bluuebunny/crossref_metadata_2025_split huggingface dataset:
Trends in prevalence and complications for smokers who underwent total hip arthroplasty from 2011 to 2019: an analysis of 243,163 patients
Authors: Hadad Matthew J , Grits Daniel , Emara Ahmed K , Orr Melissa N , Murray Trevor G , Piuzzi Nicolas Santiago 
Published: February 2024

Background: Smoking is an established risk factor for postoperative complications after total hip arthroplasty (THA). It is unknown if the decreasing prevalence of adult smoking in the United States is reflected in the elective THA patient population. We aimed to investigate recent trends in: (1) the prevalence of smoking pre-THA, stratified by patient demographics; and (2) rates of 30-day complications and increased healthcare utilisation post-THA in smokers versus non-smokers. Methods: Patients who underwent primary elective THA (2011–2019) were identified using the National Surgical Quality Improvement Program database. A total of 243,163 cases (Smokers: n = 30,536; Non-smokers: n = 212,627) were included. Trends analyses were performed for smoking prevalence across the study period. Smokers were propensity score-matched (1:1) to a cohort of non-smokers ( n = 29,628, each), and rates of 30-day complications, readmission, and non-home discharge were compared. Results: The rate of preoperative smoking significantly decreased from 14.0% in 2011 to 11.6% in 2019 ( p-trend = 0.0286). When stratified, a significant decreasing trend in smoking was found for males and all races; within races, American-Indian/Alaska-Native race had the sharpest decline (2011:36.3% vs. 2019:23.2%). No significant change in 30-day complication rates among smokers or non-smokers was observed ( p-trend > 0.05), but non-home discharge significantly decreased for both smokers ( p-trend = 0.001) and non-smokers ( p-trend < 0.001). After matching, higher rates of superficial surgical site infections (SSI) (0.9% vs. 0.5%; p < 0.001), deep SSI (0.5% vs. 0.3%; p < 0.001), wound disruption (0.2% vs. 0.1%; p = 0.006), and readmission (4.2% vs. 3.1%; p = <0.001) were found in smokers versus non-smokers. Conclusions: The present study is encouraging that national efforts to reduce the prevalence of smoking may be successful within the THA population, but there is a persistently elevated risk of postoperative complications in smokers after THA.
Nurse-focused ultrasound-guided IV program improves core emergency department process measures
Authors: Kessler Ross , Hall Jane , Chipman Anne K , Hall Michael Kennedy , Amick Ashley 
Published: February 2024

Introduction: Ultrasound-guided peripheral IV catheter (USGIV) insertion is as an effective procedure to establish access in patients with difficult intravenous access (DIVA), a condition frequently encountered in the Emergency Department (ED). This study describes a DIVA quality improvement program focusing on rapid identification of DIVA patients and emergency nurse USGIV training and evaluates its impact on overall frequency of USGIV use and process measures related to quality of patient care. Methods: This is a retrospective cohort study of patients over 18 years of age, presenting to a single, tertiary care hospital between September 1, 2018 and September 30, 2020. Difference-in-difference analysis was used to compare ED process measures pre- and post-implementation of the DIVA Program, and multivariate logistic regression was used to identify associations between patient characteristics and difficult IV access. Results: The frequency of ED encounters associated with USGIV placement more than doubled post-implementation of the DIVA Program, rising from 606 to 1323. There were improved covariate-adjusted time estimates of core ED process measures for encounters associated with USGIV placement post-implementation, including decreases in time to CT with contrast from 4.8 h (95% CI = 4.4–5.2) to 4.1 h (95% CI = 3.8–4.4), pain medications from 2.4 h (95% CI = 2.1–2.6) to 1.8 h (95% CI = 1.6–2.0), IV antibiotics from 3.0 h (95% CI = 2.4–3.7) to 2.1 h (95% CI = 1.5–2.6), and ED length of stay from 6.4 h (95% CI = 6.2–6.6) to 6.0 h (95% CI = 5.9–6.2). Conclusion: A nurse-focused quality improvement program focused on teaching and promoting USGIV as a modality for managing difficult IV access was associated with increases in USGIV placement and improvements in core process measures related to quality of patient care.
Clinicopathological Features and Treatment Outcomes of Male Breast Cancer in Pakistani Population: A 10-Year Retrospective Cross-Sectional Study
Authors: Khalid Ibtissam Bin , Sarwar Albash , Khalid Hassham Bin , Sajjad Barka , Rehman Bushra , Parvaiz Muhammad Asad 
Published: February 2024

