Quality Measures Research Articles

Implementation of a Technology-Based Writing Intervention to Support Writing Quality

ABSTRACT This study investigated teacher implementation of a technology-based writing intervention package with embedded Universal Design for Learning features. Three teachers at a private school in the Eastern United States provided instruction to 65 elementary and secondary students. Changes in both writing quantity and quality from pretest to posttest with the intervention and from pretest to delayed posttest without the intervention are reported. The study extends previous research by also examining the changes in student performance among the disaggregated writing quality elements at different testing times. The results show that all students demonstrated statistically significant improvements in the number of transition words and holistic writing quality that were maintained even when the technology-based writing intervention was removed. While both elementary and secondary students demonstrated improved quality of writing, elementary students also increased how much they wrote. Improved elements of persuasive writing quality included Identify the Opinion, Determine Reasons, and Explain Why or Say More. The areas that could be further improved included Summarize and Word Selection. Student outcomes in this study demonstrate the versatility of the technology-based writing intervention. Authors discuss how looking at targeted elements of a writing quality measure has implications for instructional practice.

Psychometric assessment of a Chinese version of a mindfulness practice quality measurement tool.

Mindfulness training is increasingly popular in China. The challenge of evaluating mindfulness practice objectively and accurately has attracted research attention. However, previous studies in China focused primarily on the quantity rather than the quality of mindfulness training. The Practice Quality - Mindfulness (PQ-M) can provide a solution. Consequently, the present study aimed to validate and assess the internal consistency and construct validity of the Chinese version of the Practice Quality - Mindfulness (Ch-PQ-M) in a non-clinical sample. One hundred and sixty participants (female:81) were recruited to practice 20min of mindfulness training daily for four consecutive days and to complete the Ch-PQ-M, the State Anxiety Inventory, and the Peace of Mind Scale immediately after each mindfulness practice. The Five Facet Mindfulness Questionnaire, the Trait Anxiety Inventory, and the Positive and Negative Affect Scale were administered pre- and post- 4-day treatment. Construct validity (confirmatory factor analysis), internal consistency, test-retest reliability, predictive validity and construct validity were examined. Ch-PQ-M demonstrated acceptable internal consistency and test-retest reliability. Confirmatory factor analysis supported the established two-factor model (perseverance and receptivity). The Ch-PQ-M attention score was significantly associated with changes of trait anxiety. It improved with short-term mindfulness practice. The perseverance score consistently correlates with scores on peace of mind, state anxiety, trait anxiety, and observe and nonreactivity. The receptivity score remains consistently correlated with the nonjudging. These findings suggest that Ch-PQ-M is a valid instrument for evaluating individual mindfulness quality for a single-session practice. Our findings suggest that Ch-PQ-M (especially for the Ch-PQ-M perseverance score) has acceptable psychometric properties and is a reliable and valid instrument for assessing mindfulness practice quality in the Chinese cultural context.

Unintended Consequences of Data Sharing Under the Meaningful Use Program.

Interoperability has been designed to improve the quality and efficiency of health care. It allows the Centers for Medicare and Medicaid Services to collect data on quality measures as a part of the Meaningful Use program. Covered providers who fail to provide data have lower rates of reimbursement. Unintended consequences also arise at each step of the data collection process: (1) providers are not reimbursed for the extra time required to generate data; (2) patients do not have control over when and how their data are provided to or used by the government; and (3) large datasets increase the chances of an accidental data breach or intentional hacker attack. After detailing the issues, we describe several solutions, including an appropriate data use review board, which is designed to oversee certain aspects of the process and ensure accountability and transparency.

Synchrotron computed tomography combined with AI-based image analysis for the advanced characterization of spray dried amorphous solid dispersion particles.

