成人日间单侧人工耳蜗植入对总体及疾病特异性生活质量、术后并发症、听力结果、耳鸣、眩晕和成本效益的影响：一项随机对照试验方案
Effect of day-case unilateral cochlear implantation in adults on general and disease-specific quality of life, postoperative complications and hearing results, tinnitus, vertigo and cost-effectiveness: protocol for a randomised controlled trial.
作者信息
Derks Laura S M, Wegner Inge, Smit Adriana L, Thomeer Hans G X M, Topsakal Vedat, Grolman Wilko
机构信息
Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
Department of Otorhinolaryngology-Head and Neck Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.
出版信息
BMJ Open. 2016 Oct 3;6(10):e012219. doi: 10.1136/bmjopen-2016-012219.
INTRODUCTION
Cochlear implantation is an increasingly common procedure in the treatment of severe to profound sensorineural hearing loss (SNHL) in children and adults. It is often performed as a day-case procedure. The major drive towards day-case surgery has been from a logistical, economical and societal perspective, but we also speculate that the patient's quality of life (QoL) is at least equal to inpatient surgery if not increased as a result of rapid discharge and rehabilitation. Even though cochlear implantation seems well suited to a day-case approach and this even seems to be common practice in some countries, evidence is scarce and of low quality to guide us towards the preferred treatment option.
METHODS AND ANALYSIS
A single-centre, non-blinded, randomised, controlled trial was designed to (primarily) investigate the effect on general QoL of day-case cochlear implantation compared to inpatient cochlear implantation and (secondarily) the effect of both methods on (subjective) hearing improvement, disease-specific QoL, tinnitus, vertigo and cost-effectiveness. 30 adult patients with severe to profound bilateral postlingual SNHL who are eligible for unilateral cochlear implantation will be randomly assigned to either the day-case or inpatient treatment group. The outcome measures will be assessed using auditory evaluations, questionnaires (preoperatively, at 1-week, 3-week, 3-month and 1-year follow-up) and costs diaries (weekly during the first month postoperatively, after which once in a month until 1-year follow-up). Preoperative and postoperative outcomes will be compared. The difference in costs and benefit will be represented using the incremental cost utility/effectiveness ratio. The analyses will be carried out on an intention-to-treat basis.
ETHICS AND DISSEMINATION
This research protocol was approved by the Institutional Review Board of the UMC Utrecht (NL45590.041.13; V.5, November 2015). The trial results will be disseminated through peer-reviewed medical journals and presented at scientific conferences.
TRIAL REGISTRATION NUMBER
NTR4464; Pre-results.
引言
人工耳蜗植入术在治疗儿童和成人重度至极重度感音神经性听力损失（SNHL）方面越来越常见。该手术通常作为日间手术进行。推动日间手术的主要动力来自后勤、经济和社会角度，但我们也推测，由于快速出院和康复，患者的生活质量（QoL）即使没有提高，至少也与住院手术相当。尽管人工耳蜗植入似乎非常适合日间手术方式，而且在一些国家这甚至似乎是常见做法，但证据稀少且质量不高，无法指导我们选择首选的治疗方案。
方法与分析
一项单中心、非盲、随机对照试验旨在（主要）研究与住院人工耳蜗植入相比，日间人工耳蜗植入对总体生活质量的影响，以及（次要）两种方法对（主观）听力改善、疾病特异性生活质量、耳鸣、眩晕和成本效益的影响。30名符合单侧人工耳蜗植入条件的重度至极重度双侧语后聋成年患者将被随机分配到日间手术组或住院治疗组。将使用听觉评估、问卷（术前、术后1周、3周、3个月和1年随访）和成本日记（术后第一个月每周记录，之后每月记录一次直至1年随访）来评估结局指标。比较术前和术后的结果。成本和效益的差异将用增量成本效用/效益比来表示。分析将基于意向性分析进行。
伦理与传播
本研究方案已获得乌得勒支大学医学中心机构审查委员会的批准（NL45590.041.13；V.5，2015年11月）。试验结果将通过同行评审的医学期刊进行传播，并在科学会议上展示。
试验注册号
NTR4464；预结果。
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