Data Capture System Research Articles

REDbox: a comprehensive semantic framework for data collection and management in tuberculosis research

Clinical research outcomes depend on the correct definition of the research protocol, the data collection strategy, and the data management plan. Furthermore, researchers often need to work within challenging contexts, as is the case in tuberculosis services, where human and technological resources for research may be scarce. Electronic Data Capture Systems mitigate such risks and enable a reliable environment to conduct health research and promote result dissemination and data reusability. The proposed solution is based on needs pinpointed by researchers, considering the need for an accommodating solution to conduct research in low-resource environments. The REDbox framework was developed to facilitate data collection, management, sharing, and availability in tuberculosis research and improve the user experience through user-friendly, web-based tools. REDbox combines elements of the REDCap and KoBoToolbox electronic data capture systems and semantics to deliver new valuable tools that meet the needs of tuberculosis researchers in Brazil. The framework was implemented in five cross-institutional, nationwide projects to evaluate the users' perceptions of the system's usefulness and the information and user experience. Seventeen responses (representing 40% of active users) to an anonymous survey distributed to active users indicated that REDbox was perceived to be helpful for the particular audience of researchers and health professionals. The relevance of this article lies in the innovative approach to supporting tuberculosis research by combining existing technologies and tailoring supporting features.

Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study.

This ongoing post-marketing surveillance monitors the long-term safety and effectiveness of vedolizumab in routine clinical practice in patients with moderate-to-severe ulcerative colitis (UC) in Japan. This interim analysis assessed induction-phase data, covering the initial three doses of vedolizumab. Patients were enrolled via a web-based electronic data capture system from approximately 250 institutions. Incidence of adverse events and treatment responses were assessed by the physicians after the patient had received three doses of vedolizumab or when the drug was discontinued, whichever occurred first. Therapeutic response was defined as any treatment response, including remission or improvement of complete or partial Mayo score, and was assessed in the total and stratified patient populations according to prior tumor necrosis factor alpha (TNFα) inhibitor treatments and/or baseline partial Mayo score. The total incidence of adverse drug reactions (ADRs) was 4.10% (11/268). Common ADRs were dizziness, nausea, and arthralgia, each reported in 0.75% of patients (2/268). Serious ADRs were herpes zoster oticus and UC, each reported in 0.37% of patients (1/268). Therapeutic response was reported in 84.5% (218/258) of all patients, 85.8% (127/148) of TNFα inhibitor-naïve patients, and 82.7% (91/110) of TNFα inhibitor-experienced patients. Among patients with partial Mayo score of ≥ 4 at baseline, partial Mayo score remission in patients without or with prior TNFα inhibitor treatment was 62.5% (60/96) and 45.6% (36/79), respectively. The results confirm a safety and effectiveness profile of vedolizumab consistent with that observed in previous trials. JapicCTI-194603, NCT03824561.

Design a custom resistive force sensors to optimize sensorized insoles

PurposeCurrently, several studies have been published using sensorized insoles for estimating ground reaction force using plantar pressure. However, information on design parameters, manufacturing techniques and guidelines for developing insoles is scarce, often leaving gaps that do not allow reproducing the insole. This study aims to empirically investigate the main parameters of constructing a sensorized insole for application in human gait.Design/methodology/approachTwo devices were built to evaluate the force sensors. The first focuses on the construction of the sensors with different settings: the density of the sensor’s conductive trails (thickness and distance of the trails) and the inertia of the sensors (use of spacers to prevent unwanted readings). The second device focuses on the data capture and processing system: resolution of the analog–digital converter, acquisition rate and sensor activation level.FindingsThe resolution increase of the analog–digital converter and acquisition rate do not contribute to noise increase. Reducing the sensors’ coverage area can increase sensorized insole capacity. The inertia of the sensors can be adjusted using spacers without changing the electrical circuit and acquisition system.Originality/valueMost sensorized insoles use commercial sensors. For this reason, it is not possible a full customization. This paper maps the main variables to manufacture custom sensors and data acquisition systems. This work also presents a case study where it is possible to see the influence of the parameters in the correlation between the sensorized insole and an instrumented treadmill with a force platform.

