TheraDoc Designs Innovative Data Collection Process to Facilitate Clinical Research.Business Editors/Health/Medical Writers SALT LAKE CITY--(BUSINESS WIRE)--Sept. 15, 2003 TheraDoc's Customized Software See custom software. and PDAs Enable Accelerated Collection and Submission of Critical Patient Data A customized data collection software program integrated into PDAs and designed by TheraDoc Inc., a medical informatics medical informatics, n the field of information science concerned with the analysis and dissemination of medical data through the application of computers to various aspects of health care and medicine. company, has proven to significantly accelerate the clinical research processes in an ongoing observational cohort study A cohort study is a form of longitudinal study used in medicine and social science. It is one type of study design. In medicine, it is usually undertaken to obtain evidence to try to refute the existence of a suspected association between cause and disease; failure to refute called "ALARM" (Assessment of Local Antimicrobial Resistance Measures), coordinated by FJ Rodino Healthcare Group. TheraDoc's unique solution allows physicians to easily collect critical study data at the patient's bedside and immediately submit the information to a secure, centralized database via wireless PDA (Personal Digital Assistant) A handheld computer for managing contacts, appointments and tasks. It typically includes a name and address database, calendar, to-do list and note taker, which are the functions in a personal information manager (see PIM). technology. ALARM's objective is to assess local patterns of antimicrobial resistance and determine the most appropriate initial empiric therapy Empiric therapy is a medical term referring to the initiation of treatment prior to determination of a firm diagnosis. It is most often used when antibiotics are given to a person before the specific microorganism causing an infection is known. for patients suspected of having ventilator-associated pneumonia (VAP (Value Added Process) An executable program in a NetWare 2.x server. Starting with NetWare 3.x, VAPs were replaced by NLMs. See NetWare. ). According to Frank J. Rodino, MHS (1) (Message Handling Service) An earlier messaging system from Novell that supported multiple operating systems and other messaging protocols, including SMTP, SNADS and X.400. It used the SMF-71 messaging format. , PA, founder and president of the FJ Rodino Healthcare Group, the ALARM study "enables an analysis of how doctors are using the information they have available to prescribe antibiotics for VAP and how accurate and effective those decisions are." The study is supported by an educational grant from Elan Pharmaceuticals and involves more than 60 physicians in demographically diverse hospitals across the country. Rodino further stated, "The steering committee and I selected TheraDoc based on the company's excellent reputation and extensive experience in developing software technologies, such as their Antibiotic Assistant, which enables physicians to address anti-microbial resistance and improve infection control in hospitals." Stanley Pestotnik, TheraDoc's co-founder and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , said, "It has been a privilege to provide a customized PDA data collection program for the ALARM study. The technology we've designed for this study is perfectly aligned with our expertise in developing software that reduces medical errors and mortality rates, improves infection control and lowers treatment costs, all in real-time." Rolf Wagenaar, product manager at Elan Pharmaceuticals, added, "TheraDoc's innovative programming is a powerful tool that takes data collection to another level, significantly accelerating the clinical investigation process. TheraDoc's user-friendly interface not only saves time, it also facilitates physician participation." The majority of clinical research studies rely on paper-based data collection processes and Wagenaar notes that the use of TheraDoc's technology for electronic data collection is "groundbreaking." Dr. Marin H. Kollef, participating physician and steering committee member, agreed. "This study provides a new strategy for conducting clinical research. Handheld devices are a very efficient way to collect data and time efficiency is the way of the future." Kollef noted, "The information collected is very important to linking therapy to outcomes. Study results should shed light on optimizing antibiotic treatment for serious infections and make an important contribution to improving mortality and morbidity rates in hospitals across the country." Dr. Kollef is an associate professor of medicine, Washington University School of Medicine Washington University School of Medicine, located in St. Louis, Missouri, is one of the most competitive and highly regarded medical schools and biomedical research institutes in the United States. ; Respiratory and Critical Care Medicine, St. Louis Missouri. TheraDoc Technology Accelerates Electronic Data Collection The steering committee designed the ALARM study to analyze outcomes of approximately 1,000 patients diagnosed with VAP. The study incorporates three of the 12 steps identified in the Centers for Disease Control's (CDC See Control Data, century date change and Back Orifice. CDC - Control Data Corporation ) guidelines for preventing hospital-acquired pneumonia hospital-acquired pneumonia Nosocomial pneumonia Infectious disease Pulmonary infection acquired during a hospital stay which