Monitoring Hearing Function in Patients With Sporadic Vestibular Schwannoma: A Feasibility Study to Inform a Future Randomized Controlled Trial.
TL;DR
This study has demonstrated sufficient eligibility and recruitment/retention rates for the proposed RCT and high-test completion rates with acceptable duration and Variability estimates of key outcome measures have been provided to determine the sample size for the RCT.
Abstract
Objective
There is a need for a definitive RCT comparing upfront stereotactic radiosurgery (SRS) versus watch-and-wait (WW) for long-term hearing preservation in vestibular schwannoma (VS). Specific objectives of this feasibility study were to: (1) assess patient eligibility and recruitment/ retention rates, (2) determine completion rates/ times, and (3) estimate the variance in key proposed outcome measures to inform sample-size estimation for an RCT. STUDY
Design
Nonrandomized, single-centre, prospective study.
Setting
Tertiary-referral centre. PATIENTS Thirty-one patients with sporadic VS undergoing WW (n = 22) or SRS (n = 9).
Interventions
Four-frequency average pure-tone audiometry (4FAPTA) thresholds, Word Recognition Scores (WRS), monaural/antiphasic Digits-in-Noise speech reception thresholds (DiN SRT50), and self-reported outcomes including the Speech, Spatial and Qualities of Hearing Scale (SSQ) and Tinnitus Functional Index (TFI). MAIN OUTCOME MEASURES Feasibility metrics (recruitment, completion rates, testing times). Variance of outcome measures (hearing-related: 4FAPTA, monoaural/ antiphasic DiN-SRT50, WRS. Patient-reported outcomes: SSQ, TFI.
Results
Forty-four patients were recruited over 7 months. Thirty-one (70.5%) met inclusion criteria, and 25 (80%) completed all tests. Average time to complete the assessments was 1 hour 42 minutes. Mean 4FAPTA (±SD) in VS-affected ears was 42 ± 14 dB HL (WW) and 55 ± 9.4 dB HL (SRS). Antiphasic DiN-SRT50 thresholds were WW: -14.2 dB SNR ± 4.1; SRS: -11.6 dB SNR ± 1.9, and 4FAPTA and antiphasic DiN-SRT50 were correlated (P < 0.001) in VS-affected ears.
Conclusions
This study has demonstrated sufficient eligibility and recruitment/retention rates for the proposed RCT and high-test completion rates with acceptable duration. Variability estimates of key outcome measures (DiN-SRT50, 4FAPTA) have also been provided to determine the sample size for the RCT.