Electronic Data Capture System Research Articles

The Pulmonary Fibrosis Foundation Patient Registry. Rationale, Design, and Methods.

Detailed understanding of longitudinal behavior, response to therapy, and applicable biomarkers for interstitial lung diseases (ILDs) is lacking. There is a need for a large multicenter registry that provides researchers and clinicians access to well-characterized data not limited to patients with idiopathic pulmonary fibrosis. The Pulmonary Fibrosis Foundation Patient Registry (PFF-PR) is a database that collects baseline and longitudinal demographic and clinical information about patients with ILDs in the United States. The objective of this study is to describe the patient population, data collection process, and opportunities for retrospective and prospective research with the PFF-PR. Individuals 18 years or older who had ILD diagnosed and who were seen at PFF-PR centers who provided informed consent were eligible to participate. Baseline and longitudinal demographic, spirometric, radiographic, morbidity, and mortality data are recorded into a secure electronic data capture system. Starting in 2016, the PFF-PR has collected data on 2,003 patients at 42 clinical sites in the United States. At the time of enrollment, the mean age of participants was 68 years old. Most (62%) of participants were male, and 58% had a positive smoking history. The mean forced vital capacity was 69% predicted, and the mean diffusing capacity of the lung for carbon monoxide was 43% predicted. Forty-one percent of patients were using supplemental oxygen, and 39% were on antifibrotic therapy. Reasons for attrition were mostly death or transplant, with low rates of loss to follow-up or withdrawal. The PFF-PR is a large multicenter United States-based registry that provides researchers and clinicians access to well-characterized ILD patient data.

Invasiveness of Treatment Is Gender Dependent in Intensive Care: Results From a Retrospective Analysis of 26,711 Cases.

Health care and outcome of critically ill patients are marked by gender-related differences. Several studies have shown that male patients in intensive care units (ICU) more often receive mechanical ventilation, dialysis, pulmonary arterial catheterization (PAC), and central venous catheterization (CVC). We investigated gender-related differences in ICU treatment and mortality. This retrospective, single-center study analyzed adult ICU patients admitted to the University Medical Center Regensburg between January 2010 and December 2017. Illness severity was measured with the Simplified Acute Physiology Score II (SAPS II) at ICU admission. We evaluated the intensity of ICU treatment according to the implementation of tracheostomy and extracorporeal membrane oxygenation (ECMO). We then assessed gender-related differences in the duration of mechanical ventilation and other invasive monitoring (PAC) and treatment methods (CVC, endotracheal intubation rate, and dialysis). ICU treatment and mortality data were obtained from an electronic data capture system. After adjusting for age, reason for hospitalization, and SAPS II score, we assessed the influence of gender on the intensity of ICU treatment using multivariable logistic regression. Odds ratios (OR) for the logistic regression models and incidence rate ratios (IRR) for the negative binomial regression models were calculated as effect estimates together with the corresponding 95% confidence intervals (95% CI). A P value of <.05 was considered significant. The study analyzed 26,711 ICU patients (64.8% men). The ICU mortality rate was 8.8%. Illness severity, ICU, and hospital mortality did not differ by gender. Women were older than men (62.6 vs 61.3 years; P < .001) at ICU admission. After multivariable adjustment, men were more likely to undergo tracheostomy (OR = 1.39 [1.26-1.54]), ECMO (OR = 1.37 [1.02-1.83]), dialysis (OR = 1.29 [1.18-1.41]), and PAC insertion (OR = 1.81 [1.40-2.33]) and had a longer duration of mechanical ventilation than women (IRR = 1.07 [1.02-1.12]). The frequency of endotracheal intubation (OR = 1.04 [0.98-1.11]) and placement of CVC (OR = 1.05 [0.98-1.11]) showed no gender-specific differences. Of ICU nonsurvivors, men were more likely to undergo tracheostomy (20.1% vs 15.3%; P = .004) and dialysis (54% vs 46.4%; P < .001) than women and had a longer duration of mechanical ventilation (6.3 vs 5.4 days; P = .015). After adjustment for severity of disease and outcome, ICU treatment differs between men and women. Men were more likely than women to undergo tracheostomy and ECMO.

A Nationwide Survey and Multicenter Registry-Based Database of Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy in Japan.

