Browsing by Subject "Registry"

Now showing 1 - 9 of 9
  • Thumbnail Image
    Item
    Approaches to Studying Outcomes in Patients With Congenital Heart Disease With Genetic Syndromes: What Down Syndrome Can Teach Us
    (American Heart Association, 2024) Ware, Stephanie M.; Medical and Molecular Genetics, School of Medicine
  • Thumbnail Image
    Item
    “Do they REALLY trust us”?: Lessons from a volunteer research registry
    (Cambridge University Press, 2024-11-11) Sotto-Santiago, Sylk; Wiehe, Sarah; Hudson, Brenda; Slaven, James; Vinaixa, Conor; Bruns, Rebecca; Claxton, Gina; Delp, Lynsey; Lynch, Dustin; Moe, Sharon; Medicine, School of Medicine
    Background: All IN for Health is a well-established community-academic partnership dedicated to helping improve the lives of Indiana residents by increasing health research literacy and promoting health resources, as well as opportunities to participate in research. It is sponsored by the Indiana Clinical and Translational Science Institute (I-CTSI). The study's purpose was to measure trust in biomedical research and healthcare organizations among research volunteers. Methods: The Relationship of Trust and Research Engagement (RTRE) survey was developed utilizing 3 validated scales. The RTRE consisted of 36 items in a 5-point Likert scale with three open-text questions. We conducted 3 focus groups with a total of 24 individuals ahead of the survey's launch. Recruitment was done through the All IN for Health newsletter. The survey was administered in the summer of 2022. Results: Six hundred and sixty-three individuals participated in the survey. Forty-one percent agreed that doctors do medical research for selfish reasons. Moreover, 50% disagree that patients get the same medical treatment regardless of race/ethnicity. Sixty-seven percent think it is safe to participate in medical research, yet 79% had never been asked to participate. Ten percent believe that researchers select minorities for their most dangerous studies and expose minoritized groups to diseases. Conclusion: The utilization of tools to measure trust will facilitate participant recruitment and will assist institutions and investigators alike in accountability. It is imperative, we work toward understanding our communities' trust in medical research, assessing our own trustworthiness, and critically reflect on the authenticity of our efforts.
  • Thumbnail Image
    Item
    Epidemiology and risk factors for varicella zoster virus reactivation in heart transplant recipients
    (Wiley, 2021) La Hoz, Ricardo M.; Wallace, Ashley; Barros, Nicolas; Xie, Donglu; Hynan, Linda S.; Liu, Terrence; Yek, Christina; Schexnayder, Scott; Grodin, Justin L.; Garg, Sonia; Drazner, Mark H.; Peltz, Matthias; Haley, Robert W.; Greenberg, David E.; Medicine, School of Medicine
    Heart transplant (HT) recipients are at higher risk of varicella zoster virus (VZV) reactivation. Risk factors for VZV reactivation are currently not well defined, impeding the ability to design and implement strategies to minimize the burden of this illness in this population. Automated data extraction tools were used to retrieve data from the electronic health record (EHR) of all adult HT recipients at our center between 2010 and 2016. Information from the Organ Procurement and Transplantation Network Standard Analysis and Research Files was merged with the extracted data. Potential cases were manually reviewed and adjudicated using consensus definitions. Cumulative incidence and risk factors for VZV reactivation in HT recipients were assessed by the Kaplan-Meier method and Cox modeling, respectively. In 203 HT recipients, the cumulative incidence of VZV reactivation at 8-years post-transplantation was 26.4% (95% CI: 17.8-38.0). The median time to VZV reactivation was 2.1 years (IQR, 1.5-4.1). Half (14/28) of the cases experienced post-herpetic neuralgia (PHN). Post-transplant CMV infection (HR 9.05 [95% CI: 3.76-21.77) and post-transplant pulse-dose steroids (HR 3.19 [95% CI: 1.05-9.68]) were independently associated with a higher risk of VZV reactivation in multivariable modeling. Identification of risk factors will aid in the development of targeted preventive strategies.
