A multicenter randomized trial to compare automatic versus as-needed follow-up for children hospitalized with common infections: The FAAN-C trial protocol.

INTRODUCTION: Physicians commonly recommend automatic primary care follow-up visits to children being discharged from the hospital. While automatic follow-up provides an opportunity to address postdischarge needs, the alternative is as-needed follow-up. With this strategy, families monitor their child's symptoms and decide if they need a follow-up visit in the days after discharge. In addition to being family centered, as-needed follow-up has the potential to reduce time and financial burdens on both families and the healthcare system. As-needed follow-up has been shown to be safe and effective for children hospitalized with bronchiolitis, but the extent to which hospitalized children with other common conditions might benefit from as-needed follow-up is unclear. METHODS: The Follow-up Automatically versus As-Needed Comparison (FAAN-C, or "fancy") trial is a multicenter randomized controlled trial. Children who are hospitalized for pneumonia, urinary tract infection, skin and soft tissue infection, or acute gastroenteritis are eligible to participate. Participants are randomized to an as-needed versus automatic posthospitalization follow-up recommendation. The sample size estimate is 2674 participants and the primary outcome is all-cause hospital readmission within 14 days of discharge. Secondary outcomes are medical interventions and child health-related quality of life. Analyses will be conducted in an intention-to-treat manner, testing noninferiority of as-needed follow-up compared with automatic follow-up. DISCUSSION: FAAN-C will elucidate the relative benefits of an as-needed versus automatic follow-up recommendation, informing one of the most common decisions faced by families of hospitalized children and their medical providers. Findings from FAAN-C will also have implications for national quality metrics and guidelines.

Impact of Local Tailoring on Acute Stroke Care in 21 Disparate Emergency Departments: A Prospective Stepped Wedge Type III Hybrid Effectiveness-Implementation Study.

BACKGROUND: Faster delivery of tPA (tissue-type plasminogen activator) results in better health outcomes for eligible patients with stroke. Standardization of stroke protocols in emergency departments (EDs) has been difficult, especially in nonstroke centers. We measured the effectiveness of a centrally led implementation strategy with local site tailoring to sustain adherence to an acute stroke protocol to improve door-to-needle (DTN) times across disparate EDs in a multihospital health system. METHODS: Prospective, type III hybrid effectiveness-implementation cohort study measuring performance at 21 EDs in Utah and Idaho (stroke centers [4]/nonstroke centers [17]) from January 2018 to February 2020 using a nonrandomized stepped-wedge design, monthly repeated site measures and multilevel hierarchical modeling. Each site received the implementation strategies in 1 of 6 steps providing control and intervention data. Co-primary outcomes were percentage of DTN times ≤60 minutes and median DTN time. Secondary outcomes included percentage of door-to-activation of neurological consult times ≤10 minutes and clinical effectiveness outcomes. Results were stratified between stroke and nonstroke centers. RESULTS: A total of 855 474 ED patient encounters occurred with 5325 code stroke activations (median age, 69 [IQR, 56-79] years; 51.8% female patients]. Percentage of door-to-activation times ≤10 minutes increased from 47.5% to 59.9% (adjusted odds ratio, 1.93 [95% CI, 1.40-2.67]). A total of 615 patients received tPA of ≤3 hours from symptom onset (median age, 71 [IQR, 58-80] years; 49.6% female patients). The percentage of DTN times ≤60 minutes increased from 72.5% to 86.1% (adjusted odds ratio, 3.38, [95% CI, 1.47-7.78]; stroke centers (77.4%-90.0%); nonstroke centers [59.3%-72.1%]). Median DTN time declined from 46 to 38 minutes (adjusted median difference, -9.68 [95% CI, -17.17 to -2.20]; stroke centers [41-35 minutes]; nonstroke centers [55-52 minutes]). No differences were observed in clinical effectiveness outcomes. CONCLUSIONS: A centrally led implementation strategy with local site tailoring led to faster delivery of tPA across disparate EDs in a multihospital system with no change in clinical effectiveness outcomes including rates of complication. Disparities in performance persisted between stroke and nonstroke centers.

Clinical Impact of Multiplex Molecular Diagnostic Testing in Children With Acute Gastroenteritis Presenting to an Emergency Department: A Multicenter Prospective Study.

