bluuebunny/crossref_metadata_2025 huggingface dataset:
High-Dose Compared With Standard-Dose Oxytocin Regimens to Augment Labor in Nulliparous Women
Authors: Son Moeun , Roy Archana , Stetson Bethany T. , Grady Nancy Tunney , Vanecko Mary Clare , Bond Nicole , Swanson Kate , Grobman William A. , Miller Emily S. , Peaceman Alan M.
Published: May 2021

OBJECTIVE:

To evaluate whether a high-dose oxytocin regimen reduces the risk for primary cesarean birth and other obstetric morbidities when compared with standard dosing.

METHODS:

In a double-blind randomized clinical trial of nulliparous women at or beyond 36 weeks of gestation who were undergoing augmentation of labor, participants were assigned to high-dose (initial and incremental rates of 6 milliunits/min) or standard-dose (initial and incremental rates of 2 milliunits/min) oxytocin regimens. The primary outcome was cesarean birth. Prespecified secondary outcomes included labor duration, clinical chorioamnionitis, endometritis, postpartum hemorrhage, Apgar score 3 or less at 5 minutes, umbilical artery acidemia, neonatal intensive care unit admission, perinatal death, and a severe perinatal morbidity composite. A sample size of 501 per group (n=1,002) was planned to detect a 6.6% absolute reduction in rate of the primary outcome, from 20% in the standard-dose group to 13.4% in the high-dose group with 80% power.

RESULTS:

From September 2015 to September 2020, 1,003 participants were randomized—502 assigned to high-dose and 501 assigned to standard dosing. The majority of participants were of White race, were married or living as married, and had commercial insurance. Baseline characteristics between groups were similar. The primary outcome occurred in 14.5% of those receiving high-dose compared with 14.4% of those receiving standard-dose oxytocin (relative risk, 1.01; 95% CI 0.75–1.37). The high-dose group had a significantly shorter mean labor duration (9.1 vs 10.5 hours; P<.001), and a significantly lower chorioamnionitis incidence (10.4% vs 15.6%; relative risk, 0.67; 95% CI 0.48–0.92) compared with standard dosing. Umbilical artery acidemia was significantly less frequent in the high-dose group in complete case analysis, but this finding did not persist after multiple imputation (relative risk, 0.55; 95% CI 0.29–1.04). There were no significant differences in other secondary outcomes.

CONCLUSION:

Among nulliparous participants who were undergoing augmentation of labor, a high-dose oxytocin regimen, compared with standard dosing, did not affect the cesarean birth risk but significantly reduced labor duration and clinical chorioamnionitis frequency without adverse effects on perinatal outcomes.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT02487797.
Fractionated Carbon Dioxide Laser for the Treatment of Vulvar Lichen Sclerosus
Authors: Mitchell Leia , Goldstein Andrew T. , Heller Debra , Mautz Theodora , Thorne Chelsea , Joyce Kong So Yeon , Sophocles Maria E. , Tolson Hillary , Krapf Jill M.
Published: May 2021

OBJECTIVE:

To estimate the efficacy of fractionated carbon dioxide (CO2) laser therapy for vulvar lichen sclerosus.

METHODS:

We conducted a prospective, double-blind, randomized, sham-controlled, trial conducted in a clinic specializing in vulvar disorders. The study participants were 40 women with active vulvar lichen sclerosus confirmed with biopsy who were abstaining from topical and systemic treatments for at least 4 weeks before enrollment. Women were randomized in a 1:1 ratio to receive either five sham laser treatments or five fractionated CO2 treatments in a 24-week period. Study participants, treating clinicians, and the evaluating pathologist were blinded. The primary endpoint was the change in the histopathology scale score between pretreatment and posttreatment biopsies. We estimated 20 per group for 80% power to detect a 40% reduction in the histopathology scale score with up to 10% attrition. A secondary endpoint was the change in the validated CSS (Clinical Scoring System for Vulvar Lichen Sclerosus).

RESULTS:

From November 2018 to June 2020, 40 women were randomized to participate in the trial, and 37 women (19 fractionated CO2, 18 sham) were included in an intention-to-treat (ITT) analysis. Three women were excluded from the ITT analysis because they did not have posttreatment biopsies and, therefore, a posttreatment histopathology scale score could not be obtained. There was a 0.20 reduction (improvement) in histopathology scale score from baseline in the active treatment group (95% CI −1.1, 0.80, P=.74) and a 0.1 increase from baseline in the sham treatment group (95% CI −0.90, 1.0, P=.91). The change in histopathology scale score between the active and sham arm was not statistically significant (95% CI −1.14, 1.06, P=.76).

CONCLUSION:

Fractionated CO2 is not an effective monotherapy treatment for vulvar lichen sclerosus.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT03665584.

FUNDING SOURCE:

Additional funding for this study was supplied by El.En Group, Florence, Italy, the manufacturer of the laser used in this study. In addition, El.En Group supplied the laser used in the study.
Risk Factors for Axial Symptoms After Anterior Surgery Treating for Multilevel Cervical Disorder with kyphosis
Authors: Wang Tao , Ding Wen-Yuan
Published: May 2021

Study Design.

A retrospective study.

Objective.

The aim of this study was to investigate the risk factors associated with axial symptoms (AS) after anterior surgery in treatment of multilevel cervical disorder with kyphosis based on subgroup of follow-up time.

Summary of Background Data.

Although many scholars reported on AS after cervical surgery, the risk factors associated with AS are controversial. Few studies have investigated the risk factors of AS after anterior cervical surgery treating multilevel cervical disorder with kyphosis.

