Multisite Experience Research Articles

Exploring robotic total hysterectomies: a multi-site experience with the Senhance Surgical System

Robotic-assisted surgery emerged as a technological advancement in the twentieth century, with gynaecology being a key adopter of this approach. The Senhance Surgical System has gained prominence for total hysterectomies from single-site experiences, but multi-site reporting are still lacking in present literature. This multi-site study, conducted at Klaipeda University Hospital and Academic Teaching Hospital Feldkirch, aimed to explore the safety and feasibility of total hysterectomies with the Senhance Surgical System. The study involved 295 cases, showcasing a well-established routine with minimal procedure times. The average age of the patients was 53.5 years (SD: 10.3 years), ranging from 18 to 80 years. The patients’ BMI averaged 25.6 kg/m2 (SD: 6.2 kg/m2), ranging from a minimum of 17.7 kg/m2 to a maximum of 69.5 kg/m2. The duration of surgery varied between 30 and 215 min, with a median of 95 min (IQR: 81–116). The docking time was a median of 3 (IQR: 2–5) min and varied between 1.0 and 30.0 min, with a minimum to a maximum range of 1.0 to 122 min. Conversion (3 cases, 1%) and adverse events (6 cases, 2%) were infrequent. Additionally, robotic malfunctions were recorded minimally in 4,1% (12 cases) of the procedures, and pain on a 0–10 visual pain scale was reduced from mild [2.7 (± 1.2)] one day postoperative to minimal [0.9 (± 0.5)] at discharge. Overall, a great routine with the Senhance Surgical System proves good control and, thus, feasibility and safety. Therefore, the Senhance Surgical System is a viable option for total hysterectomy.

Arterial Spin Labeling: Key Concepts and Progress Towards Use as a Clinical Tool.

Arterial spin labeling (ASL), a non-invasive MRI technique, has emerged as a valuable tool for researchers that can measure blood flow and related parameters. This review aims to provide a qualitative overview of the technical principles and recent developments in ASL and to highlight its potential clinical applications. A growing literature demonstrates impressive ASL sensitivity to a range of neuropathologies and treatment responses. Despite its potential, challenges persist in the translation of ASL to widespread clinical use, including the lack of standardization and the limited availability of comprehensive training. As experience with ASL continues to grow, the final stage of translation will require moving beyond single site observational studies to multi-site experience and measurement of the added contribution of ASL to patient care and outcomes.

42407 Teledermatology in Practice: Report of Multi-site Experience During the COVID-19 Pandemic

42407 Teledermatology in Practice: Report of Multi-site Experience During the COVID-19 Pandemic

Pediatric ERCP: Factors for Success and Complication A 17-Year, Multisite Experience.

Endoscopic retrograde cholangiopancreatography (ERCP) is an increasingly utilized procedure in pediatric populations. A lack of dedicated pediatric research has led endoscopists to extrapolate adult risk factors and preventative strategies to children. The aim of this multisite, retrospective study was to identify risks for adverse events, procedure failure, and prolonged courses in pediatric patients undergoing ERCP. Pediatric patients who had an ERCP at one of our academic centers were identified by query of their electronic medical records. Pre-procedure and post-procedure data were collected with ERCP-related adverse events defined according to the consensus criteria developed by Cotton et al, 2010. Between 1/2004 and 1/2021, 287 children had a total of 716 ERCPs. The procedure success rate was 95.5% with no mortality and an adverse event rate of 12.7%. Younger age was associated with increased case complexity, increased adverse events, and an increased rate of repeat ERCP. Case complexity score correlated with increased procedure time (p < 0.001) and increased adverse events (tau 0.24, p < 0.01), Stent removal and pancreatic stenting were more likely to precede an adverse event. Pancreatitis, pancreatic divisum, and pancreatic stricture/stenosis were associated with increased adverse events and rates of repeat ERCP. Pediatric ERCP adverse event rates are higher than adults. The complexity grading system proposed by the Cotton et al appears to have applicability to pediatric patients. Young age and interventions affecting the pancreatic duct are associated with adverse ERCP outcomes in pediatrics.

