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4. Characteristics associated with subjective and objective measures of treatment success in women undergoing percutaneous tibial nerve stimulation vs sham for accidental bowel leakage.

Author

Luchristt, Douglas, Carper, Benjamin, Balgobin, Sunil, Meyer, Isuzu, Myers, Deborah, Mazloomdoost, Donna, Gantz, Marie, Andy, Uduak, Zyczynski, Halina, and Lukacz, Emily

Subjects
Accidental bowel leakage, Fecal incontinence, Patient-centered outcomes, Percutaneous tibial nerve stimulation, St Mark’s score, Treatment success definition, Humans, Female, Transcutaneous Electric Nerve Stimulation, Treatment Outcome, Fecal Incontinence, Tibial Nerve, Factor Analysis, Statistical
Abstract

INTRODUCTION AND HYPOTHESIS: In randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial. METHODS: This planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Marks score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p

Published
2023

5. Cortisol awakening response and developmental outcomes at 6–7 years in children born extremely preterm

Author

Jobe, Alan H, Caplan, Michael S, Polin, Richard A, Laptook, Abbot R, Hensman, Angelita M, Vieira, Elisa, Little, Emilee, Johnson, Katharine, Alksninis, Barbara, Keszler, Mary Lenore, Knoll, Andrea M, Leach, Theresa M, McGowan, Elisabeth C, Watson, Victoria E, Walsh, Michele C, Fanaroff, Avroy A, Payne, Allison, Wilson-Costello, Deanne E, Newman, Nancy S, Siner, Bonnie S, Zadell, Arlene, DiFiore, Julie, Bhola, Monika, Friedman, Harriet G, Yalcinkaya, Gulgun, Goldberg, Ronald N, Cotten, C Michael, Gustafson, Kathryn E, Goldstein, Ricki F, Ashley, Patricia, Auten, Kathy J, Fisher, Kimberley A, Foy, Katherine A, Freedman, Sharon F, Lohmeyer, Melody B, Malcolm, William F, Wallace, David K, Carlton, David P, Stoll, Barbara J, Adams-Chapman, Ira, Buchter, Susie, Piazza, Anthony J, Carter, Sheena, Fritz, Sobha, Hale, Ellen C, Hutchinson, Amy K, LaRossa, Maureen Mulligan, Loggins, Yvonne, Bottcher, Diane, Higgins, Rosemary D, Archer, Stephanie Wilson, Poindexter, Brenda B, Sokol, Gregory M, Harmon, Heidi M, Papile, Lu-Ann, Hines, Abbey C, Wilson, Leslie D, Herron, Dianne E, Smiley, Lucy, Granger, Douglas A, Kennedy, Kathleen A, Tyson, Jon E, Duncan, Andrea F, Dempsey, Allison G, John, Janice, Jones, Patrick M, Lillie, M Layne, Siddiki, Saba, Sperry, Daniel K, Blaisdell, Carol J, Das, Abhik, Wallace, Dennis, Gantz, Marie G, O’Donnell Auman, Jeanette, Hammond, Jane A, Newman, Jamie E, Poole, W Kenneth, Van Meurs, Krisa P, Stevenson, David K, Ball, M Bethany, DeAnda, Maria Elena, Goodlin, Gabrielle T, Frantz, Ivan D, Fiascone, John M, Kurfiss, Anne, MacKinnon, Brenda L, Nylen, Ellen, Brussa, Ana, Sibley, Cecelia, Carlo, Waldemar A, Ambalavanan, Namasivayam, Collins, Monica V, Cosby, Shirley S, Phillips, Vivien A, Domanovich, Kristy, Whitley, Sally, Smith, Leigh Ann, Kiser, Carin R, and Finer, Neil N

Subjects
Paediatrics, Biomedical and Clinical Sciences, Basic Behavioral and Social Science, Behavioral and Social Science, Mind and Body, Mental Health, Neurosciences, Clinical Research, Pediatric, 2.3 Psychological, social and economic factors, Aetiology, Mental health, Child, Female, Humans, Infant, Newborn, Executive Function, Hydrocortisone, Hypothalamo-Hypophyseal System, Infant, Extremely Premature, Pituitary-Adrenal System, SUPPORT NEURO School-Age Study Subcommittee of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network, Paediatrics and Reproductive Medicine, Public Health and Health Services, Pediatrics
Abstract

BackgroundExtremely preterm (EPT) birth has been related to dysregulation of stress responses and behavioral/learning problems at school age. Early adverse experiences can blunt HPA axis reactivity. We hypothesized that an attenuated cortisol awakening response would be associated with developmental and behavioral problems at school age in EPT children.MethodsThis secondary analysis of a sub-cohort of the SUPPORT study included children born between 24 and 27 weeks, evaluated at 6-7 years with a neurodevelopmental battery and cortisol measures. Differences were tested between EPT and a term-born group. Relationships of cortisol awakening response to test scores were analyzed.ResultsCortisol was measured in 110 EPT and 29 term-born 6-7 year olds. Unadjusted WISC-IV and NEPSY-II scores were significantly worse among EPT children only. Conners Parent Rating Scale behavior scores were significantly worse among EPT children. After adjusting for covariates, blunted cortisol awakening responses were found to be associated with poorer scores on memory tests and greater problems with inattention for the EPT group (p

Published
2023

6. Use of term reference infants in assessing the developmental outcome of extremely preterm infants: lessons learned in a multicenter study

Author

Green, Charles E., Tyson, Jon E., Heyne, Roy J., Hintz, Susan R., Vohr, Betty R., Bann, Carla M., Das, Abhik, Bell, Edward F., Debsareea, Sana Boral, Stephens, Emily, Gantz, Marie G., Petrie Huitema, Carolyn M., Johnson, Karen J., Watterberg, Kristi L., Mosquera, Ricardo, Peralta-Carcelen, Myriam, Wilson-Costello, Deanne E., Colaizy, Tarah T., Maitre, Nathalie L., Merhar, Stephanie L., Adams-Chapman, Ira, Fuller, Janell, Hartley-McAndrew, Michelle E., Malcolm, William F., Winter, Sarah, Duncan, Andrea F., Myer, Gary J., Kicklighter, Stephen D., Wyckoff, Myra H., DeMauro, Sara B., Hibbs, Anna Maria, Stoll, Barbara J., Carlo, Waldemar A., Van Meurs, Krisa P., Rysavy, Matthew A., Patel, Ravi M., Sánchez, Pablo J., Laptook, Abbot R., Cotten, C. Michael, D’Angio, Carl T., and Walsh, Michele C.

Published
2023
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8. Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.

Author

Zyczynski, Halina M, Richter, Holly E, Sung, Vivian W, Lukacz, Emily S, Arya, Lily A, Rahn, David D, Visco, Anthony G, Mazloomdoost, Donna, Carper, Benjamin, Gantz, Marie G, and NICHD Pelvic Floor Disorders Network

Subjects
NICHD Pelvic Floor Disorders Network, Tibial Nerve, Humans, Fecal Incontinence, Transcutaneous Electric Nerve Stimulation, Single-Blind Method, Quality of Life, Aged, Middle Aged, Female, Clinical Research, Clinical Trials and Supportive Activities, Digestive Diseases, Oral and gastrointestinal, Clinical Sciences, Gastroenterology & Hepatology
Abstract

IntroductionTo determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments.MethodsWomen aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model.ResultsOf 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group.DiscussionAlthough symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.

Published
2022

9. Adherence to Perioperative Behavioral Therapy With Pelvic Floor Muscle Training in Women Receiving Vaginal Reconstructive Surgery for Pelvic Organ Prolapse

Author

Borello-France, Diane, Newman, Diane K., Markland, Alayne D., Propst, Katie, Jelovsek, J. Eric, Cichowski, Sara, Gantz, Marie G., Balgobin, Sunil, Jakus-Waldman, Sharon, Korbly, Nicole, Mazloomdoost, Donna, and Burgio, Kathryn L.

Subjects
Patient compliance -- Methods, Uterus -- Prolapse, Behavior therapy -- Patient outcomes, Vaginoplasty -- Complications and side effects, Pelvis -- Muscles
Abstract

Objective. The objective of this study was to describe adherence to behavioral and pelvic floor muscle training in women undergoing vaginal reconstructive surgery for organ prolapse and to examine whether adherence was associated with 24-month outcomes. Methods. Participants were women [greater than or equal to]18 years of age, with vaginal bulge and stress urinary incontinence symptoms, planning to undergo vaginal reconstructive surgery for stages 2 to 4 vaginal or uterine prolapse. They were randomized to either sacrospinous ligament fixation or uterosacral ligament suspension and to perioperative behavioral and pelvic floor muscle training or usual care. Measurements included anatomic failure, pelvic floor muscle strength, participant-reported symptoms, and perceived improvement. Analyses compared women with lower versus higher adherence. Results. Forty-eight percent of women performed pelvic floor muscle exercises (PFMEs) daily at the 4- to 6-week visit. Only 33% performed the prescribed number of muscle contractions. At 8 weeks, 37% performed PFMEs daily, and 28% performed the prescribed number of contractions. No significant relationships were found between adherence and 24-month outcomes. Conclusion. Adherence to a behavioral intervention was low following vaginal reconstructive surgery for pelvic organ prolapse. The degree of adherence to perioperative training did not appear to influence 24-month outcomes in women undergoing vaginal prolapse surgery. Impact. This study contributes to the understanding of participant adherence to PFMEs and the impact that participant adherence has on outcomes at 2, 4 to 6, 8, and 12 weeks and 24 months postoperatively. It is important to educate women to follow up with their therapist or physician to report new or unresolved pelvic symptoms. Keywords: Behavior Therapy, Pelvic Floor Disorders, Women's Health, Introduction Pelvic floor disorders, including pelvic organ prolapse (POP) and urinary incontinence (UI), affect approximately one-fourth of women in the United States. (1) Pelvic floor muscle training (PFMT) is a [...]

Published
2023
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10. Association between the urogenital microbiome and surgical treatment response in women undergoing midurethral sling operation for mixed urinary incontinence

Author

Richter, Holly E, Carnes, Megan U, Komesu, Yuko M, Lukacz, Emily S, Arya, Lily, Bradley, Megan, Rogers, Rebecca G, Sung, Vivian W, Siddiqui, Nazema Y, Carper, Benjamin, Mazloomdoost, Donna, Dinwiddie, Darryl, Gantz, Marie G, and Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Aging, Urologic Diseases, Clinical Research, Female, Humans, Lactobacillus, Microbiota, Middle Aged, Suburethral Slings, Treatment Outcome, Urinary Incontinence, Urinary Tract, Vagina, midurethral sling procedure, mixed urinary incontinence, surgical outcomes, urinary microbiome, vaginal microbiome, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine
Abstract

BackgroundThe urogenital microbiome is associated with urgency and mixed urinary incontinence symptoms and differential treatment responses to pharmacotherapy for urgency urinary incontinence.ObjectiveThis study aimed to describe whether the preoperative urinary and vaginal microbiomes were associated with surgical treatment responses at 12 months after a midurethral sling operation in women with mixed urinary incontinence.Study designThis cohort study compared the preoperative microbiome compositions of urine and vaginal samples from a subset of women undergoing a midurethral sling operation in the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence trial (NCT01959347) and compared the microbiota in women who were surgical responders vs surgical nonresponders. Twelve-month objective response was defined as a ≥70% reduction from baseline urinary incontinence episodes on a 3-day diary. Subjective response was defined as a change from baseline in the Urogenital Distress Inventory scores. Bacterial abundance and beta diversity were assessed using 16S ribosomal RNA sequencing. The primary differential abundance analysis described predominant bacterial operational taxonomic units associated with responders vs nonresponders using unadjusted and age-adjusted linear models.ResultsObjective nonresponders (n=28) compared with responders (n=72) were older (58.5±10.7 vs 51.6±10.2 years) and more likely postmenopausal without hormone use (odds ratio, 6.4; 95% confidence interval, 1.8-22.6). Vaginal and urinary microbiota beta diversities were associated with age (P

Published
2022

11. Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study.

Author

Zyczynski, Halina M, Arya, Lily A, Lukacz, Emily S, Richter, Holly E, Rahn, David D, Sung, Vivian W, Visco, Anthony G, Shaffer, Amanda, Jelovsek, J Eric, Rogers, Rebecca, Mazloomdoost, Donna, Gantz, Marie G, and Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network (PFDN)

Subjects
Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network, Tibial Nerve, Humans, Fecal Incontinence, Treatment Outcome, Transcutaneous Electric Nerve Stimulation, Quality of Life, Female, Digestive Diseases, Clinical Research, Clinical Trials and Supportive Activities, Comparative Effectiveness Research, Oral and gastrointestinal, fecal incontinence, accidental bowel leakage, percutaneous tibial nerve stimulation, posterior tibial nerve stimulation, neuromodulation, sham electrical stimulation, randomized controlled trial
Abstract

ObjectivesHigh-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage.MethodsThe rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function.ResultsSample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks.ConclusionsThe methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.

Published
2021

12. Subgroups of failure after surgery for pelvic organ prolapse and associations with quality of life outcomes: a longitudinal cluster analysis

Author

Jelovsek, J Eric, Gantz, Marie G, Lukacz, Emily S, Zyczynski, Halina M, Sridhar, Amaanti, Kery, Caroline, Chew, Rob, Harvie, Heidi S, Dunivan, Gena, Schaffer, Joseph, Sung, Vivian, Varner, R Ed, Mazloomdoost, Donna, Barber, Matthew D, and Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Patient Safety, Contraception/Reproduction, Clinical Research, Clinical Trials as Topic, Cluster Analysis, Female, Humans, Longitudinal Studies, Pelvic Organ Prolapse, Quality of Life, Reoperation, Retrospective Studies, Treatment Failure, clustering, failure definition, failure subtypes, machine learning, pelvic organ prolapse, quality-adjusted life-year, quality of life, success definition, surgical outcomes, machine, learning, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine
Abstract

BackgroundTreatment outcomes after pelvic organ prolapse surgery are often presented as dichotomous "success or failure" based on anatomic and symptom criteria. However, clinical experience suggests that some women with outcome "failures" are asymptomatic and perceive their surgery to be successful and that other women have anatomic resolution but continue to report symptoms. Characterizing failure types could be a useful step to clarify definitions of success, understand mechanisms of failure, and identify individuals who may benefit from specific therapies.ObjectiveThis study aimed to identify clusters of women with similar failure patterns over time and assess associations among clusters and the Pelvic Organ Prolapse Distress Inventory, Short-Form Six-Dimension health index, Patient Global Impression of Improvement, patient satisfaction item questionnaire, and quality-adjusted life-year.Study designOutcomes were evaluated for up to 5 years in a cohort of participants (N=709) with stage ≥2 pelvic organ prolapse who underwent surgical pelvic organ prolapse repair and had sufficient follow-up in 1 of 4 multicenter surgical trials conducted by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Surgical success was defined as a composite measure requiring anatomic success (Pelvic Organ Prolapse Quantification system points Ba, Bp, and C of ≤0), subjective success (absence of bothersome vaginal bulge symptoms), and absence of retreatment for pelvic organ prolapse. Participants who experienced surgical failure and attended ≥4 visits from baseline to 60 months after surgery were longitudinally clustered, accounting for similar trajectories in Ba, Bp, and C and degree of vaginal bulge bother; moreover, missing data were imputed. Participants with surgical success were grouped into a separate cluster.ResultsSurgical failure was reported in 276 of 709 women (39%) included in the analysis. Failures clustered into the following 4 mutually exclusive subgroups: (1) asymptomatic intermittent anterior wall failures, (2) symptomatic intermittent anterior wall failures, (3) asymptomatic intermittent anterior and posterior wall failures, and (4) symptomatic all-compartment failures. Each cluster had different bulge symptoms, anatomy, and retreatment associations with quality of life outcomes. Asymptomatic intermittent anterior wall failures (n=150) were similar to surgical successes with Ba values that averaged around -1 cm but fluctuated between anatomic success (Ba≤0) and failure (Ba>0) over time. Symptomatic intermittent anterior wall failures (n=82) were anatomically similar to asymptomatic intermittent anterior failures, but women in this cluster persistently reported bothersome bulge symptoms and the lowest quality of life, Short-Form Six-Dimension health index scores, and perceived success. Women with asymptomatic intermittent anterior and posterior wall failures (n=28) had the most severe preoperative pelvic organ prolapse but the lowest symptomatic failure rate and retreatment rate. Participants with symptomatic all-compartment failures (n=16) had symptomatic and anatomic failure early after surgery and the highest retreatment of any cluster.ConclusionIn particular, the following 4 clusters of pelvic organ prolapse surgical failure were identified in participants up to 5 years after pelvic organ prolapse surgery: asymptomatic intermittent anterior wall failures, symptomatic intermittent anterior wall failures, asymptomatic intermittent anterior and posterior wall failures, and symptomatic all-compartment failures. These groups provide granularity about the nature of surgical failures after pelvic organ prolapse surgery. Future work is planned for predicting these distinct outcomes using patient characteristics that can be used for counseling women individually.

