背景:本系统综述旨在确定,比较和对比在调查旨在恢复单侧耳聋(SSD)成人双侧(双侧)和/或双耳(双耳)听力的干预措施的研究中报告的结局领域和结局工具.研究结果可以为制定循证指南提供信息,以促进验证性试验的设计决策。
方法:通过搜索MEDLINE来识别记录,EMBASE,PubMed,CINAHL,ClinicalTrials.gov,ISRCTN,中部,WHOICTRP和NIHR英国临床试验门户。搜索包括1946年至2020年3月发布的记录。纳入的研究如下:(a)招募18岁或以上被诊断患有SSD的成年人,听力较差的耳朵平均阈值严重程度低于70dBHL,听力较好的耳朵听力正常(或接近正常),(b)评估干预措施以恢复双侧和/或双耳听力,以及(c)将这些成年人纳入对照试验,前后研究或交叉研究。仅未达到参与者资格标准的研究被纳入单独的敏感性分析中。
结果:纳入了96项研究(72项完全纳入,24敏感性分析)。对于完全纳入的研究,37项专门评估了恢复双侧听力的干预措施,29项专门评估了恢复双耳听力的干预措施。总的来说,确定了520个结果域(350个主要域和170个次要域)。语音相关的结果领域是最常见的(74%的研究),其次是空间相关领域(60%的研究)。总共报告了344种独特的结果工具。语音相关的结果域由73种不同的仪器测量,空间相关的领域由43种不同的仪器测量。随访时间有相当大的差异,从急性(基线)测试到干预后10年。敏感性分析没有发现额外的结果域。
结论:本综述发现,在评估SSD干预措施的治疗益处和危害的研究中,结果域和工具的报告存在很大差异。报告经常忽略有关研究打算评估哪些领域的信息,以及使用哪些仪器来测量哪些领域。
背景:系统评价方案已在PROSPERO(国际前瞻性系统评价登记册)上注册:注册号为CRD42018084274。注册于2018年3月13日,最后修订于2019年5月7日。
BACKGROUND: This systematic review aimed to identify, compare and contrast outcome domains and outcome instruments reported in studies investigating interventions that seek to restore bilateral (two-sided) and/or binaural (both ears) hearing in adults with single-sided deafness (SSD). Findings can inform the development of evidence-based guidance to facilitate design decisions for confirmatory trials.
METHODS: Records were identified by searching MEDLINE, EMBASE, PubMed, CINAHL, ClinicalTrials.gov, ISRCTN, CENTRAL, WHO ICTRP and the NIHR UK clinical trials gateway. The search included records published from 1946 to March 2020. Included studies were those as follows: (a) recruiting adults aged 18 years or older diagnosed with SSD of average threshold severity worse than 70 dB HL in the worse-hearing ear and normal (or near-normal) hearing in the better-hearing ear, (b) evaluating interventions to restore bilateral and/or binaural hearing and (c) enrolling those adults in a controlled trial, before-and-after study or cross-over study. Studies that fell just short of the participant eligibility criteria were included in a separate sensitivity analysis.
RESULTS: Ninety-six studies were included (72 full inclusion, 24 sensitivity analysis). For fully included studies, 37 exclusively evaluated interventions to re-establish bilateral hearing and 29 exclusively evaluated interventions to restore binaural hearing. Overall, 520 outcome domains were identified (350 primary and 170 secondary). Speech-related outcome domains were the most common (74% of studies), followed by spatial-related domains (60% of studies). A total of 344 unique outcome instruments were reported. Speech-related outcome domains were measured by 73 different instruments and spatial-related domains by 43 different instruments. There was considerable variability in duration of follow-up, ranging from acute (baseline) testing to 10 years after the intervention. The sensitivity analysis identified no additional outcome domains.
CONCLUSIONS: This review identified large variability in the reporting of outcome domains and instruments in studies evaluating the therapeutic benefits and harms of SSD interventions. Reports frequently omitted information on what domains the study intended to assess, and on what instruments were used to measure which domains.
BACKGROUND: The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): Registration Number CRD42018084274 . Registered on 13 March 2018, last revised on 7th of May 2019.