Development of HRQOL Instruments for Children with CIs and their Parents

为 CI 儿童及其家长开发 HRQOL 工具

• 批准号: 9100250
• 负责人: Ivette Cejas
• 金额: $ 16.19万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9100250
• 关键词: Adolescent; Age; Agreement; Area; Audiotape; Auditory; Behavior Therapy; Bilateral; Birth; Child; Childhood; Clinical; Clinical Trials; Cochlear Implants; Cochlear implant procedure; Cognitive; Communication; Communities; Consensus; Cost-Benefit Analysis; Data Collection; Development; Device or Instrument Development; Devices; Disease; Effectiveness; Electronics; Emotional; Ensure; Evaluation; Family; Focus Groups; Frequencies; Generations; Generic Drugs; Health; Health Status; Hearing Impaired Persons; Hour; Infant; Intervention; Interview; Language; Language Development; Literature; Measurable; Measures; Medical; Operative Surgical Procedures; Outcome; Outcome Measure; Parents; Pathologist; Patient Outcomes Assessments; Patient Self-Report; Patient-Focused Outcomes; Patients; Performance; Personal Satisfaction; Pharmaceutical Preparations; Phase; Physical Function; Population; Procedures; Provider; Proxy; Psyche structure; Psychologist; Psychometrics; Quality of life; Rehabilitation therapy; Reporting; Respondent; School-Age Population; Social Functioning; Speech; Speech Pathologist; Surgeon; Techniques; Thinking; United States Food and Drug Administration; Validity and Reliability; Walkers; World Health Organization; base; clinical decision-making; cognitive testing; daily functioning; deafness; disability impact; ethnic diversity; functional status; health related quality of life; hearing impairment; instrument; intervention effect; meetings; physical symptom; primary outcome; public health relevance; racial and ethnic; response; secondary outcome; skills; social; teacher; validation studies

 DESCRIPTION (provided by applicant): Severe to profound hearing loss is associated with measurable deficits in health-related quality of life (HRQoL), reflecting its concomitant effects o language learning, social and emotional functioning, and academic performance. However, studies of cochlear implantation (CI) typically focus on clinical measures of efficacy related to communication development (e.g., auditory, speech, language skills), which does not represent the intervention's effects on daily functioning. HRQoL measures provide a crucial assessment of the impact of the condition and its treatment on physical, social and emotional functioning. To date, there are no CI-specific HRQoL measures for young children, adolescents and their parents (Morettin et al., 2013). The purpose of this study is to develop the first HRQoL instruments for pediatric cochlear implant recipients and their parents. We plan to complete the first two phases of instrument development for: 1) parents of children birth to five years, 2) school-age children 6-12, plus a parent-proxy measure and 3) adolescents with CIs ages 13-18. Instrument development will adhere to the FDA Guidance on patient-reported outcomes (FDA, 2009). Phase I consists of a synthesis and integration of existing literature and prior HRQoL instruments for this population and data collection at national CI Centers to ensure geographic and racial/ethnic diversity, and includes: 1) an integration of prior literature and instruments to form a testable conceptual framework, 2) focus groups with stakeholders (surgeons, audiologists, speech pathologists), 3) open-ended interviews with parents of children birth to 18 years, children ages 6 to 18 years, and 4) cognitive testing of the 4 draft instruments. Eight one-hour focus groups will be conducted with stakeholders, such as CI surgeons, pediatric audiologists, auditory verbal therapists, and community providers. Next, open-ended interviews will be conducted and audiotaped with 110 parents and children to identify the effects of both deafness and CI use on several areas of functioning. All focus groups and open-ended interviews will be transcribed and content-analyzed to identify key themes and quantify the frequency of their endorsement. Items will then be generated based on saturation matrices of specific content, resulting in draft versions of all four QOL-CI measures. Lastly, cognitive interviews, using standardized "think aloud" procedures, will be performed with 96 parents and CI users (ages 6 to 18). Cognitive interviewing techniques are now widely used to gain information from respondents about the clarity and comprehensiveness of the items and response scales. Completion of this project will yield the final draft instruments to be field-testd in a national, psychometric validation study to assess reliability, validity, and responsivity to change. Instruments will be developed using an electronic format to enhance their utility and interpretability. These instruments will facilitate evaluation of the effectiveness of CI's over tie, provide patient-centered outcome measures for other interventions (e.g., auditory-verbal therapy, behavioral interventions), and provide information at the patient/family level for targete interventions.

 描述（由申请人提供）：重度至极重度听力损失与健康相关生活质量（HRQoL）的可测量缺陷相关，反映了其对语言学习、社交和情感功能以及学业成绩的伴随影响。然而，人工耳蜗植入（CI）的研究通常集中在与通信发展相关的疗效的临床测量（例如，听觉，言语，语言技能），这并不代表干预对日常功能的影响。HRQoL措施提供了一个重要的评估的影响条件和治疗的身体，社会和情绪功能。到目前为止，还没有针对幼儿、青少年及其父母的CI特异性HRQoL测量（Morettin等人，2013年）。本研究的目的是为儿童人工耳蜗植入者及其父母开发第一个HRQoL仪器。我们计划完成仪器开发的前两个阶段：1）出生至5岁儿童的父母，2）6-12岁学龄儿童，加上父母代理措施和3）13-18岁CI的青少年。仪器开发将遵循FDA关于患者报告结局的指南（FDA，2009）。第I阶段包括综合和整合现有文献和该人群的既往HRQoL工具以及国家CI中心的数据收集，以确保地理和种族/民族多样性，并包括：1）整合既往文献和工具， 形成一个可测试的概念框架，2）与利益相关者（外科医生、听力学家、言语病理学家）的焦点小组，3）与出生至18岁儿童、6至18岁儿童的父母进行开放式访谈，以及4）对4份文书草案进行认知测试。八个一小时的焦点小组将与利益相关者，如CI外科医生，儿科听力学家，听觉语言治疗师和社区提供者进行。接下来，将进行开放式访谈，并与110名家长和儿童进行录音，以确定耳聋和CI使用对几个功能领域的影响。所有焦点小组和不限成员名额的访谈都将被转录和内容分析，以确定关键主题并量化其认可的频率。然后将根据特定内容的饱和度矩阵生成项目，从而生成所有四个QOL-CI测量的草案版本。最后，认知访谈，使用标准化的“大声思考”程序，将与96名家长和CI用户（6至18岁）进行。认知访谈技术现在被广泛用于从受访者那里获得关于项目和反应量表的清晰度和全面性的信息。该项目的完成将产生最终草案文书进行实地测试，在一个国家，心理验证研究，以评估可靠性，有效性和变化的反应。将使用电子格式编制文书，以提高其实用性和可解释性。这些工具将有助于评估CI的有效性，为其他干预措施提供以患者为中心的结果指标（例如，言语治疗，行为干预），并提供信息，在病人/家庭层面的目标干预。