Published
2021

13. Defining mechanisms of recurrence following apical prolapse repair based on imaging criteria

Author

Bowen, Shaniel T, Moalli, Pamela A, Abramowitch, Steven D, Lockhart, Mark E, Weidner, Alison C, Ferrando, Cecile A, Nager, Charles W, Richter, Holly E, Rardin, Charles R, Komesu, Yuko M, Harvie, Heidi S, Mazloomdoost, Donna, Sridhar, Amaanti, Gantz, Marie G, Albo, Michael E, Alperin, Marianna, Columbo, Joann, Curry, Jodi, Ferrante, Kimberly, Herrala, Kyle, Johnson, Sherella, Kirby, Anna C, Lukacz, Emily S, Ruppert, Erika, Wasenda, Erika, Diwadkar, Gouri B, Dyer, Keisha Y, Mackinnon, Linda M, Menefee, Shawn A, Tan-Kim, Jasmine, Zazueta-Damian, Gisselle, Amundsen, Cindy, Bruton, Yasmeen, Coleman-Taylor, Notorious, Gilliam, Robin, Harris, Acacia, Hayes, Akira, Kawasaki, Amie, Longoria, Nicole, McLean, Shantae, Raynor, Mary, Siddiqui, Nazema, Visco, Anthony G, Ballard, Alicia, Carter, Kathy, Ellington, David, Patel, Sunita, Saxon, Nancy, Varner, R Edward, Willis, Velria, Carberry, Cassandra, Douglas, Samantha, Hampton, B Star, Korbly, Nicole, Meers, Ann S, Myers, Deborah L, Sung, Vivian W, Viscione, Elizabeth-Ann, Wohlrab, Kyle, Box, Karen, Dunivan, Gena, Jeppson, Peter, Middendorf, Julia, Rogers, Rebecca G, Arya, Lily, Andy, Uduak, Butler, Norman, Cain, Doris, Carney, Teresa, Flick, Lorraine, Khanijow, Kavita Desai, Kingslee, Michelle, Lee, Daniel, O’Donnell, Patricia, Smith, Ariana, Thompson, Donna, Bonidie, Michael, Gruss, Judy, Lowder, Jerry, Shepherd, Jonathan, Sutkin, Gary, Zyczynski, Halina M, Barber, Matthew, Dastoli, Kathleen, Edington, Maryori, Graham, Annette, Krishnan, Geetha, Jelovsek, Eric, Paraiso, Marie Fidela R, Pung, Ly, Ferrando, Cecile, Walters, Mark, Meikle, Susan, Burd, Andrew, Burdekin, Kate, Glass, Kendra, Grant, Tracey, and Grey, Scott

Subjects
Clinical Research, Clinical Trials and Supportive Activities, Aged, Female, Gynecologic Surgical Procedures, Humans, Hysterectomy, Vaginal, Imaging, Three-Dimensional, Magnetic Resonance Imaging, Middle Aged, Pelvis, Recurrence, Treatment Failure, Uterine Prolapse, hysteropexy, magnetic resonance imaging, pelvic organ prolapse, prolapse surgery, transvaginal mesh, vaginal hysterectomy, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine
Abstract

BackgroundProlapse recurrence after transvaginal surgical repair is common; however, its mechanisms are ill-defined. A thorough understanding of how and why prolapse repairs fail is needed to address their high rate of anatomic recurrence and to develop novel therapies to overcome defined deficiencies.ObjectiveThis study aimed to identify mechanisms and contributors of anatomic recurrence after vaginal hysterectomy with uterosacral ligament suspension (native tissue repair) vs transvaginal mesh (VM) hysteropexy surgery for uterovaginal prolapse.Study designThis multicenter study was conducted in a subset of participants in a randomized clinical trial by the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Overall, 94 women with uterovaginal prolapse treated via native tissue repair (n=48) or VM hysteropexy (n=46) underwent pelvic magnetic resonance imaging at rest, maximal strain, and poststrain rest (recovery) 30 to 42 months after surgery. Participants who desired reoperation before 30 to 42 months were imaged earlier to assess the impact of the index surgery. Using a novel 3-dimensional pelvic coordinate system, coregistered midsagittal images were obtained to assess study outcomes. Magnetic resonance imaging-based anatomic recurrence (failure) was defined as prolapse beyond the hymen. The primary outcome was the mechanism of failure (apical descent vs anterior vaginal wall elongation), including the frequency and site of failure. Secondary outcomes included displacement of the vaginal apex and perineal body and change in the length of the anterior wall, posterior wall, vaginal perimeter, and introitus of the vagina from rest to strain and rest to recovery. Group differences in the mechanism, frequency, and site of failure were assessed using the Fisher exact tests, and secondary outcomes were compared using Wilcoxon rank-sum tests.ResultsOf the 88 participants analyzed, 37 (42%) had recurrent prolapse (VM hysteropexy, 13 of 45 [29%]; native tissue repair, 24 of 43 [56%]). The most common site of failure was the anterior compartment (VM hysteropexy, 38%; native tissue repair, 92%). The primary mechanism of recurrence was apical descent (VM hysteropexy, 85%; native tissue repair, 67%). From rest to strain, failures (vs successes) had greater inferior displacement of the vaginal apex (difference, -12 mm; 95% confidence interval, -19 to -6) and perineal body (difference, -7 mm; 95% confidence interval, -11 to -4) and elongation of the anterior vaginal wall (difference, 12 mm; 95% confidence interval, 8-16) and vaginal introitus (difference, 11 mm; 95% confidence interval, 7-15).ConclusionThe primary mechanism of prolapse recurrence following vaginal hysterectomy with uterosacral ligament suspension or VM hysteropexy was apical descent. In addition, greater inferior descent of the vaginal apex and perineal body, lengthening of the anterior vaginal wall, and increased size of the vaginal introitus with strain were associated with anatomic failure. Further studies are needed to provide additional insight into the mechanism by which these factors contribute to anatomic failure.

Published
2021

14. Umbilical Cord Milking vs Delayed Cord Clamping and Associations with In-Hospital Outcomes among Extremely Premature Infants

Author

Kumbhat, Neha, Eggleston, Barry, Davis, Alexis S, DeMauro, Sara B, Van Meurs, Krisa P, Foglia, Elizabeth E, Lakshminrusimha, Satyan, Walsh, Michele C, Watterberg, Kristi L, Wyckoff, Myra H, Das, Abhik, Handley, Sara C, Network, Generic Database Subcommittee of the National Institute of Child Health and Human Development Neonatal Research, Polin, Richard A, Laptook, R, Keszler, Martin, Hensman, Angelita M, Vieira, Elisa, St. Pierre, Lucille, Hibbs, Anna Maria, Truog, William E, Pallotto, Eugenia K, Parimi, Prabhu S, Gauldin, Cheri, Holmes, Anne, Knutson, Allison, Gaetano, Lisa, Poindexter, Brenda B, Schibler, Kurt, Merhar, Stephanie L, Grisby, Cathy, Kirker, Kristin, Cotten, C Michael, Goldberg, Ronald N, Finkle, Joanne, Fisher, Kimberley A, Laughon, Matthew M, Bose, Carl L, Bernhardt, Janice, Bose, Gennie, Clark, Cindy, Kicklighter, Stephen D, Rhodes-Ryan, Ginger, White, Donna, Carlton, David P, Patel, Ravi M, Loggins, Yvonne, Mackie, Colleen, Bottcher, Diane I, Bremer, Andrew A, Higgins, Rosemary D, Archer, Stephanie Wilson, Sokol, Gregory M, Herron, Dianne E, Tyson, Jon E, Khan, Amir M, Kennedy, Kathleen A, Pedrozza, Claudia, Eason, Elizabeth, Stephens, Emily K, McDavid, Georgia E, Martin, Karen, Hall, Donna, Wright, Sharon L, Sánchez, Pablo J, Nelin, Leif D, Jadcherla, Sudarshan R, Luzader, Patricia, Clark, Erna, Gutentag, Julie, Park, Courtney, Shadd, Julie C, Stein, Melanie, Baugher, Hallie, McCool, Jacqueline, Gantz, Marie G, Bann, Carla M, Wallace, Dennis, Zaterka-Baxter, Kristin M, Gabrio, Jenna, Leblond, David, Auman, Jeanette O'Donnell, Stevenson, David K, Chock, Valerie Y, Ball, M Bethany, Proud, Melinda S, Reichert, Elizabeth N, Williams, R Jordan, Carlo, Waldemar A, Ambalavanan, Namasivayam, Collins, Monica V, Cosby, Shirley S, McNair, Tara, Devaskar, Uday, Garg, Meena, Chanlaw, Teresa, Geller, Rachel, Bell, Edward F, Colaizy, Tarah T, and Ellsbury, Dan L

Subjects
Paediatrics, Biomedical and Clinical Sciences, Prevention, Preterm, Low Birth Weight and Health of the Newborn, Infant Mortality, Clinical Research, Neurosciences, Cardiovascular, Clinical Trials and Supportive Activities, Perinatal Period - Conditions Originating in Perinatal Period, Pediatric, Reproductive health and childbirth, Good Health and Well Being, Cerebral Intraventricular Hemorrhage, Constriction, Female, Gestational Age, Hospital Mortality, Humans, Infant, Extremely Premature, Infant, Newborn, Male, Retrospective Studies, Umbilical Cord, Generic Database Subcommittee of the National Institute of Child Health and Human Development Neonatal Research Network, Neonatal Research Network, intraventricular hemorrhage, placental transfusion, Human Movement and Sports Sciences, Paediatrics and Reproductive Medicine, Pediatrics
Abstract

ObjectiveTo compare in-hospital outcomes after umbilical cord milking vs delayed cord clamping among infants

Published
2021

15. Do Women Who Self-report More Exercise Have Increased Rates of Symptomatic Stress Urinary Incontinence After Midurethral Slings?

Author

Ferrante, Kimberly L, Gantz, Marie G, Sridhar, Amaanti, Smith, Ariana, Rahn, David D, Ellington, David R, Weidner, Alison C, Wohlrab, Kyle, Mazloomdoost, Donna, Moalli, Pamela, Lukacz, Emily S, and NICHD Pelvic Floor Disorders Network

Subjects
NICHD Pelvic Floor Disorders Network, Humans, Urinary Incontinence, Stress, Treatment Failure, Exercise, Reoperation, Aged, Middle Aged, Female, Suburethral Slings, Self Report, Urologic Diseases, Contraception/Reproduction, Clinical Research, Renal and urogenital, Reproductive health and childbirth, stress urinary incontinence, activity, exercise, midurethral sling
Abstract

ObjectivesThere is a paucity of data on postoperative exercise and how it relates to surgical failure, specifically after midurethral sling (MUS) surgery. We aimed to assess if women with higher self-reported activity levels as measured by strenuous exercise are more likely to experience stress urinary incontinence (SUI) symptoms after MUS than women with lower self-reported activity.MethodsThis is a secondary analysis of Operations and Pelvic Muscle Training in the Management of Apical Support Loss: the OPTIMAL Trial, a randomized trial comparing sacrospinous ligament suspension versus uterosacral ligament suspension, both with concomitant retropubic MUS. Participants completed a validated assessment of activity preoperatively and postoperatively. Women in the upper quartile for strenuous exercise (≥90 minutes per week) were compared with the remaining participants. Symptomatic SUI was defined as retreatment or reoperation for SUI and/or any positive response to Pelvic Floor Disorders Inventory stress incontinence questions 20 to 22.ResultsA total of 351 participants in the OPTIMAL study received MUS along with their prolapse repair and had postoperative exercise and Pelvic Floor Disorders Inventory data. At 2 years, 87 (29%) of 305 exercised strenuously for at least 90 minutes per week, and 63 (23%) of 277 experienced SUI. Women who were less active at 2 years were significantly more likely to experience SUI than women who were more active (26.6% vs 12.8%, P = 0.0138).ConclusionsIn this study, symptomatic SUI occurred more frequently in women with lower self-reported exercise levels 2 years after MUS surgery.

