Prospective Cohort Trial Research Articles

Evaluating Self-Directed Rehabilitation for Knee and Hip Arthroplasty During the COVID-19 Pandemic: A Multicenter Study

The COVID-19 pandemic has triggered the adoption of new technologies to reduce the need for in-person physical therapy (PT). This study evaluated the impact of the COVID-19 pandemic on PT utilization and outcomes of patients prescribed a smartphone-based care management platform (sbCMP) for self-directed rehabilitation (SDR). A secondary analysis of data collected in a multicenter, prospective cohort trial investigating a mobile platform to deliver SDR after arthroplasty was performed. Patients who used the sbCMP for 2 weeks prior to undergoing partial knee arthroplasty (PKA), total knee arthroplasty (TKA), or total hip arthroplasty (THA) and provided 3 months of post-operative data were included. Use of adjunct PT at 3 months, step counts, and KOOS JR and HOOS JR scores were compared during the early versus late pandemic period. The cohort data was available for 1665 patients. Use of SDR without adjunct PT was higher in the early period of the COVID-19 pandemic in TKA (35.3% vs. 27.6%, p = 0.03) and THA (72.5% vs. 59.3%, p < 0.001), but not in the PKA cohort (58.9% vs. 53.3%, p = 0.53). Post-operative step counts improved at 3 months compared to pre-operative levels in all procedure types. Change in HOOS JR and KOOS JR scores from pre-operative to post-operative levels were similar by pandemic period in all cohorts. Use of SDR increased early during the COVID-19 pandemic, corresponding to pandemic restrictions, without negatively impacting patient outcomes. SDR facilitated via a sbCMP may be beneficial for patients unable or unwilling to participate in traditional PT visits.

Characteristics of longitudinal maternal health studies in sub-Saharan Africa: A systematic mapping of literature between 2012 and 2022.

High maternal mortality rates in sub-Saharan Africa necessitate the need for aligned research focusing on prevalent causes and neglected conditions in the region. This mapping review aimed to describe the characteristics of longitudinal maternal health studies between 2012 and 2022 in sub-Saharan Africa and identify gaps in priority conditions or geographical locations. We identified references through a Medline (PubMed) search covering September 2012 to June 2022. We included prospective cohort or clinical trials that enrolled at least 1000 pregnant women, with a study site in sub-Saharan Africa, and published in English or French. Screening and data extraction were done in duplicate using EPPI-reviewer software. Descriptive analysis was used to summarize the results, identifying patterns in studies across time, country, study design, topics, and funders. We identified 213 eligible studies, which were covered in 534 publications. We identified studies in 33 of the 48 sub-Saharan African countries, with the majority in east and southern Africa. The predominant study topics were HIV (36.4%), nutrition (20%), and malaria (16.3%), with very few publications on hypertensive disorders of pregnancy (6.4%), ante/postpartum hemorrhage (3.7%), and sexually transmitted infections (3.2%). More studies were cohorts (115/213; 54%) than clinical trials. The National Institutes of Health (31.5%), Bill and Melinda Gates Foundation (22.1%), and USAID (10.8%) were the largest research funders. Identifying research trends and mismatches between research topics and disease burden provides useful information for guiding future research prioritization. In particular, gaps exist for studies on hypertensive disorders of pregnancy and ante/postpartum hemorrhage, among the top causes of maternal mortality in sub-Saharan Africa.

Efficacy of Intracameral Mydriatics in Pediatric Lens Surgery

Introduction: The aim of this study was to evaluate the efficacy of intracameral administration of Mydrane® in children undergoing lens surgery. Methods: We set up a single center prospective cohort trial including 40 consecutive patients between 8 weeks and 17 years old who were planned for lens surgery, including cataract, persistent fetal vasculature or lens subluxation. We injected 0.1 mL of intracameral Mydrane at the beginning of surgery, no preoperative mydriatic eye drops were used. The aim of the study was to measure pupil size and to monitor the evolution of the pupil size during surgery and the need for additional pupil expanding techniques. Results: In 30 patients (75% [95% CI: 59–87%]), we did not need additional manipulations to obtain sufficient pupillary dilatation to perform the surgery and to implant an intraocular lens following the bag-in-the-lens (BIL) technique. In the remaining 10 patients (25%), we saw an initiation of dilatation but not to the required pupil diameter to continue the surgery without additional surgical maneuvers. The duration of surgery was significantly longer in the partial response group, reflecting the need for additional surgical steps. A significant relation between increase of pupillary diameter and age (p = 0.003), gender (p = 0.032), and horizontal corneal diameter (p < 0.001) could be shown. Even at baseline, there is a larger pupil diameter in eyes with larger horizontal corneal diameters (p = 0.039). No adverse events were observed during this study. Conclusion: Intracameral administration of Mydrane resulted in some degree of dilatation in all eyes in this series, 75% of eyes did not need additional techniques to proceed with the surgery. Smaller pupils at baseline, younger age, male sex and small horizontal corneal diameter were related to a poorer response to Mydrane. The mydriasis persisted for the entire duration of the surgery, no ocular adverse events were observed during this study. This leads us to conclude that intracameral Mydrane is an effective and safe way to dilate the pupil in pediatric lens surgery.

