Follow-up Protocol Research Articles

Low local recurrence rates following marginal surgical resection of non-coelomic Atypical Lipomatous Tumours/Well-differentiated Liposarcomas

IntroductionHigh rates of local recurrence (LR) have been reported following resection of extremity Atypical lipomatous tumours/Well-differentiated liposarcomas (ALTs). This retrospective study of patients who underwent resection of primary deep extremity and trunk ALTs at a specialist sarcoma centre aims to assess morbidity and factors associated with low local recurrence rates (LRR). MethodsTo review a homogeneous cohort of patients with low-grade disease, tumours with known high-risk histological features were excluded. Prognostic variables potentially influencing local recurrence (LR) (age, size, site, margin status, and histological findings) were analysed. Endpoints were LR, distant recurrence (DR) and local disease-free survival (LDFS). Results127 patients were identified, with median follow-up of 54 months (0–235). Median tumour size was 17.5 cm (5–36). 85 % occurred in the lower limb. 93.7 % underwent marginal resection. No patients received radiotherapy. Median hospital stay was 3 days (0–16). 7.9 % returned to theatre for evacuation of haematoma or infected seroma and 18.1 % had outpatient seroma aspiration. Surgical margins were R0/R1 in 93.7 % of patients and R2 in 6.3 % with a LR rate of 8.4 % and 75 % respectively at median time of 54 months. One- and 5-year LDFS was 100 % and 88.4 %, respectively. DR rate was 0.8 % (1/127) this patient had pleomorphic liposarcomatous transformation on recurrence and subsequently developed distant metastases. No patients died of disease. ConclusionFunction-preserving marginal resection of non-coelomic ALTs has low morbidity, low LR and extremely low rates of distant relapse. Patients with lower limb ALT were found to have significantly lower LR, which may impact follow-up protocols.

Optimising Radioligand Therapy for Patients with Gastro-Entero-Pancreatic Neuroendocrine Tumours: Expert Opinion from an Italian Multidisciplinary Group.

Radioligand therapy (RLT) with lutetium (177Lu) oxodotreotide is an approved therapy in combination with somatostatin analogues (SSAs) for patients with advanced, well-differentiated G1-G2, gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs) that progress on SSAs. We conducted a series of round table meetings throughout Italy to identify issues related to RLT delivery to patients with GEP-NETs. Four key issues were identified: (1) the proper definition of tumour progression prior to RLT initiation; (2) the impact of RLT in patients with bone metastases and/or high hepatic tumour burden; (3) the optimal follow-up protocol after RLT; and (4) organisational issues related to RLT use and managerial implications. This article reviews the literature relating to the aforementioned issues and makes recommendations based on available evidence and Italian NET experts' opinions. In particular, the group recommends the development of a diagnostic-therapeutic care pathway (DTCP) for patients undergoing RLT which provides systematic guidance but can still be individualised for each patient's clinical and psychosocial needs. A DTCP may clarify the diagnostic, therapeutic and post-treatment monitoring process, and improve communication and the coordination of care between hub and spoke centres. The DTCP may also contribute to changes in the care process related to the 2013/59/EURATOM Directive and to the definition of costs when planning for future or updated reimbursement of RLT in Italy.

Discussions Concerning the Generalist-Specialist Combination Management Model of Chronic Kidney Disease

In recent years, the effective management of patients with chronic kidney disease (CKD) is gaining growing attention. In 2014, our hospital established the CKD generalist-specialist combination management model, which incorporates a set of CKD management processes. The generalist component incorporates the following, general practitioners from 6 community health centers in the surrounding areas (with about 650 000 permanent residents in the region) joining hands, setting up a management team composed of doctors and nurses, and formulating management protocols for patient follow-up, patient record management, screening, risk assessment, examination and treatment, nutrition and exercise, and two-way referrals. The specialist component of the model incorporates the following, providing trainings for general practitioners in the in the community in the form of lectures on special topics and case discussion sessions, and organizing 7 national-level workshops for continuing medical education in the past decade, covering about 1 400 participants. In addition, regular meetings of the support groups of patients with renal diseases were organized to carry out information and education activities for patients. We have set up 4 community-based training centers and 6 specialized disease management centers, including one for diabetic nephropathy. We have retrospectively analyzed the risk factors of elderly CKD patients by establishing the elderly physical examination database (which has a current enrollment of 26 000 people), the elderly community CKD cross-sectional survey database, and the elderly CKD information management system. After 10 years of management practice, the level of institutionalization and standardization of CKD specialty management in our hospital has been improved. Moreover, we have expanded the management team and extended the management base from the hospital to community. We have improved the level of CKD management in community health centers and improved the specialty competence of the general practitioners in the communities. The generalist-specialist combination management model makes it possible for CKD patients to receive early screening and treatment, obtain effective and convenient follow-up and referral services, and improve their quality of life. Patients with complications such as diabetes, hypertension, and sarcopenia could access treatments with better precision. It is necessary to carry out the generalist-specialist integrated management of CKD, which is worthy of further development and improvement.

