Faculty Bibliography

Objective: To compare pregnancy latency achieved with oral labetalol versus extended-release nifedipine during expectant management of preterm preeclampsia with severe features (PEC-SF).
Study Design: This is a retrospective cohort study of patients initiated on antihypertensive therapy with oral labetalol or extended-release nifedipine during admission for expectant management of PEC-SF < 34 weeks between 1/2013 and 4/2022. Those on antihypertensive therapy prior to admission or with another indication for delivery < 34 weeks were excluded (monochorionic-monoamniotic twins, higher order multiples, absent or reversed umbilical artery Dopplers). Pregnancy latency (from oral agent initiation to delivery decision) was compared between groups. Secondary outcomes included need for initial agent dose uptitration, addition of second oral agent, acute antihypertensive therapy, and delivery for refractory hypertension. Linear and modified Poisson regression models were used to estimate adjusted mean differences (AMD) with 95% confidence intervals.
Result(s): The cohort included 78 patients (Table 1). Comparing those initiated on labetalol versus extended-release nifedipine (Table 2), there was no difference in latency (6.2 (7.5) vs 5.4 (7.4) days, AMD 1.1 days, 95% CI [-2.1, 4.4]), nor in the proportion of patients achieving 1 week latency (25.0% vs 23.8%, respectively, AMD 2.9%, 95% CI [-16.5, 22.3]). Those initiated on labetalol were less likely to require a second agent (16.7% vs 38.1% for nifedipine, AMD -18.4, 95% CI [-37.3, 0.5]). There were no differences in need for initial agent uptitration, acute antihypertensive therapy, or delivery for refractory hypertension.
Conclusion(s): There was no difference in pregnancy latency among patients with PEC-SF initiated on oral labetalol versus extended-release nifedipine. Patients on labetalol may be less likely to require a second antihypertensive agent, but comparative outcome estimates may be limited by small cohort size. Further investigations with a larger cohort should be performed to evaluate for any relative advantages of the two oral agents. [Formula presented] [Formula presented]
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BACKGROUND:As people living with HIV (PLWH) experience earlier and more pronounced onset of noncommunicable diseases (NCDs), advancing integrated care networks and models in low-resource-high-need settings is critical. Leveraging current health system initiatives and addressing gaps in treatment for PLWH, we report our approach using a late-stage (T4) implementation research study to test the adoption and sustainability of a proven-effective implementation strategy which has been minimally applied in low-resource settings for the integration of hypertension control into HIV treatment. We detail our protocol for the Managing Hypertension Among People Living with HIV: an Integrated Model (MAP-IT) trial, which uses a stepped wedge cluster randomized trial (SW-CRT) design to evaluate the effectiveness of practice facilitation on the adoption of a hypertension treatment program for PLWH receiving care at primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria. DESIGN:In partnership with the Nigerian Federal Ministry of Health (FMOH) and community organizations, the MAP-IT trial takes place in 30 PHCs. The i-PARiHS framework guided pre-implementation needs assessment. The RE-AIM framework will guide post-implementation activities to evaluate the effect of practice facilitation on the adoption, implementation fidelity, and sustainability of a hypertension program, as well as blood pressure (BP) control. Using a SW-CRT design, PHCs sequentially crossover from the hypertension program only (usual care) to hypertension plus practice facilitation (experimental condition). PHCs will recruit and enroll an average of 28-32 patients to reach a maximum of 960 PLWH participants with uncontrolled hypertension who will be followed longitudinally for BP outcomes. DISCUSSION:Given the need for integrated NCD-HIV care platforms in low-resource settings, MAP-IT will underscore the challenges and opportunities for integrating hypertension treatment into HIV care, particularly concerning adoption and sustainability. The evaluation of our integration approach will also highlight the potential impact of a health systems strengthening approach on BP control among PLWH. TRIAL REGISTRATION:Clinicaltrials.gov ( NCT05031819 ). Registered on 2nd September 2021.