ACVECC‐Veterinary Committee on Trauma registry report 2017–2019

To report summative data from the American College of Veterinary Emergency and Critical Care Veterinary Committee on Trauma (VetCOT) registry. Multi-institutional registry data report, April 1, 2017 to December 31, 2019. VetCOT identified and verified Veterinary Trauma Centers (VTCs). Dogs and cats with evidence of trauma. Data were input to a web-based data capture system (Research Electronic Data Capture) by data entry personnel trained in data software use and operational definitions of data variables. Data on demographics, trauma type, preadmission care, trauma severity assessment at presentation (modified Glasgow Coma Scale and Animal Trauma Triage score), key laboratory parameters, interventions, and case outcome were collected. Summary descriptive data for each species are reported. Thirty-one VTCs contributed data from 20,842 canine and 4003 feline trauma cases during the 33-month reporting period. Most cases presented directly to a VTC (82.1% dogs, 82.1% cats). Admission to hospital rates were slightly lower in dogs (27.8%) than cats (32.7%). Highest mortality rates by mechanism of injury in dogs were struck by vehicle (18.3%), ballistic injury (17.6%), injured inside vehicle (13.2%), nonpenetrating bite wound (10.2%), and choking/pulling injury (8.5%). Highest mortality rates by mechanism of injury in cats were struck by vehicle (43.3%), ejected from vehicle (33.3%), nonpenetrating bite wound (30.7%), ballistic injury (27.8%), and choking/pulling injury (25.0%). The proportion of animals surviving to discharge was 93.1% (dogs) and 82.5% (cats). The VetCOT registry is a powerful resource for collection of a large dataset on trauma in dogs and cats seen at VTCs. Overall survival to discharge was high indicating low injury severity for most recorded cases. Further evaluation of data on subsets of injury types, patient assessment parameters, interventions, and associated outcome are warranted. Data from the registry can be leveraged to inform clinical trial design and justification for naturally occurring trauma as a translational model to improve veterinary and human trauma patient outcome.

Proton beam therapy for gliomas: a multicenter prospective registry study from all proton beam facilities in Japan

Abstract We reviewed the outcomes of glioma patients enrolled in a prospective observational registry study of proton beam therapy (PBT) in Japan. The inclusion criteria were glioma patients registered in the Electronic Data Capture system, the Proton-net, between May 2016 and July 2019. Data on patient characteristics, treatments, late adverse events, survival status, recurrence and secondary tumors were extracted and statistically analyzed. The primary endpoint was the overall survival (OS) rate, and the secondary endpoints were the progression-free survival (PFS) rate and cumulative local recurrence rate (cLRR). Of the 65 primary brain tumor patients registered, 29 glioma patients from eight of 19 PBT facilities met the inclusion criteria. There were 19 glioblastoma patients, eight of other malignant gliomas, and two of low-grade gliomas. For glioblastomas, with a median follow-up period of 16 months, the median survival time was 21.2 months and the OS at 1, 2, 3 and 4 years were 77.4%, 44.9%, 23.9% and 23.9%, respectively. The median PFS period was 10.1 months, the 1, 2, 3 and 4-year PFS were 32.4%, 19.4%, 9.7% and 9.7%, respectively. The 1, 2, 3 and 4-year cLRR were 56.1%, 68.8%, 78.4 and 78.4%, respectively. Grade 3 brain necrosis was observed in two patients. No secondary tumor was observed. This is the first report on the current status of PBT for gliomas in Japan. For glioblastomas, the outcomes of PBT are estimated to be equivalent to historical data of photon therapy. The results of a prospective comparative evaluation of PBT and photon therapy are awaited.

