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)有极大的负面影响。国际尿失禁咨询(ICI)为男性和女性开发了全面的、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尿路、肠道和盆底疾病。已经开发了ICI问卷(ICIQ)模块，并对FI和相关肠道症状进行了验证。以患者为中心的ICIQ-肠道症状模块(ICIQ-B)是为在英式英语中使用而开发的，与其他现有测量方法相比，具有良好的心理测量数据(有效性、内部一致性和对变化的敏感度)。美英版本将改进以患者为中心的结果的测量和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。在这项为期两年的发展研究中，我们的具体目标是评估书面和基于网络版本的美英ICIQ-B问卷的心理测量学特性(内部一致性、短期重复性、结构效度和对变化的敏感性)，该问卷经过语言验证后，在60名接受FI治疗的退伍军人中进行。60名FI退伍军人的纳入标准是：1)FI至少每周发生一次，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)大陆诊所和伯明翰VAMC初级保健诊所招募。退伍军人将按FI严重程度分层，然后随机分为基于网络的ICIQ-B或基于纸质的ICIQ-B。包括ICIQ-B在内的数据将根据GRECC大陆临床方案(对变化的敏感性)在治疗后3个月间隔2周的2次治疗前访问(短期重复性)和1次额外的邮件/电话联系中收集。ICIQ-B的结构效度将通过与Vaizey FI严重程度评分、患者对改善的总体评估以及SF-12在退伍军人中验证对症状和生活质量的影响进行比较来衡量。ICIQ-B在说美国英语的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衡量。 公共卫生相关性： 项目叙事大便失禁(FI)是一种严重影响生活质量(QOL)的破坏性疾病。大小便失禁国际咨询组织在英国开发了一份强大的肠道症状问卷(ICIQ-B)。经过验证的英英版ICIQ-B，包括评估严重程度、对生活质量的影响以及适应性机制的使用领域，是在临床研究和实践中衡量治疗结果的良好工具。然而，需要进一步的心理测试和基于网络的版本，以便在未来的美国退伍军人临床试验中使用。这项问卷编制试点/发展研究将在两年内完成，招募60名患有FI的退伍军人。这项研究的结果将是一份心理测量学上可靠的问卷，供患有FI和其他肠道症状的退伍军人使用。

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. PUBLIC HEALTH RELEVANCE: Project Narrative Fecal incontinence (FI) is a devastating disorder that greatly affects quality of life (QOL). The International Consultation on Incontinence has developed a robust questionnaire for bowel symptoms (ICIQ-B) in the United Kingdom (UK). The validated UK-English version of the ICIQ-B, with domains assessing severity, impact on QOL, and the use of adaptive mechanisms, is a good tool to use for measuring treatment outcomes in clinical research and practice. However, further psychometric testing and a web-based version is needed for use in future clinical trials among veterans in the US. This questionnaire development pilot/developmental study will be completed in two years and recruit 60 veterans with FI. The product of this study will be a psychometrically robust questionnaire for use among veterans with FI and other bowel symptoms.