Background: Male breast cancer (MBC) accounts for 1% of global breast cancer cases. On account of its rarity, very few prospective clinical trials have been carried out on MBC. Pakistan has the highest incidence of breast cancer in Asia, but very limited data are available on MBC. Objectives: The objective is to determine the clinicopathological characteristics and treatment patterns of MBC in Pakistani population. Design: This is a retrospective cross-sectional study. Methods: A retrospective cross-sectional study carried out using the cancer database of Shaukat Khanum Memorial Cancer Hospital & Research Center. Men with a histologically proven breast cancer, stage 0 to III disease and requiring surgical intervention were included. The Kaplan-Meier curve and log-rank test were used for survival analysis. Results: Sixty-eight patients with MBC were included with a median age at diagnosis of 55 years. Most patients were stage II (47.1%). Invasive ductal carcinoma (IDC) was the commonest type (89.7%). Estrogen receptor (ER), progesterone receptor (PR), and Her-2 receptor positivity were 92.6%, 86.8%, and 32.4%, respectively. Mastectomy was performed in 95.6% of the cases. Neoadjuvant and adjuvant chemotherapy was administered in 25 (36.8%) and 26 (38.2%) patients, respectively. Fifty-five (80.9%) patients received adjuvant radiotherapy. Most of the patients (89.7%) received tamoxifen. The 5-year overall and disease-free survival was 88.2% and 80.9%, respectively. Patients receiving neoadjuvant chemotherapy had a better overall and disease-free survival ( P = .025). Conclusions: Male breast cancer occurs at a relatively earlier age in Pakistani population as compared with Western men. Mastectomy is the preferred surgical option for MBC on account of the advanced disease and delayed presentation. Neoadjuvant chemotherapy has a statistically significant effect on overall and disease-free survival, but in spite of these benefits, it remains underutilized.
Short- and long-term outcome after colon cancer resections performed by male and female surgeons: A single-center retrospective cohort study
Authors: Engdahl Jenny , Öberg Astrid , Bech-Larsen Sandra , Bergenfeldt Henrik , Vedin Tomas , Edelhamre Marcus , Öberg Stefan 
Published: February 2024

Background and objective: To assess the effect of surgeon sex on short- and long-term outcomes after colon cancer resections. Methods: Clinical data of patients who underwent colon cancer resections between 2010 and 2020 at Helsingborg Hospital, Sweden, were retrospectively obtained from medical records. The sex of the surgeon of each procedure was recorded. Morbidity, mortality, and long-term survival were compared in patients operated by male and female surgeons. Results: Colon cancer resections were performed by 23 male and 9 female surgeons in 1113 patients (79% elective, 21% emergent). After elective surgery, there was no difference in postoperative complications, 30-day mortality, or long-term survival between patients operated by male and female surgeons. Following emergent resections, the complication rate was significantly lower in patients operated by female surgeons (41.3% vs 58.1%, p = 0.019). Similarly, the rates of R1-resections (0% vs 5.2%, p = 0.039), reoperations (3.8% vs 14.2%, p = 0.014), and intensive care unit (ICU) care (6.3% vs 17.4%, p = 0.018) were significantly lower for patients operated by female surgeons, but there was no difference in 30-day mortality (6.3% vs 5.2%, p = 0.767). Cox regression analysis showed that long-term and cancer-free survival in patients emergently operated by male surgeons was significantly shorter than that of patients operated by female surgeons (hazard ratio = 1.9 (95% confidence interval (CI) = 1.3–2.8), p = 0.001 and hazard ratio = 1.7 (95% CI = 1.1–2.7), p = 0.016). Conclusions: The short- and long-term outcome after elective colon cancer resections were similar in patients operated by male and female surgeons. The outcome following emergent resections performed by female surgeons compared favorably with that of male surgeons, with fewer complications and reoperations and better long-term survival.
A Systematic Review on Thoracic Endovascular Repair Outcomes in Blunt Thoracic Aortic Injuries
Authors: Nana Petroula , Spanos Konstantinos , Behrendt Christian-Alexander , Brodis Alexandros , Haulon Stéphan , Kölbel Tilo 
Published: February 2024