Digital Outcome Measurement to Improve Care for Patients With Immune-Mediated Inflammatory Diseases: Protocol for the IMID Registry

Despite enormous clinical improvements, due to better management strategies and the availability of biologicals, immune-mediated inflammatory diseases (IMIDs) still have a significant impact on patients' lives. To further reduce disease burden, provider- as well as patient-reported outcomes (PROs) should be taken into account during treatment and follow-up. Web-based collection of these outcomes generates valuable repeated measurements, which could be used (1) in daily clinical practice for patient-centered care, including shared decision-making; (2) for research purposes; and (3) as an essential step toward the implementation of value-based health care (VBHC). Our ultimate goal is that our health care delivery system is completely aligned with the principles of VBHC. For aforementioned reasons, we implemented the IMID registry. The IMID registry is a digital system for routine outcome measurement that mainly includes PROs to improve care for patients with IMIDs. The IMID registry is a longitudinal observational prospective cohort study within the departments of rheumatology, gastroenterology, dermatology, immunology, clinical pharmacy, and outpatient pharmacy of the Erasmus MC, the Netherlands. Patients with the following diseases are eligible for inclusion: inflammatory arthritis, inflammatory bowel disease, atopic dermatitis, psoriasis, uveitis, Behçet disease, sarcoidosis, and systemic vasculitis. Generic and disease-specific (patient-reported) outcomes, including adherence to medication, side effects, quality of life, work productivity, disease damage, and activity, are collected from patients and providers at fixed intervals before and during outpatient clinic visits. Data are collected and visualized through a data capture system, which is linked directly to the patients' electronic health record, which not only facilitates a more holistic care approach, but also helps with shared decision-making. The IMID registry is an ongoing cohort with no end date. Inclusion started in April 2018. From start until September 2022, a total of 1417 patients have been included from the participating departments. The mean age at inclusion was 46 (SD 16) years, and 56% of the patient population is female. The average percentage of filled out questionnaires at baseline is 84%, which drops to 72% after 1 year of follow-up. This decline may be due to the fact that the outcomes are not always discussed during the outpatient clinic visit or because the questionnaires were sometimes forgotten to set out. The registry is also used for research purposes and 92% of the patients with IMIDs gave informed consent to use their data for that. The IMID registry is a web-based digital system that collects provider- and PROs. The collected outcomes are used to improve care for the individual patient with an IMID and facilitate shared decision-making, and they are also used for research purposes. The measurement of these outcomes is an essential step toward the implementation of VBHC. DERR1-10.2196/43230.

Cross-Sectional Survey of Acupuncturists in the United States Who Prescribed Chinese Herbal Medicine for Patients with Symptoms Likely Related to COVID-19.

Objective: The objective of this study was to examine the prescribing of Chinese herbal medicine (CHM) by licensed acupuncturists in the United States during the COVID-19 pandemic. Methods: A 28-question survey with nine branching questions was disseminated through collegial networks, paid advertisements, and a study website in April-July 2021. Participants indicated that they were licensed acupuncturists who treated more than five patients for symptoms likely related to COVID-19 to gain entry to the full survey. Surveys were undertaken electronically through the Research Electronic Data Capture (REDCap) system. Results: The survey was undertaken by 103 participants representing all US geographic regions and had an average of 17 years in practice. Sixty-five percent received or intended to receive the COVID-19 vaccine. Phone and videoconference were the predominant methods of patient contact; granules and pill forms of CHM were the most prescribed. A wide variety of information sources were used in devising patient treatments inclusive of anecdotal, observational, and scientific sources. Most patients were not receiving biomedical treatment. Ninety-seven percent of participants reported that they had no patients die of COVID-19, and the majority reported that <25% of their patients developed long hauler syndrome (post-acute sequelae SARS-CoV-2 infection). Conclusions: This study demonstrates that licensed acupuncturists were treating COVID-19 infected individuals in the United States during the early stages of the pandemic, and for many such patients this was the only therapeutic intervention they had access to from a licensed health care provider. Information disseminated from China through collegial networks, along with published sources including scientific studies, informed the approach to treatment. This study provides insight into an unusual circumstance in which clinicians needed to establish evidence-based approaches to the treatment of a new disease during a public health emergency.

