bluuebunny/crossref_metadata_2025 huggingface dataset:
Predictors of SARS-CoV-2 RNA From Nasopharyngeal Swabs and Concordance With Other Compartments in Nonhospitalized Adults With Mild to Moderate COVID-19
Authors: Moser Carlee , Li Jonathan Z , Eron Joseph J , Aga Evgenia , Daar Eric S , Wohl David A , Coombs Robert W , Javan Arzhang Cyrus , Bender Ignacio Rachel A , Jagannathan Prasanna , Ritz Justin , Sieg Scott F , Parikh Urvi M , Hughes Michael D , Currier Judith S , Smith Davey M , Chew Kara W ,   ACTIV-2/A5401 Study Team, Hosey Lara , Roa Jhoanna , Patel Nilam , Degli-Angeli Emily , Goecker Erin , Daza Glenda , Harb Socorro , Dragavon Joan , Aldrovandi Grace , Murtaugh William , Cooper Marlene , Gutzman Howard , Knowles Kevin , Bowman Rachel , Erhardt Bill , Adams Stacey
Published: November 2022

Background

Identifying characteristics associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA shedding may be useful to understand viral compartmentalization, disease pathogenesis, and risks for viral transmission.

Methods

Participants were enrolled August 2020 to February 2021 in ACTIV-2/A5401, a placebo-controlled platform trial evaluating investigational therapies for mild-to-moderate coronavirus disease 2019 (COVID-19), and underwent quantitative SARS-CoV-2 RNA testing on nasopharyngeal and anterior nasal swabs, oral wash/saliva, and plasma at entry (day 0, pretreatment) and days 3, 7, 14, and 28. Concordance of RNA levels (copies/mL) across compartments and predictors of nasopharyngeal RNA levels were assessed at entry (n = 537). Predictors of changes over time were evaluated among placebo recipients (n = 265) with censored linear regression models.

Results

Nasopharyngeal and anterior nasal RNA levels at study entry were highly correlated (r = 0.84); higher levels of both were associated with greater detection of RNA in plasma and oral wash/saliva. Older age, White non-Hispanic race/ethnicity, lower body mass index (BMI), SARS-CoV-2 immunoglobulin G seronegativity, and shorter prior symptom duration were associated with higher nasopharyngeal RNA at entry. In adjusted models, body mass index and race/ethnicity associations were attenuated, but the association with age remained (for every 10 years older, mean nasopharyngeal RNA was 0.27 log10 copies/mL higher; P < .001). Examining longitudinal viral RNA levels among placebo recipients, women had faster declines in nasopharyngeal RNA than men (mean change, −2.0 vs −1.3 log10 copies/mL, entry to day 3; P < .001).

Conclusions

SARS-CoV-2 RNA shedding was concordant across compartments. Age was strongly associated with viral shedding, and men had slower viral clearance than women, which could explain sex differences in acute COVID-19 outcomes.
Palliative Rehabilitation in Acute Inpatient Rehabilitation: Prognostic Factors and Functional Outcomes in Patients with Cancer
Authors: Tennison Jegy M , Asher Arash , Hui David , Javle Milind , Bassett Roland L , Bruera Eduardo
Published: November 2022

Background

Prognosis has a vital role for patients with cancer undergoing palliative rehabilitation in acute inpatient rehabilitation. This study aimed to identify the proportion of patients who survived <2 months after discharge and the associated prognostic factors.

Materials and Methods

This was a secondary analysis of a retrospective study of 163 consecutive patients admitted to acute inpatient rehabilitation from September 1, 2017, to February 28, 2018 at a cancer center. Baseline demographics, clinical characteristics, and putative prognostic factors, including Activity Measure for Post-Acute Care (AM-PAC) functional scores, were analyzed.

Results

Of 163 patients, 27 (17%; 95% CI, 11-23) died within 60 days of discharge. These patients were more likely to be male (OR = 2.83; 95% CI, 1.16-6.92; P = .017); have longer hospital stays (OR = 1.02; 95% CI, 1-1.04; P = .015); receive ≥ weekly packed red blood cell (OR = 5.31; 95% CI, 1.86-15.1; P = .003) or platelet (OR = 4.57; 95% CI, 1.44-14.5; P = .014) transfusions; have lower AM-PAC daily activity scores upon discharge (OR = 0.90; 95% CI, 0.83-0.97; P = .006); and have lower AM-PAC basic mobility scores upon admission (OR = 0.91; 95% CI, 0.85-0.98; P = .018) and discharge (OR = 0.88; 95% CI, 0.82-0.94; P = <.001). Multivariate analysis showed that the male sex (OR = 2.71; 95% CI, 1.03-7.15; P = .037) was independently associated with ≤2 months survival, whereas AM-PAC basic mobility score at admission of >33 (OR = 0.24, 95% CI, 0.07-0.79; P = .022) was less likely.

