Background and objectives: With improved diagnostic means of early breast cancer, the percentage of cases with metastasis in axillary lymph nodes has decreased from 50–75% to 15–30%. Lymphadenectomy and sentinel lymph node biopsy are not treatment procedures, as they aim at axillary nodal staging in breast cancer. Being surgical interventions, they can lead to various complications. Therefore, recently much attention has been paid to the identification of non-invasive methods for axillary nodal staging. In many countries, ultrasound is a first-line method to evaluate axillary lymph node status. The aim of this study was to evaluate the prognostic value of ultrasound in detecting intact axillary lymph nodes and to assess the accuracy of ultrasound in detecting a heavy nodal disease burden. The additional objective was to evaluate patients’ and tumor characteristics leading to false-negative results. Materials and Methods: A total of 227 women with newly diagnosed pT1 breast cancer were included to this prospective study conducted at the Breast Surgery Unit, Clinic of Surgery, Hospital of Lithuanian University of Health Sciences Kauno Klinikos, between May 1, 2016, and May 31, 2018. All patients underwent preoperative axillary ultrasound examination. Ultrasound data were compared with the results of histological examination. The accuracy and true-negative rate of ultrasound were calculated. The reasons of false-negative results were analyzed. Results: Of the 189 patients who had normally appearing axillary lymph nodes on preoperative ultrasound (PAUS-negative), 173 (91.5%) patients were also confirmed to have intact axillary lymph nodes (node-negative) by histological examination after surgery. The accuracy and the negative predictive value of ultrasound examination were 84.1% and 91.5%, respectively. In ≥3 node-positive cases, the accuracy and the negative predictive value increased to 88.7% and 98.3%, respectively. In total, false-negative results were found in 8.5% of the cases (n = 16); in the PAUS-negative group, false-negative results were recorded only in 1.6% of the cases (n = 3). The results of PAUS and pathological examination differed significantly between patients without and with lymphovascular invasion (LV0 vs. LV1, p < 0.001) as well as those showing no human epidermal growth factor receptor 2 (HER2) expression and patients with weakly or strongly expressed HER2 (HER2(0) vs. HER2(1), p = 0.024). Paired comparisons revealed that the true-negative rate was significantly different between the LV0 and LV1 groups (91% vs. 66.7%, p < 0.05), and the false-negative rate was statistically significant different between the HER2(0) and HER2(1) groups (10.5% vs. 1.2%, p < 0.05). Evaluation of other characteristics showed both the groups to be homogenous. Conclusions: Negative axillary ultrasound excluded axillary metastatic disease in 91.5% of the patients. PAUS had an accuracy of 88.7% in detecting a heavy nodal disease burden. With the absence of lymphovascular invasion (LV0), we can rely on PAUS examination that axillary lymph nodes are intact (PAUS-negative), and this patients’ group could avoid sentinel lymph node biopsy. Patients without HER2 expression are at a greater likelihood of false-negative results; therefore, the findings of ultrasound that axillary lymph nodes are intact (PAUS-negative results) should be interpreted with caution.
About 70% of early breast cancer cases axillary lymph nodes are intact and surgical axillary intervention is unnecessary. There is an ongoing search for non-invasive methods to evaluate the status of axillary lymph nodes in order to prevent Axillary Lymph Node Dissection (ALND) or Sentinel Lymph Node Biopsy (SLNB). Patients with normal axillary physical exam and ultrasound rarely harbor a large nodal disease burden (pN2). There are studies suggesting that the Preoperative Axillary Ultrasound (PAUS) can replace SLNB when the axillary surgery is no longer curative and only biomarkers are important for adjuvant chemotherapy. The purpose of this study was to determine the accuracy and reliability of the ultrasound examination in detecting more than three metastatic axillary lymph nodes (pN2) and to assess the clinicopathological factors that lead to the truenegative and false-negative results of the ultrasound study. All patients underwent the PAUS as part of their staging. The nodal status assessed by PAUS was compared with histological findings. Determining pN2, the accuracy of PAUS was 91.2% and the NPV -96.5%. False-negative results of PAUS were 18.7 %. On bivariate analysis, primary Tumor Size (T), the tumor spreading in blood and Lymphatic Vessels (LV), Tumor Grade (G) and patient age were found to be significantly different between true-and false-negative PAUS. We found that PAUS is sufficiently accurate to detect a heavy nodal disease burden and in most cases an additional axillary surgery can be avoided. PAUS findings may be less accurate in young age and in patients with T2, G3 and LV1.
Aim: To explore the relationships between social, emotional, and functional values, and satisfaction of patients with type 2 diabetes mellitus (T2DM) with an emphasis on Lithuanian primary health care services providers. Background: Academics and practitioners are encouraging more research on service value conceptually and empirically. Primary health care settings (PHCS) use modern management of value creation for patients with chronic diseases to increase the satisfaction of patients. Satisfaction of patients is the most important factor of competitive advantage for the PHCS. In this study, perceived value concept is dealt with in a multidimensional way. The fact that the perceived value in health sector has not previously been examined as multidimentionally has increased the importance of this research. Methods: The study strategy is based on focus group discussions of executives and survey of patients with T2DM in the primary health care sector. The target of focus group discussions is to gain knowledge about factors developing the competitive advantage of PHCS. The survey of patients with T2DM is the background to test the conceptual model of perceived value importance on satisfaction. The study uses coefficients of correlation, exploratory factor analysis, and linear regression. Findings: The results of focus groups revealed the factors of competitive advantage related to perspectives of health policy, organization, human resources, and patients. The results of the survey established statistically significant links between social value and satisfaction, and functional value and satisfaction. Emotional value decreased satisfaction of patients with T2DM.
Background: Despite the fact that for over ten years, Lithuanian consumers have been able to report adverse drug reactions (ADR) directly to the competent authority, reporting rates remain low. A comprehensive understanding of consumer perceptions and experiences regarding ADRs is needed to ascertain further factors impacting their engagement in ADR reporting. This study aimed to assess consumer knowledge of, attitude toward, and practice of reporting ADRs. Methods: A questionnaire-guided cross-sectional survey among 404 consumers between October 2021 and June 2022 was conducted. The semi-structured questionnaire comprised open-ended and closed-ended questions to explore the sociodemographic characteristics and general knowledge of ADRs and pharmacovigilance. Other question items evaluated attitudes toward ADR reporting and ADR reporting practice. The data were summarised using descriptive statistics, while the chi-square test was used to assess categorical variables at p < 0.05. The overall percent score in the knowledge and attitude domains was divided into groups of “poor”, “moderate”, and “good” knowledge, as well as “positive” and “negative” attitudes. Results: While having a generally poor understanding, this study demonstrates that Lithuanian consumers have a favourable attitude toward pharmacovigilance, particularly regarding issues involving the requirement for reporting. The data also revealed the justifications for reporting and not reporting ADRs. Conclusions: The current study provided the first understanding of consumer awareness and ADR reporting intentions, which can help to develop educational campaigns and interventions addressing pharmacovigilance and ADR reporting.
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