ObjectivesClinical characteristics of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) include migraine, recurrent stroke, white matter lesions, and vascular dementia. CADASIL is one of the most common hereditary cerebral small vessel diseases. Clinical presentation of CADASIL varies and a racial gap may exist between the Asian and Caucasian populations. This is the first nationwide epidemiological survey which aimed to elucidate the clinical features of CADASIL in Japan. Moreover, the registration database of CADASIL was constructed.MethodsSubjects included CADASIL patients who visited the hospitals (totally 1,448 hospitals) certified by the Japanese Society of Neurology and/or Japan Stroke Society in 2016. This study consisted of a two-step survey; patients with CADASIL were identified genetically by the first questionnaire, and their clinical features were assessed by the second questionnaire. Selected 6 hospitals registered the data of all CADASIL patients using a Research Electronic Data Capture (REDCap) system for the second questionnaire.ResultsBased on the criteria, 88 patients (50 male and 38 female) with CADASIL were enrolled. The mean age of symptom onset was 49.5 years. Sixteen (18.2%) patients had an elderly onset (>60 years). Thirteen patients (13.6%) had history of migraine with aura and 33 patients (37.5%) had vascular risk factor(s). From among the 86 patients who were examined using magnetic resonance imaging, abnormal deep white matter lesions were detected in 85 patients (98.8%), WMLs extending to anterior temporal pole in 73 patients (84.9%), and cerebral microbleeds in 41 patients (47.7%). Anti-platelet therapy was received by 65 patients (73.9%). Thirty-eight patients (43.2%) underwent treatment with lomerizine hydrochloride. Thirty-four different mutations of NOTCH3 were found in exons 2, 3, 4, 5, 6, 8, 11, 14, and 19. Most of the mutations existed in exon 4 (n = 44, 60.3%). The prevalence rate of CADASIL was 1.20 to 3.58 per 100,000 adults in Japan.ConclusionThis questionnaire-based study revealed clinical features and treatment status in Japanese CADASIL patient, although it may not be an exhaustive search. We have constructed the REDCap database for these CADASIL patients.

Study Design of the Nationwide Japanese Lead Extraction (J-LEX) Registry: Protocol for a Prospective, Multicenter, Open Registry.

BackgroundTransvenous lead extractions (TLEs) in Japan have grown to become the standard therapy since the approval of the laser extraction system in 2008. However, little is known about the current indications, methods, success rate, and acute complications in the real‐world setting.MethodsThe Japanese Lead EXtraction (J‐LEX) registry is a nationwide, multicenter, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center. This study is a nationwide registry ordered by the JHRS and its data are collected prospectively using the Research Electronic Data Capture (REDCap) system. The acute success rate at discharge and complications associated with TLEs will be collected in all cases. Based on the provided information, the annual incidence and predictive factors for the outcomes will be investigated by the Event Assessment Committee (EAC). This registry started in July 2018 and the number of participating medical institutions will be more than 50 hospitals and the target number of procedures will be 500‐1000 per year. We will also compare the results with other registries in foreign countries.ResultThe results of this study are currently under investigation.ConclusionThe J‐LEX registry will provide real‐world data regarding the results and complications of TLEs for the various types of indications, methods, and performing hospitals in Japan.

An Automatic Image Collection System for Multicenter Clinical Studies.

The acquisition of medical images from multiple medial institutions has become important for high-quality clinical studies. In recent years, electronic data submission has enabled the transmission of image data to independent institutions more quickly and easily than before. However, the selection, anonymization, and transmission of medical images still require human resources in the form of clinical research collaborators. In this study, we developed an image collection system that works with the electronic data capture (EDC) system. In this image collection system, medical images are selected based on EDC input information, patient ID is anonymized to a subject ID issued by the EDC, and the selected anonymized images are transferred to the research institute without human intervention. In the research institute, clinical information registered by the EDC and clinical images collected by the image collection system are managed by the same subject ID and can be used for clinical studies. In October 2019, our image collection system was introduced to 13 medical institutions and has now begun collecting medical images from the in-hospital picture archiving and communication system (PACS) of those institutions.

Abstract 06: Streamlining data management for clinical trials

Abstract The purpose of this study is to answer the FDA’s call to action for new research paradigms that rely on real-world data (RWD) to increase the efficiency of clinical trials and to conduct research using an approach that is less disruptive to the patient-provider clinical care setting. With the expansion of electronic health record (EHR) vendor structured data models, clinical study data can be directly captured using the patient’s EHR data as documented in the health care organization’s (HCOs) electronic medical record (EMR) system(s) and other electronic data sources (eSources). In partnership with HCOs, the Optum Digital Research Network is conducting a pilot to enable effective RWD extraction, normalization, and transcription from EMRs and other eSource to a read-only electronic data capture (EDC) system, effectively eliminating the need for duplicative data entry during the study. Optum is developing custom database queries to extract structured EMR data (including demographics, medications, labs, vitals, and encounters) from the respective domains of each EMR into a staging database. The raw data are then curated, normalized, and mapped into a common data model study database. In this case, the Observational Medical Outcomes Partnership (OMOP) data standard is employed as the clinical data management (CDM) model. The curated data are then mapped to Clinical Data Acquisition Standards Harmonization (CDASH) variables and transmitted to an EDC system using the EDC vendor’s application programming interface (API). The entire process is scheduled on a daily cadence (removing any duplicate data) to capture any updated visit information, medications, labs, or vitals. The EDC form fields are read-only. If there is a discrepancy or query, sites are notified requesting to confirm or correct their EHR data, which may result in an update to the respective read-only EDC form fields. Through this pilot project, Optum’s successful transfer of structured EMR data to a read-only EDC system has substantial implications for clinical research. Using data and technology, this methodology is projected to improve the efficiency (and lower costs) of clinical trials while minimizing the burden on HCOs. Citation Format: Brook Norris, Lauren Neighbors, Lucas Wale. Streamlining data management for clinical trials [abstract]. In: Proceedings of the AACR Special Conference on Advancing Precision Medicine Drug Development: Incorporation of Real-World Data and Other Novel Strategies; Jan 9-12, 2020; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(12_Suppl_1):Abstract nr 06.

