Abstract
ObjectiveSelecting subjects for clinical trials on hearing loss therapies relies on the patient meeting the audiological inclusion criteria. In studies on the treatment of idiopathic sudden sensorineural hearing loss, the patient’s acute audiogram is usually compared with a previous audiogram, the audiogram of the non-affected ear, or a normal audiogram according to an ISO standard. Generally, many more patients are screened than actually fulfill the particular inclusion criteria. The inclusion criteria often require a calculation of pure-tone averages, selection of the most affected frequencies, and calculation of hearing loss differences.Materials and methodsA software tool was developed to simplify and accelerate this inclusion procedure for investigators to estimate the possible recruitment rate during the planning phase of a clinical trial and during the actual study. This tool is Microsoft Excel-based and easy to modify to meet the particular inclusion criteria of a specific clinical trial. The tool was retrospectively evaluated on 100 patients with acute hearing loss comparing the times for classifying automatically and manually. The study sample comprised 100 patients with idiopathic sudden sensorineural hearing loss.Results and conclusionThe age- and sex-related normative audiogram was calculated automatically by the tool and the hearing impairment was graded. The estimated recruitment rate of our sample was quickly calculated. Information about meeting the inclusion criteria was provided instantaneously. A significant reduction of 30 % in the time required for classifying (30 s per patient) was observed.Supplementary fileAdditional material to this article (Rahne_InclusionCriteria_v.en2.1.xlsx) will be available online at 10.1007/s00106-015-0089-3
Highlights
MethodsA Microsoft Excel 2010 (Version 14.0. 7151.5001; Microsoft, Redmond, Wash.) spreadsheet was developed
When compared with the audiogram of the opposite, non-affected ear, three consecutive frequencies with hearing change due to the incident ≥30 dB could be found in the frequency ranges of 0.125–0.5 kHz, 0.25–1 kHz, 0.5–2 kHz, 1–3 kHz, and 2–4 kHz
If (1) no previous audiogram of the affected ear is available and if (2) according to the patient’s medical history hearing was symmetric before the incident, the patient would be recommended for inclusion into the clinical trial
Summary
A Microsoft Excel 2010 (Version 14.0. 7151.5001; Microsoft, Redmond, Wash.) spreadsheet was developed. The “minimum hearing level” difference is calculated as the maximum difference between the mean hearing thresholds of three consecutive frequencies of the acute audiogram and the respective baseline. The hearing thresholds of the acute and the baseline audiograms are entered in the “audiograms” table. The “recommendation on inclusion” is based on the inclusion parameters, separately for every baseline audiogram If both the severity of hearing loss and the hearing loss of three consecutive frequencies meet the predefined inclusion criteria, a positive decision is recommended and the color of the fields change from red to green. Audiograms of 100 patients with ISSHL were classified to meet the respective inclusion criteria and the time needed for manual classification was compared with automatic classification using the tool
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