Definitive Evaluation Research Articles

Implicit Reward Structures for Implicit Reliability Models

A new methodology for effective definition and efficient evaluation of dependability-related properties is proposed. The analysis targets the systems composed of a large number of components, each one modeled implicitly through high-level formalisms, such as stochastic Petri nets. Since the component models are implicit, the reward structure that characterizes the dependability properties has to be implicit as well. Therefore, we present a new formalism to specify those reward structures. The focus here is on component models that can be mapped to stochastic automata with one or several absorbing states so that the system model can be mapped to a stochastic automata network with one or several absorbing states. Correspondingly, the new reward structure defined on each component's model is mapped to a reward vector so that the dependability-related properties of the system are expressed through a newly introduced measure defined starting from those reward vectors. A simple, yet representative, case study is adopted to show the feasibility of the method.

Evaluation of Clinical Case Definitions for Respiratory Syncytial Virus Lower Respiratory Tract Infection in Young Children.

Various case definitions of respiratory syncytial virus lower respiratory tract infection (RSV-LRTI) are currently proposed. We assessed the performance of 3 clinical case definitions against the World Health Organization definition recommended in 2015 (WHO 2015). In this prospective cohort study conducted in 8 countries, 2401 children were followed up for 2 years from birth. Suspected LRTIs were detected via active and passive surveillance, followed by in-person clinical evaluation including single timepoint respiratory rate and oxygen saturation (by pulse oximetry) assessment, and nasopharyngeal sampling for RSV testing by polymerase chain reaction. Agreement between case definitions was evaluated using Cohen's κ statistics. Of 1652 suspected LRTIs, 227 met the WHO 2015 criteria for RSV-LRTI; 73 were classified as severe. All alternative definitions were highly concordant with the WHO 2015 definition for RSV-LRTI (κ: 0.95-1.00), but less concordant for severe RSV-LRTI (κ: 0.47-0.82). Tachypnea was present for 196/226 (86.7%) WHO 2015 RSV-LRTIs and 168/243 (69.1%) LRTI/bronchiolitis/pneumonia cases, clinically diagnosed by nonstudy physicians. Low oxygen saturation levels were observed in only 55/226 (24.3%) WHO 2015 RSV-LRTIs. Three case definitions for RSV-LRTI showed high concordance with the WHO 2015 definition, while agreement was lower for severe RSV-LRTI. In contrast to increased respiratory rate, low oxygen saturation was not a consistent finding in RSV-LRTIs and severe RSV-LRTIs. This study demonstrates that current definitions are highly concordant for RSV-LRTIs, but a standard definition is still needed for severe RSV-LRTI. NCT01995175.

0846 Prevalence of Obstructive Sleep Apnea Among Medical ICU Patients

Abstract Introduction The prevalence of Obstructive Sleep Apnea (OSA) among medical intensive care unit (MICU) patients is unknown. However, OSA prevalence in the general population and in conditions that are frequently comorbid in ICU populations (e.g., diabetes and cardiovascular disease) suggests that OSA may be common among MICU patients. Our objective is to prospectively examine the prevalence and severity of OSA in patients admitted to a tertiary academic MICU. Methods This was a prospective observational study that included patients admitted to the MICU from July to December 2022. Patient charts were reviewed for patient demographics, clinical characteristics, and evidence of pre-existing OSA. Pre-existing OSA was assessed via in depth review of the electronic medical record and included data fields such as the past medical history, documentation of OSA treatment, description of OSA diagnosis in outpatient provider notes, and/or sleep study records. Based on chart review, we also assigned confidence ratings for the OSA diagnosis (high versus low) and noted patients for whom outpatient providers had a high clinical suspicion for OSA in the absence of definitive sleep evaluation. Results Herein, we present preliminary analysis of 345 MICU patients. Mean age (SD) was 64 (18) years; 49% were female, 23% were Black, and 67% were White. Acute respiratory failure (36%) and septic shock (24%) were the leading reasons for admission. Mean (SD) APACHE II severity of illness score was 19.6 (8.8) and body mass index was 27.5 (8.5). Pre-existing OSA was identified in 19% of patients; 63% of pre-existing OSA patients were characterized as “high confidence” in OSA diagnosis. An additional 6% of patients had high clinical suspicion of OSA. Severity data was sparse in the chart with only 17% of OSA patients having severity data available; OSA severity distribution was as follows: mild 9%, moderate 27%, and severe 64%. Conclusion Our preliminary analysis indicates that OSA is notably prevalent among MICU patients. We hypothesize that OSA is under-recognized and consequently undertreated in MICU patients. With this in mind, future directions include investigation of the recognition, treatment, and outcomes related to pre-existing OSA in critically ill patients. Support (if any) NHLBI, NIH T35HL007649

Choosing the Best Design in Surgical Research.

