Assessment of current patient reported outcome measures for three core outcome domains for single-sided deafness device intervention trials.

IF 2.4 Q2 HEALTH CARE SCIENCES & SERVICES
Roulla Katiri, Deborah A Hall, Derek J Hoare, Sandra Smith, Bethany Adams, Kathryn Fackrell, Adele Horobin, Nicholas Hogan, Nóra Buggy, Pádraig T Kitterick
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Abstract

Background: Outcome reporting in clinical trials of auditory interventions for adults with Single-Sided Deafness (SSD) is inconsistent. The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) initiative has recommended three outcome domains as a minimum standard in the design of SSD intervention clinical trials. These are, Spatial orientation, Group conversations in noisy social situations, and Impact on social situations. The study objectives were to (i) understand exactly what the outcome domains mean to SSD experts, and (ii) identify and assess candidate PROMs in terms of how well they measure the experts' conceptualisation of those SSD outcome domains.

Methodology: Stakeholder representatives participated in two semi-structured online focus groups. Participants were four adults diagnosed with SSD with experience of auditory interventions, two healthcare professionals working in the field, and one clinical researcher with experience in evaluating interventions. Thematic analysis was used to determine conceptual elements of each domain. COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative recommendations were adopted to assess the relevance and comprehensiveness (content validity) of available candidate instruments.

Results: Multiple key concepts were identified for each outcome domain, and presented as a taxonomy. To be acceptable, any measurement instrument would need to achieve good coverage of all concepts in this taxonomy. From the 76 candidate instruments reviewed, none met accepted standards for content validity for SSD. The best performing candidates were (i) Spatial orientation: the Spatial Hearing Questionnaire and two variants of the Speech, Spatial and Qualities scale (SSQ-12, SSQ-18-C), (ii) Group conversations in noisy situations: the Communication Profile for Hearing Impaired (CPHI) questionnaire, SSQ-12, SSQ-18-C, and a multi-item questionnaire developed by Schafer and colleagues, and (iii) Impact on social situations: the CPHI questionnaire.

Conclusions: Multi-dimensional outcome domains introduce specific considerations for how they should be measured. Although some candidates instruments had reasonable comprehensiveness, modification is needed to ensure that there is overall greater relevance to the key concepts.

评估当前患者报告的单侧耳聋装置干预试验的三个核心结果域的结果措施。
背景:听力干预治疗成人单侧耳聋(SSD)的临床试验结果报告不一致。单侧耳聋核心康复结果集(CROSSSD)倡议推荐了三个结果域作为设计单侧耳聋干预临床试验的最低标准。这三门课程分别是:空间取向、嘈杂社会环境中的群体对话、对社会环境的影响。研究目标是(i)准确理解结果域对SSD专家的意义,以及(ii)根据专家对这些SSD结果域的概念化程度来确定和评估候选prom。方法:利益相关者代表参加了两个半结构化的在线焦点小组。参与者是四名有听觉干预经验的被诊断为SSD的成年人,两名在该领域工作的医疗保健专业人员,以及一名有评估干预经验的临床研究人员。专题分析用于确定每个领域的概念要素。采用了基于共识的卫生测量工具选择标准(COSMIN)倡议的建议,以评估可用候选工具的相关性和全面性(内容效度)。结果:为每个结果域确定了多个关键概念,并以分类法的形式呈现。为了能够被接受,任何测量工具都需要很好地覆盖该分类法中的所有概念。在审查的76个候选仪器中,没有一个符合SSD内容效度的公认标准。表现最好的考生是(i)空间取向:空间听力问卷和两种变体的言语、空间和素质量表(SSQ-12, SSQ-18-C); (ii)嘈杂环境下的群体对话:听力障碍沟通概况(CPHI)问卷,SSQ-12, SSQ-18-C和Schafer及其同事开发的多项目问卷;(iii)对社交情境的影响:CPHI问卷。结论:多维结果域介绍了如何测量它们的具体考虑因素。虽然一些候选文书具有合理的全面性,但仍需要进行修改,以确保与关键概念有更大的总体相关性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Patient-Reported Outcomes
Journal of Patient-Reported Outcomes Health Professions-Health Information Management
CiteScore
3.80
自引率
7.40%
发文量
120
审稿时长
20 weeks
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