Pulmonary Low Malignant Potential Adenocarcinoma: A Validation of the Proposed Criteria for This Novel Subtype.

Adenocarcinoma (ADC) is the most common histologic type of lung cancer, including in situ (lepidic), minimally invasive, and invasive forms. While the former 2 types are associated with a favorable outcome, the latter includes tumors with variable behavior, often tumor stage-related. A recent study proposed strict morphologic criteria defining a new subgroup of resected stage I invasive ADC (16% of cases) with favorable outcomes (100% disease-specific survival), named "ADC of low malignant potential (LMP-ADC)." The following criteria were met: ≤3cm size, nonmucinous histotype, ≥15% lepidic growth, and the absence of the following: high-grade patterns, >1 mitosis/2mm 2 , necrosis, and vascular/pleural invasion. The aim of the present study was to validate the performance of such criteria to identify LMP-ADC in a series of 274 stage IA resected lung ADCs from a single institution. Thirty-four tumors (12.4%) met the proposed criteria for LMP-ADC, as confirmed by additional stains for mitotic figures, Ki67 index, and elastic fibers (helpful to assess alveolar wall invasion). Minor differences between the lepidic and invasive components were observed regarding cell atypia and proliferation. p53 was normally expressed by invasive tumor cells. Mutations occurred in known lung cancer genes (mostly KRAS and EGFR). Five patients (14.7%) developed disease progression and 2 of them (5.9%) died of the disease. In our series, the disease-specific survival was 94.1%. In conclusion, in resected invasive lung ADC, a subgroup presenting low-grade morphologic features and associated with favorable prognosis does exist. Morphologic criteria for LMP-ADC supported by ancillary techniques represent a valid tool to better define this novel subgroup and to refine the stratification of invasive lung ADC, possibly suggesting modified follow-up protocols, based on the observed indolent behavior in most cases.

Lymph Node Ratio as a Predictor of Survival for Colon Cancer: A Systematic Review and Meta-Analysis.

Lymph node ratio is the number of lymph nodes with evidence of metastases on pathological review compared to the total number of lymph nodes harvested during oncologic resection. Lymph node ratio is a proven predictor of long-term survival. These data have not been meta-analyzed to determine the prognosis associated with different lymph node ratio cut-offs in colon cancer. Medline, Embase, and CENTRAL were systematically searched. Articles were included if they compared 5-year overall survival (OS) or disease-free survival (DFS) between different lymph node ratios for patients undergoing oncologic resection for stages I-III colon cancer. Pairwise meta-analyses using inverse variance random effects were performed. From 2587 citations, nine studies with 97,631 patients (female: 51.9%, median age: 61.65years) were included. A lymph node ratio above .1 resulted in a 49% decrease in the odds of 5-year OS (2 studies; OR: 0.51, 95% CI: 0.49-.53, P < .00001). A lymph node ratio above .25 resulted in a 56% decrease in the odds of 5-year OS (3 studies; OR: 0.44, 95% CI: 0.43-.45, P < .00001). A lymph node ratio above .5 resulted in a 65% decrease in the odds of 5-year OS (3 studies; OR: 0.35, 95% CI: 0.33-.37, P < .00001). Lymph node ratios from .1 to .5 are effective predictors of 5-year OS for colon cancer. There appears to be an inverse dose-response relationship between lymph node ratio and 5-year OS. Further study is required to determine whether there is an optimal lymph node ratio cut-off for prognostication and whether it can inform which patients may benefit from more aggressive adjuvant therapy and follow-up protocols.