Particle engineering aims to design particles with specific properties. A deeper understanding of how particle formation relates to material attributes and process conditions are critical to strengthen knowledge on powder properties and enhance modeling capabilities. New, alternative powder characterization techniques can offer novel and more accurate measures for particle properties, giving more advanced characterization information. In this context, a case study is presented in which spray dried amorphous solid dispersion powders produced by modifying process conditions were characterized by both well-established compendial methods (i.e., laser light diffraction, SEM image analysis, bulk and tapped density, and gas adsorption), as well as a new method combining synchrotron computed tomography (SyncCT) with AI-based image analysis. SyncCT was used to classify and quantify the spray dried particles as hollow spheres and solid particles, giving a more detailed quality measure of the particle shape, as they impact downstream processing differently. Moreover, hollow particle wall thicknesses, as well as internal and external particle surface areas were measured by SyncCT. Altogether, powder characterization data from SyncCT show similar trends to that obtained from compendial techniques and giving additional quality measure regarding particle shape, showing promise of this new and advanced characterization method.

The psychometric properties of the amharic version of EuroQoL five-dimensions-five level among Ethiopian cervical cancer patients.

Despite being a widely used generic measure of health-related quality of life worldwide, there is limited evidence on the psychometric properties of the EuroQoL Five-dimensions five level (EQ-5D) among cervical cancer patients in Ethiopia. To evaluate psychometric properties of the Amharic version of EQ-5D among Ethiopian cervical cancer patients. A longitudinal survey of cervical cancer patients receiving treatment at two Ethiopian tertiary care facilities was conducted from March 2022 to July 2023. Participants completed the EQ-5D and the European Organization for Research and Therapy of Cancer (EORTC QLQ-C30) at baseline and after three months on treatment. Effect size and standardized response mean were used to assess responsiveness. Anchor-based and distribution-based methods were used to calculate the minimal clinically important difference (MCID). Minimal detectable change (MDC) ratios were computed at the individual and group levels. Statistical significance was determined at p < 0.05. Three hundred seventy-one patients completed the survey at baseline and follow-up with a mean age of 49.72 (10.80) years. The majority (268,73%) of the patients had early-stage cancer. The EQ-5D index and EQ VAS scores respectively improved by 0.04 and 7.0 post-treatment.The physical domains of EORTC QLQ-C30 had showed high correlation with physical dimensions of EQ-5D (r > 0.6) and the instrument showed good discriminate validity between patients with different health states. The effect size ranged between - 0.12 and 0.60 for the EQ-5D index value and - 0.12 to 1.16 for the EQ VAS, indicating small to large responsiveness. The average (range) MCID value of the EQ-5D index was 0.10-0.15. The findings showed that MCID to MDC ratios at the group level were more clinically meaningful than the individual level. The EQ-5D effectively detected changes and discriminate patients with different levels of health. While group-level MCIDs were established in this study, further studies are recommended to prove its usefulness at the individual-level.

Social Determinants of Health and Language and Academic Outcomes in Pediatric Cochlear Implantation: A Systematic Review and Meta-Analysis.

Cochlear implants can restore sound and enable speech and language development for children with severe to profound sensorineural hearing loss. Long-term outcomes of pediatric cochlear implant recipients are variable. Although the association between social determinants of health (SDH) and pediatric cochlear implant outcomes has been explored, the strength of this association has not been quantitatively synthesized in the literature. To determine the association of SDH with language and academic outcomes in pediatric cochlear implant recipients. In August 2023, the following databases were searched: Embase.com, Ovid MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, Cumulated Index to Nursing and Allied Health Literature Plus, APA PsycINFO, and ClinicalTrials.gov. Following duplicate exclusion of 8687 results, 5326 records were finalized. Abstract screening, full-text review, and risk of bias assessment was performed by 1 to 2 reviewers. Articles were included if an effect size for an SDH variable that was associated with measures of language, communication, reading, academics, and quality of life was reported. A random-effects meta-analysis was performed, with standardized regression coefficients measuring the relative direction and magnitude of a variable association with the outcome of interest. Of 5326 articles, 40 articles that included a total of 3809 children were included in the systematic review; 20 articles that included a total of 1905 children were included in the meta-analysis. Parental involvement, education level, and low socioeconomic status were moderately to strongly associated with language outcomes (β = 0.30; 95% CI, 0.13-0.48; β = 0.45; 95% CI, 0.29-0.62; β = -0.47; 95% CI, -0.83 to -0.10, respectively). Known determinants of language outcomes, such as the age of cochlear implantation and duration of cochlear implant use, demonstrated moderate to no associations with language outcomes (β = -0.30; 95% CI, -0.43 to -0.17; β = 0.19; 95% CI, -0.26 to 0.63, respectively). The results of this systematic review and meta-analysis suggest that SDH are associated with childhood language development and academic achievement. In addition to efforts to expedite cochlear implant placement in eligible children, optimal outcomes may be achieved with interventions centered on the child's home, primary medical care, and school environment.

