Research Overview

Since 2010, GIQuIC has set the standard in the collection and reporting of quality measures in the practice of gastrointestinal endoscopy. This robust dataset is an invaluable resource for practice benchmarking and further provides an excellent opportunity for those interested in gastroenterology research.

GIQuIC registry data are contributed from endoscopy units in various practice settings across the United States. Data enters the registry via two methods: direct data entry or, more commonly, upload from an endoscopic health writer (endowriter). For the purpose of research, GIQuIC registry data undergoes a de-identification process and is transferred to the Research Data Warehouse. This separate database is stored on a different secure server from the registry data and can only be accessed by GIQuIC staff.

The Research Data Warehouse contains de-identified information on sites, providers, patients, and procedures that allows investigators to address complex and varied research questions. For an overview of data included in the registry, please refer to the colonoscopy and EGD data collection forms:

The GIQuIC research committee carefully reviews all project proposals, evaluating the project’s feasibility, novelty, and potential impact. All analyses are completed by GIQuIC’s team of in-house data analysts, who work closely with principal investigators (PIs) in order to best address the research question. Most projects are hypothesis-driven and are undertaken with the intention of publishing results in a peer-reviewed journal.

For all research inquiries, contact research@giquic.org.

GIQuIC Research Committee

Ashwin Ananthakrishnan, MD, MPH, FACG, AGAF

Dr. Ashwin Ananthakrishnan is the Director of the Massachusetts General Hospital Crohn’s and Colitis Center and an Associate Professor of Medicine at Harvard Medical School. He completed his medical school training at JIPMER in India and subsequently obtained his Master of Public Health degree at the Johns Hopkins University Bloomberg School of Public Health. After completing his GI fellowship at the Medical College of Wisconsin, he joined the faculty at Massachusetts General Hospital where he is involved in clinical care, research, and teaching. In addition to his clinical expertise in the management of patients with complex IBD, he has been involved in investigations using large prospective cohorts to define the role of environment on IBD. He is also conducting NIH-funded studies aiming to personalize IBD therapy by defining individual patient trajectories and to understand the appropriate treatment algorithms in vulnerable populations including the elderly. He has published over 250 manuscripts, has co-authored two textbooks on IBD, and has served on the editorial boards of multiple journals.

Linda Cummings, MD, MS, FACG, AGAF, FASGE

Dr. Linda Cummings is a gastroenterologist at University Hospitals Cleveland Medical Center and Louis Stokes Cleveland VA Medical Center and an Associate Professor of Medicine at Case Western Reserve University School of Medicine in Cleveland, Ohio. Following undergraduate education at Harvard University, Dr. Cummings completed medical school at Washington University in St. Louis, Missouri and internal medicine residency at Barnes-Jewish Hospital in St. Louis, Missouri. She completed her gastroenterology fellowship at University Hospitals Cleveland Medical Center and Louis Stokes Cleveland VA Medical Center, during which she obtained a master’s degree in clinical research. Dr. Cummings’ clinical interests include cystic fibrosis, small bowel capsule endoscopy, and gastrointestinal cancers, particularly esophageal and colorectal cancer. Dr. Cummings was awarded a Junior Faculty Development Grant from the American College of Gastroenterology to support her research using large databases to assess long-term outcomes in esophageal cancer patients. She is currently involved in a multi-center clinical trial supported by the Cystic Fibrosis Foundation assessing sensitivity of stool-based testing in patients with cystic fibrosis undergoing screening colonoscopy and a study supported by NIH evaluating a potential biomarker of Parkinson’s disease with dementia in the colon. She is the recipient of the 2020 Helen Evans Mid-Career Faculty Development Award from the Women Faculty of the School of Medicine at Case Western Reserve University. She is a longstanding member of her hospital’s gastrointestinal endoscopy lab quality assurance committee and currently serves on the ASGE Quality Assurance in Endoscopy Committee.

