Efficacy of microwave ablation in the treatment of large benign thyroid nodules: a multi-center study.

OBJECTIVE: To evaluate the efficacy, safety, and improvement of symptoms by ultrasound-guided microwave ablation (MWA) for patients with large benign thyroid nodules (BTNs). METHODS: Eighty-seven patients with 87 BTNs (≥ 4 cm) treated with MWA between April 2015 and March 2021 were enrolled in this retrospective multicenter study, with clinical and ultrasound examinations performed at the 1st, 3rd, 6th, and 12th months. A multivariable linear mixed effects model was employed to explore the alterations in volume and volume reduction ratio (VRR), as well as the potential factors associated with VRR. RESULTS: The mean age of the 87 patients was 45.69 ± 14.21 years (range 18-76 years), and the ratio of men to women was 1:4.8. The mean volumes were much decreased at the 12th month after ablation compared to the initial volumes (p < .001). The mean VRR was 76.09% at the 12th month. The technique efficacy (VRR > 50%) was 90.80% at the 12th month. A multivariate analysis revealed that VRR was related to the initial volume (p = .015), annular flow (p = .010), and nodule composition (p = .024). The mean symptomatic score decreased from 4.40 ± 0.28 to 0.26 ± 0.06 at the 12th month (p < .001). At the same time, the mean cosmetic score decreased from 3.22 ± 0.10 to 1.31 ± 0.08 (p < .001). CONCLUSION: MWA could serve as a safe and effective therapy for large BTNs, significantly reducing the volume of BTNs and significantly improving compressive symptoms and appearance problems. CLINICAL RELEVANCE STATEMENT: Microwave ablation could serve as a safe and effective therapy for large benign thyroid nodules, leading to significant volume reduction and satisfied symptom and cosmetic alleviation period. KEY POINTS: • This multicenter study investigated the feasibility and safety of microwave ablation for large benign thyroid nodules. • After ablation, the nodule volume was significantly reduced, and patients' symptoms and appearance problems were significantly improved. • Microwave ablation is feasible for large benign thyroid nodules and has been a supplement treatment.

Design and implementation of multicenter pediatric and congenital studies with cardiovascular magnetic resonance: Big data in smaller bodies.

Cardiovascular magnetic resonance (CMR) has become the reference standard for quantitative and qualitative assessment of ventricular function, blood flow, and myocardial tissue characterization. There is a preponderance of large CMR studies and registries in adults; However, similarly powered studies are lacking for the pediatric and congenital heart disease (PCHD) population. To date, most CMR studies in children are limited to small single or multicenter studies, thereby limiting the conclusions that can be drawn. Within the PCHD CMR community, a collaborative effort has been successfully employed to recognize knowledge gaps with the aim to embolden the development and initiation of high-quality, large-scale multicenter research. In this publication, we highlight the underlying challenges and provide a practical guide toward the development of larger, multicenter initiatives focusing on PCHD populations, which can serve as a model for future multicenter efforts.

Development, contributions, and future directions of a multicenter child abuse research network.

CAPNET is a multicenter child abuse pediatrics research network developed to support research that will make the medical care of potentially abused children more effective, safe, and fair. CAPNET currently collects detailed clinical data from child physical abuse evaluations from 11 leading pediatric centers across the U.S. From its inception, the goal of CAPNET was to support multiple research studies addressing the care of children undergoing evaluations for physical abuse and to create a flexible data collection and quality assurance system to be a resource for the wider community of child maltreatment l researchers. Annually, CAPNET collects rich clinical data on over 4000 children evaluated due to concerns for physical abuse. CAPNET's data are well-suited to studies improving the standardization, equity, and accuracy of evaluations in the medical setting when child physical abuse is suspected. Here we describe CAPNET's development, content, lessons learned, and potential future directions of the network.

Seguimiento Funcional hasta Seis Meses después de Sobrevivir a Cuidados Intensivos: Lecciones aprendidas de un Estudio Chileno Multicéntrico / Functional follow-up six months after surviving intensive care: lessons learned from a Chilean multicenter study

