Prospective Research with CORI
CORI provides support for prospective research projects, including research that involves interventions or the longitudinal collection of data, or that requires patient data that is not captured in the CORI software. CORI practices have the option to participate or not participate in specific research projects, most of which will require approval of that practice's Institutional Review Board.
Consent to be Contacted for Research Purposes. The Consent to be Contacted for Research Purposes is an important tool for many prospective research projects. The process identifies patients willing to be contacted regarding participation in research studies at some time after their endoscopy. Depending on the site, either a separate consent document is signed at the time of endoscopy, or this consent is included in the procedure consent document. Whether or not consent too be contacted was obtained is then documented in the CORI reporting software. This allows the CORI research team to identify potential patients based on the data in the NED and to then contact those patients or their providers for enrollment in specific research projects. The requirements for obtaining consent to be contacted for research purposes will vary by site. CORI's research team will work closely with you to meet those requirements.
Research Staff. CORI Research Services consists of a team of data analysts, statisticians, epidemiologists, database architects and software engineers with extensive experience in conducting prospective studies within the CORI framework. Over the years CORI has developed a strong relationship with its research sites and has successful experience with the consent to be contacted process. Most CORI prospective studies are performed by the CORI staff as our call center model has proven to be the most successful in terms of patient recruitment and follow-up.
Clinical Trials Data Collection Support. The CORI reporting software is a valuable tool for collecting data in clinical trials involving endoscopic procedures. Screen additions or modifications, if required, can be made at a cost to the investigator. This research data is stored in CORI's data repository and available to the investigators for analysis. The CORI engineers will also develop study specific databases to store survey data which can later be merged with procedure data from the NED.
Funding of Prospective Research. Due to the substantial cost to run a prospective study, all projects will require outside funding. The CORI team is available to help you design your study, provide you with pilot data, if available, and provide other services to help you complete your research application.
Recent Prospective Research Projects
- Complications of Colonoscopy Performed on Asymptomatic Patients (Cynthia Ko, PI). The CORI research team contacted over 18,000 patients to estimate the overall risk of major complications of colonoscopy
- A Cross-Sectional Study of Acid Related Upper Endoscopy Findings in Subjects with Diabetes as Compared to Non-Diabetics (Astra Zeneca). The aim of this study was to investigate and estimate the prevalence of acid-related EGD findings for diabetic and non-diabetic subjects. Out of 1663 eligible patients contacted for the study, 1573 (95%) agreed to participate.
- Use of the CORI Database to Determine Adverse Events Associated with Peri-Endoscopy Warfarin Management (Lauren Gerson, PI). The aim of this study was to determine the risk of adverse events in anticoagulated patients in the peri-endoscopic period. The CORI research team contacted 561 study-eligible patients, of which 409 (73%) consented and completed the study interview
- Prospective Study of Endoscopy Outcomes in Patients with Chronic Constipation (Novartis). The aim was to measure the prevalence of selected findings in patients with chronic constipation. The CORI research team contacted 2235 study-eligible patients, of which 1595 (71%) consented and completed the study interview.
If you are an investigator, and wish to initiate a prospective research project with CORI, please contact CORI Research Services by clicking here.
FAQs on Prospective Research
If I am a CORI user, do I have to participate in all of the research projects?
No. You will be contacted about proposed research projects and you will be given the option whether or not to participate.
My site is a private practice. How do I obtain permission from an IRB?
If you do not have your own Institutional Review Board (IRB), you may use the IRB at Oregon Health & Science University (OHSU). A principle investigator must be designated for your site and that person, along with research personnel at your site, if any, must take online training from OHSU in research integrity and provide conflict of interest documentation. CORI staff will work with you to make this process as smooth as possible.
If I obtain a Consent to be Contacted for Research Purposes from a patient, who will contact that patient if they are eligible for a research project?
In most cases, a CORI Clinical Studies Assistant will contact study-eligible patients to explain the study and complete the consent process and any study measures over the telephone and through the mail. However, in some situations, practices have preferred that their own practice staff contact patients.
As an investigator, will I be able to conduct custom-designed research projects and use CORI to collect and assimilate that data?
Yes, CORI will provide research services to support custom-designed research projects. This includes modifications to the CORI reporting software screens as well as design of specialized electronic, paper or scannable forms. CORI will continue to store this special information in the data repository, merge it with other form data, and will provide it to the investigator as needed.