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Nevin Manimala Statistics

The impact of Libman-sacks endocarditis on inpatient outcomes with systemic lupus erythematosus: A retrospective study

Lupus. 2024 Apr 2:9612033241243179. doi: 10.1177/09612033241243179. Online ahead of print.

ABSTRACT

INTRODUCTION: The existing literature offers limited insights into the influence of Libman-Sacks Endocarditis (LSE) on inpatient outcomes in individuals with Systemic Lupus Erythematosus (SLE). This study aimed to explore the characteristics and prognosis of SLE patients with LSE and the impact of LSE in patients with SLE on inpatient outcomes including inpatient mortality, length of stay, acute heart failure, atrial fibrillation, and cerebrovascular accidents (CVA).

METHODS: This study included adult patients who were hospitalized with SLE between the years 2019 and 2020, using the National Inpatient Sample (NIS) database. The total number of patients with a diagnosis of SLE in the years 2019 and 2020 in the NIS database was 150,411. Of those, 349 had a diagnosis of LSE. The study population was divided into two groups: one group with SLE and LSE, and another group with SLE but without LSE.

RESULTS: Caucasians made up 54.9% of the patients with a diagnosis of SLE in our patient population, while African Americans made up 26.9% and the Hispanics accounted for 12.2%. Of patients with LSE, Caucasians and African Americans represented 42.9% each. Patients with a diagnosis of LSE had a higher inpatient mortality than those with SLE without LSE (aOR: 9.74 CI 1.12-84.79, p 0.04). Patients with SLE with LSE were more likely to have acute heart failure than those without LSE, although this was not statistically significant (aOR 1.18 CI 0.13-11.07, p 0.88). Similarly, patients with SLE with LSE were more likely to have atrial fibrillation than those without LSE (aOR 4.45 CI: 0.77-25.57, p 0.10). CVAs were significantly higher in SLE patients with LSE than those without LSE (aOR 141.43 CI 16.59-1205.52, p < .01).

DISCUSSION: Patients who develop LSE were found to have significantly higher risks of inpatient mortality and cerebrovascular accidents. Early and precise detection of LSE in such patients may ensure timely intervention and prevention of the associated adverse outcomes. Further studies may attempt to develop screening methods for detection of LSE to effectively reduce morbidity and mortality associated with SLE.

PMID:38564733 | DOI:10.1177/09612033241243179

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Nevin Manimala Statistics

Building a Practice Ready and Resilient Nursing Workforce

Nurs Adm Q. 2024 Apr-Jun 01;48(2):127-138. doi: 10.1097/NAQ.0000000000000631. Epub 2024 Mar 29.

ABSTRACT

Nurse leaders depend upon resiliency skills to support their practice. It is important to provide opportunities for nursing students to learn, practice, and observe these skills, which are needed to navigate challenging work environments. This article describes the impact of a resiliency curricular component in a grant-funded BSN elective course, Concepts of Primary Care. Program evaluation was performed using a pre/posttest format and 2 surveys, the Brief Resilience Scale (BRS) and the Brief Resilience Coping Scale (BRCS). Three open-ended questions were administered upon completion of the elective course. A concurrent nested design was utilized with a thematic analysis undertaken to analyze qualitative data. Analysis of quantitative data was performed using descriptive statistics. Undergraduate BSN students showed an overall increase in resiliency (BRS: P = .112; BCRS: P = .064), and responses to open-ended questions supported the ability to apply and analyze most of the resiliency skills presented during the didactic portion of the elective course. This course promoted the development and refinement of undergraduate BSN student resilience skills. Integration of resilience content in the primary care course also supported student professional development. The addition of resiliency concepts and skills into undergraduate nursing curricula is recommended to enhance the ability of novice nurses to address work-related challenges and promote career satisfaction for the future.

PMID:38564723 | DOI:10.1097/NAQ.0000000000000631

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Nevin Manimala Statistics

Bereavement Care Team: Improving ICU Nurses’ Professional Bereavement and Patient Family Experience

Nurs Adm Q. 2024 Apr-Jun 01;48(2):97-106. doi: 10.1097/NAQ.0000000000000634. Epub 2024 Mar 29.