BACKGROUND:Low nursing home staffing in the United States is a growing safety concern. Socioeconomic deprivation in the local areas surrounding a nursing home may be a barrier to improving staffing rates but has been poorly studied. Thus, the objective of this paper was to assess the relationship between neighborhood deprivation and nursing home staffing in the United States. METHODS:This cross-sectional study used 2018 daily payroll-based staffing records and address data for 12,609 nursing homes in the United States linked with resident assessment data. Our primary exposure of interest was severe economic deprivation at the census block group (neighborhood) level, defined as an area deprivation index score ≥85/100. The primary outcome was hours worked per resident-day among nursing home employees providing direct resident care. Marginal linear regression models and generalized estimating equations with robust sandwich-type standard errors were used to estimate associations between severe neighborhood deprivation and staffing rates. RESULTS:Compared to less deprived neighborhoods, unadjusted staffing rates in facilities located within severely deprived neighborhoods were 38% lower for physical and occupational therapists, 30% lower for registered nurses (RNs), and 5% lower for certified nursing assistants. No disparities in licensed practical nurse (LPN) staffing were observed. In models with state-level and rurality fixed effects and clustered on the county, a similar pattern of disparities was observed. Specifically, RN staffing per 100 resident-days was significantly lower in facilities located within severely deprived neighborhoods as compared to those in less deprived areas (mean difference: 5.6 fewer hours, 95% confidence interval [CI] 4.2-6.9). Disparities of lower magnitude were observed for other clinical disciplines except for LPNs. CONCLUSIONS:Significant staffing disparities were observed within facilities located in severely deprived neighborhoods. Targeted interventions, including workforce recruitment and retention efforts, may be needed to improve staffing levels for nursing homes in deprived neighborhoods.

BACKGROUND:Limited data from prospective studies suggest that higher dietary intake of long-chain omega-3 polyunsaturated fatty acids (LCn3PUFA), which hold anti-inflammatory properties, may reduce endometrial cancer risk; particularly among certain subgroups characterized by body mass and tumor pathology. MATERIALS AND METHODS:Data from 12 prospective cohort studies participating in the Epidemiology of Endometrial Cancer Consortium were harmonized as nested case-control studies, including 7268 endometrial cancer cases and 26,133 controls. Habitual diet was assessed by food frequency questionnaire, from which fatty acid intakes were estimated. Two-stage individual-participant data mixed effects meta-analysis estimated adjusted odds ratios (OR) and 95% confidence intervals (CI) through logistic regression for associations between study-specific energy-adjusted quartiles of LCn3PUFA and endometrial cancer risk. RESULTS:Women with the highest versus lowest estimated dietary intakes of docosahexaenoic acid, the most abundant LCn3PUFA in diet, had a 9% increased endometrial cancer risk (Quartile 4 vs. Quartile 1: OR 1.09, 95% CI: 1.01-1.19; P trend = 0.04). Similar elevated risks were observed for the summary measure of total LCn3PUFA (OR 1.07, 95% CI: 0.99-1.16; P trend = 0.06). Stratified by body mass index, higher intakes of LCn3PUFA were associated with 12-19% increased endometrial cancer risk among overweight/obese women and no increased risk among normal-weight women. Higher associations appeared restricted to White women. The results did not differ by cancer grade. CONCLUSION:Higher dietary intakes of LCn3PUFA are unlikely to reduce endometrial cancer incidence; rather, they may be associated with small to moderate increases in risk in some subgroups of women, particularly overweight/obese women.

BACKGROUND:Short interpregnancy interval has been associated with increased risk of preterm delivery; recent studies employing within-sibship designs suggest that this risk may be exaggerated. There are unresolved issues regarding properties of this design. OBJECTIVES/OBJECTIVE:To compare directly the results, for short intervals, of between-person and within-sibship analyses when applied to the same target population. METHODS:Cross-sectional data are from the National Survey of Family Growth, a statistically representative survey of women and men in the USA, 2006-2015. Participants provided a complete pregnancy history including outcome, duration and ending date, enabling calculation of interval. Conventional analysis employed log-linear regression, controlling survey design, early life events, demographic variables, pregnancy intendedness, breastfeeding of the previous birth and obstetric history. Within-sibship analyses, utilising conditional log-linear regression, controlled the same variables, except those remaining static within each participant. RESULTS:Among participants with at least three live- or stillbirths, the percentage of pregnancies in each interval, and the percent of deliveries that were preterm following that interval were 9.2%, 14.6% for <6, and 14.7%, 15.4% for 6-11, versus 12.2%, 14.7% for 18-23 months. Among participants with at least three live- or stillborn infants, those in the within-sibship analysis had a higher risk profile than comparably parous, ineligible participants. In a between-participant analysis, among those included in within-sibship models, the adjusted risk ratios (vs 18-23 months) for preterm delivery for intervals <6 and 6-11 months were 0.74 (95% CI 0.63, 0.88) and 0.85 (95% CI 0.74, 0.98). The corresponding risk ratios were 0.56 (95% CI 0.14, 2.30) and 0.49 (95% CI 0.13, 1.80) for those ineligible for the within-sibship models. CONCLUSIONS:When comparable analyses were employed, the association between interval and preterm delivery was similar between participants included in the within-sibship analysis and those ineligible for the within-sibship analysis, but differed from those in the full cohort, perhaps due to different target populations.

