Publications by authors named "Bethany Horton"

17 Publications

  • Page 1 of 1

Optimizing Telemedicine Technologic Infrastructure with Animal Models: A Case in Telecystoscopy.

Telemed J E Health 2020 Sep 9. Epub 2020 Sep 9.

Department of Urology, University of Virginia, Charlottesville, Virginia, USA.

Rapid evolution of telemedicine technology requires procedures in telemedicine to adapt frequently. An example in urology, telecystoscopy, allows certified advanced practice providers to perform cystoscopy, endoscopic examination of the bladder, in rural areas with real-time interpretation and guidance by an off-site urologist. We have previously shown the technological infrastructure for optimized video quality. Newer models of cystoscope and coder/decoder (codec) are available with anticipation that components used in our original model will become unavailable. Our objective is to assess the diagnostic ability of two cystoscopes (Storz, Wolf) with old (SX20) and new (DX70) codecs. A single urologist performed flexible cystoscopy on an porcine bladder. Combinations of cystoscope (Storz vs. Wolf), codec (SX20 vs. DX70), and internet transmission speed were used to create eight distinct recordings. Deidentified videos were reviewed by expert urologist reviewers via electronic survey with questions on video quality and diagnostic ability. A logistic regression model was used to assess the ability to make a diagnosis. Eight transmitted cystoscopy videos were reviewed by 16 urologists. Despite new technology, the Storz cystoscope combined with the SX20 codec (the original combination) provides the best diagnostic capacity. Technical infrastructure must be routinely validated to assess the component impact on overall quality because newer is not always better. Should the SX20 become obsolete, animal models are safe, inexpensive anatomic models for testing. As technology continues to evolve, procedures in telemedicine must critically scrutinize the impact of new technologic components to uphold quality.
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September 2020

"Moving Away From Cancer" Prospective Exercise Trial for Female Rural Cancer Survivors: How Can We Step It Up?

JCO Oncol Pract 2021 Jan 2;17(1):e16-e25. Epub 2020 Sep 2.

Department of Kinesiology, Curry School of Education and Human Development, University of Virginia, Charlottesville, VA.

Purpose: This prospective trial's objective was to determine feasibility and outcomes of an exercise-based intervention for rural overweight/obese female cancer survivors.

Materials And Methods: Survivors of endometrial, breast, or ovarian cancer enrolled in a 6-month program of increased aerobic activity (30 minutes daily walking) and strength-training exercises using exercise bands (THERABAND; Akron, OH) with personalized telephone motivational coaching. Baseline demographics, anthropomorphic measurements, quality of life (QOL), fitness, and readiness to adopt exercise changes were assessed; daily steps, band use, and follow-up measurements were assessed at 3 and 6 months. Study completion was modeled using logistic regression.

Results: The mean age of the 99 women was 59.9 years, the mean body mass index (BMI) was 35.9 kg/m, 88.9% were white, and 41.4% reported current exercise. Fifty-five women (55.6%) completed the 6-month program, and 36 (36.4%) completed exercise interventions. Using logistic regression to model study completion, only baseline QOL scores (physical component summary) and mental component summary) remained significant predictors. The mean weight change was a gain (0.88 kg). Higher MCS baseline scores and prior regular exercise predicted continued exercise and increased step counts, whereas higher BMI and baseline sleep predicted decreased QOL. Top walking barriers were feeling unwell and weather; barriers to strength exercises were band dislike and pain.

Conclusion: The most significant predictor of trial completion and improved exercise outcomes was a higher baseline mental QOL. Motivation, belief in the importance of exercise, and prescribed/monitored exercise regimens were not sufficient; supportive and cognitive behavioral therapy interventions for survivors are needed to sustain uptake.
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January 2021

Blinded Comparison of Clarity, Proficiency and Diagnostic Capability of Tele-Cystoscopy Compared to Traditional Cystoscopy: A Pilot Study.

J Urol 2020 10 24;204(4):811-817. Epub 2020 Apr 24.

Urology Department, University of Virginia, Charlottesville, Virginia.

Purpose: In order to expand the availability of cystoscopy to underserved areas we have proposed using advanced practice providers to perform cystoscopy with real-time interpretation by the urologist on a telemedicine platform, termed "tele-cystoscopy." The purpose of this study is to have blinded external reviewers retrospectively compare multisite, prospectively collected video data from tele-cystoscopy with the video of traditional cystoscopy in terms of video clarity, practitioner proficiency and diagnostic capability.