BACKGROUND: Multiplex molecular diagnostic panels have greatly enhanced detection of gastrointestinal pathogens. However, data on the impact of these tests on clinical and patient-centered outcomes are limited. METHODS: We conducted a prospective, multicenter, stepped-wedge trial to determine the impact of multiplex molecular testing at 5 academic children's hospitals on children presenting to the emergency department with acute gastroenteritis. Caregivers were interviewed on enrollment and 7-10 days after enrollment to determine symptoms, risk factors, subsequent medical visits, and impact on family members. During the pre-intervention period, diagnostic testing was performed at the clinician's discretion . During the intervention period, multiplex molecular testing was performed on all children, with results available to clinicians. The primary outcome was return visits to a healthcare provider within 10 days of enrollment. RESULTS: Potential pathogens were identified by clinician-ordered tests in 19 of 571 (3.3%) in the pre-intervention period compared with 434 of 586 (74%) in the intervention period; clinically relevant pathogens were detected in 2.1% and 15%, respectively. In the multivariate model, the intervention was associated with a 21% reduction in the odds of any return visit (odds ratio, 0.79; 95% confidence interval, .70-.90) after adjusting for potential confounders. Appropriate treatment was prescribed in 11.3% compared with 19.6% during the intervention period (P = .22). CONCLUSIONS: Routine molecular multiplex testing for all children who presented to the ED with acute gastroenteritis detected more clinically relevant pathogens and led to a 21% decrease in return visits. Additional research is needed to define patients most likely to benefit from testing. Clinical Trials Registration. NCT02248285.

Examining the Relationship Between Individual Patient Factors and Substantial Clinical Benefit From Telerehabilitation Among Patients With Chronic Low Back Pain.

OBJECTIVE: The coronavirus disease-2019 pandemic has facilitated the emergence of telerehabilitation, but it is unclear which patients are most likely to respond to physical therapy provided this way. The purpose of this study was to examine the relationship between individual patient factors and substantial clinical benefit from telerehabilitation among a cohort of patients with chronic low back pain (LBP). METHODS: This is a secondary analysis of data collected during a prospective longitudinal cohort study. Patients with chronic LBP (N = 98) were provided with a standardized physical therapy protocol adapted for telerehabilitation. We examined the relationship between patient factors and substantial clinical benefit with telerehabilitation, defined as a ≥50% improvement in disability at 10 weeks, measured using the Oswestry Disability Index. RESULTS: Sixteen (16.3%) patients reported a substantial clinical benefit from telerehabilitation. Patients reporting substantial clinical benefit from telerehabilitation had lower initial pain intensity, lower psychosocial risk per the STarT Back Screening Tool, higher levels of pain self-efficacy, and reported higher therapeutic alliance with their physical therapist compared to other patients. CONCLUSION: Patients with lower psychosocial risk and higher pain-self efficacy experienced substantial clinical benefit from telerehabilitation for chronic LBP more often than other patients in our cohort. Therapeutic alliance was higher among patients who experienced a substantial clinical benefit compared to those who did not. IMPACT: This study indicates that psychosocial factors play an important role in the outcomes of patients receiving telerehabilitation for chronic LBP. Baseline psychosocial screening may serve as a method for identifying patients likely to benefit from this approach.

A randomized, double-blinded, placebo-controlled clinical trial of sterile filtered human amniotic fluid for treatment of COVID-19.

IMPORTANCE: Acellular human amniotic fluid (hAF) is an antimicrobial and anti-inflammatory fluid that has been used to treat various pro-inflammatory conditions. In a feasibility study, we have previously demonstrated that hAF could be safely administered to severely ill patients with coronavirus disease-19 (COVID-19). The impact of acellular hAF on markers of systemic inflammation and clinical outcomes during COVID-19 infection remain unknown. OBJECTIVE: To determine the safety and efficacy of acellular, sterile processed intravenously administered hAF on markers of systemic inflammation during COVID-19. DESIGN, SETTINGS AND PARTICIPANTS: This single-center Phase I/II randomized, placebo controlled clinical trial enrolled adult (age ≥ 18 years) patients hospitalized for respiratory symptoms of COVID-19, including hypoxemia, tachypnea or dyspnea. The study was powered for outcomes with an anticipated enrollment of 60 patients. From 09/28/2020 to 02/04/2022 we enrolled and randomized 47 (of an anticipated 60) patients hospitalized due to COVID-19. One patient withdrew consent after randomization but prior to treatment. Safety outcomes to 30 days were collected through hospital discharge and were complete by the end of screening on 6/30/2022. INTERVENTIONS: Intravenous administration of 10 cc sterile processed acellular hAF once daily for up to 5 days vs placebo. MAIN OUTCOME AND MEASURES: Blood biomarkers of inflammation, including C-Reactive protein (CRP), lactate dehydrogenase, D-dimer, and interleukin-6 (IL-6), as well as safety outcomes. RESULTS: Patients who were randomized to hAF (n = 23) were no more likely to have improvements in CRP from baseline to Day 6 than patients who were randomized to placebo (n = 24) hAF: -5.9 [IQR -8.2, -0.6] vs placebo: -5.9 [-9.4, -2.05]; p = 0.6077). There were no significant differences in safety outcomes or adverse events. Secondary measures of inflammation including lactate dehydrogenase, D-dimer and IL-6 were not statistically different from baseline to day 6. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial involving hospitalized patients with COVID-19, the intravenous administration of 10 cc of hAF daily for 5 days did not result in statistically significant differences in either safety or markers of systemic inflammation compared to placebo, though we did not achieve our enrollment target of 60 patients. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov as #NCT04497389 on 04/08/2020.