Purpose: Blunt thoracic aortic injury (BTAI) represents a potentially life-threatening condition and thoracic endovascular aortic repair (TEVAR) is recommended as the first-line treatment (Class I level of evidence C) by the current guidelines. The aim of this systematic review was to determine the perioperative and mid-term follow-up outcomes of patients with BTAI treated with TEVAR. Materials and Methods: We reviewed the English literature published between 2000 and 2022, via Ovid, using MEDLINE, EMBASE, and CENTRAL databases, until July 30, 2022. Observational studies and case series, with ≥5 patients, reporting on the perioperative and follow-up outcomes of patients who underwent TEVAR for BTAI were included. The Newcastle-Ottawa Scale was used to assess the risk of bias. Primary outcomes were technical success and 30-day mortality, cerebrovascular morbidity. Secondary outcomes were mortality and re-interventions during the mid-term follow-up. Results: From 5201 articles identified by the literature search, 35 eligible studies were included in this review. All studies had a retrospective study design. In total, 991 patients were included. The mean age was 34.5±16.5 years (range=16–89 years). Technical success was 98.0% (odds ratio [OR], 95% confidence interval [CI]=0.98, 0.99, p<0.001, I2=0%). Mortality at 30 days was 5.0% (OR, 95% CI=0.03, 0.06, p<0.001, I2=5.56%). Spinal cord ischemia occurred in 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and stroke rate was 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%). The available follow-up was estimated at 29 months (range=3–119 months) with mortality rate at 2.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=0%) and re-intervention rate at 1.0% (OR, 95% CI=0.01, 0.02, p<0.001, I2=10.5%). Conclusion: Thoracic endovascular aortic repair showed high technical success and low early cerebrovascular morbidity and mortality rates. In the mid-term follow-up, the estimated mortality and re-intervention rates were also low. Furthermore, higher quality prospective studies are needed. Clinical Impact Thoracic endovascular aortic repair (TEVAR) is recommended as the first line treatement in patients with blunt thoracic aortic injuries (BTAI). This systematic review of 35 retrospective studies and 991 patients showed high technical success (98.0%) with an associated 30-day mortality at 5.0% and low spinal cord ischemia (1%) and stroke rates (2.0%). Mid-term mortality and re-intervention rates reassure the effectiveness of TEVAR in BTAI cases.
Rethinking the clinical research protocol: Lessons learned from the COVID-19 pandemic and recommendations for reducing noncompliance
Authors: Gooden Matthew J , Norato Gina , Landry Katherine , Martin Sandra B , Nath Avindra , Reoma Lauren 
Published: February 2024

Background/Aims Since the onset of the coronavirus disease 2019 (COVID-19) pandemic, 103.4 million cases and 1.1 million deaths have occurred nationally as of November 2023. Despite the benefit of mitigating measures, the pandemic’s effect on participant safety is rarely documented. Methods This study assessed noncompliance occurring from July 2019 to August 2021 that were stratified by the date of noncompliance (before or after restrictions). Events were described by size, site, noncompliance type, primary category, subcategory, and cause. In addition, noncompliance associated with COVID-19 was analyzed to determine characteristics. Results In total, 323 noncompliance events occurred across 21,146 participants at risk in 35 protocols. The overall rate of noncompliance increased from 0.008 events per participant to 0.022 events per participant after the COVID-19 restrictions ( p < 0.001). For onsite protocols, the median within protocol change in rates was 0.001 (interquartile range = 0.141) after the onset of COVID-19 restrictions ( p = 0.54). For large-sized protocols ( n ≥ 100), the median within protocol change in rates was also 0.001 (interquartile range = 0.017) after COVID-19 restrictions ( p = 0.15). For events related to COVID-19 restrictions, 160/162 (99%) were minor deviations, 161/162 (99%) were procedural noncompliance, and 124/162 (77%) were an incomplete study visit. Conclusion These noncompliance events have implications for clinical trial methodology because nonadherence to trial design can lead to participant safety concerns and loss of trial data validity. Protocols should be written to better facilitate the capture of all safety and efficacy data. This recommendation should be considered when changes occur to the protocol environment that are outside of the study team’s control.
A real-world study of quality of life following treatment with xylometazoline hydrochloride in individuals with common cold
Authors: Hagen Martina , Clark Kim , Kalita Pranab , Serra Gessica , Sanchez Edwin , Varbiro Gabor , Albasser Mathieu M. 
Published: February 2024