Methods.

Totally, 103 patients who suffered from multilevel cervical disorder with kyphosis receiving anterior surgery from July 2015 to June 2017 were reviewed for clinical and radiological outcomes. These data were collected at the time of before surgery, 1 week, 3 months, 6 months, 1 year, and 2 years after surgery. Data were performed to compare between the patients with and without AS.

Results.

In our study, the occurrence of AS was 46.6%, 34.0%, 20.4%, 12.6%, and 10.7% at the time of 1 week, 3 months, 6 months,1 year, and 2 years after surgery, respectively. Our findings showed that patients with smoking, disease duration, preoperative Modic changes (Mcs), post-operative Cobb angle of C2–7, cervical range of motion (ROM) and T1 slope, and change of Cobb angle of C2–7, cervical ROM and T1 slope were associated with AS within 1 year after surgery. However, patients with smoking and preoperative Mcs were found to be risk factors associated with AS at at any follow-up.

Conclusion.

In the present study, many factors were related to AS during 1-year after surgery. What's more, patients with smoking and preoperative Mcs were associated with AS at any follow-up. We hope this article can provide a reference for spinal surgeons to predict which patients were susceptible to suffer from AS after anterior surgery in treatment of multilevel cervical disorder with kyphosis.

Level of Evidence: 3
Comparison of Surgical Outcomes After Open- and Double-Door Laminoplasties for Patients with Cervical Ossification of the Posterior Longitudinal Ligament
Authors: Nagoshi Narihito , Yoshii Toshitaka , Egawa Satoru , Sakai Kenichiro , Kusano Kazuo , Nakagawa Yukihiro , Hirai Takashi , Wada Kanichiro , Katsumi Keiichi , Fujii Kengo , Kimura Atsushi , Furuya Takeo , Kanchiku Tsukasa , Nagamoto Yukitaka , Oshima Yasushi , Nakashima Hiroaki , Ando Kei , Takahata Masahiko , Mori Kanji , Nakajima Hideaki , Murata Kazuma , Matsunaga Shunji , Kaito Takashi , Yamada Kei , Kobayashi Sho , Kato Satoshi , Ohba Tetsuro , Inami Satoshi , Fujibayashi Shunsuke , Katoh Hiroyuki , Kanno Haruo , Watanabe Kota , Imagama Shiro , Koda Masao , Kawaguchi Yoshiharu , Takeshita Katsushi , Nakamura Masaya , Matsumoto Morio , Yamazaki Masashi , Okawa Atsushi
Published: May 2021

Study Design.

A prospective multicenter study.

Objective.

To evaluate and compare the surgical outcomes after open-door (OD) and double-door (DD) laminoplasties in subjects with cervical ossification of the posterior longitudinal ligament (OPLL).

Summary of Background Data.

Although previous studies compared clinical results after OD and DD laminoplasties, they were performed at a single institution with a relatively small sample size targeting mixed pathologies, including cervical spondylotic myelopathy.

Methods.

This study was performed by the Japanese Multicenter Research Organization for Ossification of the Spinal Ligament. A total of 478 patients with myelopathy caused by cervical OPLL from 28 institutions were prospectively registered from 2014 to 2017 and followed up for 2 years. Of these, 41 and 164 patients received OD and DD laminoplasties, respectively. Demographic information, medical history, and imaging findings were collected. Clinical outcomes were assessed using the cervical Japanese Orthopaedic Association, Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire, and visual analog scale scores.

Results.

Age, sex, symptom duration, and comorbidities were not significantly different between the groups. Segmental ossification was the most frequent in both the groups. No significant differences in K-line type, canal occupying ratio, C2 to C7 angles, and range of motion were found. Both the procedures reduced the cervical range of motion postoperatively. A comparable frequency of perioperative complications was observed between the groups. The cervical Japanese Orthopaedic Association scores showed a similar improvement at 2 years postopera- tively. The reduction in visual analog scale score for neck pain was favorable in the OD group (P = 0.02), while other pain assessments did not show any significant differences between the groups. The functional outcomes assessed using the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire presented equivalent effective rates.

Conclusion.

The results demonstrated almost comparable surgical outcomes between OD and DD laminoplasties. Lamino- plasty is a valuable technique as a therapeutic option for cervical OPLL.

Level of Evidence: 2
Biomechanical Investigation of Lumbar Interbody Fusion Supplemented with Topping-off Instrumentation Using Different Dynamic Stabilization Devices
Authors: Fan Wei , Guo Li-Xin
Published: May 2021

Study Design.

A biomechanical comparison study using finite element method.

Objective.

The aim of this study was to investigate effects of different dynamic stabilization devices, including pedicle-based dynamic stabilization system (PBDSS) and interspinous process spacer (ISP), used for topping-off implants on biomechanical responses of human spine after lumbar interbody fusion.

Summary of Background Data.

Topping-off stabilization technique has been proposed to prevent adjacent segment degeneration following lumbar spine fusion. PBDSS and ISP are the most used dynamic stabilizers for topping-off instrumentation. However, biomechanical differences between them still remain unclear.

Methods.

A validated, normal FE model of human lumbosacral spine was employed. Based on this model, rigid fusion at L4–L5 and moderately disc degeneration at L3–L4 were simulated and used as a comparison baseline. Subsequently, Bioflex and DIAM systems were instrumented at L3–L4 segment to construct PBDSS-based and ISP-based topping-off models. Biomechanical responses of the models to bending moments and vertical vibrational excitation were computed using FE static and random response analyses, respectively.

Results.

