bluuebunny/crossref_metadata_2025_split huggingface dataset:
Can Tonsillar Retractor–Induced Tongue Edema Be a New Complication in Pediatric Patients Undergoing Tonsillectomy Detected by Ultrasonography? A Prospective, Case-Controlled, Observational Study
Authors: Onal Merih , Colpan Bahar , Elsurer Cagdas , Bozkurt Mete Kaan , Ozturk Mehmet , Onal Ozkan , Turan Alparslan 
Published: July 2020

Background: Tonsillectomy is one of the most common surgical procedures in pediatric patients. The tonsillar retractor, which is routinely used during a tonsillectomy, applies high pressure to the patient’s tongue and can lead to various complications. Aims: This study aimed to explore tongue edema induced by the pressure applied by tonsillar retractor, using ultrasonography in pediatric patients undergoing tonsillectomy surgeries. Materials and Methods: Sixty-one patients were included in the study. The tonsillectomy group included 31 patients who underwent tonsillectomy surgery, while the control group included 30 patients who underwent inguinal hernia and circumcision surgery. Submental coronal plane ultrasonography examinations of the tongue were performed twice for each patient. In the tonsillectomy group, the first examination of tongue area (TA1) was done immediately after intubation but before the placement of tonsillar retractor. The second examination (TA2) was done at the end of the tonsillectomy surgery after the removal of the tonsillar retractor but before extubation. In the control group, the first examination (TA1) was done immediately after intubation, whereas the second examination (TA2) was done at the end of the surgery before extubation. These results were compared with those for the control group. Results: Groups were similar in terms of demographics and intubation duration. Groups did not significantly differ in terms of TA1 ( P = .212), but they significantly differed in terms of TA2 ( P = .000). They also significantly differed in terms of tongue edema defined as TA2 − TA1 ( P = .000). Conclusions and Significance: Tonsillar retractor does cause tongue edema in tonsillectomy surgeries. This tongue edema seems to be a result of the pressure applied by the tonsillar retractor. This study is the first to demonstrate the possible role of ultrasonography examination in determining the tonsillar retractor–induced tongue edema in pediatric patients.
National Database Research in Head and Neck Reconstructive Surgery: A Call for Increased Transparency and Reproducibility
Authors: Bur Andrés M. , Villwock Mark R. , Nallani Rohit , Gomez Ernest D. , Varvares Mark A. , Villwock Jennifer A. , Cannady Steven B. , Wax Mark K. 
Published: July 2020

ObjectiveTo reproduce a published study comparing outcomes of patients who underwent microvascular reconstruction by plastic surgeons and otolaryngologists and to examine how case selection and methodology using the National Surgical Quality Improvement Program (NSQIP) data set can affect results and conclusions.Study DesignCross‐sectional analysis of US national database.SettingAmerican College of Surgeons National Surgical Quality Improvement Program (NSQIP) from 2005 to 2017.Subjects and MethodsA recently published study that used the NSQIP database to compare outcomes after head and neck free tissue transfer between plastic surgeons and otolaryngologists was reproduced. Different approaches to case selection and statistical analysis were evaluated and their effects on statistical significance and study conclusions were compared.ResultsWhen all cases of free tissue transfer, captured in NSQIP between 2005 and 2017, were compared between plastic surgery and otolaryngology, plastic surgery patients appeared to have lower rates of complications and length of stay. However, a more in‐depth analysis demonstrated that these results were confounded by older and sicker otolaryngology patients. A second analysis of the same NSQIP data, limited to only head and neck oncologic reconstructions, demonstrated that otolaryngology patients had fewer complications on univariate and multivariable analysis.ConclusionWe demonstrated how case selection and analysis can significantly affect results. It is incumbent upon researchers who use NSQIP and other publicly available data sets to fully detail their methodology to allow other researchers to reproduce and evaluate their work and for the journal editorial process to carefully evaluate the methodology and conclusions of their contributing authors.
Bioimpedance spectroscopy and volumetry in the immediate/short-term monitoring of intensive complex decongestive treatment of lymphedema
Authors: Cavezzi Attilio , Urso Simone U , Paccasassi Stefania , Mosti Giovanni , Campana Fausto , Colucci Roberto 
Published: July 2020