Examining noncommunicable diseases using satellite imagery: a systematic literature review

IntroductionNoncommunicable diseases (NCDs) are the leading cause of morbidity and mortality worldwide, accounting for 74% of deaths annually. Satellite imagery provides previously unattainable data about factors related to NCDs that overcome limitations of traditional, non-satellite-derived environmental data, such as subjectivity and requirements of a smaller geographic area of focus. This systematic literature review determined how satellite imagery has been used to address the top NCDs in the world, including cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes.MethodsA literature search was performed using PubMed (including MEDLINE), CINAHL, Web of Science, Science Direct, Green FILE, and Engineering Village for articles published through June 6, 2023. Quantitative, qualitative, and mixed-methods peer-reviewed studies about satellite imagery in the context of the top NCDs (cancer, cardiovascular disease, chronic respiratory disease, and diabetes) were included. Articles were assessed for quality using the criteria from the Oxford Centre for Evidence-Based Medicine.ResultsA total of 43 studies were included, including 5 prospective comparative cohort trials, 22 retrospective cohort studies, and 16 cross-sectional studies. Country economies of the included studies were 72% high-income, 16% upper-middle-income, 9% lower-middle-income, and 0% low-income. One study was global. 93% of the studies found an association between the satellite data and NCD outcome(s). A variety of methods were used to extract satellite data, with the main methods being using publicly available algorithms (79.1%), preprocessing techniques (34.9%), external resource tools (30.2%) and publicly available models (13.9%). All four NCD types examined appeared in at least 20% of the studies.ConclusionResearchers have demonstrated they can successfully use satellite imagery data to investigate the world’s top NCDs. However, given the rapid increase in satellite technology and artificial intelligence, much of satellite imagery used to address NCDs remains largely untapped. In particular, with most existing studies focusing on high-income countries, future research should use satellite data, to overcome limitations of traditional data, from lower-income countries which have a greater burden of morbidity and mortality from NCDs. Furthermore, creating and refining effective methods to extract and process satellite data may facilitate satellite data’s use among scientists studying NCDs worldwide.

Эффективность комбинации бортезомиба, леналидомида и дексаметазона в качестве индукционной терапии у больных множественной миеломой, осложненной терминальной почечной недостаточностью

AIM. To analyze our own experience in the use of the VRd regimen in the induction therapy for patients with newly diagnosed multiple myeloma (MM) complicated by the end-stage renal disease (ESRD). MATERIALS &amp; METHODS. This prospective cohort trial enrolled 15 newly diagnosed MM patients with ESRD (eGFR &lt; 15 mL/min/1.73 m2) in the period from February to October 2019. Six original RVd induction cycles were planned: lenalidomide 25 mg per os on Days 1, 4, 8, 11, and 15 (administered after hemodialysis), bortezomib 1.3 mg/m2 subcutaneously on Days 1, 4, 8, and 11, as well as dexamethasone 20 mg per os or IV on Days 1, 2, 4, 5, 8, 9, 11, and 12. Blood sampling for pharmacokinetic analysis was performed in 5 (33 %) patients prior to therapy (end-point 0) as well as 4, 24, and 96 hours after the first lenalidomide dose during the 1st RVd cycle. RESULTS. The median age of patients was 67 years (range 55–74 years); there were 9 women and 6 men. All of them were hemodialysis-dependent. The median GFR was 6.3 (5.7; 12.5) mL/min/1.73 m2. In all patients, the serum β2-microglobuline concentration was &gt; 5.5 mg/L (ISS III = 100 %). In 4 (26.7 %) out of 15 patients, renal response was achieved (group I), whereas 11 (73.3 %) patients showed no renal recovery and remained hemodialysis-dependent (group II). Overall (hematologic) response was 80 % (CR 26.7 %, VGPR 20 %, PR 33.3 %). With the median follow-up of 4.64 years, the 5-year overall survival (OS) in all 15 patients was 33.3 ± 12.2 %. In group I (n = 4), life expectancy of patients was 4.45+, 1.81, 4.93+, and 4,68+ years. Out of them, 3 patients are being further followed-up, one died. In group II (n = 11; 9 events), the median OS was 1.75 years. The median maximum serum lenalidomide concentration as reported 4 hours after the first dose of the drug administration was 470 (364; 496) ng/mL. After 24 hours, the lenalidomide concentration decreased 5.7-fold to 82 (54; 269) ng/mL. CONCLUSION. The proposed original VRd regimen ensures high rates of overall response (80 %) and deep remissions (³ VGPR 46.7 %). The originality of the VRd regimen consisted in intermittent administration of 25 mg lenalidomide on Days 1, 4, 8, 11, and 15 after hemodialysis reaching a cumulative dose of 125 mg per 21-day cycle. The maximum lenalidomide concentration (Cmax) did not exceed that in patients with normal renal function and gradually decreased by the next hemodialysis session and the next drug administration. The incidence and severity of adverse events did not exceed those resulting from similar regimens for treatment of hemodialysis-dependent MM patients with ESRD.