Clinical Impact of Multiplex Molecular Diagnostic Testing in Children with Acute Gastroenteritis Presenting to An Emergency Department: A Multicenter Prospective Study.

Background: Multiplex molecular diagnostic panels have greatly enhanced detection of gastrointestinal pathogens. However, data on the impact of these tests on clinical and patient-centered outcomes are limited. Methods: We conducted a prospective, multicenter, stepped-wedge trial to determine the impact of multiplex molecular testing at five academic children's hospitals in children presenting to the ED with acute gastroenteritis. Caregivers were interviewed on enrollment and again 7-10 days after enrollment to determine symptoms, risk factors, subsequent medical visits, and impact on family members. During the pre-intervention period, diagnostic testing was performed at the discretion of clinicians. During the intervention period, multiplex molecular testing was performed on all children with results available to clinicians. Primary outcome was return visits to a health care provider within 10 days of enrollment. Results: Potential pathogens were identified by clinician ordered tests in 19/571 (3.3%) in the pre-intervention period compared to 434/586 (74%) in the intervention period; clinically relevant pathogens were detected in 2.1% and 15% respectively. In the multivariate model adjusting for potential confounders, the intervention was associated with a 21% reduction in the odds of any return visit (OR 0.79; 95% CI 0.70-0.90). Appropriate treatment was prescribed in 11.3% compared to 19.6% during the intervention period(P=0.22). Conclusions: Routine molecular multiplex testing for all children presenting to the ED with AGE detected more clinically relevant pathogens and led to a 21% decrease in return visits. Additional research is needed to define patients most likely to benefit from testing.

Identifying Perceptions, Experiences, and Recommendations of Telehealth Physical Therapy for Patients With Chronic Low Back Pain: A Mixed Methods Survey.

OBJECTIVE: To describe concerns, advantages, and disadvantages encountered in an evidence-based physical therapy (PT) program for persons with chronic low back pain (CLBP) delivered by telehealth. DESIGN: Mixed methods survey and semistructured interview of persons with CLBP. SETTING: Prospective observational cohort study of persons with CLBP from 3 health care systems receiving 8 sessions of evidence-based telehealth PT. PARTICIPANTS: Participants were selected after completing week 10 (from baseline) assessment from an ongoing cohort study. We enrolled 31 of 126 participants (mean age, 42.4 years; 71.0% female) from the cohort study (N=31). INTERVENTIONS: Participants had completed 8 sessions of evidence-based telehealth PT and participated in semistructured interviews. MAIN OUTCOME MEASURES: Baseline and week 10 and 26 assessments assessed psychosocial risk (StarTBack Screening Tool), working alliance (Working Alliance Inventory-Short Form), pain (Oswestry Disability Index), and health-related quality of life (Patient-Reported Outcomes Measurement Information System-29 profile, version 2). Semistructured interviews were conducted by telephone and consisted of open-ended questions assessing perception, satisfaction, and likelihood of recommending telehealth PT. Participants identified advantages and disadvantages to telehealth PT. Interviews were recorded, transcribed, and coded using an iterative qualitative process. Statistical comparisons by experience were made using analysis of variance (continuous) and Fisher exact test (categorical). RESULTS: Compared with the negative experience group (n=5), participants in positive (n=16) and neutral (n=10) experience groups endorsed higher bond working alliance with their therapist. Participants with a positive experience were more likely to view telehealth PT as cost-saving (n=10, 62.5%) compared with those with a neutral (n=1, 10.0%) or negative (n=1, 20.0%) experience and less likely to view telehealth PT as lower quality (n=0, 0.0%; n=1, 10.0%; n=2, 40.0%, respectively). Prior to starting telehealth, based on semistructured interviews, 18 participants (58.1%) had concerns and these persisted after starting in half of this group. Concerns regarded telehealth being different from or inferior to in-person PT, lack of physical correction, and worries of not using technology appropriately. Convenience, time savings, and personalization were seen as advantages. Difficulty making a personal connection with the therapist, lack of physical correction, and problems with technology were seen as disadvantages. Many participants endorsed a hybrid approach that included in-person and telehealth PT. Providing necessary equipment and technology assistance was seen as ways to improve telehealth PT experience. CONCLUSIONS: Telehealth is an acceptable modality to deliver PT for patients with CLBP with most having a positive experience and reporting advantages. Improvements could include offering a hybrid approach (in-person and telehealth combined) and providing necessary equipment and technical support. More research is needed to optimize the most effective strategies for providing telehealth PT for patients with CLBP.

Outcomes of Telehealth Physical Therapy Provided Using Real-Time, Videoconferencing for Patients With Chronic Low Back Pain: A Longitudinal Observational Study.