Electronic data capture for large scale typhoid surveillance, household contact tracing, and health utilisation survey: Strategic Typhoid Alliance across Africa and Asia.

Electronic data capture systems (EDCs) have the potential to achieve efficiency and quality in collection of multisite data. We quantify the volume, time, accuracy and costs of an EDC using large-scale census data from the STRATAA consortium, a comprehensive programme assessing population dynamics and epidemiology of typhoid fever in Malawi, Nepal and Bangladesh to inform vaccine and public health interventions. A census form was developed through a structured iterative process and implemented using Open Data Kit Collect running on Android-based tablets. Data were uploaded to Open Data Kit Aggregate, then auto-synced to MySQL-defined database nightly. Data were backed-up daily from three sites centrally, and auto-reported weekly. Pre-census materials' costs were estimated. Demographics of 308,348 individuals from 80,851 households were recorded within an average of 14.7 weeks range (13-16) using 65 fieldworkers. Overall, 21.7 errors (95% confidence interval: 21.4, 22.0) per 10,000 data points were found: 13.0 (95% confidence interval: 12.6, 13.5) and 24.5 (95% confidence interval: 24.1, 24.9) errors on numeric and text fields respectively. These values meet standard quality threshold of 50 errors per 10,000 data points. The EDC's total variable cost was estimated at US$13,791.82 per site. In conclusion, the EDC is robust, allowing for timely and high-volume accurate data collection, and could be adopted in similar epidemiological settings.

MP53-04 RECOVERY OF SEXUAL FUNCTION IN MEN TREATED WITH ANDROGEN DEPRIVATION THERAPY FOR LOCALIZED PROSTATE CANCER

You have accessJournal of UrologyProstate Cancer: Localized: Radiation Therapy (MP53)1 Apr 2020MP53-04 RECOVERY OF SEXUAL FUNCTION IN MEN TREATED WITH ANDROGEN DEPRIVATION THERAPY FOR LOCALIZED PROSTATE CANCER Daniel D. Joyce*, Amy N. Luckenbaugh, Heather L. Huelster, Zighuo Zhao, Karen E. Hoffman, Li-Ching Huang, Tatsuki Koyama, Ralph Conwill, David F. Penson, and Daniel A. Barocas Daniel D. Joyce*Daniel D. Joyce* More articles by this author , Amy N. LuckenbaughAmy N. Luckenbaugh More articles by this author , Heather L. HuelsterHeather L. Huelster More articles by this author , Zighuo ZhaoZighuo Zhao More articles by this author , Karen E. HoffmanKaren E. Hoffman More articles by this author , Li-Ching HuangLi-Ching Huang More articles by this author , Tatsuki KoyamaTatsuki Koyama More articles by this author , Ralph ConwillRalph Conwill More articles by this author , David F. PensonDavid F. Penson More articles by this author , and Daniel A. BarocasDaniel A. Barocas More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000915.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Decreased sexual function during androgen deprivation therapy (ADT) is well described; however, limited data exist regarding sexual function recovery following ADT use in treatment of localized prostate cancer. In this study, we compared sexual function in men who received ADT plus external beam radiation treatment (EBRT) to EBRT alone and identified patient-level predictors of sexual function recovery. METHODS: We prospectively enrolled a population-based cohort of men who underwent EBRT with and without ADT for intermediate- or high-risk localized prostate cancer as part of the Comparative Effectiveness Analysis of Surgery and Radiation study. Sexual function was assessed longitudinally out to 5 years using the validated Expanded Prostate Cancer Index Composite survey. Sexual and hormone domain scores range from 0 (worst) to 100 (best) points. Men with erections sufficient for intercourse at baseline were selected for inclusion. Patients still receiving ADT at 5 years were excluded from analysis. RESULTS: A total of 167 patients were included. Of these, 73 underwent EBRT alone and 94 received ADT plus EBRT (51 with intermediate-risk and 43 with high-risk disease). Baseline sexual function was similar between groups (p=0.218). Compared to EBRT alone, ADT in high-risk disease was associated with worse sexual function at 3 years (Effect: -20.3 points, CI -31.8, -8.8, p<0.001) but not at 5 years (Effect: -3.4 points, CI -17.2, 10.5, p=0.633). Neither baseline function, age, nor cardiovascular health influenced receipt of ADT. CONCLUSIONS: ADT plus EBRT is associated with worse sexual function through 3-years follow-up in men with high-risk prostate cancer compared to EBRT alone. The addition of ADT in treatment of intermediate-risk disease does not appear to result in worse sexual function at 3 or 5-year follow-up compared to EBRT alone. Source of Funding: This study was supported by the Agency for Healthcare Research and Quality (1R01HS019356, 1R01HS022640) and the Patient-Centered Outcomes Research Institute (CE-12-11-4667). Data management was facilitated by Vanderbilt University’s Research Electronic Data Capture (REDCap) system, which is supported by the Vanderbilt Institute for Clinical and Translational Research grant (UL1TR000011 from NCATS/NIH). © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e782-e783 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel D. Joyce* More articles by this author Amy N. Luckenbaugh More articles by this author Heather L. Huelster More articles by this author Zighuo Zhao More articles by this author Karen E. Hoffman More articles by this author Li-Ching Huang More articles by this author Tatsuki Koyama More articles by this author Ralph Conwill More articles by this author David F. Penson More articles by this author Daniel A. Barocas More articles by this author Expand All Advertisement PDF downloadLoading ...