Aims To assess (a) immediate/short-term outcomes of intensive complex decongestive treatment of lower limb lymphedema, by means of bioimpedance spectroscopy and tape measurement-based volumetry, and (b) correlation between these two methods. Patients and methods Cohort study on patients affected by unilateral primary or secondary lymphedema, stage II or III. Patients underwent complex decongestive treatment (manual and electro-sound lymphatic drainage, compression bandage, exercises, low-carb nutrition, and dietary supplements) for six days. Before (D0), three and six days after complex decongestive treatment (D3 and D6), volumetry and bioimpedance spectroscopy data of the total limb and lower leg were collected. Statistical analysis was applied to pre–post treatment outcomes and to the volumetry/bioimpedance spectroscopy correlation. Results Forty-one patients (15 males and 26 females, mean age: 50.7 years) were included. A progressive improvement of volumetry and bioimpedance spectroscopy figures was recorded. Total limb and leg volumetry (mean value in cc) was, respectively, 11,072.9 and 3150.8 at D0, 10,493 (−5.2%, p = 0.001) and 2980.2 (−5.4%, p < 0.001) at D6. Total limb lymphatic index at D0 and D6 was 18.9 and 14.8 (−21.5%, p < 0.001). Total limb resistance at D0, D3, and D6 was 200.4, 225.7, and 237.5 (+18.5%, p < 0.001), respectively; leg resistance at D0 and D6 was 117.5 and 150 (+27.7%, p < 0.001), respectively. Total limb reactance at D0, D3, and D6 was 12.2, 15, and 16.6 (+35.5%, p < 0.001), respectively. Leg reactance at D0 and D6 was 7.7 and 11.5 (+ 49.6%, p < 0001), respectively. Correlation volumetry/bioimpedance spectroscopy data were (a) total limb volumetry/resistance rho = −0.449, p < 0.01; volumetry/reactance rho=−0.466, p < 0.01; volumetry/lymphatic index rho = 0.581, p < 0.01; (b) leg volumetry/resistance rho=−0.579, p < 0.01; volumetry/reactance rho=−0.469, p < 0.01; volumetry/lymphatic index rho = 0.466, p < 0.05. Conclusions Complex decongestive treatment on lymphedematous limbs was effective at short term; both volumetry and bioimpedance spectroscopy showed a statistically significant improvement. Resistance and reactance increase, with lymphatic index decrease, correlated with volumetry decrease. Bioimpedance spectroscopy proved to help to assess fluid decrease and the tissue-related parameters variations.
Association Between the Prothrombin Time–International Normalized Ratio and Concomitant Use of Antibiotics in Warfarin Users: Focus on Type of Antibiotic and Susceptibility of Bacteroides fragilis to Antibiotics
Authors: Yagi Tatsuya , Naito Takafumi , Kato Ayami , Hirao Kensho , Kawakami Junichi 
Published: July 2020

Background: The difference in type of antibiotics and susceptibility of Bacteroides fragilis to antibiotics may influence warfarin anticoagulation. However, these influences have not been clarified in clinical settings. Objectives: This study aimed to investigate association the between the prothrombin time–international normalized ratio (PT-INR) and concomitant use of antibiotics in a real-world population of warfarin users. Methods: This was a single-center cohort study using data from health records and included patients who received β-lactams (BLs)/fluoroquinolones (FQs) during ongoing warfarin treatment (2011-2015) at Hamamatsu University Hospital in Japan. Antibiotics were categorized into those to which B fragilis is susceptible (BLsus, FQsus) and those to which it is not (BLnon, FQnon) and into those given orally (BLpo, FQpo) or intravenously (BLiv, FQiv). Outcomes were excessive PT-INR and changes in PT-INR, defined as the ratio (INR ratio) and difference (ΔINR) of maximum PT-INR and baseline PT-INR. Excessive PT-INR was graded as INR ratio of >1.5 or >2.5. Results: A total of 1185 warfarin users were included. The proportion of INR ratio >2.5 in FQiv was higher than in BLiv (95% CI: 1.59-46.5). The proportions with an INR ratio of >1.5 in BLsus and FQsus were higher than in BLnon (1.72-14.1) and FQnon (1.05-9.36), respectively. ΔINR values in FQpo, FQiv, and FQsus were higher than those in BLpo, BLiv, and FQnon, respectively. Conclusions and Relevance: Concomitant use of FQs, or of antibiotics to which B fragilis is susceptible is associated with higher risk of excessive anticoagulation. These findings would contribute to safe and proper antibiotic treatment in warfarin users.
Comparison of two different intravenous serotonin antagonists used for chemotherapy-induced nausea and vomiting prophylaxis in patients treated with moderately emetogenic risk regimens: A retrospective analysis from a large academic medical center
Authors: Gamble Melissa , Carroll Elisabeth , Wright Garth C , Glode Ashley E 
Published: July 2020