Conclusion

Approximately 1 in 6 patients who completed acute inpatient rehabilitation died within 2 months of discharge, had poorer baseline functional status, and were less likely to regain function than those who lived longer.
Climate change and economic activity: evidence from US states
Authors: Mohaddes Kamiar , Ng Ryan N C , Pesaran M Hashem , Raissi Mehdi , Yang Jui-Chung
Published: November 2022

We investigate the long-term macroeconomic effects of climate change across 48 US states over the period 1963–2016 using a novel econometric strategy that links deviations of temperature and precipitation (weather) from their long-term moving-average historical norms (climate) to various state-specific economic performance indicators at the aggregate and sectoral levels. We show that climate change has a long-lasting adverse impact on real output in various states and economic sectors, and on labour productivity and employment in the United States. Moreover, in contrast to most cross-country results, our within US estimates tend to be asymmetrical with respect to deviations of climate variables (including precipitation) from their historical norms.
Transitioning unions: what constitutes a just transition for Swedish trade unions?
Authors: Gärdebo Johan
Published: November 2022

The inclusion of ‘just transition’ in the Paris Agreement in 2015 has inspired subsequent attempts, and hopes, to bridge jobs versus climate divide in attempts to decarbonize industrial society. But what are the imperatives for a just tr[ansition of the workforce? And what are the nationally defined development priorities for the creation of decent work and quality jobs? Through interviews with Swedish trade union representatives from Sweden’s three largest industrial emitters (steel, petroleum refining, cement) along with representatives at the central level, this study illustrates contrasting interpretations of what constitutes a just transition. The main tensions concern the time a climate transition is allowed to take; if policies should support local inhabitants or global concerns over climate change; why allegiances are limited to the industrial town or encompass a wider trade union movement; and whether national politics or European coordination is what makes a transition ‘just’. While central levels of Swedish trade unions understand just transition in international and intergenerational terms, local level trade unions advocate for an emplaced understanding of just transition. Given the risk of growing conflicts between different segments of trade unions over the issue of climate transition policies, a progressive alliance between the labour- and climate movements is improbable as matters stand at present.
Police Leadership 2.0.: A comprehensive systematic review of the literature
Authors: de Moura Rui Coelho , Borges Andreia , Morgado Sónia , Ramalho Nelson
Published: November 2022

Police are required to operate in complex social, political, and organizational environments. Nowadays, challenging times highlight the role that police leaders play in ensuring that the organization is effective in dealing with such environments. The purpose of this paper is to expand the systematic review of literature of Pearson-Goff and Herrington (2014, ‘Police Leadership: A Systematic Review of the Literature.’ Policing: A Journal of Policy and Practice 8(1): 14–26) by: (1) including studies after the date considered by the authors; (2) following the PRISMA-P approach to systematic reviews; and (3) include European studies. Based on 7,041 records, which ended up in 101 eligible empirical pieces, evidence supports previous findings about what are the characteristics of police leaders as well as the actions expected by them. This comprehensive systematic review also identifies additional characteristics and actions that are important nowadays in police leadership. Overall, the current study encourages future studies on the thematic, and contributes to practitioners aiming to develop continuous improvement strategies inside the police.
Effects of a mixture of Lentilactobacillus hilgardii, Lentilactobacillus buchneri, Pediococcus pentosaceus and fibrolytic enzymes on silage fermentation, aerobic stability, and performance of growing beef cattle
Authors: Nair Jayakrishnan , Yang Hee-Eun , Redman Abby-Ann , Chevaux Eric , Drouin Pascal , McAllister Tim A , Wang Yuxi
Published: November 2022

This study evaluated the effects of novel silage inoculants containing lactic acid bacteria (LAB) and fibrolytic enzymes on ensiling, aerobic stability (AS), and the performance of growing beef cattle. Whole-plant corn forage was either uninoculated (CON) or inoculated with a mixture of LAB containing (cfu g−1 fresh forage) 1.5 × 105L. hilgardii (CNCM I-4785), 1.5 × 105L. buchneri (NCIMB 40788) and 1.0 × 105P. pentosaceus (NCIMB 12455) for a total of 4.0 × 105 cfu g−1 fresh forage LAB (IB), or a combination of IB plus fibrolytic enzymes (xylanase + β-glucanase) (IC). All treatments were ensiled in mini-silos, whereas CON and IC were also ensiled in silo bags for the growth performance study. Total bacteria (TB) counts were lower (P = 0.02) for IC than CON after 14 d of ensiling, whereas TB counts of IC and IB were greater (P ≤ 0.01) than CON after 60 d of ensiling in mini-silos. The LAB in IC and IB ensiled in mini-silos were greater than CON on d 60 (P ≤ 0.01) and 90 (P ≤ 0.001) of ensiling and after 3 d (P ≤ 0.01) of aerobic exposure (AE). Silage pH of IC ensiled in silo bags was lower than CON on d 3 (P < 0.01), 7 (P < 0.001), and 14 (P = 0.02) of AE. Yeast counts were lower for IC than CON in terminal silage (P < 0.001), and after 3 (P < 0.001) and 7 d (P < 0.01) of AE. Acetate (AC) concentrations were higher (P ≤ 0.02) for IC than CON throughout AE, whereas lactate (LA) concentrations of IC were greater than CON on d 3 (P < 0.001), 7 (P < 0.01), and 14 (P < 0.001) of AE. Greater AC concentration and lower yeast counts resulted in greater (P < 0.001) stability for IC ensiled in silo bags than CON after 14 d of AE. Growth performance of steers was similar (P > 0.05) as the nutrient composition of silage was similar across diets. Improved AS of IC could potentially have a greater impact on DMI, production efficiency, and growth performance in large-scale commercial feedlot operations where silage at the silo face may be exposed to air for longer periods of time.
Obstetric and Neonatal Outcomes 1 or More Years After a Diagnosis of Breast Cancer
Authors: Jorgensen Kirsten , Nitecki Roni , Nichols Hazel B. , Fu Shuangshuang , Wu Chi-Fang , Melamed Alexander , Brady Paula , Chavez Mac Gregor Mariana , Clapp Mark A. , Giordano Sharon , Rauh-Hain J. Alejandro
Published: November 2022

OBJECTIVE:

To evaluate obstetric and neonatal outcomes of the first live birth conceived 1 or more years after breast cancer diagnosis.

