bluuebunny/crossref_metadata_2025_split huggingface dataset:
Psychometric Validation of the Danish Version of the Oswestry Disability Index in Patients With Chronic Low Back Pain
Authors: Comins Jonathan , Brodersen John , Wedderkopp Niels , Lassen Michael Rud , Shakir Hassan , Specht Kirsten , Brorson Stig , Christensen Karl Bang 
Published: March 2020

Study Design.
Registry-based repeated-measures psychometric validation of the Danish Oswestry Disability Index (ODI).

Objective.
The goal was to use classical and modern psychometric validation methods to assess the measurement properties and the minimally clinical important difference (MCID) of the ODI in a Danish cohort of patients with chronic low back pain being treated with spinal surgery.

Summary of Background Data.
Scores for the ODI, EQ-5D, SF-36, leg pain, back pain, and a general rating of pain item from 800 patients with chronic low back pain were extracted from the National Danish Spine Registry (DaneSpine) at baseline and 1-year postspine surgery.

Methods.
Confirmatory factor analysis and item response theory (IRT) models were used to assess the psychometric properties of the ODI. MCID was also calculated based on generic legacy PROMs (EQ-5D and SF-36) and follow-up pain scores.

Results.
While ODI did not fit a Rasch model, adequate fit to a confirmatory factor analysis and a two-parameter item response theory model was found when accounting for differential item functioning across diagnostic subgroups (degenerative spondylolisthesis, spondylosis, spinal stenosis, and herniated intervertebral disc). In addition, each group exhibited substantially different MCID values.

Conclusion.
The Danish version of the ODI is valid and responsive, but only within each of the four major diagnosis subgroups: degenerative spondylolisthesis, spondylosis, spinal stenosis, and herniated intervertebral disc.

Level of Evidence: 4
Identification of Risk Factors for Readmission in Patients Undergoing Anterior Cervical Discectomy Fusion
Authors: Siracuse Brianna L. , Ippolito Joseph A. , Shin John , Harris Colin B. , Vives Michael J. 
Published: March 2020

Study Design:
This was a retrospective cohort study.

Objective:
The objective of this study was to analyze readmission rates among patients undergoing anterior cervical discectomy and fusion (ACDF), determine which factors were associated with higher readmission rates, and develop a scale for utilization during surgical planning.

Summary of Background Data:
ACDF is the most common surgical treatment for many cervical disk pathologies. With the Centers for Medicare and Medicaid Services selecting readmissions as a measure of health care quality, there has been an increased focus on reducing readmissions.

Materials and Methods:
There were 114,174 recorded ACDF surgeries in the derivation cohort, the State Inpatient Database (SID) of New York and California between 2006 and 2014. There were 115,829 ACDF surgeries recorded in the validation cohort, the SID from Florida and Washington over the same time period. After identification of risk factors using univariate and multivariate analysis of the derivation cohort, a predictive scale was generated and tested utilizing the validation cohort.

Results:
Overall, readmission rates within 30 days of discharge were 5.87% and 5.52% in the derivation and validation cohorts, respectively. On multivariate analysis of the derivation cohort, age older than 80 years [odds ratio (OR), 1.67] male sex (OR, 1.16), Medicaid insurance (OR, 1.90), Medicare insurance (OR, 1.64), revision ACDF (OR, 1.43), anemia (OR, 1.45), chronic lung disease (OR, 1.23), coagulopathy (OR, 1.42), congestive heart failure (OR, 1.31), diabetes (OR, 1.23), fluid and electrolyte disorder (OR, 1.56), liver disease (OR, 1.37), renal failure (OR, 1.59), and myelopathy (OR, 1.19) were found to be statistically significant predictors for readmission. These factors were incorporated into a numeric scale that, that when tested on the validation cohort, could explain 97.1% of the variability in readmission rate.

Conclusions:
Overall, 30-day readmission following ACDF surgery was 5%–6%. A novel risk scale based on factors associated with increased readmission rates may be helpful in identifying patients who require additional optimization to reduce perioperative morbidity.