Published
2021

18. Early-Life Outcomes in Relation to Social Determinants of Health for Children Born Extremely Preterm

Author

Jobe, Alan H., Caplan, Michael S., Polin, Richard A., Laptook, Abbot R., Keszler, Martin, Hensman, Angelita M., Alksninis, Barbara, Bishop, Carmena, Burke, Robert T., Caskey, Melinda, Hoffman, Laurie, Johnson, Katharine, Keszler, Mary Lenore, Knoll, Andrea M., Lamberson, Vita, Leach, Teresa M., Little, Emilee, McGowan, Elisabeth C., Stephens, Bonnie E., Vieira, Elisa, St. Pierre, Lucille, Ventura, Suzy, Watson, Victoria E., Hibbs, Anna Maria, Walsh, Michele C., Wilson-Costello, Deanne E., Newman, Nancy S., Bhola, Monika, Payne, Allison H., Siner, Bonnie S., Yalcinkaya, Gulgun, Truog, William E., Pallotto, Eugenia K., Kilbride, Howard W., Gauldin, Cheri, Holmes, Anne, Johnson, Kathy, Scott, Allison, Parimi, Prabhu S., Gaetano, Lisa, Poindexter, Brenda B., Schibler, Kurt, Kallapur, Suhas G., Donovan, Edward F., Merhar, Stephanie, Grisby, Cathy, Yolton, Kimberly, Alexander, Barbara, Beiersdorfer, Traci, Bridges, Kate, Cahill, Tanya E., Dudley, Juanita, Fischer, Estelle E., Gratton, Teresa L., Hayes, Devan, Hessling, Jody, Jackson, Lenora D., Kirker, Kristin, Mincey, Holly L., Muthig, Greg, Stacey, Sara, Steichen, Jean J., Tepe, Stacey, Thompson, Julia, Wuertz, Sandra, Cotten, C. Michael, Goldberg, Ronald N., Goldstein, Ricki F., Malcolm, William F., Mago-Shah, Deesha, Ashley, Patricia L., Finkle, Joanne, Auten, Kathy J., Fisher, Kimberley A., Grimes, Sandra, Gustafson, Kathryn E., Lohmeyer, Melody B., Laughon, Matthew M., Bose, Carl L., Bernhardt, Janice, Bose, Gennie, Clark, Cindy, Talbert, Jennifer, Warner, Diane, Trembath, Andrea, O'Shea, T. Michael, Wereszczak, Janice, Kicklighter, Stephen D., Rhodes-Ryan, Ginger, White, Donna, Patel, Ravi M., Carlton, David P., Stoll, Barbara J., Hale, Ellen C., Loggins, Yvonne C., Adams-Chapman, Ira, Blackwelder, Ann, Bottcher, Diane I., Carter, Sheena L., Kendrick-Allwood, Salathiel, Laursen, Judith, LaRossa, Maureen Mulligan, Mackie, Colleen, Sanders, Amy, Seabrook, Irma, Smikle, Gloria, Wineski, Lynn C., Higgins, Rosemary D., Bremer, Andrew A., Archer, Stephanie Wilson, Sokol, Gregory M., Dusick, Anna M., Papile, Lu Ann, Gunn, Susan, Hamer, Faithe, Harmon, Heidi M., Herron, Dianne E., Hines, Abbey C., Lytle, Carolyn, Miller, Lucy C., Minnich, Heike M., Richard, Leslie, Smiley, Lucy, Wilson, Leslie Dawn, Tyson, Jon E., Kennedy, Kathleen A., Khan, Amir M., Duncan, Andrea, Mosquera, Ricardo, Stephens, Emily K., McDavid, Georgia E., Alaniz, Nora I., Allain, Elizabeth, Arldt-McAlister, Julie, Burson, Katrina, Dempsey, Allison G., Eason, Elizabeth, Evans, Patricia W., Garcia, Carmen, Green, Charles, Hall, Donna, Harris, Beverly Foley, Jiminez, Margarita, John, Janice, Jones, Patrick M., Lillie, M. Layne, Lis, Anna E., Martin, Karen, Martin, Sara C., Mason, Carrie M., McKee, Shannon, Morris, Brenda H., Rennie, Kimberly, Rodgers, Shawna, Siddiki, Saba Khan, Simmons, Maegan C., Sperry, Daniel, Pierce Tate, Patti L., Wright, Sharon L., Sánchez, Pablo J., Nelin, Leif D., Jadcherla, Sudarshan R., Slaughter, Jonathan L., Yeates, Keith O., Keim, Sarah, Maitre, Nathalie L., Timan, Christopher J., Luzader, Patricia, Clark, Erna, Fortney, Christine A., Gutentag, Julie, Park, Courtney, Shadd, Julie, Sullivan, Margaret, Stein, Melanie, Nelin, Mary Ann, Newton, Julia, Small, Kristi, Burkhardt, Stephanie, Purnell, Jessica, Pietruszewski, Lindsay, Levengood, Katelyn, Batterson, Nancy, Morehead, Pamela, Carey, Helen, Yoseff-Salameh, Lina, Sullivan, Rox Ann, Hague, Cole, Grothause, Jennifer, Fearns, Erin, Fowler, Aubrey, Notestine, Jennifer, Tonneman, Jill, Hay, Krystal, Chao, Michelle, Warnimont, Kyrstin, Marzec, Laura, Miller, Bethany, Beckford, Demi R., Baugher, Hallie, DeSantis, Brittany, Hanlon, Cory, McCool, Jacqueline, Das, Abhik, Gantz, Marie G., Bann, Carla M., Wallace, Dennis, Crawford, Margaret M., Gabrio, Jenna, Leblond, David, Newman, Jamie E., Petrie Huitema, Carolyn M., O'Donnell Auman, Jeanette, Poole, W. Kenneth, Zaterka-Baxter, Kristin M., Van Meurs, Krisa P., Chock, Valerie Y., Stevenson, David K., Adams, Marian M., Ball, M. Bethany, Bentley, Barbara, Bruno, Elizabeth, Davis, Alexis S., Elena DeAnda, Maria, DeBattista, Anne M., Huffman, Lynne C., Ismael, Magdy, Kohn, Jean G., Krueger, Casey, Lowe, Janice, Lucash, Ryan E., Palmquist, Andrew W., Patel, Jessica, Proud, Melinda S., Reichert, Elizabeth N., John, Nicholas H. St., Sivakumar, Dharshi, Taylor, Heather L., Wager, Natalie, Williams, R. Jordan, Weiss, Hali, Frantz, Ivan D., III, Fiascone, John M., MacKinnon, Brenda L., Furey, Anne, Nylen, Ellen, Church, Paige T., Sibley, Cecelia E., Brussa, Ana K., Carlo, Waldemar A., Ambalavanan, Namasivayam, Peralta-Carcelen, Myriam, Nelson, Kathleen G., Bailey, Kirstin J., Biasini, Fred J., Chopko, Stephanie A., Collins, Monica V., Cosby, Shirley S., Johnston, Kristen C., Moses, Mary Beth, Patterson, Cryshelle S., Phillips, Vivien A., Preskitt, Julie, Rector, Richard V., Whitley, Sally, Devaskar, Uday, Garg, Meena, Purdy, Isabell B., Chanlaw, Teresa, Geller, Rachel, Finer, Neil N., Vaucher, Yvonne E., Kaegi, David, Rasmussen, Maynard R., Arnell, Kathy, Demetrio, Clarence, Fuller, Martha G., Rich, Wade, Bell, Edward F., Colaizy, Tarah T., Widness, John A., Brumbaugh, Jane E., Acarregui, Michael J., Johnson, Karen J., Eastman, Diane L., Goeke, Claire A., Schmelzel, Mendi L., Walker, Jacky R., Baack, Michelle L., Hogden, Laurie A., Broadbent, Megan, Elenkiwich, Chelsey, Henning, Megan M., Van Muyden, Sarah, Ellsbury, Dan L., Campbell, Donia B., Tud, Tracy L., Duara, Shahnaz, Bauer, Charles R., Everett-Thomas, Ruth, Fajardo-Hiriart, Sylvia, Rigaud, Arielle, Calejo, Maria, Frade Eguaras, Silvia M., Berkowits, Michelle Harwood, Garcia, Andrea, Pierre, Helina, Stoerger, Alexandra, Watterberg, Kristi L., Fuller, Janell, Ohls, Robin K., Beauman, Sandra Sundquist, Lacy, Conra Backstrom, Duncan, Andrea F., Hanson, Mary, Hartenberger, Carol, Kuan, Elizabeth, Lowe, Jean R., Thomson, Rebecca A., DeMauro, Sara B., Eichenwald, Eric C., Schmidt, Barbara, Kirpalani, Haresh, Chaudhary, Aasma S., Abbasi, Soraya, Mancini, Toni, Catts, Christine, Cook, Noah, Cucinotta, Dara M., Bernbaum, Judy C., Gerdes, Marsha, Ghavam, Sarvin, Hurt, Hallam, Snyder, Jonathan, Vangala, Saritha, Ziolkowski, Kristina, D'Angio, Carl T., Phelps, Dale L., Guillet, Ronnie, Myers, Gary J., Andrews-Hartley, Michelle, Johnson, Julie Babish, Binion, Kyle, Bowman, Melissa, Boylin, Elizabeth, Burnell, Erica, Coleman, Kelly R., Fallone, Cait, Farooq, Osman, Hunn, Julianne, Hust, Diane, Jensen, Rosemary L., Jones, Rachel, Kachelmeyer, Jennifer, Kushner, Emily, Maffett, Deanna, McKee, Kimberly G., Merzbach, Joan, Orme, Constance, Prinzing, Diane, Reubens, Linda J., Rochez, Daisy, Rowan, Mary, Sabaratnam, Premini, Scorsone, Ann Marie, Wadkins, Holly I.M., Yost, Kelley, Zwetsch, Lauren, Lakshminrusimha, Satyan, Reynolds, Anne Marie, Sacilowski, Michael G., Guilford, Stephanie, Li, Emily, Williams, Ashley, Zorn, William A., Wyckoff, Myra H., Brion, Luc P., Salhab, Walid A., Rosenfeld, Charles R., Heyne, Roy J., Vasil, Diana M., Adams, Sally S., Chen, Lijun, De Leon, Maria M., Eubanks, Francis, Guzman, Alicia, Hensley, Gaynelle, Heyne, Elizabeth T., Lee, Lizette E., Leps, Melissa H., Madden, Linda A., McDougald, E. Rebecca, Miller, Nancy A., Morgan, Janet S., Pavageau, Lara, Sepulveda, Pollieanna, Tolentino-Plata, Kristine, Boatman, Cathy Twell, Vera, Azucena, Waterbury, Jillian, Yoder, Bradley A., Baserga, Mariana, Faix, Roger G., Winter, Sarah, Minton, Stephen D., Sheffield, Mark J., Rau, Carrie A., Baker, Shawna, Bird, Karie, Burnett, Jill, Christensen, Susan, Cole-Bledsoe, Laura, Davis, Brandy, Elmont, Jennifer O., Jensen, Jennifer J., Loertscher, Manndi C., Jordan, Jamie, Marchant, Trisha, Maxson, Earl, McGrath, Kandace M., Osborne, Karen A., Parry, D. Melody, Reich, Brixen A., Schaefer, Susan T., Spencer, Cynthia, Steffen, Michael, Tice, Katherine, Weaver-Lewis, Kimberlee, Woodbury, Kathryn D., Zanetti, Karen, Dillard, Robert G., Washburn, Lisa K., Jackson, Barbara G., Peters, Nancy, Chiu, Korinne, Allred, Deborah Evans, Goldstein, Donald J., Halfond, Raquel, Peterson, Carroll, Waldrep, Ellen L., Welch, Cherrie D., Morris, Melissa Whalen, Hounshell, Gail Wiley, Shankaran, Seetha, Sood, Beena G., Natarajan, Girija, Pappas, Athina, Abramczyk, Katherine, Agarwal, Prashant, Bajaj, Monika, Bara, Rebecca, Billian, Elizabeth, Chawla, Sanjay, Childs, Kirsten, De Jesus, Lilia C., Driscoll, Debra, February, Melissa, Goldston, Laura A., Johnson, Mary E., Muran, Geraldine, Panaitescu, Bogdan, Prentiss, Jeannette E., White, Diane, Woldt, Eunice, Barks, John, Wiggins, Stephanie A., Christensen, Mary K., Carlson, Martha D., Ehrenkranz, Richard A., Jacobs, Harris, Butler, Christine G., Cervone, Patricia, Greisman, Sheila, Konstantino, Monica, Poulsen, JoAnn, Taft, Janet, Williams, Joanne, Romano, Elaine, Vohr, Betty R., Travers, Colm P., and Hintz, Susan R.

Published
2023
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19. Performance, acceptability, and validation of a phone application bowel diary

Author

Zyczynski, Halina M, Richter, Holly E, Sung, Vivian W, Arya, Lily A, Lukacz, Emily S, Visco, Anthony G, Rahn, David D, Carper, Benjamin, Mazloomdoost, Donna, Gantz, Marie G, and Network, for the NICHD Pelvic Floor Disorders

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Digestive Diseases, Clinical Trials and Supportive Activities, Clinical Research, Aged, Aged, 80 and over, Cross-Over Studies, Data Collection, Defecation, Fecal Incontinence, Female, Humans, Middle Aged, Reproducibility of Results, Telephone, accidental bowel leakage, Bowel eDiary, electronic bowel diary, fecal incontinence, phone application diary, NICHD Pelvic Floor Disorders Network, Neurosciences, Urology & Nephrology, Clinical sciences
Abstract

AimsTo assess performance, acceptability, external validity, and reliability of a phone application electronic bowel diary (PFDN Bowel eDiary).MethodsWomen reporting refractory accidental bowel leakage (ABL) were enrolled in a randomized, crossover trial evaluating paper versus eDiary documentation of bowel movements (BM) and fecal incontinence episodes (FIE). Events were characterized by the presence or absence of urgency and Bristol stool scale consistency. The eDiary entries were date/time stamped and prompted by twice-daily phone notifications. Women were randomized to complete up to three consecutive 14-day diaries in two sequences. Diary events were compared between formats using the Pearson correlation. System usability scale (SUS) assessed eDiary usability. The eDiary test-retest reliability was assessed with intraclass correlations (ICCs).ResultsPaired diary data were available from 60/69 (87%) women 63.8 ± 9.8 years old with mean 13.2 BM per week and 6.5 FIE per week (nearly half with urgency). Among those providing diaries, adherence did not differ by paper or eDiary (93.3% vs. 95.0%). Notifications prompted 29.6% of eDiary entries, improving adherence from 70% to 95%. Paper and eDiaries were moderate to-strongly correlated for BMs per week (r = .61), urgency BMs per week (r = .76), FIE per week (r = .66), urgency FIE per week (r = .72). Test-retest reliability was good (ICC = .81 BMs per week, .79 urgency BMs per week, .74 FIE per week, and .62 urgency FIE per week). The mean SUS score was high, 82.3 ± 17.5 (range, 0-100) with 91.4% rating it easy to use, and 75.9% preferring the eDiary over paper.ConclusionThe PFDN Bowel eDiary correlated well with paper diary was considered easy to use, preferred to paper diaries, had high rates of confirmed real-time diary completion that obviated staff data entry.

Published
2020

20. Outcomes of native tissue transvaginal apical approaches in women with advanced pelvic organ prolapse and stress urinary incontinence

Author

Meyer, Isuzu, Whitworth, Ryan E, Lukacz, Emily S, Smith, Ariana L, Sung, Vivian W, Visco, Anthony G, Ackenbom, Mary F, Wai, Clifford Y, Mazloomdoost, Donna, Gantz, Marie G, and Richter, Holly E

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Research, Urologic Diseases, Reproductive health and childbirth, Renal and urogenital, Female, Gynecologic Surgical Procedures, Humans, Pelvic Organ Prolapse, Suburethral Slings, Treatment Outcome, Urinary Incontinence, Stress, Uterine Prolapse, Advanced prolapse, Pelvic organ prolapse, Prolapse repair, Sacrospinous ligament fixation, Uterosacral ligament suspension, Vaginal prolapse repair, NICHD Pelvic Floor Disorders Network and the National Institutes of Health Office of Research on Women’s Health, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine, Midwifery
Abstract

Introduction and hypothesisLimited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.MethodsThis was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.ResultsSuccess did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.ConclusionsSurgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.

Published
2020

21. Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse.

Author

Lukacz, Emily S, Sridhar, Amaanti, Chermansky, Christopher J, Rahn, David D, Harvie, Heidi S, Gantz, Marie G, Varner, R Edward, Korbly, Nicole B, and Mazloomdoost, Donna

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Patient Safety, Contraception/Reproduction, 6.4 Surgery, Evaluation of treatments and therapeutic interventions, Reproductive health and childbirth, Aged, Dyspareunia, Female, Humans, Middle Aged, Pelvic Organ Prolapse, Postoperative Complications, Randomized Controlled Trials as Topic, Retrospective Studies, Risk Factors, Sexual Behavior, Time Factors, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine
Abstract

ObjectiveTo describe sexual activity and risks for dyspareunia after pelvic organ prolapse surgery.MethodsThis was a secondary analysis of data from four randomized trials conducted between 2002 and 2018. Standard assessments and validated measures of sexual function were assessed at baseline and at 12 months postoperatively. Anterior apical surgeries were grouped by approach: transvaginal native tissue repairs, transvaginal mesh or graft-augmented repairs, and abdominal sacrocolpopexy. Additional surgeries, which included posterior repair, hysterectomy, and slings, were analyzed. Bivariate analyses and logistic regression models identified risk factors for postoperative dyspareunia.ResultsOf the 1,337 women enrolled in the trials, 932 had sufficient outcome data to determine dyspareunia status. Of these before surgery, 445 (47.8%) were sexually active without dyspareunia, 89 (9.6%) were sexually active with dyspareunia, 93 (10.0%) were not sexually active owing to fear of dyspareunia, and 305 (32.7%) were not sexually active for other reasons. At 12 months, dyspareunia or fear of dyspareunia was present in 63 of 627 (10.0%); occurred de novo in 17 of 445 (3.8%) and resolved in 136 of 182 (74.7%). Multivariable regression demonstrated baseline dyspareunia as the only factor associated with postoperative dyspareunia (adjusted odds ratio 7.8, 95% CI 4.2-14.4). No other factors, including surgical approach, were significantly associated with postoperative dyspareunia. Too few had de novo dyspareunia to perform modeling.ConclusionDyspareunia is common in one in five women before undergoing prolapse surgery. Surgical repair resolves dyspareunia in three out of four women with low rates of de novo dyspareunia at less than 4%. Preoperative dyspareunia appears to be the only predictor of postoperative dyspareunia.Clinical trial registrationClinicalTrials.gov, NCT00065845, NCT00460434, NCT00597935, and NCT01802281.

Published
2020

22. Defining the relationship between vaginal and urinary microbiomes

Author

Komesu, Yuko M, Dinwiddie, Darrell L, Richter, Holly E, Lukacz, Emily S, Sung, Vivian W, Siddiqui, Nazema Y, Zyczynski, Halina M, Ridgeway, Beri, Rogers, Rebecca G, Arya, Lily A, Mazloomdoost, Donna, Levy, Josh, Carper, Benjamin, Gantz, Marie G, and Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Urologic Diseases, Infectious Diseases, Renal and urogenital, Adult, Burkholderiales, Case-Control Studies, Clostridiales, Discriminant Analysis, Escherichia, Female, Flavobacterium, Gardnerella, Humans, Lactobacillus, Linear Models, Microbiota, Middle Aged, Prevotella, RNA, Ribosomal, 16S, Streptococcus, Ureaplasma, Urinary Incontinence, Urinary Tract, Urine, Vagina, mixed urinary incontinence, urinary microbiome, urologic conditions, vaginal microbiome, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine
Abstract

BackgroundAlthough the vaginal and urinary microbiomes have been increasingly well-characterized in health and disease, few have described the relationship between these neighboring environments. Elucidating this relationship has implications for understanding how manipulation of the vaginal microbiome may affect the urinary microbiome and treatment of common urinary conditions.ObjectiveTo describe the relationship between urinary and vaginal microbiomes using 16S rRNA gene sequencing. We hypothesized that the composition of the urinary and vaginal microbiomes would be significantly associated, with similarities in predominant taxa.Study designThis multicenter study collected vaginal swabs and catheterized urine samples from 186 women with mixed urinary incontinence enrolled in a parent study and 84 similarly aged controls. Investigators decided a priori that if vaginal and/or urinary microbiomes differed between continent and incontinent women, the groups would be analyzed separately; if similar, samples from continent and incontinent women would be pooled and analyzed together. A central laboratory sequenced variable regions 1-3 (v1-3) and characterized bacteria to the genus level. Operational taxonomic unit abundance was described for paired vaginal and urine samples. Pearson's correlation characterized the relationship between individual operational taxonomic units of paired samples. Canonical correlation analysis evaluated the association between clinical variables (including mixed urinary incontinence and control status) and vaginal and urinary operational taxonomic units, using the Canonical correlation analysis function in the Vegan package (R version 3.5). Linear discriminant analysis effect size was used to find taxa that discriminated between vaginal and urinary samples.ResultsUrinary and vaginal samples were collected from 212 women (mean age 53±11 years) and results from 197 paired samples were available for analysis. As operational taxonomic units in mixed urinary incontinence and control samples were related in canonical correlation analysis and since taxa did not discriminate between mixed urinary incontinence or controls in either vagina or urine, mixed urinary incontinence and control samples were pooled for further analysis. Canonical correlation analysis of vaginal and urinary samples indicated that that 60 of the 100 most abundant operational taxonomic units in the samples largely overlapped. Lactobacillus was the most abundant genus in both urine and vagina (contributing on average 53% to an individual's urine sample and 64% to an individual's vaginal sample) (Pearson correlation r=0.53). Although less abundant than Lactobacillus, other bacteria with high Pearson correlation coefficients also commonly found in vagina and urine included: Gardnerella (r=0.70), Prevotella (r=0.64), and Ureaplasma (r=0.50). Linear discriminant analysis effect size analysis identified Tepidimonas and Flavobacterium as bacteria that distinguished the urinary environment for both mixed urinary incontinence and controls as these bacteria were absent in the vagina (Tepidimonas effect size 2.38, P