Materials And Methods: Each patient underwent tele-cystoscopy by a trained advanced practice provider and traditional cystoscopy with an onsite urologist. Prospectively collected tele-cystoscopy transmitted video, tele-cystoscopy onsite video and traditional cystoscopy video were de-identified and blinded to external reviewers. Each video was evaluated and rated twice by independent reviewers and diagnostic agreement was quantified.

Results: Six tele-cystoscopy encounters were reviewed for a total of 36 assessments. Video clarity, defined by speed of transmission and image resolution, was better for onsite compared to transmitted tele-cystoscopy. Practitioner proficiency for thoroughness of inspection was rated at 92% for tele-cystoscopy and 100% for traditional cystoscopy. Confidence in identification of an abnormality was equivalent. Four of 6 videos had 100% agreement between reviewers for next action taken, indicating high diagnostic agreement. Additionally, provider performing cystoscopy and location did not statistically influence the ability to make a diagnosis or action taken.

Conclusions: This model has excellent completeness of examination, equivalent ability to identify abnormalities and external validation of action taken. This pilot study demonstrates that tele-cystoscopy may expand access to bladder cancer surveillance.
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October 2020

Consequences of Performing Parallel Dose Finding Trials in Heterogeneous Groups of Patients.

JNCI Cancer Spectr 2019 Jun 7;3(2):pkz013. Epub 2019 May 7.

Division of Translational Research and Applied Statistics, Department of Public Health Sciences, University of Virginia, Charlottesville, VA.

Patient heterogeneity, in which patients can be grouped by risk of toxicity, is a design challenge in early phase dose finding trials. Carrying out independent trials for each group is a readily available approach for dose finding. However, this often leads to dose recommendations that violate the known order of toxicity risk by group, or reversals in dose recommendation. In this manuscript, trials for partially ordered groups are simulated using four approaches: independent parallel trials using the continual reassessment method (CRM), Bayesian optimal interval design, and 3 + 3 methods, as well as CRM for partially ordered groups. Multiple group order structures are considered, allowing for varying amounts of group frailty order information. These simulations find that parallel trials in the presence of partially ordered groups display a high frequency of trials resulting in reversals. Reversals occur when dose recommendations do not follow known order of toxicity risk by group, such as recommending a higher dose level in a group of patients known to have a higher risk of toxicity. CRM for partially ordered groups eliminates the issue of reversals, and simulation results indicate improved frequency of maximum tolerated dose selection as well as treating a greater proportion of trial patients at this dose compared with parallel trials. When information is available on differences in toxicity risk by patient subgroup, methods designed to account for known group ordering should be considered to avoid reversals in dose recommendations and improve operating characteristics.
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June 2019

Shift models for dose-finding in partially ordered groups.

Clin Trials 2019 02 11;16(1):32-40. Epub 2018 Oct 11.

Division of Translational Research & Applied Statistics, Department of Public Health Sciences, The University of Virginia Health System, Charlottesville, VA, USA.

Background: Limited options are available for dose-finding clinical trials requiring group-specific dose selection. While conducting parallel trials for groups is an accessible approach to group-specific dose selection, this approach allows for maximum tolerated dose selection that does not align with clinically meaningful group order information.

Methods: The two-stage continual reassessment method is developed for dose-finding in studies involving three or more groups where group frailty order is known between some but not all groups, creating a partial order. This is an extension of the existing continual reassessment method shift model for two ordered groups. This method allows for dose selection by group, where maximum tolerated dose selection follows the known frailty order among groups. For example, if a group is known to be the most frail, the recommended maximum tolerated dose for this group should not exceed the maximum tolerated dose recommended for any other group.

Results: With limited alternatives for dose-finding in partially ordered groups, this method is compared to two alternatives: (1) an existing method for dose-finding in partially ordered groups which is less computationally accessible and (2) independent trials for each group using the two-stage continual reassessment method. Simulation studies show that when ignoring information on group frailty, using independent continual reassessment method trials by group, 30% of simulations would result in maximum tolerated dose selection that is out of order between groups. In addition, the two-stage continual reassessment method for partially ordered groups selects the maximum tolerated dose more often and assigns more patients to the maximum tolerated dose compared to using independent continual reassessment method trials within each group. Simulation results for the proposed method and the less computationally accessible approach are similar.