  • Thumbnail Image
    Item
    Impact of post-transplantation maintenance therapy on health-related quality of life in patients with multiple myeloma: data from the Connect® MM Registry
    (Springer, 2018-12) Abonour, Rafat; Wagner, Lynne; Durie, Brian G.M.; Jagannath, Sundar; Narang, Mohit; Terebelo, Howard R.; Gasparetto, Cristina J.; Toomey, Kathleen; Hardin, James W.; Kitali, Amani; Gibson, Craig J.; Srinivasan, Shankar; Swern, Arlene S.; Rifkin, Robert M.; Medicine, School of Medicine
    Maintenance therapy after autologous stem cell transplantation (ASCT) is recommended for use in multiple myeloma (MM); however, more data are needed on its impact on health-related quality of life (HRQoL). Presented here is an analysis of HRQoL in a Connect MM registry cohort of patients who received ASCT ± maintenance therapy. The Connect MM Registry is one of the earliest and largest, active, observational, prospective US registry of patients with symptomatic newly diagnosed MM. Patients completed the Functional Assessment of Cancer Therapy-MM (FACT-MM) version 4, EuroQol-5D (EQ-5D) questionnaire, and Brief Pain Inventory (BPI) at study entry and quarterly thereafter until death or study discontinuation. Patients in three groups were analyzed: any maintenance therapy (n = 244), lenalidomide-only maintenance therapy (n = 169), and no maintenance therapy (n = 137); any maintenance and lenalidomide-only maintenance groups were not mutually exclusive. There were no significant differences in change from pre-ASCT baseline between any maintenance (P = 0.60) and lenalidomide-only maintenance (P = 0.72) versus no maintenance for the FACT-MM total score. There were also no significant differences in change from pre-ASCT baseline between any maintenance and lenalidomide-only maintenance versus no maintenance for EQ-5D overall index, BPI, FACT-MM Trial Outcomes Index, and myeloma subscale scores. In all three groups, FACT-MM, EQ-5D Index, and BPI scores improved after ASCT; FACT-MM and BPI scores deteriorated at disease progression. These data suggest that post-ASCT any maintenance or lenalidomide-only maintenance does not negatively impact patients' HRQoL. Additional research is needed to verify these findings.
  • Thumbnail Image
    Item
    INternational Study Group of Pediatric Pancreatitis: In Search for a CuRE Cohort Study: Design and Rationale for INSPPIRE 2 From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer
    (Wolters Kluwer, 2018-11) Uc, Aliye; Perito, Emily R.; Pohl, John F.; Shah, Uzma; Abu-El-Haija, Maisam; Barth, Bradley; Bellin, Melena D.; Ellery, Kate M.; Fishman, Douglas S.; Gariepy, Cheryl E.; Giefer, Matthew J.; Gonska, Tanja; Heyman, Melvin B.; Himes, Ryan W.; Husain, Sohail Z.; Maqbool, Asim; Mascarenhas, Maria R.; McFerron, Brian A.; Morinville, Veronique D.; Lin, Tom K.; Liu, Quin Y.; Nathan, Jaimie D.; Rhee, Sue J.; Ooi, Chee Y.; Sellers, Zachary M.; Schwarzenberg, Sarah Jane; Serrano, Jose; Troendle, David M.; Werlin, Steven L.; Wilschanski, Michael; Zheng, Yuhua; Yuan, Ying; Lowe, Mark E.; Pediatrics, School of Medicine
    We created the INternational Study Group of Pediatric Pancreatitis: In Search for a CuRE (INSPPIRE 2) cohort to study the risk factors, natural history, and outcomes of pediatric acute recurrent pancreatitis and chronic pancreatitis (CP). Patient and physician questionnaires collect information on demographics, clinical history, family and social history, and disease outcomes. Health-related quality of life, depression, and anxiety are measured using validated questionnaires. Information entered on paper questionnaires is transferred into a database managed by Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer's Coordinating and Data Management Center. Biosamples are collected for DNA isolation and analysis of most common pancreatitis-associated genes.Twenty-two sites (18 in the United States, 2 in Canada, and 1 each in Israel and Australia) are participating in the INSPPIRE 2 study. These sites have enrolled 211 subjects into the INSPPIRE 2 database toward our goal to recruit more than 800 patients in 2 years. The INSPPIRE 2 cohort study is an extension of the INSPPIRE cohort study with a larger and more diverse patient population. Our goals have expanded to include evaluating risk factors for CP, its sequelae, and psychosocial factors associated with pediatric acute recurrent pancreatitis and CP.
