bluuebunny/crossref_metadata_2025_split huggingface dataset:
Is Routine Use of External Spinal Orthoses Necessary After Operative Stabilization of Cervical Spine Injuries?
Authors: Moody Derek , Showery James , Lador Ran , Hernandez Isaac , Prasarn Mark L. 
Published: April 2024

Study Design:
Retrospective Review.

Objective:
The purpose of this study is to evaluate the efficacy of postoperative cervical orthoses to prevent fixation failure and loss of reduction after operative treatment of cervical spine fractures.

Summary of Background Data:
While cervical orthoses are most times tolerated in trauma patients, it is not clear that postoperative bracing is effective at reducing the rate of fixation failure or nonunion in this patient population. Cervical collars may delay rehabilitation, increase the risk of dysphagia and aspiration, and can contribute to skin breakdown.

Methods:
All patients who underwent operative stabilization for cervical spine injuries at a single institution between January 2015 and August 2019 were identified through the institutional Research Electronic Data Capture (REDcap) database. Patient data, including cervical spine injury, surgery, post-operative orthosis use, and secondary surgeries for loss of reduction or infection, were recorded for all patients meeting the inclusion criteria. The primary outcome was the loss of reduction or failure of fixation, requiring revision surgery. Statistical analysis was performed using Jamovi (Version 1.1) statistical software.

Results:
In all, 201 patients meeting inclusion and exclusion criteria were identified within the study period. Overall, 133 (66.2%) patients were treated with a cervical orthosis postoperatively and 68 (33.8%) patients were allowed to mobilize as tolerated without a cervical orthosis. Fixation failure and loss of reduction occurred in 4 (1.99%) patients. Of these 4, three patients were treated with a cervical orthosis postoperatively. There was no significant difference in the risk of instrumentation failure between patients in the postoperative orthosis and no orthosis groups (P=0.706).

Conclusion:
The use of cervical orthoses after operative stabilization of cervical spine injuries remains controversial. There was no statistically significant difference in hardware failure or loss of fixation between patients treated in cervical orthoses postoperatively and those who were not.
Assessing the Economic Benefits of Enhanced Recovery After Surgery (ERAS) Protocols in Adult Cervical Deformity Patients
Authors: Tretiakov Peter S. , Onafowokan Oluwatobi O. , Lorentz Nathan , Galetta Matthew , Mir Jamshaid M. , Das Ankita , Dave Pooja , Yee Timothy , Buell Thomas J. , Jankowski Pawel P. , Eastlack Robert , Hockley Aaron , Schoenfeld Andrew J. , Passias Peter G. 
Published: April 2024

Objective:
To assess the financial impact of Enhanced Recovery After Surgery (ERAS) protocols and cost-effectiveness in cervical deformity corrective surgery.

Study Design:
Retrospective review of prospective CD database.

Background:
Enhanced Recovery After Surgery (ERAS) can help accelerate patient recovery and assist hospitals in maximizing the incentives of bundled payment models while maintaining high-quality patient care. However, the economic benefit of ERAS protocols, nor the heterogeneous components that make up such protocols, has not been established.

Methods:
Operative CD patients ≥18 y with complete pre-(BL) and up to 2-year(2Y) postop radiographic/HRQL data were stratified by enrollment in Standard-of-Care ERAS beginning in 2020. Differences in demographics, clinical outcomes, radiographic alignment targets, perioperative factors, and complication rates were assessed through means comparison analysis. Costs were calculated using PearlDiver database estimates from Medicare pay scales. QALY was calculated using NDI mapped to SF6D using validated methodology with a 3% discount rate to account for a residual decline in life expectancy.

Results:
In all, 127 patients were included (59.07±11.16 y, 54% female, 29.08±6.43 kg/m2) in the analysis. Of these patients, 54 (20.0%) received the ERAS protocol. Per cost analysis, ERAS+ patients reported a lower mean total 2Y cost of 35049 USD compared with ERAS− patients at 37553 (P<0.001). Furthermore, ERAS+ patients demonstrated lower cost of reoperation by 2Y (P<0.001). Controlling for age, surgical invasiveness, and deformity per BL TS-CL, ERAS+ patients below 70 years old were significantly more likely to achieve a cost-effective outcome by 2Y compared with their ERAS- counterparts (OR: 1.011 [1.001–1.999, P=0.048].

