bluuebunny/crossref_metadata_2025_split huggingface dataset:
Median Effective Volume of 0.5% Ropivacaine for Ultrasound-guided Costoclavicular Block
Authors: Kewlani Anu , Bhatia Nidhi , Makkar Jeetinder Kaur , Kumar Vishal 
Published: February 2021

Background
The median effective dose of ropivacaine required for producing an effective costoclavicular block has not yet been determined. The authors conducted this dose-finding study with the objective of determining the median effective dose of 0.5% ropivacaine required to produce a successful costoclavicular block for surgical anesthesia in 50% of the patients (ED50) as well as the calculated dose required for effective blockade in 95% of the patients (ED95).

Methods
This single-armed prospective study was conducted on 40 American Society of Anesthesiologists physical status I or II patients, aged 18 to 60 yr, with a body mass index of 18 to 30 kg/m2, scheduled to undergo forearm and hand surgeries under ultrasound-guided costoclavicular block. A volume of 0.5% ropivacaine administered in the costoclavicular space was determined using the sample up-and-down sequential allocation study design of binary response variables. The first patient received a volume of 26 ml of 0.5% ropivacaine. After a successful or unsuccessful block, the volume of local anesthetic was decreased or increased, respectively, by 2 ml in the next patient. Evaluation of sensory and motor block was performed every 5 min for 30 min and graded using a 3-point scale. Surgical anesthesia was considered to be successful if a minimum score of 14 was achieved and the surgeon was able to proceed with surgery without needing to supplement anesthesia.

Results
The volume of local anesthetic administered ranged from 8 to 26 ml. Centered isotonic regression with a bias-corrected Morris 95% CI derived by bootstrapping showed ED50 of 13.5 ml (95% CI, 11.5 to 15.4 ml) and ED95 of 18.9 ml (95% CI, 17.9 to 27.5 ml).

Conclusions
A 19-ml dose of 0.5% ropivacaine is likely to produce an effective ultrasound-guided costoclavicular block for providing adequate surgical anesthesia to 95% of the patients.

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Associations Between Sexual Assault and Reproductive and Family Planning Behaviors and Outcomes in Female Veterans
Authors: Edmonds Stephanie W. , Mengeling Michelle A. , Syrop Craig H. , Torner James C. , Sadler Anne G. 
Published: February 2021

OBJECTIVE:
To examine the relationship between lifetime sexual assault (defined as someone having experienced sexual assault in their lifetime) and reproductive health care seeking, contraception usage, and family planning outcomes in female veterans.

METHODS:
We conducted a secondary analysis of data collected between 2005 and 2008 from computer-assisted telephone interviews with 1,004 female veterans aged 20–52 years who were enrolled at two Midwestern Department of Veterans Affairs (VA) health care systems. Participants were asked about reproductive, mental, and general health histories, and about lifetime sexual assault. We assessed associations between reproductive histories and contraceptive use among participants who reported lifetime sexual assault, compared with those who had not experienced lifetime sexual assault, by using bivariate and multivariable logistic regression analyses. Lastly, we examined reasons why these participants had not sought Pap test screening.

RESULTS:
More than half (62%) of participants reported experiencing lifetime sexual assault. Because there was an association between older age and history of lifetime sexual assault (P<.001), we stratified the analysis by age. Women with a history of lifetime sexual assault were more likely to have had unprotected intercourse for a year or more (adjusted odds ratio [aOR] 2.31, 95% CI 1.35–3.96) and a teen pregnancy (aOR 2.10, 95% CI 1.07–4.12) than women who did not report lifetime sexual assault. When stratified by age, women aged 40–52 years with a history of lifetime sexual assault were more likely to report more than a year of unprotected sex, teen pregnancy, and not seeking prenatal care with their first pregnancy, than women aged 40–52 who did not report lifetime sexual assault. Women who experienced lifetime sexual assault were more likely to report not seeking Pap tests in the past owing to fear and anxiety when compared with women who had not experienced lifetime sexual assault.

CONCLUSION:
Female veterans who reported lifetime sexual assault had differences in family planning behaviors compared with women who did not report lifetime sexual assault. These findings have implications for clinicians and VA policymakers when determining family planning and reproductive care delivery needs for female veterans of reproductive age.
Locating Hormone-Releasing Contraceptive Implants Using Near-Infrared Light
Authors: Akturk Halis Kaan 
Published: February 2021

BACKGROUND:
Long-term hormone-releasing contraceptive (etonogestrel) implants are highly effective in preventing pregnancy. In a minority of patients, implants cannot be located by palpation, increasing the risk of complications related to removal. Ultrasonography can be used to locate migrated or deeply inserted implants, but this requires expertise. Thus, alternative methods to locate contraceptive implants are needed.