Choosing the Best Design in Surgical Research.

Development of a Supported Self-management Intervention for People With Severe Mental Illness and Type 2 Diabetes: Theory and Evidence-Based Co-design Approach.

Type 2 diabetes is 2 to 3 times more common among people with severe mental illness (SMI). Self-management is crucial, with additional challenges faced by people with SMI. Therefore, it is essential that any diabetes self-management program for people with SMI addresses the unique needs of people living with both conditions and the inequalities they experience within health care services. We combined theory, empirical evidence, and co-design approaches to develop a type 2 diabetes self-management intervention for people with SMI. The development process encompassed 4 steps: step 1 involved prioritizing the mechanisms of action (MoAs) and behavior change techniques (BCTs) for the intervention. Using findings from primary qualitative research and systematic reviews, we selected candidate MoAs to target in the intervention and candidate BCTs to use. Expert stakeholders then ranked these MoAs and BCTs using a 2-phase survey. The average scores were used to generate a prioritized list of MoAs and BCTs. During step 2, we presented the survey results to an expert consensus workshop to seek expert agreement with the definitive list of MoAs and BCTs for the intervention and identify potential modes of delivery. Step 3 involved the development of trigger films using the evidence from steps 1 and 2. We used animations to present the experiences of people with SMI managing diabetes. These films were used in step 4, where we used a stakeholder co-design approach. This involved a series of structured workshops, where the co-design activities were informed by theory and evidence. Upon the completion of the 4-step process, we developed the DIAMONDS (diabetes and mental illness, improving outcomes and self-management) intervention. It is a tailored self-management intervention based on the synthesis of the outputs from the co-design process. The intervention incorporates a digital app, a paper-based workbook, and one-to-one coaching designed to meet the needs of people with SMI and coexisting type 2 diabetes. The intervention development work was underpinned by the MoA theoretical framework and incorporated systematic reviews, primary qualitative research, expert stakeholder surveys, and evidence generated during co-design workshops. The intervention will now be tested for feasibility before undergoing a definitive evaluation in a pragmatic randomized controlled trial.

Evaluation of administrative case definitions for hypertension in Canadian children

Hypertension is increasing in children and warrants disease surveillance. We therefore sought to evaluate the validity of case definitions to identify pediatric hypertension in administrative healthcare data. Cases of hypertension in children 3–18 years of age were identified utilizing blood pressures recorded in the Manitoba Primary Care Research Network (MaPCReN) electronic medical record from 2014 to 2016. Prevalence of hypertension and associated clinical characteristics were determined. We then evaluated the validity of 18 case definitions combining outpatient physician visits (ICD9CM codes), hospital claims (ICD9CM/ICD10 codes) and antihypertensive use within 1–3 years of data housed at the Manitoba Centre for Health Policy. The MaPCReN database identified 241 children with hypertension and 4090 without (prevalence = 5.6%). The sensitivity of algorithms ranged between 0.18 and 0.51 and the specificity between 0.98 and 1.00. Pharmaceutical use increased the sensitivity of algorithms significantly. The algorithms with the highest sensitivity and area under the ROC curve were 1 or more hospitalization OR 1 or more physician claim OR 1 or more pharmaceutical record. Evaluating 2 years of data is recommended. Administrative data alone reflects diagnosis of hypertension with high specificity, but underestimate the true prevalence of this disease. Alternative data sources are therefore required for disease surveillance.

Quantitative and dynamic scenario analysis of SDGs outcomes upon global sustainability 1990–2050

The UN Sustainable Development Goals (SDGs) are the keystone policy framework for countries to achieve sustainable development. However, in fulfilling the SDGs, there is no definitive evaluation of the potential long-term outcomes upon the level, nature, and dynamics of global sustainability. This is crucial to understand, as otherwise, governments and societies may implement policies which achieve the SDGs, but are detrimental to the long-term global co-evolutionary environment-human relationship and system. Therefore, this paper determines and evaluates the potential global sustainability outcomes of the implementation of the SDGs for the specified period of 1990–2050. This is achieved by the application of the Sustainability Dynamics Framework to the results of the Earth3 model. The Earth3 model evaluated the degree of success of implementing the SDGs in respect to four development scenarios: (1) Same (business-as-usual); (2) Faster; (3) Harder and (4) Smarter. The results from the SDF application indicate that Scenario 4 (Smarter) had the best potential outcomes of the scenarios evaluated, approaching a borderline weak-strong sustainability state by the end of the specified period. The other scenarios had relatively stagnant levels of very weak sustainability. Based upon the results obtained, the broader context and implications are discussed, primarily in respect to the role and impact of the SDGs. The paper concludes by stating that humanity as a species needs to fundamentally transform its relationship with the environment, or risk being lost not only as a species, but also to the planet as well.