Editor's Choice – Early Outcomes of a Novel Off the Shelf Preloaded Inner Branch Endograft for the Treatment of Complex Aortic Pathologies in the ItaliaN Branched Registry of E-nside EnDograft (INBREED)

The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies. Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days. In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I - III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n= 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n= 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention. In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.

Disaggregating Racial and Ethnic Data: A Step Toward Diversity, Equity, and Inclusion

Disaggregating Racial and Ethnic Data: A Step Toward Diversity, Equity, and Inclusion

Development and Implementation of a Mobile Data Capture System for Oral Immunotherapy

Oral immunotherapy (OIT) is increasingly gaining acceptance as a food allergy treatment. Treatment success requires adherence to daily dosing and adjustments due to missed doses, illness, or adverse events (AEs). Therefore, treatment teams need timely access to safety and adherence data.

Impact of the COVID-19 Pandemic on Injury Incidence in Japanese Male Professional Soccer Players.

The outbreak of the 2019 novel coronavirus disease (COVID-19) led to an enforced quarantine period and limited training and match activities for athletes. To report the influence of the COVID-19 pandemic on the occurrence of injury in Japanese male professional soccer players. Descriptive epidemiology study. In total, 21 clubs in the 2019 season and 28 clubs in the 2020 season from the Japan Professional Football League were prospectively followed, and 16 clubs in 2019 and 24 clubs in 2020 were analyzed in this study. Individual training, match exposure, and time-loss injuries were recorded using an electronic data capture system. The influence of COVID-19-related suspension during the 2020 season was retrospectively investigated via comparisons with the 2019 season. Total activity time included 114,001 hours in training and 16,339 hours in matches in 2019 and 170,798 hours in training and 25,411 hours in matches in 2020. The mean training interruption period caused by COVID-19 in 2020 was 39.9 days (range, 3-65 days), and the mean game-interruption period was 70.1 days (range, 58-79 days). The total number of injuries was 1495 in 2019 and 1701 in 2020. The overall injury incidence per 1000 hours of exposure was 5.7 in 2019 and 5.8 in 2020. The overall injury burden per 1000 hours of exposure was 155.5 days in 2019 and 130.2 days in 2020. The muscle injury incidence was highest in May 2020, immediately after the suspension period. The overall injury incidence did not differ between 2019 and 2020. However, muscle injury incidence notably increased in the 2 months after the COVID-19 pandemic suspension period.

Federated electronic data capture (fEDC): Architecture and prototype

In clinical research as well as patient care, structured documentation of findings is an important task. In many cases, this is achieved by means of electronic case report forms (eCRF) using corresponding information technology systems. To avoid double data entry, eCRF systems can be integrated with electronic health records (EHR). However, when researchers from different institutions collaborate in collecting data, they often use a single joint eCRF system on the Internet. In this case, integration with EHR systems is not possible in most cases due to information security and data protection restrictions.To overcome this shortcoming, we propose a novel architecture for a federated electronic data capture system (fEDC). Four key requirements were identified for fEDC: Definitions of forms have to be available in a reliable and controlled fashion, integration with electronic health record systems must be possible, patient data should be under full local control until they are explicitly transferred for joint analysis, and the system must support data sharing principles accepted by the scientific community for both data model and data captured.With our approach, sites participating in a joint study can run their own instance of an fEDC system that complies with local standards (such as being behind a network firewall) while also being able to benefit from using identical form definitions by sharing metadata in the Operational Data Model (ODM) format published by the Clinical Data Interchange Standards Consortium (CDISC) throughout the collaboration. The fEDC architecture was validated with a working open-source prototype at five German university hospitals.The fEDC architecture provides a novel approach with the potential to significantly improve collaborative data capture: Efforts for data entry are reduced and at the same time, data quality is increased since barriers for integrating with local electronic health record systems are lowered. Further, metadata are shared and patient privacy is ensured at a high level.

Stakeholder-driven development and implementation of CRICIT: an app to support high-quality data capture and protocol monitoring for outpatient clinical trials with vulnerable populations.

