Efficacy, safety, and cost-effectiveness of pegylated PEG-rhg-CSF in pediatric patients receiving high-intensity chemotherapy: results from a phase II study.

Background: High-intensity chemotherapy can cause life-threatening complications in pediatric patients. Therefore, this study investigated safety and efficacy of long-acting pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF; Jinyouli®) in children undergoing high-intensity chemotherapy. Methods: Treatment-naive patients received post-chemotherapy PEG-rhG-CSF as primary prophylaxis for two cycles. The primary endpoints were drug-related adverse events (AEs) and bone pain scores. Secondary endpoints included grade 3-4 neutropenia, duration of neutropenia recovery, absolute neutrophil count changes, febrile neutropenia (FN), reduced chemotherapy intensity, antibiotic usage, and AE severity. The cost-effectiveness of PEG-rhG-CSF was compared with that of rhG-CSF (Ruibai®). Results: Here, 307 and 288 patients underwent one and two PEG-rhG-CSF cycles, respectively. Ninety-one patients experienced drug-related AEs, primarily bone pain (12.7%). Moreover, Grade 3-4 neutropenia and FN were observed. Median FN durations were 3.0 days in both cycles. No drug-related delays were observed during chemotherapy. One patient experienced grade 4 neutropenia-induced reduction in chemotherapy intensity during cycle 2. In total, 138 patients received antibiotics. PEG-rhG-CSF exhibited superior cost-effectiveness compared to rhG-CSF. Conclusion: Our findings indicate that PEG-rhG-CSF is safe, efficient, and cost-effective in pediatric patients undergoing high-intensity chemotherapy, providing preliminary evidence warranting further randomized controlled trials.

Investigating the Correlation between Handedness and Emotion Regulation Strategies in Asthma and Allergy Patients.

Background: Asthma and allergic diseases are common chronic non-communicable conditions that can negatively impact the quality of life of patients. Psychological factors play a role in both the onset and progression of these conditions. The purpose of this study was to examine the relationship between handedness and emotion regulation and cognitive emotion regulation strategies in patients with asthma and allergies in Isfahan, central Iran. Methods: We employed a causal-comparative research design. The study population consisted of all patients visiting Asthma and Allergy Clinic in Isfahan. One hundred participants were selected through probability sampling. Data were collected using the Emotion Regulation Questionnaire and the Cognitive Emotion Regulation Strategies Questionnaire, and were analyzed using univariate analysis of variance (ANOVA). Results: Cognitive emotion regulation was significantly different between right-handed and left-handed patients with asthma and allergies (P=0.0001). A significant difference was also observed between the two groups in their emotion regulation strategies (P=0.031). The rate of positive and negative cognitive regulation strategies was higher in left-handed individuals with asthma and allergies, compared to right-handed individuals. Conclusion: Overall, handedness has a significant impact on the behavior and mental health of patients suffering from asthma and allergies. Therefore, handedness should be taken into consideration in interventions for emotion regulation.

Comparison of the Fecal Incontinence Severity Scores between Self-administration by Patients and an Oral Interview by a Physician.

Objectives: To compare patients' self-administered responses to the Fecal Incontinence Severity Index (FISI) questionnaire (A1) with their responses to physician's oral interview (A3). Methods: Patients (n=100: mean age: 72 years; 66 women) with FI completed the FISI and the modified FISI (with written explanations) questionnaires, followed by a physician interview. To identify a threshold for the rating gap between A1 and A3, we calculated each patient's mean difference in the FISI scores. Results: There was no significant difference in the FISI scores between A1 and A3. A rating gap existed in the FISI scores (mean difference=8.9). It occurred in 37% of the patients, making its threshold 9. Multivariate analysis revealed that older age and no history of pelvic floor surgery were independently associated with the presence of a rating gap in the FISI scores. The in-coincidence of ticked boxes to all types of leakage between the self-administered responses and those by physician's oral history was 49% (197/400). Older age was associated with the in-coincidence of a ticked box between the assessment results of gas or solid stool leakage. Conclusions: Some non-negligible discrepancy existed between patients' self-administered responses and their responses to physician's oral interview, especially in older patients.

An Extremely Rare Case of a 24-Year-Old Female Diagnosed With High-Grade Muscle-Invasive Urothelial Carcinoma in the Bladder.

Bladder cancer most commonly affects older adults. Although extremely rare, it can still be detected in the younger population. Bladder cancer often exhibits distinct behavior in these cases, typically manifesting as a low-grade, non-muscle-invasive disease. We documented a remarkable case involving a 24-year-old female diagnosed with high-grade muscle-invasive bladder cancer. Our report emphasizes the distinctive challenges encountered by clinicians in the journey of diagnosis, treatment, and follow-up of bladder cancer in young patients.

