bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety of Recombinant Influenza Vaccine Compared to Inactivated Influenza Vaccine in Adults: An Observational Study
Authors: Hansen John , Goddard Kristin , Timbol Julius , Zhang Lea , Lewis Ned , Dunkle Lisa , Izikson Ruvim , Klein Nicola P 
Published: May 2020

Abstract

Background
Recombinant trivalent influenza vaccine (RIV3) was initially licensed in 2013 and approved for all adults ≥18 in 2014. This study evaluated the safety of RIV3 compared with trivalent standard-dose, inactivated influenza vaccine (IIV3) in Kaiser Permanente Northern California (KPNC).

Methods
This Phase 4 observational, postmarketing safety study included persons ≥18 years vaccinated with RIV3 or IIV3 in KPNC during the 2015–2016 influenza season. We compared (1) the rates of prespecified diagnoses of interest (Guillain-Barré Syndrome, pericarditis, pleural effusion, narcolepsy/cataplexy, asthma, acute hypersensitivity reactions, and fever) during various postvaccination risk intervals as well as (2) all-cause hospitalization and mortality 0–180 days after vaccination. We estimated odds ratios (ORs) and 95% confidence intervals (CIs) using logistic regression analyses adjusted for age, sex, race/ethnicity, month of vaccination, and concomitant receipt of other vaccinations.

Results
Comparing the 21 976 persons who received RIV3 with the 283 683 who received IIV3, there were statistically significant differences in the prespecified diagnoses of interest between the 2 groups. Specifically, RIV3 vaccination was associated with fewer fever diagnoses during the 0–41 days postvaccination (OR, 0.38; 95% CI, 0.14–0.86). Also, RIV3 was associated with fewer all-cause hospitalizations during the 0–180 days postvaccination (OR, 0.66; 95% CI, 0.61–0.73), which was mostly related to pregnancy-related hospitalizations in IIV3 recipients. There were no serious adverse events or deaths related to RIV3.

Conclusions
This study did not identify any safety concerns regarding the use of RIV3 in adults.
A new lease of life for Donatio Mortis Causa?
Authors: Farran Sue , Hewitson Russell 
Published: May 2020

Abstract
Coronavirus has thrown the world into disarray. New developments and contingency measures are being adopted on a daily basis. New legislation has been adopted to regulate people’s lives. As every law student learns, equity developed to address the inadequacies of the common law and achieve justice when to deny it would be unconscionable. Ideally, all those confronting the possibility of death from this virus would have had the time and resources to draw up a will. The reality is that many will not have had either. This article considers the equitable institution of Donatio Mortis Causa and its relevance in the current crisis.
Combining In Vivo and Organotypic In Vitro Approaches to Assess the Human Relevance of Basimglurant (RG7090), a Potential CAR Activator
Authors: Nudischer Ramona , Renggli Kasper , Bertinetti-Lapatki Cristina , Hoflack Jean-Christophe , Flint Nicholas , Sewing Sabine , Pedersen Lykke , Schadt Simone , Higgins Larry G , Vardy Audrey , Lenz Barbara , Gand Laurent , Boess Franziska , Elcombe Barbara M , Hierlemann Andreas , Roth Adrian B 
Published: May 2020