OBJECTIVE: To describe the feasibility of an evidence-based physical therapy (PT) program for persons with chronic low back pain (LBP) originally designed for in-person delivery, adapted for telehealth using videoconferencing. DESIGN: Prospective, longitudinal cohort. SETTING: Three health care systems in the United States. PARTICIPANTS: Adults, aged 18-64 years (N=126), with chronic LBP recruited from August through December 2020. INTERVENTION: Up to 8 weekly sessions of telehealth PT. MAIN OUTCOME MEASURES: Follow-up assessments were 10 and 26 weeks after baseline. Participant outcomes collected were the Oswestry Disability Index, Patient-Reported Outcomes Measurement Information System-29 health domains, and pain self-efficacy. Implementation outcomes included acceptability, adoption, feasibility, and fidelity assessed using participant surveys and compliance with session attendance. RESULTS: We enrolled 126 participants (mean age, 51.5 years; 62.7% female). Baseline perceptions about telehealth were generally positive. Eighty-eight participants (69.8%) initiated telehealth PT, with a median of 5 sessions attended. Participants in telehealth PT were generally satisfied (76.3%), although only 39.5% perceived the quality equal to in-person PT. Telehealth PT participants reported significant improvement in LBP-related disability, pain intensity, pain interference, physical function, and sleep disturbance at 10- and 26-week follow-ups. CONCLUSIONS: The findings generally support the feasibility of telehealth PT using videoconferencing. Implementation and participant outcomes were similar to in-person PT as delivered in the participating health care systems. We identified barriers that may detract from the patient experience and likelihood of benefitting from telehealth PT. More research is needed to optimize and evaluate the most effective strategies for providing telehealth PT for patients with chronic LBP.

Breastfeeding Attitudes and Practices in a Rural Utah Navajo Community.

OBJECTIVES: Despite known health benefits of breastfeeding, the Navajo have low reported frequency of breastfeeding initiation and support. We evaluated breastfeeding frequencies and practices in the predominately Navajo community of rural San Juan County, Utah, to identify factors that affect breastfeeding decisions and duration. METHODS: We performed retrospective chart review for 135 infants aged 0 to 12 months, and surveys of 85 mothers of infants aged 0 to 2 years, and eight primary care providers. We characterized demographic factors using counts/percentages and medians/inter-quartile ranges, and compared mothers who breastfed for 6 months or less versus greater than 6 months. RESULTS: In 96 infants with complete feeding documentation, 86 infants (90%) received some breast milk and 36 infants (38%) were exclusively breastfed at age 2 months. In 67 infants with complete feeding documentation at ≥ 6 months, 22 infants (33%) were exclusively breastfed 6 months. Most mothers knew about breastfeeding benefits. In 56 mothers whose infants were aged ≥ 6 months at the time of the survey, breastfeeding for more than 6 months had been planned by 44 mothers (79%) but performed by only 29 mothers (52%). Mothers who breastfed for > 6 months were more likely to have been influenced by WIC and less likely to have introduced formula at an early age. Barriers to breastfeeding included maternal pain, latch difficulties, and concerns about inadequate milk supply. Primary care providers reported limited confidence in providing breastfeeding support but would support telehealth-driven interventions. CONCLUSIONS FOR PRACTICE: Practical, culturally sensitive interventions, including telehealth and improved provider education, may improve breastfeeding outcomes and community health in this underserved population.

Hospital Outcomes of Infants with Neonatal Opioid Withdrawal Syndrome at a Tertiary Care Hospital with High Rates of Concurrent Nonopioid (Polysubstance) Exposure.

OBJECTIVE: Neonatal opioid withdrawal syndrome (NOWS) describes infants' withdrawal signs and symptoms after birth due to an interruption of prenatal opioid exposure. Many infants with NOWS are also exposed to nonopioids, however. This study was to determine hospital outcomes of infants exposed to opioids alone or coexposed with nonopioid substances (polysubstance). STUDY DESIGN: We reviewed infants of ≥34 weeks of gestation with prenatal opioid exposure from April 2015 to May 2018. We compared the median lengths of stay (LOS) and treatment (LOT) and the percentages of infants requiring pharmacologic and adjunctive treatment in infants exposed to opioids alone or polysubstance. We used Wilcoxon's test for continuous outcomes or Chi-squared test for categorical outcomes to determine statistical significance. We used multivariable regression model to calculate each drug category's estimates of adjusted mean ratios for LOS and LOT plus estimates of adjusted odds ratios for pharmacologic/adjunctive treatments. RESULTS: Of the 175 infants, 33 (19%) infants had opioid exposure alone. Opioid exposure included short- and/or long-acting opioids. A total of 142 (81%) had polysubstance exposure with 47% of mothers using nicotine products. We saw similar hospital outcomes between infants exposed to opioids alone or polysubstance; however, a higher percentage of infants with both short- and long-acting opioid exposure required pharmacologic treatment compared with either opioid alone. Focusing on individual drug categories, we detected differential hospital outcomes in which short-acting opioids decreased LOT, whereas long-acting opioids increased LOS, LOT, and need for pharmacologic and adjunctive treatment. Coexposure of opioids with stimulants decreased LOT and reduced need for adjunctive treatment. Coexposures with antidepressants increased LOT, while with antiepilepetics increased LOS. CONCLUSION: Because infants with NOWS often have coexposures to other nonopioid substances, appreciating the associated risks of individual or combination of drugs in modulating hospital outcomes may help counsel families on their infants' expected hospital course. KEY POINTS: · Hospital outcomes were similar between infants exposed to opioids alone or polysubstance including opioids.. · Infants with short- and long-acting opioids required pharmacologic treatment more often than either opioid alone.. · Differential hospital outcomes exist for various co-exposures of opioids with nonopioids..