Introducción. Las tasas de retención en los estudios de seguimiento oscilan entre el 32 y 100%, demostrando el desafío que implica realizar estudios longitudinales de sobrevivientes de la unidad de cuidados intensivos (UCI). Objetivo. Identificar las estrategias implementadas y lecciones aprendidas en un estudio prospectivo multicéntrico de seguimiento de sobrevivientes de la UCI durante la pandemia. Métodos. Estudio post-hoc de las lecciones aprendidas mediante encuestas y entrevistas dirigidas a explorar la experiencia de los investigadores y coordinadores del estudio IMPACCT COVID-19, realizado en siete centros chilenos entre octubre 2020 y abril 2021 evaluando el síndrome post-cuidados intensivos de sobrevivientes hasta seis meses después. Resultados. Identificamos ocho lecciones: 1) selección de instrumentos de medición, 2) identificación de centros participantes, 3) aprobación del estudio, 4) financiamiento, 5) capacitación de evaluadores, 6) coordinación/aseguramiento de calidad, 7) reclutamiento y 8) seguimiento de pacientes. Incluso durante el primer año de pandemia, reclutamos 252 pacientes a una tasa de 1,4 pacientes/día con una retención del 48% a los 6 meses de seguimiento. El uso de redes académicas existentes y las estrategias de comunicación entre investigadores, coordinadores y evaluadores fueron aspectos positivos; mientras que la fidelización con evaluadores al egreso de la UCI y con pacientes durante el seguimiento son aspectos que deberían considerarse en futuros estudios. Conclusiones. Se evaluaron más de 250 pacientes en seis meses durante la pandemia, con tasas de retención post UCI acorde a la literatura. Futuros estudios debiesen optimizar los procesos de medición y de seguimiento para minimizar la pérdida de pacientes.

Background. Retention rates of follow-up studies range from 32 to 100%, demonstrating the challenge to conduct longitudinal studies of intensive care unit (ICU) survivors. Objective. To identify the strategies implemented and lessons learned in a multicenter prospective follow-up study of ICU survivors during pandemic times. Methods. Post-hoc study of lessons learned through surveys and interviews aimed at exploring the experience of the researchers and coordinators of the IMPACCT COVID-19 study. The original study was performed in seven Chilean sites between October 2020 and April 2021 evaluating the post-intensive care syndrome of survivors up to six-month follow-up. Results. We identified eight lessons: 1) selection of measurement instruments, 2) identification of participating sites, 3) Study approval, 4) funding, 5) evaluators training, 6) coordination/quality assurance, 7) recruitment, and 8) patient follow-up. Even during the first year of the pandemic, we recruited 252 patients at a rate of 1.4 patients/day with a retention rate of 48% at 6 months of follow-up. The use of existing academic networks and communication strategies between researchers, coordinators and evaluators were positive aspects; while evaluators fidelity at ICU discharge and patient engagement during follow-up are aspects should be considered. Conclusions. More than 250 patients were evaluated in six months during the pandemic, with post-ICU retention rates consistent with the literature. Future studies should optimize measurement and monitoring processes to minimize patient atrition.

Intravenous Magnesium: Prompt Use for Asthma in Children Treated in the Emergency Department (IMPACT-ED): Protocol for a Multicenter Pilot Randomized Controlled Trial.

BACKGROUND: Children managed for asthma in an emergency department (ED) may be less likely to be hospitalized if they receive intravenous magnesium sulfate (IVMg). Asthma guidelines recommend IVMg for severely sick children but note a lack of evidence to support this recommendation. All previous trials of IVMg in children with asthma have been too small to answer whether IVMg is effective and safe. A few major questions remain about IVMg. First, it has not been tested early in the course of ED treatment, when the impact on hospitalization would be greatest. Second, the clinical impact of hypotension, a known adverse effect of IVMg, has not been well characterized in previous research. Third, no trials have compared different IVMg doses or serial serum magnesium (total and ionized) concentrations to optimize dosing, so the most effective dose is unknown. A large, conclusive, randomized, placebo-controlled clinical trial of IVMg might be challenging due to the need to enroll and complete study procedures quickly, a lack of understanding of blood pressure changes after IVMg, and a lack of pharmacologic information to guide the optimal doses of IVMg to be tested. Therefore, a pilot study to inform the above gaps is warranted before conducting a definitive trial. OBJECTIVE: The objectives of this study are to (1) demonstrate the feasibility of enrolling children with severe acute asthma in the ED in a multicenter, randomized controlled trial of a placebo, low-dose IVMg, or high-dose IVMg; (2) demonstrate the feasibility of timely delivery of study medication, assessment of blood pressure, and evaluation of adverse events in a standardized protocol; and (3) externally validate a previously constructed pharmacokinetic model and develop a combined pharmacokinetic/pharmacodynamic model for IVMg using magnesium (total and ionized) serum concentrations and their correlation with measures of efficacy and safety. METHODS: This pilot trial tests procedures and gathers information to plan a definitive trial. The pilot trial will enroll as many as 90 children across 3 sites, randomize each child to 1 of 3 study arms, measure blood pressure frequently, and collect 3 blood samples from each participant with corresponding clinical asthma scores. RESULTS: The project was funded by the National Heart, Lung, and Blood Institute (1 R34HL152047-2) in March 2022. Enrollment began in September 2022, and 43 children have been enrolled as of April 2023. We will submit the results for publication in late 2023. CONCLUSIONS: The results of this study will guide the planning of a large, definitive, multicenter trial powered to evaluate if IVMg reduces hospitalization. Blood pressure measurements will inform a monitoring plan for the larger trial, and blood samples and asthma scores will be used to validate pharmacologic models to select the optimal dose of IVMg to be evaluated in the definitive trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05166811; https://clinicaltrials.gov/ct2/show/NCT05166811. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48302.

