Clinicopathological and molecular predictors of [18F]FDG-PET disease detection in HER2-positive early breast cancer: RESPONSE, a substudy of the randomized PHERGain trial.

BACKGROUND: The PHERGain study (NCT03161353) is assessing early metabolic responses to neoadjuvant treatment with trastuzumab-pertuzumab and chemotherapy de-escalation using a [18Fluorine]fluorodeoxyglucose-positron emission tomography ([18F]FDG-PET) and a pathological complete response-adapted strategy in HER2-positive (HER2+) early breast cancer (EBC). Herein, we present RESPONSE, a PHERGain substudy, where clinicopathological and molecular predictors of [18F]FDG-PET disease detection were evaluated. METHODS: A total of 500 patients with HER2 + EBC screened in the PHERGain trial with a tumor size > 1.5 cm by magnetic resonance imaging (MRI) were included in the RESPONSE substudy. PET[-] criteria entailed the absence of  ≥ 1 breast lesion with maximum standardized uptake value (SUVmax) ≥ 1.5 × SUVmean liver + 2 standard deviation. Among 75 PET[-] patients screened, 21 with SUVmax levels < 2.5 were randomly selected and matched with 21 PET[+] patients with SUVmax levels ≥ 2.5 based on patient characteristics associated with [18F]FDG-PET status. The association between baseline SUVmax and [18F]FDG-PET status ([-] or [+]) with clinicopathological characteristics was assessed. In addition, evaluation of stromal tumor-infiltrating lymphocytes (sTILs) and gene expression analysis using PAM50 and Vantage 3D™ Cancer Metabolism Panel were specifically compared in a matched cohort of excluded and enrolled patients based on the [18F]FDG-PET eligibility criteria. RESULTS: Median SUVmax at baseline was 7.2 (range, 1-39.3). Among all analyzed patients, a higher SUVmax was associated with a higher tumor stage, larger tumor size, lymph node involvement, hormone receptor-negative status, higher HER2 protein expression, increased Ki67 proliferation index, and higher histological grade (p < 0.05). [18F]FDG-PET [-] criteria patients had smaller tumor size (p = 0.014) along with the absence of lymph node involvement and lower histological grade than [18F]FDG-PET [+] patients (p < 0.01). Although no difference in the levels of sTILs was found among 42 matched [18F]FDG-PET [-]/[+] criteria patients (p = 0.73), [18F]FDG-PET [-] criteria patients showed a decreased risk of recurrence (ROR) and a lower proportion of PAM50 HER2-enriched subtype than [18F]FDG-PET[+] patients (p < 0.05). Differences in the expression of genes involved in cancer metabolism were observed between [18F]FDG-PET [-] and [18F]FDG-PET[+] criteria patients. CONCLUSIONS: These results highlight the clinical, biological, and metabolic heterogeneity of HER2+ breast cancer, which may facilitate the selection of HER2+ EBC patients likely to benefit from [18F]FDG-PET imaging as a tool to guide therapy. TRIAL REGISTRATION: Clinicaltrials.gov; NCT03161353; registration date: May 15, 2017.

Optimal [18F]FDG PET/CT Cutoff for Pathologic Complete Response in HER2-Positive Early Breast Cancer Patients Treated with Neoadjuvant Trastuzumab and Pertuzumab in the PHERGain Trial.

