bluuebunny/crossref_metadata_2025_split huggingface dataset:
Sutimlimab: A Complement C1s Inhibitor for the Management of Cold Agglutinin Disease–Associated Hemolysis
Authors: Moore Donald C. , Arnall Justin R. 
Published: December 2022

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, dosing and administration, and place in therapy of sutimlimab for the management of cold agglutinin disease (CAD)-associated hemolysis. Data Sources: A literature search of PubMed (1966-October 2022) was conducted using the keywords sutimlimab, BIVV009, and cold agglutinin. Data were also obtained from prescribing information, meeting abstracts, and clinicaltrials.gov. Study Selection and Data Extraction: All published prospective clinical trials, prescribing information, and meeting abstracts on sutimlimab for the treatment of CAD were reviewed. Data Synthesis: Sutimlimab is a first-in-class complement C1s inhibitor indicated for the treatment of CAD-associated hemolysis. This approval was based on the phase III CARDINAL trial, which evaluated sutimlimab in patients with CAD-associated hemolysis. The primary endpoint of achieving a hemoglobin of ≥12 g/dL or increase of ≥2 above baseline was achieved by 54% of patients with sutimlimab in the 26-week trial. The phase III CADENZA trial was a placebo-controlled trial in which sutimlimab has demonstrated a significant improvement in the composite endpoint of hemoglobin increase of ≥1.5 g/dL, avoidance of transfusion, and avoidance of additional CAD therapies (73% sutimlimab vs 15% placebo). Relevance to Patient Care and Clinical Practice in Comparison with Existing Drugs: Sutimlimab rapidly halts hemolysis, improves hemoglobin, and improves quality-of-life in patients with CAD. Safety issues with sutimlimab include infusion-related reactions and risk of serious infections with encapsulated bacteria. Conclusions: Sutimlimab provides an additional therapeutic option in the treatment of CAD-associated hemolysis that can lead to rapid improvement in hemoglobin and anemia-related symptoms.
Establishment and Validation of a Pathologic Upgrade Prediction Nomogram Model for Gastric Low-Grade Intraepithelial Neoplasia Patients After the Eradication of Helicobacter pylori
Authors: Ruan Yejiao , Lu Guangrong , Zhu Yuesheng , Ma Xianhui , Shi Yuning , Zhang Xuchao , Zhu Zheng , Cai Zhenzhai , Xia Xuanping 
Published: December 2022

Background As yet, there is no unified method of treatment for the evaluation and management of gastric low-grade intraepithelial neoplasia (LGIN) worldwide. Methods Patients with gastric LGIN who had been treated with Helicobacter pylori eradication were gathered retrospectively. Based on several relevant characteristics described and analyzed by LASSO regression analysis and multivariable logistic regression, a prediction nomogram model was established. C-index, the area under the receiver operating characteristic curve (AUC), calibration plot, and decision curve analysis (DCA) were adopted to evaluate the accuracy and reliability of the model. Results A total of 309 patients with LGIN were randomly divided into the training groups and the validation groups. LASSO regression analysis and multivariable logistic regression identified that 6 variables including gender, size, location, borderline, number, and erosion were independent risk factors. The nomogram model displayed good discrimination with a C-index of .765 (95% confidence interval: .702-.828). The accuracy and reliability of the model were also verified by an AUC of .764 in the training group and .757 in the validation group. Meanwhile, the calibration curve and the DCA suggested that the predictive nomogram had promising accuracy and clinical utility. Conclusions A predictive nomogram model was constructed and proved to be clinically applicable to identify high-risk groups with possible pathologic upgrade in patients with gastric LGIN. Since it is regarded that strengthening follow-up or endoscopic treatment of high-risk patients may contribute to improving the detection rate or reducing the incidence of gastric cancer, the predictive nomogram model provides a reliable basis for the treatment of LGIN.
Differential Neutralization of Apixaban, Betrixaban, Edoxaban, and Rivaroxaban by Andexanet Alfa as Measured by Whole Blood Thromboelastographic Analysis
Authors: Mehrotra Siddharth , Hoppensteadt Debra , Jeske Walter , Siddiqui Fakiha , Iqbal Omer , Tafur Alfonso , Lewis Bruce , Jaradeh Mark , Kantarcioglu Bulent , Fareed Jawed 
Published: December 2022