The iCRF Generator: Generating interoperable electronic case report forms using online codebooks

Semantic interoperability of clinical data is essential to preserve its meaning and intent when the data is exchanged, re-used or integrated with other data. Achieving semantic operability requires the use of a communication standard, such as HL7, as well as (functional) information standards. Manually mapping clinical data to a medical thesaurus, such as SNOMED CT, is complicated and requires expert knowledge of both the dataset, including its context, and the thesaurus. As an alternative, the (re-)use of codebooks, data definitions which may already have been mapped to a thesaurus, can be a viable approach. We've developed the iCRF Generator, a Java program that can generate the core of an interoperable electronic case report form (iCRF) for several of the major electronic data capture systems (EDCs). To build their CRFs, users can select one or more items from established codebooks, available from an online system called ART-DECOR. By providing an easy to use method to create CRFs for multiple EDCs based on the same codebooks, interoperability can be more easily attained.

The iCRF Generator: Generating interoperable electronic case report forms using online codebooks

Semantic interoperability of clinical data is essential to preserve its meaning and intent when the data is exchanged, re-used or integrated with other data. Achieving semantic operability requires the use of a communication standard, such as HL7, as well as (functional) information standards. Manually mapping clinical data to a medical thesaurus, such as SNOMED CT, is complicated and requires expert knowledge of both the dataset, including its context, and the thesaurus. As an alternative, the (re-)use of codebooks, data definitions which may already have been mapped to a thesaurus, can be a viable approach. We’ve developed the iCRF Generator, a Java program that can generate the core of an interoperable electronic case report form (iCRF) for several of the major electronic data capture systems (EDCs). To build their CRFs, users can select one or more items from established codebooks, available from an online system called ART-DECOR. By providing an easy to use method to create CRFs for multiple EDCs based on the same codebooks, interoperability can be more easily attained.

PENINGKATAN KUALITAS LAYANAN SISTEM ELECTRONIC DATA CAPTURE UNTUK MENINGKATKAN LOYALITAS MERCHANT

This study aims to produce instruments as a reference for measuring the quality of EDC system services from the acquirer to increase merchant loyalty. The dimensions of the SERVQUAL instruments namely reliability, assurance, tangible, responsiveness and empathy are adapted to produce EDC system quality measurement instruments with 4 dimensions as follows: business attentiveness; business availability; system dependability; credibility. Service quality is an important factor in merchant loyalty, so acquirers need to measure service quality to find out how the service quality factors of an EDC (electronic data capture) system can increase merchant loyalty. The indicators of measurement instruments must always be adjusted to the business development of the EDC system so that the accuracy of the measurement instruments of the EDC system's service quality will be maintained. Keywords: Electronic Data Capture, Service Quality

Design and implementation of a mobile health electronic data capture platform that functions in fully-disconnected settings: a pilot study in rural Liberia

BackgroundMobile phones and personal digital assistants have been used for data collection in developing world settings for over three decades, and have become increasingly common. However, the use of electronic data capture (EDC) through mobile phones is limited in many areas by inconsistent network connectivity and poor access to electricity, which thwart data transmission and device usage. This is the case in rural Liberia, where many health workers live and work in areas without any access to cellular connectivity or reliable power. Many existing EDC mobile software tools are built for occasionally-disconnected settings, allowing a user to collect data while out of range of a cell tower and transmit data to a central server when he/she regains a network connection. However, few tools exist that can be used indefinitely in fully-disconnected settings, where a user will never have access to the internet or a cell network. This led us to create and implement an EDC software tool that allows for completely offline data transfer and application updating.ResultsWe designed, pilot-tested, and scaled an open-source fork of Open Data Kit Collect (an Android application that can be used to create EDC systems) that allows for offline Bluetooth-based bidirectional data transfer, enabling a system in which permanently-offline users can collect data and receive application updates. We implemented this platform among a cohort of 317 community health workers and 28 supervisors in a remote area of rural Liberia with incomplete cellular connectivity and low access to power sources.ConclusionsRunning a fully-offline EDC program that completely bypasses the cellular network was found to be feasible; the system is still running, over 4 years after the initial pilot program. The users of this program can theoretically collect data offline for months or years, assuming they receive hardware support when needed. Fully-offline EDC has applications in settings where cellular network coverage is poor, as well as in disaster relief settings in which portions of the communications infrastructure may be temporarily nonfunctional.