Conclusion: The proposed continual reassessment method for partially ordered groups ensures appropriate maximum tolerated dose order and improves accuracy of maximum tolerated dose selection, while allowing for trial implementation that is computationally accessible.
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February 2019

Risk of Major Bleeding with Ibrutinib.

Clin Lymphoma Myeloma Leuk 2018 11 1;18(11):755-761. Epub 2018 Aug 1.

Division of Hematology-Oncology, Department of Medicine and Cancer Center, University of Virginia Health System, Charlottesville, VA.

Background: The Bruton tyrosine kinase inhibitor, ibrutinib, is an effective therapy against mature B-cell malignancies. Although generally well tolerated, serious bleeding emerged during developmental clinical trials as an unexpected, although uncommon, adverse event. As the use of ibrutinib increases outside of the clinical trial setting and in patients with more comorbidities, the rate of major bleeding could be greater.

Materials And Methods: A retrospective analysis the data from all patients at our center and its regional clinics who had been prescribed ibrutinib from January 2012 to May 2016 were reviewed for demographic data, comorbid illnesses, bleeding events, and concurrent medications.

Results: We identified 70 patients. Bleeding of any grade occurred in 56% of patients, mostly grade 1 to 2 bruising and epistaxis. Major bleeding, defined as grade ≥ 3, occurred in 19% of patients, greater than previously reported. Anemia (hemoglobin < 12 g/dL; hazard ratio [HR], 5.0; 95% confidence interval [CI], 1.4-18.2; P = .02) and an elevated international normalized ratio (> 1.5; HR, 9.5; 95% CI, 2.7-33.5; P < .01) at ibrutinib initiation were associated with an increased risk of major bleeding. Of those with major bleeding, most patients were also taking an antiplatelet agent (70%), an anticoagulant (17%), or a CYP 3A4 inhibitor (7%), with 13% taking both antiplatelet and anticoagulant medications. The use of both antiplatelet and anticoagulant therapy significantly increased the risk of a major bleed event (HR, 19.2; 95% CI, 2.3-166.7; P < .01).

Conclusion: The results of the present study have demonstrated a greater rate of major bleeding with ibrutinib use in a standard clinical setting than previously reported. Patients with anemia or an elevated international normalized ratio or requiring anticoagulant and/or antiplatelet medications during ibrutinib therapy have a significantly increased risk of major bleeding. Careful consideration of the risks and benefits for this population is needed. The combination of antiplatelet and anticoagulation medications with ibrutinib therapy is of particular concern.
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November 2018

High dose-rate tandem and ovoid brachytherapy in cervical cancer: dosimetric predictors of adverse events.

Radiat Oncol 2018 Jul 16;13(1):129. Epub 2018 Jul 16.

Department of Radiation Oncology, University of Virginia School of Medicine, 1240 Lee Street, Box 800383, Charlottesville, VA, 22908, USA.

Background: Brachytherapy (BT) is a vital component of the curative treatment of locally advanced cervical cancer. The American Brachytherapy Society has published guidelines for high dose rate (HDR) BT with recommended dose limits. However, recent reports suggest lower doses may be needed to avoid toxicity. The purpose of this study is to investigate incidence and predictive factors influencing gastrointestinal (GI) and genitourinary (GU) toxicity following HDR intracavitary brachytherapy for locally advanced cervical cancer.

Methods: We retrospectively evaluated a cohort of patients with locally advanced cervical cancer who received CT-based HDR BT. Cumulative doses were calculated using the linear-quadratic model. Statistical analyses were used to investigate clinical and dosimetric predictors of GI and GU toxicity following HDR brachytherapy according to CTCAE v4.0 grading criteria.

Results: Fifty-six women with FIGO IB1 - IVA cervical cancer were included. The overall rate of any GU adverse event (Grade 1+) was 23.3% (n = 13) and severe adverse events (Grade 3+) was 7.1% (n = 4). Of those, the bladder equivalent dose in 2- Gray (Gy) fractions (EQD) D was ≥80 for three of the four patients. The overall rate of any GI adverse event was 26.8% (n = 15) and the rate of severe adverse events was 14.3% (n = 8). Of those, six of the eight patients had a rectal EQD D ≥ 65 Gy and seven patients had a sigmoid D2cc ≥ 65 Gy. Amongst clinically meaningful factors for development of adverse events (i.e. diabetes, smoking status, ovoid size, and treatment duration), there were no statistically significant prognostic factors identified.