Introduction The available oral anti-Xa agents are routinely used for the management of thrombotic disorders. A molecularly modified recombinant coagulation FXa, also known as Andexanet Alfa (AA), that has been developed as an antidote to neutralize the bleeding effects of oral FXa inhibitors, such as Apixaban and Rivaroxaban. Materials and Methods This study utilized thromboelastography (TEG 5000 Hemostasis System), to investigate the neutralizing effects of AA at different concentrations of oral FXa inhibitors measuring such parameters as R-Time, K-Time, Angle, and Max Amplitude (MA). Apixaban, Betrixaban, Edoxaban, and Rivaroxaban were obtained commercially in powdered form. Each of these drugs was supplemented with freshly drawn whole citrated blood at a concentration of 1 μg/mL. And subsequently mixed with AA at 50 or 100 μg/mL. Results At a concentration of 1 μg/mL, all FXa inhibitors produced variable anticoagulant effects in the order of Edoxaban > Betrixaban > Rivaroxaban > Apixaban. AA at 100 μg/mL produced a complete neutralization of these inhibitors whereas at 50 μg/mL relatively weaker neutralization as measured by various parameters. Conclusion These results suggest that regardless of the variable anticoagulant effects exhibited by the FXa Inhibitors, AA at FC = 100 μg/mL fully neutralized these agents as measured by the TEG parameters. AA was shown to be more effective in neutralizing Betrixaban and least effective in Apixaban. The neutralization of various FXa inhibitors was dose and donor-dependent warranting dosage adjustment for optimal outcomes.
Mortality risk prediction with ILD-GAP index in a fibrotic hypersensitivity pneumonitis cohort
Authors: Mendonça Almeida Leonor , Fernandes Ana Luísa , Gouveia Cardoso Catarina , Lima Bruno , Neves Inês , Novais-Bastos Hélder , Caetano Mota Patrícia , Melo Natália , Souto Moura Conceição , Guimarães Susana , Carvalho André , Cunha Rui , Pereira José Miguel , Morais António 
Published: December 2022

Background: Fibrotic hypersensitivity pneumonitis (fHP) is associated with significant morbidity and mortality. Interstitial lung disease–gender-age-physiology (ILD-GAP) performance in fHP outside the initial cohort was never performed. Aim: To assess the ILD-GAP index’s ability to predict mortality in a Portuguese cohort of patients with fHP and analyse whether other clinical variables add value. Methods: Retrospective analysis of fHP cohort in two Portuguese ILD centres. The baseline ILD-GAP index was calculated. Survival was analysed in months; mortality was the primary outcome. Univariate and multivariate analyses to identify mortality risk factors were performed. Results: A total of 141 patients were included. Fifty-three patients (37.6%) died during the follow-up. The usual interstitial pneumonia (UIP) pattern was found in 49.6%, and their survival was inferior to non-UIP [32 months (interquartile range, IQR = 19, 60) versus 52 months (IQR = 28, 98), p = 0.048]. Patients with an ILD-GAP index higher than three double their risk of mortality [hazard ratio (HR) = 6.48, 95% confidence interval (CI) = (3.03–13.96)] when compared with the patients with an index between 2 and 3 [HR = 3.04, 95% CI = (1.62–5.71)] adjusting for acute exacerbation history. Even though UIP patients had worse survival, it did not reach statistical significance when UIP pattern was added to this model. Acute exacerbation history was an independent risk factor for mortality; however, ILD-GAP still predicted mortality after adjusting for this factor. PaO2 and 6-minute walk test desaturation were not significant risk factors. Conclusion: ILD-GAP index is a good predictor for mortality in fHP, even after adjusting for other mortality risk factors.
Impact of recurrent hospitalization for Clostridioides difficile on longitudinal outcomes in patients with inflammatory bowel diseases: a nationally representative cohort
Authors: Venkat Preethi G. , Nguyen Nghia H. , Luo Jiyu , Qian Alexander S. , Khanna Sahil , Singh Siddharth 
Published: December 2022