The iCRF Generator: Generating interoperable electronic case report forms using online codebooks.

Semantic interoperability of clinical data is essential to preserve its meaning and intent when the data is exchanged, re-used or integrated with other data. Achieving semantic operability requires the use of a communication standard, such as HL7, as well as (functional) information standards. Manually mapping clinical data to a medical thesaurus, such as SNOMED CT, is complicated and requires expert knowledge of both the dataset, including its context, and the thesaurus. As an alternative, the (re-)use of codebooks, data definitions which may already have been mapped to a thesaurus, can be a viable approach. We've developed the iCRF Generator, a Java program that can generate the core of an interoperable electronic case report form (iCRF) for several of the major electronic data capture systems (EDCs). To build their CRFs, users can select one or more items from established codebooks, available from an online system called ART-DECOR. By providing an easy to use method to create CRFs for multiple EDCs based on the same codebooks, interoperability can be more easily attained.

Effects of supplement amount, with or without calcium salts of fatty acids, on growth performance and intake behavior of grazing Bos indicus bulls.

This study evaluated the effects of 2 supplement dry matter (DM) amounts, with or without calcium salts of fatty acids (CSFA), on growth performance, supplement and water intake behavior of grazing beef bulls. On day 0, 32 Nellore bulls were ranked by initial body weight (BW; 318 ± 11.2 kg), and then, randomly assigned to treatments (n = 8 bulls/treatment), in a 2 × 2 factorial design, which consisted of energy-based supplement DM amount of 0.3 (SP03) or 1.0 (SP1) % of BW with (+) or without (-) CSFA fortification (90 to 100 g/bull daily). During the experiment (98 d), all bulls were managed as single group and rotated between 2 Brachiaria pastures every 9 to 11 d. Each pasture contained an individual electronic data capture system with 2 feed bunks/treatment and 1 water through to determine individual supplement DM and water intake, as well number of visits, time spent at the feeder/waterer, and intake per visit (IPV). A supplement effect was detected (P = 0.02) for final BW. Bulls supplemented at 1.0% of BW, regardless of CSFA inclusion amount, were heavier at the end of the experiment vs. SP03 bulls. Overall average daily gain (ADG) was greater (P = 0.05) for SP03+ vs. SP03- bulls, and did not differ (P = 0.87) between SP1+ vs. SP1- bulls. No supplement amount, CSFA, or supplement amount × CSFA effects were observed (P ≥ 0.13) for supplement and water intake behavior, number of visits to the feeder or IPV. However, SP1 bulls spent (P = 0.05) more time at the feeder than SP1+ bulls, whereas bulls supplemented with CSFA tended (P = 0.10) to consume less water (as % of BW) than cohorts supplemented without CSFA. In summary, CSFA fortification into 0.3% of BW supplements increased ADG when compared with cohorts not offered CSFA. On the other hand, no benefits were observed when CSFA was included into 1.0% of BW supplements, primarily due to the lower than projected supplement, and consequently, CSFA intake. Moreover, CSFA fortification tended to reduced water intake, demonstrating a potential of this technology to increase performance of beef herds, while maintaining the utilization of natural resources.

Predictors of vaginal delivery after cervical ripening using a synthetic osmotic dilator

ObjectiveTo evaluate the determinants of vaginal delivery and safety in women undergoing cervical ripening with a synthetic osmotic dilator (Dilapan-S) prior to induction of labor. MethodsWe conducted a secondary analysis of an international multicenter prospective observational study of Dilapan-S for cervical ripening in pregnancies greater than 32 weeks. Data were obtained in a standardized fashion and entered into a centralized electronic data capture system. The association between Bishop score and vaginal delivery was further evaluated with a multivariate receiver-operating characteristic (ROC) curve analysis. A Wilcoxon rank test and multivariable logistic regression were used for statistical analysis (significance: P < .05). ResultsBetween May 2015 and July 2016, 444 pregnant women were included. Three hundred ten (70 %) delivered vaginally. Compared to patients who underwent cesarean delivery, those who delivered vaginally were more likely to have a history of prior vaginal delivery. Vaginal delivery rates were significantly correlated with Bishop scores of pre and post Dilapan-S and difference. After adjusting for age, BMI, number of dilators, cervical ripening time, and gestational age, both prior vaginal delivery and post-Dilapan-S Bishop scores were strong predictors of vaginal delivery (estimate coefficient: 0.1275 ± 0.03 P = .0002; 0.049 ± 0.01 P = .0001; respectively). Aggregate ROC accounting for these variables further supported these findings (AUC = 0.734). The lower confidence interval limit of vaginal delivery rates was above 50 % when post-Dilapan-S Bishop scores were ≥ 5. Cox regression analyses demonstrated that the duration of labor was significant shorter in women that had vaginal delivery. ConclusionBishop scores after cervical ripening with Dilapan-S are good predictors of vaginal delivery. Bishop scores < 5 post Dilapan-S may warrant further cervical ripening. Further level 1 trials are needed to compare osmotic dilators to other ripening methods.