E-consultation as existential media: Exploring doctor-patient 'digital thrownness' in Danish general practice.

In this article we use an existential media framework to explore the asynchronous, written and digital form of GP-patient communication that takes place through e-consultations in a Danish general practice context. This approach acknowledges e-consultation as more than a tool for information delivery and frames GP and patient not as skilful media users but as dependent co-existers: Both thrown into and trying to navigate the digital healthcare ecology. Through a thematic analysis of 38 semi-structured qualitative interviews with patients and GPs we carve out three themes unpacking the existential dimensions of e-consultation: 1. Patient and GP are placed in a Culture of non-stop connectivity and we show the ambivalences arising herein fostering both relief, reassurance and new insecurities. 2. Ethical challenges of responsible co-existence points to dilemmas of boundary setting and caring for self and co-exister in the digital encounter. 3. We-experiences illustrates the potential of e-consultation to signal GP presence, even when the GP is silent. We also discuss the existential ethics of care emerging from the contemporary digital healthcare ecology and call for empirically grounded studies of the existential dimensions tied to encounters in contemporary digital care infrastructures.

Tumor microenvironment RNA test to predict immunotherapy outcomes in advanced gastric cancer: The TIMES001 trial.

BACKGROUND: Clinical trials support the efficacy of immune checkpoint blockades (ICBs) plus chemotherapy in a subset of patients with metastatic gastric cancer (mGC). To identify the determinants of response, we developed a TMEscore model to assess tumor microenvironment (TME), which was previously proven to be a biomarker for ICBs. METHODS: A reference database of TMEscore assays was established using PCR assay kits containing 30 TME genes. This multi-center prospective clinical trial (NCT#04850716) included patients with mGC who were administered ICB combined with chemotherapy as a first-line regimen. Eighty-six tumor samples extracted from five medical centers before treatment were used to estimate the TMEscore, PD-L1 (CPS), and mismatch repair deficiency. FINDINGS: The objective response rate (ORR) and median PFS of the cohort were 31.4% and six months. Enhanced ORR was observed in TMEscore-high mGC patients (ORR = 59%). The survival analysis demonstrated that high TMEscore was significantly associated with a more favorable PFS and OS. Moreover, TMEscore was found to be a predictive biomarker that surpassed MSI and CPS (AUC = 0.873, 0.511, and 0.524, respectively). By integrating the TMEscore and clinical variables, the fused model further enhances the predictive efficiency and translational application in a clinical setting. CONCLUSIONS: This prospective clinical study indicates that the TMEscore assay is a robust biomarker for screening patients with mGC who may derive survival benefits from ICB plus chemotherapy. FUNDING: Guangdong Basic and Applied Basic Research Foundation (2023A1515011214), Science and Technology Program of Guangzhou (202206080011), and Guangzhou Science and Technology Project (2023A03J0722 and 2023A04J2357).

Health-related quality of life in older hematological cancer survivors (70+) compared to older general population-A German cancer-register-based cross-sectional comparative study.

OBJECTIVES: The extent of health-related quality of life (HRQOL) impairments in older hematological cancer survivors (HCS) has not been sufficiently studied. We therefore examined HRQOL in older HCS compared to a community sample (CS) and investigated sociodemographic, disease- and treatment-specific, geriatric, and psychosocial factors associated with reduced HRQOL. MATERIALS AND METHODS: In this cancer-register-based cross-sectional comparative study 200 HCS, aged ≥70 years, and 252 persons of an age- and gender-matched CS completed validated questionnaires including the EORTC QLQ-C30 and EORTC QLQ-ELD14. RESULTS: Older HCS reported a reduced HRQOL in the dimensions of global QOL, physical, role, and social functioning (small clinical significance) and higher symptom burden of fatigue, nausea and vomiting, appetite loss, and poorer mobility compared to the CS (fatigue and mobility with medium, the others with small clinical significance). Perceived disease burden of comorbidities, functional disabilities, psychological distress, and depression showed statistical significance for reduced HRQOL in older HCS in multiple linear regression analysis (R2 = .602, p < .001). DISCUSSION: The screening and treatment of functional limitations and individual symptoms and the integration of a geriatric assessment into oncological practice can help to identify supportive care needs, to implement individualized, patient-centered cancer survivorship care programs and to improve older HCS's HRQOL.

