Department of Otolaryngology, University of Miami Ear Institute, Miami, Florida, USA.
Behavioral Health Systems Research Health Systems Research, Miami, Florida, USA.
Ear Hear. 2021 July/Aug;42(4):1072-1083. doi: 10.1097/AUD.0000000000001004.
Severe to profound hearing loss is associated with communication, social, and behavioral difficulties that have been linked to worse health-related quality of life (HRQoL) compared to individuals with normal hearing. HRQoL has been identified as an important health outcome that measures functional ability, particularly for chronic conditions and disabilities. The current study developed the QoL-cochlear implant (CI) for early childhood and adolescents using the recommended Food and Drug Administration and European Medicines Agency guidelines on patient-reported outcomes.
Three phases of instrument development were conducted for both the early childhood (0 to 5 years old; parent proxy) and adolescent/young adult (13 to 22 years old) versions of the QoL-CI. Phase 1 included the development of our conceptual framework, which informed the discussion guides for stakeholder focus groups (e.g., audiologists, physicians, and therapists) at CI clinics in Miami and Philadelphia (n = 39). Open-ended interviews with parents (N = 18 for early childhood; N = 6 for adolescent/young adult version) and adolescents/young adults using CIs (n = 17) were then completed at both sites during phase 2. All interviews were transcribed and coded to identify common themes, which were then used to draft items for the QoL-CI. Both versions of the QoL-CI were developed using Qualtrics to allow for quick, easy electronic administration of the instruments on a tablet device. Last, phase 3 included cognitive testing in a new sample (N = 19 early childhood, N = 19 adolescent) to ensure that the draft instruments were clear, comprehensive, and easy to use.
Participant responses obtained via the open-ended interviews yielded an early childhood and adolescent version of the QoL-CI that was reportedly easy to complete and comprehensive. The final QoL-CI Early Childhood instrument yielded 35 questions across eight functional domains (environmental sounds, communication, social functioning, behavior, CI device management and routines, school, CI benefits, and early intervention). Similarly, the final QoL-CI adolescent/young adult version consisted of 46 items across eight domains (noisy environments, communication, CI usage and management, advocacy, social functioning, emotional functioning, acceptance, and independence).
The QoL-CI is a condition-specific QoL instrument that can be used for children ages birth through 22 years. These instruments capture the "whole" child by not only focusing on communication and auditory skills but also academic, social and emotional functioning. Once validated, these CI-specific measures will enable providers to track long-term outcomes and evaluate the efficacy of new interventions to improve overall CI use and QoL for pediatric and young adult users.
严重至极重度听力损失与沟通、社交和行为困难有关，与正常听力的个体相比，这些困难与较差的健康相关生活质量（HRQoL）相关。HRQoL 已被确定为衡量功能能力的重要健康结果，特别是对于慢性疾病和残疾。本研究使用食品和药物管理局和欧洲药品管理局推荐的患者报告结局指南，为婴幼儿和青少年开发了 QoL-人工耳蜗（CI）。
为婴幼儿（0 至 5 岁；父母代理）和青少年/年轻成人（13 至 22 岁）版本的 QoL-CI 进行了三个阶段的仪器开发。第 1 阶段包括我们的概念框架的开发，该框架为迈阿密和费城的 CI 诊所的利益相关者焦点小组（例如，听力学家、医生和治疗师）的讨论指南提供了信息（n=39）。然后在第 2 阶段在两个地点完成了对使用 CI 的父母（婴幼儿组 n=18；青少年/年轻成人组 n=6）和青少年/年轻成人的开放式访谈。对所有访谈进行了转录和编码，以确定共同主题，然后将这些主题用于起草 QoL-CI 的项目。QoL-CI 的两个版本均使用 Qualtrics 开发，以便在平板电脑设备上快速、轻松地进行电子管理。最后，第 3 阶段包括在新样本（婴幼儿组 n=19，青少年组 n=19）中进行认知测试，以确保草案仪器清晰、全面且易于使用。
通过开放式访谈获得的参与者反应产生了一个婴幼儿和青少年版本的 QoL-CI，据报道该版本易于完成且全面。最终的 QoL-CI 婴幼儿仪器由 8 个功能领域的 35 个问题组成（环境声音、沟通、社交功能、行为、CI 设备管理和常规、学校、CI 益处和早期干预）。同样，最终的 QoL-CI 青少年/年轻成人版本由 8 个领域的 46 个项目组成（嘈杂环境、沟通、CI 使用和管理、倡导、社交功能、情绪功能、接受和独立）。
QoL-CI 是一种特定于 CI 的生活质量工具，可用于 0 至 22 岁的儿童。这些工具不仅关注沟通和听觉技能，还关注学业、社交和情绪功能，从而全面地了解儿童。一旦验证，这些特定于 CI 的测量方法将使提供者能够跟踪长期结果，并评估新干预措施的疗效，以改善儿科和年轻成人使用者的整体 CI 使用和生活质量。
