Development & Psychometric Evaluation of the ICIQ-B

发展

• 批准号: 8181325
• 负责人: Alayne Denise Markland
• 金额: --
• 依托单位: BIRMINGHAM VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8181325
• 关键词: Acute; Adult; Affect; Aftercare; Age-Years; American; Applications Grants; Behavior Therapy; Behavioral; British; Client satisfaction; Clinic; Clinical; Clinical Research; Clinical Trials; Companions; Computers; Consultations; Data; Development; Diabetes Mellitus; Diagnosis; Disease; Education; Elderly; England; Evaluation; Fecal Incontinence; Feces; Focus Groups; Foundations; Functional Gastrointestinal Disorders; Funding; Future; Guidelines; Incontinence; International; Intervention; Intervention Trial; Intestines; K-Series Research Career Programs; Language; Link; Liquid substance; Literature; Mails; Measurement; Measures; National Health and Nutrition Examination Survey; Obesity; Online Systems; Operative Surgical Procedures; Outcome; Outcome Measure; Outcomes Research; Paper; Patient-Focused Outcomes; Patients; Pelvic Floor Disorders; Pelvic floor structure; Population; Prevalence; Primary Health Care; Property; Protocols documentation; Psychometrics; Publishing; Quality of life; Questionnaires; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Recruitment Activity; Rehabilitation Research; Rehabilitation therapy; Reproducibility; Research; Rome; SF-12; Severities; Solid; Structure; Symptoms; TBI Patients; Telephone; Testing; Treatment Protocols; Treatment outcome; United Kingdom; Validation; Veterans; Visit; Woman; Writing; base; clinical care; clinical practice; clinically significant; evidence base; health related quality of life; improved; inclusion criteria; men; novel; patient oriented; programs; research and development; research clinical testing; sound; tool; tool development; treatment as usual; trial comparing; urinary

DESCRIPTION (provided by applicant): Fecal incontinence (FI) occurs in 8-15% of older adults and has an extremely negative impact on quality of life (QOL). The International Consultation on Incontinence (ICI) has developed comprehensive and universally-applicable modular questionnaires for men and women for the diagnosis and measurement of a variety of urinary, bowel, and pelvic floor disorders in research and clinical practice. An ICI-Questionnaire (ICIQ) module has been developed and validated for FI and related bowel symptoms. The patient-centered, ICIQ - bowel symptoms module (ICIQ-B) was developed for use in UK-English with sound psychometric data (validity, internal consistency, and sensitivity to change) in comparison to other existing measures. A US-English version would improve measurements of patient-centered outcomes and comparability between clinical trials and provide an invaluable tool for research and clinical evaluation for FI in the US. In this 2-year developmental study, our specific aim is to evaluate the psychometric properties (internal consistency, short-term reproducibility, construct validity, and sensitivity to change) of a written and web-based version of the linguistically validated US-English ICIQ-B questionnaire in 60 veterans presenting for FI treatment. Inclusion criteria for the 60 veterans with FI are: 1) FI occurring at least weekly and 2) actively seeking treatment for FI. Veterans will be recruited primarily from the Birmingham Geriatric Research, Education, and Clinical Center's (GRECC) Continence Clinic and the Birmingham VAMC Primary Care Clinics. Veterans will be stratified by FI severity and then randomized to either web-based ICIQ-B or paper-based ICIQ-B. Data including the ICIQ-B will be collected over 2 pre-treatment visits separated by 2 weeks (short term reproducibility) and 1 additional mailing/telephone contact 3 months after treatment per the GRECC Continence Clinic protocol (sensitivity to change). Construct validity of the ICIQ-B will be measured with comparison to the Vaizey FI severity score, patient's global assessment of improvement, and the SF-12 validated for use in veterans for impact on symptoms and quality of life. The psychometric validation of the ICIQ-B in a US-English speaking veteran population will improve outcome measurement in clinical care and research for FI.

描述（由申请人提供）： 大便失禁 (FI) 发生在 8-15% 的老年人中，对生活质量 (QOL) 产生极其负面的影响。国际失禁咨询 (ICI) 为男性和女性开发了全面且普遍适用的模块化调查问卷，用于在研究和临床实践中诊断和测量各种泌尿、肠道和盆底疾病。已针对 FI 和相关肠道症状开发并验证了 ICI 问卷 (ICIQ) 模块。以患者为中心的 ICIQ - 肠道症状模块 (ICIQ-B) 专为在英式英语中使用而开发，与其他现有测量方法相比，具有可靠的心理测量数据（有效性、内部一致性和对变化的敏感性）。美英版本将改善对以患者为中心的结果的衡量以及临床试验之间的可比性，并为美国 FI 的研究和临床评估提供宝贵的工具。在这项为期 2 年的发展研究中，我们的具体目标是评估经过语言验证的美式英语 ICIQ 的书面和网络版本的心理测量特性（内部一致性、短期再现性、结构有效性和对变化的敏感性） -B 对 60 名接受 FI 治疗的退伍军人进行的问卷调查。 60 名患有 FI 的退伍军人的纳入标准是：1) 至少每周发生一次 FI，2) 积极寻求 FI 治疗。退伍军人将主要从伯明翰老年研究、教育和临床中心 (GRECC) 失禁诊所和伯明翰 VAMC 初级保健诊所招募。退伍军人将根据 FI 严重程度进行分层，然后随机分配到基于网络的 ICIQ-B 或基于纸质的 ICIQ-B。包括 ICIQ-B 在内的数据将在间隔 2 周的 2 次治疗前就诊中收集（短期可重复性），并根据 GRECC 失禁诊所方案（对变化的敏感性）在治疗后 3 个月进行 1 次额外的邮寄/电话联系。 ICIQ-B 的构建有效性将通过与 Vaizey FI 严重程度评分、患者的整体改善评估以及经验证可用于退伍军人的 SF-12 对症状和生活质量的影响进行比较来衡量。 ICIQ-B 在美国英语退伍军人群体中的心理测量验证将改善 FI 临床护理和研究的结果测量。