Vitamin D, bone density, and nephrocalcinosis in preterm infants: a prospective study.

BACKGROUND: Vitamin D (VitD) supplementation is recommended by the American Academy of Pediatrics (AAP) for preterm infants to improve bone density. Complications of VitD supplementation include hypercalciuria and nephrocalcinosis (NC). NC has been reported in 7-64% infants < 32 weeks gestational age (GA) or < 1500 g birth weight (BW). The relationships between VitD supplementation, serum 25-hydroxy VitD levels, bone density, hypercalciuria and development of NC in preterm infants are not well established. METHODS: Prospective, observational cohort study of 56 infants with GA ≤ 32 weeks or BW ≤ 1800 g. Demographics, dietary intakes, serum 25-hydroxy VitD levels and weekly urinalyses were collected until 40 weeks corrected GA or discharge. Bone mineral density (BMD) and content (BMC) were assessed using dual-energy X-ray absorptiometry (DEXA) scan. NC was identified by kidney ultrasound. RESULTS: 56 infants received on average 447 IU/day of VitD with average serum 25-hydoxy VitD level 39.6 ng/mL. DEXA scan showed average BMD 0.13 g/cm2 and BMC 35.8 g. 23/56 (41%) infants were diagnosed with NC. Infants with NC had lower GA (p < 0.01) and BW (p < 0.01) and increased presence of calcium oxalate crystals (78% vs. 36%) (p = 0.002). There were no differences in VitD intake, urine calcium/creatinine ratios or BMD and BMC in infants with versus without NC. CONCLUSIONS: VitD supplementation per AAP guidelines resulted in acceptable serum 25-hydroxyVitD levels, but no improvement in BMD or BMC compared to previously reported values. However, infants receiving recommended amounts born at earlier GA and lower BW are at increased risk of NC. VitD supplementation and serum levels should be closely monitored in this high-risk population. A higher resolution version of the Graphical abstract is available as Supplementary information.

Perceptions of Telehealth Physical Therapy Among Patients with Chronic Low Back Pain.

Background: Coronavirus disease 2019 prompted the rapid adoption of telehealth to provide physical therapy. Patients' perceptions about telehealth physical therapy are mostly unknown. This study describes perceptions of telehealth physical therapy among patients with chronic low back pain (LBP). Methods: This study surveyed participants in an ongoing multisite clinical trial of nonpharmacological LBP treatments. Participants were asked about their willingness to use telehealth for physical therapy and with other providers and completed the PROMIS-29. Results: Surveys were received from 102 participants (mean age = 48.5 [standard deviation; SD = 11.6]). Thirty-six (35.3%) expressed willingness to receive telehealth physical therapy, 22 were neutral (21.6%), and 44 were unwilling (43.1%). The percentage expressing willingness for telehealth physical therapy was lower than it was for family medicine (p < 0.001) or mental health (p < 0.001). Older (p = 0.049) and Black participants (p = 0.01) more likely expressed willingness to use telehealth for physical therapy. Conclusion: Education and familiarity may help patients view telehealth physical therapy more favorably. Clinical Trial Registration (clinicaltrials.gov NCT03859713).

Physical activity in the early postpartum period in primiparous women.

Little is known about early postpartum physical activity (PA). OBJECTIVES: We aimed to describe PA amount and types and compare moderate-vigorous PA (MVPA) at 12-25 (T1) and 33-46 days (T2) postpartum. DESIGN: Cross-sectional study. METHODS: Participants, primiparas delivered vaginally, wore wrist accelerometers and completed questionnaires. Median and interquartile range (IQR) describe minutes/day of PA intensities in total minutes, 5- and 10-minute bouts. Wilcoxon Signed Rank test compared MVPA. RESULTS: 577 (age: 28.3 (SD: 5.1)) had accelerometry or questionnaire at either time-point. 405 had accelerometry at both time-points. Median (IQR) total minutes/day for light, moderate, vigorous and MVPA were 295.8 (256.1-331.7), 54.6 (40-72.7), 0.4 (0.2-0.8), and 55.5 (40.4-74.3), respectively, at T1 and 329 (289.4-367.1), 63.6 (46.9-82.2), 0.6 (0.3-1.3), and 64.5 (47-84.8), respectively, at T2. Median (IQR) minutes/day for MVPA in 5- and 10-minute bouts were 1.6 (0-5.5) and 0 (0-3.8) at T1, and 3 (0-9.2) and 0 (0-5.5) at T2. At T1, 75% (406/541) and at T2, 72.4% (397/548) reported non-impact activities. At T1, 4% and at T2, 13% reported impact/straining activities. MVPA was greater at T2 than T1 (p < 0.0001) with medians (IQR) of: total: 64.7 (47-84.6) vs 56.5 (41-74.9) minutes; 5-minute bouts: 3 (0-9.8) vs 1.7 (0-5.6) minutes; and 10-minute bouts: 1.3(0-6) vs 0(0-3.8) minutes. CONCLUSIONS: Women had high daily MVPA, though MVPA in bouts remained low. Significant increases in MVPA from T1 to T2 were small, few women reported impact/straining activities. Realistic return to pre-pregnancy PA levels should recognize the relative lack of sustained/strenuous activity in early postpartum.