Prevalence and factors associated with anxiety during echocardiography procedure

Purpose: Echocardiography is the main modality for definitive diagnosis and evaluation of children with congenital heart disease. Anxiety is the most common feeling experienced by children when they visit healthcare facilities. The first aim of this study was to give an overview of the prevalence of anxiety symptoms, and the second aim was to investigate the factors associated with anxiety during the echocardiography procedure. Patients and methods: The cross-sectional study was conducted in the pediatric cardiology outpatient clinic at Prof. Dr. I G.N.G. Ngoerah General Hospital, Denpasar-Bali period February 2022 to August 2022. Children aged 18 months-6 years who underwent echocardiography evaluation were included. The visual analog scale of anxiety (VAS-A) was used to measure the severity of anxiety. The analysis is using chi-square test and logistic regression. The significance of risk factors is reported as a prevalence ratio with 95% confidence intervals and p<0.05. Results: In a total of 156 subjects, the prevalence of anxiety during the procedure was 64,1% with a similar gender proportion. Multivariate analysis found that age ≤3 years old and did not attend school were associated with anxiety (PR 60.53; 95% CI 13.07-280; p<0.001 and PR 5.59; 95% CI 1.31-23.77; p < 0.001). Conclusion: Anxiety during the echocardiography procedure is common. Age ≤3 years old and did not attend school were associated with anxiety during echocardiography.

Finding the (biomarker-defined) subgroup of patients who benefit from a novel therapy: No time for a game of hide and seek.

An important element of precision medicine is the ability to identify, for a specific therapy, those patients for whom benefits of that therapy meaningfully exceed the risks. To achieve this goal, treatment effect usually is examined across subgroups defined by a variety of factors, including demographic, clinical, or pathologic characteristics or by molecular attributes of patients or their disease. Frequently such subgroups are defined by the measurement of biomarkers. Even though such examination is necessary when pursuing this goal, the evaluation of treatment effect across a variety of subgroups is statistically fraught due to both the danger of inflated false-positive error rate from multiple testing and the inherent insensitivity to how treatment effects differ across subgroups.Pre-specification of subgroup analyses with appropriate control of false-positive (i.e. type I) error is recommended when possible. However, when subgroups are specified by biomarkers, which could be measured by different assays and might lack established interpretation criteria, such as cut-offs, it might not be possible to fully specify those subgroups at the time a new therapy is ready for definitive evaluation in a Phase 3 trial. In these situations, further refinement and evaluation of treatment effect in biomarker-defined subgroups might have to take place within the trial. A common scenario is that evidence suggests that treatment effect is a monotone function of a biomarker value, but optimal cut-offs for therapy decisions are not known. In this setting, hierarchical testing strategies are widely used, where testing is first conducted in a particular biomarker-positive subgroup and then is conducted in the expanded pool of biomarker-positive and biomarker-negative patients, with control for multiple testing. A serious limitation of this approach is the logical inconsistency of excluding the biomarker-negatives when evaluating effects in the biomarker-positives, yet allowing the biomarker-positives to drive the assessment of whether a conclusion of benefit could be extrapolated to the biomarker-negative subgroup.Examples from oncology and cardiology are described to illustrate the challenges and pitfalls. Recommendations are provided for statistically valid and logically consistent subgroup testing in these scenarios as alternatives to reliance on hierarchical testing alone, and approaches for exploratory assessment of continuous biomarkers as treatment effect modifiers are discussed.