Cervical Cancer Prevention, Its Challenges and Solutions in Iran and Worldwide: A Systematic Review.

Widespread use of screening in high-income countries has led to significant reductions in mortality from cervical cancer. However, in Iran, the main reason for the late diagnosis of cervical cancer was the failure to perform a Pap smear (Papanicolaou). We aimed to investigate the status of cervical cancer prevention and its challenges and solutions in Iran. We conducted a systematic review of literature published from 1974 to 2021 in the electronic databases, including PubMed, Web of Science, Embase, Scopus, and Google Scholar, and retrieved all English-language articles. Following the application of the inclusion and exclusion criteria, full-text articles were identified and evaluated for eligibility. Finally, these publications were analyzed as part of the synthesis. Lower social-economic level, inadequate knowledge of screening tests and health centers for Pap test performance leading to worse outcomes such as lower screening participation or coverage. By addressing these challenges through increasing education, increasing service accessibility, expanding screening programs, improving public awareness, improving insurance coverage, and establishing a control protocol for follow-up, it is possible to reduce cervical cancer incidence and mortality.

Practical and Statistical Considerations for the Long Term Follow-Up of Gene Therapy Trial Participants.

Study sponsors and market authorization holders are required by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to enroll patients administered a gene therapy product, whether in a trial setting or post-licensure, in a long term follow-up safety study to continue the safety assessments of their product. These follow-up studies range between 5 and 15 years after dosing. This unprecedented duration of engagement with patients and caregivers raises logistical challenges that will require innovation and collaboration across sponsors and regulators. In this paper we delineate some of the key considerations for designing long term follow-up protocols in the gene therapy setting, with an eye toward platform and master protocol approaches, and offer guidance for innovative operational and statistical methods that can help assess the safety profile and durability of response for these novel therapeutics.

Real-life after sacral nerve modulation implantation: Rate, reasons, and risk factors for mid-term follow-up discontinuation

To evaluate follow-up after implantation of a sacral nerve modulation implantable pulse generator (IPG) and to investigate the reasons and risk factors for follow-up discontinuation. All patients who underwent an IPG implantation to treat lower urinary tract symptoms between 2014-2019 within 6hospital centers located in the district of "Hauts-de-France" (France) were systematically called during the year 2020 for a standardized (tele)consultation. Patients were divided into 3 distinct profiles according to the regularity of their 5-year postoperative follow-up: "Regular follow-up", "Irregular follow-up" and "Lost to follow-up". The primary outcome was the change in the annual proportion of the 3 follow-up profiles over the 5 years following IPG implantation. As secondary outcomes we described the reasons reported for follow-up discontinuation and looked for risk factors associated with. Overall, 259 patients were included. At the time of data collection, after a mean follow-up of 28.4 (±19.8) months, 139 patients (53.7%) had a "Regular follow-up", 54 (20.8%) had an "Irregular follow-up" and 66 (25.5%) were "Lost to follow-up". The proportion of patients with a "Regular follow-up" decreased year by year, representing only 46.2% of patients at five-years. 175 patients (67.6%) underwent a standardized (tele)consultation. In multivariate analysis, only "lack of knowledge of the follow-up protocol" was statistically associated with follow-up discontinuation (OR=5.16; 95% CI [2.12-13.57]). The proportion of patients followed up after IPG implantation decreased steadily over the years, often related to a lack of therapeutic education.