METHOD:
Near-infrared light is sometimes used to facilitate venipuncture and has been described as a technique to locate implanted glucose sensors. Herein, I describe using near-infrared light to locate contraceptive implants. The near-infrared light was positioned perpendicularly and held 33 cm away from the arm. As soon as it is powered up, a reflection of the contraceptive implant is noticeable on the skin. The location of the implant is then marked before the removal procedure.

EXPERIENCE:
This method allowed the easy location of nonpalpable etonogestrel implants in five women.

CONCLUSION:
Near-infrared light was successful in locating nonpalpable etonogestrel implants. This novel method can be used as an alternative to ultrasonography.
Leveraging Real-World Evidence: A Paradigm Shift in Regulation
Authors: De Sugato , Larson Leanne , Kelly Kim , Hanson Beate , Mack Christina D. 
Published: February 2021

Summary:
The study methodology and regulatory frameworks for real-world data collection is quickly evolving, opening new avenues to use valid and robust real-world evidence (RWE) to support regulatory decision making. Although the Food and Drug Administration has historically accepted specific applications of RWE to support regulatory determinations, significant progress has been made in recent years to examine conditions in which this information can be used to support specific types of premarket decisions. Of note, hybrid study designs that incorporate aspects of randomized clinical trials, including randomization and pragmatic outcomes, are expected to be a driving factor to accelerate the adoption of RWE in regulatory contexts. Generation of RWE to better understand effectiveness and safety of orthopaedic- and trauma-related devices requires careful planning, but it is achievable as demonstrated by the Bioventus Observational Non-Interventional EXOGEN Studies (BONES) clinical development program. This article examines the role of RWE in regulatory decision making and reviews key concepts in RWE study design methodology to facilitate creation of valid scientific evidence in support of marketing authorizations.
Percent of Normal: A Pragmatic Patient-Reported Outcome Measure for the Orthopaedic Trauma Clinic
Authors: Parry Joshua A. , Peterson Shian L. , Strage Katya E. , Hadeed Michael , Heare Austin , Stacey Stephen C. , Mauffrey Cyril 
Published: February 2021

Objectives:
To compare a single numerical patient-reported outcome measure (PROM) to general health and injury-specific PROMs.

Design:
Retrospective cohort.

Setting:
Urban Level 1 trauma center.

Patients/Participants:
The study included 175 patients with 34 humerus, 54 pelvis, 31 acetabular, and 56 ankle fractures.

Main Outcome Measurements:
Patients were administered 3 PROMs: the 12-item short-form (SF-12), an injury-specific PROM (QuickDASH—humerus; Majeed Pelvic Outcome Score (Majeed)—pelvis; modified Merle d’Aubigne score (Merle)—acetabular; Foot and Ankle Disability Index (FADI)—ankle, and the Percent of Normal (PON) PROM, a single numerical PROM, which asked, “How would you rate yourself, if 100% is back to normal?” Floor/ceiling effect, convergent validity, and responsiveness of PROMs were assessed.

Results:
None of the PROMs demonstrated a floor effect. The Merle was the only PROM with a ceiling effect (19%). The PON had a strong correlation with the QuickDASH (r = 0.78) and Majeed (r = 0.78); a moderate association with the SF-12 physical component score (r = 0.63), Merle (r = 0.67), and FADI (r = 0.55); and a weak association with the SF-12 mental component score (r = 0.22). The regression coefficient for change in PROM over time, a measure of responsiveness, was greater for the PON compared with the SF-12 physical component score/mental component score, Majeed, Merle, and FADI, but not the QuickDASH.

Conclusions:
The PON is a pragmatic PROM that can be easily administered in clinic by the physician to quickly assess and manage a variety of fractures, avoiding the disadvantages of nonrelative general or region-specific PROMs.
Modified K-Line in Neck Extension Is a Prognostic Indicator of the Surgical Outcome at 5 Years After Cervical Laminoplasty for Cervical Spondylotic Myelopathy
Authors: Takeuchi Kazunari , Yokoyama Toru , Wada Kanichiro , Kumagai Gentaro , Kudo Hitoshi , Tanaka Sunao , Asari Toru , Sasaki Eiji , Koyama Kazushige , Ichinohe Masayuki , Ishibashi Yasuyuki 
Published: February 2021

Study Design.
A retrospective comparison of the surgical outcome after cervical laminoplasty for cervical spondylotic myelopathy (CSM) using a modified K-line based on lordosis in neck extension as a predictor: in K-line Back CSM (KB group), the K-line crosses the ventral edge of any of the spinous processes, whereas in K-line Front CSM (KF group), the K-line does not.