METHODS:

We performed a population-based study to compare live births between women with a history of breast cancer (case group) and matched women with no cancer history (control group). Individuals in the case and control groups were identified using linked data from the California Cancer Registry and California Office of Statewide Health Planning and Development data sets. Individuals in the case group were diagnosed with stage I–III breast cancer at age 18–45 years between January 1, 2000, and December 31, 2012, and conceived 12 or more months after breast cancer diagnosis. Individuals in the control group were covariate–matched women without a history of breast cancer who delivered during 2000–2012. The primary outcome was preterm birth at less than 37 weeks of gestation. Secondary outcomes were preterm birth at less than 32 weeks of gestation, small for gestational age (SGA), cesarean delivery, severe maternal morbidity, and neonatal morbidity. Subgroup analyses were used to assess the effect of time from initial treatment to fertilization and receipt of additional adjuvant therapy before pregnancy on outcomes of interest.

RESULTS:

Of 30,021 women aged 18–45 years diagnosed with stage I–III breast cancer during 2000–2012, 553 met the study inclusion criteria. Those with a history of breast cancer and matched women in the control group had similar odds of preterm birth at less than 37 weeks of gestation (odds ratio [OR], 1.29; 95% CI 0.95–1.74), preterm birth at less than 32 weeks of gestation (OR 0.77; 95% CI 0.34–1.79), delivering an SGA neonate (less than the 5th percentile: OR 0.60; 95% CI 0.35–1.03; less than the 10th percentile: OR 0.94; 95% CI 0.68–1.30), and experiencing severe maternal morbidity (OR 1.61; 95% CI 0.74–3.50). Patients with a history of breast cancer had higher odds of undergoing cesarean delivery (OR 1.25; 95% CI 1.03–1.53); however, their offspring did not have increased odds of neonatal morbidity compared with women in the control group (OR 1.15; 95% CI 0.81–1.62).

CONCLUSION:

Breast cancer 1 or more years before fertilization was not strongly associated with obstetric and neonatal complications.
Allostatic Load and Adverse Pregnancy Outcomes
Authors: Lueth Amir J. , Allshouse Amanda A. , Blue Nathan M. , Grobman William A. , Levine Lisa D. , Simhan Hyagriv N. , Kim Jin Kyung , Johnson Jasmine , Wilson Fernando A. , Murtaugh Maureen , Silver Robert M. ,   for the National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b), and National Heart, Lung, and Blood Institute (NHLBI) nuMoM2b Heart Health Study (nuMoM2b-HHS)
Published: November 2022

OBJECTIVE:

To assess the association between allostatic load, as an estimate of chronic stress, and adverse pregnancy outcomes.

METHODS:

This was a secondary analysis of nuMoM2b (Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be), a prospective observational cohort study. Our primary exposure was dichotomous high allostatic load in the first trimester, defined as 4 or more of 12 biomarkers in the “worst” quartile. The primary outcome was a composite adverse pregnancy outcome: hypertensive disorders of pregnancy (HDP), preterm birth, small for gestational age (SGA), and stillbirth. Secondary outcomes included components of the composite. Multivariable logistic regression was used to test the association between high allostatic load and adverse pregnancy outcomes, adjusted for potential confounders. Mediation and moderation analyses were conducted to assess the role of allostatic load along the causal pathway between racial disparities and adverse pregnancy outcomes.

RESULTS:

Among 4,266 individuals, 34.7% had a high allostatic load. Composite adverse pregnancy outcome occurred in 1,171 (27.5%): 14.0% HDP, 8.6% preterm birth (48.0% spontaneous and 52.2% indicated), 11.0% SGA, and 0.3% stillbirth. After adjustment for maternal age, gravidity, smoking, bleeding in the first trimester, and health insurance, high allostatic load was significantly associated with a composite adverse pregnancy outcome (adjusted odds ratio [aOR] 1.5, 95% CI 1.3, 1.7) and HDP (aOR 2.5, 95% CI 2.0–2.9), but not preterm birth or SGA. High allostatic load partially mediated the association between self-reported race and adverse pregnancy outcomes. The association between allostatic load and HDP differed by self-reported race, but not for a composite adverse pregnancy outcome, preterm birth, or SGA.

CONCLUSION:

High allostatic load in the first trimester is associated with adverse pregnancy outcomes, particularly HDP. Allostatic load was a partial mediator between race and adverse pregnancy outcomes. The association between allostatic load and HDP differed by self-reported race.
A Bedside Test to Detect the Presence of Embryonic or Fetal Tissue in Vaginal Blood
Authors: Volovsky Michelle , Duarte Ayala Maria G. , Narayanamoorthy Sujatha , Chiware Tendai M. , Kotlyar Alexander M. , Taylor Hugh S. , Seifer David B. , Mor Amir
Published: November 2022

OBJECTIVE:

To evaluate a rapid bedside test that detects alpha-fetoprotein (AFP) and insulin-like growth factor–binding protein 1 (IGFBP-1) to identify the presence of embryonic or fetal tissue in vaginal blood.

METHOD:

This was a prospective cohort study. Reproductive-aged individuals were recruited into three groups: a negative control group consisting of nonpregnant individuals undergoing dilation and curettage (D&C) or experiencing vaginal bleeding; a positive control group of individuals with confirmed intrauterine pregnancy undergoing D&C; and the study group of pregnant individuals with first-trimester bleeding. Lateral flow immunoassay strips capable of detecting both AFP and IGFBP-1 were used to test vaginal blood for the presence of embryonic or fetal tissue.

