Prospective Observational Study Research Articles

Association between pretreatment emotional distress and immune checkpoint inhibitor response in non-small-cell lung cancer.

Emotional distress (ED), commonly characterized by symptoms of depression and/or anxiety, is prevalent in patients with cancer. Preclinical studies suggest that ED can impair antitumor immune responses, but few clinical studies have explored its relationship with response to immune checkpoint inhibitors (ICIs). Here we report results from cohort 1 of the prospective observational STRESS-LUNG study, which investigated the association between ED and clinical efficacy of first-line treatment of ICIs in patients with advanced non-small-cell lung cancer. ED was assessed by Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scale. The study included 227 patients with 111 (48.9%) exhibiting ED who presented depression (Patient Health Questionnaire-9 score ≥5) and/or anxiety (Generalized Anxiety Disorder 7-item score ≥5) symptoms at baseline. On the primary endpoint analysis, patients with baseline ED exhibited a significantly shorter median progression-free survival compared with those without ED (7.9 months versus 15.5 months, hazard ratio 1.73, 95% confidence interval 1.23 to 2.43, P = 0.002). On the secondary endpoint analysis, ED was associated with lower objective response rate (46.8% versus 62.1%, odds ratio 0.54, P = 0.022), reduced 2-year overall survival rate of 46.5% versus 64.9% (hazard ratio for death 1.82, 95% confidence interval 1.12 to 2.97, P = 0.016) and detriments in quality of life. The exploratory analysis indicated that the ED group showed elevated blood cortisol levels, which was associated with adverse survival outcomes. This study suggests that there is an association between ED and worse clinical outcomes in patients with advanced non-small-cell lung cancer treated with ICIs, highlighting the potential significance of addressing ED in cancer management. ClinicalTrials.gov registration: NCT05477979 .

From Emergency Department to clinic center: management of patients with Heart Failure with Reduced Ejection Fraction

Aims: primary outcomes - cardiovascular and all-cause mortality evaluation within 1 year in elderly patients enrolled with Angiotensin Receptor Inhibitor (ARNI) and/or Sodium Glucose Co-Transporter Type 2 Inhibitors (SGLT2-i) in an Internal Medicine Department; recurrent hospitalization assessment for acute Heart Failure with Reduced Ejection Fraction (HFrEF); length of hospitalization analysis compared to not-enrolled patients. Secondary endpoints - to identify any parameters predicting the length of hospitalization; safety assessment through the incidence of complications and treatment interruption. Materials and Methods: prospective observational real-life cohort study that analyzes the recruitment during hospitalization and follow-up 3-6-12 months after discharge. Several clinical parameters were recorded for each patient of any ethnicity, considering a diagnosis of acute HFrEF with NT-proBNP and chest x-ray. Results: the enrolled group (34 patients) showed a hospitalization period lower than the not-enrolled one. The rehospitalizations percentage was inferior to Randomized Clinical Trials (RCTs) for ARNI. Cardiovascular-cause mortality, symptomatic hypotension, and Urinary Tract Infections (UTI) were lower than RCTs data. Age, eGFR, NT-proBNP, Cumulative Illness Rating Scale (CIRS), and severe comorbidities, except for EF, predicted the lengthening of hospitalization. Hypoglycemia wasn’t recorded. Conclusions: ARNI/SGLT2-i are effective and safe in elderly patients. Comorbidities and bio-humoral features influence HFrEF and quality of life. The future aim is to confirm the results obtained so far.

In Vivo Classification and Characterization of Carotid Atherosclerotic Lesions with Integrated 18F-FDG PET/MRI

