Browsing by Author "Dyer, Keisha Y"

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    Impact of treatment for Fecal Incontinence on Constipation Symptoms.
    (American journal of obstetrics and gynecology, 2019-11-22) Andy, Uduak U; Jelovsek, J Eric; Carper, Benjamin; Meyer, Isuzu; Dyer, Keisha Y; Rogers, Rebecca G; Mazloomdoost, Donna; Korbly, Nicole B; Sassani, Jessica C; Gantz, Marie G; Pelvic Floor Disorders Network
    OBJECTIVE:Defecatory symptoms, such as sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence (FI). Treatments for FI, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for FI with education only, loperamide, anal muscle exercises with biofeedback, or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and non-responders to FI treatment. METHODS:This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for FI in a 2x2 factorial design. Women with at least monthly FI and normal stool consistency were randomized to 4 groups: 1) oral placebo plus education only, 2) oral loperamide plus education only, 3) placebo plus anorectal manometry-assisted biofeedback and 4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at baseline, 12 weeks and 24 weeks. The PAC-SYM consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to FI treatment were defined as women with a minimally important clinical improvement of ≥5-points on the St. Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in PAC-SYM scores from baseline through 24 weeks. RESULTS:At 24 weeks, there were small changes in PAC-SYM global scores in all four groups: oral placebo plus education (-0.3; 95% CI -0.5, -0.1), loperamide plus education (-0.1, 95% CI -0.3, 0.0), oral placebo plus biofeedback (-0.3, 95% CI -0.4, -0.2), and loperamide plus biofeedback (-0.3, 95% CI -0.4, -0.2). No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82). Change in PAC-SYM scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in PAC-SYM scores than non-responders (-0.4; 95% CI -0.5, -0.3 vs. -0.2; 95% CI -0.3, -0.0, p<0.01, mean difference 0.2, 95% CI 0.1, 0.4). CONCLUSION:Change in constipation symptoms following treatment of FI in women are small and are not significantly different between groups. Loperamide treatment for FI does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in FI symptoms report greater improvement in constipation symptoms.
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    ItemOpen Access
    Minimum important differences for scales assessing symptom severity and quality of life in patients with fecal incontinence.
    (Female Pelvic Med Reconstr Surg, 2014-11) Jelovsek, John Eric; Chen, Zhen; Markland, Alayne D; Brubaker, Linda; Dyer, Keisha Y; Meikle, Susie; Rahn, David D; Siddiqui, Nazeema Y; Tuteja, Ashok; Barber, Matthew D
    OBJECTIVES: The objective of this study was to estimate the minimum important difference (MID) for the Fecal Incontinence Severity Index (FISI), the Colorectal-Anal Distress Inventory (CRADI) scale of the Pelvic Floor Distress Inventory, the Colorectal-Anal Impact Questionnaire (CRAIQ) scale of the Pelvic Floor Impact Questionnaire, and the Modified Manchester Health Questionnaire (MMHQ). METHODS: We calculated the MIDs using anchor-based and distribution-based approaches from a multicenter prospective cohort study investigating adaptive behaviors among women receiving nonsurgical and surgical management for fecal incontinence (FI). Patient responses were primarily anchored using a Global Impression of Change scale. The MID was defined as the difference in mean change from baseline between those who indicated they were "a little better" and those who reported "no change" on the Global Impression of Change scale 3 months after treatment. The effect size and SE of measurement were the distribution methods used. RESULTS: The mean changes (SD) in FISI, CRADI, CRAIQ, and MMHQ scores from baseline to 3 months after treatment were -8.8 (12.0), -52.7 (70.0), -60.6 (90.0), and -12.6 (19.2), respectively. The anchor-based MID estimates suggested by an improvement from no change to a little better were -3.6, -11.4 and -4.7, -18.1 and -8.0, and -3.2 for the FISI, CRADI (long and short version), CRAIQ (long and short version), and MMHQ, respectively. These data were supported by 2 distribution-based estimates. CONCLUSIONS: The MID values for the FISI are -4, CRADI (full version, -11; short version, -5), CRAIQ (full version, -18; short version, -8), and MMHQ -3. Statistically significant improvements that meet these thresholds are likely to be clinically important.