Estimation of the difference between peritoneal microenvironment and core body temperature during laparoscopic surgery – a prospective observational study

Maintaining patients’ temperature during surgery is beneficial since hypothermia has been linked with perioperative complications. Laparoscopic surgery involves the insufflation of carbon dioxide (CO2) into the peritoneal cavity and has become the standard in many surgical indications since it is associated with better and faster recovery. However, the use of cold and dry CO2 insufflation can lead to perioperative hypothermia. We aimed to assess the difference between intraperitoneal and core temperatures during laparoscopic surgery and evaluate the influence of duration and CO2 insufflation volume by fitting a mixed generalized additive model. In this prospective observational single-center cohort trial, we included patients aged over 17 with American Society of Anesthesiology risk scores I to III undergoing laparoscopic surgery. Anesthesia, ventilation, and analgesia followed standard protocols, while patients received active warming using blankets and warmed fluids. Temperature data, CO2 ventilation parameters, and intraabdominal pressure were collected. We recruited 51 patients. The core temperature was maintained above 36 °C and progressively raised toward 37 °C as pneumoperitoneum time passed. In contrast, the intraperitoneal temperature decreased, thus creating a widening difference from 0.4 [25th–75th percentile: 0.2–0.8] °C at the beginning to 2.3 [2.1–2.3] °C after 240 min. Pneumoperitoneum duration and CO2 insufflation volume significantly increased this temperature difference (P < 0.001 for both parameters). Core vs. intraperitoneal temperature difference increased linearly by 0.01 T °C per minute of pneumoperitoneum time up to 120 min and then 0.05 T °C per minute. Each insufflated liter per unit of time, i.e. every 10 min, increased the temperature difference by approximately 0.009 T °C. Our findings highlight the impact of pneumoperitoneum duration and CO2 insufflation volume on the difference between core and intraperitoneal temperatures. Implementing adequate external warming during laparoscopic surgery effectively maintains core temperature despite the use of dry and unwarmed CO2 gases, but peritoneal hypothermia remains a concern, suggesting the importance of further research into regional effects.Trial registration: Clinicaltrials.gov: NCT04294758.

Pilot robotic mastectomy in Singapore (PRoMiSing I) study: first safety and feasibility prospective cohort trial in South East Asia.

Robotic mastectomy has been performed worldwide since 2015. The advantages of the robotic approach in nipple-sparing mastectomy have been proven with better visualization and preservation of blood supply to the nipple-areolar complex, with a lower incidence of necrosis. It also allows smaller incisions for both mastectomy and immediate breast reconstruction. To date, no centers in Singapore and Southeast Asia offer robotic mastectomy. We believe that robotic mastectomy is a feasible and safe technique that our population can utilize. This study aimed to ascertain the surgical outcomes and perform a learning curve analysis in patients undergoing robotic mastectomy in a multi-ethnic South East Asian population. A single-arm prospective pilot study of eligible patients aged 21-70 years old with early breast cancer or high-risk patients indicated for risk-reducing mastectomy who were eligible and consented to robotic mastectomy were enrolled in this trial from December 22, 2022 to December 15, 2023. A total of 29 consecutive robotic mastectomies were performed. The mean total operative time was 95±10.2min. The average blood loss was 5.7±1.9ml, and the average length of stay was 1.05 days. The mean mastectomy specimen weight was 251g, and there was no conversion to conventional mastectomy in any case. Furthermore, there were no 30-day morbidity or complications in terms of wound infection requiring intervention, flap, and nipple-areolar complex necrosis, and postoperative hematoma/bleeding requiring intervention. This study contributes to the current evidence that robotic mastectomy is a safe and feasible option and could prove to be a great alternative to conventional mastectomy. Further prospective trials examining the long-term oncological outcomes of robotic mastectomy will be performed to establish the oncologic safety of this technique in breast cancer treatment.