ABSTRACT

When nurses care for dying patients, their compassion fatigue may increase and lead to burnout and feelings of professional bereavement. However, if a nurse perceives that the patient had a “good death,” it may have a positive impact on them and reduce their emotional distress. The purpose of this project is to reduce nurses’ feelings of professional bereavement by implementing a Bereavement Care Team (BCT) in the intensive care unit (ICU). This study is a pre-post quasi-experimental design. The Chen and Chow bereavement subscales Factor 1 and Factor 2 measured elements of a nurse’s professional bereavement, and 5 items were statistically significant. Nurses felt a reduction in their exhaustion, frustration, and feeling fatigue in their job, reduced feelings about being nervous and worried about potential professional/patient conflicts, and nurses were moved by the patient’s family’s understanding of the patient’s death. Implementing a BCT in the ICU provided an environment that created a “good death” for the patient and their loved ones. These findings supported the need for the BCT as they demonstrated an improvement in the ICU nurses’ feelings of professional bereavement.

PMID:38564720 | DOI:10.1097/NAQ.0000000000000634

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Nevin Manimala Statistics

Neoadjuvant Chemotherapy With Oxaliplatin and Fluoropyrimidine Versus Upfront Surgery for Locally Advanced Colon Cancer: The Randomized, Phase III OPTICAL Trial

J Clin Oncol. 2024 Apr 2:JCO2301889. doi: 10.1200/JCO.23.01889. Online ahead of print.

ABSTRACT

PURPOSE: The role of neoadjuvant chemotherapy (NAC) in colon cancer remains unclear. This trial investigated whether 3 months of modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine and oxaliplatin (CAPOX) as NAC could improve outcomes in patients with locally advanced colon cancer versus upfront surgery.

PATIENTS AND METHODS: OPTICAL was a randomized, phase III trial in patients with clinically staged locally advanced colon cancer (T3 with extramural spread into the mesocolic fat ≥5 mm or T4). Patients were randomly assigned 1:1 to receive six preoperative cycles of mFOLFOX6 or four cycles of CAPOX, followed by surgery and adjuvant chemotherapy (NAC group), or immediate surgery and the physician’s choice of adjuvant chemotherapy (upfront surgery group). The primary end point was 3-year disease-free survival (DFS) assessed in the modified intention-to-treat (mITT) population.

RESULTS: Between January 2016 and April 2021, of the 752 patients enrolled, 744 patients were included in the mITT analysis (371 in the NAC group; 373 in the upfront surgery group). At a median follow-up of 48.0 months (IQR, 46.0-50.1), 3-year DFS rates were 82.1% in the NAC group and 77.5% in the upfront surgery group (stratified hazard ratio [HR], 0.74 [95% CI, 0.54 to 1.03]). The R0 resection was achieved in 98% of patients who underwent surgery in both groups. Compared with upfront surgery, NAC resulted in a 7% pathologic complete response rate (pCR), significantly lower rates of advanced tumor staging (pT3-4: 77% v 94%), lymph node metastasis (pN1-2: 31% v 46%), and potentially improved overall survival (stratified HR, 0.44 [95% CI, 0.25 to 0.77]).

CONCLUSION: NAC with mFOLFOX6 or CAPOX did not show a significant DFS benefit. However, this neoadjuvant approach was safe, resulted in substantial pathologic downstaging, and appears to be a viable therapeutic option for locally advanced colon cancer.

PMID:38564700 | DOI:10.1200/JCO.23.01889

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Identification of Pancreatic Cancer Germline Risk Variants With Effects That Are Modified by Smoking

JCO Precis Oncol. 2024 Mar;8:e2300355. doi: 10.1200/PO.23.00355.

ABSTRACT

PURPOSE: Pancreatic cancer (PC) is a deadly disease most often diagnosed in late stages. Identification of high-risk subjects could both contribute to preventative measures and help diagnose the disease at earlier timepoints. However, known risk factors, assessed independently, are currently insufficient for accurately stratifying patients. We use large-scale data from the UK Biobank (UKB) to identify genetic variant-smoking interaction effects and show their importance in risk assessment.

METHODS: We draw data from 15,086,830 genetic variants and 315,512 individuals in the UKB. There are 765 cases of PC. Crucially, robust resampling corrections are used to overcome well-known challenges in hypothesis testing for interactions. Replication analysis is conducted in two independent cohorts totaling 793 cases and 570 controls. Integration of functional annotation data and construction of polygenic risk scores (PRS) demonstrate the additional insight provided by interaction effects.

RESULTS: We identify the genome-wide significant variant rs77196339 on chromosome 2 (per minor allele odds ratio in never-smokers, 2.31 [95% CI, 1.69 to 3.15]; per minor allele odds ratio in ever-smokers, 0.53 [95% CI, 0.30 to 0.91]; P = 3.54 × 10-8) as well as eight other loci with suggestive evidence of interaction effects (P < 5 × 10-6). The rs77196339 region association is validated (P < .05) in the replication sample. PRS incorporating interaction effects show improved discriminatory ability over PRS of main effects alone.