RESULTS:

Ninety individuals were recruited: 31 in the positive control group, 23 in the negative control group, and 36 in the study group, including 12 individuals with ectopic pregnancies, 16 with active miscarriages, four with threatened miscarriages, and four with complete miscarriages. Vaginal blood from 14 of the 16 individuals with active miscarriages was correctly positive for embryonic or fetal tissue. Vaginal blood from all individuals with ectopic pregnancies, threatened miscarriages, and complete miscarriages was negative for embryonic or fetal tissue. Overall, 45 of 47 individuals with confirmed embryonic or fetal tissue in vaginal blood correctly tested positive using the test strips, a test sensitivity of 95.7% (95% CI 85.5–99.5%). Of the 43 individuals with confirmed absence of embryonic or fetal tissue in their vaginal blood, 42 were correctly negative, a test specificity of 97.7% (95% CI 87.7–99.9%).

CONCLUSION:

A rapid test strip detecting both AFP and IGFBP-1 can accurately identify the presence of embryonic or fetal tissue in vaginal blood. When positive, this could aid in diagnosing miscarriage and ruling out ectopic pregnancy at the bedside.
Association of Myomectomy With Anti-Müllerian Hormone Levels and Ovarian Reserve
Authors: Aharon Devora , Sekhon Lucky , Getrajdman Chloe , Naert Mackenzie , Hanley William , Kerr Ahmad , Ghofranian Atoosa , Hernandez-Nieto Carlos , Lee Joseph A. , Copperman Alan , Ascher-Walsh Charles
Published: November 2022

OBJECTIVE:

To assess whether open and minimally invasive myomectomy are associated with changes in postoperative ovarian reserve as measured by serum anti-müllerian hormone (AMH) level.

METHODS:

This prospective cohort study included patients who were undergoing open abdominal myomectomy that used a tourniquet or minimally invasive (robot-assisted or laparoscopic) myomectomy that used vasopressin. Serum AMH levels were collected before the procedure and at 2 weeks, 3 months, and 6 months after surgery. The mean change in AMH level at each postsurgery timepoint was compared with baseline. The effect of surgical route on the change in AMH level at each timepoint was assessed by using multivariable linear regression. A subanalysis evaluated postoperative changes in AMH levels among the open myomectomy and minimally invasive myomectomy groups individually.

RESULTS:

The study included 111 patients (mean age 37.9±4.7 years), of whom 65 underwent open myomectomy and 46 underwent minimally invasive myomectomy. Eighty-seven patients contributed follow-up data. Serum AMH levels declined significantly at 2 weeks postsurgery (mean change −0.30 ng/mL, 95% CI −0.48 to −0.120 ng/mL, P=.002). No difference was observed at 3 months or 6 months postsurgery. On multiple linear regression, open myomectomy was significantly associated with a decline in AMH level at 2 weeks postsurgery (open myomectomy vs minimally invasive myomectomy: β=−0.63±0.22 ng/mL, P=.007) but not at 3 months or 6 months. Subanalysis revealed a significant decline in mean serum AMH levels in the open myomectomy group at 2 weeks (mean change −0.46 ng/mL, 95% CI −0.69 to −0.25 ng/mL, P<.001) postsurgery but not at three or 6 months. In the minimally invasive myomectomy group, no significant differences in mean AMH levels were detected between baseline and any postoperative timepoint.

CONCLUSION:

Myomectomy is associated with a transient decline in AMH levels in the immediate postoperative period, particularly after open surgery in which a tourniquet is used. Anti-müllerian hormone levels returned to baseline by 3 months after surgery, indicating that myomectomy is not associated with a long-term effect on ovarian reserve, even with the use of a tourniquet to decrease blood loss.

FUNDING SOURCE:

This study was funded in part by a Roche Diagnostics Investigator-Initiated Study Grant.
Facilitating an Optimal Transition to Residency in Obstetrics and Gynecology
Authors: Winkel Abigail Ford , George Karen , Wagner Sarah , Schoppen Zachary , Banks Erika , Bienstock Jessica , Ogburn Tony , Marzano David , Hammoud Maya M. , Morgan Helen K.
Published: November 2022

The transition to residency in obstetrics and gynecology is difficult, threatening the well-being of residents as well as their preparedness to care for patients. In addition to essential foundational knowledge and skills, obstetrics and gynecology interns must develop professional identity and a growth mindset toward learning to acquire the self-directed learning skills required of physicians throughout their careers. The transition to residency is a critical opportunity for learning and development. A group of educators and learners from around the country created a preparedness program building on available resources. The result is a national curriculum for improving the transition to obstetrics and gynecology residency on three levels: self-directed learning, facilitated small-group workshops, and coaching. Sharing tools for preparing matched applicants for residency in obstetrics and gynecology ensures adequate residency preparation for all interns, independent of medical school attended. This program aims to address potential threats to equity in the training of our future workforce and to ensure that all obstetrics and gynecology interns are prepared to thrive in residency training.
Endometrial Hyperplasia
Authors: Ring Kari L. , Mills Anne M. , Modesitt Susan C.
Published: November 2022