Conclusions:
Patients undergoing ERAS protocols experience improved cost-effectiveness and reduced total cost by 2Y post-operatively. Due to the potential economic benefit of ERAS for patients incorporation of ERAS into practice for eligible patients should be considered.
A Novel Cervical Sagittal Classification for Asymptomatic Population Based on Cluster Analysis
Authors: Gong Zhaoyang , Xu Haocheng , Yang Yong , Xia Xinlei , Lyu Feizhou , Jiang Jianyuan , Wang Hongli , Ma Xiaosheng 
Published: April 2024

Study Design:
Cross-sectional study.

Objective:
To propose a novel cervical sagittal classification for asymptomatic people so as to deepen the understanding of cervical sagittal alignment.

Summary of Background Data:
Cervical spine sagittal morphology varies in people. There is a lack of widely-accepted cervical sagittal classification method.

Methods:
In all, 183 asymptomatic subjects were included. A series of global and segmental cervical sagittal parameters were measured. Subjects with cervical lordosis (CL)<0 degrees were incorporated directly into the kyphosis (K) group. For subjects with CL ≥0 degrees, a two-step cluster analysis was used to arrive at the optimal number of clusters. The results of the expressions for the subtypes were derived by graphing. The 60 randomly selected lateral cervical spine films were evaluated by 4 spine surgeons at 4-week intervals using our classification method, the Toyama classification method and the Donk classification method. The 3 classification methods’ reliability was expressed by the intra-group correlation coefficient (ICC), and convenience was expressed by the measuring time. Finally, the distribution of 4 subtypes was depicted, and sagittal parameters were compared among subtypes.

Results:
Four subtypes of the cervical spine were suggested: Large lordosis (LL): CL≥-1.5×T1 slope (TS)+70°; Small lordosis (SL): -1.5×TS+50°≤CL<-1.5×TS+70°; Straight (S): 0°≤CL<-1.5×TS+50°; and K: CL<0°. The measuring time for our classification method was significantly less than the Toyama classification method (P<0.001). Our classification method showed high inter-observer reliability (ICC=0.856) and high to excellent intra-observer reliability (ICC between 0.851 and 0.913). SL was the most common type (37.7%). Men had more LL type and women had more S type and K type. The proportion of S and K increased with age. Cervical sagittal parameters were significantly different among the subtypes except for C4 vertebral body (VB) angle (P=0.546), C2-C7 SVA (P=0.628) and NT (P=0.816).

Conclusions:
We proposed a novel cervical sagittal classification for an asymptomatic population, which proved to be simple to implement with satisfactory reliability.
Assessing the Influence of Intraoperative Core Body Temperature on Postoperative Venous Thromboembolism after Abdominal Wall Reconstruction
Authors: Zhang Kevin K. , Ormseth Benjamin H. , Sarac Benjamin A. , Raj Vijay , Palettas Marilly , Janis Jeffrey E. 
Published: April 2024

Background:
Venous thromboembolism (VTE) is a dangerous postoperative complication after abdominal wall reconstruction (AWR). Intraoperative core body temperature has been associated with thrombotic events in other surgical contexts. This study examines the effects of intraoperative temperature on VTE rate after AWR.

Methods:
A retrospective study was performed on AWR patients. Cohorts were defined by postoperative 30-day VTE. Intraoperative core body temperature was recorded as the minimum, maximum, and mean intraoperative temperatures. Study variables were analyzed with logistic regression and cutoff analysis to assess for association with VTE.

Results:
In total, 344 patients met inclusion criteria. Fourteen patients were diagnosed with 30-day VTE for an incidence of 4.1%. The VTE cohort had a longer median inpatient stay (8 days versus 5 days, P < 0.001) and greater intraoperative change in peak inspiratory pressure (3 mm H2O versus 1 mm H2O, P = 0.01) than the non-VTE cohort. Operative duration [odds ratio (OR) = 1.32, P = 0.01], length of stay (OR = 1.07, P = 0.001), and intraoperative PIP difference (OR = 1.18, P = 0.045) were significantly associated with 30-day VTE on univariable regression. Immunocompromised status (OR = 4.1, P = 0.023; OR = 4.0, P = 0.025) and length of stay (OR = 1.1, P < 0.001; OR = 1.1, P < 0.001) were significant predictors of 30-day VTE on two multivariable regression models. No significant associations were found between temperature metrics and 30-day VTE on cutoff point or regression analysis.