O-210 Detection of small copy number variations as incidental findings in PGT-A: clinical utility from a multisite experience including 12,157 patients

Abstract Study question What is the technical accuracy and clinical utility of reporting small copy number variants (CNVs below 3Mb) detected by a targeted next-generation sequencing-based PGT-A platform? Summary answer Some pathogenic or likely pathogenic CNVs &amp;lt;3Mb can be accurately detected by this assay, increasing clinical utility of PGT-A for a subset of IVF patients. What is known already CNVs are linked to a wide range of phenotypes, spanning from syndromes that include reduced penetrance and variable expressivity to more severe phenotypes. Prenatally, the prevalence of pathogenic CNVs is approximately 1.5%. Most PGT-A platforms that rely on whole genome amplification and shallow sequencing have a resolution limit of 5-10 Mb, preventing the detection of smaller CNVs. Here, we report an innovative PGT-A assay that interrogates thousands of targeted sites in the genome to provide robust copy number analysis allowing for the identification of some small CNVs (incidental findings, IF), outside the primary scope of detecting whole-chromosome aneuploidies in PGT-A. Study design, size, duration Retrospective observational study performed between 2020-2022, involving 12,157 patients who underwent PGT-A performed by targeted-NGS (PGTseq-A) for whole chromosome and large segmental aneuploidies. If an IF &amp;lt; 3 Mb was detected in multiple embryos, the couple was advised to undergo follow-up analysis by chromosomal microarray (CMA) to confirm the parental origin of the CNV, define its breakpoints and determine whether it is classified as benign-likely benign (B/LB), variant of uncertain significance (VUS) or pathogenic-likely pathogenic (P/LP). Participants/materials, setting, methods The PGTseq-A assay employed amplifies 5,000 amplicons across the genome to evaluate copy number. Validation was performed using 5-cell samples from cell lines with known CNVs, and trophectoderm biopsies from embryos with known parental structural rearrangements. An IF was reported when a gain/loss of at least three consecutive amplicons appeared in at least two embryos from the same cycle. Transfer data was reviewed to determine which embryos were transferred. This study received IRB approval. Main results and the role of chance In 77 out of 12,157 PGT-A patients (0.63%;95%CI:0.5-0.8%), an IF that met reporting criteria was identified. To determine the size and pathogenicity, a CMA follow up was requested and performed on 67 couples. In all cases, one of the partners was confirmed to have the CNV identified in the embryos (100.0%: N 67/67 95%CI:94.6-100). The identified CNV was of maternal origin in 36 cases (53.7%) and of paternal origin in 31 cases (46.2%). A strong correlation was identified between PGT-A-predicted CNVs and the genomic coordinates defined by the CMA on parental DNA (r = 0.86). All CNVs intervals predicted by the PGT-A included the CMA genomic region. Twenty-seven (40.2%) were classified as B/LB, 31 (46.2%) as a VUS, and 9 (13.4%) as P/LP. Six of the nine P/LP cases (66.6%) involved imbalances of 16p. The remaining P/LP cases involved deletions of X, 15q and 18p11.32. From a review of transfer data, patients typically transferred embryos negative for IFs as first option regardless of the morphology and pathogenicity classification of CNV-positive sibling embryos. Specifically, in 8 cycles where a detected CNV was classified as B, LB or as VUS, negative embryos were prioritized for transfer despite their poorer morphology. Limitations, reasons for caution De novo CNVs were not considered by design because the reported CNVs had to be present in at least two embryos from the same cohort. Furthermore, the detection of small CNVs is not uniform in the genome and the negative predictive value of the assay for non-targeted regions is null. Wider implications of the findings This PGT-A assay accurately detects small pathogenic CNVs without prior knowledge of parental inheritance, enhancing clinical utility in a subset of patients. Additionally, reporting of VUS and B/LB findings may impact couples’ decision-making concerning embryo selection, reinforcing that scientific rigor is a necessity when evaluating the capabilities of PGT-A. Trial registration number not applicable

A Deep Learning-based Model for Detecting Abnormalities on Brain MR Images for Triaging: Preliminary Results from a Multisite Experience.

To develop a deep learning model for detecting brain abnormalities on MR images. In this retrospective study, a deep learning approach using T2-weighted fluid-attenuated inversion recovery images was developed to classify brain MRI findings as "likely normal" or "likely abnormal." A convolutional neural network model was trained on a large, heterogeneous dataset collected from two different continents and covering a broad panel of pathologic conditions, including neoplasms, hemorrhages, infarcts, and others. Three datasets were used. Dataset A consisted of 2839 patients, dataset B consisted of 6442 patients, and dataset C consisted of 1489 patients and was only used for testing. Datasets A and B were split into training, validation, and test sets. A total of three models were trained: model A (using only dataset A), model B (using only dataset B), and model A + B (using training datasets from A and B). All three models were tested on subsets from dataset A, dataset B, and dataset C separately. The evaluation was performed by using annotations based on the images, as well as labels based on the radiology reports. Model A trained on dataset A from one institution and tested on dataset C from another institution reached an F1 score of 0.72 (95% CI: 0.70, 0.74) and an area under the receiver operating characteristic curve of 0.78 (95% CI: 0.75, 0.80) when compared with findings from the radiology reports. The model shows relatively good performance for differentiating between likely normal and likely abnormal brain examination findings by using data from different institutions.Keywords: MR-Imaging, Head/Neck, Computer Applications-General (Informatics), Convolutional Neural Network (CNN), Deep Learning Algorithms, Machine Learning Algorithms© RSNA, 2021Supplemental material is available for this article.