  • Thumbnail Image
    Item
    Patient-Reported Outcomes in Autosomal Dominant Osteopetrosis: Findings From the Osteopetrosis Registry Study
    (Oxford University Press, 2025) Polgreen, Lynda E.; Villa-Lopez, Eva; Chen, Liz; Liu, Ziyue; Katz, Amy; Parks-Schenck, Corinne; Hart, Marian; Imel, Erik A.; Econs, Michael J.; Biostatistics and Health Data Science, Richard M. Fairbanks School of Public Health
    Context: Autosomal dominant osteopetrosis (ADO) is a rare sclerotic bone disease characterized by impaired osteoclast activity, resulting in high bone mineral density and skeletal fragility. The full phenotype and disease burden on patients' daily lives has not been systematically measured. Objective: We developed an online registry to ascertain population-based data on the spectrum and rate of progression of disease and to identify relevant patient-centered outcomes that could be used to measure treatment effects and guide the design of future clinical trials. Methods: Cross-sectional data from participants with osteopetrosis were collected using an online REDCap-based database. Thirty-four participants with a confirmed diagnosis of ADO, aged 4-84 years were included. Participants aged 18 years and older completed the PROMIS 57, participants aged 8-17 years completed the PROMIS Pediatric 49, and parents of participants aged <18 years completed the PROMIS Parent Proxy 49. Results: Based on the PROMIS 57, relative to the general population, adults with ADO reported low physical function and low ability to participate in social roles and activities, and high levels of anxiety, fatigue, sleep problems, and pain interference. Daily pain medications were reported by 24% of the adult population. In contrast, neither pediatric participants nor their parent proxy reported a negative impact on health-related quality of life. Conclusion: Data from this registry demonstrate the broad spectrum of ADO disease severity and high impact on health-related quality of life in adults with ADO.
  • Thumbnail Image
    Item
    Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study
    (Frontiers Media, 2023-02-23) Alkhalifah, Joud Mohammed; Al Seraihi, Ahad; Al-Tawfiq, Jaffar A.; Alshehri, Badr Fadhel; Alhaluli, Alhanouf Hani; Alsulais, Naif Mansour; Alessa, Mohammed Mesfer; Seddiq, Waleed; Aljeri, Thamer; Qahtani, Mohammad Hassan; Barry, Mazin; Al-Otaiby, Maram; Medicine, School of Medicine
    Background: Vaccination against coronavirus disease 2019 (COVID-19) is the most effective way to end the pandemic. Any development of adverse events (AEs) from various vaccines should be reported. We therefore aimed to explore major and minor AEs among vaccinated individuals in Saudi Arabia. Methods: This is a nationwide report based on the Saudi Arabian Ministry of Health (MOH) registry. It included those who received COVID-19 vaccines from 17th December 2020 to 31st December 2021. The study included spontaneous self-reported adverse effects to COVID-19 vaccines where the study participants used a governmental mobile app (Sehhaty) to report their AEs following vaccination using a checklist option that included a selection of side-effects. The primary outcome was to determine AEs reported within 14 days of vaccination which included injection site itching, pain, reaction, redness, swelling, anxiety, dizziness, fever, headache, hoarseness, itchiness, loss of consciousness, nausea, heartburn, sleep disruption, fatigue, seizures, anaphylaxis, shortness of breath, wheezing, swelling of lips, face, and throat, loss of consciousness, and admissions into the intensive care unit (ICU). Results: The study included a total number of 28,031 individuals who reported 71,480 adverse events (AEs); which were further classified into minor and major adverse events including ICU admissions post vaccination. Of the reported AEs, 38,309 (53. 6%) side-effects were reported following Pfizer-BioNTech, 32,223 (45%) following Oxford-AstraZeneca, and 948 (1.3%) following Moderna. The following reported AEs were statistically significant between the different vaccine types: shortness of breath\difficulty of breathing, dizziness, fever above 39°C, headache, hoarseness, injection site reactions, itchiness, nausea, sleep disruption, fatigue, wheezing, swelling of lips/face and\or throat, and loss of consciousness (p-value < 0.05). Fever and seizure were the only statistically significant AEs amongst the number of vaccine doses received (p-value < 0.05). Ten ICU admissions were reported in the 14 days observation period post-COVID-19 vaccination with the following diagnoses: acute myocardial infarction, pneumonia, atherosclerosis, acute respiratory failure, intracranial hemorrhage, grand mal seizure, Guillain-Barré syndrome, abnormal blood gas levels, and septic shock. Conclusion: This study demonstrated that the most prevalent SARS-CoV-2 vaccine side-effects among adults in Saudi Arabia were mild in nature. This information will help reduce vaccine hesitancy and encourage further mass vaccination to combat the COVID-19 pandemic, especially as booster doses are now available. Further studies are warranted to obtain a better understanding of the association between risk factors and the experiencing of side-effects post vaccination.