The PHERGain trial investigated the potential of metabolic imaging to identify candidates for chemotherapy deescalation in human epidermal growth factor receptor 2 (HER2)-positive, invasive, operable breast cancer with at least 1 breast lesion evaluable by [18F]FDG PET/CT. [18F]FDG PET/CT responders were defined as patients with an SUVmax reduction (ΔSUVmax) of at least 40% in all of their target lesions after 2 cycles of trastuzumab and pertuzumab (HP) (with or without endocrine therapy). In total, 227 of 285 patients (80%) included in the HP arm showed a predefined metabolic response and received a total of 8 cycles of HP (with or without endocrine therapy). Pathologic complete response (pCR), defined as ypT0/isN0, was achieved in 37.9% of the patients. Here, we describe the secondary preplanned analysis of the best cutoff of ΔSUVmax for pCR prediction. Methods: Receiver-operating-characteristic analysis was applied to look for the most appropriate ΔSUVmax cutoff in HER2-positive early breast cancer patients treated exclusively with neoadjuvant HP (with or without endocrine therapy). Results: The ΔSUVmax capability of predicting pCR in terms of the area under the receiver-operating-characteristic curve was 72.1% (95% CI, 65.1-79.2%). The optimal ΔSUVmax cutoff was found to be 77.0%, with a 51.2% sensitivity and a 78.7% specificity. With this cutoff, 74 of 285 patients (26%) would be classified as metabolic responders, increasing the pCR rate from 37.9% (cutoff ≥ 40%) to 59.5% (44/74 patients) (P < 0.01). With this optimized cutoff, 44 of 285 patients (15.4%) would avoid chemotherapy in either the neoadjuvant or the adjuvant setting compared with 86 of 285 patients (30.2%) using the original cutoff (P < 0.001). Conclusion: In the PHERGain trial, an increased SUVmax cutoff (≥77%) after 2 cycles of exclusive HP (with or without endocrine therapy) achieves a pCR in the range of the control arm with chemotherapy plus HP (59.5% vs. 57.7%, respectively), further identifying a subgroup of patients with HER2-addicted tumors. However, the original cutoff (≥40%) maximizes the number of patients who could avoid chemotherapy.

Worldwide survey on implantation of and outcomes for conduction system pacing with His bundle and left bundle branch area pacing leads.

BACKGROUND: Adoption and outcomes for conduction system pacing (CSP), which includes His bundle pacing (HBP) or left bundle branch area pacing (LBBAP), in real-world settings are incompletely understood. We sought to describe real-world adoption of CSP lead implantation and subsequent outcomes. METHODS: We performed an online cross-sectional survey on the implantation and outcomes associated with CSP, between November 15, 2020, and February 15, 2021. We described survey responses and reported HBP and LBBAP outcomes for bradycardia pacing and cardiac resynchronization CRT indications, separately. RESULTS: The analysis cohort included 140 institutions, located on 5 continents, who contributed data to the worldwide survey on CSP. Of these, 127 institutions (90.7%) reported experience implanting CSP leads. CSP and overall device implantation volumes were reported by 84 institutions. In 2019, the median proportion of device implants with CSP, HBP, and/or LBBAP leads attempted were 4.4% (interquartile range [IQR], 1.9-12.5%; range, 0.4-100%), 3.3% (IQR, 1.3-7.1%; range, 0.2-87.0%), and 2.5% (IQR, 0.5-24.0%; range, 0.1-55.6%), respectively. For bradycardia pacing indications, HBP leads, as compared to LBBAP leads, had higher reported implant threshold (median [IQR]: 1.5 V [1.3-2.0 V] vs 0.8 V [0.6-1.0 V], p = 0.0008) and lower ventricular sensing (median [IQR]: 4.0 mV [3.0-5.0 mV] vs. 10.0 mV [7.0-12.0 mV], p < 0.0001). CONCLUSION: In conclusion, CSP lead implantation has been broadly adopted but has yet to become the default approach at most surveyed institutions. As the indications and data for CSP continue to evolve, strategies to educate and promote CSP lead implantation at institutions without CSP lead implantation experience would be necessary.

Nurse Intervention: Attitudes and Knowledge About Organ Donation and Transplantation in Adolescents.