Conclusions:
Intraoperative core body temperature did not associate with 30-day VTE after AWR, though operative duration, length of stay, immunocompromised status, and intraoperative PIP difference did. Surgeons should remain mindful of VTE risk after AWR, and future research is warranted to elucidate all contributing factors.
Management of Immobile Scalp Skin Tumors and Analysis of Skin Graft Survival on Burred Calvaria
Authors: Al-Aswad Firas , Al-Hassani Fawaz , Fernandez-Diaz Oscar F. , Al Naser Mutaz 
Published: April 2024

Background:
Surgeons face challenges associated with adherent cutaneous scalp malignancy. Traditional general anesthetic excision involves periosteal removal and burring of the outer table of the calvaria for deep margin clarity and tissue reconstruction. Research on this practice is limited, and graft survival in burr-treated bones is underexplored. This study aimed to assess the clinical margin accuracy for immobile scalp malignancies, identify deep-invading malignancy types, and evaluate graft survival in burr-treated calvariae. It compares split-thickness grafts (STSGs) and full-thickness grafts (FTSGs).

Methods:
Twelve fixed scalp malignancies were excised under anesthesia, allowing immediate STSG or FTSG for defect reconstruction. Postsurgery, graft take, malignancy type, and margin clearance were evaluated.

Results:
Histopathological diagnosis identified seven squamous cell carcinomas, two melanomas, one basal cell carcinoma, one adenocarcinoma, and one metastatic squamous cell carcinoma. Deep margins ranged from 0 to 0.9 mm, and peripheral margins ranged from 0 to 15 mm. The graft take was 100% in eight cases, with total failure in two cases, and 75%–90% in two cases. The five STSGs had 100% take and 90% take. The three FTSGs had 100%, 75%, and two failed.

Conclusions:
Clinical examination effectively gauges the tumor fixation depth, but large lesions may require imaging. Most deep-invading tumors were SCCs. STSGs performed better on burr-treated Calvaria than FTSGs.
Combatting Antibiotic Resistance: Regulatory Exclusivities for New Antibiotic Development in the United States and Europe
Authors: Murthannagari Vivek Reddy , Thumpati Vaishnavi Parimala , GNK Ganesh 
Published: April 2024

Abstract
Antimicrobial resistance is a global concern that has led to millions of deaths worldwide. Genetic changes occur naturally in pathogens such as viruses, bacteria, parasites, and fungi. To overcome these concerns, there is a need to develop a new generation of antimicrobials. In an effort to encourage innovation, both the United States (US) and the European Union have introduced exclusivity programs. The US offered 5 years of additional nonpatent exclusivity for Qualified Infectious Disease Products under the Generating Antibiotic Incentives Now Act. In parallel, the European Commission offers a patent extension of 12 months across Europe (EU) countries or the option to sell the vouchers to other pharmaceutical companies through transferable exclusivity extension vouchers. This review focuses on the most important innovative strategies of antibiotic development the drug approvals, their mode of action, spectra of activity, and targeting of microorganisms, in past 5 years were mentioned, and discusses how to overcome the challenges of drug approval under antibiotic exclusivity in the US and EU, which will benefit the companies to develop novel drugs in several nations.
Adenovirus F40/41 Gastroenteritis-Associated Emphysematous Gastritis: A Case Report
Authors: Lathiya Maulik K. , La Nou Abigail T. , Linnaus Maria E. , Cullinan Susan M. 
Published: April 2024

Abstract
Emphysematous gastritis (EG) is a rare form of gastritis characterized by gastric wall pneumatosis. It is associated with a high mortality rate. Our case report describes a patient with a history of atrial fibrillation treated with apixaban, prior stroke, and schizoaffective disorder who showed epigastric tenderness on examination. However, no peritonitis signs were recorded, and laboratory values revealed high lactate levels and the presence of adenovirus F40/41. Abdominal computed tomography scan showed extensive portal venous gas in the left hepatic lobe of the liver, as well as pneumatosis involving the entire stomach, indicating EG. The diagnosis was histologically confirmed and initially managed medically, which proved inefficacious, necessitating surgical intervention in the form of a laparotomy and esophagojejunostomy with Roux-en-Y reconstruction. This case report suggests a potential association between EG and adenovirus F40/41–induced gastroenteritis, thereby emphasizing the challenging nature of EG. It underscores the need for comprehensive research to enhance our understanding of its underlying causes and effective treatment strategies.
The Association Between Mood Stabilizers, Sleep Quality, and Functioning in Patients With Remitted Bipolar Disorder
Authors: Gokcay Hasan , Solmaz Mustafa 
Published: April 2024

Abstract

Purpose/Background
The current study aimed to examine the differences in sleep quality, illness severity, and functioning in remitted bipolar disorder patients who are using mood stabilizers and antipsychotics either as monotherapy or as combination/additional therapy.