AbstractBasimglurant (RG7090), a small molecule under development to treat certain forms of depression, demonstrated foci of altered hepatocytes in a long-term rodent-toxicity study. Additional evidence pointed toward the activation of the constitutive androstane receptor (CAR), an established promoter of nongenotoxic and rodent-specific hepatic tumors. This mode of action and the potential human relevance was explored in vivo using rodent and cynomolgus monkey models and in vitro using murine and human liver spheroids. Wild type (WT) and CAR/pregnane X receptor (PXR) knockout mice (CAR/PXR KO) were exposed to RG7090 for 8 consecutive days. Analysis of liver lysates revealed induction of Cyp2b mRNA and enzyme activity, a known activation marker of CAR, in WT but not in CAR/PXR KO animals. A series of proliferative genes were upregulated in WT mice only, and immunohistochemistry data showed increased cell proliferation exclusively in WT mice. In addition, primary mouse liver spheroids were challenged with RG7090 in the presence or absence of modified antisense oligonucleotides inhibiting CAR and/or PXR mRNA, showing a concentration-dependent Cyp2b mRNA induction only if CAR was not repressed. On the contrary, neither human liver spheroids nor cynomolgus monkeys exposed to RG7090 triggered CYP2B mRNA upregulation. Our data suggested RG7090 to be a rodent-specific CAR activator, and that CAR activation and its downstream processes were involved in the foci of altered hepatocytes formation detected in vivo. Furthermore, we demonstrated the potential of a new in vitro approach using liver spheroids and antisense oligonucleotides for CAR knockdown experiments, which could eventually replace in vivo investigations using CAR/PXR KO mice.
Short-Term Quality of Life After Myomectomy for Uterine Fibroids From the Compare-UF Fibroid Registry
Authors: Laughlin-Tommaso Shannon K. , Lu Di , Thomas Laine , Diamond Michael , Wallace Kedra , Wegienka Ganesa , Vines Anissa , Anchan Ray , Wang Tracy , Maxwell G. Larry , Jacoby Vanessa , Marsh Erica E. , Spies James B. , Nicholson Wanda , Stewart Elizabeth A. , Myers Evan 
Published: May 2020

(Abstracted from Am J Obstet Gynecol 2020;222:345.e1–345.e22)
Uterine fibroids can have a substantial impact on quality of life of reproductive aged women and are a leading cause of morbidity and surgery in affected women. A uterine-sparing treatment option for patients with symptomatic uterine fibroids is myomectomy.
Thermal Ablation Versus Cryotherapy or Loop Excision to Treat Women Positive for Cervical Precancer on Visual Inspection With Acetic Acid Test: Pilot Phase of a Randomised Controlled Trial
Authors: Pinder Leeya F. , Parham Groesbeck P. , Basu Partha , Muwonge Richard , Lucas Eric , Nyambe Namakau , Sauvaget Catherine , Mwanahamuntu Mulindi H. , Sankaranarayanan Rengaswamy , Prendiville Walter 
Published: May 2020

(Abstracted from Lancet Oncol 2020;21:175–184)
The most commonly used approach for women with cervical precancer in low-income and middle-income countries (LMICs) is screening by visual inspection with acetic acid (VIA) followed by immediate cryotherapy of VIA-positive women (see-and-treat). There are a number of logistical problems with cryotherapy that have prompted development and evaluation of a cordless, lightweight, and battery-operated thermal ablator that has a much faster treatment duration (20–40 seconds) and does not require a gas supply.
Maternal Infection and Antibiotic Use in Pregnancy and the Risk of Childhood Obesity in Offspring: A Birth Cohort Study
Authors: Li De-Kun , Chen Hong , Ferber Jeannette , Odouli Roxana 
Published: May 2020

(Abstracted from Int J Obes (Lond) 2020;44:771–780)
The microbiome begins during birth and delivery, and the maternal microbiome can have implications for the infant's microbiome. It has been reported that an infant's microbiome can contribute to the risk of developing childhood obesity.
Endometrial Thickness and IVF Cycle Outcomes: A Meta-analysis
Authors: Gao Ge , Cui Xianfeng , Li Shuang , Ding Pan , Zhang Shuai , Zhang Yunshan 
Published: May 2020

(Abstracted from Reprod Biomed Online 2020;40(1):124–133)
Endometrial evaluation by ultrasound is a convenient and noninvasive practice used during in vitro fertilization (IVF) cycles to analyze factors including endometrial thickness (EMT), endometrial pattern, endometrial volume, and endometrial and subendometrial blood flow. These factors are all believed to contribute to endometrial receptivity and IVF success.
No Evidence of Altered Reactivity to Experimentally Induced Pain Among Regular Cannabis Users
Authors: St. Pierre Michelle , Russo Ethan B. , Walsh Zach 
Published: May 2020