A time-dependent Poisson-Gamma model for recruitment forecasting in multicenter studies.

Forecasting recruitments is a key component of the monitoring phase of multicenter studies. One of the most popular techniques in this field is the Poisson-Gamma recruitment model, a Bayesian technique built on a doubly stochastic Poisson process. This approach is based on the modeling of enrollments as a Poisson process where the recruitment rates are assumed to be constant over time and to follow a common Gamma prior distribution. However, the constant-rate assumption is a restrictive limitation that is rarely appropriate for applications in real studies. In this paper, we illustrate a flexible generalization of this methodology which allows the enrollment rates to vary over time by modeling them through B-splines. We show the suitability of this approach for a wide range of recruitment behaviors in a simulation study and by estimating the recruitment progression of the Canadian Co-infection Cohort.

Diffusion-Weighted Magnetic Resonance Imaging for Preoperative Evaluation of Patients With Breast Cancer: Protocol of a Prospective, Multicenter, Observational Cohort Study.

PURPOSE: Detection of multifocal, multicentric, and contralateral breast cancers in patients affects surgical management. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can identify additional foci that were initially undetected by conventional imaging. However, its use is limited owing to low specificity and high false-positive rate. Multiparametric MRI (DCE-MRI + diffusion-weighted [DW] MRI) can increase the specificity. We aimed to describe the protocols of our prospective, multicenter, observational cohort studies designed to compare the diagnostic performance of DCE-MRI and multiparametric MRI for the diagnosis of multifocal, multicentric cancer and contralateral breast cancer in patients with newly diagnosed breast cancer. METHODS: Two studies comparing the performance of DCE-MRI and multiparametric MRI for the diagnosis of multifocal, multicentric cancer (NCT04656639) and contralateral breast cancer (NCT05307757) will be conducted. For trial NCT04656639, 580 females with invasive breast cancer candidates for breast conservation surgery whose DCE-MRI showed additional suspicious lesions (breast imaging reporting and data system [BI-RADS] category ≥ 4) on DCE-MRI in the ipsilateral breast will be enrolled. For trial NCT05307757, 1098 females with invasive breast cancer whose DCE-MRI showed contralateral lesions (BI-RADS category ≥ 3 or higher on DCE-MRI) will be enrolled. Participants will undergo 3.0-T DCE-MRI and DW-MRI. The diagnostic performance of DCE-MRI and multiparametric MRI will be compared. The receiver operating characteristic curve, sensitivity, specificity, positive predictive value, and characteristics of the detected cancers will be analyzed. The primary outcome is the difference in the receiver operating characteristic curve between DCE-MRI and multiparametric MRI interpretation. Enrollment completion is expected in 2024, and study results are expected to be presented in 2026. DISCUSSION: This prospective, multicenter study will compare the performance of DCE-MRI versus multiparametric MRI for the preoperative evaluation of multifocal, multicentric, and contralateral breast cancer and is currently in the patient enrollment phase. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04656639, NCT05307757. Registered on April 1 2022.

Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial.

BACKGROUND: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. OBJECTIVE: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. STUDY DESIGN: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. RESULTS: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. CONCLUSION: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.

Variability in Ethics Review for Multicenter Protocols in Buenos Aires, Argentina. An Observational Study.

It has been reported that significant variability in the ethics review process affects multisite studies. We analyzed 1,305 applications for multicenter studies (409 unique protocols), from 1st January 2020 to 20th September 2021. We examined the variability in the times to approval and the first observation and the variation in the level of risk assigned. The median [IQR] variabilities were 42.19 [15.23-82.36] days and 8.00 [3.12-16.68] days, for the times to approval and to the first observation, respectively. There was disagreement in the level of risk assigned by the Research Ethics Committee (REC) in 24.0% of cases. Independent predictors of variability included the number of REC members. In our study, we found substantial variability in the ethics review process among health research protocols. Also, we describe methods to readily measure the delays and the variations in the ethics review process.