The objectives of this Clinical Expert Series on endometrial hyperplasia are to review the etiology and risk factors, histologic classification and subtypes, malignant progression risks, prevention options, and to outline both surgical and nonsurgical treatment options. Abnormal uterine and postmenopausal bleeding remain the hallmark of endometrial pathology, and up to 10–20% of postmenopausal bleeding will be either hyperplasia or cancer; thus, immediate evaluation of any abnormal bleeding with either tissue procurement for pathology or imaging should be undertaken. Although anyone with a uterus may develop atypical hyperplasia, also known as endometrial intraepithelial neoplasia (EIN), genetic predispositions (eg, Lynch syndrome), obesity, chronic anovulation, and polycystic ovarian syndrome all markedly increase these risks, whereas use of oral contraceptive pills or progesterone-containing intrauterine devices will decrease the risk. An EIN diagnosis carries a high risk of concomitant endometrial cancer or eventual progression to cancer in the absence of treatment. The definitive and curative treatment for EIN remains hysterectomy; however, the obesity epidemic, the potential desire for fertility-sparing treatments, the recognition of varying rates of malignant transformation, medical comorbidities, and an aging population all may factor into decisions to employ nonsurgical treatment modalities.
Risk of Severe Postpartum Hemorrhage in Twin Pregnancies According to the Sum of Birth Weights
Authors: Loussert Lola , Schmitz Thomas , Korb Diane , Seco Aurélien , Azria Elie , Sentilhes Loïc , Goffinet François , Deneux-Tharaux Catherine ,   for the JUmeaux Mode d’Accouchement (JUMODA) study group and the Groupe de Recherche en Obstétrique et Gynécologie (GROG)
Published: November 2022

OBJECTIVE:

To characterize the strength and patterns of association between birth weights and severe postpartum hemorrhage in twin pregnancies.

METHODS:

This was a secondary analysis of the JUMODA (JUmeaux Mode d’Accouchement) cohort, a national, prospective, population-based study of twin deliveries, conducted from February 2014 to March 2015 in France. We excluded patients with a fetal death, medically indicated termination of pregnancy, antepartum hemorrhage, placenta previa, placental abruption, or missing birth weight. The primary outcome was severe postpartum hemorrhage, defined as a postpartum hemorrhage requiring at least one of the following: transfusion of 4 or more units of red blood cells, uterine artery embolization, uterine balloon tamponade, vascular ligation, uterine suture, emergency hysterectomy, admission to an intensive care unit, or postpartum hemorrhage considered severe by the obstetrician or leading to maternal death. The exposure was the sum of the birth weights of the two twins. To assess the association between the sum of twins' birth weights and severe postpartum hemorrhage, we used multilevel multivariable modified Poisson regression modeling. Analyses were conducted for the overall population and by planned and actual mode of delivery.

RESULTS:

A total of 8,373 patients were analyzed. Severe postpartum hemorrhage occurred in 4.5% (379/8,372, 95% CI 4.1–5.0), from 2.1% (15/722) for a sum of twins’ birth weights less than 3,000 g up to 8.8% (12/136) for a sum exceeding 6,500 g. In the multivariable analysis, the association between the sum of the twins’ birth weights and severe postpartum hemorrhage was linear, with an adjusted relative risk of severe postpartum hemorrhage of 1.36 (95% CI 1.24–1.49) for each 500-g increase in the sum of twins' birth weights.

CONCLUSION:

In twin pregnancies, the risk of severe postpartum hemorrhage increased linearly with the sum of the twins' birth weights.
Agreement Between Pregnant Individuals' Self-Report of Coronavirus Disease 2019 (COVID-19) Vaccination and Medical Record Documentation
Authors: Wielgosz Kristina , Dawood Fatimah S. , Stockwell Melissa S. , Varner Michael , Newes-Adeyi Gabriella , Ellington Sascha , Vargas Celibell , Bruno Ann M. , Powers Emily , Morrill Tyler , Reichle Lawrence , Battarbee Ashley N. , Tita Alan T.
Published: November 2022

For public health research such as vaccine uptake or effectiveness assessments, self-reported coronavirus disease 2019 (COVID-19) vaccination status may be a more efficient measure than verifying vaccination status from medical records if agreement between sources is high. We assessed agreement between self-reported and medical record–documented COVID-19 vaccination status among pregnant individuals followed in a cohort during August 2020–October 2021. At end of pregnancy, participants completed questionnaires about COVID-19 vaccine receipt during pregnancy; staff verified vaccination status using medical records. Agreement was assessed between self-reported and medical record vaccination status using Cohen's kappa. There was high agreement between self-reported and medical record vaccination status (Kappa coefficient=0.94, 95% CI 0.91–0.98), suggesting that self-report may be acceptable for ascertaining COVID-19 vaccination status during pregnancy.
Ultrasound-Confirmed, Age-Specific Uterine Leiomyoma Incidence in a Cohort of Black Individuals
Authors: Wegienka Ganesa , Havstad Suzanne , Coleman Chad , Cooper Tracy , Wesselink Amelia , Upson Kristen , Marsh Erica E. , Vines Anissa I. , Harmon Quaker , Baird Donna , Wise Lauren A.
Published: November 2022

OBJECTIVE:

To estimate the age-specific incidence of uterine leiomyomas identified by transvaginal ultrasonography among participants in SELF (Study of Environment, Lifestyle & Fibroids).

METHODS:

SELF is a longitudinal cohort study of individuals aged 23–35 years who self-identified as Black. Participants were recruited from the Detroit, Michigan, area and underwent up to five transvaginal ultrasonograms over a period of up to 10 years to identify uterine leiomyomas. We randomly imputed incidence dates between the last ultrasonogram date in which no leiomyomas were detected and the date of the ultrasonogram in which leiomyomas were first detected. We used Poisson regression to estimate age-specific incidence rates per 1,000 person-years with 95% CIs. The rates were then compared with those of the BWHS (Black Women's Health Study) and the NHS II (Nurses' Health Study II)—two prospective cohort studies based on self-reported leiomyoma diagnoses.