Evaluation of the outcomes of fistulotomy with primary sphincter reconstruction in the management of high trans-sphincteric fistula and supra-sphincteric fistula-in-ano : Asingle-center prospective cohort study.

Supra-sphincteric and high trans-sphincteric fistula are very challenging procedures for both the patient and the surgeon. We aimed to evaluate the outcomes of anal sphincter repair in the management of supra-sphincteric and high trans-sphincteric fistula-in-ano in terms of postoperative wound infection, bleeding, incontinence to flatus or stool, and recurrence within 1year. This single-center prospective cohort trial conducted from June 2020 to December 2023 at the Ain Shams University Hospitals included 20patients who presented with supra-sphincteric or high trans-sphincteric fistula. There were nine (45%) male and11 (55%) female patients, with a mean age of 41.5years postoperatively. The mean duration of the procedure was 90.3 min (SD ± 11.9). During the first 2weeks,ten (50%) patients scored their postoperative pain as mild, eight (40%) as moderate, and two (10%) as severe. Wound infection occurred in two (10%) patients and postoperative bleeding in three (15%) patients in the form of spotting after defecation. There were no cases of incontinence to stool. However, there were three (15%) cases of incontinence to gases. There were two cases (10%) of recurrence at the 1‑year follow-up. Postoperative patient satisfaction was assessed on a 5‑point Likert scale after 2weeks: One patient (5%) was very dissatisfied, three (15%) patients were dissatisfied, andtwo (10%) patients were unsure, while five (25%) patients were satisfied and nine (45%) were very satisfied. Immediate sphincter repair in supra-sphincteric and high trans-sphincteric fistula through a lay-open procedure was determined to be safe, easier than classic operations, and associated with alow incidence of recurrence at the 1‑year follow-up and ahigh quality of life.

Anti-interleukin-5/anti-interleukin-5 receptor α treatment improves self-reported work productivity in patients with severe eosinophilic asthma: a prospective cohort trial.

Severe asthma affects the working life of millions of people worldwide. Interleukin (IL)-5/anti-interleukin-5 receptor α (IL-5Rα) antibodies are highly effective in reducing symptoms in patients with severe eosinophilic asthma. We analysed effects of anti-IL-5/anti-IL-5Rα treatment on self-reported productivity and absenteeism at work in patients with severe eosinophilic asthma. In this prospective single-centre study, patients with severe eosinophilic asthma received a questionnaire assessing their actual occupational status and the influence asthma has on their work life, productivity and missed days at work prior to initiation of antibody treatment and after 6 and 12 months of therapy. Among others, the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) was used. Out of 54 patients with a median age of 60 years, 27 (50%) were employed. In addition to an increase in asthma control and lung function, self-reported productivity increased significantly with a decrease on the WPAI:SHP from 30% (interquartile range (IQR) 20-50%) to 10% (IQR 0-27.5%) under treatment (p=0.001). Furthermore, self-reported missed days at work were reduced from 2 days·month-1 (IQR 1.75-6 days·month-1) to 0 days·month-1 (IQR 0-2 days·month-1; p=0.067). At baseline 22 employed patients (81%) stated they were affected at work by their asthma. After 12 months of treatment, this number decreased to eight patients (30%; p=0.038). This prospective analysis could prove the substantial impact severe asthma has on patients' working life. Anti-IL-5/anti-IL-5Rα treatment in patients with severe eosinophilic asthma leads to a significant increase in self-reported productivity at work, and after 12 months of treatment patients state substantially fewer negative effects on their working situation.