Dynamic evolution of spatial equilibrium degree of water resources composite system in system-region two stages: The case of Lianshui Basin, China

The water resources in Lianshui Basin is facing a prominent contradiction between production and ecology, as well as fierce competition among various regions. However, existing researches on spatial equilibrium typically tend to address only one of the dimensions among water resources system and other systems or among different regions, which can not meet the requirements for optimal allocation of water resources aiming for spatial equilibrium under the high-quality development strategy. The definition and quantitative evaluation method of spatial equilibrium remain unclear. In order to respond to the policy of spatial equilibrium and overcome the dilemma of water resources development and utilization under the new normal, the connotation of spatial equilibrium at two levels of system and region was presented, a quantitative dynamic evaluation method for the spatial equilibrium degree in system-region two stages was proposed in this study. A comprehensive evaluation indicators system was built for the water resources composite system composed of three subsystems: water resources, social economy and ecological environment, and a dynamic quantization model of coupling coordination degree based on the comprehensive evaluation indices of three subsystems was established, the temporal and spatial dynamic evolution process of the coupling coordination degree of water resources composite system was analyzed. At the same time, Theil index was used to research the dynamic evolution characteristics of the regional difference in coupling coordination degree in Lianshui Basin. This paper also identified the main source of difference based on the decomposition of Theil index, and the degree and trend of spatial equilibrium of water resources in Lianshui Basin were comprehensively analyzed. The results showed that the coupling coordination degree of the composite system of each district in Lianshui Basin was continuously improving, but there was no significant trend in the difference of coupling coordination degree among regions, which means the degree of spatial equilibrium in the “system stage” has notably improved, but the degree of spatial equilibrium in the “region stage” had no significant and stable increase. In addition, the difference within the region was always the main reason for the deficiency of spatial equilibrium.

Definition and grading of anastomotic stricture/stenosis following low anastomosis after total mesorectal excision: A single-center study

BackgroundAnastomotic stricture/stenosis (AS) is an alarming complication after colorectal surgery, and there is still no recognized definition for AS. This study aimed to determine the status and change of AS after rectal surgery using a special AS definition and grading system, discuss various risk factors for AS. MethodsThis study included patients with rectal cancer who underwent total mesorectal excision between May 2014 and May 2021. A five-degree special AS definition and grading system was used to determine AS status, and clinical outcomes and risk factors for AS were investigated. ResultsA total of 473 patients were enrolled in this study. Univariate and multivariate analyses of patient-related and technical risk factors for AS were performed 3 months postoperatively. For univariate analysis, female sex was a lower risk factor for AS. Defunctioning stoma, neoadjuvant chemoradiotherapy, chemotherapy, and anastomotic leakage were higher risk factors for AS (all p < 0.05). For multivariate analysis, only neoadjuvant chemoradiotherapy, chemotherapy, and anastomotic leakage were still higher risk factors for AS (all p < 0.05). ConclusionsThrough a special AS definition and grading system's evaluation, we noted that neoadjuvant chemoradiotherapy, chemotherapy, and anastomotic leakage were the higher risk factors for AS.

Outcomes of Cesarean Scar Pregnancies in Early Gestation According to the New Delphi Consensus Criteria.

Clinical evaluation of the new Delphi consensus definition of cesarean scar pregnancy (CSP) in early gestation. A retrospective cohort of 36 women diagnosed with CSP and treated with combined local and systemic methotrexate (MTX) between 2008 and 2021. The CSPs were classified according to the new Delphi consensus criteria into three subgroups based on the depth of the gestational sac herniation in the sagittal plane. Subgroup A included 8 (22.2%) cases in which the largest part of the gestational sac protruded toward the uterine cavity. Subgroup B included 22 (61.1%) cases in which the largest part of the gestational sac was embedded in the myometrium, and subgroup C included 6 (16.7%) cases in which the gestational was partially located outside the outer contour of the cervix or uterus. The β-HCG level upon admission was significantly lower in subgroup A than in subgroups B or C (11,075 ± 7109, 18,787 ± 16,585, and 58,273 ± 55,267 mIU/mL, respectively, P=.01). All subgroup C patients had repeated courses of MTX and surgical interventions (laparotomy, uterine artery embolization, and operative hysteroscopy) at double the rate of subgroups A or B (100, 50, and 40.9%, respectively, P=.036). The duration of hospitalization was significantly shorter in subgroup A than in subgroups B or C (1.9 ± 1.5, 2.1 ± 1.1, and 5.4 ± 4.9 days, P=.01). The outcome according to Delphi consensus criteria for defining CSP in early gestation has implications for clinical decision-making, patient care, and the follow-up of CSP.

Liver-related mortality among people with hepatitis B and C: Evaluation of definitions based on linked healthcare administrative datasets.

