The Share Thoughts On Breast Cancer Study: A Greater Plains Collaborative Cohort Characterization Project

Abstract Background. The Greater Plains Collaborative (GPC) is a new clinical data research network in PCORNet, the National Patient-Centered Clinical Research Network sponsored by the Patient-Centered Outcomes Research Institute to conduct patient-centered outcomes research and comparative effectiveness research. The Phase I GPC network brought together a diverse population of 10 million people across 1300 miles covering seven states with a combined area of 679 159 square miles. Using input from community members, breast cancer was selected as a focus for cohort building activities. Objective. To test the GPC's integrated data sources, technical components, and governance by demonstrating the ability to select, characterize, and achieve at least a 50% response rate for a cohort of breast cancer patients from across the GPC. Methods. Each participating medical center extracted, transformed and loaded North American Association of Central Cancer Registries (NAACCR)-formatted data from their institution's tumor registry into its Informatics for Integrating Biology and the Bedside (i2b2) research warehouse. The GPC i2b2 research warehouse is fully de-identified with re-identification possible when accompanied by an approved IRB protocol. From these data, each medical center selected a cohort of all patients age 18 or older diagnosed with breast cancer between January 2013 and May 2014. De-identified data files were submitted to the GPC Honest Broker who applied eligibility criteria and selected a random sample of 250 eligible patients from each center's file. Eligible patients were women with microscopically-confirmed ductal carcinoma in situ or invasive (but not metastatic) breast cancer diagnosed during the study period. Women who had previously been diagnosed with cancer per tumor registry records were excluded as were women known to be deceased at the time the sample was selected. The sample of patients plus a list of up to 10 replacement patients was provided to each center for re-identification and mailing. Patients participated in designing the study materials. Results. IRBs at 7 of 8 collaborating medical centers ceded IRB review to the University of Iowa IRB pursuant to the GPC reliance agreement. Upon patient advice to ensure a representative cohort, a mailed questionnaire with patient incentive was employed. All study materials were mailed in a single packet containing a cover letter from the participating medical center, a 21-page questionnaire, medical record consent and $10 incentive. Questionnaires were mailed over a six-week period beginning June 19, 2015 and one remailing to nonrespondents was conducted 4 weeks after the initial mailing. A total of 1,986 patients were invited and 1,235 (62.2%) responded. Signed consent to obtain information from medical records was obtained for 852 (69%). The survey dataset for consented subjects was linked to the research warehouse to obtain tumor and treatment data and diagnosis and procedure codes from billing sources. Conclusion. The GPC's integrated data sources, honest broker-mediated approach to extract data and apply standardized clinical criteria, IRB reliance model, and patient study design partners were implemented successfully. Citation Format: Chrischilles EA, Gryzlak B, McDowell BD, Connolly DW, Waitman LR. The share thoughts on breast cancer study: A Greater Plains collaborative cohort characterization project [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P5-08-23.