The Role of Early Diagnosis and Intervention in Improving Outcomes for Lung Cancer

Introduction : For lung cancer patients, early diagnosis and treatments are essential to battering outcomes. The objective of this world is to compare early diagnosis vs late diagnosis in terms of overall survival ,progression _free survival, quality of life and adverse events associated to treatment. Methodology: A Prospective cohort trial of seventy_ eight lung cancer patients was Conducted at Hayatabad Medical Complex in Peshawar from December 2021 to March 2024. 39 patients had early diagnosis (n=39) while 39 received late diagnosis(n=39) . Low_ dose Computed Tomography (DCT) screening and prompt symptom presentation lead to early diagnosis; incidental or symptomatic results were the basis for late diagnosis. Overall Survival(OS) , progression_ free survival (PFS), quality of life(QoL) , and frequency of serious adverse events associated to therapy were the outcomes. Results: At a median 'OS of 38 months compared to 14 months in the late diagnosis group (p&lt;0.001) and median PFS of 34 months compared to 10 months(p&lt;0.001), the early diagnosis group showed noticeably superior results. At 12 months, 'the early diagnosis group had a better QoL scores' a mean global health status of 75 compared to 55(p&lt;0.01). Early diagnosis group (18%) had a lower frequency of serious adverse effects than did the late diagnosis group(45%). Conclusion: In patients with lung cancer, early detection and intervention greatly increases survival rates, prolong intervals without progression, improves quality of life, and lower serious side effects associated to therapy. The results emphasized the need of early diagnosis techniques and efficient screening programs in the treatment of lung cancer. Keywords: lung Cancer, early diagnosis, low dose computed tomography, overall survival, progression free survival, quality of life, treatment related adverse events

Assessing Residual Gastric Fluid Volume after Administering Diluted Oral Contrast until One Hour Prior to Anesthesia in Children: An Observational Cohort Study.

Background: Gastric fluid volume has been used as a surrogate marker for pulmonary aspiration risk in studies evaluating fasting protocol safety. This study measured residual gastric fluid volume in children using a protocol in which diluted oral contrast medium was administered up until one hour before anesthesia. Methods: This was a single-center prospective observational cohort trial of 70 children for elective abdominal/pelvic computed tomography (CT). Imaging was performed after diluted enteral contrast medium administration, beginning two hours before and ending at least one hour before induction. For each patient, gastric fluid volume was calculated using an image region of interest. The primary outcome measure was gastric fluid volume measured using the computed tomography image. Results: The median time from the end of contrast administration to imaging was 1.5 h (range: 1.1 to 2.2 h). Residual gastric volume, measured using CT was <0.4 mL/Kg in 33%; ≥0.4 mL/Kg in 67%; and ≥1.5 mL/Kg in 44% of patients. Residual gastric volumes measured using CT and aspiration were moderately correlated (Spearman's correlation coefficient = 0.41, p = 0.0003). However, the median residual gastric volume measured using CT (1.17, IQR: 0.22 to 2.38 mL/Kg) was higher than that of aspiration (0.51, IQR: 0 to 1.58 mL/Kg, p = 0.0008 on differences in paired measures). Three cases of vomiting were reported. No evidence of pulmonary aspiration was identified. Conclusions: Children who receive large quantities of clear fluid up to one hour before anesthesia can have a significant gastric residual volume.

Effect of maternal supplementation on nutritional status of children at aged 24 month in West Sumatra Province: A prospective cohort trial

Effect of maternal supplementation on nutritional status of children at aged 24 month in West Sumatra Province: A prospective cohort trial

Remimazolam for sedation and anesthesia in children: A scoping review.

Remimazolam, a novel intravenous benzodiazepine recently approved by both the European Medicines Agency and the Food and Drug Agency, shows considerable promise in clinical practice. Its pharmacodynamic profile closely resembles that of midazolam, while its pharmacokinetic properties are similar to those of remifentanil. While research in adult populations continues to accumulate, the pace of pediatric studies is not as significant. This scoping review aims to systematically examine published studies, clinical trials, observational research, case reports, and relevant literature to provide a comprehensive understanding of remimazolam in pediatric sedation and anesthesia. By synthesizing the gathered evidence, we aim to identify gaps in the literature, guide future research endeavors, and inform clinical practices. The review follows the guidelines outlined by the Preferred Reporting Items for Systematic Review and Meta-Analysis for Scoping Review. A thorough search strategy was implemented across prominent peer-reviewed databases, with focused efforts to identify relevant grey literature. All primary studies involving the use of remimazolam in pediatric populations were included in this review. Eighteen studies were included in this analysis, comprising 2 randomized controlled trials, 4 prospective cohort trials, 12 case reports, and 692 children in total. This scoping review highlights the increasing interest in using remimazolam as a sedative or anesthetic for children. Although initial evidence indicates its effectiveness and safety, more research is necessary to fill knowledge gaps, establish standard protocols, and optimize its use in pediatric anesthesia and sedation. Addressing these challenges will enable clinicians to improve the quality of care and outcomes for pediatric patients undergoing sedation and anesthesia.