The Impact of COVID-19 on Brachytherapy During the Pandemic: A Rutgers-Robert Wood Johnson Barnabas Health Multisite Experience

PurposeThis study aimed to evaluate whether the coronavirus disease of 2019 (COVID-19) pandemic resulted in treatment delays in patients scheduled for or undergoing brachytherapy. Methods and MaterialsA retrospective cohort study was conducted across 4 affiliated sites after local institutional review board approval. The eligibility criteria were defined as all patients with cancer whose treatment plan included brachytherapy during the COVID-19 pandemic from February 24, 2020 to June 30, 2020. Treatment delays, cancellations, alterations of fractionation regimens, and treatment paradigm changes were evaluated. ResultsA total of 47 patients were eligible for the analysis. Median patient age at the time of treatment was 62 years (interquartile range, 56-70 years). Endometrial, cervical, and prostate cancers were the most common sites included in this analysis. Three patients (6.4%) with cervical cancer were diagnosed with COVID-19 during the course of their treatment. Interruptions of external beam radiation therapy (EBRT), cancellations of EBRT, cancellations of brachytherapy, and treatment delays due to COVID occurred in 5 (10.6%), 3 (6.4%), 8 (17%), and 9 (19%) patients, respectively. The mean and median number of days delayed for patients who experienced treatment interruptions were 16.3 days (standard deviation: 13.9 days) and 14 days (interquartile range, 5.75-23.75 days), respectively. For patients with cervical cancer, the mean and median overall treatment times defined as the time from the start of EBRT to the end of brachytherapy were 56 and 49 days, respectively. ConclusionsDespite the challenges the health care system faced during the pandemic, most patients with cancer were safely treated with minor treatment delays and interruptions. Long-term follow up is needed to assess the impact of COVID-19 and treatment interruptions on oncologic outcomes.

Trimodality Therapy is Associated with Improved Overall Survival in Gliosarcoma: A Multi-Site Experience

Gliosarcoma (GS) is a rare pathologic variant of glioblastoma with a lack of guidance for optimal management. We present our analysis of treatment outcomes and prognostic factors for patients with GS. One-hundred and eighteen (118) consecutive patients with GS underwent treatment from 1997 to 2019 at our multi-site institution. Patient, tumor, and treatment characteristics were analyzed with chi-squared testing. Overall survival (OS), cancer-specific survival (CSS), and progression-free survival (PFS) were calculated using the Kaplan-Meier method and compared with the log-rank test. Prognostic factors were assessed using univariate and multivariate cox regressions for the final models. Data at time of first recurrence was analyzed. Median follow-up of surviving patients was 12.1 (range, 0.4-131.6) months. Sixty-four percent of patients were male, and 87.3% of patients had an ECOG performance status of 0-1. The temporal lobe was the most common site of disease (46.6%). Of 40 patients tested for MGMT methylation status, 20% were methylated. Seventy-seven (65.3%) patients underwent gross total resection; 38 (32.2%) patients underwent subtotal resection, and 3 (2.5%) patients underwent biopsy. Nighty-five (80.5%) patients received trimodality therapy (any degree of resection other than biopsy and adjuvant chemoradiation); 103 (87.3%) patients received chemotherapy; 8 (6.8%) patients received tumor-treating fields. In those who received adjuvant radiotherapy (RT) (99%), RT was delivered with a median of 60 (range, 40-76) Gy in 30 (range, 15-42) fractions. For the entire cohort, median OS, CSS, and PFS was 16.8 (95% CI, 14.4-18), 16.8 (95% CI, 15.6-19.2), and 8.4 (95% CI, 7.2-8.4) months, respectively. On multivariate analysis, trimodality therapy was associated with improved OS (HR 0.29; 95% CI 0.15-0.54; P<0.01), CSS (HR 0.30; 95% CI 0.15-0.62; P<0.01), and PFS (HR 0.27, 95% CI 0.15-0.50; P<0.01). ECOG status of 0 or 1 was associated with improved OS (HR 0.21, 95% CI 0.09-0.45; P<0.01). On subgroup analysis, patients with gross total resection trended towards improved OS compared to subtotal resection, but this difference was not statistically significant (HR 0.70, 95% CI 0.44-1.13; P = 0.16). Treatment at time of first recurrence was associated with improved OS (HR 0.06, 95% CI 0.02-0.14; P<0.01). No other factors were associated with OS including age, MGMT methylation status, RT total dose, and RT dose fractionation. Our clinical outcomes of gliosarcoma are comparable to glioblastoma. Trimodality therapy is associated with improved overall survival in patients with gliosarcoma. While acknowledging potential selection bias, our study supports trimodality therapy as well as treatment at time of first recurrence for this rare malignancy especially in patients with good performance status.