Akwi W. Asombang, MD, MPH, FACG, FASGE

Dr Akwi Asombang is an interventional gastroenterologist at Massachusetts General Hospital (MGH), Harvard Medical School and is the Director of Global Health Programs in Gastroenterology. She completed her advanced endoscopy fellowship at Beth Israel Deaconess Medicine Center (BIDMC), Harvard Medical School, Boston, Massachusetts. She completed her gastroenterology fellowship at Washington University School of Medicine, St Louis, Missouri and a Fogarty International Clinical Research fellowship. Prior to her fellowships, she completed a combined Internal Medicine/Pediatrics residency at Saint Louis University School of Medicine, St Louis, Missouri and her Master of Public Health at Saint Louis University School of Public Health. She is a graduate of Kasturba Medical College, Manipal, India. Her professional interests are endoscopy (ERCP/EUS), gastrointestinal cancers, medical education, and global health.

Dr. Asombang has extensive service to multiple national professional societies and experience in global health including clinical experience in Zambia, Nigeria, Tanzania, and India and her research has been published and presented at national and international meetings. Her travels around the world, upbringing, and interaction with various populations led her to form POHER to tackle the problems faced by most of the African communities. Pan-African Organization for Health, Education and Research (POHER), is a non-governmental organization (NGO) with a focus on the soundness of the health sector as the cornerstone of social and economic development of all African countries. She is also the founder of The African Association of Future gastroenterologists (AAFG). AAFG aims to provide a platform for mentorship, networking, and collaboration for medical students and doctors interested in gastroenterology and hepatology in Africa.

Jason Dominitz, MD, MHS, FACG, FASGE

Dr. Jason Dominitz is the National Program Director for Gastroenterology for the US Veterans Health Administration. He completed his undergraduate education at the Johns Hopkins University in Baltimore, MD and received his medical degree from the University of Maryland. He then trained in internal medicine and gastroenterology at Duke University in Durham, NC. Concurrently, he studied health services research and received a master’s degree in health sciences from Duke University.

Since 1997, Dr. Dominitz has been a staff physician at the VA Puget Sound Health Care System (VAPSHCS) in Seattle, WA and is also a professor of medicine at the University of Washington. He has a longstanding interest in colorectal cancer screening and is the co-chair of an 18-year, VA-funded, randomized, prospective trial comparing two leading strategies of colorectal cancer screening in 50,000 average-risk veterans. This study, involving 46 VA medical centers across the country, is the first large-scale, prospective study in the United States comparing screening colonoscopy to a non-invasive fecal immunochemical test and assessing their impact on cancer mortality and incidence. Dr. Dominitz also has received research funding from the National Institutes of Health (NIH) and the Department of Defense. In 2011, Dr. Dominitz assumed the role of national program director for gastroenterology where he focuses his efforts on improving the quality of gastroenterology care for veterans, especially with respect to the quality of colonoscopy. He is also involved in crafting policy related to other aspects of care, including cancer screening, liver disease, and other key healthcare issues.

Prasad Iyer, MD, FACG, FASGE

Dr. Prasad Iyer attended medical school at All India Institute of Medical Sciences in New Delhi, India. He completed his residency at the University of Wisconsin Medical School in Milwaukee, WI, and his GI fellowship at Mayo Clinic College of Medicine, Rochester, MN, where he also completed a postdoctoral master’s degree in clinical research. Dr. Iyer is a consultant and professor in the Barrett’s Esophagus Unit, Division of Gastroenterology and Hepatology at Mayo Clinic, Rochester, MN, where he has been on staff since 2006. He is a member of the esophageal interest group and advanced endoscopy group.  Dr. Iyer is Associate Editor of Gastrointestinal Endoscopy and the Chair of the International Committee of the American Society for Gastrointestinal Endoscopy (ASGE).  His clinical and research interests include early detection, risk stratification, and therapy of Barrett’s-related neoplasia and endoscopic ultrasound. He has published over 140 peer-reviewed articles as well as several book chapters. He is a reviewer for many journals, including American Journal of Gastroenterology, Clinical Gastroenterology and Hepatology, and Gastrointestinal Endoscopy.

GIQuIC Research Task Force Report

Vision: Our vision is to improve digestive health through the consistent use of high-quality endoscopy and well-established care pathways informed by best evidence.