A call for objectivity: Radiologists' proposed wishlist for response evaluation in solid tumors (RECIST 1.1).

The Response Evaluation in Solid Tumors (RECIST) 1.1 provides key guidance for performing imaging response assessment and defines image-based outcome metrics in oncology clinical trials, including progression free survival. In this framework, tumors identified on imaging are designated as either target lesions, non-target disease or new lesions and a structured categorical response is assigned at each imaging time point. While RECIST provides definitions for these categories, it specifically and objectively defines only the target disease. Predefined thresholds of size change provide unbiased metrics for determining objective response and disease progression of the target lesions. However, worsening of non-target disease or emergence of new lesions is given the same importance in determining disease progression despite these being qualitatively assessed and less rigorously defined. The subjective assessment of non-target and new disease contributes to reader variability, which can impact the quality of image interpretation and even the determination of progression free survival. The RECIST Working Group has made significant efforts in developing RECIST 1.1 beyond its initial publication, particularly in its application to targeted agents and immunotherapy. A review of the literature highlights that the Working Group has occasionally employed or adopted objective measures for assessing non-target and new lesions in their evaluation of RECIST-based outcome measures. Perhaps a prospective evaluation of these more objective definitions for non-target and new lesions within the framework of RECIST 1.1 might improve reader interpretation. Ideally, these changes could also better align with clinically meaningful outcome measures of patient survival or quality of life.

Revision of a self-assessment tool for research ethics committees in low- and middle-income countries: Incorporation of elements that safeguard participants' rights and welfare.

Evaluating the quality of research ethics committees (RECs) is crucial but challenging due to the difficulty of developing meaningful quality measures. Recently, commentators assessed ten quality instruments for RECs, including the Research Ethics Committee Quality Assurance Self-Assessment Tool developed for RECs in the Arab Middle East. They identified several missing items in this tool regarding safeguarding participants' rights and welfare. To address these gaps, we aimed to redesign the tool. Using the Delphi method, we involved 15 REC chairs to provide feedback and recommendations for a revised tool. This process led to a modified instrument that incorporated the missing items and additional elements regarding the monitoring of research conduct (an essential oversight function of RECs), and the independence of the RECs from institutional and external influences. We conclude that the revised tool effectively addresses the quality of RECs by including elements relevant to participant outcomes, board deliberations, and participant protection. The added focus on ethics oversight enhances its robustness, significantly impacting participants' rights and welfare.

The Association of Hospital-Cardiologist Integration With Patient Outcomes, CareQuality, and Utilization.