BACKGROUND:Lack of access to reliable transportation is a barrier to timely receipt of prenatal care. OBJECTIVES/OBJECTIVE:We aimed to assess the impact of modernisation of non-emergency medical transportation services on patient satisfaction, prenatal care utilisation, and preterm delivery. METHODS:We conducted a randomised controlled pilot trial among pregnant Medicaid recipients in Franklin County, Ohio, a county with high rates of infant mortality. Individuals were randomly assigned to usual non-emergency medical transportation services or enhanced smart transportation (EST) services (i.e. on-demand transportation with access to a mobile application and trips to the grocery store, food bank or pharmacy). The primary outcome was satisfaction with transportation services. Secondary outcomes included adequacy of prenatal care utilisation (APNCU) and preterm delivery <37 weeks. RESULTS:Women were screened between 31 May 2019 and 30 June 2020, with 143 being eligible and enrolling. Evidence of increased satisfaction with transportation was observed in the intervention group compared to usual transportation, with 83.8% and 68.8% reporting being somewhat satisfied or very satisfied respectively [risk difference 14.78%, 95% confidence interval [CI] (0.51, 29.06). There were no meaningful differences in APNCU or preterm delivery between groups (risk difference for APNCU 2.08%, 95% CI -13.99, 18.16 and [risk difference for preterm delivery -3.87%, 95% CI -17.02, 9.29). CONCLUSIONS:We found evidence of increased transportation satisfaction among pregnant women randomly assigned to EST versus usual transportation. It remains unclear whether the provision of EST increases prenatal care utilisation or decreases preterm delivery.

OBJECTIVE: To examine whether vaginal progesterone is noninferior to 17-α hydroxyprogesterone caproate (17OHP-C) in the prevention of recurrent preterm birth (PTB). STUDY DESIGN/METHODS: This retrospective cohort study included singleton pregnancies among women with a history of spontaneous PTB who received prenatal care at a single tertiary center from 2011 to 2016. Pregnancies were excluded if progesterone was not initiated prior to 24 weeks or the fetus had a major congenital anomaly. The primary outcome was PTB <37 weeks. A priori, noninferiority was to be established if the upper bound of the adjusted two-sided 90% confidence interval (CI) for the difference in PTB fell below 9%. Inverse probability of treatment weighting (IPTW) was used to carefully control for confounding associated with choice of treatment and PTB. Adjusted differences in PTB proportions were estimated via IPTW regression, with standard errors adjustment for multiple pregnancies per woman. Secondary outcomes included PTB <34 and <28 weeks, spontaneous PTB, neonatal intensive care unit admission, and gestational age at delivery. RESULTS: = 505) were given 17OHP-C. Vaginal progesterone use was more common later in the study period, and among women who established prenatal care later, had prior PTBs at later gestational ages, and whose race/ethnicity was neither non-Hispanic white nor non-Hispanic black. Vaginal progesterone did not meet noninferiority criteria compared with 17-OHPC in examining PTB <37 weeks, with an IPTW adjusted difference of 3.4% (90% CI: -3.5, 10.3). For secondary outcomes, IPTW adjusted differences between treatment groups were generally small and CIs were wide. CONCLUSION/CONCLUSIONS: We could not conclude noninferiority of vaginal progesterone to 17OHP-C; however, women and providers may be willing to accept a larger difference (>9%) when considering the cost and availability of vaginal progesterone versus 17OHP-C. A well-designed randomized trial is needed. KEY POINTS/CONCLUSIONS:· Vaginal progesterone is not noninferior to 17OHP-C.. · PTB risk may be 10% higher with vaginal progesterone.. · Associations did not differ based on obesity status..