Background: The aim of this study was to exploit integrated PET/MRI to simultaneously evaluate the morphological, component, and metabolic features of advanced atherosclerotic plaques and explore their incremental value. Methods: In this observational prospective cohort study, patients with advanced plaque in the carotid artery underwent 18F-FDG PET/MRI. Plaque morphological features were measured, and plaque component features were determined via MRI according to AHA lesion-types. Maximum standardized uptake values (SUVmax) and tissue to background ratio (TBR) on PET were calculated. Area under the receiver-operating characteristic curve (AUC) and net reclassification improvement (NRI) were used to compare the incremental contribution of FDG uptake when added to AHA lesion-types for symptomatic plaque classification. Results: A total of 280 patients with advanced plaque in the carotid artery were recruited. A total of 402 plaques were confirmed, and 87 of 402 (21.6%) were symptomatic plaques. 18F-FDG PET/MRI was performed a mean of 38 days (range 1–90) after the symptom. Increased stenosis degree (61.5% vs. 50.0%, p < 0.001) and TBR (2.96 vs. 2.32, p < 0.001) were observed in symptomatic plaques compared with asymptomatic plaques. The performance of the combined model (AHA lesion type VI + stenosis degree + TBR) for predicting symptomatic plaques was the best among all models (AUC = 0.789). The improvement of the combined model (AHA lesion type VII + stenosis degree + TBR) over AHA lesion type VII model for predicting symptomatic plaques was the highest (AUC = 0.757/0.454, combined model/AHA lesion type VII model), and the NRI was 50.7%. Conclusions: Integrated PET/MRI could simultaneously evaluate the morphological component and inflammation features of advanced atherosclerotic plaques and provide supplementary optimization information over AHA lesion-types for identifying vulnerable plaques in atherosclerosis subjects to achieve further stratification of stroke risk.

Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India.

Evidence on the long-term safety of COVID-19 vaccines is scarce. Here, in continuation of our previously published results on short-term safety, we provide data on the long-term safety of the BBV152 vaccine in adolescents and adults. This was a prospective observational study conducted from January 2022 to August 2023. Adolescents and adults receiving the BBV152 vaccine were interviewed telephonically about long-term adverse events of special interest (AESIs) after 1 year of vaccination. Risk factors of AESIs and AESIs persistent for at least 1 month were identified. Out of 1024 individuals enrolled, 635 adolescents and 291 adults could be contacted during the 1-year follow-up. Viral upper respiratory tract infections were reported by 304 (47.9%) adolescents and 124 (42.6%) adults in this period. New-onset skin and subcutaneous disorders (10.5%), general disorders (10.2%), and nervous system disorders (4.7%) were the common AESIs in adolescents. General disorders (8.9%), musculoskeletal disorders (5.8%), and nervous system disorders (5.5%) were the common AESIs in adults. Menstrual abnormalities were noticed in 4.6% of female participants. Ocular abnormalities and hypothyroidism were observed in 2.7% and 0.6% of participants, respectively. Among serious AESIs (1%), stroke and Guillain-Barre syndrome were identified in 0.3% and 0.1% of participants, respectively. Among adolescents, female individuals, those with a history of allergy and post-vaccination typhoid were respectively at 1.6, 2.8, and 2.8 times higher risk of AESIs. The majority of the AESIs persisted at the 1-year follow-up. Female individuals, adolescents with pre-vaccination COVID-19, those with co-morbidities, and those with post-vaccination typhoid had respectively 1.6, 2, 2.7, and 3.2 times higher odds of persistent AESIs. Adults with co-morbidities had more than 2 times higher odds of AESIs and persistent AESIs. The patterns of AESIs developing after BBV152 differed from those reported with other COVID-19 vaccines as well as between adolescents and adults. With the majority of AESIs persisting for a significant period, extended surveillance of COVID-19-vaccinated individuals is warranted to understand the course and outcomes of late-onset AESIs. Serious AESIs might not be uncommon and necessitate enhanced awareness and larger studies to understand the incidence of immune-mediated phenomena post-COVID-19 vaccination. The relationship of AESIs with sex, co-morbidities, pre-vaccination COVID-19, and non-COVID illnesses should be explored in future studies.

The Effect of Denosumab on Rotator Cuff Repair in Women Aged 60 and over with Osteoporosis: A Prospective Observational Study