is often more severe than community-acquired pneumonia Risk factors Immune compromise, alcoholism, elderly, aspiration due to intubation. . TheraDoc's customized solution determines patient inclusion or exclusion according to study protocols. Once a patient is added to the study, physicians then use the customized PDAs to collect data at the point of care -- the bedside. Demographics, patient history, the results of physical exams and diagnostic testing Diagnostic testing Testing performed to determine if someone is affected with a particular disease. Mentioned in: Von Willebrand Disease , and illness severity measurements such as CPIS CPIS Clinical Pulmonary Infection Score CPIS Child Protection Information System (Australia) CPIS Child Protective Investigation Section CPIS Computer Programming and Information Systems CPIS Computerized Personnel Information System and APACHE II scores are entered into the program. If a patient has not responded to the first round of therapeutic treatment, which may demonstrate antibiotic resistance antibiotic resistance, n the ability of certain strains of microorganisms to develop resistance to antibiotics. antibiotic resistance , this is also recorded along with corrective actions. After entering case information, physicians can quickly forward it to the study's central database. Once submitted, data is compiled for analysis and is ultimately utilized to evaluate the efficacy of each institution's current empiric treatment of suspected VAP cases. Steering committee member, Dr. Michael S. Niederman, chairman, Department of Medicine at Winthrop University Hospital in Mineola, New York Mineola is a village in Nassau County, New York, USA. The population was 19,233 at the 2000 census. The name is derived from a Native American word meaning a "pleasant place." It is the county seat of Nassau CountyGR6. , said, "TheraDoc worked with us to develop an uncomplicated, useful and portable data collection tool that gets the job done. The software program adapted well to the PDAs." Niederman added, "The ALARM study is an excellent paradigm for facilitating clinical research, anywhere in the hospital." Rodino, Wagenaar and the steering committee expect that study results will help critical care clinicians gain a better understanding of how to minimize antimicrobial resistance and improve care for patients with VAP. Wagenaar reports that the study will continue indefinitely after an initial six-months of data collection. At the end of the initial phase, each hospital can generate an institution-specific antibiogram specific to VAP. It is anticipated that the growing database will provide for additional evaluations, which may further strengthen institutional infection control and other patient safety initiatives. Wagenaar also noted that the steering committee plans to publish the results in a peer-reviewed journal peer-reviewed journal Refereed journal Academia A professional journal that only publishes articles subjected to a rigorous peer validity review process. Cf Throwaway journal. . About TheraDoc TheraDoc is a medical informatics company specializing in therapeutic, real-time decision support that improves the quality, safety, and efficiency of patient care in large and small healthcare organizations. Integrated with disparate information systems or electronic medical records, TheraDoc's technology helps clinicians manage multiple processes of care across multiple conditions and diseases. Founded in 1999, TheraDoc designs, develops, and supports a suite of clinical decision support technologies. TheraDoc's founders and core medical informatics team are internationally recognized for their pioneering work in medical expert systems. Their experience in clinical decision support design and development spans two decades. On the Net: TheraDoc's site: www.TheraDoc.com About FJ Rodino Healthcare Group FJ Rodino Healthcare specializes in post-marketing surveillance, advocacy development, strategic communications and medical education programs for the biopharmaceutical industry. Its client roster includes Abbott Laboratories, Elan Pharmaceuticals and Baxter Healthcare. The addition of Churchill Communications, which will take over strategic publishing and medical communications programs, allows the FJ Rodino Healthcare division to focus on its core advocacy development and post-marketing surveillance activities. www.fjrodino.com About Elan Pharmaceuticals Elan is focused on the discovery, development, manufacturing, selling and marketing of novel therapeutic products in neurology, pain management and autoimmune diseases Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause . Elan shares trade on the New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com. Note to Editors: The ALARM study steering committee consists of nationally recognized VAP experts including the following: -- Marin H. Kollef, associate professor of medicine, Washington University School of Medicine; Respiratory and Critical Care Medicine, St. Louis, Missouri -- Kenneth V. Leeper, associate professor of medicine, Emory University; chief, Pulmonary Division, Crawford Long Hospital, Atlanta, Georgia -- Michael S. Niederman, chairman, Department of Medicine, Winthrop University Hospital, Mineola, New York; vice-chairman, Department of Medicine, SUNY SUNY - State University of New York at Stony Brook -- Antonio Anzeuto, associate professor of medicine, University of Texas, San Antonio; Audie Murphy VA Hospital, San Antonio, Texas |
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