Background: The common cold is a frequent, acute, and mild upper respiratory human disease. Nasal congestion has been considered the most bothersome symptom in the common cold, impacting quality of life (QoL). Topical decongestants containing steroids benefit QoL in allergic rhinitis, but no published research has assessed the impact of topical decongestants on QoL in the common cold. Objective: To evaluate the effects of xylometazoline hydrochloride 0.1% (Otrivin, GSK Consumer Healthcare SARL, Switzerland) for up to 7 days on QoL in participants with nasal congestion associated with the common cold. Design: This was a decentralized, longitudinal, open-label study. Methods: The study enrolled 136 participants (⩾18 years) with early symptoms of the common cold, of which 102 were included in the modified intention-to-treat (mITT) population. Within 24 h of study product receipt, participants confirmed a ‘plugged nose’ and ⩾1 other common cold symptom. Primary endpoints were Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) total score, total and individual symptom scores, and total QoL score. Secondary endpoints were additional QoL scores. Exploratory and post hoc analyses included median days to resolution for each QoL factor and analyses of five QoL categories. Results: Consistent improvements in symptoms and QoL were seen in the mITT population. From day 1, improvements were seen in the ‘plugged nose’ symptom ( p = 0.0023), WURSS-21 total QoL score, and all individual QoL scores ( p < 0.0001 for all). After the last dose needed, significant improvements were seen in sleep quality (73%), vitality (76%), physical activity (71%), social activity (80%), and sensation (81%). No serious or unexpected adverse events were reported. Conclusion: This study is the first to demonstrate in a real-life setting that treating nasal congestion in adults with xylometazoline hydrochloride 0.1% during the common cold positively impacts QoL factors relevant to daily living [Otrivin: Quality of Life (QoL) Impact in a Real-World Setting; https://clinicaltrials.gov/study/NCT05556148 ].
Role of TNF superfamily members lymphotoxin-α, sCD40L, and TNF-α in endometriosis-related infertility
Authors: Rahmawati Nanda Yuli , Ahsan Fadhil , Santoso Budi , Mufid Alfin Firasy , Sa’adi Ashon , Dwiningsih Sri Ratna , Tunjungseto Arif , Widyanugraha M. Yohanes Ardianta 
Published: February 2024

Introduction: TNF-α, LT-α, and sCD40L belong to the TNF superfamily and play a pivotal role in chronic inflammatory disease. Yet, these soluble molecules are largely unexplored in endometriosis cases with infertility. The present study aimed to evaluate serum and peritoneal fluid levels of these molecules and correlate its level to the endometriosis severity. Methods: Peripheral blood and peritoneal fluid samples were obtained from 87 infertility cases who underwent laparoscopy, consisting of 44 endometriotic women and 43 non-endometriotic women. The levels of TNF-α, LT-α, and sCD40L were determined using ELISA. Results: Serum and peritoneal TNF-α levels were significantly elevated in the endometriosis group compared to the control group ( p = 0.028; p = 0.027), but not the sCD40L and LT-α level. Serum and peritoneal TNF-α levels were significantly different between late-endometriosis (stage III or IV) compared to the control group ( p = 0.026, p = 0.041, respectively). Moreover, the serum LT-α level was significantly higher in late-endometriosis cases compared to the early-endometriosis (stage I or II) cases ( p = 0.03) and showed a positive correlation with endometriosis rASRM score ( p = 0.001). ROC curve analysis showed a significant diagnostic value of serum LT-α in differentiating the late cases to the early endometriosis patients (AUC = 0.751, p = 0.007). A negative correlation between LT-α and total Endometriosis Fertility Index (EFI) score was also observed ( p = 0.012). Conclusion: Severe endometriosis and lower EFI score are associated with higher serum LT-α level. Serum LT-α is a potential staging biomarker among endometriosis cases. Serum and peritoneal TNF-α levels were elevated in women with severe endometriosis among infertility cases. Further study should address the role and predictive value of LT-α in endometriosis-related infertility.
Effect of Compressive Shoulder Draping With Adhesive Incise Drape on Soft Tissue Swelling in Shoulder Arthroscopy: A Prospective Randomized Trial
Authors: Uri Ofir , Alfandari Liad , Yaron Ram , Kettanie Amir , Laufer Gil , Behrbalk Eyal 
Published: February 2024