Catheter-directed therapies impact on intermediate-high- and high-risk pulmonary embolism patients

Abstract Introduction Intermediate-high- and high-risk pulmonary embolism (PE) patients treated with anticoagulation alone are associated with a considerable risk of circulatory collapse, death, or long-term pulmonary hypertension. Pulmonary Embolism Response Teams (PERT) have been created to deliver PE patients a better care. Catheter Directed Therapies (CDT), with mechanical thrombolysis and/or local fibrinolysis allow faster reperfusion and hemodynamic improvement without the systemic hemorrhagic effects of systemic fibrinolysis. The clinical evidence of its benefits is lacking. Objectives This analysis aims to describe the hemodynamics, morphological and perfusion improvement in intermediate-high- and high-risk acute PE patients submitted to CDT. Methods Prospective registry of consecutive intermediate-high- and high-risk PE patients submitted to CDT (mechanical thrombolysis with PenumbraÔ aspiration system and/or intrapulmonary local fibrinolysis with alteplase) in a single tertiary center. A multiparametric follow-up protocol was designed to evaluate echocardiographic, CT-scan, pulmonary angiogram, and right heart catheterization data at admission and at 3 months after CDT. The paired samples t-Test was used for the analysis of the variables. Results 26 PE patients (42.3% male, mean age 59 years old) were submitted to CDT (19% combined Penumbra and local fibrinolysis, 12% isolated Penumbra and 69% isolated local fibrinolysis). Baseline characteristics, laboratorial, imaging and procedure data are summarized in the figure 1. No major bleeding was seen during or after the procedure. 1 pulmonary artery dissection and 1 Penumbra burr partial avulsion occurred, both with conservative treatment with good result. 3 patients died during the follow-up (1 for oncologic disease, 1 for septic shock and 1 after discharge with undetermined cause). Of the remaining, 18 patients completed the 3-month follow-up protocol. At 3 months, a significant improvement was seen in the patients’ hemodynamics with 3.3mmHg mean drop of RA pressure (p 0.007), 16.1mmHg mean drop of systolic PA pressure (p &amp;lt;0.001), 8.0mmHg mean drop of mean PA pressure (p&amp;lt;0.001), 1.4L/min and 0.7L/min/m2 mean increases in cardiac output and index (p 0.003, p 0.001), and a tendency to a 0.8 Wood units decrease in the pulmonary vascular resistance (p 0.093). It was also seen an improvement in the perfusion defects with a mean drop of 7.9 points in the modified Miller index (p &amp;lt;0.001) and an improvement in the RV function with a mean decrease of 0.5 in the RV/LV ratio by CT-scan (p &amp;lt;0.001), a mean increase of 5.6mm in TAPSE (p &amp;lt;0.001) and a decrease of median NT-proBNP levels in 2866pg/ml (p &amp;lt;0.001). Conclusions In patients with intermediate-high- and high-risk PE, the use of CDT with mechanical thrombolysis and/or local fibrinolysis is safe and associated with improvement in hemodynamics, RV function and perfusion defects.Table 1.baseline characteristicsTable 2.results

Percutaneous image-guided ablation for hepatic metastases.

The presence of hepatic metastases indicates advanced disease and is associated with significant morbidity and mortality, especially when the hepatic disease is not amenable to locoregional treatments. The primary tumour of origin, the distribution and extent of metastatic disease, the underlying liver reserve, the patient performance status and the presence of comorbidities are factors that determine whether a patient will benefit from hepatectomy or local curative-intent treatments. For patients with metastatic colorectal cancer, the most common primary cancer that spreads to the liver, several studies have demonstrated a survival benefit for patients who can be treated with hepatectomy and/or percutaneous ablation, compared to those treated with chemotherapy alone. Despite advances in surgical techniques increasing the percentage of patients eligible for surgery, most patients have unresectable disease or are poor surgical candidates. Percutaneous ablation can be used to provide local disease control and prolong survival for both surgical and non-surgical candidates. This is typically offered to patients with small hepatic metastases that can be ablated with optimal (≥10 mm) or at least adequate minimum ablation margins (≥5 mm), as high local tumour control rates can be achieved for these patients which are comparable to surgical resection. This review summarizes available evidence and outcomes following percutaneous ablation of the most frequently encountered types of hepatic metastases in the clinical practice of interventional oncology. Patient selection, technical considerations, follow-up protocols and oncologic outcomes are presented and discussed.