Impact of COVID-19 in the incidence of venous thromboembolism (VTE) and clinical outcomes in cancer patients: a cohort study.

PURPOSE: To determine the incidence of VTE and clinical outcomes in a cohort of cancer patients and COVID-19 infection, and to establish possible predictive factors of VTE. METHODS/PATIENTS: A single-center retrospective cohort study was performed to determine the incidence of VTE and mortality in 118 cancer patients with SARS-CoV-2 infection from March to August 2020. We calculated individual Khorana Risk and CATS-MICA scores in order to evaluate their utility to identify risk of VTE or death. Continuous variables were compared using Wilcoxon or Student's T test, and categorical variables were compared using the Chi-Square or Fisher's exact text among patients with and without VTE. A Log-Rank test was performed to detect mortality differences between the groups. RESULTS: A total of 118 patients were included. VTE global incidence was 4.2% (n = 5), and mortality 25.4% (n = 30). Obesity (p = 0.05), recent chemotherapy (p = 0.049) and use of steroids (p = 0.006) were related to higher risk of VTE in the univariate analysis, although they were not confirmed in the multivariate analysis as independent risk factors. Statistically significant differences in all-cause, COVID-19-related and cancer-related mortality according to the Khorana risk score (KRS) were observed. CATS-MICA score (CMS) also showed statistically significant differences in mortality between low- and high-risk patients. Prediction of risk of VTE development with these scores showed a tendency towards significance. CONCLUSIONS: In this cohort, VTE incidence was similar to previously reported in the general population with SARS-CoV-2 infection. KRS was associated with overall and specific-cause mortality, and might be a useful prognostic tool in this setting.

The impact of elexacaftor/tezacaftor/ivacaftor on cystic fibrosis health-related quality of life and decision-making about daily treatment regimens: a mixed methods exploratory study.

Background: Elexacaftor/tezacaftor/ivacaftor (ETI) has reduced many symptoms of cystic fibrosis (CF). Objectives: We sought to identify the impact of ETI on both symptoms and treatment decisions among adults with CF. Design: Participants were enrolled in a cross-sectional study. Surveys were sent via a RedCap link. Semistructured interviews were administered remotely via Microsoft Teams. Interviews were audio recorded and professionally transcribed. Methods: We assessed Cystic Fibrosis Questionnaire-Revised (CFQ-R) subscales for physical, respiratory, emotion, and treatment, and analyzed semistructured interviews covering CF treatment regimens and daily living. Quantitative and qualitative results were analyzed separately and via a mixed-methods convergence coding matrix. Results: Twenty-four adults with CF taking ETI were included. CFQ-R subscale scores (mean scores/standard deviation) were physical (82.1/22.8), respiratory (83.7/11.2), emotion (65.3/14.2), and treatment (57.5/20.1). Three themes about decision-making for non-ETI-treatments emerged: (1) How I'm feeling, (2) Not noticing a difference, and (3) Uncertainty about long-term impact of modifying treatment regimens, and we found participants weighed each of these factors in their treatment decisions. Key findings from mixed-methods analysis show that among individuals experiencing higher CFQ-R scores for physical and respiratory compared to emotion and treatment, there were statements indicating that while those participants were experiencing better physical health, many continued their burdensome treatment regimens. Conclusion: With little long-term data on the impact of reducing non-ETI treatments, participants weighed how they were feeling, treatment efficacy beliefs, and risk tolerance when making treatment decisions.

The impact of Trikafta on CF health, health-related quality of life, and treatment adherence People with cystic fibrosis may be experiencing many health benefits from taking Trikafta, leading some people to cut back on or stop their other non-Trikafta treatments. We explored the impact of Trikafta on CF health, health-related quality of life, and treatment adherence for people with CF currently taking Trikafta. We compared health-related quality of life subscales from the CF Questionnaire-Revised questionnaire focused on physical symptoms, respiratory symptoms, treatment burden, and emotional well-being to assess whether people with CF were experiencing improved physical and respiratory health compared to emotional health and feelings of treatment burden. We found that many people were feeling better physically, but were still experiencing poor mental health and high treatment burden. We then looked at results from open-ended interviews to see if our qualitative data could explain the differences in the health-related quality of life scores. We found that while people were feeling better physically, many people were still continuing with the pre-Trikafta treatment regimens which may explain why physical health and respiratory health scores were higher than emotional well-being and treatment burden scores. At this time, we believe that more research is needed to guide treatment decisions related to cutting back or stopping burdensome treatment regimens.