Death of hospitalized neonates of different gestational age in Shaanxi Province: a multi-center survey / 中华围产医学杂志

Objective:To investigate the current status of hospitalized neonatal death of different gestational ages in Shaanxi Province.Methods:All neonatal deaths in six hospitals in Shaanxi Province from 2016 to 2020 were retrospectively analyzed, and the differences in perinatal complications, the causes of death, and the age at death were compared using Chi-square (or Fisher's exact ) test. Results:(1) Totally, 220 488 neonates were delivered in the obstetric department of the six hospitals during the study period; 71 782 out of them were admitted to the neonatal department. While 424 neonatal death was reported, giving the total hospitalized neonates mortality rate of 5.5‰ (394/71 782), which included 152 deaths of transferred patients ( n=9 103, 16.7‰), 226 premature (53.3%), 196 term (46.2%), and two post-term infants (0.5%). (2) Among mothers of dead neonates, 73.6% were found to have at least one perinatal complication. The most common one was fetal distress (146 cases, 34.4%), followed by gestational diabetes mellitus (113 cases, 26.7%), amniotic fluid abnormalities ( n=73, 17.2%), maternal infectious diseases ( n=71, 16.8%), and hypertensive disorders in pregnancy (HDP) ( n=52, 12.3%). The lower the gestational age, the higher the proportion of multiple pregnancies and assisted reproduction technology applied (Fisher exact test, P<0.05). On the contrary, the higher the gestational age, the higher the cesarean section rate ( χ 2=26.69, P<0.001). HDP was more likely to occur in the gestational age of 28-31 +6 and 32-34 +6 weeks ( χ 2=37.16, P<0.001), and amniotic fluid abnormalities were more likely to occur in those over 37 weeks ( χ 2=27.47, P<0.001). (3) The five leading causes of neonatal death were neonatal respiratory distress syndrome (NRDS, n=100, 23.6%), neonatal asphyxia ( n=88, 20.8%), maternal infectious diseases ( n=80, 18.9%), and birth defects ( n=54, 12.7%), and pulmonary hemorrhage ( n=22, 5.2%). The first three causes of death in term and post-term infants were neonatal asphyxia ( n=65, 32.8%), birth defects ( n=42, 21.2%), and infectious diseases ( n=26, 13.1%). NRDS ( n=83, 36.7%), infectious diseases ( n=54, 23.9%), and neonatal asphyxia ( n=23, 10.2%) were the three leading causes of death of premature babies. (4) Out of the 326 (76.9%) neonatal deaths within seven days after birth, 162 (38.2%) died within 24 h after birth and 164 cases (38.7%) between one to seven days after birth. Conclusions:Most neonatal deaths occurred among preterm ones and within seven days after birth, whose mothers suffered perinatal complications. The causes of neonatal death vary among different gestational age groups.

Harmonization Strategies in Multicenter MRI-Based Radiomics.

Radiomics analysis is a powerful tool aiming to provide diagnostic and prognostic patient information directly from images that are decoded into handcrafted features, comprising descriptors of shape, size and textural patterns. Although radiomics is gaining momentum since it holds great promise for accelerating digital diagnostics, it is susceptible to bias and variation due to numerous inter-patient factors (e.g., patient age and gender) as well as inter-scanner ones (different protocol acquisition depending on the scanner center). A variety of image and feature based harmonization methods has been developed to compensate for these effects; however, to the best of our knowledge, none of these techniques has been established as the most effective in the analysis pipeline so far. To this end, this review provides an overview of the challenges in optimizing radiomics analysis, and a concise summary of the most relevant harmonization techniques, aiming to provide a thorough guide to the radiomics harmonization process.

Establishing a framework for privacy-preserving record linkage among electronic health record and administrative claims databases within PCORnet®, the National Patient-Centered Clinical Research Network.

