Katiri Roulla, Hall Deborah A, Killan Catherine F, Smith Sandra, Prayuenyong Pattarawadee, Kitterick Pádraig T
National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC), Ropewalk House, 113 The Ropewalk, Nottingham, NG1 5DU, UK.
Department of Audiology, Mater Misericordiae University Hospital, Dublin, D07 R2WY, Ireland.
Trials. 2021 Mar 20;22(1):220. doi: 10.1186/s13063-021-05160-5.
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.
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.
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.
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.
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.
本系统评价旨在识别、比较和对比在研究中报告的结局领域和结局指标，这些研究调查了旨在恢复单侧耳聋（SSD）成年人双侧（两侧）和/或双耳（双耳）听力的干预措施。研究结果可为制定循证指南提供参考，以促进确证性试验的设计决策。
通过检索MEDLINE、EMBASE、PubMed、CINAHL、ClinicalTrials.gov、ISRCTN、CENTRAL、世界卫生组织国际临床试验平台（WHO ICTRP）和英国国家卫生研究院（NIHR）临床试验网关来识别记录。检索范围包括1946年至2020年3月发表的记录。纳入的研究如下：（a）招募年龄在18岁及以上、被诊断为SSD的成年人，其听力较差耳的平均阈值严重程度比70dB HL更差，听力较好耳为正常（或接近正常）听力；（b）评估恢复双侧和/或双耳听力的干预措施；（c）将这些成年人纳入对照试验、前后对照研究或交叉研究。略低于参与者纳入标准的研究纳入单独的敏感性分析。
纳入了96项研究（72项完全纳入，24项敏感性分析）。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。总体而言，共识别出520个结局领域（350个主要领域和170个次要领域）。与言语相关的结局领域最为常见（74%的研究），其次是与空间相关的领域（60%的研究）。共报告了344种独特的结局指标。与言语相关的结局领域由73种不同的指标测量，与空间相关的领域由43种不同的指标测量。随访时间差异很大，从急性（基线）测试到干预后10年不等。敏感性分析未识别出额外的结局领域。
本评价发现，在评估SSD干预措施的治疗益处和危害的研究中，结局领域和指标的报告存在很大差异。报告经常遗漏关于研究打算评估哪些领域以及使用哪些指标来测量哪些领域的信息。
该系统评价方案已在国际前瞻性系统评价注册库（PROSPERO）注册：注册号CRD4,201,808,4274。于2018年3月13日注册，最后一次修订于2019年5月7日。