Nurse-driven protocol for the management and follow-up of subclinical atrial fibrillation episodes in pacemaker patients

Abstract Background Atrial high-rate episodes (AHREs) compatible with atrial fibrillation (AF) detected in pacemakers are associated with an increased risk of stroke. Nurses trained in pacemaker (PM) follow-up can detect theses AHREs during patient’ scheduled visits and provide the best care option to the patients. Purpose To evaluate a nurse protocol applied in these patients focused on a) identifying those with AHREs and taking into account the timing of these events and their duration, and b) provide the best care and follow-up then after. Methods and Results To create our protocol, we evaluated PM patients without a previous history of AF and classified the incidence of AHREs into 3 groups: &amp;gt;5 minutes to 24 hours; &amp;gt;24 hours and patients who are in clinical AF (documented on ECG) at the time of the visit. We also evaluate the time elapsed since PM implantation (£ 3 months vs &amp;gt; 3 months) and the type of atrial electrode fixation (active vs passive). In a prior study we analyzed 110 patients with AHREs &amp;gt;5 minutes and &amp;lt;24 hours (56% male, age 75 ± 9 years, mean CHA2DS2VACS scores of 3.5 ± 1.5). After 24 ± 9 months, 40 patients (36.4%) presented AHREs, and CT images showed ischemic brain lesions in 26 of them (23.6%). The presence of AHREs at 3 months was more frequent in patients with a recent MP implantation (17% vs 4.5%) and with a significant relationship with the type of active fixation of the electrode. The presence of ischemic lesions on CT was related to the detection of AHREs during follow-up, but not with AHREs in the first 3 months. Therefore, we designed a dedicated protocol for follow-up in these patients (AHREs &amp;gt;5 minutes and &amp;lt;24 hours) after PM implantation with repetitive follow-up visits assessing the evolution of AHREs. In cases of &amp;gt;24 hours and those with ECG documented AF, Guidelines recommendations were followed. Conclusions In PM patients, the presence of AHREs might be related to serious clinical complications. On the other hand, AHREs occur regularly during the first 3 months after PM implantation, maybe related to the procedure itself and the use of active fixation for the atrial lead. AHREs in this period may not be related to major complications and individual risk should be carefully assessed before starting anticoagulation. A dedicated protocol for closer follow-up visits in these patients might help to identify those at risk and prevent clinical events.

Transtyretin cardiac amyloidosis in the elderly patient: always a wild type?

Abstract Background Transthyretin amyloidosis (ATTR) exists in two forms: a genetic form transmitted by autosomal dominant inheritance (ATTRv) and a wild type form (ATTRwt). Clinically, the hereditary form tends to have an early onset in adulthood and it is characterized by a particular tropism for nervous as well as cardiac tissue. In contrast, the "wild type" form has a later onset with major cardiac involvement and neurological manifestations usually limited to carpal tunnel syndrome (1). Methods and results in our centre, from January to October 2022, 20 patients older than 75 years received a diagnosis of cardiac ATTR (73% male, 27% female, mean age 83±5). In all patients, blood tests showed a significant and stable increase in the values of troponin Ths (0.070± 0.074 ng/mL) and NT-proBNP (1533±1204 pg/ml), with the absence of a monoclonal component in the blood and urine, and miocardial bisphosphonate scintigraphy positive grade 2/3. All patients showed absence of peripheral neuropathy with the presence of carpal tunnel syndrome in 9 cases. Before starting therapy with Tafamidis all patients underwent genetic testing by amplification of exons 2,3 and 4 of the TTR gene with subsequent sequencing. Unexpectedly, in 3 elderly male patients (15%) the genetic test resulted positive with 3 different mutations of pathogenetic significance (Val50Met; Ile88Leu; Val142Ile). First-degree relatives (10 consanguineous, average age 49±12 years) agreed to be subjected to genetic screening; of these 4 (1 male and 3 females, age 47±8 years) were positive for the corresponding mutation and underwent echocardiogram, MRI and myocardial scintigraphy. All of these tests were normal and they were included in an annual follow-up protocol at the to identify an early manifestation of the disease. Conclusions our experience shows that 15% of patients older than 75 years and diagnosed with cardiac ATTR may be affected by a genetic form. Making genetic diagnosis in this context is particularly important for screening family members: current therapies are in fact much more effective if started early before organ damage can occur (2).