Choosing an appropriate electronic data capture system (EDC) is a critical decision for all randomized controlled trials (RCT). In this paper, we document our process for developing and implementing an EDC for a multisite RCT evaluating the efficacy and implementation of an enhanced primary care model for individuals with opioid use disorder who are returning to the community from incarceration. Informed by the Knowledge-to-Action conceptual framework and user-centered design principles, we used Claris Filemaker software to design and implement CRICIT, a novel EDC that could meet the varied needs of the many stakeholders involved in our study. CRICIT was deployed in May 2021 and has been continuously iterated and adapted since. CRICIT's features include extensive participant tracking capabilities, site-specific adaptability, integrated randomization protocols, and the ability to generate both site-specific and study-wide summary reports. CRICIT is highly customizable, adaptable, and secure. Its implementation has enhanced the quality of the study's data, increased fidelity to a complicated research protocol, and reduced research staff's administrative burden. CRICIT and similar systems have the potential to streamline research activities and contribute to the efficient collection and utilization of clinical research data.

Anticoagulation Interventions by Pharmacists in Acute Care.

Clinical pharmacy key performance indicators (cpKPIs) relate to activities performed by pharmacists that have been shown to improve patient outcomes. Within Saskatchewan Health Authority (SHA) Regina, most cpKPIs are incorporated into the organization's clinical practice standards, which provide guidance in prioritizing care, especially for high-risk medications, including anticoagulants. To track pharmacists' interventions associated with clinical practice standards, a locally developed electronic data-capture system (known as AIM High) was implemented. To quantify and describe pharmacists' anticoagulation interventions on 16 wards with dedicated ward-based clinical pharmacists and to compare intervention rates between the cardiology and internal medicine wards to further evolve the organization's practice model. Data from the electronic data-capture system were retrospectively analyzed for a 5-year period (January 2016 to December 2020). A total of 94 201 interventions were recorded in the AIM High system (average 362 interventions per week or 26 interventions per pharmacist per week). Of these, 15 661 (16.6%) cited the anticoagulation standard (average 60 anticoagulation interventions per week or 4 anticoagulant interventions per pharmacist per week). For the cardiology and internal medicine wards, 4183 of 11 888 (35.2%) and 9034 of 54 843 (16.5%) interventions cited the anticoagulation standard, respectively. The top 4 types of anticoagulation interventions were dose changed (n = 4372 or 27.9%), drug started or restarted (n = 3867 or 24.7%), patient education (n = 3094 or 19.8%), and drug discontinued (n = 2944 or 18.8%). Dedicated ward-based clinical pharmacists were following clinical practice standards incorporating the majority of cpKPIs to complete anticoagulation interventions. The types of anticoagulation interventions evolved over time and were influenced by the patient population.

Software development process of Neotree - a data capture and decision support system to improve newborn healthcare in low-resource settings.

The global priority of improving neonatal survival could be tackled through the universal implementation of cost-effective maternal and newborn health interventions. Despite 90% of neonatal deaths occurring in low-resource settings, very few evidence-based digital health interventions exist to assist healthcare professionals in clinical decision-making in these settings. To bridge this gap, Neotree was co-developed through an iterative, user-centered design approach in collaboration with healthcare professionals in the UK, Bangladesh, Malawi, and Zimbabwe. It addresses a broad range of neonatal clinical diagnoses and healthcare indicators as opposed to being limited to specific conditions and follows national and international guidelines for newborn care. This digital health intervention includes a mobile application (app) which is designed to be used by healthcare professionals at the bedside. The app enables real-time data capture and provides education in newborn care and clinical decision support via integrated clinical management algorithms. Comprehensive routine patient data are prospectively collected regarding each newborn, as well as maternal data and blood test results, which are used to inform clinical decision making at the bedside. Data dashboards provide healthcare professionals and hospital management a near real-time overview of patient statistics that can be used for healthcare quality improvement purposes. To enable this workflow, the Neotree web editor allows fine-grained customization of the mobile app. The data pipeline manages data flow from the app to secure databases and then to the dashboard. Implemented in three hospitals in two countries so far, Neotree has captured routine data and supported the care of over 21,000 babies and has been used by over 450 healthcare professionals. All code and documentation are open source, allowing adoption and adaptation by clinicians, researchers, and developers.

