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Diagnostic inaccuracy and subject exclusions render placebo and observational studies of acute otitis media
Michael E Pichichero1, Janet R Casey
1Department of Microbiology and Immunology, University of Rochester Medical Center, Rochester, NY 14642, USA. michael_pichichero@urmc.rochester.edu
Insights
Critically evaluating acute otitis media (AOM) trials reveals flawed diagnostic and selection criteria. Current evidence supporting observation for AOM requires reconsideration due to significant biases in study design.
Area of Science:
- Pediatrics
- Infectious Diseases
- Clinical Trial Design
Background:
- Accurate diagnosis and appropriate patient selection are crucial for trials evaluating observation or placebo for acute otitis media (AOM).
- Existing studies on AOM management often lack representative patient populations, potentially skewing results.
Purpose of the Study:
- To evaluate the diagnostic, inclusion, and exclusion criteria used in observational and natural history studies of acute otitis media (AOM).
- To identify potential biases in study designs that may affect the interpretation of AOM management trials.
Main Methods:
- A systematic review of 12 observational studies (1958-2005) and 13 natural history studies (1968-2006) was conducted.
- Key criteria analyzed included diagnostic indicators, subject inclusion, and subject exclusion criteria.
Main Results:
- Few studies required a bulging tympanic membrane, a key indicator of bacterial AOM.
- Inclusion criteria often allowed subjects without AOM or with other ear conditions; exclusion criteria frequently removed young children and those with severe AOM indicators.
- This resulted in study populations not reflecting the true epidemiology of AOM.
Conclusions:
- Inaccurate diagnosis and biased inclusion/exclusion criteria in AOM trials compromise the validity of findings.
- Current evidence supporting observation for AOM, based on these flawed studies, should be re-evaluated.
- Improved study designs are necessary for reliable AOM management research.
Background:
Diagnostic accuracy and appropriate inclusion/exclusion criteria representative of children at greatest risk is of paramount importance in trials to evaluate placebo or observation as an option for acute otitis media (AOM) management.
Methods:
Twelve observational studies spanning the time frame 1958-2005 and 13 natural history studies spanning the time frame 1968-2006 were evaluated for the diagnostic criteria, inclusion criteria, and exclusion criteria applied within the study design.
Results:
Although a bulging or full tympanic membrane (TM) with effusion is the best indication of a diagnosis of bacterial AOM based on tympanocentesis findings, few observational and natural history studies required a bulging TM. Examination of subject inclusion criteria showed that many subjects did not have AOM but rather had no middle ear disease at all or they had otitis media with effusion. Exclusion criteria of subjects were also remarkable. Frequently children <2 years old were excluded; mean age among the studies reflected an older age group, unlike the true epidemiology of AOM. Otitis prone children, those with severe disease, with a bulging TM, with fever, with a definite need for antibiotics, with recent antibiotic treatment, with recent AOM, or with perforation of the TM were often excluded.
Conclusions:
Guidelines and some authorities have overlooked or discounted the importance of the issues of inaccurate diagnosis on study entry, broad inclusion criteria, and the creation of bias in exclusion criteria among placebo/natural history trials in AOM. The current data favoring observation of children with AOM should be reconsidered until better studies are conducted.
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