CONCLUSION: This study of genome-wide germline variants identified smoking to modify the effect of rs77196339 on PC risk. Interactions between known risk factors can provide critical information for identifying high-risk subjects, given the relative inadequacy of models considering only main effects, as demonstrated in PRS. Further studies are necessary to advance toward comprehensive risk prediction approaches for PC.

PMID:38564682 | DOI:10.1200/PO.23.00355

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Nevin Manimala Statistics

Investigating the Role of Anger and Cognitive Malfunction in Mental Health: A Cross-Sectional Exploration Paving the Way for a Subsequent Experiment

J Psychol. 2024 Apr 2:1-23. doi: 10.1080/00223980.2024.2334289. Online ahead of print.

ABSTRACT

The functional outcomes associated with subjective well-being (SWB) and the detrimental aspects of psychological distress (PD) make it essential to explore contributing factors. The present study investigated a model about the existing gap in the determining role of trait anger (TA), state anger (SA), cognitive reappraisal (CR), rumination and cognitive failure (CF) as predictors of SWB and PD. The study contributes by exploring the interaction of dispositional, situation factors and emotional regulation strategies in shaping SWB and PD in the Indian Sample. A cross-sectional survey design was employed wherein 600 young adults aged 18-40 (Mage = 22.13, SDage = 4.06) were recruited from Uttar Pradesh, India using a multi-level cluster sampling method. The data were collected using questionnaires in the field setting during August-December 2021. Regression and path analysis revealed that the proposed predictors explained significant variance in SWB and PD, i.e., R2 = 0.24, F (5, 594) = 38.03, p < 0.01, Cohen f2 =0.31 and R2 = 0.35, F (5, 594) = 66.40, p < 0.01, Cohen f2 = 0.53, respectively. The models also fit well with the statistical indices. Except CR, all predictors emerged as significant risk factors. The findings suggest that the interventions to reduce PD and enhance SWB may consider inculcating CR and reducing higher levels of TA, SA, rumination and CF to enhance an individual’s adaptive functioning. The findings pave the way for conducting a pre-planned experiment to study the outcomes of various levels of TA in regulating incidental anger (SA) employing CR and rumination.

PMID:38564674 | DOI:10.1080/00223980.2024.2334289

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Investigation of the effects of pentoxifylline and alpha tocopherol treatment on recovery in rats with Achilles tendon rupture

J Orthop Res. 2024 Apr 2. doi: 10.1002/jor.25844. Online ahead of print.

ABSTRACT

Although the Achilles tendon is the largest and strongest tendon in the body, healing of the Achilles tendon is the most common injury, and this process is difficult due to poor tendon circulation; moreover, the underlying mechanism has not been fully elucidated. In our study, we aimed to investigate the effects of pentoxifylline and alpha-tocopherol administered separately or in combination on rats with Achilles tendon injury. Forty-eight male Wistar rats weighing 230 ± 30 g were used in the study. The rats were randomly divided into eight groups of six animals each. Tendons were evaluated histopathologically and biomechanically. According to the statistical analysis, the vascularity density in the pentoxifylline group on day 14 was significantly greater than that in the other groups (p < 0.05). The collagen arrangement in the pentoxifylline and alpha-tocopherol groups on day 14 was found to be firmer and smoother than that in the control group (p < 0.05). The collagen arrangement in the pentoxifylline group on day 28 was greater than that in the other groups (p < 0.05). The biomechanical results were significantly greater in all groups (p < 0.05). Pentoxifylline contributed to tendon healing both through neovascularization in the early period and by improving collagen orientation in the late period, while alpha-tocopherol had a positive effect on collagen orientation in the early period. No beneficial effects were observed when pentoxifylline and alpha-tocopherol were used together. We believe that further research is needed to understand the effects of this combination therapy on tendon healing.

PMID:38564283 | DOI:10.1002/jor.25844

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Unraveling Temporal Dynamics of Multidimensional Statistical Learning in Implicit and Explicit Systems: An X-Way Hypothesis

Cogn Sci. 2024 Apr;48(4):e13437. doi: 10.1111/cogs.13437.