Report from a text-based blood pressure monitoring prospective cohort trial among postpartum women with hypertensive disorders of pregnancy

BackgroundHypertensive disorders of pregnancy are a main cause of maternal morbidity and mortality in the United States and worldwide, and it is estimated that approximately 60% of maternal deaths in the United States occur during the postpartum period. The utilization of telehealth modalities such as home blood pressure monitoring has shown improvement in blood pressure control and adherence with follow up visits. Our study sought to determine if standardized education improved patient hypertension knowledge and if this when combined with home blood pressure telemonitoring increased participants’ postpartum self-blood pressure monitoring and postpartum visit attendance.MethodsThis is an Institutional Review Board approved prospective cohort study conducted at the University of Mississippi Medical Center. Women with a hypertensive disorder of pregnancy who met the inclusion criteria and provided written informed consent to participate were enrolled. Participants received a baseline pre-education questionnaire designed to assess their knowledge of their hypertensive diagnosis, hypertension management, and postpartum preeclampsia (PreE). Participants then received standard education, a blood pressure monitor, and were scheduled a follow-up visit during the first 10 days following discharge. Remote home blood pressure monitoring was performed via text messages and voice calls for 6-weeks postpartum. At the conclusion of the study, participants repeated their original questionnaire.Results250 women provided informed consent to participate in the study and were included in this analysis. Relative to the baseline survey, there was a significant increase (p = 0.0001) in the percentage of correct responses. There was not an association between study engagement and percentage of correct responses on end of study questionnaire (p = 0.33) or postpartum visit attendance (p = 0.69). Maternal age was found to drive study engagement, even when adjusted for community-level distress (p = 0.03) and maternal race (p = 0.0002).ConclusionImplementing a standardized postpartum education session was associated with improvement in patient’s knowledge. Further studies are needed with more longitudinal follow up to assess if this program would also result in improved long-term outcomes and decreased hospital readmission rates.Trial registrationNCT04570124.

Dynamic bTMB combined with residual ctDNA improves survival prediction in locally advanced NSCLC patients with chemoradiotherapy and consolidation immunotherapy

BackgroundLiquid biopsy-based biomarkers, including circulating tumor DNA (ctDNA) and blood tumor mutational burden (bTMB), are recognized as promising predictors of prognoses and responses to immune checkpoint inhibitors (ICIs), despite insufficient sensitivity of single biomarker detection. This research aims to determine whether the combinatorial utility of longitudinal ctDNA with bTMB analysis could improve the prognostic and predictive effects. MethodsThis prospective two-center cohort trial, consisting of discovery and validation datasets, enrolled unresectable locally advanced non-small-cell lung cancer (LA-NSCLC) patients and assigned them to chemoradiotherapy (CRT) or CRT + consolidation ICI cohorts from 2018 to 2022. Blood specimens were collected pretreatment, 4 weeks post-CRT, and at progression to assess bTMB and ctDNA using 486-gene next-generation sequencing. Dynamic ∆bTMB was calculated as post-CRT bTMB minus baseline bTMB levels. Decision curve analyses were performed to calculate Concordance index (C-index). ResultsOne hundred twenty-eight patients were enrolled. In the discovery dataset (n = 73), patients treated with CRT and consolidation ICI had significantly longer overall survival (OS; median not reached [NR] vs 20.2 months; P < 0.001) and progression-free survival (PFS; median 25.2 vs 11.4 months; P = 0.011) than those without ICI. Longitudinal analysis demonstrated a significant decrease in ctDNA abundance post-CRT (P < 0.001) but a relative increase with disease progression. Post-CRT detectable residual ctDNA correlated with significantly shorter OS (median 18.3 months vs NR; P = 0.001) and PFS (median 7.3 vs 25.2 months; P < 0.001). For patients with residual ctDNA, consolidation ICI brought significantly greater OS (median NR vs 14.8 months; P = 0.005) and PFS (median 13.8 vs 6.2 months; P = 0.028) benefit, but no significant difference for patients with ctDNA clearance. Dynamic ∆bTMB was predictive of prognosis. Patients with residual ctDNA and increased ∆bTMB (∆bTMB > 0) had significantly worse OS (median 9.0 vs 23.0 months vs NR; P < 0.001) and PFS (median 3.4 vs 7.3 vs 25.2 months; P < 0.001). The combinatorial model integrating post-CRT ctDNA with ∆bTMB had optimal predictive effects on OS (C-index = 0.723) and PFS (C-index = 0.693), outperforming individual features. In the independent validation set, we confirmed residual ctDNA predicted poorer PFS (median 50.8 vs 14.3 months; P = 0.026) but identified more consolidation ICI benefit (median NR vs 8.3 months; P = 0.039). The combined model exhibited a stable predictive advantage (C-index = 0.742 for PFS). ConclusionsThe multiparameter assay integrating qualitative residual ctDNA testing with quantitative ∆bTMB dynamics improves patient prognostic risk stratification and efficacy predictions, allowing for personalized consolidation therapy for LA-NSCLC.