Methods/Procedures
A total of 113 remitted outpatients with Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) bipolar disorder were recruited. The patients were classified on the basis of their current treatment regimen: 44 patients were receiving a single mood stabilizer, 21 patients were receiving a single antipsychotic, and 48 patients were receiving a combination therapy of a single mood stabilizer and a single antipsychotic. The Pittsburgh Sleep Quality Index (PSQI), Global Assessment of Functioning (GAF), and Insomnia Severity Index (ISI) were applied.

Findings/Results
The GAF score was significantly lower in the combination group compared with the other 2 groups. Scores on the PSQI and ISI did not differ between the 3 groups. More than half (66.4%) of all patients had poor sleep quality. Total score on the PSQI was significantly correlated with age, body mass index, and GAF. Insomnia Severity Index was significantly correlated with the duration of illness, total number of episodes, and GAF. Multiple linear regression analysis indicated that GAF (β = −0.114) and ISI (β = 0.661) were significantly associated with the PSQI total score.

Implications/Conclusions
Our findings suggest that implementing interventions to enhance functioning is crucial for improving sleep quality in remitted bipolar patients.
Efficacy and Safety of Adding Lurasidone to Ongoing Therapy With Lithium or Valproate for the Treatment of an Acute Bipolar Depressive Episode
Authors: Tocco Michael , Mao Yongcai 
Published: April 2024

Abstract

Purpose
The aim of this study was to compare the efficacy and safety profile of lurasidone combined with either lithium or valproate, in the short-term treatment of patients with bipolar depression.

Methods
Data were pooled from two 6-week, double-blind, placebo-controlled trials of patients with bipolar depression on stable doses of lithium or valproate randomized to lurasidone (20–120 mg/d) or placebo. Efficacy measures included the Montgomery-Åsberg Depression Rating Scale, Clinical Global Impressions Bipolar Scale, and the Quick Inventory of Depressive Symptomatology via self-assessment and were analyzed using a mixed model for repeated measures approach.

Results
Notably larger week 6 effect sizes were observed when lurasidone was added to lithium, compared with when lurasidone was added to valproate, on 2 of the 3 depression outcome measures, Montgomery-Åsberg Depression Rating Scale total score (d = 0.45 vs 0.22) and Quick Inventory of Depressive Symptomatology via self-assessment (d = 0.63 vs 0.29); the efficacy advantage was smaller on the Clinical Global Impressions Bipolar Scale depression score (d = 0.34 vs 0.29). Similar adverse event profiles were observed for lurasidone treatment in combination with either lithium or valproate. The most frequently reported events (≥5%) in both groups were nausea, parkinsonism, somnolence, akathisia, and insomnia. Minimal changes in weight, lipids, and measures of glycemic control were observed during treatment with lurasidone combined with either lithium or valproate.

Conclusions
Lurasidone added to either lithium or valproate was found to be an effective treatment for bipolar depression, with a larger antidepressant effect observed when lurasidone was combined with lithium. There were no clinically meaningful differences in the safety or tolerability of lurasidone when used adjunctively with lithium or valproate.
A Rapid Review of the Effects of the COVID-19 Vaccine Among Individuals Taking Clozapine
Authors: Das Aparna , Sawyer Amanda T. , Bagla Prabhava 
Published: April 2024

Abstract

Background
The COVID-19 pandemic prompted the rapid development of vaccines to combat the virus. Several COVID-19 vaccines have proven effective in preventing infection, hospitalization, and death. Vaccination has been especially recommended for vulnerable populations, such as individuals with psychiatric illnesses who face increased risks due to comorbidities and socioeconomic factors. This rapid review identifies and analyzes the effects of COVID-19 vaccines among individuals taking clozapine.

Methods
The review included articles from PubMed, OVID, Clinical Key, Web of Science, and Google Scholar, published between September 2020 and December 2023. Inclusion criteria were peer-reviewed journals, English language, patients on clozapine receiving a COVID-19 vaccine, and documented vaccine-related adverse effects.