Conclusions: Severe adverse events are observed even with adherence to current ABS guidelines. In the era of recent multi-institutional study results, our data also supports more stringent dosimetric goals. We suggest cumulative D2cc dose limits of: less than 80 Gy for the bladder and less than 65 Gy for the rectum and sigmoid.
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July 2018

The Use of Central Pathology Review With Digital Slide Scanning in Advanced-stage Mycosis Fungoides and Sézary Syndrome: A Multi-institutional and International Pathology Study.

Am J Surg Pathol 2018 06;42(6):726-734

Dermatology, Stanford University, Palo Alto.

This pathology PILOT study aims to define the role and feasibility of centralized pathology review in a cohort of 75 patients from different centers in the United States and Europe using digital slide scanning. The pathologic material from 75 patients who had been diagnosed with mycosis fungoides/Sézary syndrome and were clinically staged as IIb or above was retrieved from 11 participating centers. Each pathology reviewer was provided with the pathologic diagnosis (by the referring pathologist), and the following list of histopathologic criteria (presence or absence) from the initial report: epidermotropism, folliculotropism (FT), large cell transformation, syringotropism, and granulomas. Patients with advance stage were selected for this study as this is a population where there is significant variability in the diagnosis of pathologic prognostic and predictive biomarkers. The slides were digitally scanned with an Aperio scanner and consensus review of cases occurred when major or minor discrepancies between the referral diagnosis and central pathology review occurred. Among the 75 cases, 70 (93.3%) had a final consensus diagnosis between the 3 central review pathologists. The overall agreement between the consensus review and the referring pathologist was 60%. The overall agreement was also higher between the reviewers and consensus review, compared with the referring pathologist and consensus. 65.3% of cases had some type of discrepancy (major or minor) between the outside and consensus review. Major discrepancies were seen in 34 of 73 cases (46.6%; 73 cases indicated a yes or no response). Minor discrepancies were seen in 32 of 75 (42.7%) of cases. Most of the major discrepancies were accounted by a difference in interpretation in the presence or absence of large cell transformation or FT. Most minor discrepancies were explained by a different interpretation in the expression of CD30. We found digital slide scanning to be a beneficial, reliable, and practical for a methodical approach to perform central pathology review in the context of a large clinical prospective study.
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June 2018

Diagnostic Efficiency in Digital Pathology: A Comparison of Optical Versus Digital Assessment in 510 Surgical Pathology Cases.

Am J Surg Pathol 2018 Jan;42(1):53-59

Department of Pathology.

Prior work has shown that digital images and microscopic slides can be interpreted with comparable diagnostic accuracy. Although accuracy has been well-validated, the interpretative time for digital images has scarcely been studied and concerns about efficiency remain a major barrier to adoption. We investigated the efficiency of digital pathology when compared with glass slide interpretation in the diagnosis of surgical pathology biopsy and resection specimens. Slides were pulled from 510 surgical pathology cases from 5 organ systems (gastrointestinal, gynecologic, liver, bladder, and brain). Original diagnoses were independently confirmed by 2 validating pathologists. Diagnostic slides were scanned using the Philips IntelliSite Pathology Solution. Each case was assessed independently on digital and optical by 3 reading pathologists, with a ≥6 week washout period between modalities. Reading pathologists recorded assessment times for each modality; digital times included time to load the case. Diagnostic accuracy was determined based on whether a rendered diagnosis differed significantly from the original diagnosis. Statistical analysis was performed to assess for differences in interpretative times across modalities. All 3 reading pathologists showed comparable diagnostic accuracy across optical and digital modalities (mean major discordance rates with original diagnosis: 4.8% vs. 4.4%, respectively). Mean assessment times ranged from 1.2 to 9.1 seconds slower on digital versus optical. The slowest reader showed a significant learning effect during the course of the study so that digital assessment times decreased over time and were comparable with optical times by the end of the series. Organ site and specimen type did not significantly influence differences in interpretative times. In summary, digital image reading times compare favorably relative to glass slides across a variety of organ systems and specimen types. Mean increase in assessment time is 4 seconds/case. This time can be minimized with experience and may be further balanced by the improved ease of electronic chart access allowed by digital slide viewing, as well as quantitative assessments which can be expedited on digital images.
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January 2018

A Phase II Study of Dovitinib in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma.