Potential rapid intraoperative cancer diagnosis using dynamic full-field optical coherence tomography and deep learning: A prospective cohort study in breast cancer patients

An intraoperative diagnosis is critical for precise cancer surgery. However, traditional intraoperative assessments based on hematoxylin and eosin (H&E) histology, such as frozen section, are time-, resource-, and labor-intensive, and involve specimen-consuming concerns. Here, we report a near-real-time automated cancer diagnosis workflow for breast cancer that combines dynamic full-field optical coherence tomography (D-FFOCT), a label-free optical imaging method, and deep learning for bedside tumor diagnosis during surgery. To classify the benign and malignant breast tissues, we conducted a prospective cohort trial. In the modeling group (n = 182), D-FFOCT images were captured from April 26 to June 20, 2018, encompassing 48 benign lesions, 114 invasive ductal carcinoma (IDC), 10 invasive lobular carcinoma, 4 ductal carcinoma in situ (DCIS), and 6 rare tumors. Deep learning model was built up and fine-tuned in 10,357 D-FFOCT patches. Subsequently, from June 22 to August 17, 2018, independent tests (n = 42) were conducted on 10 benign lesions, 29 IDC, 1 DCIS, and 2 rare tumors. The model yielded excellent performance, with an accuracy of 97.62%, sensitivity of 96.88% and specificity of 100%; only one IDC was misclassified. Meanwhile, the acquisition of the D-FFOCT images was non-destructive and did not require any tissue preparation or staining procedures. In the simulated intraoperative margin evaluation procedure, the time required for our novel workflow (approximately 3 min) was significantly shorter than that required for traditional procedures (approximately 30 min). These findings indicate that the combination of D-FFOCT and deep learning algorithms can streamline intraoperative cancer diagnosis independently of traditional pathology laboratory procedures.

Impact of preoperative carbohydrate loading on postoperative course and morbidity in debulking surgery for epithelial ovarian cancer.

Despite the theoretical benefits, the favorable effect of preoperative carbohydrate loading on postoperative morbidity remains controversial. Most of the outcomes reported in the literature are derived from non-gynecologic surgery data, with only one study involving a limited number of patients specifically in gynecological oncology. The present study aimed to investigate the impact of carbohydrate loading, as a single element of enhanced recovery after surgery protocols, on postoperative course and morbidity in patients undergoing debulking surgery for epithelial ovarian cancer (EOC). The present study was a non-randomized, prospective cohort trial enrolling patients with EOC who underwent surgery between June 2018 and December 2021. An oral carbohydrate supplement with a dose of 50 g was given to patients 2-3 h before anesthesia. Data on postoperative course and morbidity were collected and compared with data of a historical cohort including consecutive patients who underwent surgery without a carbohydrate loading between January 2015 and June 2018. Analyses were performed on a total of 162 patients, including 72 patients in the carbohydrate loading group and 90 patients in the control group. Median length of hospital stay (11 days vs. 11 days; P=0.555), postoperative days 1-7 serum c-reactive protein levels (P=0.213), 30-day readmission (11.6% vs. 11.5%, P=0.985), 30-day relaparotomy (2.8% vs. 3.4%, P=0.809) and 30-day morbidity (48.6% vs. 46.7%; P=0.805) were comparable between the cohorts. No significant differences in grades of morbidities were identified between the cohorts (P=0.511). Multivariate analysis revealed that the sole independent risk factor for any postoperative morbidity was operative time. In conclusion, based on the results of the present study, postoperative course and morbidity seemed to be unaffected by carbohydrate loading in patients undergoing debulking surgery for EOC.