Results
Twelve articles were included, consisting of 8 case reports, 1 cross-sectional study, and 3 prospective observational studies, involving 298 subjects, with 9 subjects from case reports. After the first vaccine dose, 27 of 248 subjects experienced adverse effects, with 1 case report advising a temporary halt and dose reduction of clozapine. The subject in this case was admitted in a delirious state 4 days after vaccination with repeated falls and urinary incontinence; active infectious and neurologic etiologies were ruled out. Second dose data were available for 261 subjects, with 31 reporting adverse effects. Adverse effects included hematological changes, delirious state, seizures, and fever.

Conclusions
The review suggests that individuals on clozapine receiving COVID-19 vaccines may experience adverse effects. Clozapine levels and immune system interactions should be monitored in these cases.
Microsampling Techniques Suitable for Therapeutic Drug Monitoring of Antipsychotics
Authors: Geers Lisanne M. , Loonen Anton J.M. , Touw Daniël J. 
Published: April 2024

Abstract

Background
Therapeutic drug monitoring (TDM) of antipsychotics for dose titration or detection of noncompliance is not uncommon in daily practice. Normally, TDM implies measuring a drug concentration in venous blood samples. This technique is invasive and requires trained assistants and patients normally need to go to an outpatient clinic. Over the past decades, sensitivity of analytical equipment has improved leading to a growing interest in microsampling techniques. These techniques are minimally invasive, require a small volume (<100 μL), usually result in stable samples, and can be collected by the patient or a caregiver at home. Before a microsampling technique can be used in daily routine, proper method development and a clinical validation study should be performed.

Method
For this review, the databases of PubMed and Embase were systematically searched. Currently available microsampling techniques for antipsychotics in blood, serum, or plasma are summarized. Subsequently, it has also been assessed whether these techniques are sufficiently validated for TDM monitoring in daily practice.

Results
Several microsampling techniques are available today, for example, dried blood spot sampling, dried plasma extraction cards, and volumetric absorptive microsampling. Eighteen studies were identified in which a microsampling technique for 1 or a few antipsychotics was chemically analytically and clinically validated. However, the majority of these studies have relevant shortcomings that mean its usefulness for different antipsychotics is not yet well established.

Conclusions
Microsampling for TDM can be recommended for patients using clozapine. For TDM of other antipsychotics, it is a very promising development.
Comparative Efficacy of Dopamine Partial Agonists by Doses for Treatment-Resistant Depression
Authors: Terao Itsuki , Kodama Wakako 
Published: April 2024

Abstract

Background
The augmentative antidepressant effects of dopamine partial agonists (aripiprazole, brexpiprazole, and cariprazine) for treatment-resistant depression have been compared in a previous network meta-analysis. However, the comparative efficacy of the dose-responses of these drugs remains unclear. Therefore, we aimed to estimate the dose-response relationships and compare the effects of each dopamine partial agonist doses.

Methods
We conducted a systematic review of the Cochrane Library, PubMed, CINHAL, and ClinicalTrials.gov databases until January 1, 2023. Double-blind, randomized, placebo-controlled trials evaluating aripiprazole, brexpiprazole, and cariprazine for treatment-resistant depression were included. A random-effect dose-response model-based network meta-analysis was conducted. This study was registered in PROSPERO (CRD42023393035).

Results
The maximum effective doses were 5.5 mg for aripiprazole, 1.6 mg for brexpiprazole, and 1.5 mg for cariprazine, respectively. Although all doses of the 3 drugs were significantly more effective than placebo, aripiprazole ranging from 5.5 to 12.5 mg was significantly more effective than brexpiprazole 0.5 mg and cariprazine ranging from 0.5 to 1 mg. Moreover, aripiprazole ranging from 7.5 to 12.5 mg was significantly more effective than all doses of cariprazine. In addition, brexpiprazole ranging from 1 to 3 mg was significantly more effective than cariprazine 0.5 mg and brexpiprazole ranging from 1.6 to 2.5 mg was significantly superior to cariprazine 1 mg. There were no doses at which brexpiprazole overcame aripiprazole, and cariprazine overcame aripiprazole or brexpiprazole.

Conclusions
Aripiprazole, brexpiprazole, and cariprazine may be effective in treatment-resistant depression in that order, with the maximum effective doses at 5.5 mg, 1.6 mg, and 1.5 mg, respectively.