Habitus and Pelvic Floor Symptoms and Support 1 Year Postpartum.

OBJECTIVE: To estimate the association between habitus measures and pelvic floor support and symptoms in primiparous women 1 year after term vaginal delivery. METHODS: In this cross-sectional study including women enrolled at seven academic and community sites, we assessed pelvic floor support, weight, height, waist circumference, and percent fat using air displacement plethysmography and participants completed questionnaires, all at one year postpartum. We tested the association of quintiles of habitus measure, including body mass index (BMI), waist circumference, percent body fat, and waist/height ratio, with the primary outcomes: anatomic support, dichotomized as maximal vaginal descent less than 0 cm (better support) compared with 0 cm or more (worse support) per the pelvic organ prolapse quantification examination and symptom burden (positive with bothersome symptoms in two or more of six symptom domains), and on five secondary outcomes. The sample size provides 90% power to detect odds ratios (ORs) of 1.78 or greater between women at mean compared with mean+1 SD of habitus measure. RESULTS: Of 592 participants, 55 (9.3%) demonstrated worse support and 321 (54.2%) symptom burden. In multivariable analyses, habitus measures were not significantly associated with anatomic support or, except for the highest waist/height ratio quintile, with symptom burden. Compared with women in the first quintile of each habitus measure, those in most higher quintiles demonstrated elevated odds of moderate to severe urinary incontinence (UI); increased odds for stress urinary incontinence (SUI) were mainly limited to the highest quintile. After adjusting for percent body fat, the increased odds for BMI on SUI (OR 2.47, 95% CI 1.43-4.28) were no longer significant (OR 1.38, 95% CI 0.54, 3.51). CONCLUSION: Habitus in primiparous patients at 1 year postpartum was not associated with anatomic support or symptom burden. Habitus was more associated with moderate to severe UI than mild UI. The association of higher BMI with SUI was attenuated by fitness, reflected by fat percentage.

Early postpartum physical activity and pelvic floor support and symptoms 1 year postpartum.

BACKGROUND: Risks of pelvic organ prolapse and urinary incontinence increase after the first vaginal delivery. During the early postpartum period, a time of active regeneration and healing of the pelvic floor, women may be particularly vulnerable to greater pelvic floor loading. OBJECTIVE: This prospective cohort study aimed to determine whether objectively measured moderate to vigorous physical activity in the early postpartum period predicts pelvic floor support and symptoms 1 year after the first vaginal birth. STUDY DESIGN: We enrolled nulliparous women in the third trimester, later excluding those who had a cesarean or preterm delivery. Participants wore triaxial wrist accelerometers at 2 to 3 weeks and 5 to 6 weeks postpartum for ≥4 days. Primary outcomes, assessed 1 year postpartum, included (1) pelvic floor support on Pelvic Organ Prolapse Quantification examination, dichotomized as maximal vaginal descent of <0 cm (better support) vs ≥0 cm (worse support); and (2) pelvic floor symptom burden, considered positive with report of ≥1 bothersome symptom in ≥2 of 6 domains, assessed using the Epidemiology of Prolapse and Incontinence Questionnaire. The primary predictor was average daily moderate to vigorous physical activity. Because we could not eliminate women with pelvic floor changes before pregnancy, we modeled prevalence, rather than risk, ratios for each outcome using modified Poisson regression. RESULTS: Of 825 participants eligible after delivery, 611 completed accelerometry and 1-year follow-up; 562 completed in-person visits, and 609 completed questionnaires. The mean age was 28.9 years (standard deviation, 5.01). The mean for moderate to vigorous physical activity measured in minutes per day was 57.3 (standard deviation, 25.4) and 68.1 (standard deviation, 28.9) at 2 to 3 weeks and 5 to 6 weeks, respectively. One year postpartum, 53 of 562 participants (9.4%) demonstrated worse vaginal support and 330 of 609 participants (54.2%) met criteria for pelvic floor symptom burden. In addition, 324 (53.1%), 284 (46.6%), 144 (23.6%), and 25 (4.1%) reported secondary outcomes of stress urinary incontinence, overactive bladder, anal incontinence, and constipation, respectively, and 264 (43.4%), 250 (41.0%), and 89 (14.6%) reported no, mild, or moderate to severe urinary incontinence, respectively. The relationship between moderate to vigorous physical activity and outcomes was not linear. On the basis of plots, we grouped quintiles of moderate to vigorous physical activity into 3 categories: first and second quintiles combined, third and fourth quintiles combined, and fifth quintile. In final multivariable models, compared with women in moderate to vigorous physical activity quintiles 3 and 4, those in the lower 2 (prevalence ratio, 0.55; 95% confidence interval, 0.31-1.00) and upper quintile (prevalence ratio, 0.70; 95% confidence interval, 0.35-1.38)) trended toward lower prevalence of worse support. However, we observed the reverse for symptom burden: compared with women in quintiles 3 and 4, those in the lower 2 (prevalence ratio, 1.20; 95% confidence interval, 1.02-1.41) and upper quintile prevalence ratio 1.34 (95% confidence interval, 1.11-1.61) demonstrated higher prevalence of symptom burden. Moderate to vigorous physical activity did not predict any of the secondary outcomes. The presence of a delivery factor with potential to increase risk for levator ani muscle injury did not modify the effect of moderate to vigorous physical activity on outcomes. CONCLUSION: Except for support, which was worse in women with moderately high levels of activity, early postpartum moderate to vigorous physical activity was either protective or had no effect on other parameters of pelvic floor health. Few women performed substantial vigorous activity, and thus, these results do not apply to women performing strenuous exercise shortly after delivery.