BACKGROUND: The problems involved in obtaining authorization in favor of organ donation have led us to evaluate the level of knowledge and attitudes of a group of Spanish adolescents (14-16 years) regarding organ donation, transplantation, and brain death. The evaluation was carried out before and after a health education intervention by nursing personnel. METHODS: Experimental, prospective and quantitative study. The educational intervention was carried out at Las Salinas high school (Laguna de Duero, Spain). We collected 86 preworkshop questionnaires and 88 post-workshop questionnaires. RESULTS: The composition of the groups did not differ significantly in sex (P = .653), age (P = .266), or in the desire to be a donor (P = .099). We found significant postworkshop improvements in knowledge about brain death (P < .001) and which organs can be donated (P < .001), as well as in the total score (18.29 ± 2.45 before vs 21.47 ± 2.70 after) (P < .001). We discovered a vast lack of knowledge about the organs that cannot be transplanted, which included the penis (38.4%), uterus (31.4%), prostate (41.9%), or bladder (37.2%); these beliefs decreased significantly after the intervention (P < .01). The increase in knowledge of the organs that can be donated, including eye (P = .024), lung (P = .025), stomach (P < .001), intestine (P = .001), and skin (P < .001), was also significant. CONCLUSIONS: The good results reflected the importance of conducting educational programs taught by health personnel on donation and organ transplantation in adolescents.

Standardizing nursing degree curriculum structure in Spain: A mixed-methods study.

BACKGROUND: Legislation regulating Spanish and European academic curricula prescribes a certain level of knowledge and skills any student must master. Spanish universities freely decide the number of credits assigned to each subject and in which year the subject will be taught. We hypothesize that this flexibility may give way to excessively heterogeneous training across universities in nursing degrees. Such curricula heterogeneity hinders inter-university transfers and weakens educational excellence. OBJECTIVES: 1) To review the existing differences in nursing degrees in Spanish universities; 2) to compare our results against current legislation; 3) to propose changes in the legislation, if necessary. DESIGN: Mixed-methods approach. SETTING: Spain. METHODS: We reviewed nursing degree curricula of all 60 Spanish universities. Inter-university differences were analyzed and checked against current legislation. A focus group proposed legislative changes accordingly. RESULTS: Several differences between public and private universities were statistically significant. During the first cycle, public universities´ course loads include more theoretical teachings, more credits in core subjects during the first year, and more compulsory subjects in second year. Private universities are more likely to offer external internships during the first cycle whereas the public ones are more likely to offer them during the second cycle. Public universities offer more credits under the following curricular blocks than private ones: "Nutrition/Dietetics," "Psychiatry," "Public and Community Health," and "Geriatrics." In turn, private universities offer more credits in the areas of "Theory/Methodology," "Ethics/Legislation," "English," and "Theology." Academic curricula meet most of the criteria established by the Spanish and European legislation. The proposed legislative changes aim at standardizing curricula by associating specific credits and their timeline to the teaching blocks. CONCLUSIONS: Nursing degree curricula among Spanish universities are highly heterogeneous. Legislative changes to homogenize teaching blocks would facilitate credit validations and student mobility across universities, in addition to increasing nursing degrees´ standardization and excellence.

Assessment of an Educational Intervention to Improve Healthy Life Habits in Children Living in Vulnerable Socioeconomic Conditions.

Nutritional condition impacts academic performance and cognitive development. In Peru, the prevalence of chronic undernutrition in children is 6.9%, increasing the risk of mortality and morbidity. This study aimed to develop an educational intervention to achieve an improvement in the healthy habits of children in a primary education school in Lima who live in vulnerable socioeconomic conditions. We conducted a prospective quasi-experimental pre-test and post-test study of an educational intervention. The information was collected through the adaptation of the WHO questionnaire "Global School-based Student Health Survey" (GSHS), with anthropometric variables, socioeconomic level, hygiene and eating habits. One hundred eight students from 5 to 13 years old from Arenitas del Mar School in Lima (Peru) participated. The educational intervention improved eating habits. Fruit and vegetable consumption 3 or more times/day (50.9%) increased after the educational intervention (49% vs. 62.9%,) p < 0.0001. There was an improvement in hygiene habits, such as the frequency of handwashing with soap (32.4% vs. 63.9%) and the frequency of weekly bathing 4-6 times/week (25% vs. 47.5%) p < 0.0001. The educational intervention promoted better healthy living behaviors, eating habits and hygiene. This kind of initiative is a crucial tool to establish healthy living habits.