Results from static analysis showed that at L3–L4, the response parameters including annulus stress and range of motion were decreased by 41.6% to 85.2% for PBDSS-based model and by 6.3% to 67% for ISP-based model compared with rigid fusion model. At L2–L3, these parameters were lower in ISP-based model than in PBDSS-based model. Results from random response analysis showed that topping-off instrumentation increased resonant frequency of spine system but decreased dynamic response of annulus stress at L3–L4. PBDSS-based model generated lower dynamic stress than ISP-based model at L3–L4, but the dynamic stress was higher at L2–L3 for PBDSSbased model.

Conclusion.

Under static and vibration loadings, the PBDSSbased topping-off device (Bioflex) provided a better protection for transition segment, and likelihood of degeneration of supraadjacent segment might be relatively lower when using the ISPbased topping-off device (DIAM).

Level of Evidence: 5
Diagnostic Accuracy of SSEP Changes During Lumbar Spine Surgery for Predicting Postoperative Neurological Deficit
Authors: Chang Robert , Reddy Rajiv P. , Coutinho Dominic V. , Chang Yue-Fang , Anetakis Katherine M. , Crammond Donald J. , Balzer Jeffrey R. , Thirumala Parthasarathy D.
Published: May 2021

Study Design.

This study is a meta-analysis of prospective and retrospective studies identified in PubMed, Web of Science, and Embase with outcomes of patients who received intraoperative somatosensory-evoked potential (SSEP) monitoring during lumbar spine surgery.

Objective.

The objective of this study is to determine the diagnostic accuracy of intraoperative lower extremity SSEP changes for predicting postoperative neurological deficit. As a secondary analysis, we evaluated three subtypes of intraoperative SSEP changes: reversible, irreversible, and total signal loss.

Summary of Background Data.

Lumbar decompression and fusion surgery can treat lumbar spinal stenosis and spondylolisthesis but carry a risk for nerve root injury. Published neurophysiological monitoring guidelines provide no conclusive evidence for the clinical utility of intraoperative SSEP monitoring during lumbar spine surgery.

Methods.

A systematic review was conducted to identify studies with outcomes of patients who underwent lumbar spine surgeries with intraoperative SSEP monitoring. The sensitivity, specificity, and diagnostic odds ratio (DOR) were calculated and presented with forest plots and a summary receiver operating characteristic curve.

Results.

The study cohort consisted of 5607 patients. All significant intraoperative SSEP changes had a sensitivity of 44% and specificity of 97% with a DOR of 22.13 (95% CI, 11.30–43.34). Reversible and irreversible SSEP changes had sensitivities of 28% and 33% and specificities of 97% and 97%, respectively. The DORs for reversible and irreversible SSEP changes were 13.93 (95% CI, 4.60–40.44) and 57.84 (95% CI, 15.95–209.84), respectively. Total loss of SSEPs had a sensitivity of 9% and specificity of 99% with a DOR of 23.91 (95% CI, 7.18–79.65).

Conclusion.

SSEP changes during lumbar spine surgery are highly specific but moderately sensitive for new postoperative neurological deficits. Patients who had postoperative neurological deficit were 22 times more likely to have exhibited intraoperative SSEP changes.

Level of Evidence: 2
Oral Midodrine Administration During the First 24 Hours of Sepsis to Reduce the Need of Vasoactive Agents: Placebo-Controlled Feasibility Clinical Trial
Authors: Lal Amos , Trivedi Vrinda , Rizvi Mahrukh S. , Amsbaugh Amy , Myers Melissa K , Saleh Khaled , Kashyap Rahul , Gajic Ognjen
Published: May 2021

Objectives:

Our preliminary data and observational studies suggested an increasing “off label” use of oral midodrine as a vasopressor sparing agent in various groups of critically ill patients, including those with sepsis. We designed this clinical trial to evaluate the feasibility of use of midodrine hydrochloride in early sepsis to reduce the duration for IV vasopressors and decrease ICU and hospital length of stay.

Design:

Pilot, two-center, placebo-controlled, double blinded randomized clinical trial.

Setting:

Medical ICUs at Mayo Clinic Rochester and Cleveland Clinic Abu Dhabi were the study sites.

Patients and Methods:

Adult patients (≥ 18 yr old) were included within 24 hours of meeting the Sepsis-3 definition if the mean arterial pressure remained less than 70 mm Hg despite receiving timely antibiotics and initial IV fluid bolus of 30 cc/kg.

Intervention:

Three doses of 10 mg midodrine versus placebo were administered.

Measurements and Main Results:

Total 32 patients were randomized into midodrine (n = 17) and placebo groups (n = 15). There were no major differences in baseline variables between the groups except for higher baseline creatinine in the midodrine group (2.0 ± 0.9 mg/dL) versus placebo group (1.4 ± 0.6 mg /dL), p = 0.03. The median duration of IV vasopressor requirement was 14.5 ± 8.1 hours in midodrine group versus 18.8 ± 7.1 hours in the placebo group, p value equals to 0.19. Patients in the midodrine group needed 729 ± 963 norepinephrine equivalent compared with 983 ± 1,569 norepinephrine equivalent in the placebo group, p value equals to 0.59. ICU length of stay was 2.29 days (interquartile range, 1.65–3.9 d) in the midodrine group, compared with 2.45 days (interquartile range, 1.6–3.2 d) in the placebo group, p value equals to 0.36. No serious adverse events were observed in either group.