Differences in Pelvic Floor Symptoms During Pregnancy Between Hispanic and Non-Hispanic White Women.

OBJECTIVES: This study aimed to describe and compare pelvic floor symptoms and symptom burden between nulliparous Hispanic and non-Hispanic white women in the third trimester of pregnancy and to determine, in women with stress urinary incontinence (SUI), whether bother differs between groups, adjusted for UI severity. METHODS: In this cross-sectional analysis, participants completed the Epidemiology of Prolapse and Incontinence and Incontinence Severity Index questionnaires. We compared differences in symptom domains between groups using logistic regression and tested the effect of ethnicity on bother in women with SUI using linear regression. RESULTS: The sample comprised 418 non-Hispanic white and 154 Hispanic women. Prevalence rates of symptom domains ranged from 5.0% and 7.1% for pelvic organ prolapse to 95.2% and 94.2% for overactive bladder in non-Hispanic white and Hispanic women, respectively. After adjusting age, height, weight, education, physical activity, and gestational age, non-Hispanic whites had 2.37-fold increased odds (95% confidence interval, 1.44-3.92) for defecatory dysfunction and had nonsignificant increases in other symptom domains. Non-Hispanic whites were more likely to endorse symptoms in 3 or more domains than Hispanic women (58.9% vs 40.3%, respectively; P = 0.0001). Given the same UI severity (Incontinence Severity Index), Hispanic women with SUI reported 7.5 points greater bother (Epidemiology of Prolapse and Incontinence) than non-Hispanic white women (P = 0.07). CONCLUSIONS: After adjustment, we found few differences in the prevalence of pelvic floor symptom domains between Hispanic and non-Hispanic white women, apart from defecatory dysfunction. If differences by ethnicity in other pelvic floor symptoms exist, they do not seem to originate during the first pregnancy.

Stillbirth Associated With Infection in a Diverse U.S. Cohort.

OBJECTIVE: To better characterize infection-related stillbirth in terms of pathogenesis and microbiology. METHODS: We conducted a secondary analysis of 512 stillbirths in a prospective, multisite, geographically, racially and ethnically diverse, population-based study of stillbirth in the United States. Cases underwent evaluation that included maternal interview, chart abstraction, biospecimen collection, fetal autopsy, and placental pathology. Recommended evaluations included syphilis and parvovirus serology. Each case was assigned probable and possible causes of death using the INCODE Stillbirth Classification System. Cases where infection was assigned as a probable or possible cause of death were reviewed. For these cases, clinical scenario, autopsy, maternal serology, culture results, and placental pathology were evaluated. RESULTS: For 66 (12.9%) cases of stillbirth, infection was identified as a probable or possible cause of death. Of these, 36% (95% CI 35-38%) were categorized as a probable and 64% (95% CI 62-65%) as a possible cause of death. Infection-related stillbirth occurred earlier than non-infection-related stillbirth (median gestational age 22 vs 28 weeks, P=.001). Fetal bacterial culture results were available in 47 cases (71%), of which 35 (53%) grew identifiable organisms. The predominant species were Escherichia coli (19, 29%), group B streptococcus (GBS) (8, 12%), and enterococcus species (8, 12%). Placental pathology revealed chorioamnionitis in 50 (76%), funisitis in 27 (41%), villitis in 11 (17%), deciduitis in 35 (53%), necrosis in 27 (41%), and viral staining in seven (11%) cases. Placental pathology found inflammation or evidence of infection in 65 (99%) cases and fetal autopsy in 26 (39%) cases. In infection-related stillbirth cases, the likely causative nonbacterial organisms identified were parvovirus in two (3%) cases, syphilis in one (2%) case, cytomegalovirus (CMV) in five (8%) cases, and herpes in one (2%) case. CONCLUSION: Of infection-related stillbirth cases in a large U.S. cohort, E coli, GBS, and enterococcus species were the most common bacterial pathogens and CMV the most common viral pathogen.