Cardiologists are increasingly moving from independent practice to direct employment by hospitals. Hospital employment has the potential to improve care coordination and delivery, but little is known about its effect on care quality and outcomes. In this study, we sought to assess the association between hospital employment of cardiologists and patient outcomes, care quality, and utilization among patients hospitalized with incident acute myocardial infarction (AMI) or heart failure (HF). We used a sample of Medicare fee-for-service beneficiaries hospitalized with incident AMI or HF from 2008 to 2019. We identified the accountable cardiologists that cared for these patients and determined their employment status by means of tax identification numbers. We used difference-in-differences methods to compare clinical outcomes, quality measures, and utilization for patients treated by hospital-employed cardiologists after switching from independent to hospital-employed practice, to outcomes for patients treated by cardiologists who remained independent. Models were adjusted for time trends and patient, hospital, and cardiologist characteristics. Patient outcomes were in-hospital mortality, 30-day mortality, and 30-day readmission. Quality measures were receipt of: 1) a guideline-recommended test to assess cardiac function; and 2) a 30-day follow-up clinic visit. Utilization measures were length of stay and, for AMI patients, the proportion receiving coronary revascularization. The proportion of U.S. cardiologists employed by hospitals increased from 26% in 2008 to 63% in 2019. We identified 186,052 AMI and 259,849 HF patients cared for by cardiologists who switched to hospital employment and 168,052 AMI and 245,769 HF patients cared for by independent cardiologists. Patient characteristics were similar (mean age 80.8 years; 47% men). We found no significant differences in outcomes (eg, adjusted difference in 30-day mortality 0.03% [95%CI:-0.39% to 0.45%] for AMI patients and-0.05% [95%CI:-0.37% to 0.27%] for HF patients); no differences in most quality metrics except a small increase in the proportion of HF patients with 30-day follow-up (adjusted difference: 1.04%; 95%CI: 0.46%-1.62%); and no differences in utilization between patients treated by hospital-employed cardiologists (postswitch) vs independent cardiologists. Among U.S. cardiologists, there has been a large shift from independent practice to direct employment by hospitals. We found minimal evidence that cardiologist employment by hospitals improves care quality or outcomes.

The implementation of algebraic complex lookup tables over non-chain Galois ring extensions and Henon map in multimedia security

Abstract Image encryption is crucial for web-based data storage and transmission. Complex algebraic structures play a vital role in providing unique features and binary operations. However, current algebraic-based techniques face challenges due to limited key space. To tackle this issue, our study uniquely connects the algebraic structures with a chaotic map. The study introduces a complex non-chain Galois ring structure and a 12-bit substitution box for image substitution. An affine map is utilized to permute image pixels, and the 12-bit substitution box is uniquely mapped to a Galois field for encryption. A two-dimensional Henon map is employed to generate different keys for the XOR operation, resulting in an encrypted image. The resilience of the scheme against various attacks is evaluated using statistical, differential, and quality measures, showcasing its effectiveness against well-known attacks.

Job Quality, Gender and Generations: A Comparative and Exploratory Analysis of European Countries

This study conducts a comparative analysis of European countries regarding job quality and its relationship with gender and generational cohorts, using data from the 2021 European Working Conditions Survey. The research focuses on the subjective evaluations of job quality by European workers and examines how gender and generations may be related with these perceptions. The study operationalizes job quality using the European Intrinsic Job Quality Index, a multidimensional measure encompassing various aspects such as autonomy, interaction, intensity, and meaningful. The results show relevant variations in Intrinsic Job Quality across European countries. The study also finds that gender and generations play a role in shaping the perception of job quality. The findings of this study contribute to the ongoing debate on the importance of job quality for wellbeing and highlight the need for targeted interventions to improve job quality, particularly taking into account specific groups. The study's results also underscore the importance of considering the subjective evaluations of job quality in policy-making and the need for more comprehensive measures of job quality that capture the diverse experiences of workers across Europe.

Efficiency of a Long-term Infectious Disease Consultation and Antimicrobial Stewardship Program at a Japanese Cancer Center: An Interrupted Time-Series Analysis

Abstract Background Patients with cancer are particularly susceptible to developing drug-resistant organisms due to the high frequency of infections during cancer treatment and the use of broad-spectrum antimicrobial agents. Therefore, patients with cancer are ideal candidates for an antimicrobial stewardship program (ASP); however, no established ASPs specifically target these patients. In this study, we evaluated the effect of a 46-month ASP intervention and infectious diseases (ID) consultation using a unique antimicrobial quality measure. Methods Our single-center, retrospective, observational study was conducted from April 1, 2018, to January 31, 2024, and evaluated two phases: pre-intervention (antimicrobial notification by the infection control team) and post-intervention (implementation of ASP and establishment of the ID consultation service). Results The days of therapy (DOT) for three intravenous carbapenems significantly decreased, and the DOT of narrow-spectrum antimicrobials significantly increased after the intervention. A significant reduction was observed in the length of hospital stay, with no change in the incidence of hospital-acquired resistant microorganisms. All-cause in-hospital mortality rates and the 30-day mortality rate among patients with bacteremia episodes were numerically reduced, although not significantly, compared to the pre-intervention period. The rate of appropriate use of antimicrobial agents increased significantly during the late post-intervention period (April 1, 2021, to January 31, 2024). Conclusions Our intervention was associated with the promotion of appropriate use of antimicrobial agents and a reduction in the length of hospital stay. These findings can help establish safer cancer treatments and improve patient prognosis.