Published
2020

23. Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery Versus Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial

Author

Sung, Vivian W, Borello-France, Diane, Newman, Diane K, Richter, Holly E, Lukacz, Emily S, Moalli, Pamela, Weidner, Alison C, Smith, Ariana L, Dunivan, Gena, Ridgeway, Beri, Nguyen, John N, Mazloomdoost, Donna, Carper, Benjamin, and Gantz, Marie G

Subjects
Renal and urogenital, Reproductive health and childbirth, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine
Published
2020

24. Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study

Author

Brubaker, Linda, Jelovsek, J Eric, Lukacz, Emily S, Balgobin, Sunil, Ballard, Alicia, Weidner, Alison C, Gantz, Marie G, Whitworth, Ryan, Mazloomdoost, Donna, and Network, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, Aged, Female, Humans, Informed Consent, Longitudinal Studies, Middle Aged, Patient Dropouts, Patient Selection, Research Subjects, Uterine Prolapse, Video Recording, Informed consent, video consent, surgical trial, pelvic organ prolapse, urinary incontinence, clinical research, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network, Statistics, Statistics & Probability, Clinical sciences, Clinical and health psychology
Abstract

Background/aimsIn this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone.MethodsIndividuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study and completed data collection events 5 years after surgery. Secondary outcomes included the proportion enrolled in the extended study, completion of follow-up at each study year, completion of data collection points, completion of in-person visits, and completion of quality of life calls. Motivation and barriers to enrollment (study-level and personal-level) and satisfaction with the study consent process were measured by questionnaire prior to recruitment into extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss. Groups were compared using an intention-to-treat principle, using unadjusted Student's t-test (continuous) and chi-square or Fisher's exact (categorical) test. A sample size of 340 (170/group) was estimated to detect a 15% difference in enrollment and study completion between groups with p

Published
2019

25. Effect of Behavioral and Pelvic Floor Muscle Therapy Combined With Surgery vs Surgery Alone on Incontinence Symptoms Among Women With Mixed Urinary Incontinence: The ESTEEM Randomized Clinical Trial.

Author

Sung, Vivian W, Borello-France, Diane, Newman, Diane K, Richter, Holly E, Lukacz, Emily S, Moalli, Pamela, Weidner, Alison C, Smith, Ariana L, Dunivan, Gena, Ridgeway, Beri, Nguyen, John N, Mazloomdoost, Donna, Carper, Benjamin, and Gantz, Marie G

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Mind and Body, Rehabilitation, Urologic Diseases, Clinical Trials and Supportive Activities, Clinical Research, Contraception/Reproduction, Reproductive health and childbirth, Renal and urogenital, Adult, Combined Modality Therapy, Exercise Therapy, Female, Follow-Up Studies, Humans, Middle Aged, Pelvic Floor, Suburethral Slings, Treatment Outcome, Urinary Incontinence, Urologic Surgical Procedures, NICHD Pelvic Floor Disorders Network, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

ImportanceMixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking.ObjectiveTo determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms.Design, setting, and participantsRandomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017.InterventionsBehavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207).Main outcomes and measuresThe primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms.ResultsAmong 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only).Conclusions and relevanceAmong women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance.Trial registrationClinicalTrials.gov Identifier: NCT01959347.

Published
2019

26. Pain and activity after vaginal reconstructive surgery for pelvic organ prolapse and stress urinary incontinence

Author

Barber, Matthew D, Brubaker, Linda, Nygaard, Ingrid, Wai, Clifford Y, Dyer, Keisha Y, Ellington, David, Sridhar, Amaanti, Gantz, Marie G, Network, NICHD Pelvic Floor Disorders, Dickersin, Kay, Jiang, Luohua, Lavender, Missy, O’Dell, Kate, Ryan, Kate, Tulikangas, Paul, Kong, Lan, McClish, Donna, Rickey, Leslie, Shade, David, Tuteja, Ashok, and Yount, Susan

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Chronic Pain, Patient Safety, Urologic Diseases, Prevention, Pain Research, Reproductive health and childbirth, Analgesics, Exercise, Female, Gynecologic Surgical Procedures, Humans, Pain Measurement, Pain, Postoperative, Pelvic Organ Prolapse, Suburethral Slings, Urinary Incontinence, Stress, functional activity, pelvic floor disorders, pelvic organ prolapse, postoperative pain, sacrospinous ligament fixation, stress urinary incontinence, uterosacral ligament suspension, vaginal reconstructive surgery, NICHD Pelvic Floor Disorders Network, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine
Abstract

BackgroundLittle is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse.ObjectiveThe objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension.Study designThis planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0-10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0-100; higher score = higher activity) prior to surgery and at 2 weeks, 4-6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role-physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected.ResultsBefore surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P = .004, and +0.74, P = .007, respectively) and then decreased below baseline at 3 months (-0.87 and -1.14, respectively, P < .001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4-6 weeks (-1.26, P = .014, and -0.95, P = .002) and 3 months (-1.97 and -1.50, P < .001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4-6 weeks (+9.24, P < .001) and 3 months (+13.79, P < .001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role-Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P < .001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4-6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs 10.5%, P = .043) but no difference in groin or thigh pain.ConclusionPain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2-4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4-6 weeks.

Published
2019

27. Association between Policy Changes for Oxygen Saturation Alarm Settings and Neonatal Morbidity and Mortality in Infants Born Very Preterm

Author

Foglia, Elizabeth E, Carper, Benjamin, Gantz, Marie, DeMauro, Sara B, Lakshminrusimha, Satyan, Walsh, Michele, Schmidt, Barbara, Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research, Caplan, Michael S, Laptook, Abbott R, Keszler, Martin, Hensman, Angelita M, Knoll, Andrea M, Little, Emilee, Vieira, Elisa, Basso, Kristin M, Keller, Jennifer A, Hibbs, Anna Maria, Fanaroff, Avroy A, Newman, Nancy S, Payne, Allison H, Schibler, Kurt, Donovan, Edward F, Grisby, Cathy, Bridges, Kate, Alexander, Barbara, Fischer, Estelle E, Mincey, Holly L, Hessling, Jody, Jackson, Lenora, Kirker, Kristin, Muthig, Greg, Tepe, Stacey, Cotten, C Michael, Goldberg, Ronald N, Auten, Kathy J, Fisher, Kimberley A, Finkle, Joanne, Carlton, David P, Stoll, Barbara J, Hale, Ellen C, Loggins, Yvonne, Bottcher, Diane I, Mackie, Colleen, Higgins, Rosemary D, Archer, Stephanie Wilson, Poindexter, Brenda B, Sokol, Gregory M, Herron, Dianne E, Miller, Lucy, Wilson, Leslie Dawn, Kennedy, Kathleen A, Tyson, Jon E, McDavid, Georgia E, Arldt-McAlister, Julie, Burson, Katrina, Garcia, Carmen, Harris, Beverly Foley, Lis, Anna E, Martin, Karen, Martin, Sara C, Rodgers, Shawna, Simmons, Maegan C, Tate, Patti L Pierce, Das, Abhik, Wallace, Dennis, Poole, W Kenneth, Auman, Jeanette O'Donnell, Crawford, Margaret M, Huitema, Carolyn M Petrie, Zaterka-Baxter, Kristin M, Van Meurs, Krisa P, Stevenson, David K, Adams, Marian M, Ball, M Bethany, Ismail, Magdy, Palmquist, Andrew W, Proud, Melinda S, Carlo, Waldemar A, Ambalavanan, Namasivayam, Collins, Monica V, Cosby, Shirley S, Bell, Edward F, Colaizy, Tarah T, Widness, John A, Johnson, Karen J, Walker, Jacky R, Watterberg, Kristi L, Ohls, Robin K, Lacy, Conra Backstrom, Hartenberger, Carol H, Beauman, Sandra Sundquist, Hanson, Mary Ruffaner, Wyckoff, Myra H, Brion, Luc P, Salhab, Walid A, Rosenfeld, Charles R, Vasil, Diana M, Chen, Lijun, and Guzman, Alicia

Subjects
Paediatrics, Biomedical and Clinical Sciences, Pediatric, Infant Mortality, Lung, Preterm, Low Birth Weight and Health of the Newborn, Prevention, Rare Diseases, Clinical Research, Perinatal Period - Conditions Originating in Perinatal Period, Neonatal Respiratory Distress, 2.4 Surveillance and distribution, Reproductive health and childbirth, Good Health and Well Being, Bronchopulmonary Dysplasia, Cohort Studies, Enterocolitis, Necrotizing, Female, Health Policy, Humans, Infant, Infant, Extremely Premature, Infant, Newborn, Intensive Care Units, Neonatal, Male, Morbidity, Oximetry, Oxygen Consumption, Policy Making, Retinopathy of Prematurity, Retrospective Studies, Surveys and Questionnaires, Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network, mortality, oxygen saturation, preterm, retinopathy of prematurity, Human Movement and Sports Sciences, Paediatrics and Reproductive Medicine, Pediatrics
Abstract

ObjectiveTo determine the impact of policy changes for pulse oximetry oxygen saturation (SpO2) alarm limits on neonatal mortality and morbidity among infants born very preterm.Study designThis was a retrospective cohort study of infants born very preterm in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants were classified based on treatment at a hospital with an SpO2 alarm policy change and study epoch (before vs after policy change). We used a generalized linear mixed model to determine the effect of hospital group and epoch on the primary outcomes of mortality and severe retinopathy of prematurity (ROP) and secondary outcomes of necrotizing enterocolitis, bronchopulmonary dysplasia, and any ROP.ResultsThere were 3809 infants in 10 hospitals with an SpO2 alarm policy change and 3685 infants in 9 hospitals without a policy change. The nature of most policy changes was to narrow the SpO2 alarm settings. Mortality was lower in hospitals without a policy change (aOR 0.63; 95% CI 0.50-0.80) but did not differ between epochs in policy change hospitals. The odds of bronchopulmonary dysplasia were greater for hospitals with a policy change (aOR 1.65; 95% CI 1.36-2.00) but did not differ for hospitals without a policy change. Severe ROP and necrotizing enterocolitis did not differ between epochs for either group. The adjusted odds of any ROP were lower in recent years in both hospital groups.ConclusionsChanging SpO2 alarm policies was not associated with reduced mortality or increased severe ROP among infants born very preterm.

Published
2019

28. The urinary microbiome in women with mixed urinary incontinence compared to similarly aged controls.

Author

Komesu, Yuko M, Richter, Holly E, Carper, Benjamin, Dinwiddie, Darrell L, Lukacz, Emily S, Siddiqui, Nazema Y, Sung, Vivian W, Zyczynski, Halina M, Ridgeway, Beri, Rogers, Rebecca G, Arya, Lily A, Mazloomdoost, Donna, Gantz, Marie G, and Pelvic Floor Disorders Network

Subjects
Pelvic Floor Disorders Network, Urinary Tract, Humans, Lactobacillus, Urinary Incontinence, RNA, Ribosomal, 16S, Linear Models, Case-Control Studies, Sequence Analysis, DNA, Adult, Middle Aged, Female, Microbiota, Surveys and Questionnaires, 16S rRNA gene sequencing, Female urinary microbiome, Menopausal status, Mixed urinary incontinence, Urinary microbiome, Obstetrics & Reproductive Medicine, Paediatrics and Reproductive Medicine
Abstract

INTRODUCTION & HYPOTHESIS:Previous studies have suggested that women with urinary incontinence have an altered urinary microbiome. We hypothesized that the microbiome in women with mixed urinary incontinence (MUI) differed from controls and tested this hypothesis using bacterial gene sequencing techniques. METHODS:This multicenter study compared the urinary microbiome in women with MUI and similarly aged controls. Catheterized urine samples were obtained; v4-6 regions of the 16S rRNA gene were sequenced to identify bacteria. Bacterial predominance (> 50% of an individual's genera) was compared between MUI and controls. Bacterial sequences were categorized into "community types" using Dirichlet multinomial mixture (DMM) methods. Generalized linear mixed models predicted MUI/control status based on clinical characteristics and community type. Post-hoc analyses were performed in women < 51 and ≥ 51 years. Sample size estimates required 200 samples to detect a 20% difference in Lactobacillus predominance with P

Published
2018

30. Milrinone in congenital diaphragmatic hernia – a randomized pilot trial: study protocol, review of literature and survey of current practices

Author

Lakshminrusimha, Satyan, Keszler, Martin, Kirpalani, Haresh, Van Meurs, Krisa, Chess, Patricia, Ambalavanan, Namasivayam, Yoder, Bradley, Fraga, Maria V, Hedrick, Holly, Lally, Kevin P, Nelin, Leif, Cotten, Michael, Klein, Jonathan, Guilford, Stephanie, Williams, Ashley, Chaudhary, Aasma, Gantz, Marie, Gabrio, Jenna, Chowdhury, Dhuly, Zaterka-Baxter, Kristin, Das, Abhik, and Higgins, Rosemary D

Subjects
Pediatric, Lung, Infant Mortality, Rare Diseases, Clinical Research, Digestive Diseases, Clinical Trials and Supportive Activities, Perinatal Period - Conditions Originating in Perinatal Period, Orphan Drug, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Extracorporeal membrane oxygenation, Oxygen, Persistent pulmonary hypertension, Phosphodiesterase, Pulmonary hypertension
Abstract

BackgroundCongenital diaphragmatic hernia (CDH) is commonly associated with pulmonary hypoplasia and pulmonary hypertension (PH). PH associated with CDH (CDH-PH) is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO) possibly due to right and left ventricular dysfunction. Milrinone is an intravenous inotrope and lusitrope with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PH. We developed this pilot study to determine if milrinone infusion would improve oxygenation in neonates ≥36 weeks postmenstrual age (PMA) with CDH.Methods/designData on pulmonary vasodilator management and outcome of CDH patients was collected from 18 university NICUs affiliated with the Neonatal Research Network (NRN) from 2011 to 2012. The proposed pilot will be a masked, placebo-controlled, multicenter, randomized trial of 66 infants with CDH with an oxygenation index (OI) ≥10 or oxygen saturation index (OSI) ≥5. The primary outcome is the oxygenation response, as determined by change in OI at 24 h after initiation of study drug. As secondary outcomes, we will determine oxygenation at 48 h and 72 h post-infusion, right ventricular pressures on echocardiogram and the incidence of systemic hypotension, arrhythmias, intracranial hemorrhage, survival without extracorporeal membrane oxygenation, and chronic lung disease (oxygen need at 28 days postnatal age). Finally, we will evaluate the pulmonary and nutritional status at 4, 8 and 12 months of age using a phone questionnaire.ResultsThree hundred thirty-seven infants with CDH were admitted to NRN NICUs in 2011 and 2012 of which 275 were ≥36 weeks PMA and were exposed to the following pulmonary vasodilators: iNO (39%), sildenafil (17%), milrinone (17%), inhaled epoprostenol (6%), intravenous epoprostenol (3%), and intravenous PGE1 (1%). ECMO was required in 36% of patients. Survival to discharge was 71%.DiscussionCDH is an orphan disease with high mortality with few randomized trials evaluating postnatal management. Intravenous milrinone is a commonly used medication in neonatal/pediatric intensive care units and is currently used in 17% of patients with CDH within the NRN. This pilot study will provide data and enable further studies evaluating pulmonary vasodilator therapy in CDH.Trial registrationClinicalTrials.gov; NCT02951130; registered 14 October 2016.

