pone.0290480.g001.tif (624.64 kB)
SPIRIT schedule of enrolment, interventions, and assessments.
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posted on 2024-02-29, 18:31 authored by Matthew E. Smith, Rachel Knappett, Deborah Vickers, David White, Chris J. Schramm, Samir Mehta, Yongzhong Sun, Ben Watkins, Marie Chadburn, Hugh Jarrett, Karen James, Elizabeth Brettell, Tracy E. Roberts, Manohar L. Bance, James R. Tysome1 = for arm 1 (oral steroid), 2 = for arm 2 (intratympanic injection), 3 = for arm 3 (combined treatment). # Optional weekly testing, for participants who have internet access. * should be performed within three days prior to commencement of treatment. **recommended to be performed on same day as pure tone audiogram or if not practicable within next working day. & Only persistent perforation of the tympanic membrane will be recorded at 12 weeks.
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tinnitus functional indexrepeated measures mixedhealth economic assessmentwithin four weeksiras 1004878 ).early steroid treatmentreduced hearing duestarfish trial aimscost per qualityoral prednisolone 1mgweeks following randomisation2 days apartsteroid administration routesoral prednisoloneline treatment7 days0khz ).hearing scalehearing nervevia oralcombined oral12 weeksunknown aetiologythroat unitssecondary outcomesrecruit adultsprimary outcomeprimary analysesinternal pilotinner eargroup meansestimated viaeffective routeconfidence intervalsarm interventionadverse eventsadjusted lifeabsolute improvement&# 8804
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