Perceived access to social support during and after TB treatment in Mbeya and Songwe regions, Tanzania: perspectives from TB patients and survivors set against health care providers.

Introduction: Pulmonary tuberculosis (PTB) remains a life-threatening disease in Tanzania, with negative physical, financial, economic and psychosocial consequences to individuals and the society. It mainly lowers the quality of life of patients, survivors and their families, especially those in the poorest and socially deprived categories. Objectives: To report and discuss a qualitative study that assessed the nature of social support desired and received by PTB patients and survivors. Participants were given a chance to share their experiences and their perceptions on whether the social support they desired had an impact on their treatment-seeking behaviour and treatment adherence. Methods: Face-to-face interviews were conducted with the three aforementioned groups, purposively selected at a TB clinic between October 2020 and March 2021. The questions covered topics related to the types of social support desired and the sources of support during and after treatment, if any. Interviews were concluded until no new information was obtained. Data analysis was facilitated using NVivo 12 software. Results: Participants pointed out a need for psychosocial, financial, and material support during and after treatment. However, they sometimes miss support from family/household members or the rest of the community. Because of this experience, they lived with difficulties, facing hardships when required to pay out of pocket for transport during the care-seeking. Survivors testified experience of a denial of support by even their close relatives who regarded them as no longer needing it after recovering. Patients and survivors also reported experience of social isolation as they were believed able to transmit PTB infections. Limited psychological support at the contacted TB clinics was another experience reported. TB clinic staff's experiences confirmed almost all the experiences shared by their clients. With limited support, resilience and self-care were identified as key mechanisms for coping. Conclusion: Complete recovery from PTB is possible, but reverting to a normal life is difficult without social support. Policies and programs need to increase opportunities for social support for TB patients and survivors. Doing so is likely to improve TB-related treatment, care-seeking practices, and adherence.

The Use of Kidneys With Lower Longevity From Deceased Donors to Improve Access to Preemptive Renal Transplantation for Elderly Patients: A Qualitative Study.

Background: There is a gap between the number of patients waiting for a transplant and the number of kidneys available. Some deceased donor kidneys are currently nonutilized, as medical teams fear that they will experience suboptimal graft survival. However, these organs could provide an acceptable therapeutic option if they were allocated for preemptive kidney transplantation in elderly candidates. Objective: This project aims to gather patients' perspectives on the allocation of kidneys with lower longevity for preemptive kidney transplantation in elderly patients. Design: Individual interviews. Setting: The Center hospitalier de l'Université de Montréal (CHUM) chronic kidney disease (CKD) clinic. Participants: Patients aged between 64 and 75 years with CKD G4-5 ND, followed at the CHUM and who have not initiated dialysis yet. Methods: Between March and July 2023, we conducted 14 individual interviews with patients aged between 64 and 75 years who had CKD G4-5 ND and were followed at the CHUM. The interviews were digitally recorded and transcribed. Thematic analysis was conducted. Results: Most participants were in favor of using kidneys with lower longevity to increase their access to transplantation, improve their quality of life, enable accelerated transplantation, and avoid dialysis. Patients also wanted to be engaged in the decision-making process, underlining the importance of informed consent. Although the use of kidneys with lower longevity offers the hope of returning to "normal" life, some patients were concerned about the risk of reduced graft survival and the need for a subsequent kidney transplant. In these cases, patients were interested in using mitigation strategies, such as prioritization for kidney transplantation from standard donors in case of early graft loss associated with receiving kidneys with lower longevity. They also recommended the development of a separate waiting list for patients consenting to preemptive transplantation with kidneys with lower longevity. Limitations: This study was conducted in only 1 nephrology clinic in the province of Quebec with French-speaking patients. Consequently, the results may not be generalizable to other populations, including ethnic minorities. Conclusion: The use of kidneys with lower longevity for preemptive kidney transplantation appears to be an interesting option for elderly kidney transplant candidates. However, patient information and participation in the decision-making process are essential. Moreover, organ donation organizations and transplant programs should develop a separate waitlist for transplant candidates who have preconsented to receive organ offers of deceased donor kidneys with lower longevity. Trial registration: Not registered.

