Pediatric

Pediatric Endoscopy Database System Clinical Outcomes Research Initiative (Your Site Name HERE) HUMAN PROTOCOL SUMMARY (IRB application number) 1. Protocol title: The NASPGN, Pediatric Endoscopy Database System for the Clinical Outcomes Research Initiative (PEDS-CORI): 2. Background Information: The field of gastroenterology experienced dramatic growth as a subspecialty in the 1970’s, fueled by major technical developments in gastrointestinal endoscopy. Endoscopy of the gastrointestinal and hepatobiliary systems led to remarkable advances in the diagnosis and treatment diseases of these organ systems. As a result of the rapid growth of adult gastroenterology, pediatricians soon began developing techniques to adapt the endoscope in the diagnosis and management of digestive disorders in children. Since the first pediatric use of gastrointestinal endoscopy in the early 1970’s, the field has grown to include a wide array of diagnostic and therapeutic procedures that can now be safely and effectively performed in children. As with nearly all-medical advances, change, such as the evolution pediatric endoscopy, does not occur without cost. In today’s dynamic and unstable healthcare environment, physicians are besieged by attempts to control cost and yet expected to improve the quality of care for their patients. In this setting, questions regarding the need, efficacy and the outcome of diagnostic and therapeutic endoscopy are being raised. Under the leadership of Dr. David Lieberman, Chief of Gastroenterology at the University of Oregon Health Sciences Center in Portland, Oregon, the Clinical Outcomes Research Initiative (CORI) project began in 1995. The goal of the CORI project was to develop a computerized national database of endoscopic procedures. The database could then be queried to determine the need, effectiveness, cost and outcome of gastrointestinal endoscopy for the diagnosis and management of digestive diseases. Beginning with data collected by hand on 200 endoscopies in 1996, the CORI database has grown to include over 50,000 procedures performed at 42 centers in 25 states with over 400 adult gastroenterologists. Using the CORI database, a qualitative and quantitative overview of adult endoscopy can now be achieved. For example, out of 18444 upper endoscopies performed to date, 57% were in males and 43% in females, with a mean patient age of 58 years. The top 3 indications for upper endoscopy were reflux (24%), abdominal pain (21%) and dysphagia (21%). The top 3 endoscopic findings included mucosal abnormalities (35%), hiatal hernia (29%) and normal (29%). What is lacking in the CORI project is data on children. Since the majority of third party payers consider their covered “lives” to occur from birth to the grave, and the natural history of many common adult gastrointestinal diseases begin in childhood, a pediatric component to the database is critically needed. In early 1999, the Executive Council for the North American Society for Pediatric Gastroenterology and Nutrition approved the PEDS-CORI proposal and the first site was established at Texas Children’s Hospital (TCH). In December of 1999, TCH and Baylor’s IRB approval lead the way to finalizing the plans to begin using the CORI system to collect PEDS data at TCH. In spring of 2000, the system was brought online and has been in use ever since. Currently, four sites are participating in the PEDSCORI project, but many more are needed. 3. Purpose of the protocol: The specific aims of the project will be: (1) to develop and maintain a computerized database of pediatric endoscopy procedures; (2) to promote scientific inquiry into the need, efficacy, costs and outcomes of pediatric endoscopy. 4. Description of the study: The following flow diagram illustrates the overall PEDS proposal. Phase 1: Development - Creation of an electronic endoscopy report form - Development of standardized nomenclature for pediatric endoscopy - Field test the endoscopy report form Phase 2: Implementation - Enroll pediatric gastroenterologists/endoscopists from across North America - Initiate data collection from clinical practices - Electronic transmission of site-specific data to data bank Phase 3: Research Development of critically needed disease-, site- and cost effectivenessspecific research projects Development of outcome projects - Phase 1: Development. In collaboration with the CORI project personnel, a new version of the CORI software was designed to capture pediatric-specific endoscopy information. The CORI system already had the basic software template available for construction of an endoscopy report (Appendix 1). Using the existing CORI software template, a suitable pediatric endoscopy report form was constructed. It has been tested initially in four (4) centers; the Texas Children’s Hospital, Houston, Texas; Egleston and Scottish Rite Children’s Hospital, Atlanta, Georgia; and the Oregon Health Science Center. Using this common endoscopy report, a network of pediatric endoscopy centers will be assembled to further refine and validate the