Routinely collected and linked healthcare administrative datasets could be used to monitor mortality among people with hepatitis B (HBV) and C (HCV). This study aimed to evaluate the concordance in records of liver-related mortality among people with an HBV or HCV notification, between data on hospitalization for end-stage liver disease (ESLD) and death certificates. In New South Wales, Australia, HBV and HCV notifications (1993-2017) were linked to hospital admissions (2001-2018), all-cause mortality (1993-2018) and cause-specific mortality (1993-2016) datasets. Hospitalization for ESLD was defined as a first-time hospital admission due to decompensated cirrhosis (DC) or hepatocellular carcinoma (HCC). Consistency of liver death definition of mortality following hospitalization for ESLD was compared with two death certificate-based definitions of liver deaths coded among primary and secondary cause-specific mortality data, including ESLD-related (deaths due to DC and HCC) and all-liver deaths (ESLD-related and other liver-related causes). Of 63,292 and 107,430 individuals with an HBV and HCV notification, there were 4478 (2.6%) post-ESLD hospitalization deaths, 5572 (3.3%) death certificate liver disease deaths and 2910 (1.7%) death certificate ESLD deaths. Between 2001 and 2016, among HBV post-ESLD hospitalization deaths (n= 891), 63% (562) had death certificate ESLD recorded, and 83% (741) had death certificate liver disease recorded. Between 2001 and 2016, among HCV post-ESLD hospitalization deaths (n= 3587), 58% (2082) had death certificate ESLD recorded, and 87% (3135) had death certificate liver disease recorded. At least one-third of death certificates with DC and HCC as cause of death had no mention of HBV, HCV or viral hepatitis. Our study identified limitations in estimating and tracking HBV and HCV liver disease mortality using death certificate-based data only. The optimum data for this purpose is either ESLD hospitalisations with vital status information or a combination of these with cause-specific death certificate data.

Safety of Outpatient Plastic Surgery: A Comparative Analysis Using the TOPS Registry with 286,826 Procedures.

Outpatient plastic surgery at office-based surgery facilities (OBSFs) and ambulatory surgery centers (ASCs) has become increasingly prevalent over the past 30 years. Importantly, historical data are inconsistent regarding the safety outcomes of these venues, with advocates for both citing supporting studies. This investigation's purpose is to provide a more definitive comparative evaluation of outcomes and safety for outpatient surgery performed in these facilities. The most common outpatient procedures were identified using the Tracking Operations and Outcomes for Plastic Surgeons database between 2008 and 2016. Outcomes were analyzed for OBSFs and ASCs. Patient and perioperative information was also analyzed using regression analysis to identify risk factors for complications. A total of 286,826 procedures were evaluated, of which 43.8% were performed at ASCs and 56.2% at OBSFs. Most patients were healthy, middle-aged women categorized as American Society of Anesthesiologists class I. The incidence of adverse events was 5.7%, and most commonly included antibiotic requirement (1.4%), dehiscence (1.3%), or seroma requiring drainage (1.1%). Overall, there was no significant difference in adverse events between ASCs and OBSFs. Age, American Society of Anesthesiologists class, body mass index, diabetes, smoking history, general anesthesia, certified registered nurse anesthetist involvement, operative duration, noncosmetic indications, and body region were associated with adverse events. This study provides an extensive analysis of common plastic surgery procedures performed in an outpatient setting in a representative population. With appropriate patient selection, procedures are safely performed by board-certified plastic surgeons in ambulatory surgery centers and office-based settings, as evidenced by the low incidence of complications in both environments. Therapeutic, III.

Abstract OT1-06-01: Preservation of axillary lymph nodes in breast cancer patients undergoing mastectomy with 1-2 metastatic sentinel lymph nodes: The current status and future perspectives of the multicenter randomized clinical trial SINODAR-ONE