Clin Cancer Res 2017 Aug 4;23(15):4138-4145. Epub 2017 Apr 4.

Wake Forest University, Winston-Salem, North Carolina.

Genetic and preclinical studies have implicated FGFR signaling in the pathogenesis of adenoid cystic carcinoma (ACC). Dovitinib, a suppressor of FGFR activity, may be active in ACC. In a two-stage phase II study, 35 patients with progressive ACC were treated with dovitinib 500 mg orally for 5 of 7 days continuously. The primary endpoints were objective response rate and change in tumor growth rate. Progression-free survival, overall survival, metabolic response, biomarker, and quality of life were secondary endpoints. Of 34 evaluable patients, 2 (6%) had a partial response and 22 (65%) had stable disease >4 months. Median PFS was 8.2 months and OS was 20.6 months. The slope of the overall TGR fell from 1.95 to 0.63 on treatment ( < 0.001). Toxicity was moderate; 63% of patients developed grade 3-4 toxicity, 94% required dose modifications, and 21% stopped treatment early. An early metabolic response based on FDG-PET scans was seen in 3 of 15 patients but did not correlate with RECIST response. gene translocation was observed and significantly correlated with overexpression of MYB but did not correlate with FGFR1 phosphorylation or clinical response to dovitinib. Dovitinib produced few objective responses in patients with ACC but did suppress the TGR with a PFS that compares favorably with those reported with other targeted agents. Future studies of more potent and selective FGFR inhibitors in biomarker-selected patients will be required to determine whether FGFR signaling is a valid therapeutic target in ACC. .
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August 2017

Quantitative Analysis of the Cellular Microenvironment of Glioblastoma to Develop Predictive Statistical Models of Overall Survival.

J Neuropathol Exp Neurol 2016 12;75(12):1110-1123

From the University of Virginia School of Medicine (JXY, FFB, JWM, BJH, JMM), Department of Biomedical Engineering, University (JXY, JMM), Department of Pathology (FFB, JWM), and Department of Public Health Sciences (BJH), Division of Translational Research and Applied Statistics, University of Virginia, Charlottesville, Virginia.

Glioblastomas, the most common primary malignant brain tumors, have a distinct tissue microenvironment. Although non-neoplastic cells contribute to glioblastoma progression, very few quantitative studies have shown the effect of tumor microenvironmental influences on patient survival. We examined relationships of the cellular microenvironment, including astrocytes, microglia, oligodendrocytes, and blood vessels, to survival in glioblastoma patients. Using histological staining and quantitative image analyses, we examined the tumor-associated parenchyma of 33 patients and developed statistical models to predict patient outcomes based on the cellular picture of the tumor parenchyma. We found that blood vessel density correlated with poorer prognosis. To examine the role of adjacent parenchymal versus higher tumor cell density bulk parenchymal tissue, we examined the glial components in these highly variable regions. Comparison of bulk and adjacent astrocytes and microglia in tissue yielded the strongest prediction of survival, with high levels of adjacent astrocytes predicted poor prognosis and high levels of microglia correlated with a better prognosis. These results indicate that parenchymal components predict survival in glioblastoma patients and in particular that the balance between reactive glial populations is important for patient prognosis.
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December 2016

Performance of toxicity probability interval based designs in contrast to the continual reassessment method.

Stat Med 2017 01 19;36(2):291-300. Epub 2016 Jul 19.

Division of Translational Research and Applied Statistics, Department of Public Health Sciences, University of Virginia, Charlottesville, VA, U.S.A.