Mission: To stimulate, support, execute and disseminate high-quality digestive health research to identify best practices and decrease harmful heterogeneity in digestive disease patient care. To promote the measure of endoscopic quality and disseminate these findings broadly to our patients, our members, payers and the public. To support the development and validation of new tools, techniques and therapies to improve digestive health.

Policies for Performing Research in GIQuIC

The central goal of research efforts in GIQuIC is to improve care of the patient with gastrointestinal disease, and to define and demonstrate quality care as provided by our members and the field of gastroenterology & hepatology. As a unique resource, GIQuIC represents the largest aggregated database of experience with gastrointestinal endoscopy in the history of our profession. The parent organizations of GIQuIC, the American Society for Gastrointestinal Endoscopy (ASGE) and the American College of Gastroenterology (ACG), seek to expand and elaborate the use of this database to further the field. The policies enumerated below lay out the processes by which GIQuIC will promote these goals through research. Importantly, this is a living document, which will continue under the stewardship of the Research Committee of GIQuIC, a standing committee of experts in both clinical research and gastroenterology. The Research Committee will be charged with executing these policies, and with modifying/updating these practices to respond to the changing landscape of our profession. As such, this document is not meant to supersede any current governance structure or document of GIQuIC nor change policy already developed by the parent organizations. Rather, it is meant to operationalize such policy, and to provide a roadmap for important issues such as interaction with governmental or industry entities, prioritization of research work, and expansion of the research enterprise.

Who Can Do Research in GIQuIC?

The goal of research efforts in GIQuIC is to accelerate discovery in gastroenterology and hepatology to improve the lives of patients with digestive diseases by publishing and disseminating research results based on testable and relevant hypotheses. Research ideas that accomplish these goals can come from a variety of sources, including GIQuIC members, non-member healthcare professionals, academic institutions, private practices, the healthcare industry, and researchers from ~~multiple~~ other disciplines, to name a few. ~~In order to~~To maximize the impact of GIQuIC as a research tool, we seek to make these data as available as logistically possible to the widest number of researchers with good ideas. Therefore, all researchers, regardless of affiliation or use of the registry, may propose research to GIQuIC. As noted below, investigator affiliation may impact the priority of the work proposed.

What is the Process for Conducting Research in GIQuIC?

Our research process generally follows the steps presented below:

Interested investigators may contact GIQuIC via research@giquic.org with research related questions. Investigators will complete a brief, standardized Project Pre-Proposal form indicating the hypotheses to be addressed, the data requested to address the hypotheses, the expected results, and the plan for dissemination of information. Logistical information, including the name, address and affiliations of the principal investigator, similar data for co-investigators and funding sources of the work will be disclosed. The purpose of the Project Pre-Proposal is to immediately identify proposed research that is not feasible given the data in the registry or does not comply with other aspects of allowable research as described in GIQuIC governance documents, so that neither investigator nor staff time is needlessly put toward further effort.

After review of the Pre-Proposal, the investigator will be contacted by a GIQuIC dData aAnalyst to review any preliminary questions and to discuss the feasibility of the proposed project. The purpose of this consultation is to further assure feasibility, not to perform the research or provide extensive consultation as to study design. The GIQuIC dData aAnalyst will furnish the investigator with the standard research Project Proposal Instructions. The more in-depth Project Proposal includes questions regarding the project background/significance, research question and/or hypothesis, and specific aims. Proposals will also include an overview of methodology and statistical analyses. A Conflict of Interest (COI) form will also be completed.

Upon receipt of a completed Project Proposal and COI form, a GIQuIC dData aAnalyst will contact the investigators to inform them that the submission has been received and, if necessary, to review any items that require immediate clarification. If necessary, preliminary edits to the Project Proposal may be suggested or requested.

If the COI form indicates a potential conflict of interest with the proposed work, this form will be forwarded to the chair of the Research Committee for evaluation and determination of disposition. The chair may either approve the work, approve the work with conditions for disclosure, or decline to involve GIQuIC in the work in cases of irredeemable conflicts of interest. In complex situations, the chair may elect to bring potential COI to the entirety of the research committee for resolution.