Abstract Introduction: Axillary lymph node dissection (ALND) has always been part of breast cancer (BC) treatment. However, during the past 25 years, the surgical management of the axilla has shifted towards a more conservative approach. Until now, ALND has remained the standard surgical technique when the sentinel lymph node (SLN) is macrometastatic. However, ALND may now be considered overtreatment for early-stage BC. The SINODAR-ONE trial is a prospective non-inferiority multicenter randomized study aimed at assessing the role of ALND in patients undergoing either breast-conserving surgery (BCS) or mastectomy for T1-2 BC presenting 1-2 macrometastatic SLNs. Objectives: The primary endpoint was to evaluate whether sentinel lymph node biopsy (SLNB) only was associated with clinically relevant worsening of the prognosis compared with ALND in terms of overall survival (OS). The secondary endpoint was to evaluate whether there was increased regional (lymph node recurrence) or distant recurrence in terms of recurrence-free survival (RFS) in patients with macrometastatic SLN who did not undergo ALND. Methods: Patients were randomly assigned (1:1 ratio) to either removal of ≥10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm). Results: The trial started in April 2015 and ceased in April 2020, involving 889 patients. The majority of the patients (75.2%) underwent BCS; 328 of 439 patients (74.7%) in the standard treatment arm, and 333 of 440 patients (75.7%) in the experimental treatment arm. 218 patients (24.8%) underwent mastectomy. SLN status at randomization was comparable between the two groups of treatment, with a median number of two SLNs removed and a median number of one positive SLN in both arms. The median number of non-SLNs identified at definitive histopathological evaluation was 16 (interquartile range [IQR] 12–21) in the ALND group. Overall, 193 of 439 patients (44.0%) in the standard treatment arm had additional macrometastases in the removed axillary lymph nodes. However, the median number of positive non SLNs was 0 (IQR 0–1) in the ALND group. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with a 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with a 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB only arm, respectively (p = 0.936). Conclusion: The 3-year survival and relapse rates of T1-2 BC patients with 1-2 macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND in patients undergoing BCS. However, given the low number of patients treated with mastectomy, there is no certainty that ALND omission can be extended also to this sub-group. In order to collect further evidence regarding the safety of the experimental treatment in patients candidates for mastectomy, the reopening of the enrollment of these patients as part of a single-arm experimental study started in June 2022. Citation Format: Damiano Gentile, Wolfgang Gatzemeier, Andrea Sagona, Erika Barbieri, Alberto Testori, Valentina Errico, Alberto Bottini, Simone Di Maria Grimaldi, Giulia Caraceni, Luca Boni, Paolo Bruzzi, Bethania Fernandes, Davide Franceschini, Ruggero Spoto, Rosalba Torrisi, Marta Scorsetti, Armando Santoro, Giuseppe Canavese, Corrado Tinterri. Preservation of axillary lymph nodes in breast cancer patients undergoing mastectomy with 1-2 metastatic sentinel lymph nodes: The current status and future perspectives of the multicenter randomized clinical trial SINODAR-ONE [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT1-06-01.

Abstract P4-02-06: Clinical and biological predictors of lymph node involvement in patients with early breast cancer for adjuvant treatment personalization

Abstract Background: Over the last years, the management of patients with node positive early breast cancer has gone through important innovations. On the medical side, new targeted therapies such as olaparib and abemaciclib have been introduced, with promising results on the invasive disease-free survival. Moreover, sparing axillary lymph node dissection has proven to be noninferior in terms of overall survival. However, no tools are currently available to predict lymph node involvement before definitive surgical evaluation. The aim of the study was to analyze clinical and pathological characteristics of patients with node positive early breast cancer to explore potential risk profiles associated with a ≥3 nodal involvement. Methods: The study retrospectively analyzed 335 node-positive breast cancer patients treated at the Breast Unit of the CRO Aviano National Cancer Institute, between 2017 and 2021. Data regarding primary tumor biological features, lymph node involvement and surgical approach were collected. Associations between clinico-pathological characteristics and ≥3 lymph node involvement were tested through stepwise logistic regression and the gradient boosting machine learning algorithm (GBM). Results: Among the 335 analyzed patients, 87.0% had a primary tumor &amp;lt; 5 cm, with a single positive lymph node in 73.3% of cases. Hormone receptors were mainly positive (respectively 93.5% and 83.4% for estrogen and progesterone receptors). Tumor grade was most frequently well differentiated (Grade 1 in 60.7%), with a Ki67 &amp;lt; 20% (59.5%). After multivariable logistic regression, a tumor size ≥ 3 cm (OR 3.24, CI95% 1.47-7.17, p = 0.004), the presence of massive lymphovascular stromal invasion (OR 2.50, CI95% 1.02-6.14, p = 0.045) and 2 or more positive sentinel lymph nodes at surgical evaluation (OR 6.08, CI95% 3.34-11.05, p &amp;lt; 0.001) were associated with a higher risk of identifying ≥ 3 positive lymph nodes after subsequent axillary dissection. Similar results were observed in the luminal-like cohort. A GBM machine learning model was then developed with a 0.77 Area Under the Curve. Features with the highest relative importance (RI) were single sentinel node involvement (RI 16.1873), followed by tumor size ≥ 3 cm (RI 10.2024), ≥2 positive sentinel lymph nodes (RI 8.5050) and lymphovascular stromal invasion (4.0217). Consistently, number of positive sentinel lymph nodes and tumor size were the predominant features in all top 20 GBM models. Conclusions: The present study explored the definition of risk profiles linked to 3 or more positive lymph nodes based on clinical and pathological features. It, moreover, tested the feasibility of developing machine learning classifiers to support future clinical decision-making. Due to the growing complexity of the adjuvant setting, finding a balance between minimally invasive surgical and staging approaches and risk definition for treatment personalization will become increasingly critical. Citation Format: Tania Pivetta, Brenno Pastò, Martina Urbani, Elisabetta Benozzi, Nicola De Pascalis, Tiziana Perin, Mario Mileto, Bruno Pasquotti, Erica Piccoli, Lorenzo Vinante, Chiara Bampo, Silvia Bolzonello, Mattia Garutti, Milena Nicoloso, Serena Corsetti, Simona Scalone, Lucia da Ros, Paola di Nardo, Camilla Lisanti, Simon Spazzapan, Barbara Belletti, Michele Bartoletti, Lorenzo Gerratana, Samuele Massarut, Fabio Puglisi. Clinical and biological predictors of lymph node involvement in patients with early breast cancer for adjuvant treatment personalization [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-02-06.