Impact of extracorporeal circulation support systems on blood product resources during the course of intensive care unit treatment

Abstract Background Extracorporeal circulatory support systems necessitate careful blood product management due to the large cannulas and exposure of blood components to artificial surfaces in the circuits. Blood component derangements can occur during implantation and the operational period of these systems, posing a significant complication. To enhance patient safety and bolster the body's own blood reserves, accurate characterization of the extent of necessary blood product substitution is imperative. Methods We analyzed data from consecutive patients who received extracorporeal circulatory support systems (Impella, veno-arterial extracorporeal membrane oxygenation (VA-ECMO), or ECMella) over a 5-year period (2016-2021). We obtained information on blood product usage, costs, and various clinical parameters. We assessed the vascular access site according to the Bleeding Academic Research Consortium (BARC) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO) criteria, and hemolysis was evaluated using serum free hemoglobin (fHb). Results We studied 370 patients (Table 1) who received extracorporeal circulatory support systems (Impella, VA-ECMO, and ECMella) from 2016 to 2021. The median number of RBC transfusions was 7 (3 - 12) for the entire cohort, with ECMella patients requiring the highest amount (12.5 (6.7 - 27.5)) and VA-ECMO patients requiring the most within the first 24 hours (57%, p &amp;lt; 0.05). Hemolysis was present in all groups, with Impella patients having the highest levels (49.8 µmol / L (21.3 – 113.1), p &amp;lt; 0.01). ECMella patients required the highest overall blood product substitution (Figure 1) and incurred the highest associated costs (1642.4 EUR (1079.1 – 3660.3), p &amp;lt; 0.01). Bleeding complications in the groin area were moderate in 45% of patients, with VA-ECMO patients having the highest incidence (58%, p &amp;lt; 0.05). Type 3a bleeding according to the BARC criteria was most common (31.7%). Conclusion Although extracorporeal circulatory support systems have made technical advances, significant resources are still required during the operational period to maintain coagulation homeostasis, particularly in ECMella patients. Complications at the insertion site are also common, with bleeding being expected, especially in emergency situations when a VA-ECMO is used. To ensure patient safety, interdisciplinary teams should establish standardized follow-up protocols to detect peripheral complications early.

Do Urine Cytology and FISH Analysis Have a Role in the Follow-Up Protocol of Upper Tract Urothelial Carcinoma?

BackgroundCurrent guidelines recommend a stringent follow-up regimen that includes interval cystoureteronephscopy, CT urography, and selective urine cytology sampling for upper tract urothelial carcinoma (UTUC) patients undergoing endoscopic treatment and management. There are no recommendations regarding FISH analysis. Our purpose was to assess the efficacy of cytology and FISH as part of the follow-up protocol and its significance to clinical decision-making in this scenario. MethodsThe medical records of all patients who managed endoscopically for UTUC at our institute between 2014 and 2022 were retrospectively analyzed. Demographic and clinical data, histology, cytology, and FISH results were collected. FISH analysis was considered malignant according to Paris criteria. ResultsDuring the study period, 62 patients underwent 561 ureteroscopies as part of the treatment and follow-up regimen of low-grade UTUC. Urine from the affected upper tract was sampled for cytology in 377 procedures, and FISH analyses were performed in 273. In 75.4% of FISH analyses, the result was different from the cytology results: FISH found malignant aberrations in 15.5% of cases where cytology was benign. Furthermore, FISH classified all the cells defined as atypical via cytology as either benign or malignant. In only one case (0.17%), the urinary cytology report changed the follow-up regimen. ConclusionCytology may be omitted from the follow-up protocol of low-grade UTUC. In the handful of cases cytology does assist the diagnosis of UTUC, there is an additional benefit to performing FISH analysis, particularly when cellular atypia is reported in the cytology results.

Transmissibility and severity of COVID-19 in a humanitarian setting: First few X investigation of cases and contacts in Juba, South Sudan, 2020.