The GIQuIC research staff will review the Project Proposal and provide the proposing researchers with an estimated cost of the research (see below regarding the determination of costs), and proposed timeline for completion of the work. The proposing researchers will review this estimate, and either approve it as written, or modify the research plan in collaboration with the GIQuIC team to bring costs within their budget. An approved, mutually agreed-uponto budget is required for the proposal to move forward.

Refined proposals with accompanying budgets will be presented to the GIQuIC Research Committee on a quarterly basis. Among other considerations, proposals are evaluated for feasibility, novelty, potential impact/importance to the GI community, and overlap with other GIQuIC research projects, using the prioritization process described below. Only those research projects for which adequate person-power for execution will be approved at one time.

Once approved by the Research Committee, the GIQuIC Publication Agreement should be signed and submitted to GIQuIC within 14 days by both parties.

Upon receipt of the signed Scope of Work, Publication Agreement, and a mutually agreed upon payment schedule, a GIQuIC ddata aanalyst will initiate the analysis and regularly communicate progress to the Principal Investigator.

Other notes:

If an investigator is applying for grant funding and wishes a letter of support to do an investigation in GIQuIC, proposals shall be submitted no fewer than 60 days prior to the deadline to allow for adequate processing time. GIQuIC will provide a letter of support once the grant submission and the scope of work have been approved. Due to the number and complexity of grants seeking to involve the rRegistry, GIQuIC is unable to provide pilot data without cost, and such requests should be submitted using the standard project request algorithms described in this document.

Unless a GIQuIC dData aAnalyst is a named co-author of the manuscript and has approved the content, investigators are required to submit draft manuscripts to the Research Committee for review prior to submission for publication. The purpose of this review is to assure that the investigators have not inappropriately interpreted GIQuIC data, and this review will not serve to alter interpretations supported by the data. If concerns are raised by the Research Committee, resolution will be required via consensus between the Research Committee and the authors before submission for consideration of publication.

If a manuscript has not been submitted to a peer-reviewed journal within 1 year of the receipt of final results completing the project, the Principal Investigator will transfer his/her rights to the use of those results back to GIQuIC.

Consultation is available on a per- hour basis (costs discussed below) for investigators who wish to consult with a GIQuIC analyst prior to the formulation of hypotheses and specific aims.

If at any point during this process it is determined that the GIQuIC Research Data Warehouse is not an appropriate fit for a project, a research staff member will notify the investigator promptly.

In the event proposed research is either identical to or closely resembles work already approved by the Research Committee, the investigators will be informed that the proposed study is already being undertaken, and therefore is not currently eligible for consideration. If, after publication of the earlier study, the research team can make a case that their research would substantially augment or differ from the earlier findings, the second study will become eligible for consideration.

How is Research in GIQuIC Paid For?

The data in the GIQuIC rRegistry is proprietary and confidential. Data are not released to any outside entity. Thus, analysts are a part of the rRegistry and rResearch process, and attendant costs must be assigned to these efforts. Several principles inform the setting of these fees. First, fees will be proportionate to the effort involved. Some proposals will be more labor-intensive than others, and this degree of complexity may not be obvious to the investigator without familiarity with the database. The Research Committee, in conjunction with GIQuIC staff, will create an annual fee schedule reflecting the best estimate of costs associated with research services. Second, a variety of services may be necessary to complete a project, and these services may involve personnel with differing skills and levels of expertise. Budgets may reflect the costs associated with each of these services. Finally, GIQuIC’s organizational values will be reflected in the cost structure of our fee schedule. For this reason, discounted rates for junior investigators and research work deemed essential to the organization may apply, as noted below.

All studies will have baseline charges for study start-up, analysis, and manuscript review. Complex studies may have additional charges for these items beyond base rates. In addition to these base charges, GIQuIC staff will provide an estimate of the hours necessary to complete the data retrieval, cleaning, and analysis. This is an estimate of costs, which may be modified as the project progresses, or, importantly, if the investigator modifies the research plan. If the actual costs of the analysis exceed the estimated costs by >10%, the GIQuIC staff will inform the investigators in writing of this change, and the investigators will acknowledge and approve the additional costs, in writing.

