Browsing by Author "Amundsen, Cindy L"

Now showing 1 - 6 of 6
  • Thumbnail Image
    ItemOpen Access
    Design and Implementation of a Career Development Program for Physician-Scientists: Lessons Learned.
    (Urogynecology (Philadelphia, Pa.), 2022-08) Kameny, Rebecca R; Amundsen, Cindy L

    Importance

    Although skills in health services research and data science have great potential to advance the field of urogynecology, few clinical researchers obtain such training.

    Objectives

    The aim of the R25 UrogynCREST Program is to prepare the next generation of physician-scientists for a successful career in urogynecologic health services research through skilled mentoring and advanced training. The purpose of this report is to describe program implementation and lessons learned.

    Study design

    Administered through the program institution and in partnership with the American Urogynecologic Society, this program provided junior faculty with advanced online training and, through a core facility, access to health care databases for research projects. Participants received individualized mentoring and biostatistical support. Anonymous surveys captured actionable, real-time feedback from participants as they moved through the program.

    Results

    Despite a limited budget, UrogynCREST maintained a core of excellent faculty, high-quality biostatistical support, and engaged, knowledgeable advisors and mentors. This allowed for similar experiences across cohorts while permitting program improvements between cohorts in faculty-participant interactions, team dynamics, and data and regulatory support. Administrative management by a single institution facilitated responses to fiscal and regulatory changes. Asynchronized learning and partnering with a society attracted a diverse group of physician-scientists.

    Conclusions

    Career development programs that incorporate online education, mentoring, database access, and biostatistical support must be prepared for midprogram changes. Regular communication among stakeholders was vital. Working with a core facility provided efficient database access, but evolving regulatory and administrative processes and costs presented challenges. Our experiences implementing this program can benefit similar programs that train early-career physician-scientists.
  • Thumbnail Image
    ItemOpen Access
    Expert Panel Recommendations on Lower Urinary Tract Health of Women Across Their Life Span.
    (J Womens Health (Larchmt), 2016-11) Losada, Liliana; Amundsen, Cindy L; Ashton-Miller, James; Chai, Toby; Close, Clare; Damaser, Margot; DiSanto, Michael; Dmochowski, Roger; Fraser, Matthew O; Kielb, Stephanie J; Kuchel, George; Mueller, Elizabeth R; Parker-Autry, Candace; Wolfe, Alan J; Mallampalli, Monica P
    Urologic and kidney problems are common in women across their life span and affect their daily life, including physical activity, sexual relations, social life, and future health. Urological health in women is still understudied and the underlying mechanisms of female urological dysfunctions are not fully understood. The Society for Women's Health Research (SWHR(®)) recognized the need to have a roundtable discussion where researchers and clinicians would define the current state of knowledge, gaps, and recommendations for future research directions to transform women's urological health. This report summarizes the discussions, which focused on epidemiology, clinical presentation, basic science, prevention strategies, and efficacy of current therapies. Experts around the table agreed on a set of research, education, and policy recommendations that have the potential to dramatically increase awareness and improve women's urological health at all stages of life.
  • Thumbnail Image
    ItemOpen Access
    OnabotulinumtoxinA vs Sacral Neuromodulation on Refractory Urgency Urinary Incontinence in Women: A Randomized Clinical Trial.
    (JAMA, 2016-10-04) Amundsen, Cindy L; Richter, Holly E; Menefee, Shawn A; Komesu, Yuko M; Arya, Lily A; Gregory, W Thomas; Myers, Deborah L; Zyczynski, Halina M; Vasavada, Sandip; Nolen, Tracy L; Wallace, Dennis; Meikle, Susan F
    Importance: Women with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information. Objective: To assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence. Design, Setting, and Participants: Multicenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence. Interventions: Cystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189). Main Outcomes and Measures: Primary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events. Results: Of the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%. Conclusions and Relevance: Among women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations.
  • Thumbnail Image
    ItemOpen Access
    Predicting outcomes after intradetrusor onabotulinumtoxina for non-neurogenic urgency incontinence in women.
    (Neurourology and urodynamics, 2021-12-02) Hendrickson, Whitney K; Xie, Gongbo; Rahn, David D; Amundsen, Cindy L; Hokanson, James A; Bradley, Megan; Smith, Ariana L; Sung, Vivian W; Visco, Anthony G; Luo, Sheng; Jelovsek, J Eric

    Aims

    Develop models to predict outcomes after intradetrusor injection of 100 or 200 units of onabotulinumtoxinA in women with non-neurogenic urgency urinary incontinence (UUI).

    Methods

    Models were developed using 307 women from two randomized trials assessing efficacy of onabotulinumtoxinA for non-neurogenic UUI. Cox, linear and logistic regression models were fit using: (1) time to recurrence over 12 months, (2) change from baseline daily UUI episodes (UUIE) at 6 months, and (3) need for self-catheterization over 6 months. Model discrimination of Cox and logistic regression models was calculated using c-index. Mean absolute error determined accuracy of the linear model. Calibration was demonstrated using calibration curves. All models were internally validated using bootstrapping.

