Wendrich Anne W, Kroese Tiuri E, Peters Jeroen P M, Cattani Guido, Grolman Wilko
*Department of Otorhinolaryngology - Head and Neck Surgery †Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
Otol Neurotol. 2017 Jun;38(5):632-641. doi: 10.1097/MAO.0000000000001405.
To systematically review the literature to evaluate the trial period of bone conduction devices (BCDs) for adult patients with single-sided deafness (SSD).
The PubMed, Embase, and Cochrane Library databases were searched from their inception up to August 15, 2016 for SSD, BCD, and their synonyms.
In total, 523 articles were retrieved, of which 12 satisfied the eligibility quality criteria. Our outcomes of interest were: 1) the BCD implantation rejection percentage, 2) reasons to reject BCD implantation, and 3) possible prognostic factors predicting the trial outcome.
At critical appraisal, six studies (n = 471 patients) scored a moderate to high directness of evidence and a medium or low risk of bias and were selected for data extraction. Due to heterogeneity between studies, pooling of data for meta-analysis was not feasible. Therefore, results of studies were summarized per outcome: 1) after the BCD trial, 32.0 to 69.6% of SSD patients rejected BCD implantation, 2) the three main reasons for rejection were experiencing limited benefit from the device, patients fearing or being unfit for surgery and cosmetic aspects, 3) no clear prognostic factors predicting the trial outcome could be identified.
Roughly half of patients rejected BCD implantation after a trial period. From the current literature it is unclear which patients could benefit most from BCD implantation. High level of evidence studies should be conducted to investigate possible prognostic factors that predict the BCD trial outcome.
系统回顾文献,以评估成人单侧耳聋(SSD)患者使用骨传导装置(BCD)的试验期。
检索了PubMed、Embase和Cochrane图书馆数据库,从建库至2016年8月15日,检索词为SSD、BCD及其同义词。
共检索到523篇文章,其中12篇符合纳入质量标准。我们感兴趣的结果为:1)BCD植入排斥率;2)拒绝BCD植入的原因;3)预测试验结果的可能预后因素。
在关键评估中,六项研究(n = 471例患者)证据的直接性为中度至高,偏倚风险为中或低,被选用于数据提取。由于研究间存在异质性,无法进行数据合并以进行荟萃分析。因此,按结果总结研究结果:1)BCD试验后,32.0%至69.6%的SSD患者拒绝BCD植入;2)拒绝的三个主要原因是从装置中获益有限、患者害怕或不适合手术以及美观方面;3)未发现明确的预测试验结果的预后因素。
约一半患者在试验期后拒绝BCD植入。从当前文献来看,尚不清楚哪些患者能从BCD植入中获益最多。应开展高质量证据研究,以调查预测BCD试验结果的可能预后因素。