Conclusions:

Phase II clinical trial powered for clinical outcomes (duration of vasopressor use, need for central venous catheter, and ICU and hospital length of stay) is justified.
A Quality Improvement Initiative to Increase Completion and Documentation of Advanced Directives in the ICU at a U.S. Community Teaching Hospital
Authors: Walter Kristin L. , Joehl Hillarie E. , Alrifai Taha , Varghese Thomas G. , Tyler Matthew J.
Published: May 2021

Objectives:

Advance directives can help guide care in the ICU. As a healthcare quality improvement initiative, we sought to increase the percentage of patients with a healthcare power of attorney and/or practitioner orders for life-sustaining treatment in our ICU and to increase medical resident experience with advance directives through routine screening and documentation of advance directives in the ICU.

Design:

Prospective analysis.

Setting:

Urban U.S. community teaching hospital.

Patients:

All patients admitted to the ICU from September 2018 to February 2019.

Interventions:

Internal medicine residents in the ICU received a lecture about advance directives and instructions to screen their patients for advance directives. For willing and decisional patients, residents facilitated the creation of a healthcare power of attorney and/or practitioner orders for life-sustaining treatment. Residents were anonymously surveyed at the beginning and end of the ICU rotation about their experience and level of comfort with healthcare power of attorney and practitioner orders for life-sustaining treatment completion.

Measurements and Main Results:

Three-hundred seventy-five patients were admitted to the ICU during the study period. Healthcare power of attorney documents were generated by 34% of all ICU patients without a prior healthcare power of attorney, increased from a baseline rate of 10% (p < 0.001). The number of practitioner orders for life-sustaining treatment documents for patients with code status of “no cardiopulmonary resuscitation” did not increase significantly. The percentage of residents who facilitated completion of a healthcare power of attorney document increased significantly from 56% to 100% (p < 0.001), whereas their practitioner orders for life-sustaining treatment experience did not change significantly by the end of their ICU rotation. On a Likert scale of 0–10, mean resident comfort increased significantly both with healthcare power of attorney documentation, rising from 6.14 to 8.84 (p = 0.005) and with practitioner orders for life-sustaining treatment form completion, increasing from 6.00 to 7.84 (p = 0.008).

Conclusions:

Training ICU medical residents to routinely screen for and facilitate completion of advance directives significantly increased the percentage of ICU patients with a healthcare power of attorney and significantly improved medical resident comfort with healthcare power of attorney and practitioner orders for life-sustaining treatment form completion.
Provider and Practice Experience Integrating the Dose-HPV Intervention into Clinical Practice
Authors: Drainoni Mari-Lynn , Biancarelli Dea , Jansen Emily , Bernstein Judith , Joseph Natalie , Eun Terresa J. , Fenton Anny H.T.R. , Clark Jack A. , Hanchate Amresh , Legler Aaron , Schuch Thomas J. , Leschly Karin , Perkins Rebecca B.
Published: May 2021

Introduction:

Few studies have rigorously evaluated the drivers of successful implementation of interventions to improve human papillomavirus (HPV) vaccination rates. The aim of this study was to evaluate the implementation of Development of Systems and Education for HPV Vaccination (DOSE HPV), a performance improvement intervention.

Methods:

Primary care providers (PCPs), nurses, and individuals with leadership roles from pediatric and family medicine practices who attended DOSE HPV intervention sessions participated in qualitative interviews immediately following intervention completion. The study team professionally transcribed interviews and performed qualitative coding using inductive methods. Final analysis employed the Promoting Action on Research implementation in Health Services (PARiHS) model.

Results:

Twenty-six individuals participated: 12 PCPs, 5 nurses, and 9 individuals with dual leadership and PCP roles. Participants described five factors that they felt contributed to program success: (1) evidence-based, goal-directed education; (2) personalized data feedback; (3) clinical leadership support; (4) collaborative facilitation; (5) repeated contacts/longitudinal structure of the intervention. Barriers to implementing the intervention included: (1) inability to standardize workflow across practices; (2) low pediatric volume, (3) competing priorities/lack of incentives, (4) ineffective involvement of nurses, (5) poor communication between clinical leadership and staff.

Discussion:

Although many HPV testing interventions have been implemented, findings have been mixed. It is clear that having an effective, evidence-based intervention by itself is not enough to get it into practice. Rather, it is crucial to consider implementation factors to ensure consistent implementation and sustainability. Key factors for the success of the DOSE HPV intervention appear to include a collaborative approach, provision of useful evidence to motivate behavior change, and repeated contacts to ensure accountability for implementing changes. Workflow issues, ineffective lines of communication, and competing priorities at both the visit and the patient and population management levels can hinder implementation.
Does the type of cryoprobe affect oncological and functional outcomes in men with clinically localized prostate cancer treated with primary whole gland prostate cryoablation?
Authors: Taha Tarek , Tan Wei Phin , Elshafei Ahmed , Aminsharifi Alireza , Given Robert , Cher Michael L. , Polascik Thomas J.
Published: May 2021

Background:

This study aimed to compare the oncological and functional outcomes of primary whole gland cryoablation of the prostate using the variable ice cryoprobe (V-Probe®) and the conventional fixed-size ice probe.

Materials and methods:

We reviewed the Cryo On-Line Data Registry for men who were treated with primary whole gland prostate cryoablation from 2000 through 2017. A multivariate Cox proportional hazards model was used to compare timing to biochemical recurrence between the V-Probe® and fixed-size ice probe after adjusting for preoperative prostate-specific antigen (PSA), neoadjuvant androgen deprivation therapy, preoperative Gleason score, and preoperative T stage.