Published
2017

31. Transforming Big Data into AI‐ready data for nutrition and obesity research

Author

Thomas, Diana M., primary, Knight, Rob, additional, Gilbert, Jack A., additional, Cornelis, Marilyn C., additional, Gantz, Marie G., additional, Burdekin, Kate, additional, Cummiskey, Kevin, additional, Sumner, Susan C. J., additional, Pathmasiri, Wimal, additional, Sazonov, Edward, additional, Gabriel, Kelley Pettee, additional, Dooley, Erin E., additional, Green, Mark A., additional, Pfluger, Andrew, additional, and Kleinberg, Samantha, additional

Published
2024
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32. Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial

Author

Jelovsek, John Eric, Barber, Mathew D., Paraiso, Marie Fidela R., Walters, Mark D., Ridgeway, Beri, Gurland, Brooke, Zutshi, Massarat, Krishnan, Geetha, Pung, Ly, Graham, Annette, Sung, Vivian W., Myers, Deborah L., Rardin, Charles R., Carberry, Cassandra, Hampton, B. Star, Wohlrab, Kyle, Meers, Ann S., Visco, Anthony, Amundsen, Cindy, Weidner, Alison, Siddiqui, Nazema, Kawasaki, Amie, McLean, Shantae, Longoria, Nicole, Carrington, Jessica, Mehta, Niti, Harm-Ernandes, Ingrid, Maddocks, Jennifer, Pannullo, Amy, Markland, Alayne, Richter, Holly E., Varner, R. Edward, Holley, Robert, Lloyd, L. Keith, Wilson, Tracy S., Ballard, Alicia, McCormick, Jeannine, Willis, Velria, Saxon, Nancy, Carter, Kathy, Meikle, Susan, Nager, Charles, Albo, Michael, Lukacz, Emily, Furey, Cindy, Riley, Patricia, Columbo, JoAnn, Johnson, Sherella, Menefee, Shawn, Luber, Karl, Dyer, Keisha, Diwadkar, Gouri, Tan-Kim, Jasmine, Rogers, Rebecca G., Komesu, Yuko, Dunivan, Gena, Jeppson, Peter, Cichowski, Sara, Miller, Christy, Yane, Erin, Middendorf, Julia, Nava, Risela, Gantz, Marie G., Wallace, Dennis, Shaffer, Amanda, Pande, Poonam, Roney, Kelly, Carper, Benjamin, Whitworth, Ryan E., Warren, Lauren Klein, Wilson, Kevin A., Hair, Brenda, Glass, Kendra, Matthews, Daryl, Pickett, James W., Tang, Yan, Terry, Tamara L., Tatum, Lynda, Bibb, Barbara, Thornberry, Jutta, Zaterka-Baxter, Kristin, Morris, Lindsay, Arya, Lily, Smith, Ariana, Harve, Heidi, Andy, Uduak Umoh, Levin, Pamela, Newman, Diane K., Wang, Mary, Thompson, Donna, Carney, Teresa, Kingslee, Michelle, Flick, Lorraine, Zyczynski, Halina M., Moalli, Pam, Sutkin, Gary, Shepherd, Jonathan, Bonidie, Michael, Abo, Steven, Harrison, Janet, Chermansky, Christopher, Geraci, Lori, Gruss, Judy, Mislanovich, Karen, Eline, Ellen, Klump, Beth, George, Susan E., Whitehead, William E., Dickersin, Kay, Jiang, Luohua, Lavender, Missy, O'Dell, Kate, Ryan, Kate, Tulikangas, Paul, Kong, Lan, McClish, Donna, Rickey, Leslie, Shade, David, Tuteja, Ashok, Yount, Susan, Jelovsek, J Eric, Markland, Alayne D, Whitehead, William E, Barber, Matthew D, Newman, Diane K, Rogers, Rebecca G, Visco, Anthony G, Zyczynski, Halina M, Meikle, Susan F, Sung, Vivian W, and Gantz, Marie G

Published
2019
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33. Umbilical Cord Milking vs Delayed Cord Clamping and Associations with In-Hospital Outcomes among Extremely Premature Infants

Author

Polin, Richard A., Laptook, Abbot R., Keszler, Martin, Hensman, Angelita M., Vieira, Elisa, Pierre, Lucille St., Hibbs, Anna Maria, Truog, William E., Pallotto, Eugenia K., Parimi, Prabhu S., Gauldin, Cheri, Holmes, Anne, Knutson, Allison, Gaetano, Lisa, Poindexter, Brenda B., Schibler, Kurt, Merhar, Stephanie L., Grisby, Cathy, Kirker, Kristin, Cotten, C. Michael, Goldberg, Ronald N., Finkle, Joanne, Fisher, Kimberley A., Laughon, Matthew M., Bose, Carl L., Bernhardt, Janice, Bose, Gennie, Clark, Cindy, Kicklighter, Stephen D., Rhodes-Ryan, Ginger, White, Donna, Carlton, David P., Patel, Ravi M., Loggins, Yvonne, Mackie, Colleen, Bottcher, Diane I., Bremer, Andrew A., Higgins, Rosemary D., Wilson Archer, Stephanie, Sokol, Gregory M., Herron, Dianne E., Tyson, Jon E., Khan, Amir M., Kennedy, Kathleen A., Pedrozza, Claudia, Eason, Elizabeth, Stephens, Emily K., McDavid, Georgia E., Martin, Karen, Hall, Donna, Wright, Sharon L., Sánchez, Pablo J., Nelin, Leif D., Jadcherla, Sudarshan R., Luzader, Patricia, Clark, Erna, Gutentag, Julie, Park, Courtney, Shadd, Julie C., Stein, Melanie, Baugher, Hallie, McCool, Jacqueline, Gantz, Marie G., Bann, Carla M., Wallace, Dennis, Zaterka-Baxter, Kristin M., Gabrio, Jenna, Leblond, David, Auman, Jeanette O'Donnell, Stevenson, David K., Chock, Valerie Y., Ball, M. Bethany, Proud, Melinda S., Reichert, Elizabeth N., Williams, R. Jordan, Carlo, Waldemar A., Ambalavanan, Namasivayam, Collins, Monica V., Cosby, Shirley S., McNair, Tara, Devaskar, Uday, Garg, Meena, Chanlaw, Teresa, Geller, Rachel, Bell, Edward F., Colaizy, Tarah T., Ellsbury, Dan L., Baack, Michelle L., Johnson, Karen J., Schmelzel, Mendi L., Walker, Jacky R., Goeke, Claire A., Tud, Tracy L., Elenkiwich, Chelsey, Henning, Megan M., Broadbent, Megan, Hogden, Laurie A., Brumbaugh, Jane E., Klein, Jonathan M., Dagle, John M., Fuller, Janell, Ohls, Robin K., Sundquist Beauman, Sandra, Backstrom Lacy, Conra, Hartenberger, Carol, Hanson, Mary, Kuan, Elizabeth, Eichenwald, Eric C., Schmidt, Barbara, Kirpalani, Haresh, Abbasi, Soraya, Catts, Christine, Chaudhary, Aasma S., Ghavam, Sarvin, Mancini, Toni, Snyder, Jonathan, D'Angio, Carl T., Guillet, Ronnie, Reynolds, Anne Marie, Wadkins, Holly I.M., Sacilowski, Michael G., Rowan, Mary, Jensen, Rosemary L., Maffett, Deanna, Prinzing, Diane, Scorsone, Ann Marie, Binion, Kyle, Guilford, Stephanie, Orme, Constance, Sabaratnam, Premini, Daisy Rochez, Li, Emily, Donato, Jennifer, Lakshminrusimha, Satyan, Jones, Rachel, Brion, Luc P., DeLeon, Maria M., Eubanks, Frances, Sepulvida, Pollieanna, Vasil, Diana M., Yoder, Bradley A., Baserga, Mariana, Minton, Stephen D., Sheffield, Mark J., Rau, Carrie A., Burnett, Jill, Davis, Brandy, Christensen, Susan, Loertscher, Manndi C., Marchant, Trisha, Maxson, Earl, McGrath, Kandace, Elmont, Jennifer O., Parry, Melody, Schaefer, Susan T., Weaver-Lewis, Kimberlee, Woodbury, Kathryn D., Shankaran, Seetha, Natarajan, Girija, Chawla, Sanjay, Childs, Kirsten, Panaitescu, Bogdan, Barks, John, White, Diane F., Kumbhat, Neha, Eggleston, Barry, Davis, Alexis S., DeMauro, Sara B., Van Meurs, Krisa P., Foglia, Elizabeth E., Walsh, Michele C., Watterberg, Kristi L., Wyckoff, Myra H., Das, Abhik, and Handley, Sara C.

Published
2021
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34. Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic–Ischemic Encephalopathy in the Late Hypothermia Trial

Author

Caplan, Michael S., Polin, Richard A., Keszler, Martin, Oh, William, Vohr, Betty R., McGowan, Elizabeth C., Alksninis, Barbara, Basso, Kristin, Bliss, Joseph, Bishop, Carmena, Burke, Robert T., Cashore, William, Caskey, Melinda, Gingras, Dan, Guerina, Nicholas, Johnson, Katharine, Keszler, Mary Lenore, Knoll, Andrea M., Leach, Theresa M., Leonard, Martha R., Little, Emilee, Stephens, Bonnie E., Vieira, Elisa, Watson, Victoria E., Hibbs, Anna Maria, Wilson-Costello, Deanne E., Newman, Nancy S., Batton, Beau, Bhola, Monika, Di Fiore, Juliann M., Friedman, Harriet G., Siner, Bonnie S., Stork, Eileen K., Yalcinkaya, Gulgun, Zadell, Arlene, Pallotto, Eugenia K., Kilbride, Howard W., Gauldin, Cheri, Holmes, Anne, Johnson, Kathy, Knutson, Allison, Schibler, Kurt, Yolton, Kimberly, Grisby, Cathy, Gratton, Teresa L., Merhar, Stephanie, Wuertz, Sandra, Cotten, C. Michael, Fisher, Kimberley A., Grimes, Sandra, Finkle, Joanne, Goldstein, Ricki F., Gustafson, Kathryn E., Malcolm, William F., Ashley, Patricia L., Auten, Kathy J., Lohmeyer, Melody B., Laughon, Matthew M., Bose, Carl L., Bernhardt, Janice, Clark, Cindy, Warner, Diane D., Wereszcsak, Janice, Aliaga, Sofia, Carlton, David P., Stoll, Barbara J., Hale, Ellen C., Loggins, Yvonne, Bottcher, Diane I., Mackie, Colleen, LaRossa, Maureen Mulligan, Adams-Chapman, Ira, Wineski, Lynn C., Carter, Sheena L., Higgins, Rosemary D., Archer, Stephanie Wilson, Harmon, Heidi M., Papile, Lu-Ann, Dusick, Anna M., Gunn, Susan, Herron, Dianne E., Hines, Abbey C., Kardatzke, Darlene, Lytle, Carolyn, Minnich, Heike M., Richard, Leslie, Smiley, Lucy C., Wilson, Leslie Dawn, Kennedy, Kathleen A., Allain, Elizabeth, Mason, Carrie M., Arldt-McAlister, Julie, Burson, Katrina, Dempsey, Allison G., Duncan, Andrea F., Evans, Patricia W., Garcia, Carmen, Green, Charles E., Jimenez, Margarita, John, Janice, Jones, Patrick M., Lillie, M. Layne, Martin, Karen, Martin, Sara C., McDavid, Georgia E., McKee, Shannon, Pierce Tate, Patti L., Rodgers, Shawna, Siddiki, Saba Khan, Sperry, Daniel K., Wright, Sharon L., Sánchez, Pablo J., Nelin, Leif D., Jadcherla, Sudarshan R., Luzader, Patricia, Fortney, Christine A., Grothause, Jennifer L., Wallace, Dennis, Gantz, Marie G., Zaterka-Baxter, Kristin M., Crawford, Margaret M., McDonald, Scott A., Newman, Jamie E., O'Donnell Auman, Jeanette, Petrie Huitema, Carolyn M., Pickett, James W., II, Yost, Patricia, Van Meurs, Krisa P., Stevenson, David K., Ball, M. Bethany, Bentley, Barbara, Chock, Valerie Y., Bruno, Elizabeth F., Davis, Alexis S., DeAnda, Maria Elena, DeBattista, Anne M., Earhart, Beth, Huffman, Lynne C., Kohn, Jean G., Krueger, Casey E., Proud, Melinda S., Rhine, William D., St. John, Nicholas H., Taylor, Heather, Weiss, Hali E., Carlo, Waldemar A., Peralta-Carcelen, Myriam, Collins, Monica V., Cosby, Shirley S., Phillips, Vivien A., Rector, Richard V., Whitley, Sally, Colaizy, Tarah T., Brumbaugh, Jane E., Johnson, Karen J., Eastman, Diane L., Acarregui, Michael J., Walker, Jacky R., Goeke, Claire A., Klein, Jonathan M., Krutzfield, Nancy J., Segar, Jeffrey L., Dagle, John M., Lindower, Julie B., McElroy, Steven J., Rabe, Glenda K., Roghair, Robert D., Meyer, Lauritz R., Ellsbury, Dan L., Campbell, Donia B., Murphy, Cary R., Bhavsar, Vipinchandra, Ohls, Robin K., Lacy, Conra Backstrom, Beauman, Sandra Sundquist, Brown, Sandra, Fernandez, Erika, Duncan, Andrea Freeman, Fuller, Janell, Kuan, Elizabeth, Lowe, Jean R., Schmidt, Barbara, Kirpalani, Haresh, DeMauro, Sara B., Dysart, Kevin C., Abbasi, Soraya, Mancini, Toni, Cucinotta, Dara M., Bernbaum, Judy C., Gerdes, Marsha, Hurt, Hallam, D'Angio, Carl, Lakshminrusimha, Satyan, Laroia, Nirupama, Myers, Gary J., Yost, Kelley, Guilford, Stephanie, Jensen, Rosemary L., Wynn, Karen, Farooq, Osman, Reynolds, Anne Marie, Wadkins, Holly I.M., Williams, Ashley, Merzbach, Joan, Conway, Patrick, Bowman, Melissa, Hartley-McAndrew, Michele, Zorn, William, Fallone, Cait, Binion, Kyle, Orme, Constance, Scorsone, Ann Marie, Brion, Luc P., Chalak, Lina F., Heyne, Roy J., Chen, Lijun, Vasil, Diana M., Adams, Sally S., Boatman, Catherine Twell, Guzman, Alicia, Heyne, Elizabeth T., Lee, Lizette E., Leps, Melissa H., Madden, Linda A., Miller, Nancy A., Ramon, Emma, Yoder, Bradley A., Osborne, Karen A., Spencer, Cynthia, Steele, R. Edison, Steffen, Mike, Strong, Karena, Weaver-Lewis, Kimberlee, Baker, Shawna, Winter, Sarah, Bird, Karie, Burnett, Jill, Sood, Beena G., Bara, Rebecca, Childs, Kirsten, De Jesus, Lilia C., Panaitescu, Bogdan, Chawla, Sanjay M.D., Prentice, Jeannette E., Goldston, Laura A., Woldt, Eunice Hinz, Natarajan, Girija, Bajaj, Monika, Barks, John, Christensen, Mary, Wiggins, Stephanie A., Laptook, Abbot R., Shankaran, Seetha, Barnes, Patrick, Rollins, Nancy, Do, Barbara T., Parikh, Nehal A., Hamrick, Shannon, Hintz, Susan R., Tyson, Jon E., Bell, Edward F., Ambalavanan, Namasivayam, Goldberg, Ronald N., Pappas, Athina, Huitema, Carolyn, Pedroza, Claudia, Chaudhary, Aasma S., Hensman, Angelita M., Das, Abhik, Wyckoff, Myra, Khan, Amir, Walsh, Michelle C., Watterberg, Kristi L., Faix, Roger, Truog, William, Guillet, Ronnie, Sokol, Gregory M., and Poindexter, Brenda B.

Published
2021
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35. Methodology for a vaginal and urinary microbiome study in women with mixed urinary incontinence

Author

Komesu, Yuko M, Richter, Holly E, Dinwiddie, Darrell L, Siddiqui, Nazema Y, Sung, Vivian W, Lukacz, Emily S, Ridgeway, Beri, Arya, Lily A, Zyczynski, Halina M, Rogers, Rebecca G, and Gantz, Marie

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Genetics, Clinical Research, Urologic Diseases, Clinical Trials and Supportive Activities, Renal and urogenital, Reproductive health and childbirth, Female, Humans, Microbiota, Middle Aged, Polymerase Chain Reaction, Research Design, Sequence Analysis, DNA, Surveys and Questionnaires, Urinary Incontinence, Stress, Urinary Incontinence, Urge, Vagina, Female urinary microbiome, Urinary taxa, Vaginal microbiome, Mixed urinary incontinence, Next-generation sequencing, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine, Midwifery
Abstract

Introduction and hypothesisWe describe the rationale and methods of a study designed to compare vaginal and urinary microbiomes in women with mixed urinary incontinence (MUI) and similarly aged, asymptomatic controls.MethodsThis paper delineates the methodology of a supplementary microbiome study nested in an ongoing randomized controlled trial comparing a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone for MUI. Women in the parent study had at least "moderate bother" from urgency and stress urinary incontinence symptoms (SUI) on validated questionnaire and confirmed MUI on bladder diary. Controls had no incontinence symptoms. All participants underwent vaginal and urine collection for DNA analysis and conventional urine culture. Standardized protocols were designed, and a central lab received samples for subsequent polymerase chain reaction (PCR) amplification and sequencing of the bacterial16S ribosomal RNA (rRNA) gene. The composition of bacterial communities will be determined by dual amplicon sequencing of variable regions 1-3 and 4-6 from vaginal and urine specimens to compare the microbiome of patients with controls. Sample-size estimates determined that 126 MUI and 84 control participants were sufficient to detect a 20 % difference in predominant urinary genera, with 80 % power and 0.05 significance level.ResultsSpecimen collection commenced January 2015 and finished April 2016. DNA was extracted and stored for subsequent evaluation.ConclusionsMethods papers sharing information regarding development of genitourinary microbiome studies, particularly with control populations, are few. We describe the rigorous methodology developed for a novel urogenital microbiome study in women with MUI.