Healthcare professionals’ perception of safety culture and the Operating Room (OR) Black Box technology before clinical implementation: a cross-sectional survey

IntroductionComprehensive data capture systems such as the Operating Room Black Box (OR Black Box) are becoming more widely implemented to access quality data in the complex environment of the OR....

Assessment of Menstrual Health and Bleeding Symptoms in Adolescent Girls and Young Women with Sickle Cell Disease

Introduction: Sickle Cell Disease (SCD) is traditionally associated with thrombotic events such as venous thromboembolism and cerebrovascular events. However, adults with SCD have an increased cumulative incidence of bleeding complications by 40 years of age, including heavy menstrual bleeding (HMB). HMB affects 40% of adolescent girls in the general population and is a common reason for referral to pediatric hematology clinics. Whether adolescent girls and young women with SCD are similarly affected by HMB and other bleeding manifestations have not been well described. This purpose of this study was to assess the menstrual health status of this population and to estimate the prevalence of HMB and other bleeding symptoms. Methods: Menarchal adolescent girls and young women aged 12-21 years old, diagnosed with any SCD genotype, and followed in one of three pediatric hematology clinics at a large tertiary care children's hospital were approached for a cross-sectional study. The study consisted of a 5-part questionnaire administered through the Research Electronic Data Capture (REDCap) system. The questionnaire included collection of demographic information, menstrual health knowledge assessment, menstrual bleeding medication rating profile, and validated instruments for patient-reported HMB outcomes and historical bleeding symptoms. The patient-reported outcome instruments consisted of the one-month recall Menstrual Bleeding Questionnaire (MBQ) and Self-Administered Bleeding Assessment Tool (Self-BAT). Statistical procedures involved chi-squared test and Kruskal-Wallis test. Statistical significance was set at p<0.05. Results: To date, 38 participants have completed the questionnaire. The mean age of the study cohort was 15.9 ± 2.3 years. Individuals with SCD genotype HbSS comprised the majority of the cohort and 53% (n = 20) reported hydroxyurea use (Table 1). Mean age of menarche was 13 years (min-max 10-15 years). On the menstrual health knowledge assessment, 6 participants (16%) correctly identified all four characteristics of normal menstruation per American College of Obstetricians and Gynecologists (ACOG) definitions. Specifically, 50% correctly identified the expected duration of menses and 45% identified all of the pharmacologic categories available for menstrual regulation. Parents/guardians were the primary source of menstrual health knowledge (84%), while social media/internet was the predominant secondary source (29%). The mean MBQ score was 14.1 ± 8.5. For comparison, the MBQ validation study performed in adult women with and without HMB reported a mean MBQ score of 30.8 ± 14 and 10.6 ± 8.6, respectively. Approximately 55% of participants reported moderate or severe pain related to menstrual cycles. Pain was not significantly associated with age, hydroxyurea use, or self-reported history of HMB. Ibuprofen (16%) and acetaminophen (11%) were the main medications listed for menstrual pain relief. For the Self-BAT, abnormal bleeding scores are classified as ≥3 in children and ≥6 in women. The cohort mean Self-BAT score was 1.6 (min-max 0-8) and 29% (n = 11) had abnormal bleeding scores. Bleeding symptoms reported were post-surgical/trauma-induced bleeding, epistaxis, prolonged bleeding from small cuts, and bleeding after tooth extraction. Interestingly, 12 participants (32%) reported a history of HMB on the Self-BAT. There were no significant differences in MBQ or Self-BAT scores by age and hydroxyurea use, although individuals with HMB had significantly higher MBQ and Self-BAT scores (Table 2). Six participants (50%) with HMB attempted ≥1 hormonal therapy method for menstrual regulation. One additional participant without HMB received hormonal therapy. Conclusions: In this study, we demonstrate that 32% of adolescent girls and young women with SCD reported a history of HMB and the majority of participants reported moderate/severe pain related to their menstrual cycle. Yet, only 50% with HMB attempted a hormonal therapy. Furthermore, most of the participants had reduced knowledge of normal menstrual health. These findings suggest a critical need for improved education and patient/provider discussion regarding menstruation. Ultimately, incorporating menstrual health assessment into SCD care is important for optimizing patient health and addressing health inequities in the adolescent and SCD population. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Study Design of the Japanese Association of Cardiac Rehabilitation Registry (J-CARRY) - Protocol for a Prospective, Multicenter, Open Registry.