Mise en contexte: Il existe un écart entre le nombre de patients en attente d'une greffe et le nombre de reins disponibles. À l'heure actuelle, un certain nombre de reins de donneurs décédés ne sont pas utilisés, car les équipes médicales craignent que la survie des greffons ne soit pas optimale. Ces organes pourraient toutefois constituer une option thérapeutique acceptable s'ils étaient attribués à des candidats âgés pour une transplantation pré-emptive. Objectifs de l'étude: Ce projet vise à connaître la position des patients quant à la transplantation pré-emptive de reins jugés de moindre longévité chez des candidats âgés. Conception: Entretiens individuels. Cadre: La clinique d'insuffisance rénale chronique du Center hospitalier de l'Université de Montréal (CHUM). Sujets: Des patients âgés de 64 à 75 ans atteints d'IRC G4-5 suivis au CHUM et n'ayant pas encore amorcé la dialyse. Méthodologie: Entre mars et juillet 2023, nous avons mené 14 entretiens individuels avec des patients de 64 à 75 ans non dialysés atteints d'IRC G4-5 suivis au CHUM. Les entrevues ont été enregistrées sous forme numérique, puis transcrites. Une analyze thématique a été effectuée. Résultats: La plupart des personnes interrogées étaient en faveur de l'utilisation de reins de moindre longévité en vue d'augmenter leur accès à la transplantation, d'améliorer leur qualité de vie, d'accélérer la transplantation et d'éviter la dialyse. Les patients souhaitaient également participer au processus décisionnel, ce qui met en lumière l'importance du consentement éclairé. Bien que l'utilisation de reins de moindre longévité offre l'espoir d'un retour à une vie « normale ¼, certains patients s'inquiétaient du risque de survie réduite du greffon et, dès lors, de l'éventuelle nécessité d'une nouvelle greffe. Dans ces cas, les personnes interrogées étaient intéressées par des stratégies d'atténuation comme une priorité donnée à la transplantation de reins provenant de donneurs standards en cas de perte précoce du greffon liée au fait d'avoir reçu un rein de moindre longévité. Les personnes répondantes ont également proposé l'établissement d'une liste d'attente distincte pour les patients qui consentent à une transplantation pré-emptive avec des reins de moindre longévité. Limites de l'étude: Cette étude a été menée dans une seule clinique de néphrologie au Québec auprès de patients francophones. Par conséquent, les résultats pourraient ne pas être généralisables à d'autres populations, notamment à des personnes issues de minorités ethniques. Conclusion: L'utilisation de reins de moindre longévité pour la transplantation rénale pré-emptive semble être une option thérapeutique intéressante pour les candidats âgés. Toutefois, il est essentiel que les patients soient bien informés et qu'ils participent au processus décisionnel. Enfin, les organismes de don d'organes et les programs de transplantation devraient établir une liste d'attente distincte pour les candidats ayant préalablement consenti à recevoir des offres d'organes pour des reins de moindre longévité provenant de donneurs décédés.

A study of critically ill obstetric patients admitted to intensive care unit of a tertiary care hospital.

Objectives: To evaluate characteristics, indications, complications and outcome of obstetric patients admitted to ICU of tertiary care hospital in KPK, Pakistan. Methods: This descriptive study was conducted in department of OBGYN of Lady Reading Hospital, Peshawar from January 2021 till December 2021. A total of 62 patients were enrolled into the study using nonprobability consecutive sampling technique. Their data were collected on a proforma. All patients were followed till their death or discharge home from hospital. Results: The mean duration of ICU stay of patients, was 6.85 ± 4.82 days. Out of 62 patients 17 (27.41%) expired in ICU, while 45 (72.58%) patients survived and were discharged. Pre-eclampsia and Eclampsia was the commonest primary diagnosis, accounting for 28 cases (45.2%) with a case fatality rate of 25%, followed by 13 cases (21%) of primary postpartum hemorrhage (PPH) as the second commonest reason for ICU admission and a case fatality rate of 38%. The underlying primary diagnosis had no statistically significant association with outcome of the patient. Acute Renal failure had statistically significant association with outcome of the patient with adjusted OR 4.79, CI:1.17-19.66, p-0.02. Similar positive association with mortality existed for patients having DIC (aOR:6.59; CI:1.34-32.34, p-0.02). Conclusion: Pre-eclampsia/Eclampsia is the commonest reason for intensive care admission, however PPH has the highest case fatality rate. The outcome of critically ill obstetric patients is dependent on complications and not primary underlying diagnosis.

Higher Onset of Periprosthetic Joint Infections in Patients With Teeth Compared to Those Without Teeth.