Electrical versus pharmacological cardioversion for emergency department patients with acute atrial fibrillation (RAFF2): a partial factorial randomised trial

Acute atrial fibrillation is the most common arrythmia treated in the emergency department. Our primary aim was to compare conversion to sinus rhythm between pharmacological cardioversion followed by electrical cardioversion (drug-shock), and electrical cardioversion alone (shock-only). Our secondary aim was to compare the effectiveness of two pad positions for electrical cardioversion. We did a partial factorial trial of two protocols for patients with acute atrial fibrillation at 11 academic hospital emergency departments in Canada. We enrolled adult patients with acute atrial fibrillation. Protocol 1 was a randomised, blinded, placebo-controlled comparison of attempted pharmacological cardioversion with intravenous procainamide (15 mg/kg over 30 min) followed by electrical cardioversion if necessary (up to three shocks, each of ≥200 J), and placebo infusion followed by electrical cardioversion. For patients having electrical cardioversion, we used Protocol 2, a randomised, open-label, nested comparison of anteroposterior versus anterolateral pad positions. Patients were randomly assigned (1:1, stratified by study site) for Protocol 1 by on-site research personnel using an online electronic data capture system. Randomisation for Protocol 2 occurred 30 min after drug infusion for patients who had not converted and was stratified by site and Protocol 1 allocation. Patients and all research and emergency department staff were masked to treatment allocation for Protocol 1. The primary outcome was conversion to normal sinus rhythm for at least 30 min at any time after randomisation and up to a point immediately after three shocks. Protocol 1 was analysed by intention to treat and Protocol 2 excluded patients who did not receive electrical cardioversion. This study is registered at ClinicalTrials.gov, number NCT01891058. Between July 18, 2013, and Oct 17, 2018, we enrolled 396 patients, and none were lost to follow-up. In the drug-shock group (n=204), conversion to sinus rhythm occurred in 196 (96%) patients and in the shock-only group (n=192), conversion occurred in 176 (92%) patients (absolute difference 4%; 95% CI 0-9; p=0·07). The proportion of patients discharged home was 97% (n=198) versus 95% (n=183; p=0·60). 106 (52%) patients in the drug-shock group converted after drug infusion only. No patients had serious adverse events in follow-up. The different pad positions in Protocol 2 (n=244), had similar conversions to sinus rhythm (119 [94%] of 127 in anterolateral group vs 108 [92%] of 117 in anteroposterior group; p=0·68). Both the drug-shock and shock-only strategies were highly effective, rapid, and safe in restoring sinus rhythm for patients in the emergency department with acute atrial fibrillation, avoiding the need for return to hospital. The drug infusion worked for about half of patients and avoided the resource intensive procedural sedation required for electrical cardioversion. We also found no significant difference between the anterolateral and anteroposterior pad positions for electrical cardioversion. Immediate rhythm control for patients in the emergency department with acute atrial fibrillation leads to excellent outcomes. Heart and Stroke Foundation of Canada and the Canadian Institutes of Health Research.

Current Neurologic Assessment and Neuroprotective Strategies in Cardiac Anesthesia: A Survey to the Membership of the Society of Cardiovascular Anesthesiologists.

Neurologic injury and cognitive disorder after cardiac surgery are associated with morbidity and mortality. Variability in the application of neuroprotective strategies likely exists during cardiac surgery. The Society of Cardiovascular Anesthesiologists (SCA) conducted a survey among its members on common perioperative neuroprotective strategies: assessment of aortic atheromatous burden, management of intraoperative blood pressure, and use of cerebral oximetry. A 15-item survey was developed by 3 members of the SCA Continuous Practice Improvement - Cerebral Protection Working Group. The questionnaire was then circulated among all working group members, adapted, and tested for face validity. On March 26, 2018, the survey was sent to members of the SCA via e-mail using the Research Electronic Data Capture system. Responses were recorded until April 16, 2018. Of the 3645 surveys e-mailed, 526 members responded (14.4%). Most responders worked in academic institutions (58.3%), followed by private practices (38.7%). Epiaortic ultrasound for the assessment of aortic atheromatous burden was most commonly utilized at the surgeon's request (46.5%). Cerebral oximetry was most commonly used in patients with increased perioperative risk of cerebral injury (41.4%). Epiaortic ultrasound (1.9%) and cerebral oximetry (5.2%) were rarely part of a standardized monitoring approach. A majority of respondents (52.0%) reported no standardized management strategies for neuroprotection during cardiac surgery at their institution. A total of 55.3% stated that no standardized institutional guidelines were in place for managing a patient's blood pressure intraoperatively or during cardiopulmonary bypass. When asked about patients at risk for postoperative cerebral injury, 41.3% targeted a blood pressure goal >65 mmHg during cardiopulmonary bypass. The majority of responders (60.4%) who had access to institutional rates of postoperative stroke/cerebral injury had standard neuroprotective strategies in place. Our data indicate that approximately half of the respondents to this SCA survey do not use standardized guidelines/standard operating procedures for perioperative cerebral protection. The lack of standardized neuroprotective strategies during cardiac surgery may impact postoperative neurologic outcomes. Further investigations are warranted and should assess the association of standardized neuroprotective approaches and postoperative neurological outcomes.