report instrument. The North American Society of Pediatric Gastroenterology and Nutrition (NASPGN) Patient Care Committee, Sub-committee on Endoscopy (Chair: Mark A. Gilger, M.D.) will serve as the initial and primary review group (Operations committee). This committee will continue to oversee the PEDS-CORI project throughout all phases of the program. Phase 2: Implementation. The next stage of the implementation process will be recruitment of additional pediatric endoscopy centers throughout North America. A vigorous effort is underway to enroll clinical pediatric gastroenterology practices from diverse geographic regions. This will provide a means of regional comparison to assess practice differences. An attempt will also be made to have representation from both private and academic practices. Each week, all affiliated sites upload data (which has already been collected by the CORI software during the report writing process) and sends it to the central data repository at the University of Oregon Health Sciences Center. The software is programmed with a toll-free telephone number that connects the site computer directly to the Sun SPARC Station (mainframe computer) in Portland. The upload takes about one minute. There is great care and much attention is given to the protection of patient and physician information. Such information as Name, Address, Practice Location, Phone Numbers etc. as well as other identifiers are removed (scrubbed) from the data prior to being sent out from each respective location. Data is encrypted and encoded, then transferred to a large database, merged with data from other sites and managed by the system manager. Only each site’s staff and employees have access to patient and practitioner information. The software acts very similar to electronic medical records, and in fact, many hospitals Forms Committee’s approve of the CORI software as the official medical record for gastroenterology department patients, and as the official operative report for procedures. Phase 3. Research. The research goals of the PEDS program will be the following: 1. Descriptive: (defining the breadth and character of the practice of pediatric endoscopy in North America). For example: a. What is the most common pediatric endoscopy procedure? b. What are the most common indications for pediatric endoscopy? Longitudinal: (characterization of the natural history of the disease process). For example: a. What is natural history of biopsy proven esophagitis from infancy into childhood? b. Evaluation of surveillance intervals for children with ulcerative colitis, Crohn’s colitis and adenomatous polyposis. Outcomes: (i.e., cost effectiveness of endoscopic diagnosis and intervention). For example: a. Is upper endoscopy cost effective in the evaluation of abdominal pain? b. Is surveillance endoscopy of potentially cancerous lesions cost effective? 2. 3. All data collected at the CORI central data repository will be available for research by any approved NASPGN research investigators who apply with a hypothesis driven research request. Investigators will be asked to submit research proposals to the Steering Committee of PEDS-CORI. After approval, the project coordinator will prepare data by retrieving queries from the repository. The data that is sent to investigators is descriptive data about the patient population collected by CORI. There is no way to connect any individual outcome or patient with any site, physician or patient. For any resulting publications, research recognition will be given to the PEDS-CORI project. Summary: It is anticipated that this PEDS-CORI proposal will serve as a research tool. It is designed as an “umbrella” protocol from which new lines of research may proliferate, allowing specific prospective research projects to take place some time down the road. Each one of these additional research proposals or projects, that require enrollment of patients in any study, will require specific IRB approval for each and every project. Our goal is to develop and maintain a database of pediatric endoscopy procedures that will be used for outcomes research, much the same as many sites collect data on their own patients for specific outcomes research at their site. This will allow research investigators to explore the discipline of pediatric endoscopy and hopefully, gain insight into the current and future practice of pediatric gastroenterology from the entire spectrum of practices around the country. 5. Subject population: Any child who has his/her endoscopy performed in the (Your name here) will be entered into the database. The number of subjects entered will be entirely dependent upon the number of endoscopies performed. For example, in (given year), about (number at your site) endoscopies were performed. As additional centers are added across North America, the number of subjects entered into the database is anticipated to be 10,000 or more annually. The projected sample size for the first five years duration is expected to be a minimum of 20,000 but us likely to be over 70,000. 