Background: Soft tissue swelling in shoulder arthroscopy is common and may lead to complications. Measures aimed at reducing this phenomenon are routinely used with limited efficacy. Purpose/Hypothesis: The purpose of the study was to assess (1) soft tissue swelling of the shoulder (the operated site) and (2) soft tissue swelling of the neck, chest, and arm (the surrounding tissue) in patients with versus without compressive draping during shoulder arthroscopy. It was hypothesized that compressive draping of the shoulder with adhesive incise drape would reduce soft tissue swelling during shoulder arthroscopy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 50 patients undergoing arthroscopic rotator cuff repair were prospectively randomized to either the study group (in which the shoulder was draped with adhesive incise drape tightened around the shoulder) or the control group (in which a standard shoulder arthroscopy drape was used). The circumferences of the shoulder, arm, chest, and neck were measured preoperatively and postoperatively and compared between the groups. Results: The shoulder circumference in the standard draping group increased by 16% during the procedure (from 21.2 ± 1.5 cm preoperatively to 24.5 ± 1.7 cm postoperatively) compared with only 6% in the compressive draping group (from 21.0 ± 1.3 cm preoperatively to 22.3 ± 1.1 cm postoperatively) ( P < .01). No serious postoperative complications were observed in either group. Conclusion: Compressive shoulder draping with adhesive incise drape was effective in reducing soft tissue swelling around the shoulder in arthroscopic rotator cuff repair compared with standard arthroscopic draping and was not associated with any adverse reactions. Registration: NCT03216590 (ClinicalTrials.gov identifier).
Helicobacter pylori in gastrointestinal manifestation of systemic sclerosis
Authors: Raja Jasmin , Muthusamy Shanthini , Ng Choung Min , Mahadeva Sanjiv 
Published: February 2024

Aim: To study the prevalence of Helicobacter pylori in systemic sclerosis patients and its gastrointestinal manifestations in comparison with Helicobacter pylori-negative systemic sclerosis patients. Systemic sclerosis gastrointestinal outcome post Helicobacter pylori eradication was evaluated. Method: In total, 70 systemic sclerosis patients and 70 age-, gender- and race-matched healthy controls had their urea breath test done. Gastrointestinal manifestations in systemic sclerosis were assessed using University of California at Los Angeles 2.0 and Leeds Dyspepsia Questionnaire questionnaires. Systemic sclerosis patients with confirmed Helicobacter pylori infection were given standard Helicobacter pylori eradication therapy. Urea breath test was repeated 6 weeks posteradication therapy with their gastrointestinal symptoms reassessed. Results: The prevalence of Helicobacter pylori was low in both systemic sclerosis patients (10%) and healthy controls (2.9%). There was no significant difference in gastrointestinal symptoms between Helicobacter pylori-positive and Helicobacter pylori-negative systemic sclerosis patients. However, the Helicobacter pylori-positive patients reported higher median severity scores for the gastrointestinal symptoms of reflux (0.5 vs 0.35), abdominal distension (1.5 vs 0.75) and social functioning impairment score (0.5 vs 0.16) using the University of California at Los Angeles 2.0 score. The Helicobacter pylori-positive patients also indicated increased upper abdominal pain (3.0 vs 0.0), regurgitation (2.0 vs 0.0) and burping (3.0 vs 0.0), observed from the Leeds Dyspepsia Questionnaire scores. Gastrointestinal outcomes post- Helicobacter pylori eradication showed either an improvement or complete resolution of symptoms. Conclusion: Gastrointestinal symptoms in systemic sclerosis patients are unlikely to be caused by Helicobacter pylori in the recent years in our cohort of patients. No significant difference in gastrointestinal symptoms was seen between Helicobacter pylori-positive and Helicobacter pylori-negative systemic sclerosis patients. Helicobacter pylori can be readily tested by urea breath test to look for present infection.
Tolerability of calcitonin gene-related peptide monoclonal antibodies and other monoclonal antibodies in adults with concurrent migraine and other medical conditions
Authors: Weber Kevin , Ferderer Tanner , Hubert Meghan , Pakalnis Ann 
Published: February 2024

Background/Hypothesis: Calcitonin gene-related peptide monoclonal antibodies (CGRP mabs) are relatively new preventive treatments in adult migraine. Co-morbid medical conditions such as autoimmune or other neurologic/oncologic disorders are not uncommon in migraine patients and some exhibit notable co-morbidity such as asthma. These clinical conditions may necessitate concomitant treatment with another monoclonal antibody with a different mechanism of action other than the CGRP pathway in some individuals with migraine. Methods: We report a retrospective case series in 23 patients identified from our headache clinic treated concurrently with a CGRP monoclonal antibody and other monoclonal antibody for another medical condition. These other medical conditions were neurologic, oncologic, or autoimmune conditions. These patients were evaluated for tolerability, safety, and stability of disease processes including their migraine response. Results/Conclusion: We did not find evidence of new adverse or serious adverse side effects with coadministration of CGRP and non-CGRP monoclonal antibodies during our study time period of 13 months, for the duration of overlap between treatments (between 3 and 12 months).