Published
2017

36. Behavior Profiles at 2 Years for Children Born Extremely Preterm with Bronchopulmonary Dysplasia

Author

Caplan, Michael S., Polin, Richard A., Laptook, Abbot R., Keszler, Martin, Hensman, Angelita M., Vieira, Elisa, Little, Emilee, Burke, Robert T., Stephens, Bonnie E., Alksninis, Barbara, Bishop, Carmena, Keszler, Mary L., Leach, Teresa M., Watson, Victoria E., Knoll, Andrea M., Walsh, Michele C., Fanaroff, Avroy A., Newman, Nancy S., Wilson-Costello, Deanne E., Payne, Allison, Bhola, Monika, Yalcinkaya, Gulgun, Siner, Bonnie S., Friedman, Harriet G., Roth, Elizabeth, Truog, William E., Pallotto, Eugenia K., Kilbride, Howard W., Gauldin, Cheri, Holmes, Anne, Johnson, Kathy, Knutson, Allison, Schibler, Kurt, Poindexter, Brenda B., Merhar, Stephanie, Yolton, Kimberly, Gratton, Teresa L., Grisby, Cathy, Kirker, Kristin, Wuertz, Sandra, Carlton, David P., Adams-Chapman, Ira, Hale, Ellen C., Loggins, Yvonne C., Bottcher, Diane I., Mackie, Colleen, Carter, Sheena L., LaRossa, Maureen Mulligan, Wineski, Lynn C., Smikle, Gloria V., Leon-Hernandez, Angela, Kendrick-Allwood, Salathiel, Cotten, C. Michael, Goldberg, Ronald N., Goldstein, Ricki F., Malcolm, William F., Ashley, Patricia L., Finkle, Joanne, Fisher, Kimberley A., Grimes, Sandra, Gustafson, Kathryn E., Laughon, Matthew M., Bose, Carl L., Bernhardt, Janice, Bose, Gennie, Warner, Diane, Wereszczak, Janice, Kicklighter, Stephen D., Rhodes-Ryan, Ginger, Higgins, Rosemary D., Wilson Archer, Stephanie, Sokol, Gregory M., Papile, Lu Ann, Hines, Abbey C., Herron, Dianne E., Gunn, Susan, Smiley, Lucy, Kennedy, Kathleen A., Tyson, Jon E., Arldt-McAlister, Julie, Burson, Katrina, Dempsey, Allison G., Evans, Patricia W., Garcia, Carmen, Jiminez, Margarita, John, Janice, Jones, Patrick M., Lillie, M. Layne, Martin, Karen, Martin, Sara C., McDavid, Georgia E., Rodgers, Shawna, Siddiki, Saba Khan, Sperry, Daniel, Pierce Tate, Patti L., Wright, Sharon L., Sánchez, Pablo J., Nelin, Leif D., Jadcherla, Sudarshan R., Luzader, Patricia, Fortney, Christine A., Besner, Gail E., Parikh, Nehal A., Wallace, Dennis, Gantz, Marie G., Newman, Jamie E., Auman, Jeanette O'Donnell, Crawford, Margaret, Gabrio, Jenna, Leblond, David, Petrie Huitema, Carolyn M., Zaterka-Baxter, Kristin M., Van Meurs, Krisa P., Chock, Valerie Y., Stevenson, David K., Adams, Marian M., Ball, M. Bethany, Bentley, Barbara, DeAnda, Maria Elena, Debattista, Anne M., Earhart, Beth, Huffman, Lynne C., Ismael, Magdy, Krueger, Casey E., Palmquist, Andrew W., Proud, Melinda S., Reichert, Elizabeth N., Sankar, Meera N., St. John, Nicholas H., Taylor, Heather L., Weiss, Hali E., Frantz, Ivan D., III, Fiascone, John M., MacKinnon, Brenda L., Nylen, Ellen, Furey, Anne, Sibley, Cecelia E., Brussa, Ana K., Carlo, Waldemar A., Ambalavanan, Namasivayam, Bailey, Kirstin J., Biasini, Fred J., Collins, Monica V., Cosby, Shirley S., Phillips, Vivien A., Rector, Richard V., Whitley, Sally, Devaskar, Uday, Garg, Meena, Purdy, Isabell B., Chanlaw, Teresa, Geller, Rachel, Finer, Neil N., Vaucher, Yvonne E., Kaegi, David, Rasmussen, Maynard R., Arnell, Kathy, Demetrio, Clarence, Fuller, Martha G., Rich, Wade, West, Radmila, Baack, Michelle L., Ellsbury, Dan L., Hogden, Laurie A., Klein, Jonathan M., Dagle, John M., Johnson, Karen J., Tud, Tracy L., Elenkiwich, Chelsey, Henning, Megan M., Broadbent, Megan, Schmelzel, Mendi L., Walker, Jacky R., Goeke, Claire A., Watterberg, Kristi L., Ohls, Robin K., Backstrom Lacy, Conra, Brown, Sandra, Fuller, Janell, Hartenberger, Carol, Lowe, Jean R., Sundquist Beauman, Sandra, Hanson, Mary Ruffner, Dupont, Tara, Kuan, Elizabeth, Schmidt, Barbara, Kirpalani, Haresh, Chaudhary, Aasma S., Abbasi, Soraya, Mancini, Toni, Cucinotta, Dara M., Bernbaum, Judy C., Gerdes, Marsha, Hurt, Hallam, D'Angio, Carl T., Guillet, Ronnie, Myers, Gary J., Lakshminrusimha, Satyan, Reynolds, Anne Marie, Hartley-McAndrew, Michelle E., Wadkins, Holly I.M., Sacilowski, Michael G., Reubens, Linda J., Jensen, Rosemary L., Merzbach, Joan, Zorn, William, Farooq, Osman, Maffett, Deanna, Williams, Ashley, Hunn, Julianne, Guilford, Stephanie, Yost, Kelley, Rowan, Mary, Prinzing, Diane M., Wynn, Karen, Fallone, Cait, Scorsone, Ann Marie, Wyckoff, Myra H., Brion, Luc P., Heyne, Roy J., Vasil, Diana M., Adams, Sally S., Chen, Lijun, De Leon, Maria M., Eubanks, Frances, Guzman, Alicia, Heyne, Elizabeth T., Madden, Linda A., Miller, Nancy A., Lee, Lizette E., Pavageau, Lara, Sepulveda, Pollieanna, Boatman, Cathy Twell, Faix, Roger G., Yoder, Bradley A., Baserga, Mariana, Osborne, Karen A., Baker, Shawna, Bird, Karie, Burnett, Jill, Christensen, Susan, Davis, Brandy, Elmont, Jennifer O., Jensen, Jennifer J., Loertscher, Manndi C., Marchant, Trisha, Maxson, Earl, Minton, Stephen D., Parry, D. Melody, Rau, Carrie A., Schaefer, Susan T., Sheffield, Mark J., Spencer, Cynthia, Steffen, Mike, Weaver-Lewis, Kimberlee, Winter, Sarah, Woodbury, Kathryn D., Zanetti, Karen, Shankaran, Seetha, Chawla, Sanjay, Sood, Beena G., Pappas, Athina, Natarajan, Girija, Bajaj, Monika, Bara, Rebecca, Johnson, Mary E., Goldston, Laura, Wiggins, Stephanie A., Christensen, Mary K., Carlson, Martha, Barks, John, White, Diane F., Ehrenkranz, Richard A., Jacobs, Harris, Butler, Christine G., Cervone, Patricia, Greisman, Sheila, Konstantino, Monica, Poulsen, JoAnn, Taft, Janet, Romano, Elaine, Brumbaugh, Jane E., Bell, Edward F., Grey, Scott F., DeMauro, Sara B., Vohr, Betty R., Harmon, Heidi M., Bann, Carla M., Rysavy, Matthew A., Logan, J. Wells, Colaizy, Tarah T., Peralta-Carcelen, Myriam A., McGowan, Elisabeth C., Duncan, Andrea F., Stoll, Barbara J., Das, Abhik, and Hintz, Susan R.

Published
2020
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37. Methods for a multicenter randomized trial for mixed urinary incontinence: rationale and patient-centeredness of the ESTEEM trial

Author

Sung, Vivian W, Borello-France, Diane, Dunivan, Gena, Gantz, Marie, Lukacz, Emily S, Moalli, Pamela, Newman, Diane K, Richter, Holly E, Ridgeway, Beri, Smith, Ariana L, Weidner, Alison C, Meikle, Susan, and for the Pelvic Floor Disorders Network

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Health Sciences, Cost Effectiveness Research, Urologic Diseases, Comparative Effectiveness Research, Clinical Trials and Supportive Activities, Mind and Body, Clinical Research, 7.1 Individual care needs, Management of diseases and conditions, Reproductive health and childbirth, Renal and urogenital, Good Health and Well Being, Female, Humans, Patient Selection, Patient-Centered Care, Quality of Life, Research Design, Surveys and Questionnaires, Urinary Incontinence, Mixed urinary incontinence, Clinical trials, Sling, Behavioral therapy, Pelvic Floor Disorders Network, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine, Midwifery
Abstract

Introduction and hypothesisMixed urinary incontinence (MUI) can be a challenging condition to manage. We describe the protocol design and rationale for the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence (ESTEEM) trial, designed to compare a combined conservative and surgical treatment approach versus surgery alone for improving patient-centered MUI outcomes at 12 months.MethodsESTEEM is a multisite, prospective, randomized trial of female participants with MUI randomized to a standardized perioperative behavioral/pelvic floor exercise intervention plus midurethral sling versus midurethral sling alone. We describe our methods and four challenges encountered during the design phase: defining the study population, selecting relevant patient-centered outcomes, determining sample size estimates using a patient-reported outcome measure, and designing an analysis plan that accommodates MUI failure rates. A central theme in the design was patient centeredness, which guided many key decisions. Our primary outcome is patient-reported MUI symptoms measured using the Urogenital Distress Inventory (UDI) score at 12 months. Secondary outcomes include quality of life, sexual function, cost-effectiveness, time to failure, and need for additional treatment.ResultsThe final study design was implemented in November 2013 across eight clinical sites in the Pelvic Floor Disorders Network. As of 27 February 2016, 433 total/472 targeted participants had been randomized.ConclusionsWe describe the ESTEEM protocol and our methods for reaching consensus for methodological challenges in designing a trial for MUI by maintaining the patient perspective at the core of key decisions. This trial will provide information that can directly impact patient care and clinical decision making.

Published
2016

38. Quality of Life and Sexual Function 2 Years After Vaginal Surgery for Prolapse

Author

Lukacz, Emily S, Warren, Lauren Klein, Richter, Holly E, Brubaker, Linda, Barber, Matthew D, Norton, Peggy, Weidner, Alison C, Nguyen, John N, and Gantz, Marie G

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Trials and Supportive Activities, Clinical Research, Prevention, 6.4 Surgery, Evaluation of treatments and therapeutic interventions, Reproductive health and childbirth, Body Image, Female, Humans, Middle Aged, Postoperative Period, Quality of Life, Sexual Behavior, Suburethral Slings, Surveys and Questionnaires, Urinary Incontinence, Uterine Prolapse, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine, Reproductive medicine
Abstract

ObjectiveTo longitudinally assess the effect of native tissue vaginal apical prolapse repair with anti-incontinence surgery on quality of life, sexual function, and body image between uterosacral and sacrospinous suspensions.MethodsA planned secondary analysis was performed on 374 women enrolled in a randomized trial of the two types of native tissue repair for apical prolapse. Condition-specific and generic quality of life, sexual function, overall and de novo dyspareunia, and body image were assessed using validated instruments at baseline; 6, 12, and 24 months postoperatively; and changes from baseline were assessed and compared between surgical groups. General linear mixed models were used for comparisons and clinically significant differences were assessed using minimum important differences.ResultsOf the women randomized, 82% had outcomes available at 2 years. Overall, clinically and statistically significant improvements in generic and condition-specific quality of life and sexual function were observed after surgery. Dyspareunia rates decreased from 25% to 16% by 24 months with only 3% of all women undergoing treatment. De novo dyspareunia occurred in 5% and 10% by 12 and 24 months, respectively. Body image scores also significantly improved from baseline. There were no clinically meaningful or statistically significant differences between groups for any of these outcomes (all P>.05).ConclusionNative tissue vaginal prolapse surgery results in statistically and clinically significant improvements in quality of life, sexual function, and body image at 24 months with no significant differences between uterosacral and sacrospinous suspensions. One in 10 women experience de novo dyspareunia but few requested treatment.Clinical trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00597935.