Introduction Chemotherapy-induced nausea and vomiting (CINV) can be a serious and debilitating adverse effect that is highly feared by cancer patients. For patients receiving moderately emetogenic chemotherapy regimens at our institution in the ambulatory infusion center, palonosetron was selected as the preferred serotonin (5-HT3) antagonist for CINV prophylaxis per the 2016 NCCN Guidelines, when a neurokinin1 antagonist was not included in the prophylactic regimen. The purpose of this study was to evaluate the efficacy of dexamethasone and palonosetron versus granisetron for the prevention of CINV in patients receiving moderately emetogenic chemotherapy regimens. Methods This study is an Institutional Review Board-approved, single-center retrospective review of electronic health records including patients who received moderately emetogenic chemotherapy regimens with CINV prophylaxis with dexamethasone and either palonosetron or granisetron. Results A total of 268 eligible patients were included in the study. Eighty-eight patients received palonosetron and 180 patients received granisetron as their 5-HT3 receptor antagonist between October 31, 2014 and October 31, 2016. There were no statistically significant differences between the two antiemetic groups for the primary outcome of presence of any change in day 1 intravenous prophylactic antiemetics. Nine (10.23%) palonosetron patients and 15 (8.33%) granisetron patients required a change in their day 1 intravenous prophylactic antiemetics ( P = 0.610). Conclusions Despite palonosetron’s better efficacy, longer half-life, and higher binding affinity, the results of this retrospective review demonstrates that the choice of serotonin antagonist, palonosetron or granisetron, did not result in a change in day 1 intravenous prophylactic antiemetics or antiemetic outpatient medications for patients undergoing moderately emetogenic chemotherapy regimens.
Wound complications after total hip arthroplasty: a prospective, randomised controlled trial comparing staples with sutures
Authors: Mallee Wouter H , Wijsbek Anne E , Schafroth Matthias U , Wolkenfelt Julius , Baas Dominique C , Vervest Ton M J S 
Published: July 2020

Objective: Does the use of staples or sutures for wound closure have a lower surgical site infection rate in patients receiving primary total hip arthroplasty (THA)? Design: Prospective, randomised controlled multicentre trial. Methods: 535 patients undergoing THA were included and randomised into 2 groups: 268 wounds were closed with staples, and 267 with sutures. Primary outcome was surgical site infection (SSI). Secondary outcomes were prosthetic joint infection (PJI), other wound complications (dehiscence, necrosis and prolonged drainage) and duration of admittance. Follow-up occurred at 2, 6, and 12 weeks, and at 1 year. Results: There were no significant demographic differences between the 2 groups. SSI occurred more frequently when wounds were closed with staples (4% compared to 1% with sutures; OR 2.8; CI, 0.885–0.952; p = 0.057). SSI was treated with oral antibiotics. The staples group showed significantly more wound complications (17% compared to 5%; OR 3.943, CI 2.073–7.498; p = 0.000). Wound discharge was significantly prolonged in the staples group ( n = 40, compared to n = 12 in the sutures group; OR 3.728; CI, 1.909–7.281; p = 0.000). There was no significant difference in PJI ( p = 0.364). Conclusions: In this large RCT comparing staples with sutures after THA, the use of staples is associated with a nearly 3 times greater risk of SSI (OR 2.8; p = 0.057). Staples significantly prolong wound discharge. The use of sutures for wound closure after THA is advised. Trial registration: Staples Or Sutures trial (S.O.S. trial) http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3946 , NTR3946.
Alternative vascular device for high-flow computed tomography angiography: ultrasound-guided long peripheral catheter (4 Fr × 10 cm)
Authors: Watts-Pajaro Fredy , Uribe-Buritica Francisco L 
Published: July 2020