Audiology Practices in the Preoperative Evaluation and Management of Adult Cochlear Implant Candidates

Currently, no clear guidelines exist regarding clinical testing methods for identifying adult cochlear implant (CI) candidates. Indications provided by the US Food and Drug Administration, Medicare, and private insurers are ambiguous concerning test materials and the level and mode of test presentation. This could lead to wide variability in clinical assessment and, potentially, unequal access to CIs for individuals with clinically significant hearing loss. To examine the preoperative testing methods used by audiologists in evaluating adult CI candidates across the United States. A survey assessing audiology practice patterns was created using a Research Electronic Data Capture system hosted at the University of Miami. A link to a survey (65 questions in multiple-choice or rank-order format was distributed electronically along with a request for completion to members of the American Cochlear Implant Alliance and to the Institute for Cochlear Implant Training forum. Responses were collected from January 17 to June 4, 2018. Participation was limited to audiologists who evaluate adult CI candidates, and respondents who do not provide adult CI care were excluded. Collected demographic information included work setting, years of experience, and highest level of education attained. Percentages, medians, and interquartile ranges were from aggregated responses concerning hearing aid verification methods; testing methods, materials, and practices; nonauditory factors that might affect CI candidacy; audiology practice patterns; and expanded indications for CIs. Anonymized surveys were returned by 99 respondents; because surveys were available electronically, the number of audiologists who viewed the survey but did not respond was not available. Seven respondents identified themselves as pediatric specialists and were excluded, resulting in a total of 92 surveys available for analysis (denominators vary because respondents could complete the survey without answering all questions). Seventy percent of respondents (51 of 72) were doctors of audiology, and nearly 50% (33 of 74) were employed at universities and academic centers performing more than 50 CIs per year. When assessing adult candidacy for implant, most respondents reported using test materials from the Minimum Speech Test Battery: 96% (51 of 53), using AzBio sentences in quiet; 89% (47 of 53), AzBio sentences in noise; and 100% (53 of 53), the consonant-vowel nucleus-consonant, monosyllabic words test. However, these tests were applied inconsistently, with 39 of 53 respondents (74%) reporting use of a sound pressure level scale and the other 14 (26%) a hearing level scale at various decibel levels, and with some using a single signal-to-noise ratio and others using multiple ratios for sound-in-noise tests. Respondents' definitions of the best aided listening condition for assessing implant candidates also varied widely. Among the nonauditory factors ranked most important for assessing CI candidacy were patient's level of cognition and expectations of CI; yet, few respondents reported including cognitive or psychological tests in the assessment protocol. Findings of this study reveal considerable variability in preoperative testing methods and practices across health care professionals assessing adult candidates for CI. This lack of standardization in the delivery of care may increase the risk for health care inequities, specifically in access to care for adults with clinically significant hearing loss.

Development of a Prospective Real-World Data Clinical Registry of Children and Adolescents With Migraine.

To develop a multicenter, multistakeholder, prospective clinical registry of children and adolescents with migraine to support the collection of real-world data of sufficient quality to support regulatory submissions and provide site-based infrastructure support for future clinical trials. As new migraine treatments come to market, pediatric efficacy and safety trials of these agents are needed. A clinical registry is an ideal regulatory strategy to provide both real-world data and site infrastructure to execute these trials. Multicenter, multistakeholder, prospective real-world data clinical registry of children and adolescents, 4-17years of age, diagnosed with migraine with or without aura. Participants will be followed for up to 12months at 3-month intervals, with interval recording of clinical data at study sites and self-reported data via mobile health application, as well as biobanking. We developed electronic case report forms that incorporated routinely collected clinical data with National Institute of Neurological Disorders and Stroke Headache Common Data Elements (Version 2.0). All data are captured in a 21 CFR Part 11 - compliant electronic data capture system - augmented by a real-time, web-based, and customizable data visualization platform. We engaged vendors to provide ancillary biobanking, patient data entry, and data visualization services. We used an iterative and highly collaborative multistakeholder approach to design and implement a streamlined registry protocol with input from all participating US sites. At each design and implementation step, we received input from therapeutic area experts, the US Food and Drug Administration (FDA), the National Institutes of Health, patient and parent advocates, health technology partners, drug developers, and site-based clinical investigators. The registry is governed by a multistakeholder steering committee with representation from sites, industry partners, patient advocates, and a member from the FDA (non-voting with respect to steering committee matters). The multistakeholder and site-driven approach to registry design and execution was highly efficient and resulted in the first patient enrolled within 6months of concept development. By ensuring regulatory compliant implementation of the registry, we created both a source of real-world data and a multisite platform for the conduct of future clinical trials that can be submitted to regulatory authorities to support inclusion of pediatric data in approved drug labeling. A highly collaborative approach with broad stakeholder engagement at all stages of the registry development was a key to our operational success.