INTRODUCTION: Bacteria can enter the bloodstream through simple actions such as brushing teeth, flossing, and even chewing food, increasing the chance of hematogenous seeding of prosthetic joints. Antibiotics before dental work in patients with orthopedic hardware is a topic of debate because of concerns for antibiotic resistance. Patients with dentures theoretically avoid this risk due to the lack of teeth and their maintenance. Most periprosthetic joint infections (PJIs) that occur in the first six months after surgery are due to wound infection, whereas late PJIs are more commonly caused by hematogenous seeding. MATERIALS AND METHODS: Charts from patients who received primary total joint arthroplasty were interrogated for the condition of their teeth at the time of operation. If the patient had a PJI, the time from surgery and the organism responsible were noted. Multivariate linear regressions were performed for statistical analysis to compare rates of dental status, infection, comorbidities, and demographics. RESULTS: From the 1,500 charts reviewed, patients with teeth and edentulous had similar rates of comorbidities. PJI patients had higher rates of chronic kidney disease than patients who did not have the infection. The overall rate of infections in patients with teeth was 2.14%, close to the national average. The rate of infection in patients without teeth was 0.78%. Patients with teeth have a higher rate of infection one month or longer from surgery than edentulous patients. CONCLUSIONS: There was an increased infection rate in patients with teeth at six months and greater since the primary total joint arthroplasty. The organisms responsible for many of the PJIs are commonly found in the mouth of humans. Having teeth is a potential risk factor for late PJI.

Comparative Effectiveness of Developed Serious Game Versus Standardized Patients' Simulation in Nursing Education.

Background: Serious games provide a realistic environment in nursing education, a stimulating and experiential learning environment for developing skills necessary for learning, recognizing, analyzing, selecting, and applying information. Methods: This study aims to determine the impact of serious games and standard patient practices developed for nursing education on students' knowledge levels, satisfaction, self-confidence, critical thinking, and problem-solving skills. A serious game was designed using the educational principles of the diabetes course and developed using the 3D interactive content creation platform UNITY. One group played the game online, whereas another had a face-to-face experience. Both groups completed forms before, after, and 4 weeks later via Google Forms. Results: Quantitative analysis showed significant improvements in knowledge and increases in student satisfaction and confidence in learning in both the serious game and standardized patient groups. The groups had no significant differences in problem-solving and critical-thinking abilities (P > 0.005). Conclusion: Developing advanced clinical proficiencies in nursing students requires an engaging and reliable educational environment. Using serious games and standardized patient simulations in nursing instruction highlights the need for diverse digital teaching tools. Therefore, it is essential to support the professional development of nursing educators in these innovative modalities.

A Nationwide Study to Evaluate Accessibility to Specialized Pediatric Palliative Care in Italy-Patients, Needs, and Critical Issues: The PalliPed Study.

Background: PalliPed is the first Italian nationwide project aimed at describing the characteristics of patients accessing specialized pediatric palliative care (PPC) and their families, in the main care settings (hospice, home care, and hospital). The project's secondary aim is to assess the extent and quality of regional PPC networks/facilities and the number of dedicated resources. In this article, we present the results of the first part of the project. Methods: All Italian PPC centers/facilities were invited to participate in the project. Children and young adults in the care of the specialized PPC networks/structures as of 24 October, 2022, including prenatal care, were involved. Children's eligibility for specialized PPC was assessed according to the Assessment Form for Complex Clinical Needs in Pediatrics (ACCAPED Scale) and after a multidisciplinary assessment by the healthcare team. Data were collected through an online survey. Results: A total of 867 patients were described. The lack of adequate specialized PPC service emerged, according to the available estimate of specialized PPC needs, as well as the need for improved referral to PPC by pediatricians or territorial services, particularly for infants and oncological patients. More family support measures also seem necessary, particularly for the mothers. Healthcare providers' communication skills should be improved to ensure greater involvement of patients and families in care decisions. Conclusions: This analysis represents the first step toward defining a constantly updated database for the census and monitoring of specialized PPC activities at the national level. This research model can be extended to other realities in different countries, allowing comparison of different care models.

Geriatric Nutritional Risk Index and 30-Day Postoperative Mortality in Geriatric Burn Patients.