Level of Evidence:
Level III—prognostic.
Pre-anaesthesia ultrasonography of the subclavian/infraclavicular axillary vein for predicting hypotension after inducing general anaesthesia
Authors: Choi Min Hee , Chae Ji Seon , Lee Hyun Jung , Woo Jae Hee 
Published: March 2020

BACKGROUNDBedside sonography of the inferior vena cava has been demonstrated to be a reliable tool for assessing intravascular volume status. Subclavian vein (SCV) assessment was proposed as a reasonable adjunct for measuring the inferior vena cava.OBJECTIVEWe examined whether the preoperative diameter and collapsibility index of the SCV or the infraclavicular axillary vein could predict the incidence of hypotension after induction of general anaesthesia in patients undergoing laparoscopic cholecystectomy.DESIGNProspective, observational study.SETTINGTertiary university hospital.PATIENTSAdults scheduled for laparoscopic cholecystectomy.INTERVENTIONSonographic evaluation of the SCV or the axillary vein (SCV-AV) before induction of anaesthesia.MAIN OUTCOME MEASURESThe main outcome was the association between the SCV-AV measurements (diameter an collapsibility index) and intra-operative hypotension (IOH) after induction of anaesthesia.RESULTSPatients who developed IOH had a higher collapsibility index of the SCV-AV during spontaneous breathing (P = 0.009) and deep inspiration (P = 0.002). After adjusting for confounding variables, the collapsibility index of the SCV-AV during spontaneous breathing was not a significant predictor of a decrease in mean arterial blood pressure (MAP) after inducing anaesthesia (P = 0.127), whereas the collapsibility index of the SCV-AV during deep inspiration was a significant predictor (P < 0.001).CONCLUSIONThe collapsibility index of the SCV-AV during deep inspiration was a significant predictor of IOH occurrence and the percentage decrease in MAP after inducing anaesthesia. Further studies in patients with higher collapsibility index are needed to confirm our findings, before the collapsibility index of the SCV-AV can be recommended unequivocally for clinical use.TRIAL REGISTRATIONThis trial was registered on 8 September 2017 at the Clinical Trial Registry of Korea (https://cris.nih.go.kr/cris/index.jsp; Identifier: KCT0001078KCT0002457), and the first patient was enrolled on 14 October 2017.
Methodological quality and transparency of clinical practice guidelines for difficult airway management using the appraisal of guidelines research & evaluation II instrument
Authors: Merchan-Galvis Angela M. , Caicedo Juan P. , Valencia-Payán Carmen J. , Calvache Jose A. 
Published: March 2020

BACKGROUND
Complications arising from airway management represent an important cause of morbidity and mortality. Clinical practice guidelines (CPGs) are systematically created documents that summarise knowledge and assist the delivery of high-quality medical care by identifying evidence that supports best clinical care.

OBJECTIVE
Using the Appraisal of Guidelines for Research & Evaluation II instrument, we aimed to evaluate the methodological rigour and transparency of unanticipated difficult airway management CPGs in adults.

DESIGN
Using PUBMED without language restrictions, we identified eligible CPGs between 1 January 1996 and 30 June 2019. All versions of a CPG were included as independent guidelines to assess improvements over time or the methodological limitations of each version. CPGs-related obstetrics or paediatrics or the management extubation in cases of difficult airway were excluded.

RESULTS
Fourteen CPGs were included. Of the six domains suggested by the Appraisal of Guidelines for Research & Evaluation II instrument, ‘applicability’ had the lowest score (23%) and ‘scope and objectives’ had the highest score (88%). The remaining domains (stakeholder involvement, editorial independence, rigour of development and clarity of presentation) had scores ranging between 56 and 81%. Overall, the highest scored CPG was the Difficult Airway Society 2015.

CONCLUSION
Future updates of CPGs for difficult airway management in adults and severely ill patients should consider more emphasis on the applicability of their recommendations to real clinical practice.
A Comparison of Tenofovir Predose Concentrations in Generic Pre-exposure Prophylaxis Formulations: A Short Communication
Authors: Cattaneo Dario , Gervasoni Cristina , Vinti Pietro , Baldelli Sara , Fusi Marta , Zagato Donatello , De Bona Anna , Suardi Elisa , Bossolasco Simona , Ancona Giuseppe , Rossotti Roberto , Cernuschi Massimo 
Published: March 2020

Background:
There is extensive evidence to show that pre-exposure prophylaxis (PrEP) using tenofovir disoproxil fumarate (TDF)-based formulations dramatically reduces the risk of HIV acquisition among individuals without HIV infection. Here, the authors aim to compare tenofovir plasma predose concentrations in subjects taking PrEP daily versus on demand and using different TDF-based generic formulations.