Results:

A total of 1124 men were included. Median age, Gleason score, and pretreatment PSA were 70 years (interquartile range [IQR]: 65–74 years), 7 (IQR: 6–7) and 5.9 ng/mL (IQR: 4.6–8.1 ng/mL), respectively. The median follow-up time was 25.0 months (IQR: 11.2–48.6 months). V-Probes® were used in 269 (23.9%) cases and fixed-size ice probes in 858 (76.1%) cases. After adjusting for clinical T stage, PSA, neoadjuvant androgen deprivation therapy and preoperative Gleason score, on the multivariate Cox regression model, we found that there was no significant difference between the type of probe and timing to biochemical recurrence (p = 0.35). On multivariate logistic regression, using the V-Probe® was associated with a 91% increase in postoperative urinary retention compared to the fixed-size ice probe (p = 0.003).

Conclusions:

The use of the V-Probe® versus conventional fixed-size ice probe was not associated with a difference in biochemical recurrence in patients undergoing primary cryoablation of the prostate.
Primary Cutaneous Aspergillosis in Immunocompetent Patients Due to Aspergillus niger: A Report of 4 Cases
Authors: Pincelli Marcella S. , García Jesús Pérez , Sangueza Omar P. , Sangueza Martin
Published: May 2021

Primary cutaneous aspergillosis is a cutaneous fungal infection due to the direct inoculation of spores ofAspergillusspecies into the disrupted skin. Primary cutaneous aspergillosis presents with a variety of localized cutaneous lesions, such as erythematous macules, papules, plaques, or nodules that can progress to necrosis, erosion, ulceration, or fistulization. Many species ofAspergilluscan cause the disease, and one of them isAspergillus nigerthat rarely affects immunocompetent patients and that has peculiar characteristics on the histopathological examination. We present a series of 4 cases of immunologically competent patients presenting with primary cutaneous aspergillosis caused byA. niger.
Primary Cutaneous Enteric Duplication Cyst: A Novel Entity
Authors: Mastin Murphy R. , Swanson Leah A. , Smyrk Thomas C. , Wieland Carilyn N. , Guo Ruifeng
Published: May 2021

Enteric duplication cysts (EDCs) are rare congenital malformations consisting of double-walled cystic or tubular structures lined by gastrointestinal type epithelium. EDCs share a common muscular wall and blood supply with the adjacent duplicated bowel with very rare exceptions. The majority of EDCs are intraabdominal with cases less commonly intrathoracic or thoracoabdominal. To the best of our knowledge, we present the first reported case of primary cutaneous EDC to occur outside the abdominal and thoracic cavities. A 17-year-old male without a significant medical or surgical history underwent excision of a cystic nodule on the left hip. On histopathology, a dermal to subcuticular cyst exhibited an epithelial lining with 2 distinct components including cuboidal to columnar mucinous cells (CK7+, CK20−, and CDX2−) and complex glandular colonic-type mucosa (CK7−, CK20+, and CDX2+). A thick muscular wall resembling muscularis mucosa and muscularis propria surrounded the cyst. Findings supported a primary cutaneous enteric duplication cyst of uncertain developmental etiology. The novel nature of this entity could represent a diagnostic challenge.
Genetic Associations With Stable Warfarin Dose Requirements in Han Chinese Patients
Authors: Xu Qingqing , Zhang Suli , Wu Chaoneng , Xiong Yuyu , Niu Jiamin , Li Fengzhen , Zhu Jinhang , Shen Lu , Zhu Bin , Xing Qinghe , He Lin , Chen Luan , Li Mo , Li Hua , Ge Junbo , Qin Shengying
Published: May 2021

Warfarin is a commonly prescribed anticoagulant for valvular heart disease that plays an important role in clinical management to prevent thrombotic events. In this study, we aim to perform a comprehensive study to investigate the genetic biomarkers of stable warfarin dose in the Han Chinese population. We performed an integrative study on 211 Han Chinese patients with valvular heart disease. A total of 40 single nucleotide polymorphisms (SNPs) in 10 important genes (CYP2C9, VKORC1, ABCB1, CYP4F2, APOE, PROC, GGCX, EPHX1, CALU, and SETD1A) which are involved in the warfarin metabolic pathway and equilibrium of coagulation and anticoagulation were selected. We applied MassARRAY technology to genotype the 40 SNPs identified in these Han Chinese patients. Our results showed that 13 SNPs on 6 genes (CYP2C9, VKORC1, ABCB1, PROC, EPHX1, and SETD1A) were associated with the individual stable warfarin dose. Two VKORC1 SNPs (rs9934438 and rs2359612) were the strongest genetic factors determining warfarin dose requirements (P = 8 × 10−6 and 9 × 10−6, respectively). Rs4889599 in SETD1A was first reported to be associated with warfarin dose at a significant level of 0.001 in our study (P
adjust = 0.040 after Bonferroni correction). We discovered that genetic variants in CYP2C9, VKORC1, ABCB1, PROC, EPHX1, and SETD1A may affect the stable warfarin dose requirement in Han Chinese patients with valvular disease. The discovery of these potential genetic markers will facilitate the development of advanced personalized anticoagulation therapy in Han Chinese patients.
Optimizing Breast Reconstruction through Integration of Plastic Surgery and Radiation Oncology
Authors: Arnautovic Aska , Olafsson Sigurast , Wong Julia S. , Agarwal Shailesh , Broyles Justin M.
Published: May 2021

Background:

Post-mastectomy radiation therapy (PMRT) is an important adjunct to improve oncologic outcomes and survival in select breast cancer patients at increased risk for local recurrence. As recommendations for PMRT broaden, an increasing number of patients will have it included as part of their breast cancer treatment plan.