The impact of an educational intervention on nursing students' critical thinking skills: A quasi-experimental study.

AIM: In this study, we identified the impact of educational activities that focused on improving the competence and critical thinking skills of university nursing students. DESIGN: A prospective quasi-experimental study was conducted, and assessments were conducted before and after the educational intervention, which consisted of seminars, lectures, case studies, and problem-solving activities. METHODS: The Critical Thinking Questionnaire was used to collect data before and after the educational intervention between September 2017 and May 2018. The sample consisted of 112 first-year undergraduate students. To examine the data that were collected as a part of this quasi-experimental study, inferential statistics were used, and the results were tested against a significance level of P < 0.05. RESULTS: The students obtained higher scores on the substantive dimension than on the dialogic one, and women scored higher than men. The educational intervention led to an improvement in every critical thinking skill across both dimensions, except listening and speaking skills, whereby men demonstrated a greater change in average scores for critical thinking skills. CONCLUSIONS: The educational intervention improved the critical thinking skills of undergraduate students and had a greater impact on men than on women. This finding underscores the need for educational interventions that can enhance critical thinking skills. Developing these skills will improve future nurses' ability to make health care management decisions in a reflective, agile, and evidence-based manner.

Impact of educational games on academic outcomes of students in the Degree in Nursing.

OBJECTIVE: The aim of using the game-based tool Kahoot! was to evaluate and reinforce the contents taught in the subject of Management and Administration of Nursing, Ethics and Health Legislation Services included in the Degree in Nursing, during the 2016-2017 academic year. METHODS: A prospective quasi-experimental study was carried out on a sample of 116 students. 10 multiple-choice questions were designed, with only one possible correct answer and a 20-second-limited response time for each of the questions. Four of these questions previously answered in the classroom using this game were chosen (20% of the exam). Each one of them corresponded to one unit of the topics taught in the subject. In order to participate in the educational game, students needed their smartphones or electronic devices. After completing the game, the students' satisfaction level derived from its use was assessed. RESULTS: The correct answer rate in the educational game was greater than 50% for all questions except for one, in which the rate was 28.8% (P<0.05). Response time as related to score presented statistically significant differences, and higher scores for those questions with lower response time (P<0.001). The questions included in the final test which had been previously answered using Kahoot! showed a significantly higher difficulty index than the rest of the final exam questions (P<0.05). Question 3 was the easiest, while being the one in which the highest-scoring students obtained more wrong answers. For the students this tool was easy to use (89.6%) and they positively valued the content acquisition and comprehension, as well as the teacher-student interaction (P<0.05). CONCLUSION: The implementation of educational games which consider response time and correct answers favors competitiveness and motivates students to actively participate in their learning process.

T-wave Oversensing with Inappropriate Therapy in Remote Monitoring.

T-wave oversensing can cause inappropriate implantable cardioverter-defibrillator (ICD) therapies that are difficult to correct. Remote monitoring allows follow-up of ICD patients without visiting the hospital and can help in early detection of any malfunctions. We describe the case of a patient who experienced inappropriate antitachycardia pacing therapy due to T-wave oversensing; the problem was promptly detected by remote monitoring and corrected by device reprogramming.

Implante de desfibrilador en un paciente con D-transposición de grandes arterias y corrección fisiológica de Mustard / Cardioverter-defibrillator implantation in a patient with D-transposition of the great arteries with mustard’s physiologic correction

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Masa cervical posterior después de una meningitis aséptica / Posterior cervical mass following aseptic meningitis

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Enfermedad de Takayasu. Reporte de un caso estudiado por Eco-Doppler-Dúplex-Color / Takayasu's disease. Report of a case studied by duplex color Doppler echocardiography

Se presenta un paciente que padece una afección poco frecuente en Cuba, como es la enfermedad de Takayasu. El diagnóstico se realizó mediante eco-doppler-dúplex-color y se demostró el valor de esta técnica en las lesiones vasculares de los vasos del cuello. Se describen las características sonográficas encontradas en esta enfermedad