Objectives:
Recent years have seen an increase in the adoption of cannabinoid medicines, which have demonstrated effectiveness for the treatment of chronic pain. However, the extent to which frequent cannabis use (CU) influences sensitivity to acute pain has not been systematically examined. Such a determination is clinically relevant in light of hypersensitivity to pain associated with prolonged use of other analgesics such as opioids, and reports of increased pain sensitivity to experimentally induced pain during acute cannabis intoxication. This study explored differences in measures of pain intensity and tolerance. The authors hypothesized that individuals who report frequent CU would demonstrate greater experimental pain sensitivity.

Materials and Methods:
Frequent cannabis users (≥3× per week; n=40) and nonusers (n=40) were compared on pain sensitivity, pain tolerance, and pain intensity in response to a cold-pressor task. Group differences were examined.

Results:
Frequent CU was not associated with hyperalgesia as cannabis users and nonusers did not exhibit differences on measures of pain tolerance (t
(78)=−0.05; P=0.96), sensitivity (t
(78)=−0.83; P=0.41), or intensity (t
(78)=0.36; P=0.72).

Discussion:
Frequent cannabis users did not demonstrate hyperalgesia. This finding should help to inform evaluations of the relative harms and benefits of cannabis analgesic therapies.
Exploring the Psychometric Properties of the Current Opioid Misuse Measure Among Adults With Chronic Pain and Opioid Use
Authors: Rogers Andrew H. , Gallagher Matthew W. , Jamison Robert N. , Zvolensky Michael J. 
Published: May 2020

Objectives:
The opioid epidemic is a significant public health problem that is associated with overdose and death. The increase in opioid-related problems can largely be attributed to increases in opioid prescriptions for the treatment of chronic pain. Unfortunately, there is not a consensus on a definition of opioid misuse in the context of chronic pain, making measurement a challenge. One commonly used measure to assess opioid misuse in the context of chronic pain is the Current Opioid Misuse Measure (COMM). The COMM was designed to assess opioid misuse generally, as captured by psychiatric symptoms and aberrant drug use behaviors. Although studies have examined cross-validation using correlations, little psychometric work has been conducted, and therefore it is currently unknown what domains the measure is assessing.

Materials and Methods:
The current study examined the factor structure of the COMM using confirmatory and exploratory factor analysis among 445 opioid-using adults with chronic pain.

Results:
The results did not support the widely accepted 1-factor opioid misuse solution; rather they supported a 2-factor, psychiatric problems and aberrant-drug-use-problems factor structure. Convergent and divergent validity were also examined at the bivariate level.

Discussion:
Given the importance and relevance for opioid misuse in the context of chronic pain, it is important for researchers to continue assessing and providing psychometric evidence for the COMM.
Enhanced Recovery after Lumbar Spine Fusion
Authors: Soffin Ellen M. , Beckman James D. , Tseng Audrey , Zhong Haoyan , Huang Russel C. , Urban Michael , Guheen Carrie R. , Kim Han-Jo , Cammisa Frank P. , Nejim Jemiel A. , Schwab Frank J. , Armendi Isabel F. , Memtsoudis Stavros G. 
Published: May 2020

Background
Prospective trials of enhanced recovery after spine surgery are lacking. We tested the hypothesis that an enhanced recovery pathway improves quality of recovery after one- to two-level lumbar fusion.

Methods
A patient- and assessor-blinded trial of 56 patients randomized to enhanced recovery (17 evidence-based pre-, intra-, and postoperative care elements) or usual care was performed. The primary outcome was Quality of Recovery-40 score (40 to 200 points) at postoperative day 3. Twelve points defined the clinically important difference. Secondary outcomes included Quality of Recovery-40 at days 0 to 2, 14, and 56; time to oral intake and discharge from physical therapy; length of stay; numeric pain scores (0 to 10); opioid consumption (morphine equivalents); duration of intravenous patient-controlled analgesia use; complications; and markers of surgical stress (interleukin 6, cortisol, and C-reactive protein).