Introduction: Radiological studies that require contrast media are common and useful in the emergency department. Alternatives have been proposed for the administration of contrast agent in patients with difficulty in the insertion of vascular access. Since 2017, our institution has used a 4-Fr × 10-cm-long peripheral catheter (Leadercath; Vygon) for venous insertion. Its ultrasound-guided insertion is carried out by emergency physicians. So far, there are no reports in the literature about the use of this long peripheral catheter for computed tomography angiography. Objective: To describe the experience with the said device, to point out the complications associated with it, and to evaluate it as an alternative way to gain vascular access for patients with limited venous access. Methods: An observational, analytical, and retrospective study was conducted. The study included patients who received an ultrasound-guided 4-Fr × 10-cm-long peripheral catheter (Leadercath; Vygon). Transparent, radiopaque, polyethylene, 18-gauge Leadercath from Vygon, sold as peripheral arterial catheter and sometimes used “off-label” as venous catheter with a flow capacity of up to 24 mL/min, was used. The flow capacity for gravity flow is 24 mL/s; with pump-driven flow, we achieved a flow infusion of 5–6 mL/s. Univariate analyses were performed. Normality was determined through the Shapiro–Wilk test. Results: In total, 172 patients met the inclusion criteria. Of them, 115 (67%) were female and the average age was 59 years. The main indication for performing the computed tomography angiography was the suspicion of pulmonary embolism (38.6%). The most frequent type of computed tomography angiography study was pulmonary tomography (88 patients, 51.5%). The contrast medium infusion rate was 6 mL/s in 51.5% (n = 88) of cases, 4.5 mL/s in 36.3%, and 5 mL/s in 12.3%. One adverse event occurred. Conclusion: An 18-gauge-long peripheral catheter (4 Fr × 10 cm, Leadercath; Vygon) following specific protocols appears to be safe for conducting high-flow computed tomography studies in patients with limited venous access.
Improvement in Compliance With Smoke-Free Environment Regulations at Hotels and Restaurants in Vietnam After an Administrative Intervention
Authors: Giang Kim Bao , Diep Pham Bich , Van Minh Hoang , Huong Nguyen Thi Diem , Lam Nguyen Tuan , Nga Pham Quynh , Takeuchi Momoe , Park Kidong 
Published: July 2020

Introduction: Vietnam is among the countries with the highest smoking prevalence among male adults, as well as high prevalence of secondhand smoke exposure at indoor places. In many countries, including Vietnam, exposure to tobacco smoking is greatest in restaurants/bars and hotels. This study aims to analyze the compliance of hotels and restaurants to smoke-free environment regulations before and after an intervention. Methods: Direct observations were done at the receptions, conference rooms, designated smoking areas, restaurants, and lobbies of 140 hotels and the dining rooms, kitchens, and toilets of 160 restaurants before and after an intervention. The intervention was a training course conducted by police officers followed by 3 monthly supervision visits by police officers. Compliance with smoke-free enviornment regulations was observed and assessed to generate a compliance score for each location and overall. Tobit regression was used to examine the relationship between compliance scores and the intervention and other variables such as hotel and restaurant characteristics. Results: Before the intervention, the highest compliance rates were found for “no tobacco advertisement” and “no cigarette selling” regulations (95%-100%) in almost all sites in hotels and restaurants. The lowest compliance rates were found for “having nonsmoking signs.” The rate of compliance with all regulations was only 5% for hotels and 0.06% of restaurants. Improvement after intervention was clearly observed, in the rate of compliance with all regulations by more hotels (15.7%) and overall compliance scores of hotels and restaurants. Conclusions: The intervention with participation of the police officers proved to be effective in improving compliance with smoke-free regulations. It is recommended to continue this intervention in the same areas as well as to expand the intervention to other areas.
Physical restraint of children and adolescents in mental health inpatient services: A systematic review and narrative synthesis
Authors: Nielson Simon , Bray Lucy , Carter Bernie , Kiernan Joann 
Published: July 2020