Methods:

This overview of the literature strives to broaden the exposure of the plastic surgeon to PMRT and describe the indications, guidelines, and considerations relevant to reconstructive surgery. The primary targets and dosing considerations will also be reviewed. Finally, the short- and long-term toxicities are outlined with the goal of providing the plastic surgeon insights with which to recognize certain toxicities in the clinic during follow up and to develop the fluency to be able to talk to patients about the potential for certain toxicities.

Results:

Generally, PMRT is safe and well tolerated. Considerations in breast reconstruction should be made on a patient-by-patient basis. Plastic surgeon familiarity with PMRT, its indications, and complications will amplify the surgeon’s ability to optimize outcomes.

Conclusions:

As more women undergo breast reconstruction, an increasing number of patients will have PMRT as part of their breast cancer treatment plan. By understanding the basic principles of PMRT, plastic surgeons can engage patients in conversations of shared decision-making and maximize outcomes.
Contraceptive Technologies: Looking Ahead to New Approaches to Increase Options for Family Planning
Authors: HADDAD LISA B. , TOWNSEND JOHN W. , SITRUK-WARE REGINE
Published: May 2021

With persistently high global rates of unintended pregnancy and contraceptive nonuse, nonadherence and discontinuation, new contraceptive methods must address the needs of women and men who seek alternatives to their current options. Methods under development aim to reduce potential side effects, improve access and ease of use, ensure safety, increase secondary benefits associated with method use and expand options for both women and men. Developmental approaches employed to enhance current methods utilize new delivery systems and novel active pharmaceutical ingredients. This will improve overall user satisfaction with the methods used while expanding the number of options available to provide choice and value user autonomy in the highly diverse contraceptive markets around the world.
ENDOPHTHALMITIS AFTER INTRAVITREAL INJECTIONS DURING THE COVID-19 PANDEMIC WITH IMPLEMENTATION OF UNIVERSAL MASKING
Authors: Naguib Mina M. , Ghauri Sophia , Mukhopadhyay Anirudh , Schefler Amy C.
Published: May 2021

Purpose:

To evaluate the rates of postintravitreal injection–related endophthalmitis during the COVID-19 pandemic with institution of both physician and patient face masking.

Methods:

All eyes receiving intravitreal injections of any kind from a single large tertiary retina practice in Houston, TX before (August 2017–March 22, 2020) and after (March 23, 2020–September 2020) COVID-19 pandemic universal masking protocols. The total number of injections and cases of acute injection-related endophthalmitis were determined from billing records and subsequent retrospective chart review. The primary outcome was the rate of endophthalmitis after intravitreal injection. Secondary outcomes included visual acuity, time until initial presentation, patient age, and differences in the overall number of injections performed monthly pre–COVID-19 and post–COVID-19.

Results:

A total of 134, 097 intravitreal injections were performed during the study period (111,679 pre–COVID-19 and 22,418 post–COVID-19 masking protocols). A total of 41 cases of acute endophthalmitis occurred in the pre-COVID group (0.04%, one in 2,500) and 7 cases in the post-COVID group (0.03%, one in 3,333) P = 0.85.

Conclusion:

In this single center, retrospective study, the implementation of universal patient and physician masking as practiced during the COVID-19 pandemic did not significantly affect the rate of postintravitreal injection endophthalmitis.
FACTORS ASSOCIATED WITH REACTIVATION AFTER INTRAVITREAL BEVACIZUMAB OR RANIBIZUMAB THERAPY IN INFANTS WITH RETINOPATHY OF PREMATURITY
Authors: Iwahashi Chiharu , Utamura Shoko , Kuniyoshi Kazuki , Sugioka Koji , Konishi Yuhei , Wada Norihisa , Kusaka Shunji
Published: May 2021

Purpose:

To investigate the efficacy and risk factors of intravitreal antivascular endothelial growth factor injection (anti-VEGF therapy) for retinopathy of prematurity (ROP).

Methods:

We retrospectively reviewed 80 consecutive eyes of 43 patients with Type 1 ROP or worse who received anti-VEGF therapy during January 2012–February 2018. Patients were divided into those who were injected with 0.25 mg of bevacizumab (IVB group, 37 eyes) and 0.25 mg of ranibizumab (IVR group, 43 eyes). Serum VEGF concentrations of 18 patients were measured before and after IVR.

Results:

Antivascular endothelial growth factor injection therapy reduced ROP activity in all eyes; however, 14 eyes (17.5%) exhibited reactivation. The reactivation rates of the IVB and IVR groups were 13.5% and 20.9%, respectively (P = 0.556). Multivariate logistic regression analysis showed that postmenstrual age ≤35 weeks at anti-VEGF therapy (P = 0.014) and aggressive posterior ROP (P = 0.044) was significantly associated with reactivation. Serum VEGF was significantly suppressed at Days 1 (P < 0.001) and 7 (P = 0.012) after IVR and returned to the preinjection level by Day 14 (P = 0.210).