Barriers to Colonoscopy Quality Measurement in Rural Wisconsin.

Patients in rural areas have reduced colonoscopy access, which is critical for colorectal cancer prevention. General surgeons perform most colonoscopies in rural areas. The Surgical Collaborative of Wisconsin's Rural Task Force identified colonoscopy as a high priority initiative due to high volume and lack of quality measure access, both necessary for assessing and improving performance. Assess the capacity for colonoscopy quality measurement and improvement in rural Wisconsin hospitals. In October 2019-January 2020, the Surgical Collaborative of Wisconsin, Rural Wisconsin Health Cooperative, and Wisconsin Collaborative for Healthcare Quality collaborated to design/distribute a survey to 44 Rural Wisconsin Health Cooperative hospitals (n = 25 completed, response rate 57%). Descriptive statistics summarized survey items. Surgeons in each of six rural hospitals participated in stakeholder interviews. Rural Wisconsin Health Cooperative hospitals. Colonoscopy providers, procedure volume/capacity, informatics and quality measurement infrastructure, barriers to quality measurement and improvement. Most colonoscopy providers in rural hospitals were surgeons (66.3%) followed by family/internal medicine (20.0%) and gastroenterologists (13.8%). Average hospital volume/week was 19.9 colonoscopies (SD = 13.4). Hospitals reported operating at ~75% capacity. Withdrawal time was the most tracked measure (44.0%), followed by adenoma detection (36.0%), and cecal intubation (28.0%) rates. Approximately one-third of hospitals (36.0%) utilized procedure reporting software. Most hospitals (80.0%) did not have access to onsite pathology. Surgeons reported barriers to quality measurement/improvement, including insufficient resources for electronic medical record-based reporting and the need for targeted educational opportunities that do not require travel. Single state; may not represent experience of all rural hospitals. The lack of access to colonoscopy quality measures suggests the opportunity to develop a flexible approach that considers reporting software availability and electronic medical record differences. Improving access to measures and education/training opportunities may improve availability of high-quality colonoscopy for patients in rural Wisconsin. See Video Abstract.

Abstract 4124974: Small delays in door-to-balloon time for patients presenting with STEMI do not impact mortality: a quasi-experimental study

Introduction: Observational studies have consistently demonstrated a strong association between longer door-to-balloon (DTB) times and increased mortality in patients presenting with ST-elevation myocardial infarction (STEMI). However, the extent to which this association is attributable to unmeasured differences between patients with different DTB times (i.e., confounding), as opposed to a causal impact of longer DTBs is unclear. Aim: In this study, we exploit a natural experiment using an instrumental variable (IV) approach based on weekday vs weekend presentation to evaluate whether incremental delays in DTB times have a causal effect on patient outcomes. Methods: We performed a retrospective analysis of patients undergoing immediate percutaneous coronary intervention (PCI) for STEMI in the CathPCI Registry from 1/2010 to 12/2021 at 1,422 sites. Time of presentation with STEMI (weekday daytime vs weekend daytime) was used as an IV to address potential confounding. A 2-stage IV analysis was used. In-hospital all-cause mortality was the primary outcome. Results: A total of 447,355 patients presented with STEMI during the study period. The average difference in weekend (N=125,787) minus weekday (N=321,568) daytime DTB times was 10.5 minutes. Patient, procedural, and hospital characteristics were well balanced between groups. Overall, in-hospital mortality was 3.5%. In the IV analysis, delays in DTB time were not associated with increased odds of in-hospital mortality (OR 0.99, 95% CI 0.95 to 1.03, P = 0.70). This null association was also observed when limited to hospitals with larger differences (19.5 minutes) between weekend and weekday DTB time (OR 1.00, 95% CI 0.96 to 1.03, P = 0.85) and among patients predicted to have the longest (mean 70.8 minutes) DTB times (OR 1.00, 95% CI 0.94 to 1.07, P = 0.96). Conclusions: Contrary to prior findings, incremental delays in DTB time for patients presenting with STEMI are not associated with increased in-hospital mortality when analyzed using quasi-experimental methods less likely to be influenced by unmeasured confounding. Efforts to further reduce DTB times in patients presenting to hospitals with STEMI are unlikely to improve outcomes. In the current era, policies intended to incentivize better care for STEMI patients should prioritize other measures of quality beyond DTB.