Background: Guidelines for the prevention and management of cardiovascular disease (CVD) highly recommend cardiac rehabilitation (CR) on the basis of abundant evidence of its effectiveness. However, the current understanding and dissemination of CR in Japan are far from sufficient. Methods and Results: The Japanese Association of Cardiac Rehabilitation Registry (J-CARRY) is an academic society-led prospective multicenter observational registry conducted by the Registration and Facility Accreditation System Committee of the Japanese Association of Cardiac Rehabilitation. Data are collected prospectively using an electronic data capture system. Items related to patients' clinical background and CR, as well as mortality and major adverse cardiac and cerebrovascular events, will be collected in all cases. This Registry started in May 2014, and the number of participating medical institutions is expected to increase to >30; the targeted number of cases exceeded 3,000 per year as of April 30, 2022. Focusing on late Phase II data collection is a novel and significantly different approach compared with previous studies. The results of this study are currently under investigation. Conclusions: J-CARRY will provide real-world data regarding the current status and prognosis of CVD in patients who undergo Phase II CR in Japan.

Web-Based System to Capture Consistent and Complete Real-world Data of Physical Therapy Interventions Following Total Knee Replacement: Design and Evaluation Study.

Electronic health records (EHRs) have the potential to facilitate consistent clinical data capture to support excellence in patient care, quality improvement, and knowledge generation. Despite widespread EHR use, the vision to transform health care system and its data to a "learning health care system" generating knowledge from real-world data is limited by the lack of consistent, structured clinical data. The purpose of this paper was to demonstrate the design of a web-based structured clinical intervention data capture system and its evaluation in practice. The use case was ambulatory physical therapy (PT) treatment after total knee replacement (TKR), one of the most common and costly procedures today. To identify the PT intervention type and intensity (or dose) used to treat patients with knee arthritis following TKR, an iterative user-centered design process refined an initial list of PT interventions generated during preliminary chart reviews. Input from practicing physical therapists and national and international experts refined and categorized the interventions. Next, a web-based, hierarchical structured system for intervention and intensity documentation was designed and deployed. The PT documentation system was implemented by 114 physical therapists agreeing to record all interventions at patient visits. Data for 161 patients with 2615 PT visits were entered by 83 physical therapists. No technical problems with data entry were reported, and data entry required less than 2 minutes per visit. A total of 42 (2%) interventions could not be categorized and were recorded using free text. The use of user-centered design principles provides a road map for developing clinically feasible data capture systems that employ structured collection of uniform data for use by multiple practitioners across institutions to complement and augment existing EHRs. Secondarily, these data can be analyzed to define best practices and disseminate knowledge to practice.

Evaluating the Accuracy of the Annual Statewide Kindergarten Vaccination Survey Submitted to Public Health Authorities by School Systems, Oklahoma, 2018.

Recent trends in vaccine hesitancy have brought to light the importance of using accurate school vaccination data. This study evaluated the accuracy of a pilot statewide kindergarten vaccination survey in Oklahoma. School vaccination and exemption data were collected from November 2017 to April 2018 via the Research Electronic Data Capture system. A multivariable linear regression model was used to evaluate the relationship between students who are up to date for all vaccines comparing school reported and Oklahoma State Department of Health-validated data. Adjusted vaccination data were overestimated by 1.0% among public schools and 3.3% among private schools. These results were validated by a random audit of participating schools finding the school-reported vaccination data to be overestimated by 0.6% compared to true student immunization records on file. Our analysis indicates that school-reported vaccination data are sufficiently valid. Immunization record audits provide confidence in available data, which drives evidence-based decision-making.