Objective.
To investigate the neurological and radiological outcomes 5 years after surgery and the contact between the spinal cord and posterior elements after laminoplasty for CSM using the modified K-line.

Summary of Background Data.
No indicators on a lateral radiograph can predict the neurological outcome after laminoplasty for CSM.

Methods.
Patients with CSM were divided into KB (n = 20) and KF groups (n = 13). We compared the postoperative Japanese Orthopedic Association (JOA) score, recovery rate, grip-and-release and foot-tapping test results, alignment, and contact between the spinal cord and posterior elements between the two groups.

Results.
The postoperative JOA score and its recovery rate were significantly lower in the KB group (12.4 points and 34.1%, respectively) than in the KF group (14.1 points and 59.0%, respectively) at final follow-up (P = 0.0415 and 0.0458). The grip-and-release and foot-tapping test results improved significantly in the KF group but not in the KB group. In the KB group, a larger lordotic angle in extension at 1 year postoperatively continued until final follow-up. The rate of recovery of the JOA score in patients with contacts at both C4/5 and C5/6 and any contact in the KB group (−1.5% and 31.9%, respectively) were lower (P = 0.0013 and 0.0534, respectively) than those in the KF group (58.6% and 60.7%, respectively).

Conclusion.
The K-line Back predicts a poor neurological outcome after laminoplasty for CSM. Decompression with fusion may be recommended for these patients.

Level of Evidence: 4
Nocturnal Hypoglycemia in Patients With Diabetes Discharged From ICUs: A Prospective Two-Center Cohort Study*
Authors: Ali Abdelhamid Yasmine , Bernjak Alan , Phillips Liza K. , Summers Matthew J. , Weinel Luke M. , Lange Kylie , Chow Elaine , Kar Palash , Horowitz Michael , Heller Simon , Deane Adam M. 
Published: February 2021

OBJECTIVES:
There is very limited information about glycemic control after discharge from the ICU. The aims of this study were to evaluate the prevalence of hypoglycemia in ICU survivors with type-2 diabetes and determine whether hypoglycemia is associated with cardiac arrhythmias.

DESIGN:
Prospective, observational, two-center study. Participants underwent up to 5 days of simultaneous blinded continuous interstitial glucose monitoring and ambulatory 12-lead electrocardiogram monitoring immediately after ICU discharge during ward-based care. Frequency of arrhythmias, heart rate variability, and cardiac repolarization markers were compared between hypoglycemia (interstitial glucose ≤ 3.5 mmol/L) and euglycemia (5–10 mmol/L) matched for time of day.

SETTING:
Mixed medical-surgical ICUs in two geographically distinct university-affiliated hospitals.

PATIENTS:
Patients with type-2 diabetes who were discharged from ICU after greater than or equal to 24 hours with greater than or equal to one organ failure and were prescribed subcutaneous insulin were eligible.

MEASUREMENTS AND MAIN RESULTS:
Thirty-one participants (mean ± sd, age 65 ± 13 yr, glycated hemoglobin 64 ± 22 mmol/mol) were monitored for 101 ± 32 hours post-ICU (total 3,117 hr). Hypoglycemia occurred in 12 participants (39%; 95% CI, 22–56%) and was predominantly nocturnal (40/51 hr) and asymptomatic (25/29 episodes). Participants experiencing hypoglycemia had 2.4 ± 0.7 discrete episodes lasting 45 minutes (interquartile range, 25–140 min). Glucose nadir was less than or equal to 2.2 mmol/L in 34% of episodes. The longest episode of nocturnal hypoglycemia was 585 minutes with glucose nadir less than 2.2 mmol/L. Simultaneous electrocardiogram and continuous interstitial glucose monitoring recordings were obtained during 44 hours of hypoglycemia and 991 hours of euglycemia. Hypoglycemia was associated with greater risk of bradycardia but did not affect atrial or ventricular ectopics, heart rate variability, or cardiac repolarization.

