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Development and Psychometric Assessment of a Fecal Incontinence and Constipation Quality of Life Instrument for Adolescents with Spina Bifida
Katherine C. Hubert, MD, MPH1, Georgios Sideridis, PhD2, Rebecca Sherlock, NP2, Jennifer Queally, PhD2, Ilina Rosoklija, MPH2, Greta Kringle, MAT2, Kathryn Johnson, BA2, Samuel Nurko, MD2, Alan Retik, MD2, Stuart Bauer, MD2.
1Riley Hospital for Children at Indiana University Health, Indianapolis, IN, USA, 2Boston Children's Hospital, Boston, MA, USA.

Background: Fecal incontinence (FI) and constipation in children with spina bifida (SB) may have a significant impact on quality of life (QOL). Existing condition-specific surveys are either parent-reported or focus on non-neurogenic bowel dysfunction. The purpose of this study was to develop an adolescent-reported survey to assess the impact of bowel dysfunction on QOL in SB patients and evaluate its reliability and factorial validity.
Methods: We performed a cross-sectional study of patients in our Spina Bifida Center from November 2010 to June 2013. Patients, ages 11-17 years, with a history of constipation and/or FI and their caregivers were recruited during clinic visits. Control patients, ages 11-17 years, with no evidence of bowel dysfunction were recruited from the stone clinic. Exclusion criteria were lack of English fluency (verbal or written), insufficient reading skills (IQ<70 or <4th grade reading level) or an incontinent urinary or fecal diversion. Participants were asked to complete a 5-day bowel diary. The Adolescent Fecal Incontinence and Constipation Quality of Life Scale (A-FICQL) was developed using expert opinion, modification of existing surveys and key informant interviews in order to evaluate clarity of the instrument and elicit additional items. This instrument measures five domains: 1) independence, 2) catheterization regimen, 3) constipation severity, 4) FI severity and 5) adapation/bother. The Flesch Kincaid Grade Level test demonstrated a fourth-grade reading level. Psychometric assessment, including reliability and construct validity using factor analysis, was performed. Test re-test reliability was measured using the Pearson correlation coefficient in 9 patients who completed the same survey two weeks later. Given that the items were scored in multiple-ordered categories, a factor analysis model with four-fold correlations was tested in order to measure the factorial validity of the instrument.
Results: Of the 65 study-eligible patients approached, 25 (of whom were 11 boys) completed the A-FICQL (median age 12.6 years, IQR 11.8-14.7 years). Twenty-one control patients also completed the A-FICQL. Nineteen completed bowel diaries. Of the 25, 9 completed a second administration of the survey. The mean correlation between repeated administrations of the survey was r = 0.43 which was consistent with moderate reliability. The Comparative Fit Index (CFI) was 0.910. Most items loaded significantly on their respective factors. Between-factor correlations were all significant (>0.30) in the predicted direction (positively correlated for items using the same Likert scale and negatively correlated for items with a reversed Likert scale). Unstandardized residuals (additional information the items in the survey carry that cannot be captured by the model) were equal to 11% [95% confidence interval: 9-13%]. Item reduction was performed on the 30-item instrument based on results of the factor analysis. The finalized instrument contained 14 items.
Conclusions:
The A-FICQL demonstrated adequate reliability with a moderate correlation. The 5-factor structure fit the data well; CFI values of >0.900 are indicative of proper fit. The unstandardized residuals were considered acceptable for a newly developed survey. The 14-item A-FICQL possesses desirable psychometric properties that make it attractive for measuring the impact of FI and constipation on quality of life in the SB population.


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