Correction to: Surveillance of Low-Grade Appendiceal Mucinous Neoplasms With Peritoneal Metastases After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: Are 5 Years Enough? A Multisite Experience.

In the original version of the article, Margaret Hofstedt's last name was misspelled.

Drug Abuse and Diversion in Pediatric Palliative Care—What You Should Know, What You Can Do, and What You Can Learn from Our Multisite Experience (TH336)

•Describe using pediatric-specific data the importance of safe opioid prescribing practices by pediatric palliative care providers.•Understand the steps needed to create reliable processes for safe opioid prescribing, standardized pediatric risk assessment and care for pediatric palliative patients.•Describe the steps to take when drug diversion is confirmed for children of all age ranges, including young children, adolescents and young adults. Prescription drug abuse is an epidemic in the US, leading to increased government oversight in opioid prescribing. The issue becomes more complicated when minor children are involved. One pediatric palliative care team found that of 62 consecutive children and young adults who were stratified for opioid misuse, >60% were at either moderate or high risk. In 6 cases, the patient was weaned from opioids or the team stopped prescribing due to diversion or misuse behaviors. Thus safe opioid prescribing should be a priority for all pediatric palliative care (PPC) teams. Using a case-based discussion, we will review pediatric-specific opioid abuse data and best evidence around safe opioid prescribing. We will discuss the safe-opioid prescribing “opioid bundle” developed by the Pediatric Palliative and Comfort Care Team (PACT) at Cincinnati Children's Hospital Medical Center and how it has been rolled out at two additional children's hospitals. We will talk in-depth about caring for high risk patients, highlighting cases of confirmed diversion and the resulting de-prescribing. We will include cases of minor children with diversion by adult caregivers as well as adolescent and young adult patients participating in drug diversion. Given the high risk of drug misuse, abuse and diversion, safe opioid prescribing is necessary for all PPC teams. The “opioid bundle” created by PACT is a practical method for PPC teams nationwide to employ in the care of their patients.

Multisite experience of fluciclovine (18F) PET/CT imaging in biochemically recurrent prostate cancer: Impact of clinical factors and intersite variation.

163 Background: Fluciclovine (18F) is an FDA-approved positron emission tomography/computerized tomography (PET/CT) tracer in clinical use for the detection and localization of biochemically recurrent (BCR) prostate cancer. Here, we report the impact of clinical factors and study site on its performance. Methods: In total, 596 subjects with BCR prostate cancer underwent fluciclovine (18F) PET/CT scanning at four sites in Italy, Norway and USA. Detection Rates (DR), including region level analyses, were stratified by prostate specific antigen (PSA) levels, PSA doubling time (PSAdt), Gleason score (GS), and by investigator/site. Extra-prostatic disease was defined as all positivity outside of residual prostate, prostate bed and seminal vesicles. Results: Fluciclovine (18F) PET/CT was positive in 67.7% (403/595) of subjects. Positive findings were detected in the prostate/bed and pelvic lymph node regions in 38.7% (232/599) and 32.6% (194/596) of scans, respectively. Metastatic involvement outside the pelvis was found in 26.2% (155/591) of scans. Generally, DR increased with increasing baseline PSA (Table 1). While subject level DR did not vary significantly with PSAdt (DR = 60-69% across all categories), a positive extra-prostatic scan was more likely in patients with shorter PSAdt (DR = 52%, 48%, 37% and 28% for PSAdt &lt;3, 3-&lt;6, 6-&lt;12 and &gt;12 months, respectively). Among 361 subjects for whom baseline GS was available, scores ≥9 were associated with the highest extra-prostatic DR (55%) compared with 23% in patients with GS ≤6. Inter-site variations in acquisition protocols may have impacted DR at low baseline PSA values; with subject level DR at PSA &gt;0.2-0.5 ng/ml = 20%, 38%, 46% and 73% at site A, B, C and D, respectively. Conclusions: Fluciclovine (18F) can detect and localize BCR prostate cancer in a wide range of subjects and, with appropriate imaging protocols, has a clinically useful DR at PSA &lt;0.5 ng/ml. Clinical trial information: NCT02443571. [Table: see text]