RESULTS:

In this cohort, 1,693 participants completed a baseline interview and ultrasonogram. We excluded 385 (22.7%) participants with leiomyomas detected during baseline, seven participants whose ultrasonograms were poor quality, and 60 participants with only a baseline ultrasonogram. Among the remaining 1,241 participants, the overall incidence rate was 53.9 cases per 1,000 person-years (95% CI 48.6–59.6). The age-specific incidence rates (cases/1,000 person-years) were: younger than 30 years: 49.7, 95% CI 40.9–59.9; 30–34 years: 55.2, 95% CI 47.0–64.3; and 35–39 years: 58.2, 95% CI 47.3–70.9. Among participants aged younger than 30 years, the incidence rate in SELF was more than double that of the BWHS or the NHS II.

CONCLUSION:

The high age-specific leiomyoma incidence rates in this prospective ultrasound-based study indicate that many young Black individuals with leiomyomas go undiagnosed. These data suggest that individuals could benefit from ultrasound screening when they experience symptoms compatible with leiomyomas (eg, heavy menstrual bleeding, anemia, pelvic pain).
Coronavirus Disease 2019 (COVID-19)–Related Stress and Menstrual Changes
Authors: Anto-Ocrah Martina , Valachovic Tori , Chen Michael , Tiffany Kimberly , DeSplinter Lindsey , Kaukeinen Kimberly , Glantz J. Christopher , Hollenbach Stefanie
Published: November 2022

OBJECTIVE:

To evaluate how stress related to the coronavirus disease 2019 (COVID-19) pandemic has affected women's menstrual cycles. We hypothesized that women with high levels of COVID-19–related stress would have more menstrual changes compared with those with lower levels of stress.

METHODS:

Using a cross-sectional study design, we recruited a representative sample of U.S. adult women of reproductive age (18–45 years) using nonhormonal birth control to participate in an online REDCap (Research Electronic Data Capture, Vanderbilt University) survey. COVID-19–related stress was assessed with the PSS-10-C (COVID-19 Pandemic-related Perceived Stress Scale) and dichotomized as low stress (scores lower than 25) and high stress (scores 25 or higher). Self-reported menstrual outcomes were identified as changes in cycle length, duration, or flow and increased frequency of spotting between cycles. We used χ2 and Fisher exact tests to compare differences in outcome between the two stress groups and logistic regression models for effect estimates.

RESULTS:

A total of 354 women of reproductive age across the United States completed both the menstrual and COVID-19–related stress components of our survey. More than half of these women reported at least one change in their menstrual cycles since the start of the pandemic (n=191), and 10.5% reported high COVID-19–related stress (n=37). Compared with those with low COVID-19–related stress, a greater proportion of women with high COVID-19–related stress reported changes in cycle length (shorter or longer; P=.008), changes in period duration (shorter or longer; P<.001), heavier menstrual flow (P=.035), and increased frequency of spotting between cycles (P=.006) compared with prepandemic times. After adjusting for age, smoking history, obesity, education, and mental health history, high COVID-19–related stress was associated with increased odds of changes in menstrual cycle length (adjusted odds ratio [aOR] 2.32; 95% CI 1.12–4.85), duration (aOR 2.38; 95% CI 1.14–4.98), and spotting (aOR 2.32; 95% CI 1.03–5.22). Our data also demonstrated a nonsignificant trend of heavier menstrual flow among women with high COVID-19–related stress (aOR 1.61; 95% CI 0.77–3.34).

CONCLUSION:

High COVID-19–related stress is associated with significant changes in menstrual cycle length, alterations in period duration, and increased intermenstrual spotting as compared with before the pandemic. Given that menstrual health is frequently an indicator of women's overall well-being, clinicians, researchers, and public health officials must consider the association between COVID-19–related stress and menstrual disturbances.
A literature review of the impact of exclusion criteria on generalizability of clinical trial findings to patients with chronic pain
Authors: Salmasi Vafi , Lii Theresa R. , Humphreys Keith , Reddy Vinay , Mackey Sean C.
Published: November 2022

The ability of clinical trials to inform the care of chronic pain may be limited if only an unrepresentative subset of patients are allowed to enroll. We summarize and report new insights on published studies that report on how trial exclusions affect the generalizability of their results. We conducted a PubMed search on the following terms: ((“eligibility criteria” AND generalizability) OR (“exclusion criteria” AND generalizability) OR “exclusion criteria”[ti] OR “eligibility criteria”[ti]) AND pain. We only considered studies relevant if they analyzed data on (1) the prevalence and nature of exclusion criteria or (2) the impact of exclusion criteria on sample representativeness or study results. The 4 articles that were identified reported differences in patients who were included and excluded in different clinical trials: excluded patients were older, less likely to have a paid job, had more functional limitations at baseline, and used strong opioids more often. The clinical significance of these differences remains unclear. The pain medicine literature has very few published studies on the prevalence and impact of exclusion criteria, and the outcomes of excluded patients are rarely tracked. The frequent use of psychosocial exclusions is especially compromising to generalizability because chronic pain commonly co-occurs with psychiatric comorbidities. Inclusion of more representative patients in research samples can reduce recruitment barriers and broaden the generalizability of findings in patients with chronic pain. We also call for more studies that examine the use of exclusion criteria in chronic pain trials to better understand their implications.
LncRNA Taurine Up-Regulated 1 plays a proapoptotic role by regulating nuclear-cytoplasmic shuttle of HuR under the condition of neuronal ischemia
Authors: Shi Xiaocheng , Wei Wei , Zou Yichun , Dong Lixin , Wu Hengping , Jiang Jiazhi , Li Xiang , Chen Jincao
Published: November 2022