    Results

    Median time to recurrence was 6 (interquartile range [IQR]: 2-12) months. Increasing age, 200 units of onabotulinumtoxinA, higher body mass index (BMI) and baseline UUIE were associated with decreased time to recurrence. The c-index was 0.63 (95% confidence interval [CI]: 0.59, 0.67). Median change in daily UUIE from baseline at 6 months was -3.5 (IQR: -5.0, -2.3). Increasing age, lower baseline UUIE, 200 units of onabotulinumtoxinA, higher BMI and IIQ-SF were associated with less improvement in UUIE. The mean absolute error predicting change in UUIE was accurate to 1.6 (95% CI: 1.5, 1.7) UUI episodes. The overall rate of self-catheterization was 17.6% (95% CI: 13.6%-22.4%). Lower BMI, 200 units of onabotulinumtoxinA, increased baseline postvoid residual and maximum capacity were associated with higher risk of self-catheterization. The c-index was 0.66 (95% CI: 0.61, 0.76). The three calculators are available at http://riskcalc.duke.edu.

    Conclusions

    After external validation, these models will assist clinicians in providing more accurate estimates of expected treatment outcomes after onabotulinumtoxinA for non-neurogenic UUI in women.
  • Thumbnail Image
    ItemOpen Access
    Subtyping of common complex diseases and disorders by integrating heterogeneous data. Identifying clusters among women with lower urinary tract symptoms in the LURN study.
    (PloS one, 2022-01) Andreev, Victor P; Helmuth, Margaret E; Liu, Gang; Smith, Abigail R; Merion, Robert M; Yang, Claire C; Cameron, Anne P; Jelovsek, J Eric; Amundsen, Cindy L; Helfand, Brian T; Bradley, Catherine S; DeLancey, John OL; Griffith, James W; Glaser, Alexander P; Gillespie, Brenda W; Clemens, J Quentin; Lai, H Henry; LURN Study Group
    We present a methodology for subtyping of persons with a common clinical symptom complex by integrating heterogeneous continuous and categorical data. We illustrate it by clustering women with lower urinary tract symptoms (LUTS), who represent a heterogeneous cohort with overlapping symptoms and multifactorial etiology. Data collected in the Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN), a multi-center observational study, included self-reported urinary and non-urinary symptoms, bladder diaries, and physical examination data for 545 women. Heterogeneity in these multidimensional data required thorough and non-trivial preprocessing, including scaling by controls and weighting to mitigate data redundancy, while the various data types (continuous and categorical) required novel methodology using a weighted Tanimoto indices approach. Data domains only available on a subset of the cohort were integrated using a semi-supervised clustering approach. Novel contrast criterion for determination of the optimal number of clusters in consensus clustering was introduced and compared with existing criteria. Distinctiveness of the clusters was confirmed by using multiple criteria for cluster quality, and by testing for significantly different variables in pairwise comparisons of the clusters. Cluster dynamics were explored by analyzing longitudinal data at 3- and 12-month follow-up. Five clusters of women with LUTS were identified using the developed methodology. None of the clusters could be characterized by a single symptom, but rather by a distinct combination of symptoms with various levels of severity. Targeted proteomics of serum samples demonstrated that differentially abundant proteins and affected pathways are different across the clusters. The clinical relevance of the identified clusters is discussed and compared with the current conventional approaches to the evaluation of LUTS patients. The rationale and thought process are described for the selection of procedures for data preprocessing, clustering, and cluster evaluation. Suggestions are provided for minimum reporting requirements in publications utilizing clustering methodology with multiple heterogeneous data domains.
  • Thumbnail Image
    ItemOpen Access
    Treatment patterns in women with urinary urgency and/or urgency urinary incontinence in the symptoms of Lower Urinary Tract Dysfunction Research Network Observational Cohort Study.
    (Neurourology and urodynamics, 2023-01) Bretschneider, Carol Emi; Liu, Qian; Smith, Abigail R; Kirkali, Ziya; Amundsen, Cindy L; Lai, Henry; Geynisman-Tan, Juila; Kirby, Anna; Cameron, Anne P; Helmuth, Margaret E; Griffith, James W; Jelovsek, John Eric; Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) Observational Cohort Study Group

    Background

    Limited epidemiological data exist describing how patients engage with various treatments for overactive bladder (OAB). To improve care for patients with OAB, it is essential to gain a better understanding of how patients interface with OAB treatments longitudinally, that is, how often patients change treatments and the pattern of this treatment change in terms of escalation and de-escalation.

    Objectives

    To describe treatment patterns for women with bothersome urinary urgency (UU) and/or urgency urinary incontinence (UUI) presenting to specialty care over 1 year.

    Study design

    The Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) study enrolled adult women with bothersome UU and/or UUI seeking care for lower urinary tract symptoms (LUTS) between January 2015 and September 2016. An ordinal logistic regression model was fitted to describe the probabilities of escalating or de-escalating level of treatment during 1-year follow-up.

    Results

    Among 349 women, 281 reported UUI and 68 reported UU at baseline. At the end of 1 year of treatment by a urologist or urogynecologist, the highest level of treatment received by participants was 5% expectant management, 36% behavioral treatments (BT), 26% physical therapy (PT), 26% OAB medications, 1% percutaneous tibial nerve stimulation, 3% intradetrusor onabotulinum toxin A injection, and 3% sacral neuromodulation. Participants using BT or PT at baseline were more likely to be de-escalated to no treatment than participants on OAB medications at baseline, who tended to stay on medications. Predictors of the highest level of treatment included starting level of treatment, hypertension, UUI severity, stress urinary incontinence, and anticholinergic burden score.

    Conclusions

    Treatment patterns for UU and UUI are diverse. Even for patients with significant bother from OAB presenting to specialty clinics, further treatment often only involves conservative or medical therapies. This study highlights the need for improved treatment algorithms to escalate patients with persistent symptoms, or to adjust care in those who have been unsuccessfully treated.