The evaluation of definitions and classifications for istiʿāra in some modern Arabic rhetoric books

Klasik dönemden günümüze değin önemli belâgat kavramlarından biri olarak görülen ve kelime veya ifadenin benzeme gayesiyle başka anlamda kullanılması anlamına gelen istiarenin bugüne kadar birbirinden farklı tanımları ve tasnifleri yapılmış ve istiare üzerine müstakil eserler telif edilmiştir. İstiareyi iki tarafından biri hazfedilen teşbih olarak tanımlayan modern dönem Arap belâgati müelliflerinden Abdülaziz Atîk (ö. 1976) fi’l-Belâgati’l-‘Arabiyye: ‘İlmü’l-beyân adlı eserinde konuyu; benzeme yönüyle tasrîhiyye ve mekniyye; istiâre yapılan sözcüğün yapısı itibariyle asliyye ve tebeiyye; istiarenin iki tarafına ait özelliklerin durumu itibariyle muraşşaha, mücerrede ve mutlaka olarak üç kategoride değerlendirmiştir. İstiare-i temsîliyyeye müstakil bir alt başlık açan Atîk’in bu kategorizasyonu, Alî el-Cârim (ö. 1949) - Mustafa Emîn’in el-Belâgatü’l-vâdiha ve Muhammed Ahmed Kâsim - Muhyiddîn Dîb’in ‘Ulûmü’l-belâğa: el-Bedî‘ ve’l-beyân ve’l-me‘ânî kitaplarında büyük ölçüde benzer şekilde olmuştur. Muhammed b. Sâlih el-‘Useymîn’nin (ö. 2001) Dürûsu’l-belâğa’sında ve Ali Bulut’un Belâgat: Meânî, beyân, bedî‘’inde ise benzer tasnif durumu olmasına rağmen bu iki müellif istiare-i temsîliyyeye değinmemiştir. el-Belâğatü’l-‘Arabiyye: Te’sîl ve tecdîd adlı eserinde istiareyi sadece tasrîhiyye ve mekniyye olarak iki kısma ayıran Mustafâ es-Sâvî el-Cüveynî’nin (ö. 1988) bu durumuna karşın, Ahmed Mustafa el-Merâğî’nin‘Ulûmü’l-belâğa, Ahmed el-Hâşimî’nin (ö. 1943) Cevâhiru’l-belâğa, Hasen Habenneke el-Meydânî’nin (ö. 2004) el-Belâgatü’l-‘Arabiyye: Üsüsühâ ve ‘ulûmühâ ve fünûnühâ ve Fadl Hasan Abbâs’ın (ö. 2011) el-Belâğa fünûnühâ ve efnânühâ kitaplarındaki istiare tasnifleri yukarıdaki müelliflerden daha kapsamlı olmuştur. Bu çalışmada son dönemde telif edilen ve ön plana çıkan bazı Arap belâgati kitaplarının istiareyle ilgili tanımları ve taksimleri incelenmiştir. Bu araştırmadaki amaç, modern dönemde telif edilen Arap belâgati eserlerinde istiare ile ilgili olarak farklı metodolojik yaklaşımları, tasnifleri ve istiareye yönelik kullanılan kavramları tespit etmektir.