Results
The analysis included 25 enhanced recovery patients and 26 usual care patients. Significantly higher Quality of Recovery-40 scores were found in the enhanced recovery group at postoperative day 3 (179 ± 14 vs. 170 ± 16; P = 0.041) without reaching the clinically important difference. There were no significant differences in recovery scores at days 0 (175 ± 16 vs. 162 ± 22; P = 0.059), 1 (174 ± 18 vs. 164 ± 15; P = 0.050), 2 (174 ± 18 vs. 167 ± 17; P = 0.289), 14 (184 ± 13 vs. 180 ± 12; P = 0.500), and 56 (187 ± 14 vs. 190 ± 8; P = 0.801). In the enhanced recovery group, subscores on the Quality of Recovery-40 comfort dimension were higher (longitudinal mean score difference, 4; 95% CI, 1, 7; P = 0.008); time to oral intake (−3 h; 95% CI, −6, −0.5; P = 0.010); and duration of intravenous patient-controlled analgesia (−11 h; 95% CI, −19, −6; P < 0.001) were shorter; opioid consumption was lower at day 1 (−57 mg; 95% CI, −130, −5; P = 0.030) without adversely affecting pain scores (−2; 95% CI, −3, 0; P = 0.005); and C-reactive protein was lower at day 3 (6.1; 95% CI, 3.8, 15.7 vs. 15.9; 95% CI, 6.6, 19.7; P = 0.037).

Conclusions
Statistically significant gains in early recovery were achieved by an enhanced recovery pathway. However, significant clinical impact was not demonstrated.

Editor’s Perspective

What We Already Know about This Topic

What This Article Tells Us That Is New
Dorsal Root Ganglion Stimulation Alleviates Pain-related Behaviors in Rats with Nerve Injury and Osteoarthritis
Authors: Yu Guoliang , Segel Ian , Zhang Zhiyong , Hogan Quinn H. , Pan Bin 
Published: May 2020

Background
Dorsal root ganglion field stimulation is an analgesic neuromodulation approach in use clinically, but its mechanism is unknown as there is no validated animal model for this purpose. The authors hypothesized that ganglion stimulation is effective in reducing pain-like behaviors in preclinical chronic pain models.

Methods
The authors provided ganglion stimulation or spinal cord stimulation to rats with traumatic neuropathy (tibial nerve injury), or osteoarthritis induced by intraarticular knee monosodium iodoacetate, or without injury (naïve). Analgesia was evaluated by testing a battery of pain-related reflexive, functional, and affective behaviors.

Results
In rats with nerve injury, multilevel L4 and L5 ganglion stimulation decreased hypersensitivity to noxious mechanical stimulation more (area under curve, −1,447 ± 423 min × % response; n = 12) than single level ganglion stimulation at L4 ([−960 ± 251 min × % response; n = 8; P = 0.012] vs. L4 and L5), and L5 ([−676 ± 295 min × % response; n = 8; P < 0.0001] vs. L4 and L5). Spontaneous pain-like behavior, evaluated by conditioned place preference, responded to single L4 (Pretest [−93 ± 65 s] vs. Test [87 ± 82 s]; P = 0.002; n = 9), L5 (Pretest [−57 ± 36 s] vs. Test [137 ± 73 s]; P = 0.001; n = 8), and multilevel L4 and L5 (Pretest: −81 ± 68 s vs. Test: 90 ± 76 s; P = 0.003; n = 8) ganglion stimulation. In rats with osteoarthritis, multilevel L3 and L4 ganglion stimulation reduced sensitivity to knee motion more (−156 ± 28 min × points; n = 8) than L3 ([−94 ± 19 min × points in knee bend test; n = 7; P = 0.002] vs. L3 and L4) or L4 ([−71 ± 22 min × points; n = 7; P < 0.0001] vs. L3 and L4). Conditioned place preference during osteoarthritis revealed analgesic effectiveness for ganglion stimulation when delivered at L3 (Pretest [−78 ± 77 s] vs. Test [68 ± 136 s]; P = 0.048; n = 9), L4 (Pretest [−96 ± 51 s] vs. Test [73 ± 111 s]; P = 0.004; n = 9), and L3 and L4 (Pretest [−69 ± 52 s; n = 7] vs. Test [55 ± 140 s]; P = 0.022; n = 7).