OBJECTIVE: The aim of this study was to determine whether a secure, privacy-preserving record linkage (PPRL) methodology can be implemented in a scalable manner for use in a large national clinical research network. RESULTS: We established the governance and technical capacity to support the use of PPRL across the National Patient-Centered Clinical Research Network (PCORnet®). As a pilot, four sites used the Datavant software to transform patient personally identifiable information (PII) into de-identified tokens. We queried the sites for patients with a clinical encounter in 2018 or 2019 and matched their tokens to determine whether overlap existed. We described patient overlap among the sites and generated a "deduplicated" table of patient demographic characteristics. Overlapping patients were found in 3 of the 6 site-pairs. Following deduplication, the total patient count was 3,108,515 (0.11% reduction), with the largest reduction in count for patients with an "Other/Missing" value for Sex; from 198 to 163 (17.6% reduction). The PPRL solution successfully links patients across data sources using distributed queries without directly accessing patient PII. The overlap queries and analysis performed in this pilot is being replicated across the full network to provide additional insight into patient linkages among a distributed research network.

Cost-Effectiveness of Robotic vs. Laparoscopic Surgery for Different Surgical Procedures: Protocol for a Prospective, Multicentric Study (ROBOCOSTES).

Background: The studies which address the impact of costs of robotic vs. laparoscopic approach on quality of life (cost-effectiveness studies) are scares in general surgery. Methods: The Spanish national study on cost-effectiveness differences among robotic and laparoscopic surgery (ROBOCOSTES) is designed as a prospective, multicentre, national, observational study. The aim is to determine in which procedures robotic surgery is more cost-effective than laparoscopic surgery. Several surgical operations and patient populations will be evaluated (distal pancreatectomy, gastrectomy, sleeve gastrectomy, inguinal hernioplasty, rectal resection for cancer, Heller cardiomiotomy and Nissen procedure). Discussion: The results of this study will demonstrate which treatment (laparoscopic or robotic) and in which population is more cost-effective. This study will also assess the impact of previous surgical experience on main outcomes.

Exposure to ambient air pollutants with kidney function decline in chronic kidney disease patients.

Chronic kidney disease (CKD) has been a global public health problem with many adverse outcomes, but data are lacking regarding the relationship between air pollutants and risk of renal progression in patients with CKD. This study was to investigate whether 1-year average exposure to ambient air pollutants -CO, NO, NO2, SO2, O3, PM2.5, and PM10-is related to renal function deterioration among patients with CKD. A total of 5301 CKD patients were included in this study between October 2008 and February 2016. To estimate each patient's exposure to ambient air pollution, we used the 24-h ambient air pollution concentration monitoring data collected one year prior to renal progression or their last renal function assessment. Renal progression was considered when estimated glomerular filtration rate (eGFR) decreased more than 25% from the baseline eGFR. Cox proportional hazard regression was performed to calculate hazard ratios (HRs). Among 5301 patients with CKD, 1813 (34.20%) developed renal progression during the 30.48 ± 14.99-month follow-up. Patients with the highest quartile exposure to CO [HR = 1.53 (95% CI: 1.24, 1.88)], NO [HR = 1.38 (95% CI: 1.11, 1.71)], NO2 [HR = 1.63 (95% CI: 1.36, 1.97)], SO2 [HR = 2.27 (95% CI: 1.83, 2.82)], PM2.5 [HR = 7.58 (95% CI: 5.97, 9.62)], and PM10 [HR = 3.68 (95% CI: 2.84, 4.78)] had a significantly higher risk of renal progression than those with the lowest quartile exposure. In the multipollutant model, the analyses yielded to similar results. These results reinforce the importance of measures to mitigate air pollution and strategies to prevent worsening of kidney function in patients with CKD. One-year high exposure to ambient CO, NO, NO2, SO2, PM2.5, and PM10 is significantly associated with deteriorated kidney function in patients with CKD among Taiwanese adults.

Enuresis and encopresis: Association with child abuse and neglect.

OBJECTIVE: Several reports suggest a possible link between child abuse and enuresis or encopresis but concern small series of children and present therefore methodological biases. The objective of the present study was to clarify this issue by examining the relationships between child abuse and enuresis or encopresis in a large sample of children. METHODS: A multicenter cross-sectional study was conducted on a sample of 428 children in social residential centers in France. Four types of child abuse were considered: sexual abuse, physical abuse, psychological abuse and neglect. The accuracy and reliability of the characterization of the type of abuse as well as that of the sphincter disorder was particularly high. In fact, all the cases benefited from both a social and a psychological investigation and from an observation in a residential center. RESULTS: More than 60% of the children were victims of at least one type of abuse. Encopresis was reported in 15 children (3.5% [95% CI: 2.0%-5.7%]), mostly among boys (13 cases). Enuresis affected 54 of the 390 children aged five years or more (13.8% [95% CI: 10.6%-17.7%]). Most of the cases also appeared in boys (38 cases). Rates of encopresis were found to be seven-fold higher in both psychologically abused and neglect children compared to non-abused children (P=0.01). Concerning enuresis, a weaker but still significant association was found with sexual (OR= 3.3, P=0.025) and physical abuse (OR=2.3, P=0.035). CONCLUSION: Our findings support the hypothesis that enuresis and encopresis are associated with specific types of child abuse.

