Browsing by Author "Markland, Alayne D"

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    Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods
    (CONTEMPORARY CLINICAL TRIALS, 2015-09) Barber, Matthew Don; Dyer, K; Gantz, Marie G; Jelovsek, John E; Markland, Alayne D; Meikle, Susan; Network, PFD; Newman, DK; Rogers, RG; Sung, VW; Sutkin, G; Visco, Anthony Gabriele; Whitehead, WE
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    Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.
    (Contemp Clin Trials, 2015-09) Eric Jelovsek, J; Markland, Alayne D; Whitehead, William E; Barber, Matthew D; Newman, Diane K; Rogers, Rebecca G; Dyer, Keisha; Visco, Anthony; Sung, Vivian W; Sutkin, Gary; Meikle, Susan F; Gantz, Marie G; Pelvic Floor Disorders Network
    The goals of this trial are to determine the efficacy and safety of two treatments for women experiencing fecal incontinence. First, we aim to compare the use of loperamide to placebo and second, to compare the use of anal sphincter exercises with biofeedback to usual care. The primary outcome is the change from baseline in the St. Mark's (Vaizey) Score 24weeks after treatment initiation. As a Pelvic Floor Disorders Network (PFDN) trial, subjects are enrolling from eight PFDN clinical centers across the United States. A centralized data coordinating center supervises data collection and analysis. These two first-line treatments for fecal incontinence are being investigated simultaneously using a two-by-two randomized factorial design: a medication intervention (loperamide versus placebo) and a pelvic floor strength and sensory training intervention (anal sphincter exercises with manometry-assisted biofeedback versus usual care using an educational pamphlet). Interventionists providing the anal sphincter exercise training with biofeedback have received standardized training and assessment. Symptom severity, diary, standardized anorectal manometry and health-related quality of life outcomes are assessed using validated instruments administered by researchers masked to randomized interventions. Cost effectiveness analyses will be performed using prospectively collected data on care costs and resource utilization. This article describes the rationale and design of this randomized trial, focusing on specific research concepts of interest to researchers in the field of female pelvic floor disorders and all other providers who care for patients with fecal incontinence.
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    Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial
    (The Lancet Gastroenterology & Hepatology, 2019-07) Jelovsek, J Eric; Markland, Alayne D; Whitehead, William E; Barber, Matthew D; Newman, Diane K; Rogers, Rebecca G; Dyer, Keisha; Visco, Anthony G; Sutkin, Gary; Zyczynski, Halina M; Carper, Benjamin; Meikle, Susan F; Sung, Vivian W; Gantz, Marie G; National Institute of Child Health and Human Development Pelvic Floor Disorders Network
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    Irritable Bowel Syndrome and Quality of Life in Women With Fecal Incontinence.
    (Female Pelvic Med Reconstr Surg, 2017-08-01) Markland, Alayne D; Jelovsek, J Eric; Rahn, David D; Wang, Lu; Merrin, Leah; Tuteja, Ashok; Richter, Holly E; Meikle, Susan; Pelvic Floor Disorders Network
    OBJECTIVES: The objectives of this work were to determine the prevalence of irritable bowel syndrome (IBS) and IBS subtypes in women presenting for fecal incontinence (FI) treatment and to assess the impact of IBS on FI symptoms and quality of life (QOL). METHODS: In this multicenter prospective cohort study, women reported at least monthly solid, liquid, or mucus FI. Rome III clinical criteria defined IBS. Women also self-reported having an IBS diagnosis. Baseline questionnaires included the following: Modified Manchester Health Questionnaire, Fecal Incontinence Severity Index, Bristol Stool Scale, Pelvic Floor Distress Inventory, and the Pelvic Floor Impact Questionnaire. RESULTS: Of the 133 women enrolled, 119 completed Rome III IBS questionnaires, and 111 reported on whether they had a previous diagnosis of IBS. The prevalence of IBS was 31% (95% confidence interval [CI], 22.9%-40.2%) according to the Rome III IBS criteria. The most common subtypes were IBS-mixed (41%) and IBS-diarrhea (35%). Twenty-four (22%) of 111 patients had a previous diagnosis of IBS. Among women who met Rome III IBS criteria, 23 (66%) of 35 women had never had a diagnosis of IBS. Women with FI and IBS reported significantly worse QOL compared to women without IBS despite similar FI severity and stool consistency. CONCLUSIONS: Irritable bowel syndrome negatively affects QOL and affects one third of women with FI presenting for care in tertiary centers. Our findings suggest that assessment of IBS symptoms and diagnosis may be important for women presenting for FI treatment.
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    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.