Methods:
Subjects providing informed signed consent for the measurement of tenofovir plasma levels were included in the study. Predose drug concentrations were stratified according to PrEP administration and the type of TDF-based formulation. The control group consisted of patients with HIV infection who were matched for renal function and were administered branded TDF that was not combined with boosted-antiretroviral drugs.

Results:
The study consisted of 100 subjects (mean age, 39 ± 10 years; body weight, 77 ± 11 kg). A wide distribution in tenofovir predose concentrations was observed, with values ranging from 17 to 297 ng/mL (coefficient of variation 77%). No significant differences were noted in tenofovir predose concentrations between subjects who were administered PrEP daily (n = 75) or on demand (n = 25) [94 (35–255) versus 104 (37–287) ng/mL; P = 0.476]. Comparable tenofovir predose concentrations were found between patients with HIV infection (n = 220) who were administered branded TDF and those without HIV infection who were treated with 5 different generic TDF-based formulations with generics-to-branded ratios. These were always within the range of 80%–125% and were used to define bioequivalence.

Conclusions:
The marketed generic formulations of TDF delivered tenofovir plasma predose concentrations comparable with those delivered by branded formulations.
Age-related macular degeneration therapy: a review
Authors: Ammar Michael J. , Hsu Jason , Chiang Allen , Ho Allen C. , Regillo Carl D. 
Published: March 2020

Purpose of review
The purpose of this review is to describe the current clinical landscape of potential future therapies for both nonexudative (dry) and exudative (wet) age-related macular degeneration (AMD). We highlight some of the more promising treatments that are furthest along in development.

Recent findings
Patients with dry AMD have long been hoping for a highly efficacious treatment that may slow disease progression or even help regain vision. Patients with wet AMD have many effective treatment options but still there are those who have suboptimal responses or are burdened by the high frequency of treatment. We detail exciting new concepts and targets for novel medications. Specifically, for dry AMD we discuss research looking at complement inhibition, neuroprotection, visual cycle modulators, cell-based therapies, and anti-inflammatory agents. For wet AMD we summarize new, potentially more durable anti-vascular endothelial growth factor agents, extended release options, and gene therapy.

Summary
There are promising new strategies for AMD. Many of the potential new treatments are in or have recently completed phase 2 or phase 3 clinical trials with promising results thus far, including some that have received US Food and Drug Administration approval. Additional therapeutic breakthroughs will likely continue to occur thanks to the number of clinical trials that are nearing the finish line.
Dermoid Cyst: Outcome Analysis in a Pediatric Referral Hospital
Authors: Montolío-Marzo Santiago , González-Valdivia Hugo , Casas-Gimeno Estér , Sebastian-Chapman Laura , Prat-Bartomeu Joan 
Published: March 2020

Purpose:
To describe the management of dermoid cysts in a pediatric referral hospital.

Methods:
Retrospective review of 115 patients with pathological diagnosis of dermoid cyst in a pediatric referral hospital between 2003 and 2019.

Results:
One hundred fifteen patients, 51 (44.3%) males, and 64 (55.7%) females were retrospectively reviewed. There were fifty-one (44.3%) right eyes and 64 (55.7%) left eyes. Mean age at surgery was 39.15 months (5.6 months–16.4 years). One hundred four (90.4%) lesions were superficial, and 11 (9.6%) were deep. Quadrant location was 63 (54.8%) superior-temporal, 45 (39.1%) superior-nasal, 4 (3.5%) inferior-temporal, and 2 (1.7%) in the nasal inferior quadrant. Most patients only had aesthetic concerns, but 3 (2.61%) showed lacrimal drainage obstruction symptoms, 2 (1.74%) had proptosis, and 1 case spontaneously drained to the cutaneous surface. Imaging was performed in 51 (44.3%) patients. Regarding to their radiodensity, 71.9% had low density content, 28.1% high density, and only 1 patient showed full liquid content; 10.9% showed heterogeneous content; 53.1% showed bone remodeling. Every patient but 1 underwent surgery for a barely accessible asymptomatic retrobulbar cyst. Nine cysts (7.8%) were breached during surgery. Three recurrences were found (2.6%), but only 1 was related to intraoperative breach.

Conclusions:
Dermoid cysts are the most common benign periorbital tumors in the pediatric population. Imaging is required for evaluation of lesions in atypical locations, deep or fixed to underlying tissue. Surgical removal is the gold standard of treatment. Multidisciplinary approach may be required in the most complex cases. After surgery, few complications and recurrences were found in our series.
Signatures in drug-induced liver injury
Authors: Tillmann Hans L. , Rockey Don C. 
Published: March 2020

Purpose of review
Drug-induced liver injury (DILI) can be induced by a myriad of drugs. Assessing whether the patient has DILI and assessing which drug is the most likely culprit are challenging. There has been too little attention paid to the concept that certain drugs appear to have unique clinical features or ‘phenotypes’.