Abstract 4126000: The Association of Cardiologist Vertical Integration With Care Quality, Patient Outcomes, and Utilization

Introduction: U.S. healthcare has experienced substantial growth in vertical integration (physicians employed by hospitals), but little is known about its effect on patient care. Aims: To assess the association between cardiologist vertical integration and patient outcomes, care quality, and utilization among patients hospitalized with incident acute myocardial infarction (AMI) or heart failure (HF). Methods: We used a sample of all Medicare fee-for-service beneficiaries hospitalized with incident AMI and a 75% sample of beneficiaries hospitalized with incident HF between 2008-2019. We identified the accountable cardiologists that cared for these patients and determined their integration status using tax identification numbers. We used difference-in-differences methods to compare outcomes for patients treated by integrated cardiologists after switching from non-integrated to integrated practice, to outcomes for patients treated by cardiologists who remained non-integrated. Patient outcomes were in-hospital mortality, 30-day mortality, and 30-day readmission. Quality measures were the proportion of patients that received 1) a guideline-recommended test to assess cardiac function and 2) a 30-day follow-up clinic visit. Utilization measures were length of stay and the proportion of AMI patients receiving percutaneous coronary intervention. Models were adjusted for time trends and patient, hospital, and cardiologist characteristics. Results: The proportion of U.S. cardiologists employed by hospitals increased from 26% in 2008 to 61% in 2018. We identified 186,052 AMI patients and 259,849 HF patients cared for cardiologists who switched to integrated practice and 168,052 AMI patients and 245,769 HF patients cared for by non-integrated cardiologists. Patients were similar in age, sex, race/ethnicity, and comorbidities. We found no significant differences in clinical outcomes (e.g., adjusted difference in 30-day mortality 0.03% [95% CI = -0.39%, 0.45%] for AMI and -0.05% [-0.37%, 0.27%] for HF patients); no differences in most quality metrics, and no differences in utilization between patients treated by integrated versus non-integrated cardiologists. Conclusions: We found minimal evidence that cardiologist employment by hospitals improves care quality or outcomes. Regulation of vertical integration should focus on other effects of integration such as higher prices paid by insurers.

Pilot study of the effect of surgical menopause on bone mineral density and quality in patients with gynecological malignancies.

To investigate the effects of surgical menopause on bone mineral density and bone quality because bilateral salpingo-oophorectomy for the treatment of gynecological malignancies is common even in premenopausal patients. This study is prospective one of bone mineral density and quality measurements after surgery for perimenopausal gynecologic malignancies. In 50 women who underwent surgical menopause for a diagnosis of gynecological malignancies, bone mineral density (BMD), blood levels of tartrate-resistant acid phosphatase 5b (TRACP-5b) and bone-specific alkaline phosphatase (BAP) as bone metabolism markers, and urinary pentosidine level as bone quality marker were measured before surgery and at multiple points up to 24 months after surgery. In a group of 22 patients who did not undergo hormone replacement therapy (HRT) (HRT- group), BMD of the lumbar spine and total hip continued to decrease significantly from 6 months postoperatively. Percentages of changes in BMD progressively increased over time after surgery. TRACP-5b and urinary pentosidine levels significantly increased 6 months postoperatively compared with preoperative levels. Comparisons between 10 patients who underwent HRT (HRT+ group) and the HRT- group revealed significant reductions in the percentage of change in lumbar spine BMD only and TRACP-5b and urinary pentosidine levels 12 months postoperatively in the former group. In this pilot study, we showed that BMD and bone-related markers are altered in patients with surgical menopause. It also suggested that HRT may reduce these influences on bone metabolism.