The study aimed to identify TUG1 as an essential regulator of apoptosis in HT22 (mouse hippocampal neuronal cells) by direct interaction with the RNA-binding protein HuR. In order to study the role of TUG1 in the context of ischemia, we used mouse hippocampal neuronal cells treated with oxyglucose deprivation to establish an in-vitro ischemia model. A bioinformatic analysis and formaldehyde RNA immunoprecipitation (fRIP) were used to investigate the biological functions. A Western blot assay and reverse transcription polymerase chain reaction were used to explore the expression of the molecules involved. A cell proliferation and cytotoxicity assay was performed to detect neuronal apoptosis. TUG1 exhibits a localization-specific expression pattern in HT22 cells under OGD treatment. The bioinformatics analysis showed a strong correlation between the TUG1 and HuR as predicted, and this interaction was subsequently confirmed by fRIP-qPCR. We found that HuR was translocated from the nucleus to the cytoplasm after ischemia treatment and subsequently targeted and stabilized COX-2 mRNA, which led to elevated COX-2 mRNA levels and apoptosis of the HT22 cells. Furthermore, nuclear-specific disruption of TUG1 prevented the translocation of HuR to the cytoplasm and decreased COX-2 mRNA expression, resulting in increased cell viability and partially reversed apoptosis. In conclusion, it was demonstrated that TUG1 accelerates the process of apoptosis by promoting the transfer of HuR to the cytoplasm and stabilizing COX-2 mRNA. These results provide useful information concerning a therapeutic target for ischemic stroke.
Helicobacter colisuis sp. nov., isolated from caecal contents of domestic pigs (Sus scrofa domesticus)
Authors: Gruntar Igor , Kostanjšek Rok , Pirš Tina , Papić Bojan
Published: November 2022

Seven

Helicobacter

-like isolates were cultured from caecal contents of 100 domestic pigs (Sus scrofa domesticus) sampled as part of the EFSA-coordinated harmonized monitoring of antimicrobial resistance in

Campylobacter

sp. in 2015. The bacteria were isolated using the standard ISO 10272 procedure for the isolation of thermotolerant

Campylobacter

with extended incubation time and formed small, grey, moist and flat colonies with a metallic sheen (small

Campylobacter

-like colonies) on modified Charcoal-Cefoperazone-Deoxycholate Agar (mCCDA) and Skirow agar plates. Morphologically, the bacterial cells were spirilli-shaped and highly motile, 1–2 µm long and ≤0.5 µm wide, Gram-negative, oxidase-positive and catalase-positive. They could not be identified using the standard-prescribed biochemical tests and had uniform, unique and reproducible MALDI-TOF mass spectra that most closely matched those of

Helicobacter pullorum

. Three strains (11154-15T, 14348–15 and 16470–15) underwent whole-genome sequencing. Analysis of 16S rRNA gene sequences revealed a high similarity (≥99.8 % identity) to

Helicobacter canadensis

. Pairwise average nucleotide identity (ANI) values revealed that the three studied strains were closely related (ANI ≥98.9 %), but distinct from the previously described

Helicobacter

species (ANI ≤90.6 %). The core genome-based phylogeny confirmed that the new strains form a distinct clade most closely related to

H. canadensis

. The conducted polyphasic taxonomic analysis confirmed that the three strains represent a novel

Helicobacter

species for which the name Helicobacter colisuis sp. nov. is suggested, with strain 11154-15T (= DSM 113688T = CCUG 76053T) as the type strain.
Mathematical-structure based Morphological Classification of Skin Eruptions and Linking to the Pathophysiological State of Chronic Spontaneous Urticaria
Authors: Seirin-Lee Sungrim , Matsubara Daiki , Yanase Yuhki , Kunieda Takuma , Takahagi Shunsuke , Hide Michihiro
Published: November 2022

Chronic spontaneous urticaria (CSU) is one of the most intractable human-specific skin diseases. However, as no experimental animal model exists, the mechanism underlying disease pathogenesisin vivoremains unclear, making the establishment of a curative treatment challenging. Here, using a novel approach combining mathematical modeling,in vitroexperiments and clinical data analysis, we show that the pathological state of CSU patients can be inferred by geometric features of the skin eruptions. Based on our hierarchical mathematical modelling and the analysis of 105 CSU patient eruption pattern geometries, analyzed by six dermatologists, we demonstrate that the eruption patterns can be classified into five categories, each with distinct histamine, basophils, mast cells and coagulation factors network signatures. Furthermore, our network analysis revealed that tissue factor degradation/activation likely determines boundary/area pattern, and that the state of spontaneous histamine release from mast cells may contribute to divergence of the boundary pattern. Thus, our study not only demonstrates that pathological states of diseases can be defined by geometric features but will also facilitate more accurate decision-making to manage CSU in the clinical setting.
Evasive spike variants elucidate the preservation of T cell immune response to the SARS-CoV-2 omicron variant
Authors: Solanki Arnav , Cornette James , Udell Julia , Vasmatzis George , Riedel Marc
Published: November 2022

The Omicron variants boast the highest infectivity rates among all SARS-CoV-2 variants. Despite their lower disease severity, they can reinfect COVID-19 patients and infect vaccinated individuals as well. The high number of mutations in these variants render them resistant to antibodies that otherwise neutralize the spike protein of the original SARS-CoV-2 spike protein. Recent research has shown that despite its strong immune evasion, Omicron still induces strong T Cell responses similar to the original variant. This work investigates the molecular basis for this observation using the neural network tools NetMHCpan-4.1 and NetMHCiipan-4.0. The antigens presented through the MHC Class I and Class II pathways from all the notable SARS-CoV-2 variants were compared across numerous high frequency HLAs. All variants were observed to have equivalent T cell antigenicity. A novel positive control system was engineered in the form of spike variants that did evade T Cell responses, unlike Omicron. These evasive spike proteins were used to statistically confirm that the Omicron variants did not exhibit lower antigenicity in the MHC pathways. These results suggest that T Cell immunity mounts a strong defense against COVID-19 which is difficult for SARS-CoV-2 to overcome through mere evolution.