Recent findings
Several case series of DILI because of various drugs have been published, and analysis of these case series points to the fact that individual drugs have characteristic DILI signatures. These clinical phenotypes can be characterized by latency, biochemical features (R-value), as well as clinical symptoms and signs. Several drugs, including isoniazid, amoxicillin-clavulanic acid, anabolic steroids, β-interferon and others, have highly unique clinical features. Such unique properties may be able to be used to improve adjudication processes.

Summary
Individual drugs have unique clinical DILI phenotypes or signatures. Furthermore, these may be able to be used to improve adjudication.
Effective use of hydroxyurea for sickle cell anemia in low-resource countries
Authors: Power-Hays Alexandra , Ware Russell E. 
Published: March 2020

Purpose of review
Over the past several decades, hydroxyurea has emerged as a well tolerated and potent disease-modifying therapy for children and adults with sickle cell anemia (SCA). Strong, evidence-based recommendations from the National Institutes of Health, American Society of Hematology, and British Society of Haematology document that hydroxyurea is now standard of care treatment for SCA. In low-resource settings, however, hydroxyurea is rarely utilized due to lack of availability, inadequate treatment guidance, and excessive costs.

Recent findings
Research trials conducted within the Caribbean and sub-Saharan Africa confirm the efficacy of hydroxyurea as a well tolerated, feasible, and beneficial treatment in low-resource countries. Hydroxyurea is therefore vital to reaching the targets for control of SCA outlined by the WHO. To maximize its utilization toward real-world effectiveness, specific attention must be given to healthcare provider education and training, public and institutional awareness, and medication access and affordability.

Summary
Efforts to introduce hydroxyurea effectively into low-resource countries should urgently address the lack of treatment guidelines, gaps in knowledge and clinical infrastructure, and medication inaccessibility. Partnerships among governmental, academic, pharmaceutical, and charitable organizations must tackle these barriers so that all individuals living with SCA worldwide can benefit from hydroxyurea.
Management of de-novo urothelial carcinoma in transplanted patients
Authors: Pradere Benjamin , Schuettfort Victor , Mori Keiichiro , Quhal Fahad , Aydh Abdulmajeed , Sari Motlagh Reza 
Published: March 2020

Purpose of reviewThe aim of this article is to review incidence, risk factors, and optimal management of de-novo urothelial carcinoma in transplant recipients.Recent findingsThere is a two to three-fold increased risk for de-novo malignant tumors after solid-organ transplantation, but there is currently no consensus regarding optimal management of de-novo urothelial carcinoma in transplanted patients. Known risk factors include polyomavirus BK, aristolochic acid, and smoking. Data suggest a higher rate of high-grade tumors, as well as predominantly higher stage at primary diagnosis, for both NMIBC and muscle-invasive bladder cancer (MIBC). Treatment for NMIBC includes TURB, mitomycin, and Bacille de Calmette-Guérin instillation with special concern to the immunosuppressive regime. Treatment of MIBC or advanced urothelial carcinoma includes radical cystectomy with chemotherapy if the patient is eligible. A screening should be performed in all transplant recipients, to allow early diagnosis.SummaryDe-novo urothelial carcinoma in transplant recipients is more frequent than in the general population and these tumors were more likely to be high-grade tumors and diagnosed at an advanced stage. There is very little information available on the optimal treatment for these patients. However, aggressive treatment and a strict management according the given recommendations are of the utmost importance.
Genetic testing in male infertility – reassessing screening thresholds
Authors: Liu James L. , Peña Vanessa , Fletcher Sean A. , Kohn Taylor P. 
Published: March 2020

Purpose of review
Genetic testing in male infertility is an essential part of the process of diagnosis. Genetic abnormalities, such as Y-chromosome microdeletion, chromosomal abnormalities and mutations for cystic fibrosis, can all negatively impact a male's fertility and can be tested for during a fertility evaluation. Both Y-chromosome microdeletion and chromosomal abnormalities increase in prevalence as sperm concentrations decrease, and azoospermic men have the greatest frequency of genetic abnormalities.