INTRODUCTION: The geriatric nutritional risk index (GNRI) can easily identify malnutrition-associated morbidity and mortality. We investigated the association between preoperative GNRI and 30-d mortality in geriatric burn patients who underwent surgery. METHODS: The study involved geriatric burn patients (aged ≥ 65 y) who underwent burn surgery between 2012 and 2022. The GNRI was computed using the following formula: 1.489 × serum albumin concentration (mg/L) + 41.7 × patient body weight/ideal body weight. Patients were dichotomized into the high GNRI (≥ 82) and low GNRI (< 82) groups. GNRI was evaluated as an independent predictor of 30-d postoperative mortality. The study also evaluated the association between GNRI and sepsis, the need for continuous renal replacement therapy (CRRT), major adverse cardiac events (MACE), and pneumonia. RESULTS: Out of 270 patients, 128 (47.4%) had low GNRI (< 82). Multivariate Cox regression analysis revealed that low GNRI was significantly associated with 30-d postoperative mortality (hazard ratio: 1.874, 95% confidence interval [CI]: 1.146-3.066, P = 0.001). Kaplan-Meier analysis revealed that the 30-day mortality rate differed significantly between the low and high GNRI groups (log-rank test, P < 0.001). The 30-d postoperative mortality (hazard ratio: 2.677, 95% CI: 1.536-4.667, P < 0.001) and the incidence of sepsis (odds ratio [OR]: 2.137, 95% CI: 1.307-3.494, P = 0.004), need for CRRT (OR: 1.919, 95% CI: 1.101-3.344, P = 0.025), MACE (OR: 1.680, 95% CI: 1.018-2.773, P = 0.043), and pneumonia (OR: 1.678, 95% CI: 1.019-2.764, P = 0.044), were significantly higher in the low GNRI group than in the high GNRI group. CONCLUSIONS: Preoperative low GNRI was associated with increased 30-d postoperative mortality, sepsis, need for CRRT, MACE, and pneumonia in geriatric burn patients.

Real-World Efficacy and Safety of Durvalumab Administration Following Chemoradiotherapy in Elderly Patients With Unresectable Locally Advanced Nonsmall Cell Lung Cancer: A Multicenter, Retrospective Study.

BACKGROUND: The PACIFIC trial established durvalumab administration after chemoradiotherapy as the standard of care for unresectable locally advanced nonsmall cell lung cancer (LA-NSCLC). However, the efficacy and safety of durvalumab in elderly patients aged 75 years or above remains unclear. This study aimed to investigate the real-world efficacy and safety of durvalumab for LA-NSCLC, with a specific focus on elderly patients. PATIENTS AND METHODS: We reviewed 214 patients who received durvalumab out of 278 patients with unresectable LA-NSCLC who underwent chemoradiotherapy at 7 institutions between July 2018 and March 2022. Propensity score matching (PSM) analysis was performed to evaluate the efficacy of durvalumab in elderly patients. RESULTS: The 2-year progression-free survival (PFS) and 2-year overall survival (OS) rates were 42.2% (95% confidence interval [CI], 34.7%-49.5%) and 77.1% (95% CI, 70.1-82.7%), respectively. Grade ≥ 3 immune-related adverse events (irAEs) occurred in 8.2% of patients. PSM analysis revealed that OS was significantly shorter in elderly patients (≥ 75 years) than in younger patients (< 75 years) (hazard ratio [HR]; 95% CI, 1.39-8.99; P = .008), whereas PFS did not differ significantly between the 2 groups (HR: 1.50, 95% CI, 0.84-2.68, P = .169). The frequency of irAEs did not differ between these groups. CONCLUSIONS: The real-world efficacy and safety of durvalumab administration following chemoradiotherapy for LA-NSCLC coincided with the PACIFIC trial's findings. Disease control achieved with this protocol did not differ significantly between elderly and younger patients but had acceptable tolerability, demonstrating its benefit even in elderly LA-NSCLC patients aged 75 years or above.

Final Analysis of a Noninterventional Study on Cabozantinib in Patients With Advanced Renal Cell Carcinoma After Prior Checkpoint Inhibitor Therapy of the German Interdisciplinary Working Group on Renal Tumors (IAG-N).