Background: In previous studies, denosumab, a RANKL human monoclonal antibody used in osteoporosis treatment, has shown efficacy in tendon healing after rotator cuff repair. This prospective study investigated the effects of denosumab on tendon healing, re-tear rates, and clinical outcomes post rotator cuff repair in women with osteoporosis. Method: This was a prospective, observational study, employing propensity score matching for the control group. From March 2018 to March 2023, female patients over the age of 60 with normal bone density undergoing arthroscopic rotator cuff repair were selected as controls through propensity score matching (PSM) and compared with female patients of the same age group with osteoporosis who were receiving denosumab treatment. The control group was matched using 1-to-2 propensity score matching. Radiological examinations and functional outcomes were assessed preoperatively and at 6 months postoperatively. Results: In the final analysis, the study comprised 34 patients in the denosumab treatment group (Group 1) and 68 patients in the control group (Group 2). The functional scores showed significant improvement at 6 months post-surgery in both groups. No significant difference in the functional scores was observed among the groups. The re-tear rate, defined according to Sugaya’s classification (types IV and V) as re-tear, was slightly higher in Group 1 at 16.7% (6 of 34) compared to Group 2 at 11.7% (8 of 68), but the difference was not statistically significant (p = 0.469). The re-tear patterns, classified according to Rhee’s classification, also showed no significant difference among the groups (Group 1: 2/4 of 6; Group 2: 4/4 of 8; p = 0.571). The occurrence of type I re-tear exhibited no significant difference between the two groups (5.9% vs. 5.9%; p = 1.000). Conclusions: The administration of denosumab following arthroscopic rotator cuff repair in women aged 60 and over with osteoporosis resulted in a re-tear rate that was similar to that observed in patients without osteoporosis. This result suggests that denosumab administration might be beneficial for rotator cuff healing, particularly in the context of osteoporosis, a known risk factor for increased retear rates. Therefore, comprehensive osteoporosis screening and treatment should be considered in conjunction with rotator cuff repair surgery in middle-aged women.

Educational training and nursing professional self-perception in Mongolia: A prospective observational pre-post design study.

To determine whether professional self-perception of nurses in Mongolia improves following an educational intervention and to identify differences in scores among participant subgroups. A prospective observational pre-post design. Using a convenience sample of 67 nurses in Mongolia in 2019, the Nursing Professional Values Scale-3 instrument was used pre- and post-intervention. Independent and paired sample t-tests were conducted. Data were analysed using IBM SPSS 28.0.1.1 and Stata/SE 16.1. This study complied with the STROBE checklist. Of the 67 nurses, 92.0% were female, mean age was 32.15 years (SD 8.96), 70.0% held a bachelor's degree, 58.0% had 5 or more years' nursing experience and 51.0% were members of a professional nursing organization. After participating in the educational training, nurses reported higher overall professional self-perception as well as across subscales: activism, professionalism and caring. Considering the nursing shortage in lower-middle-income countries, it is important to recognise the influence of nurses' professional self-perception on nursing retention. This study highlights the significant role continuing educational opportunities play in increasing nurses' professional self-perception. It is imperative to explore ways of improving this perception and focusing on subgroups of nurses to help guide the use of limited resources. Further research is necessary to include nurses in other areas of Mongolia. Accurately assessing nursing professional self-perception and providing educational opportunities could improve nursing professional self-perception, nursing satisfaction, patient safety and nursing retention in lower-middle-income countries. What problem did the study address? This study meets the need for current study on the nursing professional self-perception of nursing from the perspective of nurses in Mongolia. It addresses the dangerous nursing shortage in Mongolia by determining if an educational intervention could improve nursing professional self-perception and thus improve nursing job satisfaction and retention. What were the main findings? Mongolian nurses in this study scored in the top quartile of the NPVS-3, indicating a baseline high NPSP. Educational intervention (including translated oral education and written clinical pathways) significantly improved the nurses' professional self-perception. Nurses were eager for training in other clinical and leadership topics. Where and on whom will the research have an impact? This research can be impactful for nurses, nurse leaders and policy makers in low- and lower-middle-income countries. Specifically for nurses in Mongolia, with increasing technologies and services such as cardiac catheterization laboratories becoming available, more education in these nursing specialty areas is imperative. Professional Nursing Organizations are poised to foster more educational offerings to their members and to increase membership. Nursing education provided by international volunteer nurses with Non-Governmental Organizations can improve NPSP in nurses in LMICs. This study complied with the STROBE checklist. No patient or public contribution.