CONCLUSIONS:
In ICU survivors with insulin-treated type-2 diabetes, hypoglycemia occurs frequently and is predominantly nocturnal, asymptomatic, and prolonged.
Health-Related Quality-of-Life and Cost Utility Analyses in Critical Care: A Systematic Review*
Authors: Lau Vincent I. , Xie Feng , Basmaji John , Cook Deborah J. , Fowler Robert , Kiflen Michel , Sirotich Emily , Iansavichene Alla , Bagshaw Sean M. , Wilcox M. Elizabeth , Lamontagne François , Ferguson Niall , Rochwerg Bram 
Published: February 2021

OBJECTIVES:
Cost utility analyses compare the costs and health outcome of interventions, with a denominator of quality-adjusted life year, a generic health utility measure combining both quality and quantity of life. Cost utility analyses are difficult to compare when methods are not standardized. It is unclear how cost utility analyses are measured/reported in critical care and what methodologic challenges cost utility analyses pose in this setting. This may lead to differences precluding cost utility analyses comparisons. Therefore, we performed a systematic review of cost utility analyses conducted in critical care. Our objectives were to understand: 1) methodologic characteristics, 2) how health-related quality-of-life was measured/reported, and 3) what costs were reported/measured.

DESIGN:
Systematic review.

DATA SOURCES:
We systematically searched for cost utility analyses in critical care in MEDLINE, Embase, American College of Physicians Journal Club, CENTRAL, Evidence-Based Medicine Reviews’ selected subset of archived versions of UK National Health Service Economic Evaluation Database, Database of Abstracts of Reviews of Effects, and American Economic Association electronic databases from inception to April 30, 2020.

SETTING:
Adult ICUs.

PATIENTS:
Adult critically ill patients.

INTERVENTIONS:
None.

MEASUREMENTS AND MAIN RESULTS:
Of 8,926 citations, 80 cost utility analyse studies were eligible. The time horizon most commonly reported was lifetime (59%). For health utility reporting, health-related quality-of-life was infrequently measured (29% reported), with only 5% of studies reporting baseline health-related quality-of-life. Indirect utility measures (generic, preference-based health utility measurement tools) were reported in 85% of studies (majority Euro-quality-of-life-5 Domains, 52%). Methods of estimating health-related quality-of-life were seldom used when the patient was incapacitated: imputation (19%), assigning fixed utilities for incapacitation (19%), and surrogates reporting on behalf of incapacitated patients (5%). For cost utility reporting transparency, separate incremental costs and quality-adjusted life years were both reported in only 76% of studies. Disaggregated quality-adjusted life years (reporting separate health utility and life years) were described in only 34% of studies.

CONCLUSIONS:
We identified deficiencies which warrant recommendations (standardized measurement/reporting of resource use/unit costs/health-related quality-of-life/methodological preferences) for improved design, conduct, and reporting of future cost utility analyses in critical care.
The Association Between Antibiotic Delay Intervals and Hospital Mortality Among Patients Treated in the Emergency Department for Suspected Sepsis*
Authors: Taylor Stephanie Parks , Anderson William E. , Beam Kent , Taylor Brice , Ellerman Justin , Kowalkowski Marc A. 
Published: February 2021

OBJECTIVES:
Rapid delivery of antibiotics is a cornerstone of sepsis therapy, although time targets for specific components of antibiotic delivery are unknown. We quantified time intervals comprising the task of antibiotic delivery and evaluated the association between interval delays and hospital mortality among patients treated in the emergency department for suspected sepsis.

DESIGN:
Retrospective cohort.

SETTING:
Twelve hospitals in Southeastern United States from 2014 to 2017.

PATIENTS:
Twenty-four thousand ninety-three encounters among 20,026 adults with suspected sepsis in 12 emergency departments.

MEASUREMENTS AND MAIN RESULTS:
We divided antibiotic administration into two intervals: time from emergency department triage to antibiotic order (recognition delay) and time from antibiotic order to infusion (administration delay). We used generalized linear mixed models to evaluate associations between these intervals and hospital mortality. Median time from emergency department triage to antibiotic administration was 3.4 hours (interquartile range, 2.0–6.0 hr), separated into a median recognition delay (time from emergency department triage to antibiotic order) of 2.7 hours(interquartile range, 1.5–4.7 hr) and median administration delay (time from antibiotic order to infusion) of 0.6 hours (0.3–1.2 hr). Adjusting for other risk factors, both recognition delay and administration delay were associated with mortality, but pairwise comparison with a no-delay reference group was not significant for up to 6 hours of recognition delay or up to 1.5 hours of administration delay.

