Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology
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Multicenter Study
Cross-cultural Adaption and Validation of the Zurich Chronic Middle Ear Inventory Translated Into Italian (ZCMEI-21-It)-a Prospective Multicenter Study.
There are no instruments available to comprehensively assess health-related quality of life (HRQoL) in chronic otitis media (COM) in Italian-speaking countries. The Zurich chronic middle ear inventory (ZCMEI-21) is a well-established instrument for the assessment of HRQoL in COM. The objective of this study was to translate and cross-culturally adapt the ZCMEI-21 into Italian and validate this questionnaire for measuring HRQoL in patients with COM. ⋯ We translated the ZCMEI-21 questionnaire into Italian and validated the ZCMEI-21-It in a prospective multicenter study. The ZCMEI-21-It is the first instrument that comprehensively assesses relevant dimensions of HRQoL in Italian-speaking patients affected by COM.
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Randomized Controlled Trial Multicenter Study
Stability, Survival, and Tolerability of an Auditory Osseointegrated Implant for Bone Conduction Hearing: Long-Term Follow-Up of a Randomized Controlled Trial.
To compare implant stability, survival, and soft tissue reactions for a novel (test) and previous generation (control) percutaneous auditory osseointegrated implant for bone conduction hearing at long-term follow-up of 5 years. ⋯ The test implant showed superiority in terms of higher mean ISQ values and less adverse soft tissue reactions, both at the single 5-year follow-up visit and during the complete follow-up. In addition, both implants showed an equally high implant survival.
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Multicenter Study Clinical Trial
Pars tensa retractions without cholesteatoma in children: predictors for ossicular chain destruction, air conduction thresholds, and postoperative retractions.
Determine predictive values of preoperative stages of pars tensa retractions, coexisting attic retraction and preoperative air conduction for ossicular destruction in isolated and combined pars tensa retraction, and predictors for successful tympanic grafts after surgery. ⋯ Absence of correlation between stage of pars tensa retraction and air conduction thresholds with ossicular defects justifies surgical exploration of the auditory ossicles, even in lower stages of retraction. Combined ossicular defect is expected in combined retractions. The usage of cartilage graft proved to be more appropriate.
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Multicenter Study
The management of peripheral facial nerve palsy: "paresis" versus "paralysis" and sources of ambiguity in study designs.
Conservative management of idiopathic or herpetic acute peripheral facial palsy (herpes zoster oticus, HZO) often leads to a favorable outcome. However, recent multicenter studies have challenged the necessity of antivirals. Whereas large numbers of patients are required to reveal statistical differences in a disease with an overall positive outcome, surprisingly few studies differentiate between patients with paresis and paralysis. Analyzing our own prospective cohort of patients and reviewing the current literature on conservative treatment of Bell's palsy and HZO, we reveal the importance of initial baseline assessment of the disease course to predict the outcome and to validate the impact of medical treatment options. STUDY DESIGN AND DATA SOURCE: Prospective analysis of consecutive patients referred to 2 tertiary referral centers and research on the Cochrane Library for current updates of their previous reviews and search of MEDLINE (1976-2009) for randomized trials on conservative treatment of acute facial palsy were conducted. ⋯ The time course for improvement and the extent of recovery is significantly different in patients presenting with an incomplete facial nerve paresis compared with patients with a total paralysis. Whereas the term "palsy" includes both entities, the term "paralysis" should only be used to describe total loss of nerve function. Patients with incomplete acute Bell's palsy (paresis) should start to improve their facial function early (1-2 wk after onset) and are expected to recover completely within 3 months. These patients do not benefit from antiviral medications and most likely do not profit from systemic steroids. Mixing patients with different severity of palsies will always lead to controversial results.
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Multicenter Study
Importance of age and postimplantation experience on speech perception measures in children with sequential bilateral cochlear implants.
Clinical trials in which children received bilateral cochlear implants in sequential operations were conducted to analyze the extent to which bilateral implantation offers benefits on a number of measures. The present investigation was particularly focused on measuring the effects of age at implantation and experience after activation of the second implant on speech perception performance. ⋯ Sequential bilateral cochlear implantation in children of diverse ages has the potential to improve speech perception abilities in the second implanted ear and to provide access to the use of binaural mechanisms such as the head shadow effect. The improvement unfolds over time and continues to grow during the 6 to 12 months after activation of the second implant. Younger children in this study achieved higher open-set speech perception scores in the second ear, but older children still demonstrate bilateral benefit in noise. Determining the long-term impact and cost-effectiveness that results from such potential capabilities in bilaterally implanted children requires additional study with larger groups of subjects and more prolonged monitoring.