Toxicity probability interval designs have received increasing attention as a dose-finding method in recent years. In this study, we compared the two-stage, likelihood-based continual reassessment method (CRM), modified toxicity probability interval (mTPI), and the Bayesian optimal interval design (BOIN) in order to evaluate each method's performance in dose selection for phase I trials. We use several summary measures to compare the performance of these methods, including percentage of correct selection (PCS) of the true maximum tolerable dose (MTD), allocation of patients to doses at and around the true MTD, and an accuracy index. This index is an efficiency measure that describes the entire distribution of MTD selection and patient allocation by taking into account the distance between the true probability of toxicity at each dose level and the target toxicity rate. The simulation study considered a broad range of toxicity curves and various sample sizes. When considering PCS, we found that CRM outperformed the two competing methods in most scenarios, followed by BOIN, then mTPI. We observed a similar trend when considering the accuracy index for dose allocation, where CRM most often outperformed both mTPI and BOIN. These trends were more pronounced with increasing number of dose levels. Copyright © 2016 John Wiley & Sons, Ltd.
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January 2017

The perinatal quality collaborative of North Carolina's 39 weeks project: a quality improvement program to decrease elective deliveries before 39 weeks of gestation.

N C Med J 2014 May-Jun;75(3):169-76

Perinatal Quality Collaborative of North Carolina; Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Background: Despite long-standing guidelines from the American College of Obstetricians and Gynecologists that call for avoiding elective births prior to 39 weeks of gestation, elective deliveries make up almost one-third of US births occurring in weeks 36-38. Poor outcomes are more likely for infants born electively before 39 weeks than for those born at 39 weeks. The Perinatal Quality Collaborative of North Carolina (PQCNC) undertook the 39 Weeks Project in 2009-2010 with the aim of reducing the number of early-term elective deliveries in North Carolina hospitals.

Methods: Participating hospitals (N = 33) provided retrospective data on all early-term deliveries and created new policies, or amended or enforced existing policies, to accomplish the project's goals. Project activities included in-person learning sessions, regional meetings, webinars, electronic newsletters, a secure extranet Web site where participating hospitals could share relevant materials, and individual leadership consultations with hospital teams. Hospitals submitted monthly data to PQCNC, which provided ongoing training and data analysis.

Results: Elective deliveries before 39 weeks of gestation decreased 45% over the project period, from 2% to 1.1% of all deliveries. The proportion of elective deliveries among all scheduled early-term deliveries also decreased, from 23.63% to 16.19%. There was an increase in the proportion of patients with documented evidence of medical indications for early delivery, from 62.4% to 88.2%.

Limitations: No data were collected to determine whether outcomes changed for patients whose deliveries were deferred. The project also depended on each hospital to code its own data.

Conclusion: The PQCNC's 39 Weeks Project successfully decreased the rate of early-term elective deliveries in participating hospitals.
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July 2014

Prevalence and risk factors for early, undesired weaning attributed to lactation dysfunction.

J Womens Health (Larchmt) 2014 May 21;23(5):404-12. Epub 2014 Mar 21.

1 Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine , Chapel Hill, North Carolina.

Background: Breastfeeding durations in the United States fall short of public health objectives. We sought to quantify the prevalence and identify risk factors for early, undesired weaning that mothers attribute to physiologic difficulties with breastfeeding.

Methods: We analyzed data from the Infant Feeding Practices Study (IFPS) II, a longitudinal study of US women. We defined disrupted lactation as early, undesired weaning attributed to at least two of the following three problems: breast pain, low milk supply, and difficulty with infant latch. We used logistic regression to estimate the association maternal body mass index (BMI), postpartum depressive symptoms, and disrupted lactation.

Results: Of 4,902 women enrolled in the IFPS II, we analyzed 2,335 women who reported prenatal intention and breastfeeding initiation. The prevalence of disrupted lactation was 12 per 100 women (95% confidence interval [CI] 11, 13) during the first year of life. Women in this group weaned earlier (median 1.2 months, interquartile range [IQR] 0.5-2.8) than women without disrupted lactation (median 7.0 months, IQR 2.8-2.0, p<0.01). In multivariable-adjusted (MV-adj.) models, we found increased odds of disrupted lactation among overweight (odds ratio [OR] 1.6, 95% CI 1.1-2.3) or obese (OR 1.7, 95% CI 1.2-2.6) women, compared with women with a normal pregravid BMI. Maternal depressive symptoms at 2 months, defined as Edinburgh Postnatal Depression Scale ≥13, were also associated with disrupted lactation (MV-adj. OR 1.7, 95% CI 1.1-2.7).

Conclusion: In a longitudinal sample of US women, disrupted lactation affected one in eight mothers who initiated breastfeeding. These findings underscore the need for both improved early breastfeeding support and targeted research to define the underlying pathophysiology and to determine management strategies that will enable more mothers to achieve their breastfeeding goals.
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May 2014

Standardizing nasal nitric oxide measurement as a test for primary ciliary dyskinesia.