Hocus Pocus: the Role of Hand-held Ultrasonography in Predicting Disease Extension and Endoscopic Activity in Ulcerative Colitis.

Ulcerative colitis [UC] assessment still requires ileocolonoscopy [IC]. Intestinal ultrasound [IUS] has emerged as a non-invasive assessment tool, and the Milan Ultrasound Criteria [MUC] score has been validated to estimate and grade UC disease activity. Recently, hand-held IUS [HHIUS] has been used in several clinical settings, but data about its use in UC are limited. We aimed to evaluate the diagnostic accuracy of HHIUS compared with conventional IUS in detecting UC extension and activity. From November 2021 to September 2022, we prospectively enrolled UC patients afferent to our third-level IBD Unit for IC evaluation. Patients underwent IC, HHIUS, and IUS. Ultrasound activity was defined by MUC >6.2, and endoscopic activity was defined by a Mayo endoscopic score [MES] >1. Cohen's k test was applied to test the concordance between IUS-MUC and HHIUS-MUC after MUC dichotomisation [MUC >6.2, yes/no]. In all, 86 patients with UC were enrolled. No significant difference was recorded between IUS and HHIUS at the per-segment extension [p = N.S.], and both procedures were comparable in terms of results of bowel wall thickness [BWT] and bowel wall stratification [BWS] assessment [p = N.S.]. IUS and HHIUS displayed excellent agreement when the MUC score system was applied [k = 0.86, p <0.01]. Hand-held intestinal ultrasound and IUS are comparable in UC extension definition and MUC evaluation. HHIUS could be reliable for detecting disease activity and estimating its extension, providing close monitoring. It also represents a non-invasive, easily practicable investigation, allowing immediate medical decisions with significant time and cost advantages.

Defining rurality: an evaluation of rural definitions and the impact on survival estimates.

Patients with cancer living in rural areas have inferior cancer outcomes; however, studies examining this association use varying definitions of "rural," complicating comparisons and limiting the utility of the results for policy makers and future researchers. Surveillance, Epidemiology, and End Results data (2000-2016) were used to assess risk of cancer mortality and mortality from any cause across 4 definitions of rurality: Urban Influence codes (UIC), National Center for Health Statistics (NCHS), Rural-Urban continuum codes (RUCC), and Index of Relative Rurality. Binary (urban vs rural) and ternary (urban, micropolitan, rural) definitions were evaluated. Multivariable parametric survival models estimated hazards of mortality overall and among 3 cancer groupings: screening related, obesity related, and tobacco related. Definition agreement was also assessed. Overall, 3 788 273 patients with an incident cancer representing 605 counties were identified. There was little discordance between binary definitions of rural vs urban and moderate agreement at the 3 levels. Adjusted models using binary definitions revealed 15% to 17% greater hazard of cancer mortality in rural compared with urban. At the 3 levels when comparing rural with metropolitan, RUCC and NCHS saw similarly increased hazard ratios; however, Index of Relative Rurality did not. Screening-related cancers saw the highest hazards of mortality and the largest divergence between definitions. Obesity-related and tobacco-related cancers saw similarly increased hazards of mortality at the binary and ternary levels. Hazard of death is similar across binary definitions; however, this differed when categorized as ternary or continuous, especially among screening-related cancers. Results suggest that study purpose should direct choice of definitions and categorization.

The Image Definition Assessment of Optoelectronic Tracking Equipment Based on the BRISQUE Algorithm with Gaussian Weights.

Defocus is an important factor that causes image quality degradation of optoelectronic tracking equipment in the shooting range. In this paper, an improved blind/referenceless image spatial quality evaluator (BRISQUE) algorithm is formulated by using the image characteristic extraction technology to obtain a characteristic vector (CV). The CV consists of 36 characteristic values that can effectively reflect the defocusing condition of the corresponding image. The image is evaluated and scored subjectively by the human eyes. The subjective evaluation scores and CVs constitute a set of training data samples for the defocusing evaluation model. An image database that contains sufficiently many training samples is constructed. The training model is trained to obtain the support vector machine (SVM) model by using the regression function of the SVM. In the experiments, the BRISQUE algorithm is used to obtain the image feature vector. The method of establishing the image definition evaluation model via SVM is feasible and yields higher subjective and objective consistency.