Evaluation of the four mg warfarin initiation dose in patients with cardiovascular disease

Background: Warfarin is the most widely used oral anticoagulant for the prevention of stroke in patients with cardiovascular disease. In Indonesia, validation of the initiation dose of warfarin has never been carried out. Objective: To evaluate the efficacy and safety of 4 mg warfarin initiation dose in achieving therapeutic targets. Methods: It was a prospective observational study involving hospitalised and ambulatory patients administered a 4 mg warfarin initiation dose between days one and three. On day four, the INR was measured for three to seven days. Subsequently, the initiation dose was adjusted to the therapeutic INR. The INR level was measured every seven days until patients achieved therapeutic INR twice. Results: A total of 14 patients were included in this study, with a mean age of 62 years. The most common indication for using warfarin was non-valvular atrial fibrillation (85.7%), with a CHA2DS2-VASc score between one and three and a HAS-BLED score ranging from zero to two. The median time to achieve therapeutic INR was 22.2 days, and the predictive value of the day four INR for determining the maintenance dose had an r2= 0.77. Conclusions: The initiation dose of 4 mg warfarin effectively achieved therapeutic INR within an acceptable time.

Determining the ideal measurement site and respiratory condition for liver transient elastography: toward clinical practice standardization

ObjectivesLiver transient elastography (TE) has been endorsed by the WHO as the first-line diagnostic tool for liver diseases. Although unreliable and invalid results caused by intercostal space (ICS)-associated factors (including excessive subcutaneous fat and a narrow ICS relative to the transducer size) and operator inexperience are not uncommon, no standard guidelines for ideal probe placement are currently available. Herein, we conducted a prospective observational study to identify an ideal measurement site and respiratory condition for TE by characterizing anatomical and biomechanical properties of the ICSs using ultrasound B-mode and elasticity imaging.MethodsIntercostal ultrasound was performed pointwise at four specific sites in 59 patients to simultaneously measure the width, stiffness, and skin‒liver capsule distance (SCD) of the ICSs over the liver, under end-inspiratory and end-expiratory conditions. Intersections between the 8th ICS and anterior axillary line, the 7th ICS and anterior axillary line, the 8th ICS and mid-axillary line, and the 7th ICS and mid-axillary line were defined as Sites 1 to 4, respectively.ResultsResults indicated that Sites 2 and 3 presented greater intercostal width; Sites 3 and 4 displayed lower intercostal stiffness; Sites 2 and 3 exhibited a shorter SCD. The ICSs were significantly wider and stiffer at end-inspiration. Additionally, the liver was more easily visualized at Sites 1 and 3.ConclusionWe recommend Site 3 for TE probe placement owing to its greater width, lower stiffness, and smaller abdominal wall thickness. Performing TE at end-inspiration is preferred to minimize transducer-rib interferences. This study paves the way toward a standardized TE examination procedure.Critical relevance statementA standardized measurement protocol for WHO-recommended liver TE was first established to improve the success and efficiency of the examination procedure.Key PointsWHO-recommended TE is unreliable or fails due to intercostal space-related factors.The 8th intercostal space on the mid-axillary line and end-inspiration are recommended.This standardized protocol aids in handling challenging cases and simplifies operational procedures.Graphical

Azathioprine/hydroxyurea preconditioning prior to nonmyeloablative matched sibling donor hematopoietic stem cell transplantation in adults with sickle cell disease: A prospective observational cohort study.

Nonmyeloablative, matched sibling donor hematopoietic stem cell transplantation with alemtuzumab/total body irradiation (TBI) conditioning is a curative therapy with low toxicity for adults with sickle cell disease (SCD). However, relatively low donor chimerism levels and graft rejection remain important challenges. We hypothesized that adding azathioprine/hydroxyurea preconditioning will improve donor chimerism levels and reduce graft failure rate. In this prospective cohort study, we enrolled consecutive adult patients with SCD undergoing matched sibling donor transplantation at the Amsterdam UMC. Patients received azathioprine 150 mg/day and hydroxyurea 25 mg/kg/day for 3 months prior to alemtuzumab 1 mg/kg and 300 cGy TBI conditioning. Twenty patients with SCD (median age 26 years [range 19-49], 13 females) were transplanted. Median follow-up was 46.0 months (IQR 21.8-57.9). One-year overall survival and event-free survival (graft failure or death) were both 95% (95% confidence interval 86-100). Mean donor myeloid and T-cell chimerism 1-year post-transplant were 95.2% (SD ±10.6) and 67.3% (±15.3), respectively. One patient (5%) experienced graft failure without autologous regeneration, resulting in infections and death. All other patients had a corrected SCD phenotype and were able to discontinue sirolimus. Three patients were successfully treated with alemtuzumab (1 mg/kg) after the transplant because of declining donor chimerism and cytopenias to revert impending graft rejection. Toxicity was mostly related to sirolimus and alemtuzumab. One patient developed steroid-responsive grade II intestinal acute graft-versus-host disease. Collectively, preconditioning with azathioprine/hydroxyurea prior to nonmyeloablative matched sibling donor transplantation resulted in excellent event-free survival and robust donor T-cell chimerism, enabling the successful withdrawal of sirolimus. ClinicalTrials.gov: NCT05249452.