INTRODUCTION AND HYPOTHESIS/OBJECTIVE:Vulvovaginal symptoms following perineal laceration may be worsened by atrophy related to decreased estrogen. Our objective was to evaluate the effect of local estrogen therapy in this setting. METHODS:We conducted a single-center, pilot, randomized, placebo-controlled trial of local estradiol in primiparous women with a second-degree or greater perineal laceration following a term vaginal delivery. Participants were randomized to twice weekly estradiol or placebo cream from delivery through 3 months postpartum. The primary outcome was a validated measure of vulvovaginal symptoms at 12 weeks postpartum. Secondary outcomes included measures of perineal pain, quality of life, sexual function, ease of use, likelihood of continued use, and adverse events. RESULTS:We planned to enroll 70 women; however, due to human subjects research restrictions related to the COVID-19 pandemic, enrollment was stopped early. A total of 59 women were randomized, 31 to the estradiol group and 28 to the placebo group. Nearly all participants (95%) were followed through 12 weeks with suggestion of marginal improvement in Vulvar Assessment Scale scores [-0.10; 90% CI = (-0.20, 0.01)] in those randomized to estradiol compared to placebo. Local estradiol was not associated with improvement in other measures, and only one non-serious adverse event was observed. CONCLUSIONS:In primiparous women with a perineal laceration, use of local estradiol showed minimal clinical benefit in vulvovaginal atrophy and related symptoms but appears to be acceptable and safe for postpartum use. Larger adequately powered trials enrolling a diverse group of postpartum women are needed to affirm these findings.

Importance/UNASSIGNED:The factors associated with the failure of nonoperative management of appendicitis and the differences in patient-reported outcomes between successful and unsuccessful nonoperative management remain unknown. Objectives/UNASSIGNED:To investigate factors associated with the failure of nonoperative management of appendicitis and compare patient-reported outcomes between patients whose treatment succeeded and those whose treatment failed. Design, Setting, and Participants/UNASSIGNED:This study was a planned subgroup secondary analysis conducted in 10 children's hospitals that included 370 children aged 7 to 17 years with uncomplicated appendicitis enrolled in a prospective, nonrandomized clinical trial between May 1, 2015, and October 31, 2018, with 1-year follow-up comparing nonoperative management with antibiotics vs surgery for uncomplicated appendicitis. Statistical analysis was performed from November 1, 2019, to February 12, 2022. Interventions/UNASSIGNED:Nonoperative management with antibiotics vs surgery. Main Outcomes and Measures/UNASSIGNED:Failure of nonoperative management and patient-reported outcomes. The relative risk (RR) of failure based on sociodemographic and clinical characteristics was calculated. Patient-reported outcomes were compared based on the success or failure of nonoperative management. Results/UNASSIGNED:Of 370 patients (34.6% of 1068 total patients; 229 boys [61.9%]; median age, 12.3 years [IQR, 10.0-14.6 years]) enrolled in the nonoperative group, treatment failure occurred for 125 patients (33.8%) at 1 year, with 53 patients (14.3%) undergoing appendectomy during initial hospitalization and 72 patients (19.5%) experiencing delayed treatment failure after hospital discharge. Higher patient-reported pain at presentation was associated with increased risk of in-hospital treatment failure (RR, 2.1 [95% CI, 1.0-4.4]) but not delayed treatment failure (RR, 1.3 [95% CI, 0.7-2.3]) or overall treatment failure at 1 year (RR, 1.5 [95% CI, 1.0-2.2]). Pain duration greater than 24 hours was associated with decreased risk of delayed treatment failure (RR, 0.3 [95% CI, 0.1-1.0]) but not in-hospital treatment failure (RR, 1.2 [95% CI, 0.5-2.7]) or treatment failure at 1 year (RR, 0.7 [95% CI, 0.4-1.2]). There was no increased risk of treatment failure associated with age, white blood cell count, sex, race, ethnicity, primary language, insurance status, transfer status, symptoms at presentation, or imaging results. Health care satisfaction at 30 days and patient-reported, health-related quality of life at 30 days and 1 year were not different. Satisfaction with the decision was higher with successful nonoperative management at 30 days (28.0 vs 27.0; difference, 1.0 [95% CI, 0.01-2.0]) and 1 year (28.1 vs 27.0; difference, 1.1 [95% CI, 0.2-2.0]). Conclusions and Relevance/UNASSIGNED:This analysis suggests that a higher pain level at presentation was associated with a higher risk of initial failure of nonoperative management and that a longer duration of pain was associated with lower risk of delayed treatment failure. Although satisfaction was high in both groups, satisfaction with the treatment decision was higher among patients with successful nonoperative management at 1 year. Trial Registration/UNASSIGNED:ClinicalTrials.gov Identifier: NCT02271932.