6. Data analysis: All data is entered into the central database located at the University of Oregon Health Sciences Center, Portland, OR. In the next phase of development the PEDS-CORI project will begin to receive a copy of all the data for those patients in the repository who are 18 or younger. This will become the PEDS-CORI data repository, where direct questions can be answered about pediatric endoscopy. For example, what is the most common type endoscopy performed in children? Each hypothesis driven research request using the PEDS-CORI database will require a specific plan for data analysis, which will be included with each project proposal. 7. Potential Risks: As a database of practice and outcomes information, there is no risk to the patient. The data is pooled from the CORI software long after the procedure has been completed, so the patient receives no difference in treatment or practice and quality of care. The anonymity that CORI and PEDS-CORI protects when each subjects procedure and results are entered into the repository provides no inherent risk to the patient. Only non-identifying information is sent from each site (examples include: indications, depth reached, duration of exam, findings, complications, etc). Once again, the patient and practitioner’s personal information is held completely confidential and no specific patient or physician can be identified beyond their own site location. 8. Benefits: There are no benefits to the individual subject. None of the patients receive any changes in treatment or care. The patient is never contacted, unless that patient is a possible candidate for some other prospective clinical research trial that has been appropriately approved and granted by this IRB, and consent has been received for that specific project and protocol. There are benefits to the pediatric patient population and society as a whole, as we will learn a better understanding of the practice of pediatric endoscopy in North America and the potential for a more cost effective use of pediatric endoscopy in the future. As with any discovery, the amount of knowledge that will become available about pediatric endoscopy is endless. Many new insights and discoveries will be made about the specialty of pediatric gastroenterology. For example, evidence suggests that pediatric patients require more time than adults for certain types of procedures. There are many other implications of benefit; all far outweigh any risk to the individual patient, as above, there is none. 9. Risk-benefit ratio: N/A. 10. Consent procedure: No Consent-Request is made, ‘Waiver of Consent’ or ‘Exempt’ status is requested. (See accompanying letters from Mark Gilger and David Leiberman) 11. Confidentiality Procedures: During the developmental phase of CORI, the issues of patient and physician confidentiality were carefully considered. All data files transmitted to the central databank are encrypted and encoded and all patient and physician identifiers are removed. The only patient data transmitted are age, gender and race. Each report is automatically assigned a code number by the computer at each site. The code number is transmitted to the central databank, allowing the data managers to identify a site, but not a specific physician. If an error or omission is discovered, the data manager contacts the site and provides the code number, which can only be decoded at the practice site. Therefore, it is not possible to identify a patient or physician at the central databank and there is no access to local information. However, any future study that would require contact of the patient or any transmission of patient names or identifiers, or a diagnosis or therapeutic intervention, would require specific patient consent covered by those additional IRB applications that support any request. The local endoscopy database is contained and controlled as a computerized medical record in the Gastrointestinal Procedures Suite of (Your Site Name here). Just as with other medical record systems in our facility patient identifiers are necessary and required. The local site-specific records in CORI are accessible only by the physicians and staff, via password-protected entry. 12. Costs: There are no costs to the individual subject. 13. Payments: There is no payment to subjects. PEDS-CORI: a program of the CORI Project and the Children’s Digestive Health and Nutrition Foundation Director: Mark A. Gilger, M.D. Associate Professor of Pediatrics Baylor College of Medicine Houston, TX Associate Director: Benjamin Gold, M.D. Associate Professor of Pediatrics Emory University School of Medicine Atlanta, GA Project Manager: Craig L. Dietrich PEDS-CORI Senior Project Coordinator Baylor College of Medicine In cooperation with the Clinical Outcomes Research Initiative (CORI) Director: David Lieberman, M.D. Co-director: David Fleisher, M.D. Director, Methodology: Mark Helfand, M.D. Director, Epidemiology: Glenn Elsen, M.D. Project Coordinator: Pat de Garmo, ANP Computer Programmer: Rick Brodner Tech Support: Rick Brodner Site Coordinator: Bob Moore