Published
2016

39. Developmental Outcomes of Extremely Preterm Infants with a Need for Child Protective Services Supervision

Author

Polin, Richard A., Laptook, Abbott R., Keszler, Martin, Hensman, Angelita M., Alksninis, Barbara, Basso, Kristin M., Burke, Robert, Caskey, Melinda, Johnson, Katharine, Keszler, Mary Lenore, Knoll, Andrea M., Leach, Theresa M., Little, Emilee, McGowan, Elisabeth C., Vieira, Elisa, Watson, Victoria E., Ventura, Suzy, Walsh, Michele C., Fanaroff, Avroy A., Hibbs, Anna Marie, Wilson-Costello, Deanne E., Newman, Nancy S., Payne, Allison H., Siner, Bonnie S., Bhola, Monika, Yalcinkaya, Gulgun, Friedman, Harriet G., Truog, William E., Pallotto, Eugenia K., Kilbride, Howard W., Gauldin, Cheri, Holmes, Anne, Johnson, Kathy, Knutson, Allison, Schibler, Kurt, Donovan, Edward F., Grisby, Cathy, Bridges, Kate, Alexander, Barbara, Fischer, Estelle E., Mincey, Holly L., Hessling, Jody, Gratton, Teresa L., Jackson, Lenora, Kirker, Kristin, Muthig, Greg, Steichen, Jean J., Tepe, Stacey, Yolton, Kimberly, Goldberg, Ronald N., Cotten, C. Michael, Goldstein, Ricki F., Ashley, Patricia L., Malcolm, William F., Auten, Kathy J., Fisher, Kimberley A., Grimes, Sandra, Gustafson, Kathryn E., Lohmeyer, Melody B., Finkle, Joanne, Laughon, Matthew M., Bose, Carl L., Bernhardt, Janice, Bose, Gennie, Clark, Cindy, Manor, Linda, Warner, Diane, Wereszczak, Janice, Carlton, David P., Stoll, Barbara J., Adams-Chapman, Ira, Hale, Ellen C., Loggins, Yvonne, Archer, Stephanie Wilson, Sokol, Gregory M., Poindexter, Brenda B., Dusick, Anna M., Papile, Lu-Ann, Gunn, Susan, Hamer, Faithe, Herron, Dianne E., Hines, Abbey C., Lytle, Carolyn, Minnich, Heike M., Smiley, Lucy, Wilson, Leslie Dawn, Sanchez, Pablo J., Nelin, Leif D., Jadcherla, Sudarshan R., Luzader, Patricia, Fortney, Christine A., Besner, Gail E., Parikh, Nehal A., Das, Abhik, Wallace, Dennis, Gantz, Marie G., Poole, W. Kenneth, Newman, Jamie E., O'Donnell Auman, Jeanette, Crawford, Margaret M., Petrie Huitema, Carolyn M., Zaterka-Baxter, Kristin M., Van Meurs, Krisa P., Stevenson, David K., Hintz, Susan R., Ball, M. Bethany, Davis, Alexis S., Palmquist, Andrew W., Proud, Melinda S., Bentley, Barbara, Bruno, Elizabeth, DeAnda, Maria Elena, DeBattista, Anne M., Earhart, Beth, Huffman, Lynne C., Kohn, Jean G., Krueger, Casey, Weiss, Hali E., Frantz, Ivan D., III, Fiascone, John M., MacKinnon, Brenda L., Furey, Anne, Nylen, Ellen, Carlo, Waldemar A., Ambalavanan, Namasivayam, Peralta-Carcelen, Myriam, Collins, Monica V., Cosby, Shirley S., Biasini, Fred J., Johnston, Kristen C., Nelson, Kathleen G., Patterson, Cryshelle S., Phillips, Vivien A., Whitley, Sally, Devaskar, Uday, Garg, Meena, Purdy, Isabell B., Chanlaw, Teresa, Geller, Rachel, Finer, Neil N., Vaucher, Yvonne E., Kaegi, David, Rasmussen, Maynard R., Arnell, Kathy, Demetrio, Clarence, Fuller, Martha G., Rich, Wade, Bell, Edward F., Colaizy, Tarah T., Acarregui, Michael J., Ellsbury, Dan L., Widness, John A., Johnson, Karen J., Campbell, Donia B., Eastman, Diane L., Walker, Jacky R., Brumbaugh, Jane E., Duara, Shahnaz, Bauer, Charles R., Everett-Thomas, Ruth, Fajardo-Hiriart, Sylvia, Rigaud, Arielle, Calejo, Maria, Frade Eguaras, Silvia M., Berkowits, Michelle Harwood, Garcia, Andrea, Pierre, Helina, Stoerger, Alexandra, Watterberg, Kristi L., Lowe, Jean R., Fuller, Janell F., Ohls, Robin K., Lacy, Conra Backstrom, Duncan, Andrea F., Montman, Rebecca, Schmidt, Barbara, Kirpalani, Haresh, DeMauro, Sara B., Chaudhary, Aasma S., Abbasi, Soraya, Mancini, Toni, Cucinotta, Dara M., Bernbaum, Judy C., Gerdes, Marsha, Hurt, Hallam, D'Angio, Carl T., Phelps, Dale L., Guillet, Ronnie, Lakshminrusimha, Satyan, Johnson, Julie Babish, Reubens, Linda J., Horihan, Cassandra A., Hust, Diane, Jensen, Rosemary L., Kushner, Emily, Merzbach, Joan, Myers, Gary J., Rowan, Mary, Wadkins, Holly I.M., Bowman, Melissa, Hunn, Julianne, Guilford, Stephanie, Maffett, Deanna, Osman, Farooq, Prinzing, Diane, Reynolds, Anne Marie, Sacilowski, Michael G., Williams, Ashley, Wynn, Karen, Yost, Kelley, Zorn, William, Zwetsch, Lauren, Kennedy, Kathleen A., Tyson, Jon E., McDavid, Georgia E., Alaniz, Nora I., Arldt-McAlister, Julie, Burson, Katrina, Evans, Patricia W., Garcia, Carmen, Green, Charles, Harris, Beverly Foley, Jiminez, Margarita, John, Janice, Jones, Patrick M., Lillie, Layne M., Lis, Anna E., Martin, Karen, Martin, Sara C., Morris, Brenda H., Poundstone, M. Layne, Robichaux, Peggy, Rodgers, Shawna, Siddiki, Saba, Simmons, Maegan C., Sperry, Daniel, Pierce Tate, Patti L., Wright, Sharon L., Wyckoff, Myra H., Brion, Luc P., Heyne, Roy J., Salhab, Walid A., Rosenfeld, Charles R., Vasil, Diana M., Chen, Lijun, Guzman, Alicia, Hensley, Gaynelle, Leps, Melissa H., Miller, Nancy A., Morgan, Janet S., Adams, Sally S., Boatman, Catherine Twell, Heyne, Elizabeth T., Madden, Linda A., Torres, Lizette E., Faix, Roger G., Yoder, Bradley A., Osborne, Karen A., Spencer, Cynthia, Weaver-Lewis, Kimberlee, Baker, Shawna, Bird, Karie, Burnett, Jill, Steffen, Michael, Jensen, Jennifer J., Winter, Sarah, Zanetti, Karen, O'Shea, T. Michael, Dillard, Robert G., Washburn, Lisa K., Jackson, Barbara G., Peters, Nancy, Chiu, Korinne, Allred, Deborah Evans, Goldstein, Donald J., Halfond, Raquel, Peterson, Carroll, Waldrep, Ellen L., Welch, Cherrie D., Morris, Melissa Whalen, Hounshell, Gail Wiley, Shankaran, Seetha, Pappas, Athina, Barks, John, Bara, Rebecca, Goldston, Laura A., Natarajan, Girija, Christensen, Mary, Wiggins, Stephanie A., White, Diane, Ehrenkranz, Richard A., Jacobs, Harris, Butler, Christine G., Cervone, Patricia, Greisman, Sheila, Konstantino, Monica, Poulsen, JoAnn, Taft, Janet, Williams, Joanne, Romano, Elaine, Laptook, Abbot. R., Lowe, Jean, Chowdhury, Dhuly, Higgins, Rosemary D., and Vohr, Betty R.

Published
2019
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40. Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods

Author

Jelovsek, J Eric, 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, and Network, on behalf of the Pelvic Floor Disorders

Subjects
Behavioral and Social Science, Digestive Diseases, Clinical Research, Contraception/Reproduction, Mind and Body, Cost Effectiveness Research, Urologic Diseases, Clinical Trials and Supportive Activities, Comparative Effectiveness Research, Health Services, Prevention, Pelvic Floor Disorders Network, Anal sphincter exercises, Factorial design, Fecal incontinence, Loperamide, Manometry-assisted biofeedback, Randomized placebo controlled trial, Medical and Health Sciences, General Clinical Medicine, Public Health
Abstract

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.

Published
2015

41. Controlling anal incontinence in women by performing anal exercises with biofeedback or loperamide (CAPABLe) trial: Design and methods.

Author

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, and Pelvic Floor Disorders Network

Subjects
Pelvic Floor Disorders Network, Anal sphincter exercises, Factorial design, Fecal incontinence, Loperamide, Manometry-assisted biofeedback, Randomized placebo controlled trial, Mind and Body, Contraception/Reproduction, Urologic Diseases, Comparative Effectiveness Research, Prevention, Digestive Diseases, Clinical Trials and Supportive Activities, Cost Effectiveness Research, Health Services, Behavioral and Social Science, Clinical Research, General Clinical Medicine, Public Health, Medical and Health Sciences
Abstract

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.

Published
2015

42. What Happens to the Posterior Compartment and Bowel Symptoms After Sacrocolpopexy?

Author

Grimes, Cara L, Lukacz, Emily S, Gantz, Marie G, Warren, Lauren Klein, Brubaker, Linda, Zyczynski, Halina M, Richter, Holly E, Jelovsek, John Eric, Cundiff, Geoffrey, Fine, Paul, Visco, Anthony G, Zhang, Min, and Meikle, Susan

Subjects
Clinical Research, Contraception/Reproduction, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine
Published
2014

43. Association between Policy Changes for Oxygen Saturation Alarm Settings and Neonatal Morbidity and Mortality in Infants Born Very Preterm

Author

Caplan, Michael S., Laptook, Abbott R., Keszler, Martin, Hensman, Angelita M., Knoll, Andrea M., Little, Emilee, Vieira, Elisa, Basso, Kristin M., Keller, Jennifer A., Hibbs, Anna Maria, Fanaroff, Avroy A., Newman, Nancy S., Payne, Allison H., Schibler, Kurt, Donovan, Edward F., Grisby, Cathy, Bridges, Kate, Alexander, Barbara, Fischer, Estelle E., Mincey, Holly L., Hessling, Jody, Jackson, Lenora, Kirker, Kristin, Muthig, Greg, Tepe, Stacey, Cotten, C. Michael, Goldberg, Ronald N., Auten, Kathy J., Fisher, Kimberley A., Finkle, Joanne, Carlton, David P., Stoll, Barbara J., Hale, Ellen C., Loggins, Yvonne, Bottcher, Diane I., Mackie, Colleen, Higgins, Rosemary D., Archer, Stephanie Wilson, Poindexter, Brenda B., Sokol, Gregory M., Herron, Dianne E., Miller, Lucy, Wilson, Leslie Dawn, Kennedy, Kathleen A., Tyson, Jon E., McDavid, Georgia E., Arldt-McAlister, Julie, Burson, Katrina, Garcia, Carmen, Harris, Beverly Foley, Lis, Anna E., Martin, Karen, Martin, Sara C., Rodgers, Shawna, Simmons, Maegan C., Pierce Tate, Patti L., Das, Abhik, Wallace, Dennis, Poole, W. Kenneth, O'Donnell Auman, Jeanette, Crawford, Margaret M., Petrie Huitema, Carolyn M., Zaterka-Baxter, Kristin M., Van Meurs, Krisa P., Stevenson, David K., Adams, Marian M., Ball, M. Bethany, Ismail, Magdy, Palmquist, Andrew W., Proud, Melinda S., Carlo, Waldemar A., Ambalavanan, Namasivayam, Collins, Monica V., Cosby, Shirley S., Bell, Edward F., Colaizy, Tarah T., Widness, John A., Johnson, Karen J., Walker, Jacky R., Watterberg, Kristi L., Ohls, Robin K., Lacy, Conra Backstrom, Hartenberger, Carol H., Beauman, Sandra Sundquist, Hanson, Mary Ruffaner, Wyckoff, Myra H., Brion, Luc P., Salhab, Walid A., Rosenfeld, Charles R., Vasil, Diana M., Chen, Lijun, Guzman, Alicia, Hensley, Gaynelle, Lee, Lizette E., Leps, Melissa H., Miller, Nancy A., Morgan, Janet S., Pavageau, Lara, Shankaran, Seetha, Pappas, Athina, Bara, Rebecca, Natarajan, Girija, Foglia, Elizabeth E., Carper, Benjamin, Gantz, Marie, DeMauro, Sara B., Lakshminrusimha, Satyan, Walsh, Michele, and Schmidt, Barbara

Published
2019
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44. Behavioral Deficits at 18-22 Months of Age Are Associated with Early Cerebellar Injury and Cognitive and Language Performance in Children Born Extremely Preterm

Author

Jobe, Alan H., Caplan, Michael S., Laptook, Abbot R., Vohr, Betty R., Oh, William, Hensman, Angelita M., Alksninis, Barbara, Andrews, Dawn, Angela, Kristen, Barnett, Susan, Cashore, Bill, Caskey, Melinda, Francis, Kim, Gingras, Dan, Johnson, Katharine, Leach, Theresa M., Stephens, Bonnie E., Watson, Victoria E., Walsh, Michele C., Fanaroff, Avroy A., Newman, Nancy S., Wilson-Costello, Deanne E., Siner, Bonnie S., Zadell, Arlene, DiFiore, Julie, Bhola, Monika, Friedman, Harriet G., Yalcinkaya, Gulgun, Bulas, Dorothy, Goldberg, Ronald N., Cotten, C. Michael, Goldstein, Ricki F., Ashley, Patricia, Auten, Kathy J., Fisher, Kimberley A., Foy, Katherine A., Freedman, Sharon F., Gustafson, Kathryn E., Lohmeyer, Melody B., Malcolm, William F., Wallace, David K., Carlton, David P., Stoll, Barbara J., Adams-Chapman, Ira, Buchter, Susie, Piazza, Anthony J., Carter, Sheena, Fritz, Sobha, Hale, Ellen C., Hutchinson, Amy K., LaRossa, Maureen Mulligan, Higgins, Rosemary D., Archer, Stephanie Wilson, Sokol, Gregory M., Poindexter, Brenda B., Dusick, Anna M., Lemons, James A., Wilson, Leslie D., Hamer, Faithe, Cook, Ann B., Herron, Dianne E., Lytle, Carolyn, Minnich, Heike M., Berberich, Mary Anne, Blaisdell, Carol J., Gail, Dorothy B., Kiley, James P., Das, Abhik, Gantz, Marie G., Newman, Jamie E., Cheng, Helen, Hastings, Betty K., McClure, Elizabeth M., Auman, Jeanette O'Donnell, Huitema, Carolyn Petrie, Poole, W. Kenneth, Pickett, James W., II, Wallace, Dennis, Wrage, Lisa A., Zaterka-Baxter, Kristin M., Van Meurs, Krisa P., Stevenson, David K., Ball, M. Bethany, Barnes, Patrick D., Bentley, Barbara, Bruno, Elizabeth F., DeAnda, Maria Elena, DeBattista, Anne M., Kohn, Jean G., Proud, Melinda S., Pyle, Renee P., Weiss, Hali E., Frantz, Ivan D., III, Fiascone, John M., McGowan, Elisabeth C., Furey, Anne, MacKinnon, Brenda L., Nylen, Ellen, Brussa, Ana, Sibley, Cecelia, Carlo, Waldemar A., Ambalavanan, Namasivayam, Collins, Monica V., Cosby, Shirley S., Phillips, Vivien A., Bailey, Kirstin J., Biasini, Fred J., Hopkins, Maria, Johnston, Kristen C., Nelson, Kathleen G., Patterson, Cryshelle S., Rector, Richard V., Rodriguez, Leslie, Soong, Amanda, Whitley, Sally, York, Sheree, Finer, Neil N., Rasmussen, Maynard R., Wozniak, Paul R., Vaucher, Yvonne E., Rich, Wade, Arnell, Kathy, Barbieri-Welge, Rene, Ben-Tall, Ayala, Bridge, Renee, Demetrio, Clarence, Fuller, Martha G., Ito, Elaine, Lukasik, Meghan, Pontillo, Deborah, Posin, Donna, Runyan, Cheryl, Wilkes, James, Zlotnik, Paul, Bell, Edward F., Widness, John A., Acarregui, Michael J., Klein, Jonathan M., Colaizy, Tarah T., Johnson, Karen J., Eastman, Diane L., Duara, Shahnaz, Bauer, Charles R., Everett-Thomas, Ruth, Calejo, Maria, Diaz, Alexis N., Frade Eguaras, Silvia M., Garcia, Andrea, Hamlin-Smith, Kasey, Berkowits, Michelle Harwood, Hiriart-Fajardo, Sylvia, Mathews, Elaine O., Pierre, Helina, Riguard, Arielle, Stroerger, Alexandra, Watterberg, Kristi L., Ohls, Robin K., Fuller, Janell, Rohr, Julie, Lacy, Conra Backstrom, Lowe, Jean, Montman, Rebecca, Brown, Sandra, Laroia, Nirupama, Phelps, Dale L., Myers, Gary J., Markowitz, Gary D., Reubens, Linda J., Hust, Diane, Augostino, Lisa, Johnson, Julie Babish, Burnell, Erica, Gelbard, Harris, Jensen, Rosemary L., Kushner, Emily, Merzbach, Joan, Mink, Jonathan, Torres, Carlos, Wang, David, Yost, Kelley, Sánchez, Pablo J., Rosenfeld, Charles R., Salhab, Walid A., Heyne, Roy J., Adams, Sally S., Allen, James, Grau, Laura, Guzman, Alicia, Hensley, Gaynelle, Heyne, Elizabeth T., Hickman, Jackie F., Leps, Melissa H., Madden, Linda A., Martin, Melissa, Miller, Nancy A., Morgan, Janet S., Solis, Araceli, Torres, Lizette E., Boatman, Catherine Twell, Vasil, Diana M., Kennedy, Kathleen A., Tyson, Jon E., Evans, Patricia W., Akpa, Esther G., Alaniz, Nora I., Harris, Beverly Foley, Green, Charles, Jiminez, Margarita, Lis, Anna E., Martin, Sarah, McDavid, Georgia E., Morris, Brenda H., Poundstone, Margaret L., Reddoch, Stacy, Siddiki, Saba, Pierce Tate, Patti L., Wright, Sharon L., Yoder, Bradley A., Faix, Roger G., Baker, Shawna, Bird, Karie, Bullwinkle, Anna E., Burnett, Jill, Cole, Laura, Osborne, Karen A., Spencer, Cynthia, Steele, R. Edison, Steffen, Michael, Weaver-Lewis, Kimberlee, O'Shea, T. Michael, Dillard, Robert G., Washburn, Lisa K., Peters, Nancy J., Jackson, Barbara G., Chiu, Korinne, Allred, Deborah Evans, Goldstein, Donald J., Halfond, Raquel, Peterson, Carroll, Waldrep, Ellen L., Welch, Cherrie D., Morris, Melissa Whalen, Hounshell, Gail Wiley, Shankaran, Seetha, Sood, Beena G., Slovis, Thomas L., Pappas, Athina, Bara, Rebecca, Billian, Elizabeth, Goldston, Laura A., Johnson, Mary, Duncan, Andrea F., Bann, Carla M., Dempsey, Allison, Peralta-Carcelen, Myriam, and Hintz, Susan

Published
2019
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45. Growth Outcomes of Preterm Infants Exposed to Different Oxygen Saturation Target Ranges from Birth