Author summary
Nav1.7 and Nav1.8 form supramolecular active clusters with TRKB in mouse and human DRG neurons during development of neuropathic pain
Authors: Sun Liting , Xian Hang , Shi Yunxin , Yang Taotan , Shuai Hongyan , Xia Ruilong , Wen Ting , Xia Wei , Qian Ran , Zhu Fengting , Liu Yuanying , Tian Zhicheng , Li Lamei , Cong Rui , Luo Ceng , Wu Shengxi , Shen Xiafeng , Yu Xin , Xie Rou-Gang , Peng Changgeng
Published: November 2022

Neuropathic pain affects 7-10% of the global population, and one of its characteristics is sensitization of somatosensory nervous system. Altered expression of ion channels and receptors has been found to be involved in neuronal hyperexcitability after injury to somatosensory nervous system, it is, however, unknown that if ion channels and receptors could gain qualitative changes on the level of structure organization when they are excessively expressed in same one neuron during the development of neuropathic pain. Here we show first that not only the expression of voltage-gated sodium channels Nav1.7 (SCN9A), Nav1.8 (SCN10A) and TRKB (also named NTRK2) increased in DRG neurons of patients with over 3-month severe neuropathic pain induced by brachial plexus avulsion (BPA), but also Nav1.7 and Nav1.8 formed supramolecular active clusters with or without TRKB in DRG neurons of mice with chronic neuropathic pain induced by spared nerve injury or diabetic neuropathy and of BPA pain patients with neuropathic pain. Nav1.7, Nav1.8 and TRKB might function in a coordinated manner in orderly organized supramolecular active clusters to geometrically increase the hyperexcitability of pathological DRG neurons. Our findings suggest that supramolecular active clusters of Nav1.7, Nav1.8 and TRKB might need be targeted for curing neuropathic pain, and that inhibition of both Nav1.7 and Nav1.8 might be required to achieve efficient relief of neuropathic pain.
Remote and semi-automated methods to conduct a randomized clinical trial
Authors: Cafaro Teresa , LaRiccia Patrick J. , Bandomer Brigid , Goldstein Helen , Brobyn Tracy L. , Hunter Krystal , Roy Satyajeet , Ng Kevin Q. , Mitrev Ludmil V. , Tsai Alan , Thwing Denise , Maag Mary Ann , Chung Myung K. , van Helmond Noud
Published: November 2022

Background

Designing and conducting randomized controlled trials is not possible for some institutions and researchers due to their associated costs and personnel requirements. Advances in telehealth for patient care and clinical trial methods adaptations were hastened due to the coronavirus 2019 pandemic. We conducted subject recruitment, screening, informed consent, study product distribution, and data collection remotely using Research Electronic Data Capture (REDCap) and other readily available applications for a prospective randomized clinical trial on vitamin D3 supplementation to prevent influenza-like illness in healthcare workers.

Objectives

To describe how to efficiently and cost-effectively conduct a randomized clinical trial using remote and semi-automated methods.

Methods

A previously described prospective, controlled, trial in healthcare workers at a tertiary university hospital that used Zelen’s design to facilitate enrollment is used as a model. A random group of healthcare workers were invited to participate in the study through email. Following an automated process, interested individuals could schedule a HIPAA compliant, video-facilitated consent interview. Following e-consenting, participants received vitamin D3 supplementation bottles by mail and electronic surveys via email. Adherence to the study intervention was monitored through survey data review and vitamin D3 safety was monitored via real-time automated warnings to study staff if any symptoms, health changes, hospitalizations, or pregnancies were reported on monthly surveys.

Results

A small study staff of 10 team members were able to screen 406 subjects and enroll 299 subjects over a 3-month period using completely remote methods. Adherence to vitamin D3 supplementation was high (87%) over 9 months. Survey data completeness was 98.5% over 9 months. Participants and study staff scored the system usability 93.8% and 90%, respectively. The automated and remote methods allowed the study maintenance period to be managed by a small study team staff of 2 members while safety monitoring was conducted by 3-4 team members.

Conclusions

The remote and automated methods developed to conduct a randomized controlled trial produced efficient subject recruitment with excellent study product adherence and data completeness. These methods can significantly minimize costs and time without sacrificing safety or quality, thereby offering greater equity in scientific research. We share our XML file for researchers to use as a template for learning purposes or designing their own clinical trials.

Trial Registration

NCT04596657
Effects of Postnatal Glucocorticoids on Brain Structure in Preterm Infants, A Scoping Review
Authors: Robles Isabella , Eidsness Margarita Alethea , Travis Katherine E. , Feldman Heidi M , Dubner Sarah E.
Published: November 2022

Glucocorticoids (GC) are used in neonatal intensive care units to prevent or reduce the severity of chronic lung disease in preterm infants and have been implicated in impaired neurodevelopment. Our objective was to identify what is known about the effects of postnatal GC treatment in human preterm infants on structural brain development and to identify gaps in the literature. Following Arksey and O’Malley’s scoping review methodological framework, we searched scientific literature databases for original research on human preterm infants, postnatal GCs, and brain structure. 11 studies assessed the effects of GCs on structural brain outcomes. 56 studies reported brain injury, but not structure. Dexamethasone was consistently associated with decreased total and regional brain volumes, including cerebellar volumes. Hydrocortisone was often, but not always associated with absence of brain volume differences. No studies examined the impact of inhaled GC on brain structure. Additional research on the effects of neonatal GCs after preterm birth on a variety of structural brain measures is required for understanding contributions to neurodevelopment and informing practice guidelines.