Effectiveness and Safety of OnabotulinumtoxinA in Adolescent Patients with Chronic Migraine

Chronic migraine (CM) significantly affects underage individuals. The study objectives are (1) to analyze the effectiveness and safety of onabotulinumtoxinA (BTX-A) in adolescents with CM; (2) to review the literature on BTX-A use in the pediatric population. This prospective observational study included patients under 18 years old with CM treated with BTX-A (PREEMPT protocol) as compassionate use. Demographic, efficacy (monthly headache days—MHD; monthly migraine days—MMD; acute medication days/month—AMDM) and side effect data were collected. A ≥ 50% reduction in MHD was considered as a response. Effectiveness and safety were analyzed at 6 and 12 months. A systematic review of the use of BTX-A in children/adolescents was conducted in July 2023. In total, 20 patients were included (median age 15 years [14.75–17], 70% (14/20) females). The median basal frequencies were 28.8 [20–28] MHD, 18 [10–28] MMD and 10 [7.5–21.2] AMDM. Compared with baseline, at 6 months (n = 20), 11 patients (55%) were responders, with a median reduction in MHD of −20 days/month (p = 0.001). At 12 months (n = 14), eight patients (57.1%) were responders, with a median reduction in MHD of −17.5 days/month (p = 0.002). No adverse effects were reported. The literature search showed similar results. Our data supports the concept that BTX-A is effective, well tolerated, and safe in adolescents with CM resistant to oral preventatives.

Coronary sodium [18F]fluoride activity predicts outcomes post-CABG: a comparative evaluation with conventional metrics.

The value of preoperative multidisciplinary approach remains inadequately delineated in forecasting postoperative outcomes of patients undergoing coronary artery bypass grafting (CABG). Herein, we aimed to ascertain the efficacy of multi-modality cardiac imaging in predicting post-CABG cardiovascular outcomes. Patients with triple coronary artery disease underwent cardiac sodium [18F]fluoride ([18F]NaF) positron emission tomography/computed tomography (PET/CT), coronary angiography, and CT-based coronary artery calcium scoring before CABG. The maximum coronary [18F]NaF activity (target-to-blood ratio [TBR]max) and the global coronary [18F]NaF activity (TBRglobal) was determined. The primary endpoint was perioperative myocardial infarction (PMI) within 7-day post-CABG. Secondary endpoint included major adverse cardiac and cerebrovascular events (MACCEs) and recurrent angina. This prospective observational study examined 101 patients for a median of 40 months (interquartile range: 19-47 months). Both TBRmax (odds ratio [OR] = 1.445; p = 0.011) and TBRglobal (OR = 1.797; P = 0.018) were significant predictors of PMI. TBRmax>3.0 (area under the curve [AUC], 0.65; sensitivity, 75.0%; specificity, 56.8%; p = 0.036) increased PMI risk by 3.661-fold, independent of external confounders. Kaplan-Meier test revealed a decrease in MACCE survival rate concomitant with an escalating TBRmax. TBRmax>3.6 (AUC, 0.70; sensitivity, 76.9%; specificity, 73.9%; p = 0.017) increased MACCEs risk by 5.520-fold. Both TBRmax (hazard ratio [HR], 1.298; p = 0.004) and TBRglobal (HR = 1.335; p = 0.011) were significantly correlated with recurrent angina. No significant associations were found between CAC and SYNTAX scores and between PMI occurrence and long-term MACCEs. Quantification of coronary microcalcification activity via [18F]NaF PET displayed a strong ability to predict early and long-term post-CABG cardiovascular outcomes, thereby outperforming conventional metrics of coronary macrocalcification burden and stenosis severity. The trial was registered with the Chinese Clinical Trial Committee (number: ChiCTR1900022527; URL: www.chictr.org.cn/showproj.html?proj=37933 ).