Recent findings
These genetic abnormalities can also be found in oligospermic men; however, on the basis of several recent studies, the prevalence of genetic abnormalities is lower in oligospermic men than previously thought.

Summary
The current screening thresholds are devised from the previously determined prevalences and have not been revised based on the emerging data; thus, in this review of the literature, we will discuss this new evidence and whether screening thresholds should be changed.
Do Antibiotics Reduce the Incidence of Infections After Percutaneous Endoscopic Gastrostomy Placement in Children?
Authors: Krom Hilde , van den Hoek Charlotte M.W. , Benninga Marc A. , Delemarre Eveline A. , de Jong Justin R. , Koot Bart G.P. , Tabbers Merit M. , Voogt Heleen , Kindermann Angelika 
Published: March 2020

ABSTRACTObjective:Percutaneous endoscopic gastrostomy (PEG) provides a long‐term solution for tube dependency. Pediatric guidelines recommend prophylactic antibiotic treatment (ABT) based on adult studies.Aim:To compare wound infection and other complications in children receiving a PEG with and without prophylactic ABT.Methods:Retrospective study including children 0 to 18 years undergoing PEG placement. Patients with (2010–2013) and without (2000–2010) ABT were compared with respect to the occurrence of wound infection and other complications.Results:In total, 297 patients were included (median age 2.9 years, 53% boys). Patients receiving ABT per PEG protocol (n = 78) had a similar wound infection rate (17.9% vs 21%, P = 0.625), significantly less fever (3.8% vs 14.6%, P = 0.013), leakage (0% vs 9.1%, P = 0.003) and shorter hospital admission (2 vs 4 days, P = 0.000), but more overgranulation (28.2% vs 8.7%, P = 0.000) compared with those without (n = 219). Patients receiving any ABT, per PEG protocol or clinical indication (n = 115), had similar occurrence of wound infection (19.1% vs 20.9%, P = 0.768), fever (7.8% vs 14.3%, P = 0.100) and leakage (3.5% vs 8.8%, P = 0.096), a significantly shorter hospital admission (3 vs 4 days, P = 0.000), but more overgranulation (21.7% vs 8.8%, P =0.003) compared with those without (n = 182).Conclusions:Prophylactic ABT does not seem to reduce the occurrence of wound infection but it might be beneficial with respect to fever, leakage and duration of hospital admission, but not overgranulation. A randomized controlled trial is needed to confirm our results.
Petechial Hemorrhages in Suicide by Hanging
Authors: Sundal Jon Andreas , Mæhle Bjørn Ove , Eide Geir Egil , Morild Inge 
Published: March 2020

AbstractHemorrhagic petechiae in the conjunctiva and the skin have been related to type of suspension and body height of the victims of hangings. In 265 cases of hanging, we retrospectively examined whether petechiae relate to type of suspension, body weight and height, body mass index (BMI), age, sex, type and thickness of the ligature, and blood alcohol content. The type of suspension was divided into completely suspended, incompletely suspended, and found with feet touching the ground. There was no significant difference in the frequency of petechiae between the feet touching the ground and complete suspension, and they were therefore considered as one group (complete suspensions). Incomplete suspensions had more (58.7%) petechiae than the complete suspension group (30.2%). Statistical analysis showed that incomplete suspension was significantly stronger related to the development of petechiae than complete suspension. Body mass index was the only variable able to add information to the type of suspension. In victims of incomplete hangings, high BMI yielded 2.58 times higher probability of developing petechiae than low BMI. These findings suggest that body size may contribute to the development of petechiae in hangings.
Surgeon's Perspective to Local Therapy in Oligometastatic Cancer
Authors: Boffa Daniel J. 
Published: March 2020

Abstract
Oligometastatic cancer has been recognized as a distinct clinical entity for over 100 years. For decades surgeons have been devising strategies to identify patients with oligmetastatic cancer that have the potential to be cured by surgically removing the oligometastases (“curative intent metastasectomy”). More recently, several studies have suggested there may be benefits to local therapy in oligometastatic cancer patients that are less likely to be cured. This has transformed the practice of local therapy in this setting away from “curative intent” to a broader purpose of “lesion-specific cytoreduction.” As a result, the pool of oligometastatic patients eligible for local therapy has been expanded. However, the boundaries that had previously framed the practice of local therapy in oligometastatic cancer have been obscured. The following is a single surgeon’s attempt to align the promise of this expanded role of local therapy, with the principles of risk-benefit deliberation that are intrinsic to the surgical discipline.