To aid investigators in planning for costs associated with research in GIQuIC, we provide the following examples of budgets necessary for recent research projects of varying complexity. Actual budgets may vary from these depending on complexity or size:

Straightforward analysis, approximate cost $10,000

Moderately complex analysis, approximate cost $25,000

Complex analysis, approximate cost $40,000

GIQuIC recognizes the need to both support young scientists, as well as to acknowledge the source of the data in the registry and the members of the founding organizations of GIQuIC, the ACG and ASGE. For these reasons, the GIQuIC fee schedule may feature discounted rates for the following groups:

Junior investigators, defined as those either in training or within 5 years of graduation of an accredited training program

ACG and ASGE members, and,

GIQuIC registry participants.

Discounts are not additive, and investigators belonging to more than one of the above groups will receive the greatest single discount of the groups to which they belong.

How Does GIQuIC Prioritize Research?

Managing and analyzing the vast database of GIQuIC requires a high degree of training, and, depending on the questions posed, can be a time-consuming process. The data in GIQuIC are not accessible or analyzable by external analysts, and it is the policy of GIQuIC to limit access as noted above. The purpose of this limited access is to improve data security, assure appropriate interpretation of variables and results, and to preserve the confidentiality of the data.

Since both personnel issues and costs constrain our ability to meet all of the requests to perform research, GIQuIC must prioritize research, and may decline to be involved in proposed meritorious research solely on the basis of these priorities and lack of staff to perform the requested work. ~~In order to~~To make this process transparent, below we list the research priorities by which GIQuIC staff and the Research Committee will order the research requests in the work queue. Note that the existence of this prioritization implies that a new request might be prioritized over an already-accepted, existing request – the staff will not adhere to a “first-come, first-served” policy should higher priority work be received. These priorities will be reviewed regularly and modified by the Research Committee as organizational prerogatives evolve.

The Task Force suggests the following prioritization of research work in GIQuIC:

Work necessary to substantiate quality to payers, to attain/maintain approval of the registry by CMS or other payers, or to assess operational aspects of the registry for ongoing maintenance,

Work funded by grants awarded by the two parent organizations or GIQuIC itself to promote specific research using GIQuIC,

Work requested by the Research Committee to address questions of importance to the field, or work specifically designed to assess health equity,

Work originating in academic centers or member practices and funded by federal or societal resources,

Work originating in academic centers or member practices and funded by institutional or philanthropic resources,

Work originating in academic centers or member practices and funded by commercial grants or stipends,

Work originating in another professional organization, governmental agency, or funded by another professional society or patient advocacy group (ex, CCFA, ECAN, etc.), with an explicit plan for dissemination of data, and,

Work originating in a commercial entity, with an explicit plan for dissemination of the data.

Please note that this list allows for research proposed by a commercial entity, such as a pharmaceutical or device company, to be performed in conjunction with GIQuIC staff, as long as the findings of this research will be disseminated to the field via an abstract or peer-reviewed publication. However, the Task Force feels strongly that the registry should not be used to gain “industry intelligence” for the use of a commercial entity, and that all research in GIQuIC should annunciate a plan for dissemination prior to approval. The Task Force additionally recommends proscribing research using data assessing small market variation, which could lead to the identification and de-anonymization of any registry user.

The above list is meant to guide the Research Committee, however we acknowledge that the Committee may occasionally prioritize a project due to extenuating circumstances (for instance, to address a pressing question for the field).

How Will GIQuIC Promote Relations with other Organizations Seeking to Promote Gastrointestinal Health?

Given the stated objectives of GIQuIC, it is vital that the organization make efforts to partner with other stakeholders to promote use of this unique resource. Multiple established entities have efforts to promote discovery in GI research, and these entities are logical partners for GIQuIC. These entities include but are not limited to the National Institutes of Health, the U.S. Food and Drug Administration, the Centers for Disease Control, and the Advanced Research Projects Agency for Health (ARPA-H), other professional organizations, large group practices or other organizational entities, electronic medical record developers and endowriter software companies, non-profit patient advocacy groups and others. In the spirit of cooperation, GIQuIC invites collaboration with other research and funding organizations to utilize this unique resource to promote our shared goals of improving digestive health through research.

Approved by the GIQuIC Board of Directors on January 24, 2023