Surgical and Functional Outcome of Laparoscopic Vaginal Suspension Combined with Suture Rectopexy for Management of Pelvic Organ Prolapse

Abstract Purpose Laparoscopic techniques to treat pelvic organ prolapse are gaining popularity around the globe due to their low recurrence rates and better functional results compared to perineal techniques. However, the optimum surgical procedures are not yet determined. In the current research, we suggest a novel surgical approach, laparoscopic vaginal suspension with suture rectopexy, to treat multiorgan pelvic prolapse. Methods This prospective cohort trial was conducted from March 2018 to March 2022 and comprised 35 females with multiorgan pelvic organ prolapse with obstructed defecation symptoms. A residual rectal prolapse was still present despite the manual reduction of uterine prolapse. Patients' conditions before and after the operation were monitored regarding the obstructed defecation score, sexual function, need for laxatives, anorectal manometry pressures, anorectal sensations, and recurrence. The mean follow-up duration was one year. Results Modified Longo score for obstructed defecation significantly decreased at six and twelve months after surgery. Additionally, a significant reduction was reported in the number of patients who needed laxatives at six and twelve months after surgery. Anorectal manometry pre- and post-surgery showed a significant elevation in the mean squeeze pressure and a decline in all rectal sensations. All parameters of the female sexual function scoring system increased postoperatively. No recurrence was reported during follow-up. Conclusion For multiorgan pelvic prolapse, laparoscopic vaginal suspension combined with suture rectopexy has excellent functional outcomes, minimal morbidity, and low cost.

Fetal Long QT Syndrome - Challenges in Perinatal Management: A Review and Case Report. Induction of Labor and Vaginal Birth Under Continuous Magnesium Therapy.

Congenital LQTS is an often undetected inherited cardiac channel dysfunction and can be a reason for intrauterine fetal demise. It can present in utero as CTG and ultrasound abnormalities, i. e., bradycardia, ventricular tachycardia, or fetal hydrops. Diagnosis is made by CTG, echocardiography, or fMCG. Intrauterine therapy with a ß blocker and i. v. magnesium should be started. Our objective was to examine the current knowledge about diagnosis and treatment of LQTS and in particular to highlight the opportunity of vaginal birth under continuous intravenous magnesium therapy. Therefore, a thorough MEDLINE and Google Scholar search was conducted. Randomized controlled trials, meta-analyses, prospective and retrospective cohort trials, and case reports were considered. We showed the possibility of vaginal delivery under continuous magnesium therapy in a case of suspected fetal LQTS. A stepwise concept for diagnosis, monitoring, and peripartum management in low, intermediate, and high risk cases of fetal LQTS is presented. If risk is low or intermediate, a vaginal delivery under continuous monitoring is reasonable. Induction of labor at term should be evaluated.

Ovarian artery Doppler velocimetry effects after myoinositol and lipoic acid therapy in PCOs patients

Background: Polycistic ovary syndrome (PCOs) is one of the most common endocrine and metabolic disorders in premenopausal women. This is the second part of an extended report regarding the significant effects of the therapy based on an Alfa Lipoic Acid (ALA)/Myoinositol (Myo) combined drug on adnexal parameters, as assessed by ultrasound technique. Methods: A prospective cohort trial. Data regarded thirty four italian nulliparous women considered for the study, control cases were chosen from an initial group of sixty-nine healthy women group paired by age and nulliparous status. Patients underwent a Myoinositol plus ALA regimen twice a day in a continued fashion in a twenty four months period. Ultrasound examinations were coincident with the fifth day of menstrual period and were set as follows: Time 0 (first evaluation), Time 12 (after twelve months) and finally Time 24 (after 24 months). Results: The mean age was 31.4 years old. Results regarding any significant change in the endometrial width, number of follicles, and the ovarian volumes within the time of the trial, showed no significant changes in the intervals considered. Conversely, the parameters dealing with color Doppler velocimetry waves of the ovarian arteries showed a significant decreasing trend, considering the first values and after 12 and 24 months. Conclusions: Considering a consistent and significant decrease in ovarian arteries resistance, we may hypothesize that Inositol plus ALA therapy may block the vascular effects of hyperadrogenism, maybe playing a role in the anti oxidant and anti inflammatory pathways