Ann Am Thorac Soc 2013 Dec;10(6):574-81

1 Department of Pediatrics.

Rationale: Several studies suggest that nasal nitric oxide (nNO) measurement could be a test for primary ciliary dyskinesia (PCD), but the procedure and interpretation have not been standardized.

Objectives: To use a standard protocol for measuring nNO to establish a disease-specific cutoff value at one site, and then validate at six other sites.

Methods: At the lead site, nNO was prospectively measured in individuals later confirmed to have PCD by ciliary ultrastructural defects (n = 143) or DNAH11 mutations (n = 6); and in 78 healthy and 146 disease control subjects, including individuals with asthma (n = 37), cystic fibrosis (n = 77), and chronic obstructive pulmonary disease (n = 32). A disease-specific cutoff value was determined, using generalized estimating equations (GEEs). Six other sites prospectively measured nNO in 155 consecutive individuals enrolled for evaluation for possible PCD.

Measurements And Main Results: At the lead site, nNO values in PCD (mean ± standard deviation, 20.7 ± 24.1 nl/min; range, 1.5-207.3 nl/min) only rarely overlapped with the nNO values of healthy control subjects (304.6 ± 118.8; 125.5-867.0 nl/min), asthma (267.8 ± 103.2; 125.0-589.7 nl/min), or chronic obstructive pulmonary disease (223.7 ± 87.1; 109.7-449.1 nl/min); however, there was overlap with cystic fibrosis (134.0 ± 73.5; 15.6-386.1 nl/min). The disease-specific nNO cutoff value was defined at 77 nl/minute (sensitivity, 0.98; specificity, >0.999). At six other sites, this cutoff identified 70 of the 71 (98.6%) participants with confirmed PCD.

Conclusions: Using a standardized protocol in multicenter studies, nNO measurement accurately identifies individuals with PCD, and supports its usefulness as a test to support the clinical diagnosis of PCD.
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December 2013

The effect of water disinfection by-products on pregnancy outcomes in two southeastern US communities.

J Occup Environ Med 2011 Oct;53(10):1172-8

Departments of Biostatistics, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA.

Objective: To determine if exposure to disinfection by-products (DBPs) during gestation increases the risk of adverse birth outcomes, specifically term small for gestational age (SGA) birth, preterm birth (PTB), and very PTB (<32 weeks' gestation).

Methods: We used weekly measurements total trihalomethanes (TTHMs), five haloacetic acids (HAA5), and total organic halides (TOX) collected from two distribution systems to evaluate the associations between DBP concentrations and term SGA, PTB, and very PTB using logistic regression.

Results: We found no associations between DBPs and term-SGA. In the site with higher concentrations of bromine-containing DBPs, we found an association between TOX and PTB; this association was larger, though less precise, for very PTB.

Conclusions: Our results do not support an association between TTHMs or HAA5 and the birth outcomes investigated, but an association was found between increased TOX and PTB.
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October 2011

Bupivacaine injection during midurethral sling and postoperative pain: a randomized controlled trial.

Int Urogynecol J 2011 Apr 12;22(4):433-8. Epub 2011 Feb 12.

Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, 3032 Old Clinic Building, Campus Box 7570, Chapel Hill, NC 27599-7570, USA.

Introduction And Hypothesis: The aim of this study was to investigate the impact of retropubic injection of 0.125% bupivacaine during midurethral sling placement on postoperative pain.

Methods: A randomized, double-blind trial of 42 women undergoing midurethral sling for stress incontinence was conducted. The intervention group received an injection of 0.125% bupivacaine in the retropubic space prior to midurethral sling placement, while the control group received no injection. Pain scores were recorded via a 10-cm visual analog scale at 2, 6, and 24 h postoperatively.

Results: Pain scores were lower in the bupivacaine group compared to the control group at 2 h (1.9 versus 2.6, p = 0.05). Mean pain scores were similar at all other time points (all p > 0.45). Participants in both groups used similar amounts of pain medication in the hospital, except that patients in the bupivacaine group used more PO non-steroidal anti-inflammatory drugs (p = 0.047).

Conclusions: Retropubic injection of 0.125% bupivacaine at the time of midurethral sling placement decreases short-term postoperative pain.
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April 2011