Background: Clostridioides difficile infection (CDI) is associated with poor outcomes in patients with inflammatory bowel diseases (IBD). Objectives: We conducted a nationally representative cohort study to evaluate the impact of recurrent CDI (rCDI)-related hospitalization on longitudinal unplanned healthcare utilization in patients with IBD. Design: This was a retrospective cohort study that utilized the 2017 Nationwide Readmissions Database (NRD). Methods: We identified 13,446 patients with IBD, hospitalized at least twice from January to June 2017 and followed through December 2017; of these, 1,148 had CDI-related hospitalizations. We compared the annual burden of hospitalization and IBD-related surgery in IBD patients with rCDI-related admission versus single CDI-related admission (primary reference), and those with one or more CDI-related admission versus no CDI-related admission (secondary reference). Results: There were no significant differences in risk and burden of unplanned healthcare utilization (time spent in-hospital, 27 days versus 27 days, p = 0.62), 6-month readmission (63% versus 64.3%, p = 0.8) or IBD-related surgery in patients with recurrent (two or more) CDI-related hospitalizations versus single CDI-related admission. However, patients with ⩾1 CDI-related admission versus no CDI admissions experienced higher rate of 6-month readmission (61.1% versus 55.7%, p<.001), total days spent in the hospital per year (median: 26 days versus 21 days, p<.001), total cost across all hospitalizations per year ($212,524 versus $184,384, p < 0.01), and inpatient mortality (3.28% versus 1.81%, p = 0.01), without an increase in risk of IBD-related surgery (6.7% versus 6.4%, p = 0.79). Conclusion: While patients with IBD hospitalized for CDI have poor longitudinal inpatient outcomes, recurrent admissions for CDI may not increase risk of adverse outcomes compared to one-time admission.
The N-brace trial: Does arm position during immobilisation of proximal humerus fractures influence outcome - A preliminary study
Authors: Gokaraju Kishan , Ahrens Philip , Boileau Pascal , Baring Tobias 
Published: December 2022

Background Traditional initial management of proximal humerus fractures (PHF) involves arm immobilisation in a simple sling (SS) in an internally rotated position. We believe this risks fracture displacement and imbalance of soft tissues, encouraging malunion and stiffness. A neutral-rotation brace (NRB) maintains an arm position which may prevent this, leading to quicker and superior recovery. Methods We randomised patients with two- to four-part PHF into 4 weeks of immobilisation with either a SS or NRB, independent of surgery. Range of motion (ROM), subjective shoulder value (SSV), DASH, Constant–Murley (CMS) and Oxford Shoulder (OSS) scores were assessed at 6-weeks, 3-months and 1-year post-injury. Results The SS group included 11 patients vs 9 in the NRB group. At final follow-up, the SS and NRB groups had mean DASH scores of 42 vs 35, OSS 42 vs 46, CMS 71 vs 86, SSV 84% vs 92%, respectively. ROM was superior with the NRB (elevation 159°, ER 47° and IR score 8 vs 140°, 37° and 7 with SS). Conclusions Despite being a small series, our results demonstrate a trend towards NRB providing better outcomes. This feasibility study supports the need for a larger multi-centre randomised controlled trial comparing these immobilisation methods for PHF.
Social Determinants of Health and Hypertension Control in Adults with Medicaid
Authors: Sonnenblick Ross , Reilly Alexa , Roye Karina , McCurley Jessica L. , Levy Douglas E. , Fung Vicki , McGovern Sydney Howard , Clark Cheryl R. , Thorndike Anne N. 
Published: December 2022

Background: Social determinants of health (SDOH) are associated with cardiovascular disease, but little is known about mechanisms underlying those relationships. We hypothesized that SDOH would be associated with uncontrolled hypertension (HTN) in adults with Medicaid. Methods: This was a retrospective analysis of adults in a Medicaid accountable care organization who had HTN diagnoses, received regular care at community health centers, and enrolled in a cohort study between December 2019 and December 2020. Baseline surveys collected demographics and SDOH, including food insecurity, unstable housing, cost-related medication underuse, and financial stress. Blood pressure (BP) measurements over 12 months after survey completion were obtained from the electronic health record. Participants were categorized as: uncontrolled HTN (mean systolic BP ≥ 140 mm Hg and/or mean diastolic BP ≥ 90 mm Hg), controlled HTN, or unknown HTN control (no BP documented). We examined the association of individual and cumulative (count, 0-4) SDOH with uncontrolled HTN and unknown HTN control using multivariable logistic regression adjusting for demographics, smoking, diabetes, and HTN medication. Results: Participants (n = 245) were mean (SD) age 51.3 (8.6) years, 66.1% female, 43.7% Hispanic, 34.3% White, and 18.0% Black. Overall, 58.0% had food insecurity, 38.0% had unstable housing, 29.4% had financial stress, and 20.0% reported cost-related medication underuse. BP was documented for 180 participants; 44 (24.4%) had uncontrolled HTN. In multivariable models, neither individual nor cumulative SDOH were associated with uncontrolled HTN or unknown HTN control. Conclusions: In a Medicaid-insured population receiving care at community health centers, adverse SDOH were prevalent but were not associated with HTN control.
Patient Safety Culture: The Impact on Workplace Violence and Health Worker Burnout
Authors: Kim Sinhye , Kitzmiller Rebecca , Baernholdt Marianne , Lynn Mary R. , Jones Cheryl B. 
Published: December 2022