Characteristics of Children with Abnormal TCD in the Modern Era: Results from the Displace Consortium

Background: Stroke is one of the most devastating complications of sickle cell anemia (SCA). In 1998, the Stroke Prevention Trial in Sickle Cell Anemia (STOP), demonstrated that a high-risk group of children with SCA could be identified using Transcranial Doppler ultrasound(TCD) and that chronic red cell transfusion therapy (CRCT) could reduce the risk of first ischemic stroke in this group by over 90% (Adams, et al NEJM 1998).At STOP studyenrollment, 9.7% of children with SCA were identified as having an abnormal TCD. Baby HUG, (NCT00006400), an NHLBI supported phase III trial showed that severe anemia in SCA was associated with elevated white blood cell (WBC) and higher TCD velocities (Lebensburger, et al Blood 2010 ). It is unclear if lower hemoglobin (Hb) and/or higher WBC are causative of elevated TCD velocities or correlative biomarkers. As new disease therapies become available, it is important to know the current rate of abnormal TCD and characteristics of those patients. The DISPLACE (Dissemination and Implementation Looking at the Care Environment) project is a multicenter, NHLBI-funded study whose primary purpose is to identify barriers to implementation of stroke screening in SCA and test novel methods for improving outcomes. DISPLACE is a 3-part study: retrospective assessment of current practice, qualitative review of barriers and facilitators to screening and a cluster-randomized intervention implementation project to improve stroke screening. Part 1 of the study showedthat TCD screening rates varied widely among institutions ranging from 30-75.2% (mean 48.4%, median 47%). We are now reporting on the rate of abnormal TCD and the characteristics and outcomes of patients with abnormal TCD. Methods: DISPLACE is a consortium of 28 US centers. Each site performed a rigorous retrospective chart review of children with SCA aged 2-16 years from 2012-2016. To be eligible for inclusion, children must have been seen at their institution at least 2x during the study period and have confirmation of SCA. A custom electronic data capture (EDC) system facilitated entry of de-identified data including demographics, TCD and MRI results, medications, transfusions, and laboratory values. For children with SCA who had TCD or central nervous system imaging prior to 2012, these results were also entered into the EDC. TCD results were recorded in the EDC as normal, conditional or abnormal based on their institutional interpretation. Labs and vitals were entered for each patient in closest proximity to each TCD. Confirmation and adjudication of each abnormal TCD and associated outcomes were performed. Stroke status was also recorded as well as presence or absence of CRCT. Results: In total, 5247 children with SCA are included in the database of whom 5225 should have received a TCD. Of this cohort, 4210 children (80.6%) had at least one TCD recorded in the database. Within this group, 207 (4.9%) of children had an abnormal TCD and 816 (19.4%) had a conditional TCD. For those children who underwent TCD during the study (2012-2016) period, there were 105 (2.9%) abnormal TCD and 501 (13.6%) conditional TCD (Table 1). The mean age of children at the time of abnormal TCD was 6.6 years (range 2-16 yr). The majority of children were &lt;10 yr at first abnormal TCD. Over 30% of patients with an abnormal TCD were identified as receiving hydroxyurea.The mean Hb associated with an abnormal TCD was 7.8 +/- 1.1g/dl (range 5.7-10.6) and the mean WBC was 13 x109/L+/- 3.6 (range 3.9-23.4) (Table 2). Of the 105 patients with abn TCD during the study period, 18% had a stroke. Of the total 5247 patients in the database, 3093 (59%) had been prescribed hydroxyurea (HU) and 999 (19%) were prescribed CRCT. CRCT was prescribed most often for abnormal TCD (37%) or secondary stroke prevention (31%). Discussion: DISPLACE is the largest contemporary cohort of children with SCA. The incidence of abnormal TCD in the DISPLACE cohort is significantly lower than at randomization in the STOP study. The number of children receiving CRCT is higher than expected which may partly account for the decrease in frequency of abnormal TCD. Many patients with abnormal TCD were receiving HU when their TCD was abnormal and were started on CRCT. Additionally, while the outcomes of children with conditional TCD are still being evaluated, many of those children reverted to normal TCD without intervention. These data may also help us redefine the use and interventions needed for abnormal TCD. Disclosures Kanter: NHLBI: Membership on an entity's Board of Directors or advisory committees; bluebird bio, Inc.: Consultancy; SCDAA: Membership on an entity's Board of Directors or advisory committees; Guidepoint Global: Consultancy; GLG: Consultancy; Sangamo: Consultancy, Honoraria; Modus: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Imara: Consultancy; Cowen: Consultancy; Jeffries: Consultancy; Medscape: Honoraria; Rockpointe: Honoraria; Peerview: Honoraria. Adams:GBT: Consultancy, Other: consultancy to companies GBT and Blueburd Bio; Bluebird: Consultancy.