The first few 'X' (FFX) studies provide evidence to guide public health decision-making and resource allocation. The adapted WHO Unity FFX protocol for COVID-19 was implemented to gain an understanding of the clinical, epidemiological, virological and household transmission dynamics of the first cases of COVID-19 infection detected in Juba, South Sudan. Laboratory-confirmed COVID-19 cases were identified through the national surveillance system, and an initial visit was conducted with eligible cases to identify all close contacts. Consenting cases and close contacts were enrolled between June 2020 and December 2020. Demographic, clinical information and biological samples were taken at enrollment and 14-21 days post-enrollment for all participants. Twenty-nine primary cases and 82 contacts were included in the analyses. Most primary cases (n= 23/29, 79.3%) and contacts (n= 61/82, 74.4%) were male. Many primary cases (n= 18/29, 62.1%) and contacts (n= 51/82, 62.2%) were seropositive for SARS-CoV-2 at baseline. The secondary attack rate among susceptible contacts was 12.9% (4/31; 95% CI: 4.9%-29.7%). All secondary cases and most (72%) primary cases were asymptomatic. Reported symptoms included coughing (n= 6/29, 20.7%), fever or history of fever (n= 4/29, 13.8%), headache (n= 3/29, 10.3%) and shortness of breath (n= 3/29, 10.3%). Of 38 cases, two were hospitalised (5.3%) and one died (2.6%). These findings were used to develop the South Sudanese Ministry of Health surveillance and contract tracing protocols, informing local COVID-19 case definitions, follow-up protocols and data management systems. This investigation demonstrates that rapid FFX implementation is critical in understanding the emerging disease and informing response priorities.

Medication Abortion Follow-Up Rates in a Rural Population Before and After Introduction of a Remote Follow-Up Option.

Background: Medication abortion (MAB) follow-up historically involves visiting a health care facility for ultrasonography or laboratory testing. In rural states such as New Mexico, many patients travel hours for MAB, making two visits burdensome. Studies demonstrate feasibility, safety, and patient preference for remote follow-up. Materials and Methods: We evaluated whether MAB follow-up by telephone had noninferior loss-to-follow-up (LTFU) rates compared with ultrasonography or laboratory follow-up in a rural population. This was a retrospective chart review of University of New Mexico MAB LTFU rates after changing to telephone follow-up (home group, n = 136). Patients were propensity-matched in a 1:2 ratio to a historical cohort (health care group, n = 272) to eliminate significant differences. We defined LTFU as no contact within 50 days. We evaluated complications requiring intervention, possible ongoing pregnancy, completion of the home follow-up protocol (7- and 30-day calls, high-sensitivity urine pregnancy test [UPT]), follow-up by intended method (home or health care), and number of call attempts. Results: LTFU rates for the home group (n = 23, 17%) were noninferior to the health care group (n = 60, 22%, p = 0.24). Rates of complications requiring intervention (p = 0.83) and possible ongoing pregnancy (p = 0.72) among the home group were similar to the health care group. Ninety-seven (71%) home group patients completed the initial call, 79 (58%) completed the UPT, and 86 (69%) completed the 30-day call. Ninety-five (70%) home group patients followed up by intended method, comparable with the health care group (n = 199, 73%, p = 0.56). Staff made a median of 3 (interquartile range: 2-4) calls per home group patient. Conclusions: Remote MAB LTFU rates were noninferior to in-person LTFU rates.

Biomarkers in Laryngeal Squamous Cell Carcinoma: The Literature Review.

Laryngeal squamous cell carcinoma (LSCC) is the second most common cancer among head and neck cancers. Despite a lower incidence of laryngeal carcinoma, new diagnostic techniques, and more targeted therapies, the overall survival has not changed significantly in the last decades, leading to a negative prognosis in advanced stages. Recently, several studies have focused on the identification of biomarkers that may play a critical role in the pathogenesis of LSCC. Reviewing the literature on the main databases, this study aims to investigate the role of some biomarkers in LSCC that are correlated with oxidative stress and inflammation: heat shock proteins; metallothioneins; nuclear factor erythroid 2-related factor 2; heme oxygenase; cyclooxygenase-2; and micro ribonucleic acids. This review shows that biomarker expression depends on the type, grade of differentiation, stage, and site of carcinoma. In addition, the role of these biomarkers in LSCC is still little-known and little-studied. However, the study of biomarker expression and the detection of a possible correlation with patients' epidemiological, clinicopathological, and therapeutics data may lead to better awareness and knowledge of the tumor, to the identification of the best therapeutic strategy, and the most proper follow-up protocol tailored for each patient. In conclusion, the achievement of these goals may improve the prognosis of LSCC patients.