CONCLUSIONS:
Both recognition delays and administration delays were associated with increased hospital mortality, but only for longer delays. These results suggest that both metrics may be important to measure and improve for patients with suspected sepsis but do not support targets less than 1 hour.
Sialic acid-binding immunoglobulin-like lectin 9 as a potential therapeutic target for chronic obstructive pulmonary disease
Authors: Chen Zi , Xu Shuang-Lan , Ge Lin-Yang , Zhu Jin , Zheng Tao , Zhu Zhou , Zhou Linfu 
Published: February 2021

Abstract
Chronic obstructive pulmonary disease (COPD) has become the third-leading cause of death worldwide, which is a severe economic burden to the healthcare system. Chronic bronchitis is the most common condition that contributes to COPD, both locally and systemically. Neutrophilic inflammation predominates in the COPD airway wall and lumen. Logically, repression of neutrophilia is an essential fashion to COPD treatment. However, currently available anti-neutrophilic therapies provide little benefit in COPD patients and may have serious side effects. Thus, there is an urgent need to explore an effective and safe anti-neutrophilic approach that might delay progression of the disease. Sialic acid-binding immunoglobulin-like lectin (Siglec)-9 is a member of the Siglec cell surface immunoglobulin family. It is noteworthy that Siglec-9 is highly expressed on human neutrophils and monocytes. Ligation of Siglec-9 by chemical compounds or synthetic ligands induced apoptosis and autophagic-like cell death in human neutrophils. Furthermore, administration of antibody to Siglec-E, mouse functional ortholog of Siglec-9, restrained recruitment and activation of neutrophils in mouse models of airway inflammation in vivo. Given the critical role that neutrophils play in chronic bronchitis and emphysema, targeting Siglec-9 could be beneficial for the treatment of COPD, asthma, fibrosis, and related chronic inflammatory lung diseases.
Long-standing Multifocal Motor Neuropathy Presenting With Delayed Clinical Features of Anti–Myelin-Associated Glycoprotein Neuropathy and Elevated Anti–Myelin-Associated Glycoprotein Antibody Titers
Authors: Bernardo Katrina A. , Weiss Michael D. 
Published: February 2021

Abstract
Multifocal motor neuropathy with conduction block (MMN) and anti–myelin-associated glycoprotein (MAG) neuropathy are rare chronic acquired demyelinating neuropathies with distinct clinical and electrophysiological characteristics. These neuropathies are generally not known to coexist. This report describes a patient with long-standing MMN who subsequently developed clinical features of anti-MAG neuropathy. This suggests that subtypes of chronic inflammatory neuropathies may not be sharply defined. In addition, a presentation of MMN with anti-MAG titers may be a prognostic indicator of poor response to standard MMN treatment.
Prevalence and Correlates of Attention-Deficit Hyperactivity Disorder in a Diverse, Treatment-Seeking Pediatric Overweight/Obesity Sample
Authors: Merrill Brittany M. , Morrow Anne S. , Sarver Dustin , Sandridge Shanda , Lim Crystal S. 
Published: February 2021

ABSTRACT:

Objective:
Attention-deficit hyperactivity disorder (ADHD) and obesity are highly prevalent, impairing, and costly conditions, affecting about 10% of children each. Research indicates heightened prevalence of childhood obesity among youth with ADHD. However, more research is needed, examining comorbid ADHD among youth with overweight/obesity (OV/OB) from diverse demographic backgrounds and effects on medically relevant behaviors. The aim of the current study was to examine the prevalence of ADHD in a racially diverse sample of youth in a weight management clinic. Furthermore, we examined the effects of race, rurality, and ADHD on weight status and health behaviors in this under-researched population.

Method:
Participants included 1003 patients (Mage = 12.55; 58% female; 67% Black/African American; MBMI Z-Score = 2.54; 98.6% with obesity) in a pediatric weight management clinic serving a rural and urban/suburban area in the southern United States. Parent-reported demographics, ADHD diagnosis, and child health behaviors were recorded.

Result:
In total, 17.6% (n = 177) of the sample had an ADHD diagnosis. ADHD status interacted with race to predict standardized body mass index (BMIz), and rurality predicted higher BMIz. Children with comorbid ADHD had significantly more meals per day and fewer active days compared with children with OV/OB without ADHD.

Conclusion:
ADHD prevalence was higher in this diverse sample of children seeking obesity treatment (17.6%) compared with the prevalence nationally (9%–10%) and in other obesity samples. Comorbid ADHD was related to higher weight status among racial minority youth and increased engagement in unhealthy lifestyle behaviors often targeted in weight management treatment. It is critical to screen for ADHD in pediatric specialty clinics and assess healthy lifestyle behaviors.