  • Thumbnail Image
    Item
    Rationale for the Cytogenomics of Cardiovascular Malformations Consortium: A Phenotype Intensive Registry Based Approach
    (MDPI, 2015-04-29) Hinton, Robert B.; McBride, Kim L.; Bleyl, Steven B.; Bowles, Neil E.; Border, William L.; Garg, Vidu; Smolarek, Teresa A.; Lalani, Seema R.; Ware, Stephanie M.; Pediatrics, School of Medicine
    Cardiovascular malformations (CVMs) are the most common birth defect, occurring in 1%-5% of all live births. Although the genetic contribution to CVMs is well recognized, the genetic causes of human CVMs are identified infrequently. In addition, a failure of systematic deep phenotyping of CVMs, resulting from the complexity and heterogeneity of malformations, has obscured genotype-phenotype correlations and contributed to a lack of understanding of disease mechanisms. To address these knowledge gaps, we have developed the Cytogenomics of Cardiovascular Malformations (CCVM) Consortium, a multi-site alliance of geneticists and cardiologists, contributing to a database registry of submicroscopic genetic copy number variants (CNVs) based on clinical chromosome microarray testing in individuals with CVMs using detailed classification schemes. Cardiac classification is performed using a modification to the National Birth Defects Prevention Study approach, and non-cardiac diagnoses are captured through ICD-9 and ICD-10 codes. By combining a comprehensive approach to clinically relevant genetic analyses with precise phenotyping, the Consortium goal is to identify novel genomic regions that cause or increase susceptibility to CVMs and to correlate the findings with clinical phenotype. This registry will provide critical insights into genetic architecture, facilitate genotype-phenotype correlations, and provide a valuable resource for the medical community.
  • Thumbnail Image
    Item
    The Society for Cardiovascular Magnetic Resonance Registry at 150,000
    (Elsevier, 2024-07-04) Tong, Matthew S.; Slivnick, Jeremy A.; Sharif, Behzad; Kim, Han W.; Young, Alistair A.; Sierra-Galan, Lilia M.; Mukai, Kanae; Farzaneh-Far, Afshin; Al-Kindi, Sadeer; Chan, Angel T.; Dibu, George; Elliott, Michael D.; Ferreira, Vanessa M.; Grizzard, John; Kelle, Sebastian; Lee, Simon; Malahfji, Maan; Petersen, Steffen E.; Polsani, Venkateshwar; Toro-Salazar, Olga H.; Shaikh, Kamran A.; Shenoy, Chetan; Srichai, Monvadi B.; Stojanovska, Jadranka; Tao, Qian; Wei, Janet; Weinsaft, Jonathan W.; Wince, W. Benjamin; Chudgar, Priya D.; Judd, Matthew; Judd, Robert M.; Shah, Dipan J.; Simonetti, Orlando P.; Medicine, School of Medicine
    Background: Cardiovascular magnetic resonance (CMR) is increasingly utilized to evaluate expanding cardiovascular conditions. The Society for Cardiovascular Magnetic Resonance (SCMR) Registry is a central repository for real-world clinical data to support cardiovascular research, including those relating to outcomes, quality improvement, and machine learning. The SCMR Registry is built on a regulatory-compliant, cloud-based infrastructure that houses searchable content and Digital Imaging and Communications in Medicine images. The goal of this study is to summarize the status of the SCMR Registry at 150,000 exams. Methods: The processes for data security, data submission, and research access are outlined. We interrogated the Registry and presented a summary of its contents. Results: Data were compiled from 154,458 CMR scans across 20 United States sites, containing 299,622,066 total images (∼100 terabytes of storage). Across reported values, the human subjects had an average age of 58 years (range 1 month to >90 years old), were 44% (63,070/145,275) female, 72% (69,766/98,008) Caucasian, and had a mortality rate of 8% (9,962/132,979). The most common indication was cardiomyopathy (35,369/131,581, 27%), and most frequently used current procedural terminology code was 75561 (57,195/162,901, 35%). Macrocyclic gadolinium-based contrast agents represented 89% (83,089/93,884) of contrast utilization after 2015. Short-axis cines were performed in 99% (76,859/77,871) of tagged scans, short-axis late gadolinium enhancement (LGE) in 66% (51,591/77,871), and stress perfusion sequences in 30% (23,241/77,871). Mortality data demonstrated increased mortality in patients with left ventricular ejection fraction <35%, the presence of wall motion abnormalities, stress perfusion defects, and infarct LGE, compared to those without these markers. There were 456,678 patient-years of all-cause mortality follow-up, with a median follow-up time of 3.6 years. Conclusion: The vision of the SCMR Registry is to promote evidence-based utilization of CMR through a collaborative effort by providing a web mechanism for centers to securely upload de-identified data and images for research, education, and quality control. The Registry quantifies changing practice over time and supports large-scale real-world multicenter observational studies of prognostic utility.