The process of developing a nutrition-sensitive agriculture intervention: a multi-site experience

Nutrition-sensitive agriculture (NSA) interventions are of increasing interest to those working in global health and nutrition. However NSA is a broad concept, and there are numerous candidate NSA interventions that could be implemented in any given setting. While most agriculture interventions can be made “nutrition-sensitive”, there are few guidelines for helping to decide what agriculture component should be tried in an NSA intervention. Based on previous models, we developed a framework with explicit questions about community factors (agricultural production, diets, power and gender), project factors (team capacity, budget, timelines) and external factors that helped our team of agriculture scientists, nutritionists and local officials identify NSA interventions that may be feasibly implemented with a reasonable chance of having positive agricultural and nutritional impacts. We applied this framework to two settings in upland Vietnam, and one setting in upland Thailand. From an initial list of nineteen interventions that have been tried elsewhere, or may reasonably be expected to be appropriate for NSA, five or six candidate interventions were chosen per site. Based on the criteria, three to four interventions were selected per site and are being implemented. Poultry rearing and home gardening were selected in each site. They and the other selected interventions, hold promise for capitalizing on underused agricultural potential to improve diets, while working with (or improving) existing gender relationships and power structures. The process for identifying NSA interventions was thorough and identified reasonable candidates, but it was very time consuming. Further efforts should focus on streamlining the process, so that promising and appropriate NSA interventions can be identified quickly and reliably.

Multisite Experience of the Safety, Detection Rate and Diagnostic Performance of Fluciclovine (18F) Positron Emission Tomography/Computerized Tomography Imaging in the Staging of Biochemically Recurrent Prostate Cancer

Sensitive detection of cancer foci in men experiencing biochemical recurrence following initial treatment of prostate cancer is of great clinical significance with a possible impact on subsequent treatment choice. We describe a multisite experience of the efficacy and safety of the positron emission tomography/computerized tomography agent fluciclovine (18F) after biochemical recurrence. A total of 596 patients underwent fluciclovine (18F) positron emission tomography/computerized tomography at 4 clinical sites. Detection rate determinations were stratified by the baseline prostate specific antigen value. Diagnostic performance was assessed against a histological reference standard in 143 scans. The subject level fluciclovine (18F) positron emission tomography/computer tomography detection rate was 67.7% (403 of 595 scans). Positive findings were detected in the prostate/bed and pelvic lymph node regions in 38.7% (232 of 599) and 32.6% of scans (194 of 596), respectively. Metastatic involvement outside the pelvis was detected in 26.2% of scans (155 of 591). The subject level detection rate in patients in the lowest quartile for baseline prostate specific antigen (0.79 ng/ml or less) was 41.4% (53 of 128). Of these patients 13 had involvement in the prostate/bed only, 16 had pelvic lymph node involvement without distant disease and 24 had distant metastases. The positive predictive value of fluciclovine (18F) positron emission tomography/computerized tomography scanning for all sampled lesions was 62.2%, and it was 92.3% and 71.8% for extraprostatic and prostate/bed involvement, respectively. Fluciclovine (18F) was well tolerated and the safety profile was not altered following repeat administration. Fluciclovine (18F) is well tolerated and able to detect local and distant prostate cancer recurrence across a wide range of prostate specific antigen values.

Banked frozen donor oocytes demonstrate high efficiency in conversion to live born infants; a collaborative multi-site experience

Previous studies have shown a <7% oocyte to live born infant rate in fresh donor cycles. The purpose of this study was to evaluate the efficiency of cryopreserved donor oocytes compared to those from fresh donor cycles.

Agile methods in biomedical software development: a multi-site experience report

BackgroundAgile is an iterative approach to software development that relies on strong collaboration and automation to keep pace with dynamic environments. We have successfully used agile development approaches to create and maintain biomedical software, including software for bioinformatics. This paper reports on a qualitative study of our experiences using these methods.ResultsWe have found that agile methods are well suited to the exploratory and iterative nature of scientific inquiry. They provide a robust framework for reproducing scientific results and for developing clinical support systems. The agile development approach also provides a model for collaboration between software engineers and researchers. We present our experience using agile methodologies in projects at six different biomedical software development organizations. The organizations include academic, commercial and government development teams, and included both bioinformatics and clinical support applications. We found that agile practices were a match for the needs of our biomedical projects and contributed to the success of our organizations.ConclusionWe found that the agile development approach was a good fit for our organizations, and that these practices should be applicable and valuable to other biomedical software development efforts. Although we found differences in how agile methods were used, we were also able to identify a set of core practices that were common to all of the groups, and that could be a focus for others seeking to adopt these methods.