THE TEN-YEAR RADIOLOGICAL RESULTS OF THE UNCEMENTED OXFORD MEDIAL COMPARTMENT KNEE ARTHROPLASTY

IntroductionThe Oxford Unicompartmental Knee Replacement (OUKA) is the most popular unicompartmental knee replacement (UKR) in the New Zealand Joint Registry with the majority utilising cementless fixation. We report the 10-year radiological outcomes.MethodsThis is a prospective observational study. All patients undergoing a cementless OUKA between May 2005 and April 2011 were enrolled. There were no exclusions due to age, gender, body mass index or reduced bone density.All knees underwent fluoroscopic screening achieving true anteroposterior (AP) and lateral images for radiographic assessment. AP assessment for the presence of radiolucent lines and coronal alignment of the tibial and femoral components used Inteliviewer radiographic software. The lateral view was assessed for lucencies as well as sagittal alignment.Results687 OUKAs were performed in 641 patients. Mean age at surgery was 66 years (39–90yrs), 382 in males and 194 right sided. 413 radiographs were available for analysis; 92 patients had died, 30 UKRs had been revised and 19 radiographs were too rotated to be analysed the remainder were lost to follow-up. Mean radiograph to surgery interval was 10.2 years (7.1–16.2yrs).RLLs were identified in zone 1 (3 knees), zone 2 (2 knees), zone 3 (3 knees), zone 5 (3 knees), zone 6 (2 knees) and zone 7 (42 knees). No RLL had progressed, and no case had any osteolysis or prosthesis subsidence.Alignment in the coronal plane: mean 2.90° varus (9.30° varus - 4.49° valgus) of the tibial component to the tibial anatomic axis and the femoral component in mean 4.57° varus (17.02° varus - 9.3° valgus). Sagittal plane posterior tibial slope was a mean 6.30° (0.44° -13.60° degrees) and mean femoral component flexion of 8.11° (23.70° flexion – 16.43° extension).ConclusionThe cementless OUKA demonstrates stable fixation with low revision rates at our centre supporting results earlier published by the design centre.

Multi-organ clinical ultrasound as a complement to the diagnostic process in an internal medicine consultation.

Evaluating outpatient cases in internal medicine consultations presents a significant diagnostic challenge. Ultrasound can be a highly useful tool in assessment and decision-making. A prospective observational study was conducted on a cohort of patients attending an internal medicine rapid assessment clinic. Eighty patients were prospectively recruited. A medical consultation was conducted as per usual clinical practice, followed by a POCUS evaluation; collecting pulmonary, cardiac, and abdominal data. All findings were analyzed and recorded, particularly those that were significant or altered the initial diagnosis, subsequent tests, or treatment. Significant ultrasound findings were found in 37.5% of the patients. Of all ultrasound scans, the most clinically relevant were in the heart region (31.9%), followed by the abdomen (26%). These findings led to a change in overall management in 27.5% of patients. Using logistic regression, a model was developed to estimate the presence of clinically relevant findings with an area under the curve (AUC) of 0.78 (95% CI 0.66-0.89; p < 0.001) with 80% Sensitivity and 66% Specificity. The systematic and standardized incorporation of clinical ultrasound in internal medicine consultations contributes to decision-making, can provide significant findings that allow for modifications in clinical suspicion and therapeutic management.

Comparison of BMI changes in Japanese adults receiving face-to-face versus online counseling for specific health guidance: a non-inferiority prospective observational study.

This study aimed to evaluate the non-inferiority of online counseling over face-to-face counseling for specific health guidance (SHG). This prospective observational study was conducted using specific health checkup (SHC) and SHG data of individuals with health insurance in Japan. We analyzed data from 1,431 participants who met the inclusion criteria, including those who underwent online or face-to-face counseling between April 1, 2020 and March 31, 2021, and received an SHC in the following year but no earlier than 90 days after their first counseling session. Assessed variables comprised demographics, counseling methods, and SHC results, including baseline questionnaire findings and body mass index (BMI) at follow-up. We performed inverse probability of treatment weighting (IPTW) using propensity scores, with changes in BMI as the objective variable and the counseling method as the explanatory variable. We set the non-inferiority margin to 0.175, based on a previous study. The online and face-to-face counseling groups comprised 455 (31.8%) and 976 (68.2%) participants, respectively. The number of men and mean age were 214 (47.0%) and 49.9 years (standard deviation: 6.9 years), respectively, in the online counseling group and 491 (50.3%) and 51.1 years (7.6 years), respectively, in the face-to-face counseling group. IPTW using propensity scores revealed a regression coefficient (95% confidence interval) of -0.014 (-0.157, 0.129) for the online group compared to the face-to-face group (p=.847). The confidence interval was within the non-inferiority margin. The effects of online counseling on BMI are likely non-inferior to those of face-to-face counseling.