BACKGROUND: Efficacy of treatment after failure of check point inhibitors (ICI) therapy remains ill-defined in metastatic renal cell carcinoma (mRCC). OBJECTIVE: To evaluate the safety and effectiveness of cabozantinib after failure of ICI-based therapies. DESIGN, SETTING AND PARTICIPANTS: Patients with mRCC who concluded cabozantinib treatment directly after an ICI-based therapy were eligible. Data was collected retrospectively from participating sites in Germany. INTERVENTIONS: Cabozantinib was administered as a standard of care. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Adverse events (AE) were reported according to CTCAE v5.0. Objective response rate according to RECIST 1.1 and Progression Free Survival (PFS) were collected from medical records. Descriptive statistics and Kaplan-Meyer-plots were utilized. RESULTS AND LIMITATIONS: About 56 eligible patients (71.4% male) with median age of 66 years and clear cell histology in 66.1% (n = 37) were analyzed. 87.5% (n = 49) had ≥ 2 previous lines. IMDC risk was intermediate or poor in 17 patients (30.4%) and missing in 66.1%. 20 patients (35.7%) started with 60 mg. 55.4% (n = 31) required dose reductions, 26.8% (n = 15) treatment delays and 1.8% (n = 1) treatment discontinuation. Partial response was reported in 10.7% (n = 6), stable and progressive disease were reported in 19.6% (n = 11) and in 12.5% (n = 7). 32 patients were not evaluable (57.1%). Median treatment duration was 6.1 months. Treatment related AE were reported in 76.8% (n = 43) and 19.6% (n = 11) had grade 3-5. Fatigue (26.8%), diarrhea (26.8%) and hand-foot-syndrome (25.0%) were the 3 most frequent AEs of any grade and causality. SAE were reported in 21.4% (n = 12), 2 were fatal. Major limitation was the retrospective data capture in our study. CONCLUSIONS: Cabozantinib followed directly after ICI-based therapy was safe and feasible. No new safety signals were reported. A lower starting dose was frequently utilized in this real-world cohort, which was associated with a favorable tolerability profile. Our data supports the use of cabozantinib after ICI treatment.

Supine or non-supine sleep apnea events: which can be treated better with Barbed Pharyngoplasty?

PURPOSE: Among the treatment options for Obstructive Sleep Apnea (OSA), intrapharyngeal surgery has undergone significant changes and received solid scientific support. However, it is crucial to identify the best candidate. This study aims to present the results of the modified Alianza technique in our clinic to show the differences in the impact of surgery on supine and non-supine apnea levels in moderate-severe OSA patients. METHODS: Adult patients affected by moderate-severe OSA (Apnea-Hypopnea Index (AHI) > 15), having circular palatal collapse, and candidates for modified Alianza Tecnique were retrospectively enrolled. Each subject performed polysomnography pre- and post-operatively, and the follow-up check was performed after at least six months. RESULTS: This study enrolled 24 patients who underwent the Modified Alianza technique for sleep apnea. We found significant reductions in both supine and non-supine AH) after surgery. Non-supine AHI showed a greater reduction (from 20.89 to 11.64 episodes/hour, p = 0.0001) than supine AHI (from 42.51 to 25.93, p = 0.0003). We subsequently divided the patients into two groups based on whether they were affected by positional OSA before surgery. There was a lower percentage decrease in non-supine AHI compared to supine AHI after surgery in patients who were positional before surgery, but this difference was not statistically significant. Conversely, in the non-positional patient group, there was a higher decrease in non-supine AHI compared to supine AHI, although this was not statistically significant. CONCLUSION: The Modified Alianza Tecnique leads to notable enhancement in AHI among patients with OSA. Non-supine apneas exhibit a more favorable response to the surgery than supine apneas.

Formulation and clinical evaluation of carbidopa/levodopa oral solution for the treatment of sepiapterin reductase deficiency.

BACKGROUND: sepiapterine reductase deficiency (SRD) is a rare levodopa (L-dopa)-responsive disorder treated with a combination therapy of controlled-release L-dopa and carbidopa. The currently available formulation of controlled-release carbidopa/L-dopa does not entirely meet the requirements for the long-term therapy in pediatric patients. In fact, administration of a manufactured tablet at a dose intended for adults necessitates its adjustment to the child's needs, as the splitting of the tablet into smaller portions or its dilution in water. It's essential to emphasize that tablets must not be crushed, as this can compromise the controlled-release mechanism and affect the efficacy of the medication. At the moment, commercial liquid formulations are not available. Given these limitations, in house drug preparation in hospitals and community pharmacies is a valid option to ensure the proper therapeutic management of these patients. MATERIALS AND METHODS: we described sample preparation, physical and microbiological analyses, taste testing, and tolerability of a 1:10 ratio carbidopa/L-dopa flavored (mint, raspberry, cacao, berries) and unflavored oral formulation (no sweetening agents were added). We also reported long-term follow-up of two pediatric patients with SRD. RESULTS: we documented the stability for 28 days at 25 °C of the liquid solution. All formulations were well-tolerated, and no adverse events were observed during or after assessing taste and tolerability. The long-term follow up of two patients was characterized by effective symptom control and optimal treatment adherence and compliance. CONCLUSIONS: in-house liquid drug formulations can be a valid option for pediatric patients with SRD. Given the significant impact of taste on medication adherence, the use of flavoring agents in the development of liquid formulations of L-dopa/carbidopa results a very useful strategy to obtain optimal adherence in the pediatric population.