Challenges in Use of Practice-based Research Networks for a Medical Device Trial to Detect SARS-CoV-2.

INTRODUCTION/OBJECTIVES: Primary care practice-based research networks (PBRNs) participated in a point of care (POC) device study funded by by the National Institutes of Health and led by the University of Massachusetts Chan Medical School (UMass) to speed the development, validation, and commercialization of POC tests to detect SARS-CoV-2. The purposes of this study were to describe the characteristics of participating PBRNs and their respective collaborators in this device trial and describe complications challenging its execution. METHODS: Semi-structured interviews were conducted with lead personnel from participating PBRNs and UMass. RESULTS: Four PBRNs and UMass were invited to participate and 3 PBRNs and UMass participated. This device trial recruited 321 subjects in 6 months; 65 subjects from PBRNs. Each PBRN and the academic medical center site enrolled and recruited subjects differently. Main challenges identified were having adequate clinic personnel to enroll and aid in consent and questionnaire completion, frequently changing inclusion/exclusion criteria, use of the digital electronic data collection platform, and having access to a -80°C freezer to store supplies. DISCUSSION: This trial involved numerous researchers, primary care clinic leaders and staff, and academic center sponsored program staff and attorneys resulting in a resource-intensive endeavor to enroll 65 subjects in the real-world clinical setting of primary care PBRNs with the academic medical center enrolling the rest. Multiple obstacles to standing up the study were encountered by the PBRNS. CONCLUSIONS: Primary care PBRNs rely largely on the goodwill established between academic health centers and participating practices. For future investigations involving device studies, collaborating PBRN leaders should assess whether recruitment criteria may change, obtain detailed lists of equipment needed, and/or know if the study is likely to be halted suddenly to appropriately prepare their member practices.

Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: study protocol.

BACKGROUND: There are nearly 50,000 colorectal cancer (CRC) deaths in the United States each year. CRC is curable if detected in its early stages. Fecal immunochemical tests (FITs) can detect precursor lesions and many can be analyzed at the point-of-care (POC) in physician offices. However, there are few data to guide test selection. Broader use of FITs could make CRC screening more accessible, especially in resource-poor settings. METHODS: A total of 3600 racially and ethnically diverse individuals aged 50 to 85 years having either a screening or surveillance colonoscopy will be recruited. Each participant will complete five FITs on a single stool sample. Test characteristics for each FIT for advanced colorectal neoplasia (ACN) will be calculated using colonoscopy as the gold standard. RESULTS: We have complete data from a total of 2990 individuals. Thirty percent are Latino and 5.3% are black/African American. We will present full results once the study is completed. CONCLUSIONS: Our focus in this study is how well FITs detect ACN, using colonoscopy as the gold standard. Four of the five FITs being used are POC tests. Although FITs have been shown to have acceptable performance, there is little data to guide which ones have the best test characteristics and colonoscopy is the main CRC screening test used in the United States. Use of FITs will allow broader segments of the population to access CRC screening because these tests require no preparation, are inexpensive, and can be collected in the privacy of one's home. Increasing CRC screening uptake will reduce the burden of advanced adenomas and colorectal cancer.

Electronic Health Record Algorithm Development for Research Subject Recruitment Using Colonoscopy Appointment Scheduling.

INTRODUCTION: Electronic health records (EHRs) are often leveraged in medical research to recruit study participants efficiently. The purpose of this study was to validate and refine the logic of an EHR algorithm for identifying potentially eligible participants for a comparative effectiveness study of fecal immunochemical tests (FITs), using colonoscopy as the standard. METHODS: An Epic report was built to identify patients who met the eligibility criteria to recruit patients having a screening or surveillance colonoscopy. With the goal of maximizing the number of potentially eligible patients that could be recruited, researchers, with the assistance of information technology and scheduling staff, developed the algorithm for identifying potential subjects in the EHR. Two validation methods, descriptive statistics and manual verification, were used. RESULTS: The algorithm was refined over 3 iterations leading to the following criteria being used for generating the report: Age, Appointment Made On/Cancel Date, Appointment Procedure, Contact Type, Date Range, Encounter Departments, ICD-10 codes, and Patient Type. Appointment Serial Number/Contact Serial Number were output fields that allowed the tracking of cancellations and reschedules. CONCLUSION: Development of an EHR algorithm saved time in that most individuals ineligible for the study were excluded before patient medical record review. Running daily reports that included cancellations and rescheduled appointments allowed for maximum recruitment in a time frame appropriate for the use of the FITs. This algorithm demonstrates that refining the algorithm iteratively and adding cancellations and reschedules of colonoscopies increased the accuracy of reaching all potential patients for recruitment.

Rural Primary Care Offices and Cancer Survivorship Care: Part of the Care Trajectory for Cancer Survivors.

BACKGROUND: A cancer diagnosis is a monumental event in a patient's life and with the number of cancer survivors increasing; most of these patients will be taken care of by a primary care provider at some point after their cancer therapy. The purpose of this study is to identify primary care physician's needs to care for a patient who has had cancer. METHODS: A cross-sectional survey of the physician members of the Iowa Research Network was conducted. The survey was designed to measure physician confidence in cancer survivor's care, office strategies regarding cancer survivorship care, and resources available for patients with cancer. Two hundred seventy-four Iowa Research Network members were invited to participate in this survey. RESULTS: Eighty-two physicians (30%) completed the questionnaire with 96% reporting that they are aware of their patient's cancer survivorship status. Seventy-one physicians reported they were aware of cancer survivorship status by an oncologist sending a note to the office, 68 being diagnosed in their office, 61 by the patient keeping the office apprised, and 15 receiving a survivorship care plan. Physicians reported the top changes in a cancer survivor's physical health as fatigue (81%) and pain (59%). Sixty-two physicians reported not feeling confident for managing chemobrain, cardiotoxicity (71%), and skin changes (35%). Male physicians were significantly more confident managing patients' skin changes (P = .049) and musculoskeletal disturbances than female physicians (P = .027), while female physicians were significantly more confident managing early-onset menopause than male physicians (P = .027). CONCLUSION: Most respondents are aware of their patients who are cancer survivors and are mostly confident in the care they provide for them related to long-term effects and side effects of cancer therapies with limited receipt of cancer survivorship care plans.