Conclusions
Dorsal root ganglion stimulation is effective in neuropathic and osteoarthritic preclinical rat pain models with peripheral pathologic origins, demonstrating effectiveness of ganglion stimulation in a placebo-free setting and justifying this model as a suitable platform for mechanistic studies.

Editor’s Perspective

What We Already Know about This Topic

What This Article Tells Us That Is New
Does Implant Removal Across the Sacroiliac Joint Improve Pain and Outcomes?
Authors: Firoozabadi Reza , Kovalenko Boris , Toogood Paul 
Published: May 2020

Objectives:
To determine if removal of previously inserted iliosacral screws improved posterior pelvic pain and Short Musculoskeletal Form Assessment (SMFA) scores.

Design:
Retrospective database review.

Setting:
Level-1 trauma center.

Patients/Intervention:
Twenty-five patients who underwent iliosacral screw removal.

Main Outcome Measure:
SMFA score.

Results:
Eighty-eight percent of patients stated that they were satisfied with the procedure and would undergo screw removal again. SMFA functional and bothersome scores decreased (improved) after the screw removal procedure, both at 3 months and at the final follow-up. Two-eight percent of the patients required narcotics before surgery compared with 8% after screw removal. No surgical complications occurred during screw removal.

Conclusion:
A select group of patients who have symptomatic screws across the sacroiliac joint may benefit from elective screw removal.

Level of Evidence:
Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Comparing the Efficiency, Radiation Exposure, and Accuracy Using C-Arm versus O-Arm With 3D Navigation in Placement of Transiliac–Transsacral and Iliosacral Screws: A Cadaveric Study Evaluating an Early Career Surgeon
Authors: Araiza Edgar T. , Medda Suman , Plate Johannes F. , Marquez-Lara Alejandro , Trammell Amy P. , Aran Fernando S. , Lara Daniel , Danelson Kerry , Halvorson Jason J. , Carroll Eben A. , Pilson Holly T. 
Published: May 2020

Objectives:
To compare the efficiency, radiation exposure to surgeon and patient, and accuracy of C-arm versus O-arm with navigation in the placement of transiliac–transsacral and iliosacral screws by an orthopaedic trauma fellow, for a surgeon early in practice.

Methods:
Twelve fresh frozen cadavers were obtained. Preoperative computed tomography scans were reviewed to assess for safe corridors in the S1 and S2 segments. Iliosacral screws were assigned to the S1 segment in dysmorphic pelvises. Screws were randomized to modality and laterality. An orthopaedic trauma fellow placed all screws. Time of procedure and radiation exposure to the cadaver and surgeon were recorded. Three fellowship-trained orthopaedic trauma surgeons rated the safety of each screw on postoperative computed tomography scan.

Results:
Six normal and 6 dysmorphic pelvises were identified. Eighteen transiliac–transsacral screws and 6 iliosacral screws were distributed evenly between C-arm and O-arm. Average operative duration per screw was significantly shorter using C-arm compared with O-arm (15.7 minutes ± 6.1 vs. 23.7 ± 8.5, P = 0.014). Screw placement with C-arm exposed the surgeon to a significantly greater amount of radiation (3.87 × 10−3 rads vs. 0.32 × 10−3, P < 0.001) while O-arm exposed the cadaver to a significantly greater amount of radiation (0.03 vs. 2.76 rads, P < 0.001). Two S2 transiliac–transsacral screws (1 C-arm and 1 O-arm) were categorized as unsafe based on scoring. There was no difference in screw accuracy between modalities.