Background: Patient and health care worker safety is an interconnected phenomenon. To date, few studies have examined the relationship between patient and worker safety, specifically with respect to work safety culture. Therefore, we examined patient safety culture, workplace violence (WPV), and burnout in health care workers to identify whether patient safety culture factors influence worker burnout and WPV. Methods: This cross-sectional study used secondary survey data sent to approximately 7,100 health care workers at a large academic medical center in the United States. Instruments included the Hospital Survey on Patient Safety Culture, a WPV scale measuring physical and verbal violence perpetrated by patients or visitors, and the Emotional Exhaustion scale from the Maslach Burnout Inventory. Findings: These analyses included 3,312 (47%) hospital staff who directly interacted with patients. Over half of nurse (62%), physician (53%), and allied health professional respondents (52%) reported experiencing verbal violence from a patient, and 39% of nurses and 14% of physicians reported experiencing physical violence from a patient. Burnout levels for nurses (2.67 ± 1.02) and physicians (2.65 ± 0.93) were higher than the overall average for all staff (2.61 ± 1.0). Higher levels of worker-reported patient safety culture were associated with lower odds of WPV (0.47) and lower burnout scores among workers ( B = −1.02). Teamwork across units, handoffs, and transitions were dimensions of patient safety culture that also influenced WPV and burnout. Conclusions/Application to Practice: Our findings suggest that improvements in hospital strategies aimed at patient safety culture, including team cohesion with handoffs and transitions, could positively influence a reduction in WPV and burnout among health care workers.
Scheduled, Simultaneous Dosing of Pregabalin, Celecoxib, and Acetaminophen Markedly Reduces or Eliminates Opioid Use After ACL Reconstruction Using Allograft or Hamstring Tendon Autograft: A Randomized Clinical Trial
Authors: Swenson Jeffrey D. , Conrad Kevin M. , Pace Nathan L. , Phillips Kathleen , Saltzman Charles L. 
Published: December 2022

Background: Opioid analgesics continue to be prescribed after ambulatory surgery despite untoward adverse effects, risk of overdose, and association with substance use disorder. Purpose/Hypothesis: The purpose was to investigate the use of a novel system to provide scheduled and simultaneous dosing of acetaminophen, celecoxib, and pregabalin after anterior cruciate ligament reconstruction (ACLR). It was hypothesized that this system would markedly reduce pain and opioid use compared with existing best practice. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Included were 100 patients scheduled for elective, primary ACLR using allograft or hamstring tendon autograft. Selection criteria included age between 18 and 65 years and weight between 65 and 120 kg. Exclusion criteria were a known allergy to any drug used in the study or the use of opioid analgesics before surgery. Patients in the intervention group received a blister pack with scheduled, simultaneous doses of acetaminophen, celecoxib, and pregabalin; patients were also given oxycodone 5 mg as needed for breakthrough pain. Patients in the control group were prescribed ibuprofen and oxycodone 5 mg/acetaminophen 325 mg as needed for pain. The primary outcome measure was pain. Secondary outcomes were nausea, itching, and daily oxycodone use. Patients were asked to quantify their average pain at rest, nausea, and itching on an 11-point verbal scale (from 0 to 10). These data were recorded for 6 days during daily telephone contacts with patients after hospital discharge. Results: Cumulative results for 6 days showed significantly lower values in the intervention group compared with the control group for pain (median [interquartile range], 28 [14-35] vs 35 [28-41], respectively; P = .009) and oxycodone use (median [interquartile range] number of tablets, 0 [0-2] vs 8 [1.25-16], respectively; P < .001). Based on these data, the upper tolerance limits for the number of oxycodone tablets required by 90% of patients in the intervention and control groups were 8 tablets and 30 tablets, respectively. Cumulative results for nausea and itching were also significantly lower for the intervention group. Most patients in the intervention group used no opioids during recovery. Conclusion: Simultaneous dosing of 3 nonopioid analgesics resulted in reduced postoperative pain and markedly lower opioid use. Registration: NCT04015908 ( ClinicalTrials.gov identifier).
Developing the Breast Utility Instrument to Measure Health-Related Quality-of-Life Preferences in Patients with Breast Cancer: Selecting the Item for Each Dimension
Authors: Tsui Teresa C. O. , Trudeau Maureen E. , Mitsakakis Nicholas , Krahn Murray D. , Davis Aileen M. 
Published: December 2022

