Development & Psychometric Evaluation of the ICIQ-B

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）有非常负面的影响。国际营养咨询（ICI）为男性和女性开发了全面且普遍适用的模块化问卷，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。针对FI和相关肠道症状开发并验证了ICI问卷（ICIQ）模块。开发了以患者为中心的ICIQ -肠道症状模块（ICIQ-B），用于英国英语，与其他现有措施相比，具有良好的心理测量数据（有效性，内部一致性和变化敏感性）。美国-英语版本将改善以患者为中心的结局的测量和临床试验之间的可比性，并为美国的FI研究和临床评价提供宝贵的工具。在这项为期2年的发展研究中，我们的具体目标是评估心理测量特性（内部一致性，短期再现性，结构效度和变化的敏感性）的书面和基于网络的版本的语言验证的美国英语ICIQ-B问卷在60退伍军人提出FI治疗。60名患有FI的退伍军人的入选标准是：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）的节制诊所和伯明翰VAMC初级保健诊所招募。退伍军人将按FI严重程度分层，然后随机分配至基于网络的ICIQ-B或基于纸质的ICIQ-B。根据GRECC尿失禁诊所方案（变化敏感性），将在2次治疗前访视（间隔2周）和1次额外的邮寄/电话联系（治疗后3个月）期间收集包括ICIQ-B在内的数据。将通过与Vaizey FI严重程度评分、患者对改善的总体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，测量ICIQ-B的结构效度。ICIQ-B在美国-英语为母语的退伍军人人群中的心理测量学验证将改善FI临床护理和研究的结果测量。

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.