Abstract：
BACKGROUND: Single-sided deafness (SSD) has functional, psychological, and social consequences. Interventions for adults with SSD include hearing aids and auditory implants. Benefits and harms (outcome domains) of these interventions are until now reported inconsistently in clinical trials. Inconsistency in reporting outcome measures prevents meaningful comparisons or syntheses of trial results. The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) international initiative used structured communication techniques to achieve consensus among healthcare users and professionals working in the field of SSD. The novel contribution is a set of core outcome domains that experts agree are critically important to assess in all clinical trials of SSD interventions.
METHODS: A long list of candidate outcome domains compiled from a systematic review and published qualitative data, informed the content of a two-round online Delphi survey. Overall, 308 participants from 29 countries were enrolled. Of those, 233 participants completed both rounds of the survey and scored each outcome domain on a 9-point scale. The set of core outcome domains was finalised via a web-based consensus meeting with 12 participants. Votes involved all stakeholder groups, with an approximate 2:1 ratio of professionals to healthcare users participating in the Delphi survey, and a 1:1 ratio participating in the consensus meeting.
RESULTS: The first round of the survey listed 44 potential outcome domains, organised thematically. A further five outcome domains were included in Round 2 based on participant feedback. The structured voting at round 2 identified 17 candidate outcome domains which were voted on at the consensus meeting. Consensus was reached for a core outcome domain set including three outcome domains: spatial orientation, group conversations in noisy social situations, and impact on social situations. Seventy-seven percent of the remaining Delphi participants agreed with this core outcome domain set.
CONCLUSIONS: Adoption of the internationally agreed core outcome domain set would promote consistent assessment and reporting of outcomes that are meaningful and important to all relevant stakeholders. This consistency will in turn enable comparison of outcomes reported across clinical trials comparing SSD interventions in adults and reduce research waste. Further research will determine how those outcome domains should best be measured.
METHODS: A long list of candidate outcome domains compiled from a systematic review and published qualitative data, informed the content of a two-round online Delphi survey. Overall, 308 participants from 29 countries were enrolled. Of those, 233 participants completed both rounds of the survey and scored each outcome domain on a 9-point scale. The set of core outcome domains was finalised via a web-based consensus meeting with 12 participants. Votes involved all stakeholder groups, with an approximate 2:1 ratio of professionals to healthcare users participating in the Delphi survey, and a 1:1 ratio participating in the consensus meeting.
RESULTS: The first round of the survey listed 44 potential outcome domains, organised thematically. A further five outcome domains were included in Round 2 based on participant feedback. The structured voting at round 2 identified 17 candidate outcome domains which were voted on at the consensus meeting. Consensus was reached for a core outcome domain set including three outcome domains: spatial orientation, group conversations in noisy social situations, and impact on social situations. Seventy-seven percent of the remaining Delphi participants agreed with this core outcome domain set.
CONCLUSIONS: Adoption of the internationally agreed core outcome domain set would promote consistent assessment and reporting of outcomes that are meaningful and important to all relevant stakeholders. This consistency will in turn enable comparison of outcomes reported across clinical trials comparing SSD interventions in adults and reduce research waste. Further research will determine how those outcome domains should best be measured.
摘要：
背景：单面耳聋（SSD）具有功能性，心理,和社会后果。成人SSD的干预措施包括助听器和听觉植入物。到目前为止，这些干预措施的益处和危害（结果领域）在临床试验中的报道不一致。报告结果测量的不一致阻碍了对试验结果进行有意义的比较或综合。针对单侧耳聋的核心康复成果集（CROSSSD）国际计划使用结构化通信技术在SSD领域的医疗保健用户和专业人员之间达成共识。新的贡献是一组核心结果领域，专家们认为这些领域对于评估SSD干预措施的所有临床试验至关重要。
方法：根据系统评价和已发布的定性数据编制的一长串候选结果域，通报了两轮在线Delphi调查的内容。总的来说,来自29个国家的308名参与者被纳入研究。其中,233名参与者完成了两轮调查，并以9分制对每个结果域进行了评分。一组核心成果域是通过一个有12名参与者的基于网络的共识会议最终确定的。投票涉及所有利益相关者团体，参与德尔福调查的专业人员与医疗保健用户的比例约为2:1，以1:1的比例参加协商一致会议。
结果：第一轮调查列出了44个潜在的结果领域，按主题组织。根据参与者的反馈，第二轮中还包括了另外五个结果域。第二轮的结构化投票确定了17个候选结果域，并在共识会议上进行了投票。对于包括三个结果域的核心结果域集合达成了共识：空间取向，在嘈杂的社交场合中进行集体对话，以及对社会状况的影响。剩余的Delphi参与者中有77％同意此核心结果域集。
结论：采用国际商定的核心结果域集合将促进对所有相关利益攸关方有意义和重要的结果的一致评估和报告。这种一致性反过来将能够比较临床试验中报告的结果，比较成人SSD干预措施，并减少研究浪费。进一步的研究将确定如何最好地测量这些结果域。
方法：根据系统评价和已发布的定性数据编制的一长串候选结果域，通报了两轮在线Delphi调查的内容。总的来说,来自29个国家的308名参与者被纳入研究。其中,233名参与者完成了两轮调查，并以9分制对每个结果域进行了评分。一组核心成果域是通过一个有12名参与者的基于网络的共识会议最终确定的。投票涉及所有利益相关者团体，参与德尔福调查的专业人员与医疗保健用户的比例约为2:1，以1:1的比例参加协商一致会议。
结果：第一轮调查列出了44个潜在的结果领域，按主题组织。根据参与者的反馈，第二轮中还包括了另外五个结果域。第二轮的结构化投票确定了17个候选结果域，并在共识会议上进行了投票。对于包括三个结果域的核心结果域集合达成了共识：空间取向，在嘈杂的社交场合中进行集体对话，以及对社会状况的影响。剩余的Delphi参与者中有77％同意此核心结果域集。
结论：采用国际商定的核心结果域集合将促进对所有相关利益攸关方有意义和重要的结果的一致评估和报告。这种一致性反过来将能够比较临床试验中报告的结果，比较成人SSD干预措施，并减少研究浪费。进一步的研究将确定如何最好地测量这些结果域。