Introduction. Generic preference-based instruments inadequately measure breast cancer (BrC) health-related quality-of-life preferences given advances in therapy. Our overall purpose is to develop the Breast Utility Instrument (BUI), a BrC-specific preference-based instrument. This study describes the selection of the BUI items. Methods. A total of 408 patients from diverse BrC health states completed the EORTC QLQ-C30 and BR45 (breast module). For each of 10 dimensions previously assessed with confirmatory factor analysis, we evaluated data fit to the Rasch model based on global model and item fit, including threshold ordering, item residuals, infit and outfit, differential item functioning (age), and unidimensionality. Misfitting items were removed iteratively, and the model fit was reassessed. From items fitting the Rasch model, we selected 1 item per dimension based on high patient- and clinician-rated item importance, breadth of item thresholds, and clinical relevance. Results. Global model fit was good in 7 and borderline in 3 dimensions. Separation index was acceptable in 4 dimensions. Item selection criteria were maximized for the following items: 1) physical functioning (trouble taking a long walk), 2) emotional functioning (worry), 3) social functioning (interfering with social activities), 4) pain (having pain), 5) fatigue (tired), 6) body image (dissatisfied with your body), 7) systemic therapy side effects (hair loss), 8) sexual functioning (interest in sex), 9) breast symptoms (oversensitive breast), and 10) endocrine therapy symptoms (problems with your joints). Conclusions. We propose 10 items for the BUI. Our next steps include assessing the measurement properties prior to eliciting preference weights of the BUI. Highlights A previous confirmatory factor analysis established 10 dimensions of the European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30) and its breast module (BR45). In this study, we selected 1 item per dimension based on fit to the Rasch model, patient- and clinician-rated item importance, breadth of item thresholds, and clinical relevance. These items form the core of the future Breast Utility Instrument (BUI). The future BUI will be a novel breast cancer–specific preference-based instrument that potentially will better reflect women’s preferences in clinical decision making and cost utility analyses.
Distal Biceps Repair: 2-Volar Incision Technique for Acute and Chronic Retracted Tears
Authors: Singh Suvleen K. , Pike J. Mattison , Bennfors Grace , Welsh Megan E. , Friedman Richard J. , Eichinger Josef K. 
Published: December 2022

Background: A distal biceps repair is performed after a rupture of the distal biceps tendon, an injury that typically affects the dominant arm of middle-aged men, resulting in weakness in supination and elbow flexion. A volar 2-incision technique minimizes skin incision length while optimizing exposure to anatomical structures through proper incision placement for acute repair and chronic reconstruction with graft. Indications: Retraction of the distal biceps away from its insertion on the proximal radius in the chronic setting can require a more extensile incision. Two transverse incisions are strategically placed on either side of the antecubital fossa to optimize exposure of the radial insertion site and proximally to retrieve the retracted tendon for either acute or chronic retracted distal biceps tears with or without graft reconstruction. Technique Description: A transverse incision is made in the forearm directly over the radial tuberosity. This facilitates direct exposure and drilling of a socket for placement of the distal biceps’ tendon with suture button and interference screw construct. A second proximal transverse incision is made to identify and retrieve the retracted tendon. The tendon is retrieved and prepared or reconstructed with graft for chronic cases with suture. The tendon and graft are tunneled under the skin bridge between the 2 incisions. The sutures are then loaded onto a titanium button, which is deployed onto the far cortex. The tendon is advanced into the tunnel, an interference screw is placed, and the sutures are tied. Results: Restoration of anatomy and correct placement of the 2 incisions is facilitated with this approach, restoring distal biceps function without requiring extensile volar exposure of the entirety of the length of the distal biceps tendon. Discussion/Conclusion: This technique mitigates the need for extensive dissection. It also facilitates improved visualization of relevant structures for cases with substantial tendon retraction, even in the case of chronic retracted tears requiring allograft reconstruction. The author(s) attests that consent has been obtained from any patient(s) appearing in this publication. If the individual may be identifiable, the author(s) has included a statement of release or other written form of approval from the patient(s) with this submission for publication.