Maximum tumor diameter and renal function can predict the declining surface dose rate after 177Lu-Dotatate: preliminary results of single institution in Japan.

This study aimed to develop a user-friendly prediction formula for dose rate adjustment after initial 177Lu-Dotatate therapy from a prospective observational study of patients. This study included consenting patients in a prospective observational study who underwent their firsttreatment in four cycles of 177Lu-Dotatate treatment at our hospital between January 2022 and February 2024. All patients received 7.4GBq of 177Lu-Dotatate. The prediction formula was derived from the regression analysis of tumor-related factors and renal function. Creatinine clearance was estimated using the Cockcroft-Gault equation in this study for renal function. Among the 13 patients (seven males, six females, median age: 59years), logarithmically transformed total tumor volume (cc) and maximum tumor diameter (mm) of primary tumors or metastases showed strong correlations (p < 0.001, R2 = 0.897). As such, the maximum tumor diameter was used as the tumor parameter in the prediction formula. Additionally, maximum tumor diameter and creatinine clearance showed strong (p < 0.001, R2 = 0.768) and moderate (p = 0.013, R2 = 445) correlations, respectively, with the ratio of the dose rate 5.5-h post-administration to the dose rate immediately post-administration (%) at 1m from the body surface. The resulting formula, 51.4 + 0.360 × maximum tumor diameter (mm) - 0.212 × creatinine clearance (ml/min), demonstrated an extremely strong correlation (p < 0.001, R2 = 0.937). The present study showed that the maximum tumor diameter and renal function affected the declining the dose rate of patients surface after 177Lu-Dotatate, which can inform post-administration dose rate management and potentially facilitate outpatient treatment in Japan.

Antenatal Corticosteroids and Their Effects on Maternal Glycemic Status: A Prospective Observational Study From an Indian Tertiary Referral Center

Antenatal Corticosteroids and Their Effects on Maternal Glycemic Status: A Prospective Observational Study From an Indian Tertiary Referral Center

Case-area targeted interventions during a large-scale cholera epidemic: A prospective cohort study in Northeast Nigeria.

Cholera outbreaks are on the rise globally, with conflict-affected settings particularly at risk. Case-area targeted interventions (CATIs), a strategy whereby teams provide a package of interventions to case and neighboring households within a predefined "ring," are increasingly employed in cholera responses. However, evidence on their ability to attenuate incidence is limited. We conducted a prospective observational cohort study in 3 conflict-affected states in Nigeria in 2021. Enumerators within rapid response teams observed CATI implementation during a cholera outbreak and collected data on household demographics; existing water, sanitation, and hygiene (WASH) infrastructure; and CATI interventions. Descriptive statistics showed that CATIs were delivered to 46,864 case and neighbor households, with 80.0% of cases and 33.5% of neighbors receiving all intended supplies and activities, in a context with operational challenges of population density, supply stock outs, and security constraints. We then applied prospective Poisson space-time scan statistics (STSS) across 3 models for each state: (1) an unadjusted model with case and population data; (2) an environmentally adjusted model adjusting for distance to cholera treatment centers and existing WASH infrastructure (improved water source, improved latrine, and handwashing station); and (3) a fully adjusted model adjusting for environmental and CATI variables (supply of Aquatabs and soap, hygiene promotion, bedding and latrine disinfection activities, ring coverage, and response timeliness). We ran the STSS each day of our study period to evaluate the space-time dynamics of the cholera outbreaks. Compared to the unadjusted model, significant cholera clustering was attenuated in the environmentally adjusted model (from 572 to 18 clusters) but there was still risk of cholera transmission. Two states still yielded significant clusters (range 8-10 total clusters, relative risk of 2.2-5.5, 16.6-19.9 day duration, including 11.1-56.8 cholera cases). Cholera clustering was completely attenuated in the fully adjusted model, with no significant anomalous clusters across time and space. Associated measures including quantity, relative risk, significance, likelihood of recurrence, size, and duration of clusters reinforced the results. Key limitations include selection bias, remote data monitoring, and the lack of a control group. CATIs were associated with significant reductions in cholera clustering in Northeast Nigeria despite operational challenges. Our results provide a strong justification for rapid implementation and scale-up CATIs in cholera-response, particularly in conflict settings where WASH access is often limited.

