PubMed · 7067011
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Z Novotný. 1982. [Divers studied with the auditory analyzer].. https://pubmed.ncbi.nlm.nih.gov/7067011/
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In non-randomized clinical studies, the regression phenomenon can confound interpretation of the effectiveness of an intervention. The regression effect arises due to daily variation and/or misclassification of the biologic marker used in selection as well as in the assessment of the intervention effect. We consider a scenario in which the selection criterion for a subject's participation in the study is such that he/she must have a positive diagnostic test at screening. The disease status is then reassessed at the end of intervention. Thus, two repeated measurements of a binary disease outcome are available, with only selected subjects having a second measurement upon follow-up. We propose methods for estimating the change in event probability resulting from implementing the intervention while adjusting for the misclassification that produces the regression effect. We extend this approach to estimation of both the placebo and intervention effects in placebo-controlled studies designed with a misclassified binary outcome. Analyses of two biomedical studies are used for illustration.
OBJECTIVE: Tinnitus is one of the most common and distressing otological symptoms. Although numerous therapeutic modalities have been tried, there is no consensus regarding effective therapeutic agents up to now. The effects of lidocaine on tinnitus have been reported in literature using either subjective or audiologic tests. Nevertheless, the otoacoustic emissions (OAEs) have not been utilized to demonstrate lidocaine's effect on the cochlea in the English literature. The aim of this study was to evaluate the effect of lidocaine on tinnitus by considering the alterations with tinnitus, it induces on OAEs and subjective symptoms. METHODS: This study was performed in 30 patients with tinnitus. Twenty-eight of the patients had normal hearing and two of them evidenced mild sensorineural hearing loss. To determine the severity of tinnitus, the patients were required to fill out a tinnitus scoring scale before lidocaine infusion on the same day. Then, lidocaine was administered intravenously to each patient at a dose of 1.5 mg/kg body weight over a period of 30 min. Spontaneous otoacoustic emissions (SOAEs) and distortion product otoacoustic emissions (DPOAEs) were measured three times; namely before lidocaine injection, at 25 min after injection and on the next day. The severity of tinnitus was scored again 1 d, 1 wk and 1 mo after lidocaine administration. RESULTS: Immediately after infusion, four patients (13.3%) declared total suppression of tinnitus, whereas three patients (10%) reported only partial relief in tinnitus subjectively. The patients, who had a subjective improved response (group 1) were compared with the patients, who had no response (group 2). Statistically significant changes (p<0.05) in DPOAE response/growth or input/output (I/O) functions were observed at 1, 2, 3, 4 and 6 kHz frequencies in lidocaine responders and at 1, 2, 3, 4 and 5 kHz frequencies in no responders at different primary stimulus levels. Statistically significant changes (p<0.05) were seen at 2 kHz for 53 dB and at 3 kHz for 62 dB SPL primaries in both groups. When the significant results of these two groups were compared with each other, differences were found insignificant. CONCLUSION: Systematic OAE measurements revealed that no changes occurred in SOAE and DPOAE levels in that alterations disappeared the next day. Subjective relief from tinnitus was stated in some of the patients and lasted for 4 wk at longest.
Cochlear compression in normal-hearing listeners was estimated at octave frequencies from 250 to 4000 Hz using a forward-masking paradigm. Temporal masking curves (TMCs) for a 10-dB SL signal were obtained with two maskers -- one equal in frequency to the signal and another an octave below the signal. The ratio of the slope of the off-frequency function to that of the mid-level portion of the on-frequency function was computed as an estimate of the amount of compression at each frequency. Compression was less frequency selective at low frequencies, so an average of the off-frequency slopes at high frequencies (1000, 2000, and 4000 Hz) was used in computing the ratio for each signal frequency. Results indicated strong compression (approximately 0.15-0.30) at all frequencies using the averaged off-frequency slopes, indicating little difference in compression across frequencies. Distortion product otoacoustic emission (DPOAE) input-output (I-O) functions were obtained for each subject at 1000, 2000, and 4000 Hz. The slopes of the DPOAE I-O functions and the psychophysical growth rates were similar to one another, reinforcing the assumption that the forward-masking procedure is providing an estimate of cochlear compression, at least at frequencies from 1000 to 4000 Hz.