Conclusion:

Both IVR and IVB seemed effective in reducing ROP activity. Reactivation after anti-VEGF therapy may be associated with younger postmenstrual age at anti-VEGF therapy and aggressive posterior ROP.
Kappa opioid receptor blockade in the nucleus accumbens shell prevents sex-dependent alcohol deprivation effect induced by inflammatory pain
Authors: Lorente Jesús D. , Cuitavi Javier , Campos-Jurado Yolanda , Montón-Molina Raquel , González-Romero Jose L. , Hipólito Lucía
Published: May 2021

Pain-induced negative affect reduces life quality of patients by increasing psychiatric comorbidities, including alcohol use disorders (AUDs). Indeed, clinical data suggest pain as a risk factor to suffer AUDs, predicting relapse drinking in abstinent patients. Here, we analyse the impact of pain on alcohol relapse and the role of kappa opioid receptor (KOR) activation in mediating these pain-induced effects because KORs play an important role in pain-driven negative affect and AUD. Female and male Sprague-Dawley rats underwent 2 alcohol intermittent access periods separated by a forced abstinence period. The complete Freund adjuvant model of inflammatory pain was introduced during abstinence, and alcohol intake before and after alcohol reintroduction was assessed. In addition, we used behavioural approaches to measure stress and memory impairment and biochemical assays to measure KOR expression in abstinence and reintroduction periods. Only female CFA-treated rats increased alcohol intake during the reintroduction period. Concomitantly, this group showed enhanced anxiety-like behaviour and increased KOR expression in the nucleus accumbens shell that was developed during abstinence and remained during the reintroduction period. Finally, KOR antagonist norbinaltorphimine was administered in the nucleus accumbens shell during abstinence to prevent a pain-induced alcohol deprivation effect, a phenomenon observed in CFA-female rats. The administration of norbinaltorphimine effectively blocked a pain-induced alcohol deprivation effect in female rats. Our data evidenced that inflammatory pain constitutes a risk factor to increase alcohol consumption during a reintroduction phase only in female rats by the rise and maintenance of stress probably mediated by KOR signalling in the nucleus accumbens.
A Phase 3, Placebo-Controlled Trial of Once-Daily Viloxazine Extended-Release Capsules in Adolescents With Attention-Deficit/Hyperactivity Disorder
Authors: Nasser Azmi , Liranso Tesfaye , Adewole Toyin , Fry Nicholas , Hull Joseph T. , Busse Gregory D. , Chowdhry Fatima , Cutler Andrew J. , Jones Nandita Joshi , Findling Robert L. , Schwabe Stefan
Published: May 2021

Purpose

This phase 3 clinical trial evaluated the efficacy and safety of viloxazine extended-release capsules (VLX-ER) as a monotherapy for attention-deficit/hyperactivity disorder (ADHD) in adolescents (12–17 years).

Methods

Eligible subjects (n = 310) were randomized to receive once-daily 200 and 400 mg VLX-ER, or placebo for 6 weeks. The primary efficacy end point was change from baseline (CFB) at the end of study (EOS) in ADHD Rating Scale-5 Total score. Key secondary end points were Clinical Global Impression—Improvement score at EOS, CFB at EOS in Conners 3—Parent Short Form Composite T-score, and CFB at EOS in Weiss Functional Impairment Rating Scale—Parent Total average score.

Results

In the 200-mg/d and 400-mg/d VLX-ER treatment groups, a significant improvement was found in the CFB at EOS in ADHD Rating Scale-5 Total (P = 0.0232, P = 0.0091) and Inattention (P = 0.0424, P = 0.0390) and Hyperactivity/Impulsivity (P = 0.0069, P = 0.0005) subscale scores versus placebo. The Clinical Global Impression—Improvement score was significantly improved at EOS in the 200-mg/d and 400-mg/d VLX-ER groups versus placebo (P = 0.0042, P = 0.0003). The Conners 3—Parent Short Form composite T-score and Weiss Functional Impairment Rating Scale—Parent Total average score exhibited improvement in both VLX-ER groups; however, the difference versus placebo was not statistically significant. The most common treatment-related adverse events were somnolence, headache, decreased appetite, nausea, and fatigue. The adverse event–related discontinuation rates were <5% in all groups.

Conclusions

Viloxazine extended-release demonstrated statistically significant and clinically meaningful improvement in ADHD symptoms in adolescents and was generally well tolerated.
Pramipexole to Improve Cognition in Bipolar Disorder
Authors: Van Meter Anna R. , Perez-Rodriguez M. Mercedes , Braga Raphael J. , Shanahan Megan , Hanna Lauren , Malhotra Anil K. , Burdick Katherine E.
Published: May 2021

Background

Adults with bipolar disorder (BD) often experience neurocognitive impairment that negatively impacts functioning and quality of life. Previous trials have found that dopamine agonist agents improve cognition in healthy volunteers and that adults with BD who have stable mood and mild cognitive deficits may also benefit. We hypothesized that pramipexole, a dopamine agonist, would improve neurocognitive function in patients with BD.

Methods

We recruited 60 adults (aged 18–65 years) with a diagnosis of BD I or II for an 8-week, double-blind, placebo-controlled trial (NCT02397837). All had stable mood and clinically significant neurocognitive impairment at baseline. Participants were randomized to receive pramipexole (n = 31) or a placebo (n = 29), dose was initiated at 0.125 mg 2 times a day and increased to a target of 4.5 mg/d.

Results

At trial end, the primary outcome, MATRICS Consensus Cognitive Battery composite score, had not improved more in the pramipexole group (mean [SD] = 1.15 [5.4]) than in the placebo group (mean [SD] = 4.12 [5.2], Cohen’s d = 0.56, P = 0.049), and mixed models, controlling for symptoms, showed no association between treatment group and MATRICS Consensus Cognitive Battery scores. No serious adverse events were reported.

