Accidental Bowel Leakage Evaluation: A New Patient-Centered Validated Measure of Accidental Bowel Leakage Symptoms in Women

Background Questionnaires assessing accidental bowel leakage lack important patient-centered symptoms. Objective We aimed to create a valid measure of accidental bowel leakage symptoms. Design We previously created a conceptual framework capturing patient-centered accidental bowel leakage symptoms. The framework included bowel leakage type, severity and bother, and ancillary bowel symptoms, including predictability, awareness, leakage control, emptying disorders, and discomfort. Settings The study was conducted in outpatient clinics. Patients Women with at least monthly accidental bowel leakage were included. Interventions Participants completed the Accidental Bowel Leakage Evaluation at baseline and 12 and 24 weeks, as well as bowel diaries and other validated pelvic floor questionnaires. A subset completed items twice before treatment. Final item selection was based on psychometric properties and clinical importance. Main outcome measures Psychometric analyses included Cronbach α, confirmatory factor, and item response theory analyses. Construct validity was based on correlations with measures of similar constructs. Results A total of 296 women completed baseline items, and 70 provided test-retest data. The cohort was predominately white (79%) and middle aged (64 ± 11 y). Confirmatory factor analyses supported the conceptual framework. The final 18-item scale demonstrated good internal consistency (Cronbach α = 0.77-0.90) and test-retest reliability (intraclass correlation = 0.80). Construct validity was demonstrated with baseline and 12- and 24-week scale scores, which correlated with the Vaizey (r = 0.52, 0.68, and 0.69), Colorectal Anal Distress Inventory (r = 0.54, 0.65, 0.71), Colorectal Anal Impact Questionnaire (r = 0.48, 0.53, 0.53), and hygiene (r = 0.39, 0.43, 0.49) and avoidance subscales scores of the adaptive index (r = 0.45, 0.44, 0.43) and average number of pad changes per day on bowel diaries (r = 0.35, 0.38, 0.31; all p Limitations The study was limited by nature of involving validation in a care-seeking population. Conclusions The Accidental Bowel Leakage Evaluation instrument is a reliable, patient-centered measure with good validity properties. This instrument improves on currently available measures by adding patient-important domains of predictability, awareness, control, emptying, and discomfort. See Video Abstract at http://links.lww.com/DCR/B172. EVALUACIoN DE FUGA INTESTINAL ACCIDENTAL: UNA NUEVA MEDIDA VALIDADA Y CENTRADA EN PACIENTES FEMENINOS CON SiNTOMAS DE FUGA INTESTINAL ACCIDENTAL: Los cuestionarios que evaluan la fuga intestinal accidental, carecen de sintomas centrados en el paciente.Nuestro objetivo fue crear una medida valida de sintomas de fuga intestinal accidental.Previamente creamos un marco conceptual centrado en el paciente, para capturar sintomas de fuga intestinal accidental. El marco incluia tipo de fuga intestinal, gravedad, molestia, y sintomas intestinales auxiliares, incluyendo previsibilidad, conciencia, control de fugas, trastornos de vaciado e incomodidad.Clinicas de pacientes externos.Mujeres con al menos una fuga intestinal accidental mensual.Las participantes completaron la Evaluacion de Fuga Intestinal Accidental al inicio del estudio y a las 12 y 24 semanas, asi como diarios intestinales y otros cuestionarios validados del piso pelvico. Un subconjunto completo los elementos dos veces antes del tratamiento. La seleccion final del elemento se baso en las propiedades psicometricas y la importancia clinica.Los analisis psicometricos incluyeron el Alfa de Cronbach, factor confirmatorio y analisis de la teoria de respuesta al elemento. La validez de constructo se baso en correlaciones con medidas de constructos similares.Un total de 296 mujeres completaron los elementos de referencia y 70 proporcionaron datos de test-retest. La cohorte fue predominantemente blanca (79%) y de mediana edad (64 +/- 11 anos). Analisis factorial confirmatorio respaldo el marco conceptual. La escala final de 18 elementos, demostro una buena consistencia interna (Alfa de Cronbach = 0,77-0,90) y fiabilidad test-retest (correlacion intraclase = 0,80). La validez de constructo se demostro con puntajes de escala de referencia de 12 y 24 semanas que se correlacionaron con Vaizey (r = 0,52, 0,68 y 0,69), Inventario de Ansiedad colorecto anal (r = 0,54, 0,65, 0,71), Cuestionarios de Impacto colorecto anal (r = 0,48, 0,53, 0,53) e higiene (r = 0,39, 0,43, 0,49), puntuaciones de subescalas de evitacion del indice adaptativo (r = 0,45, 0,44, 0,43), numero promedio de cambios de almohadilla por dia, de los diarios intestinales (r = 0.35, 0.38, 0.31), todos p