careful history and examination
of the ear canal and tympanic membrane. All too often, the
pediatrician is frustrated by the inability to adequately
examine the ear due to cerumen impaction. There are several
studies of the agents used commonly in practice to alleviate
cerumen obstruction,1-6 but they include very few children.
There is even a meta-analysis on the topic7 that shows
heterogeneous effects based on the studies of low quality that
existed before this study.
This study sought to identify any differences in efficacy of
the most commonly used agents, docusate, and
triethanolamine polypeptide (Cerumenex). Their study design
was sound, but found no difference between the two drugs
studied, and even had a trend toward the saline control being
more effective. Unfortunately, it was relatively underpowered
with an 80% chance of finding a 40% difference between groups.
Perhaps pediatricians would be happy deciding between the
two alternatives if only a 10% to 20% difference existed.
Detecting this difference would have required a much larger
sample size to achieve (>300 in each group). In the meantime,
pediatricians are left with their clinical judgment and
Clinical Research Abstracts for Pediatricians
experience in selecting from the variety of agents and
procedures to clear ear wax for a good view.
Brett Robbins, MDUniversity of RochesterRochester, NY 14620
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