Protocol for a 20-year follow-up after a randomized controlled trial of a Mediterranean diet in pregnancy: maternal and offspring risk factors for cardiovascular disease.

An inadequate maternal diet during pregnancy can impair offspring health and may increase the risk of cardiovascular disease later in life. The purpose of the proposed study is to assess the risk factors associated with cardiovascular disease in both mothers and their offspring 20 years following their participation in a Mediterranean diet intervention trial during pregnancy. The "Cardiovascular Risk Reduction Diet In Pregnancy" (CARRDIP) study was a randomized controlled trial performed between 1999 and 2001. The participants were randomized to adhere to either a Mediterranean diet or their regular diet during pregnancy. An extensive amount of data such as diet information, ultrasound measurements, anthropometry, and biomarkers from these mothers during pregnancy and their offspring in the neonatal period were collected. The mother-offspring pairs (n = 269) from the CARRDIP study will be invited to participate in a clinical examination and blood sample collection. This follow-up study, conducted 20 years after the original CARRDIP study, will investigate cardiovascular risk factors in mothers and offspring. The primary outcome will be the blood pressure of the offspring. In addition, the study will explore various aspects of cardiovascular health, including metabolic and inflammatory status, clinical history, and body composition of the participants. Previous studies investigating the effects of nutrition during pregnancy on maternal and offspring health have been either observational studies, animal studies, or randomized controlled trials with a follow-up period of less than 5 years. This project aims to study the long-term effects of dietary intervention during pregnancy on maternal and offspring cardiovascular risk markers. Clinicaltrials.gov, identifier (NCT05030922).

Copy-number-gain of telomerase reverse transcriptase (hTERT) is associated with an unfavorable prognosis in esophageal adenocarcinoma

Esophageal adenocarcinoma exhibits one of the highest mortality rates among all cancer entities. Multimodal therapy strategies have improved patients’ survival significantly. However, patients in early stages are currently limited to receiving only local therapies, even though some patients within this group showcase short survival periods. Until now, there has been no widely established clinically used biomarker to detect these high-risk patients. Telomerase reverse transcriptase (TERT), a gene encoding a crucial subunit of the telomerase enzyme, plays a significant role in establishing cancer cell immortality and is under suspicion for its potential contribution to tumor progression. Therefore, we aimed to evaluate the clinical relevance of the TERT amplification status. We included 643 patients with esophageal adenocarcinoma, who underwent Ivor-Lewis esophagectomy at the University Hospital of Cologne. The TERT amplification status was characterized using fluorescence in situ hybridization. Clinicopathological values and patients’ overall survival were compared between patients with and without TERT amplification. Further sub-cohort analyses were conducted for patients with pT1N0-3 tumor stage. Eighty-One patients (12.6%) exhibited TERT amplification. Patients with amplified TERT showed significantly worse overall survival (median OS: 22.6 vs. 36.8 months, p = 0.009). Interestingly, TERT amplification could be characterized as an independent risk factor for worse overall survival in multivariate analysis in patients with pT1N0-3 tumor stage (HR = 2.440, 95% CI 1.095–5.440, p = 0.029). In this study, we describe the TERT amplification status as an independent risk factor for worse survival in patients diagnosed with esophageal adenocarcinoma at pT1N0-3 tumor stage, encompassing cases involving tumor infiltration of the lamina propria, muscularis mucosae, and/or submucosa. Based on our findings, we put forth the proposition that evaluating the TERT amplification status may serve as a valuable tool in identifying a specific subgroup of patients, namely those with TERT amplification and pT1N0-3 tumor-stage esophageal adenocarcinoma. The patients of this subgroup could potentially benefit from enhanced follow-up protocols, more aggressive treatment approaches, or possible targeted TERT inhibition therapies, all aimed at improving their overall clinical outcomes.

Feasibility and impact of online HIV/STI screening addressed to men who have sex with men and transgender women users of pre-exposure prophylaxis (PrEP) in Spain (TESTATE PrEP): a study protocol for a non-blinded randomised controlled trial

IntroductionThe objectives of the study are: to design and implement a pilot intervention to offer self-sampling kits to detect HIV, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Treponema pallidum (TP)...