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.
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.
|Markland, Alayne D; Burgio, Kathryn L; Whitehead, William E et al. (2015) Loperamide Versus Psyllium Fiber for Treatment of Fecal Incontinence: The Fecal Incontinence Prescription (Rx) Management (FIRM) Randomized Clinical Trial. Dis Colon Rectum 58:983-93|