Conclusions:
A difference in accuracy between modalities could not be elucidated, whereas efficiency was improved with utilization of C-arm, with statistical significance. A statistically significant increase in radiation exposure to the surgeon using C-arm was found, which may be clinically significant over a career. The results of this study can be extrapolated to a fellow or surgeon early in practice. The decision between use of these modalities will vary depending on surgeon preference and hospital resources.
A Needs Assessment and Educational Intervention Addressing the Care of Sexual Assault Patients in the Emergency Department
Authors: Chandramani Ayushi , Dussault Nicole , Parameswaran Ramya , Rodriguez Jaclyn , Novack Jared , Ahn James , Oyola Sonia , Carter Keme 
Published: May 2020

ABSTRACT
Emergency department (ED) providers serve as the primary point-of-contact for many survivors of sexual assault but are often ill-prepared to address their unique treatment needs. Sexual assault nurse examiners (SANEs) are therefore an important resource for training other ED providers. The objective of this project was to create a SANE-led educational intervention addressing this training gap. We achieved this objective by (a) conducting a needs assessment of ED providers' self-reported knowledge of, and comfort with, sexual assault patient care at an urban academic adult ED and, (b) using these results to create and implement a SANE-led educational intervention to improve emergency medicine residents' ability to provide sexual assault patient care. From the needs assessment survey, ED providers reported confidence in medical management but not in providing trauma-informed care, conducting forensic examinations, or understanding hospital policies or state laws. Less than half of the respondents felt confident in their ability to avoid retraumatizing sexual assault patients, and only 29% felt comfortable conducting a forensic examination. On the basis of these results, a SANE-led educational intervention was developed for emergency medicine residents, consisting of a didactic lecture, two standardized patient cases, and a forensic pelvic examination simulation. Preintervention and postintervention surveys showed an increase in respondents' self-perceived ability to avoid retraumatizing patients, comfort with conducting forensic examinations, and understanding of laws and policies. These results show the value of an interprofessional collaboration between physicians and SANEs to train ED providers on sexual assault patient care.
Report on the Short Endoscopic Exocrine Pancreatic Function Test in Children and Young Adults
Authors: Mehta Devendra I. , He Zhaoping , Bornstein Jeffrey , Molle-Rios Zarela , Conwell Darwin L. , Horvath Karoly 
Published: May 2020

Objectives
Endoscopic pancreatic function test (ePFT) has been in use for exocrine function testing since the 1990s. In patients, short ePFT assesses acinar function, unlike the longer version for ductal function in adults. The present study summarizes characteristics of 1913 short ePFTs (S-ePFT) performed at 2 centers since 2001.

Methods
The main indications in patients presenting at ages infancy to 24.3 years, for the S-ePFT were failure to thrive, weight loss, diarrhea, and abdominal pain with bloating. Secretin was administered as bolus, and 4 aliquots of fluid were collected between 4 and 10 minutes after administration. Amylase, lipase, trypsin, and chymotrypsin activities were measured in the laboratory.

Results
The pH of consecutive samples increased by 0.3 to 0.7. Overall, 36.7% had abnormal S-ePFT with selective amylase deficiency (9.5%) and generalized enzyme deficiency (8.9%) being the most frequent. Retest reproducibility, repeatability, and clinical validity were high. By adding S-ePFT to endoscopy for the suspicion of malabsorption, the abnormal findings increased by 36.9%.

Conclusions
Short ePFT assesses pancreatic acinar function in a reliable and clinically meaningful way in patients. Diagnostic yield of endoscopy increased substantially albeit with increased sedation time. By S-ePFT ductal function, cytokines and proteomics can also be assessed.