Conclusions

These results suggest that pramipexole is not an efficacious cognitive enhancement agent in BD, even in a sample enriched for characteristics that were associated with a beneficial response in prior work. There are distinct cognitive subgroups among adults with BD and may be related differences in neurobiology that affect response to pramipexole. Additional research to better understand the onset and nature of the cognitive deficits in people with BD will be an important step toward a more personalized approach to treatment.
Accessing Healthcare Services During the COVID-19 Pandemic: The Plight of Sexual Assault Survivors
Authors: Munro-Kramer Michelle L. , Cannon Lindsay M. , Scheiman Lisa , St Ivany Amanda R. , Bailey Joanne M.
Published: May 2021

Introduction

Despite a global focus on intimate partner violence during the COVID-19 pandemic, there has been little exploration into how the pandemic and its associated restrictions have impacted sexual assault survivors and their ability to access specialized care and resources. The purpose of this research brief is to use longitudinal data to compare the number of medical forensic examinations done seasonally prepandemic and during the COVID-19 pandemic shelter-in-place order.

Methods

This analysis uses retrospective data on medical forensic examinations from January 2010 through November 2020 from one large academic Midwestern hospital.

Results

Results show that monthly medical forensic examinations have increased over time, from a mean of 4.5 cases per month (range: 1–9) in 2010 to a mean of 9 cases per month (range: 7–11) in 2019. In April 2020, when COVID-19-related shutdowns were at their first peak, cases dropped to a historic low of 0 examinations (the lowest number of cases in the past 10 years).

Conclusions

The data show an initial drop in the number of survivors seeking postassault care after the COVID shutdown; however, cases rebounded through the second full month of shutdown orders. Programs that provide medical forensic examinations need to be prepared for subsequent waves of survivors, who may be COVID-19 positive. We must be better prepared for many of the adverse consequences impacting individuals around the country related to COVID-19 responses.
Hospital Partnerships for Population Health: A Systematic Review of the Literature
Authors: Hilts Katy Ellis , Yeager Valerie A. , Gibson P. Joseph , Halverson Paul K. , Blackburn Justin , Menachemi Nir
Published: May 2021

EXECUTIVE SUMMARY

The U.S. healthcare system continues to experience high costs and suboptimal health outcomes that are largely influenced by social determinants of health. National policies such as the Affordable Care Act and value-based payment reforms incentivize healthcare systems to engage in strategies to improve population health. Healthcare systems are increasingly expanding or developing new partnerships with community-based organizations to support these efforts. We conducted a systematic review of peer-reviewed literature in the United States to identify examples of hospital–community partnerships; the main purposes or goals of partnerships; study designs used to assess partnerships; and potential outcomes (e.g., process- or health-related) associated with partnerships. Using robust keyword searches and a thorough reference review, we identified 37 articles published between January 2008 and December 2019 for inclusion. Most studies employed descriptive study designs (n = 21); health needs assessments were the most common partnership focus (n = 15); and community/social service (n = 21) and public health organizations (n = 15) were the most common partner types. Qualitative findings suggest hospital–community partnerships hold promise for breaking down silos, improving communication across sectors, and ensuring appropriate interventions for specific populations. Few studies in this review reported quantitative findings. In those that did, results were mixed, with the strongest support for improvements in measures of hospitalizations. This review provides an initial synthesis of hospital partnerships to address population health and presents valuable insights to hospital administrators, particularly those leading population health efforts.
Enhancing Residents' Warmth in Greeting Caregivers: An Inpatient Intervention to Improve Family-Centered Communication
Authors: Bayer Nathaniel D. , Taylor April , Atabek Zoey , Santolaya Jacobo L. , Bamat Tara W. , Washington Nicole
Published: May 2021

Hospitals are increasingly motivated to improve the patient and family experience and increase patient satisfaction scores. The manner by which a provider greets patients and their families sets the tone for the hospital stay. This study aimed to improve residents' greetings of caregivers in the inpatient pediatric setting to improve family-centered communication. The study was conducted from October 2017 to April 2018 at a single, urban children's hospital on a unit with patients primarily <5 years old. The intervention consisted of posting a prominent board outside of patients' rooms that (1) listed caregivers' preferred names (e.g., Mom/Dad, first names), (2) instructed residents to greet caregivers warmly by their preferred names, and (3) identified residents for families by name and photograph. During implementation, we conducted 5 Plan-Do-Study-Act cycles and surveyed 114 caregivers. Improvement was assessed using run charts. The primary outcome was the percentage of caregivers who rated residents' warmth of greetings as “excellent.” This measure increased from a baseline median of 62.5%–84.4% with ≥6 consecutive postintervention points above the baseline median. The intervention improved caregiver-perceived quality of residents' greetings and could serve as a model for other hospitals to enhance provider-family rapport and improve communication.
Improving Operating Room Start Times
Authors: Duffy Melissa , Capusan Karen Y. , Shea Ann
Published: May 2021

The Pre-Surgical Testing program at Cohen Children's Medical Center launched in 2012. We evaluate approximately 7,000 patients per year who are scheduled for outpatient and inpatient surgeries from all pediatric surgical services. The Pre-Surgical Testing program providers are pediatric and family nurse practitioners (NPs). In 2017, the NP role expanded into the inpatient setting. We started to evaluate patients scheduled for emergency procedures, sedated radiology studies, and invasive procedures. We identified high-risk patients, which provided anesthesiologists with the critical information they needed to deliver safe patient care. In 2018, the NPs further expanded into the ambulatory setting. Our role includes preoperative orders, managing postoperative pain, entering discharge medications, and providing continuing education to nursing staff. From February 2018 to August 2018, first-case start times have improved by 20%. The combination of clinical knowledge and experience makes NPs uniquely qualified to identify high-risk patients scheduled for surgery. Other institutions may consider NPs in their postoperative areas to improve OR start times and, more generally, patient safety.