Evaluation of serological assays for the diagnosis of childhood tuberculosis disease: a study protocol

BackgroundTuberculosis (TB) poses a major public health challenge, particularly in children. A substantial proportion of children with TB disease remain undetected and unconfirmed. Therefore, there is an urgent need for a highly sensitive point-of-care test. This study aims to assess the performance of serological assays based on various antigen targets and antibody properties in distinguishing children (0–18 years) with TB disease (1) from healthy TB-exposed children, (2) children with non-TB lower respiratory tract infections, and (3) from children with TB infection.MethodsThe study will use biobanked plasma samples collected from three prospective multicentric diagnostic observational studies: the Childhood TB in Switzerland (CITRUS) study, the Pediatric TB Research Network in Spain (pTBred), and the Procalcitonin guidance to reduce antibiotic treatment of lower respiratory tract infections in children and adolescents (ProPAED) study. Included are children diagnosed with TB disease or infection, healthy TB-exposed children, and sick children with non-TB lower respiratory tract infection. Serological multiplex assays will be performed to identify M. tuberculosis antigen-specific antibody features, including isotypes, subclasses, Fc receptor (FcR) binding, and IgG glycosylation.DiscussionThe findings from this study will help to design serological assays for diagnosing TB disease in children. Importantly, those assays could easily be developed as low-cost point-of-care tests, thereby offering a potential solution for resource-constrained settings.ClinicalTrials.gov IdentifierNCT03044509.

Low-level laser therapy: an efficient supplement to treatments of vulvar Lichen sclerosus to improve quality of life

Background Lichen sclerosus (LS) is a chronic, inflammatory disease of the genital and extra genital skin, causing pruritus, soreness, pain and dyspareunia. The aim of this study was to investigate whether Low Level Laser Therapy (LLLT) can improve the quality of life in women with Lichen sclerosus (LS) and insufficient topical treatment. Methods In a descriptive prospective observational study conducted between 02.01.2016 and 08.01.2018, we included 100 women with LS with insufficient topical treatment because of poor response of symptoms. All participants received ten LLLT treatments (808 nm and 500 mW) over a period of 8 weeks. The first four treatments were planned as two treatments per week. The remaining six treatments were planned as once a week. A Danish health-related quality of life tool (HRQoL test) monitored the effect. Results A total of 94 patients completed the study, median age of 62 [InterQuartile Range 53–69]. There was a statistically significant improvement in seven of the eight domains of the HRQoL test after ten LLLT. We found the results of DoloTest to be statistically significant in all of the groups except for smoking (p < 0.094). Conclusions LLLT treatment can improve the quality of life in women with LS.

Sexual health of women using combined oral contraceptive containing estetrol and drospirenone: A prospective observational study

Aim. To evaluate the effect of a combined oral contraceptive (COC) containing estetrol and drospirenone on the sexual function of women using it. Materials and methods. A total of 251 women aged 21–35 years (mean age, 25.30±2.82 years) referred for contraceptive fitting were included in the study (ICD-10: Z30.0 General contraceptive advice and counseling, Z30.4 Contraceptive drug monitoring). Women in the study cohort used the original formulation containing 15 mg estetrol and 3 mg drospirenone in a 24+4 regimen for contraceptive purposes, according to the current instructions. All female participants (n=251) were assessed for sexual function at baseline, 6 and 12 months using FSFI (The Female Sexual Function Index), FSDS-R (The Female Sexual Distress Scale-Revised) and SQoL-F (The Sexual Quality of Life-Female) scales. Study design. An open, independent, prospective observational study. Results. Women taking COC containing estetrol 15 mg and drospirenone 3 mg maintained a baseline high level of sexual satisfaction (p0.05) throughout the study, as assessed by FSFI, SQoL-F and FSDS-R scales. Conclusion. The results obtained indicate that there is no negative effect of COC containing 15 mg estetrol and 3 mg drospirenonone on the sexual function of women. High contraceptive efficacy of the drug was confirmed.