Abstract 4137264: Subclassification of Peripheral Artery Disease Based on Muscle Force: Leg Failure with Reduced Muscle Force and Leg Failure with Preserved Muscle Force

Introduction: All claudicating patients with peripheral artery disease (PAD) exhibit leg failure, as evidenced by distinct walking impairment. However, based on a detailed evaluation of leg biomechanics, some claudicating patients maintain preserved leg muscle strength, while others demonstrate reduced strength. In this study, we aim to compare the clinical and physiological characteristics of the two groups. Methods: Fifty-four claudicating patients were categorized into two groups: leg failure with preserved muscle force (LEF-PF) versus leg failure with reduced muscle force (LEF-RF), based on the peak torque (PT) from performing maximum isometric plantar flexion contractions on a Biodex system. All patients underwent history and physical exam, measurement of leg hemodynamics, walking performance and quality of life, and gastrocnemius biopsy to evaluate the histology and biochemistry of the affected leg muscles. We used independent samples T test and chi-square test to compare the two groups. Results: LEF-PF (N=19, PT 92±15 Nm) and LEF-RF (N=35, PT 49±13 Nm) had similar demographic and comorbidity profiles. While ankle-brachial index didn't differ between the two groups, during the reactive hyperemia test, ankle pressure of LEF-RF dropped more significantly (p=0.021) upon occlusion release and took longer to recover (p=0.023). Both groups performed similarly on the Gardner Treadmill test, but LEF-PF performed better in the 6-Minute Walking test (p=0.062). LEF-PF also trended towards higher scores on the modified falls efficacy scale (p=0.056). Histologically, gastrocnemius muscle from LEF-PF had larger myofibers, while biochemically, they exhibited lower mitochondrial respiratory activity dependent on complex-II compared to LEF-RF. Conclusion: Our study presents a novel approach to understanding the physiology of claudication, focusing on the strength of the ischemic muscles. Despite comparable demographics and hemodynamics at rest, notable differences separate the two groups during stress-induced hemodynamics, walking performance, myofiber histology, and mitochondrial biochemistry. Further investigations are necessary to elucidate the underlying mechanisms behind the differences in muscle strength among patients with claudication. Such insights may enhance our understanding of PAD physiology and potentially correlate with variations in mortality rates, progression to more advanced PAD stages, and responses to different therapeutic interventions.

Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis refractory to biologic therapy: 2-year clinical and radiographic results from the open-label extension of the SELECT-AXIS 2 study.

