The public health significance of this study is to provide researchers and clinicians interested in the study and treatment of Otitis Media with effusion (OME) with a better understanding of the associations between covariates and antibiotic treatment with the resolution of OME, which in turn will inform the decision-to-treat process. In a secondary analysis of the data from a series of three efficacy trials, we focus on the roles of laterality (unilateral vs. bilateral disease) and sidedness (right vs. left ear) as prognostic factors. The D&A trial compared the efficacy of decongestant and antihistamine (D/A) to placebo, the ABI trial was similar but compared amoxicillin (with and without to D/A) to placebo, and the ABII trial compared the efficacy of 2 promising antibiotics to amoxicillin. Each trial assessed subjects for OME at baseline, 2 weeks, and 4 weeks.
The prevalence of OME at each time point was described by laterality and sidedness. McNemars test showed no evidence that left and right ears differ with respect to prevalence rates at 2 or 4 weeks (OR = 1.106 and OR = 0.858, respectively). Transition matrices of changes in OME status from 0 to 2 weeks and 2 to 4 weeks described the dependence of prior effusion status on a subjects current OME status. Multinomial regression was used to assess baseline covariates associated with prevalence and transitions of effusion status at each time point. We identified statistically significant prognostic factors of OME, including duration of effusion. Our analyses showed no differences in either prevalence of OME or in transitions of effusion status attributable to sidedness. A Chi Square Goodness-of-Fit test at each timepoint rejected the hypothesis of independence, p < 0.001. An ear-level GEE analysis demonstrated that effusion status of a contralateral ear was a significant predictor of effusion in the other ear (OR = 1.44, p < 0.001). There was no significant effect of sidedness (p = 0.86) and bilateral disease does not resolve at the rate predicted by unilateral resolution. This reanalysis using correlated data methods augments the initial findings by further examining sidedness and documenting transitions over time.
| Identifer | oai:union.ndltd.org:PITT/oai:PITTETD:etd-12072007-112302 |
| Date | 30 January 2008 |
| Creators | Titmus, Joshua |
| Contributors | Ellen M. Mandel, Roslyn A. Stone, Howard E. Rockette, John W. Wilson |
| Publisher | University of Pittsburgh |
| Source Sets | University of Pittsburgh |
| Language | English |
| Detected Language | English |
| Type | text |
| Format | application/pdf |
| Source | http://etd.library.pitt.edu/ETD/available/etd-12072007-112302/ |
| Rights | unrestricted, I hereby certify that, if appropriate, I have obtained and attached hereto a written permission statement from the owner(s) of each third party copyrighted matter to be included in my thesis, dissertation, or project report, allowing distribution as specified below. I certify that the version I submitted is the same as that approved by my advisory committee. I hereby grant to University of Pittsburgh or its agents the non-exclusive license to archive and make accessible, under the conditions specified below, my thesis, dissertation, or project report in whole or in part in all forms of media, now or hereafter known. I retain all other ownership rights to the copyright of the thesis, dissertation or project report. I also retain the right to use in future works (such as articles or books) all or part of this thesis, dissertation, or project report. |
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