Physical restraint is regularly used in children and adolescent mental health care, often as a reactive behaviour management strategy. Physical restraint has been associated with physical injury, but psychological consequences are poorly understood. The aim of this systematic review was to examine physical restraint of children and adolescents in inpatient mental healthcare services. Healthcare databases were searched to identify English language publications discussing anyone aged ≤18 years who had experienced physical restraint as a mental health inpatient. No date restrictions were applied. Sixteen quantitative studies are included within this review. Most studies are retrospective in nature. Publications were appraised using the Critical Appraisal Skills Programme quality assessment tool. Common characteristics associated with children and adolescents who experience physical restraint include age, gender, diagnosis, and history. Most studies associate physical restraint with the management of aggression. Findings suggest that it may be a combination of patient (intrinsic) and environmental (extrinsic) factors which ultimately lead to children and adolescents experiencing restraint. This review confirms that little is known about children and adolescents’ first-hand experiences of physical restraint. Future research should address children and adolescents’ perceptions and first-hand experiences of physical restraint.
Low-cut, low-vacuum vitrectomy for releasing an embedded intraocular foreign body
Authors: Aruna SK , Ganne Pratyusha , Baskaran Prabu 
Published: July 2020

Background Removal of an embedded intraocular foreign body remains challenging due to the risks of bleeding and retinal damage. We present a novel technique to deal with this situation. Case report A 32-year man presented with two months of decreased vision in one eye (best corrected visual acuity of 20/200), a year after a workplace injury that necessitated surgery for an open globe injury. Examination revealed the sequalae of his previous surgery, a subtotal retinal detachment and an embedded intraocular foreign body close to inferior ora serrata at the 6 'o clock position confirmed by imaging. The other eye was normal. A pars plana vitrectomy was performed and the embedded intraocular foreign body was released from surrounding dense adhesions using the vitrectomy probe set at 1000 cuts/minute and 100 mm Hg vacuum, followed by fluid air exchange and endolaser with silicon oil injection. The retinal detachment settled well post-operatively, and at the end of one month, the patient had best corrected visual acuity of 20/60. Conclusions The low-cut, low-vacuum vitrectomy technique can be considered as a safe option for releasing the embedded intraocular foreign body in complex ocular trauma scenarios.
A comparison of phase I dose-finding designs in clinical trials with monotonicity assumption violation
Authors: Abbas Rachid , Rossoni Caroline , Jaki Thomas , Paoletti Xavier , Mozgunov Pavel 
Published: July 2020

Background/Aims In oncology, new combined treatments make it difficult to order dose levels according to monotonically increasing toxicity. New flexible dose-finding designs that take into account uncertainty in dose levels ordering were compared with classical designs through simulations in the setting of the monotonicity assumption violation. We give recommendations for the choice of dose-finding design. Methods Motivated by a clinical trial for patients with high-risk neuroblastoma, we considered designs that require a monotonicity assumption, the Bayesian Continual Reassessment Method, the modified Toxicity Probability Interval, the Bayesian Optimal Interval design, and designs that relax monotonicity assumption, the Bayesian Partial Ordering Continual Reassessment Method and the No Monotonicity Assumption design. We considered 15 scenarios including monotonic and non-monotonic dose–toxicity relationships among six dose levels. Results The No Monotonicity Assumption and Partial Ordering Continual Reassessment Method designs were robust to the violation of the monotonicity assumption. Under non-monotonic scenarios, the No Monotonicity Assumption design selected the correct dose level more often than alternative methods on average. Under the majority of monotonic scenarios, the Partial Ordering Continual Reassessment Method selected the correct dose level more often than the No Monotonicity Assumption design. Other designs were impacted by the violation of the monotonicity assumption with a proportion of correct selections below 20% in most scenarios. Under monotonic scenarios, the highest proportions of correct selections were achieved using the Continual Reassessment Method and the Bayesian Optimal Interval design (between 52.8% and 73.1%). The costs of relaxing the monotonicity assumption by the No Monotonicity Assumption design and Partial Ordering Continual Reassessment Method were decreases in the proportions of correct selections under monotonic scenarios ranging from 5.3% to 20.7% and from 1.4% to 16.1%, respectively, compared with the best performing design and were higher proportions of patients allocated to toxic dose levels during the trial. Conclusions Innovative oncology treatments may no longer follow monotonic dose levels ordering which makes standard phase I methods fail. In such a setting, appropriate designs, as the No Monotonicity Assumption or Partial Ordering Continual Reassessment Method designs, should be used to safely determine recommended for phase II dose.