Consent Builder: an innovative tool for creating research informed consent documents.

Objective: To describe process innovations related to research informed consent documents, and development and formative evaluation of Consent Builder, a platform for generating consent documents for multicenter studies. Materials and Methods: Analysis of Institutional Review Board workflows and documents, followed by process redesign, document redesign, and software development. Locally developed software leverages REDCap and LaTeX. A small-scale usability study was conducted. Results: Process innovations were combining document types, and conceptualizing 2-part informed consent documents: part 1 standardizing the study description and part 2 with local site verbiage. Consent Builder was implemented in the Trial Innovation Network. User survey scores were acceptable; but areas for improvement were noted. LaTeX coding was the biggest challenge for users. Discussion: The process changes were generally well accepted. The software implementation uncovered un-accounted for assumptions, and variability in IRB review workflow across centers. Technical modifications may be needed before widespread implementation. Conclusion: We demonstrated proof-of-concept of an approach to generate research consent documents that are consistent across sites in study description, but which allow for customization of local site verbiage. The Consent Builder tool is an example of an operational innovation, helping meet a need that arose in part due to regulations around use of Single IRB for multicenter trials.

Structure, function, and productivity from the National Dental Practice-Based Research Network.

Introduction: Following inception in 2005 as a multiregional practice-based research network (PBRN), the "National Dental PBRN" expanded nationwide in 2012, and in 2019 implemented additional organizational changes. The objectives are to: (1) describe the new structure and function of the network; and (2) quantify its scientific productivity since 2005. Methods: A national Administrative and Resource Center is based in Alabama; regional and specialty nodes are based in Alabama, Florida, Illinois, Minnesota, Oregon, New York, and Texas. A Network Coordinating Center is based in Oregon. Studies are funded via investigator-initiated grants. Scientific productivity is assessed using specific metrics, including the Relative Citation Ratio. Results: To date, 58 studies have been completed or are in data collection or development. These studies have investigated a broad range of topics using a wide variety of study designs. Of the studies that have completed enrollment, 70,665 patients were enrolled, as were 19,827 practitioners (some participated in multiple studies), plus electronic records for 790,493 patients in two data-only studies. To date, these studies have led to 193 peer-reviewed scientific publications in 62 different journals. The mean (1.40) Relative Citation Ratio of Network publications connotes a greater-than-average influence in their fields. Conclusions: These metrics demonstrate that the PBRN research context can successfully engage practitioners and patients from diverse settings nationally with a high and sustained level of scientific productivity. This infrastructure has enabled clinical scientists in oral health and nonoral health topics and provided additional recruitment venues outside of the typical academic health center research context.

French Imaging Database Against Coronavirus (FIDAC): A large COVID-19 multi-center chest CT database.

PURPOSE: During the first wave of the COVID-19 pandemic, the French Society of Radiology and the French College of Radiology, in partnership with NEHS Digital, have set up a system to collect chest computed tomography (CT) examinations with clinical, virological and radiological metadata, from patients clinically suspected of COVID-19 pneumonia. This allowed the constitution of an anonymized multicenter database, named FIDAC (French Imaging Database Against Coronavirus). The aim of this report was to describe the content of this public database. MATERIALS AND METHODS: Twenty-two French radiology centers participated to the data collection. The data collected were chest CT examinations in DICOM format associated with the following metadata: patient age and sex, originating facility identifier, originating facility region, time from symptom onset to CT examination, indication for CT examination, reverse transcription-polymerase chain reaction (RT-PCR) results and normalized CT report performed by a senior radiologist. All the data were anonymized and sent through a NEHS Digital system to a centralized data center. RESULTS: A total of 5944 patients were included from the 22 centers aggregated into 8 regions with a mean number of patients of 743 ± 603.3 [SD] per region (range: 102-1577 patients). Reasons for CT examination and normalized CT reports were provided for all patients. RT-PCR results were provided in 5574 patients (93.77%) with a positive result of RT-PCR in 44.6% of patients. CONCLUSION: The FIDAC project allowed the creation of a large database of chest CT images and metadata available, under conditions, in open access through the CERF-SFR website.