Author

Das, Abhik, Gantz, Marie, Jobe, Alan H., Caplan, Michael S., Fanaroff, Avroy A., Wilson-Costello, Deanne E., Siner, Bonnie S., Zadell, Arlene, DiFiore, Julie, Bhola, Monika, Friedman, Harriet G., Yalcinkaya, Gulgun, Donovan, Edward F., Narendran, Vivek, Yolton, Kimberly, Bridges, Kate, Alexander, Barbara, Grisby, Cathy, Mersmann, Marcia Worley, Mincey, Holly L., Hessling, Jody, Gratton, Teresa L., Goldberg, Ronald N., Goldstein, Ricki F., Ashley, Patricia, Auten, Kathy J., Fisher, Kimberley A., Foy, Katherine A., Freedman, Sharon F., Gustafson, Kathryn E., Lohmeyer, Melody B., Malcolm, William F., Wallace, David K., Stoll, Barbara J., Adams-Chapman, Ira, Buchter, Susie, Carlton, David P., Carter, Sheena, Fritz, Sobha, Hale, Ellen C., Hutchinson, Amy K., LaRossa, Maureen Mulligan, Smikle, Gloria V., Archer, Stephanie Wilson, Dusick, Anna M., Lemons, James A., Myers, Gary J., Wilson, Leslie D., Hamer, Faithe, Cook, Ann B., Herron, Dianne E., Lytle, Carolyn, Minnich, Heike M., Berberich, Mary Anne, Blaisdell, Carol J., Gail, Dorothy B., Kiley, James P., Poole, W. Kenneth, Newman, Jamie E., Hastings, Betty K., O'Donnell Auman, Jeanette, Huitema, Carolyn Petrie, Pickett, James W., II, Wallace, Dennis, Zaterka-Baxter, Kristin M., Stevenson, David K., Hintz, Susan R., Ball, M. Bethany, Bentley, Barbara, Bruno, Elizabeth F., Davis, Alexis S., DeAnda, Maria Elena, DeBattista, Anne M., Huffman, Lynne C., Kohn, Jean G., Proud, Melinda S., Pyle, Renee P., St. John, Nicholas H., Weiss, Hali E., Fiascone, John M., McGowan, Elisabeth C., Furey, Anne, MacKinnon, Brenda L., Nylen, Ellen, Brussa, Ana, Sibley, Cecelia, Ambalavanan, Namasivayam, Peralta-Carcelen, Myriam, Collins, Monica V., Cosby, Shirley S., Phillips, Vivien A., Bailey, Kirstin J., Biasini, Fred J., Hopkins, Maria, Johnston, Kristen C., Krzywanski, Sara, Nelson, Kathleen G., Patterson, Cryshelle S., Rector, Richard V., Rodriguez, Leslie, Soong, Amanda, Whitley, Sally, York, Sheree, Widness, John A., Acarregui, Michael J., Klein, Jonathan M., Colaizy, Tarah T., Johnson, Karen J., Eastman, Diane L., Bauer, Charles R., Everett-Thomas, Ruth, Calejo, Maria, Diaz, Alexis N., Frade Eguaras, Silvia M., Garcia, Andrea, Hamlin-Smith, Kasey, Berkowits, Michelle Harwood, Hiriart-Fajardo, Sylvia, Pierre, Helina, Rigaud, Arielle, Stroerger, Alexandra, Ohls, Robin K., Fuller, Janell, Rohr, Julie, Lacy, Conra Backstrom, Lowe, Jean, Montman, Rebecca, Brion, Luc, Rosenfeld, Charles R., Salhab, Walid A., Heyne, Roy J., Adams, Sally S., Allen, James, Chen, Lijun, Grau, Laura, Guzman, Alicia, Hensley, Gaynelle, Heyne, Elizabeth T., Hickman, Jackie, Lepps, Melissa H., Madden, Linda A., Miller, Nancy A., Morgan, Janet S., Solis, Araceli, Torres, Lizette E., Boatman, Catherine Twell, Vasil, Diana M, Kennedy, Kathleen A., Tyson, Jon E., Akpa, Esther G., Alaniz, Nora I., Dieterich, Susan, Evans, Patricia W., Green, Charles, Harris, Beverly Foley, Jiminez, Margarita, Lis, Anna E., Martin, Karen, Martin, Sarah, McDavid, Georgia E., Morris, Brenda H., Poundstone, M. Layne, Reddoch, Stacey, Siddiki, Saba, Simmons, Maegan C., Pierce Tate, Patti L., Wright, Sharon L., Sood, Beena G., Pappas, Athina, Bara, Rebecca, Billian, Elizabeth, Goldston, Laura A., Johnson, Mary, Bhandari, Vineet, Jacobs, Harris C., Cervone, Pat, Gettner, Patricia, Konstantino, Monica, Poulsen, JoAnn, Taft, Janet, Butler, Christine G., Close, Nancy, Gilliam, Walter, Greisman, Sheila, Romano, Elaine, Williams, Joanne, Navarrete, Cristina T., Wrage, Lisa A., Carlo, Waldemar A., Walsh, Michele C., Rich, Wade, Gantz, Marie G., Schibler, Kurt, Newman, Nancy S., Piazza, Anthony J., Poindexter, Brenda B., Shankaran, Seetha, Sánchez, Pablo J., Frantz, Ivan D., III, Van Meurs, Krisa P., Cotten, C. Michael, Ehrenkranz, Richard A., Bell, Edward F., Watterberg, Kristi L., Higgins, Rosemary D., and Duara, Shahnaz

Published
2016
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46. What happens to the posterior compartment and bowel symptoms after sacrocolpopexy? evaluation of 5-year outcomes from E-CARE.

Author

Grimes, Cara L, Lukacz, Emily S, Gantz, Marie G, Warren, Lauren Klein, Brubaker, Linda, Zyczynski, Halina M, Richter, Holly E, Jelovsek, J Eric, Cundiff, Geoffrey, Fine, Paul, Visco, Anthony G, Zhang, Min, Meikle, Susan, and NICHD Pelvic Floor Disorders Network

Subjects
NICHD Pelvic Floor Disorders Network, Sacrococcygeal Region, Humans, Colposcopy, Treatment Outcome, Reoperation, Gynecologic Surgical Procedures, Defecation, Aged, Middle Aged, Female, Pelvic Organ Prolapse, Clinical Research, obstructed defecation, posterior prolapse, sacrocolpopexy
Abstract

ObjectivesThe objective of this study was to describe posterior prolapse (pPOP) and obstructed defecation (OD) symptoms 5 years after open abdominal sacrocolpopexy (ASC).MethodsWe grouped the extended colpopexy and urinary reduction efforts trial participants with baseline and 5-year outcomes into 3 groups using baseline posterior Pelvic Organ Prolapse Quantification (POP-Q) points and concomitant posterior repair (PR) (no PR, Ap

Published
2014

47. Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse

Author

Barber, Matthew D, Brubaker, Linda, Burgio, Kathryn L, Richter, Holly E, Nygaard, Ingrid, Weidner, Alison C, Menefee, Shawn A, Lukacz, Emily S, Norton, Peggy, Schaffer, Joseph, Nguyen, John N, Borello-France, Diane, Goode, Patricia S, Jakus-Waldman, Sharon, Spino, Cathie, Warren, Lauren Klein, Gantz, Marie G, and Meikle, Susan F

Subjects
Clinical Trials and Supportive Activities, Contraception/Reproduction, Urologic Diseases, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.4 Surgery, Renal and urogenital, Reproductive health and childbirth, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine
Published
2014

48. Comparison of 2 Transvaginal Surgical Approaches and Perioperative Behavioral Therapy for Apical Vaginal Prolapse: The OPTIMAL Randomized Trial

Author

Barber, Matthew D, Brubaker, Linda, Burgio, Kathryn L, Richter, Holly E, Nygaard, Ingrid, Weidner, Alison C, Menefee, Shawn A, Lukacz, Emily S, Norton, Peggy, Schaffer, Joseph, Nguyen, John N, Borello-France, Diane, Goode, Patricia S, Jakus-Waldman, Sharon, Spino, Cathie, Warren, Lauren Klein, Gantz, Marie G, and Meikle, Susan F

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Research, Comparative Effectiveness Research, Clinical Trials and Supportive Activities, Urologic Diseases, Prevention, Evaluation of treatments and therapeutic interventions, 6.4 Surgery, Reproductive health and childbirth, Renal and urogenital, Adult, Aged, Aged, 80 and over, Behavior Therapy, Exercise Therapy, Female, Gynecologic Surgical Procedures, Humans, Middle Aged, Pelvic Floor, Suburethral Slings, Treatment Outcome, Urinary Incontinence, Stress, Urination, Uterine Prolapse, Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

ImportanceMore than 300,000 surgeries are performed annually in the United States for pelvic organ prolapse. Sacrospinous ligament fixation (SSLF) and uterosacral ligament suspension (ULS) are commonly performed transvaginal surgeries to correct apical prolapse. Little is known about their comparative efficacy and safety, and it is unknown whether perioperative behavioral therapy with pelvic floor muscle training (BPMT) improves outcomes of prolapse surgery.ObjectiveTo compare outcomes between (1) SSLF and ULS and (2) perioperative BPMT and usual care in women undergoing surgery for vaginal prolapse and stress urinary incontinence.Design, setting, and participantsMulticenter, 2 × 2 factorial, randomized trial of 374 women undergoing surgery to treat both apical vaginal prolapse and stress urinary incontinence was conducted between 2008 and 2013 at 9 US medical centers. Two-year follow-up rate was 84.5%.InterventionsThe surgical intervention was transvaginal surgery including midurethral sling with randomization to SSLF (n = 186) or ULS (n = 188); the behavioral intervention was randomization to receive perioperative BPMT (n = 186) or usual care (n = 188).Main outcomes and measuresThe primary outcome for the surgical intervention (surgical success) was defined as (1) no apical descent greater than one-third into vaginal canal or anterior or posterior vaginal wall beyond the hymen (anatomic success), (2) no bothersome vaginal bulge symptoms, and (3) no re-treatment for prolapse at 2 years. For the behavioral intervention, primary outcome at 6 months was urinary symptom scores (Urinary Distress Inventory; range 0-300, higher scores worse), and primary outcomes at 2 years were prolapse symptom scores (Pelvic Organ Prolapse Distress Inventory; range 0-300, higher scores worse) and anatomic success.ResultsAt 2 years, surgical group was not significantly associated with surgical success rates (ULS, 59.2% [93/157] vs SSLF, 60.5% [92/152]; unadjusted difference, -1.3%; 95% CI, -12.2% to 9.6%; adjusted odds ratio [OR], 0.9; 95% CI, 0.6 to 1.5) or serious adverse event rates (ULS, 16.5% [31/188] vs SSLF, 16.7% [31/186]; unadjusted difference, -0.2%; 95% CI, -7.7% to 7.4%; adjusted OR, 0.9; 95% CI, 0.5 to 1.6). Perioperative BPMT was not associated with greater improvements in urinary scores at 6 months (adjusted treatment difference, -6.7; 95% CI, -19.7 to 6.2), prolapse scores at 24 months (adjusted treatment difference, -8.0; 95% CI, -22.1 to 6.1), or anatomic success at 24 months.Conclusions and relevanceTwo years after vaginal surgery for prolapse and stress urinary incontinence, neither ULS nor SSLF was significantly superior to the other for anatomic, functional, or adverse event outcomes. Perioperative BPMT did not improve urinary symptoms at 6 months or prolapse outcomes at 2 years.Trial registrationclinicaltrials.gov Identifier: NCT00597935.

Published
2014

49. Urinary Microbiome Community Types Associated with Urinary Incontinence Severity in Women

Author

CARNES, Megan U., primary, SIDDIQUI, Nazema Y., additional, KARSTENS, Lisa, additional, GANTZ, Marie G., additional, DINWIDDIE, Darrell L., additional, SUNG, Vivian W., additional, BRADLEY, Megan, additional, BRUBAKER, Linda, additional, FERRANDO, Cecile A., additional, MAZLOOMDOOST, Donna, additional, RICHTER, Holly E., additional, ROGERS, Rebecca G., additional, SMITH, Ariana L., additional, and KOMESU, Yuko M., additional

Published
2023
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50. Extreme Preterm Infant Rates of Overweight and Obesity at School Age in the SUPPORT Neuroimaging and Neurodevelopmental Outcomes Cohort

Author

Jobe, Alan H., Caplan, Michael S., Polin, Richard A., Laptook, Abbot R., Hensman, Angelita M., McGowan, Elisabeth C., Vieira, Elisa, Little, Emilee, Johnson, Katharine, Alksninis, Barbara, Keszler, Mary Lenore, Knoll, Andrea M., Leach, Theresa M., Watson, Victoria E., Walsh, Michele C., Fanaroff, Avroy A., Wilson-Costello, Deanne E., Payne, Allison, Newman, Nancy S., Taylor, H. Gerry, Siner, Bonnie S., Zadell, Arlene, DiFiore, Julie, Bhola, Monika, Friedman, Harriet G., Yalcinkaya, Gulgun, Bulas, Dorothy, Goldberg, Ronald N., Cotten, C. Michael, Goldstein, Ricki F., Gustafson, Kathryn E., Ashley, Patricia, Auten, Kathy J., Fisher, Kimberley A., Foy, Katherine A., Freedman, Sharon F., Lohmeyer, Melody B., Malcolm, William F., Wallace, David K., Carlton, David P., Stoll, Barbara J., Adams-Chapman, Ira, Buchter, Susie, Piazza, Anthony J., Carter, Fritz, Sobha, Hale, Ellen C., Hutchinson, Amy K., LaRossa, Maureen Mulligan, Loggins, Yvonne, Bottcher, Diane, Archer, Stephanie Wilson, Poindexter, Brenda B., Sokol, Gregory M., Harmon, Heidi M., Papile, Lu-Ann, Hines, Abbey C., Wilson, Leslie D., Herron, Dianne E., Smiley, Lucy, Kennedy, Kathleen A., Tyson, Jon E., Duncan, Andrea Freeman, Dempsey, Allison G., John, Janice, Jones, Patrick M., Lillie, M. Layne, Siddiki, Saba, Sperry, Daniel K., Berberich, Mary Anne, Blaisdell, Carol J., Gail, Dorothy B., Kiley, James P., Wallace, Dennis, Gantz, Marie G., Newman, Jamie E., Auman, Jeanette O'Donnell, Hammond, Jane A., Poole, W. Kenneth, Van Meurs, Krisa P., Stevenson, David K., DeAnda, Maria Elena, Ball, M. Bethany, Goodlin, Gabrielle T., Frantz, Ivan D., III, Fiascone, John M., Furey, Anne, MacKinnon, Brenda L., Nylen, Ellen, Brussa, Ana, Sibley, Cecelia, Carlo, Waldemar A., Ambalavanan, Namasivayam, Peralta-Carcelen, Myriam, Collins, Monica V., Cosby, Shirley S., Phillips, Vivien A., Bailey, Kirstin J., Biasini, Fred J., Hopkins, Maria, Johnston, Kristen C., Nelson, Kathleen G., Patterson, Cryshelle S., Rector, Richard V., Rodriguez, Leslie, Soong, Amanda, Whitley, Sally, York, Sheree, Guest, Kristy, Smith, Leigh Ann, Finer, Neil N., Garey, Donna, Rasmussen, Maynard R., Wozniak, Paul R., Vaucher, Yvonne E., Fuller, Martha G., Akshoomoff, Natacha, Rich, Wade, Arnell, Kathy, Bridge, Renee, Bell, Edward F., Colaizy, Tarah T., Widness, John A., Klein, Jonathan M., Johnson, Karen J., Acarregui, Michael J., Eastman, Diane L., Wilgenbusch, Tammy L.V., Watterberg, Kristi L., Ohls, Robin K., Fuller, Janell, Lowe, Jean, Rohr, Julie, Lacy, Conra Backstrom, Montman, Rebecca, Brown, Sandra, Sánchez, Pablo J., Rosenfeld, Charles R., Salhab, Walid A., Brion, Luc, Adams, Sally S., Allen, James, Grau, Laura, Guzman, Alicia, Hensley, Gaynelle, Heyne, Elizabeth T., Hickman, Jackie F., Leps, Melissa H., Madden, Linda A., Martin, Melissa, Miller, Nancy A., Morgan, Janet S., Solis, Araceli, Lee, Lizette E., Boatman, Catherine Twell, Vasil, Diana M., Yoder, Bradley A., Faix, Roger G., Winter, Sarah, Baker, Shawna, Osborne, Karen A., Rau, Carrie A., Cunningham, Sean, Ford, Ariel, Shankaran, Seetha, Pappas, Athina, Sood, Beena G., Bara, Rebecca, Slovis, Thomas L., Billian, Elizabeth, Goldston, Laura A., Johnson, Mary, Vohr, Betty R., Heyne, Roy, Bann, Carla M., Das, Abhik, Higgins, Rosemary D., and Hintz, Susan R.

Published
2018
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