Trajectories of lower back, upper back, and pelvic girdle pain during pregnancy and early postpartum in primiparous women.

OBJECTIVE: Most studies about truncal pain during and after pregnancy focus on low back pain, few prospectively define change in pain, and even fewer evaluate pain in all three major truncal areas: upper back, lower back, and pelvic girdle. Thus, the objective of this prospective cohort study was to describe, in primiparous women delivered vaginally, prevalence rates and severities of upper back, lower back, and pelvic girdle pain during pregnancy and 6-10 weeks postpartum and to describe the trajectory of pain constellations between time points. STUDY DESIGN: Participants completed questionnaires at each time point. Pain intensity was rated on a visual analogue scale ranging from 0 to 100. RESULTS: Of the 288 participants, 94% reported truncal pain during pregnancy, while 75% did so postpartum. Prevalence rates of upper back, lower back, and pelvic girdle pain with or without other types of pain during pregnancy were 42%, 77%, and 74% and postpartum were 43%, 52%, and 41%, respectively. Pain severity was highest for women endorsing pain in three locations (median 55-60). Of women with the most common pain constellation during pregnancy, lower back and pelvic girdle (32%), 18% had persistent low back and pelvic girdle pain postpartum, 20% had no pain, and the remainder had pain in a different location. Of women with pain in all three locations during pregnancy (27%), 34% had persistent pain in three locations postpartum, 13% had no pain, and the remainder had pain in at least one location. CONCLUSION: More women experience pain in a constellation of locations than in a single location. Severity increases as number of pain sites increase. Women with pain in three sites during pregnancy are least likely to have pain resolve. Interventions should focus on the entire trunk and not simply one site of pain.

Neonatal Outcomes Associated with Umbilical Cord Milking in Preterm Multiple Gestations.

OBJECTIVE: Our aim was to evaluate the effect of umbilical cord milking on outcomes for preterm multiples. STUDY DESIGN: We implemented a policy of cord milking in neonates born at less than 30 weeks' gestation in September 2011. We compared cord milking in multiples with a historical cohort. Multivariable logistic regression models estimated the effect of cord milking on a composite neonatal adverse outcome. Secondary outcomes were hematocrit at birth, need for blood transfusion, and inotrope use. RESULTS: We identified 149 neonates (120 twins, 29 triplets), 51 historical controls, and 98 neonates with cord milking. Cord milking was associated with a lower rate of adverse composite neonatal outcome in univariable analysis (odds ratio [OR]: 0.36; 95% confidence interval [CI]: 0.15-0.84). However, in multivariable modeling, the effect was not significant (adjusted OR [aOR]: 0.54, 95% CI: 0.23-1.28). Hematocrit was 4.6 unit % (95% CI: 2-7.3) higher in the cord milking group, and cord milking was associated with a lower rate of blood transfusion (aOR: 0.28; 95% CI: 0.1-0.74; p = 0.01). There was no difference in inotrope administration. CONCLUSION: Umbilical cord milking was not associated with a decrease in composite neonatal adverse outcome. However, we observed an increase in hematocrit and decreased need for blood transfusion in neonates with cord milking.

Economic Burden of Home Antimicrobial Therapy: OPAT Versus Oral Therapy.

BACKGROUND: There is increasing evidence that outpatient parenteral antimicrobial therapy (OPAT) is overused for children and that outcomes with oral therapy are equivalent. Our objective was to compare economic burden between OPAT and oral therapy, accounting for direct and indirect costs and caregiver quality of life (QoL). METHODS: We conducted a prospective cohort study of caregivers for children after hospitalization who were treated with prolonged antimicrobial therapy. We collected data about missed work and school and time spent administering therapy. Caregivers completed the Pediatric Quality of Life Inventory to assess QoL. Clinical information included length of stay, treatment indication, and type of therapy (OPAT versus oral therapy). Direct medical costs were obtained by using a microcosting system and accounted for medication, supplies, and home-nursing visits. The primary cost outcome was the mean daily cost of therapy. Multivariable models were developed to adjust for potential confounders. RESULTS: Two hundred and twelve caregivers completed surveys: 123 (58%) for oral therapy and 89 (42%) for OPAT. Caregivers administering OPAT reported more missed work, missed school for their children, time with daily medication administration (90 vs 6 minutes; P < .01) and lower QoL scores (77.8 vs 68.9) than caregivers administering oral therapy. The mean daily cost was $65 (95% confidence interval: $51-$78) for OPAT and $7 (95% confidence interval: $4-$9) for oral therapy. Relative differences in cost and QoL between groups did not change after model adjustment. CONCLUSIONS: The overall burden of OPAT is substantially higher than that of oral therapy, including higher direct and indirect costs and greater impact on caregiver QoL. These findings strongly support efforts to use oral therapy in place of OPAT when clinically appropriate.