The efficacy and safety of upadacitinib in patients with ankylosing spondylitis (AS) and inadequate response/intolerance to biologic disease-modifying antirheumatic drugs (bDMARD-IR) were evaluated through 1 year in the SELECT-AXIS 2 study. Here, we assess 2-year efficacy, safety, and imaging outcomes in SELECT-AXIS 2. Patients who received continuous upadacitinib, and those who switched from placebo to upadacitinib at week 14, could enter the open-label extension (OLE). Efficacy endpoints included Assessment of SpondyloArthritis international Society (ASAS) and Axial Spondyloarthritis Disease Activity Score (ASDAS) responses, and changes from baseline in measures of disease activity, back pain, function, and quality of life. Radiographic progression was evaluated using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). As observed (AO) and AO with non-responder imputation (AO-NRI) analyses were used for binary endpoints; AO with mixed-effects model for repeated measures (AO-MMRM) for continuous endpoints; and AO-analysis of covariance for mSASSS. Treatment-emergent adverse events (TEAEs) in patients receiving ≥ 1 upadacitinib dose through week 104 are presented as events (E)/100 patient-years (PY). Subgroup analyses were performed by prior tumor necrosis factor/interleukin-17 inhibitor exposure and bDMARD lack of efficacy/intolerance. Of 420 patients who entered the bDMARD-IR AS study, 409 entered the OLE, and 331 (continuous upadacitinib, n = 163; placebo to upadacitinib, n = 168) completed week 104. Improvements in efficacy measures were sustained through the OLE, with similar response rates between the continuous upadacitinib and placebo to upadacitinib groups at week 104. At week 104, 64.9% and 61.7% of patients, respectively, had achieved ASAS 40% response (AO-NRI). Mean changes from baseline were similar between the two groups at week 104 across measures (ASDAS: -2.1 and -2.0; total back pain: -4.9 and -4.6, respectively; AO-MMRM). Over 93.0% of patients showed no radiographic progression (mSASSS mean change from baseline < 2) at week 104. The overall TEAE rate was 165.2 E/100 PY, with low rates of major adverse cardiovascular and venous thromboembolic events (0.3 E/100 PY each). Upadacitinib efficacy, including very low rates of radiographic progression, was demonstrated through 104 weeks in treatment-refractory patients with active AS. Treatment was well tolerated, with no newly identified safety signals. NCT04169373.

Abstract 4114694: A Large Animal Model of Persistent Atrial Fibrillation

Purpose: Persistent atrial fibrillation (AFib), the most common sustained cardiac arrhythmia in the United States, poses substantial health hazards, such as the formation of blood clots, stroke, and heart failure. Despite available therapies such as ablation and antiarrhythmic drugs, there still is no definitive cure for AFib. Our study aims to bridge this gap by investigating the genetic and molecular factors underlying AFib through the development of an AFib model using Yucatan mini swine as the medium that closely mimics human cardiac physiology. Methods: We selected Yucátan mini swine as animal models because they closely resemble humans physiologically and are of a convenient size for performing extended experiments. We surgically implanted pacing leads, implantable cardiac monitors (ICMs), and pacing generators into the swine, along with external Fitbark 2.0 Collars to use activity levels as a measurement of quality of life. After the procedures the swine underwent rapid atrial pacing with the intention to induce persistent atrial fibrillation. Findings: An electrocardiogram (ECG) showed that the method of stimulating the right atrium of the heart induced persistent atrial fibrillation in pigs and decreased levels of activity, indicating a decline in their general health. This continued for &gt;7 days after atrial pacing was terminated. Overcoming challenges associated with animal dimensions and model design, we devised specific surgical techniques, including jugular cut-down, lateral cervical implantation coupled with antibiotic support, long sheaths, and customized styluses. These innovations were instrumental in achieving a successful AFib model and overcoming anatomical obstacles. Summary: Our study demonstrates the feasibility of creating a large animal model of AFib using Yucatan mini swine. This model closely resembles the clinical presentation of human AFib and could provide valuable insights into the disease mechanism and potential therapeutic strategies. Animal heart and vascular dimensions were the most challenging surgically.

Analyzing the Correlation Between Toxic Comments and Code Quality

ABSTRACTSoftware development has a relevant human side, and this could, for example, imply that developers' feelings have an impact on certain aspects of software development such as quality, productivity, or performance. This paper explores the effects of toxic emotions on code quality and presents the SentiQ tool, which gathers and analyzes sentiments from commit messages (obtained from GitHub) and code quality measures (obtained from SonarQube). The SentiQ tool we proposed performs a sentiment analysis (based on natural language processing techniques) and relates the results to the code quality measures. The datasets extracted are then used as the basis on which to conduct a preliminary case study, which demonstrates that there is a relationship between toxic comments and code quality that may affect the quality of the whole software project. This has resulted in the drafting of a predictive model to validate the correlation of the impact of toxic comments on code quality. The main implication of this work is that these results could, in the future, make it possible to estimate code quality as a function of developers' toxic comments.