ABSTRACT

Statistical learning enables humans to involuntarily process and utilize different kinds of patterns from the environment. However, the cognitive mechanisms underlying the simultaneous acquisition of multiple regularities from different perceptual modalities remain unclear. A novel multidimensional serial reaction time task was developed to test 40 participants’ ability to learn simple first-order and complex second-order relations between uni-modal visual and cross-modal audio-visual stimuli. Using the difference in reaction times between sequenced and random stimuli as the index of domain-general statistical learning, a significant difference and dissociation of learning occurred between the initial and final learning phases. Furthermore, we used a negative and positive occurrence-frequency-and-reaction-time correlation to indicate implicit and explicit learning, respectively, and found that learning simple uni-modal patterns involved an implicit-to-explicit segue, while acquiring complex cross-modal patterns required an explicit-to-implicit segue, resulting in a X-shape crossing of regularity learning. Thus, we propose an X-way hypothesis to elucidate the dynamic interplay between the implicit and explicit systems at two distinct stages when acquiring various regularities in a multidimensional probability space.

PMID:38564270 | DOI:10.1111/cogs.13437

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Nevin Manimala Statistics

Innovative Design and Development of Personalized Ankle-Foot Orthoses for Survivors of Stroke With Equinovarus Foot: Protocol for a Feasibility and Comparative Trial

JMIR Res Protoc. 2024 Apr 2;13:e52365. doi: 10.2196/52365.

ABSTRACT

BACKGROUND: Ankle-foot orthoses (AFOs) are vital in gait rehabilitation for patients with stroke. However, many conventional AFO designs may not offer the required precision for optimized patient outcomes. With the advent of 3D scanning and printing technology, there is potential for more individualized AFO solutions, aiming to enhance the rehabilitative process.

OBJECTIVE: This nonrandomized trial seeks to introduce and validate a novel system for AFO design tailored to patients with stroke. By leveraging the capabilities of 3D scanning and bespoke software solutions, the aim is to produce orthoses that might surpass conventional designs in terms of biomechanical effectiveness and patient satisfaction.

METHODS: A distinctive 3D scanner, complemented by specialized software, will be developed to accurately capture the biomechanical data of leg movements during gait in patients with stroke. The acquired data will subsequently guide the creation of patient-specific AFO designs. These personalized orthoses will be provided to participants, and their efficacy will be compared with traditional AFO models. The qualitative dimensions of this experience will be evaluated using the Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST) assessment tool. Feedback from health care professionals and the participants will be considered throughout the trial to ensure a rounded understanding of the system’s implications.

RESULTS: Spatial-temporal parameters will be statistically compared using paired t tests to determine significant differences between walking with the personalized orthosis, the existing orthosis, and barefoot conditions. Significant differences will be identified based on P values, with P<.05 indicating statistical significance. The Statistical Parametric Mapping method will be applied to graphically compare kinematic and kinetic data across the entire gait cycle. QUEST responses will undergo statistical analysis to evaluate patient satisfaction, with scores ranging from 1 (not satisfied) to 5 (very satisfied). Satisfaction scores will be presented as mean and SD values. Significant variations in satisfaction levels between the personalized and existing orthosis will be assessed using a Wilcoxon signed rank test. The anticipation is that the AFOs crafted through this innovative system will either match or outperform existing orthoses in use, with higher patient satisfaction rates.

CONCLUSIONS: Embracing the synergy of technology and biomechanics may hold the key to revolutionizing orthotic design, with the potential to set new standards in patient-centered orthotic solutions. However, as with all innovations, a balanced approach, considering both the technological possibilities and individual patient needs, will be paramount to achieving optimal outcomes.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52365.

PMID:38564249 | DOI:10.2196/52365

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Nevin Manimala Statistics

A two-stage group-sequential design for delayed treatment responses with the possibility of trial restart

Stat Med. 2024 Apr 2. doi: 10.1002/sim.10061. Online ahead of print.

ABSTRACT

Common statistical theory applicable to confirmatory phase III trial designs usually assumes that patients are enrolled simultaneously and there is no time gap between enrollment and outcome observation. However, in practice, patients are enrolled successively and there is a lag between the enrollment of a patient and the measurement of the primary outcome. For single-stage designs, the difference between theory and practice only impacts on the trial duration but not on the statistical analysis and its interpretation. For designs with interim analyses, however, the number of patients already enrolled into the trial and the number of patients with available outcome measurements differ, which can cause issues regarding the statistical analyses of the data. The main issue is that current methodologies either imply that at the time of the interim analysis there are so-called pipeline patients whose data are not used to make a statistical decision (like stopping early for efficacy) or the enrollment into the trial needs to be at least paused for interim analysis to avoid pipeline patients. There are methods for delayed responses available that introduced error-spending stopping boundaries for the enrollment of patients followed by critical values to reject the null hypothesis in case the stopping boundaries have been crossed beforehand. Here, we will discuss other solutions, considering different boundary determination algorithms using conditional power and introducing a design allowing for recruitment restart while keeping the type I error rate controlled.

PMID:38564226 | DOI:10.1002/sim.10061