Background: During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. Methods: We developed and distributed an anonymous survey assessing COVID-19–related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. Results: A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had >5 years’ professional experience in clinical research, and 56% had personal experience with a COVID-19–related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with >5 years’ professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (P=.04) and therapy shipment (P=.02). Conclusions: Clinical research professionals perceive that COVID-19–related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience—both specific to COVID-19–related changes and more generally—are more likely to recommend that these adjustments continue in the future.
David E. Gerber, Thomas Y. Sheffield, M. Shaalan Beg, Erin L. Williams, Valerie L. Clark, Yang Xie, M.E. Blair Holbein, Celette Sugg Skinner and Simon J. Craddock Lee
Melissa Magrath, Edward Yang, Chul Ahn, Christian A. Mayorga, Purva Gopal, Caitlin C. Murphy, Samir Gupta, Deepak Agrawal, Ethan A. Halm, Eric K. Borton, Celette Sugg Skinner and Amit G. Singal
Background: Surveillance colonoscopy is required in patients with polyps due to an elevated colorectal cancer (CRC) risk; however, studies suggest substantial overuse and underuse of surveillance colonoscopy. The goal of this study was to characterize guideline adherence of surveillance recommendations after implementation of an electronic medical record (EMR)–based Colonoscopy Pathology Reporting and Clinical Decision Support System (CoRS). Methods: We performed a retrospective cohort study of patients who underwent colonoscopy with polypectomy at a safety-net healthcare system before (n=1,822) and after (n=1,320) implementation of CoRS in December 2013. Recommendations were classified as guideline-adherent or nonadherent according to the US Multi-Society Task Force on CRC. We defined surveillance recommendations shorter and longer than guideline recommendations as potential overuse and underuse, respectively. We used multivariable generalized linear mixed models to identify correlates of guideline-adherent recommendations. Results: The proportion of guideline-adherent surveillance recommendations was significantly higher post-CoRS than pre-CoRS (84.6% vs 77.4%; P<.001), with fewer recommendations for potential overuse and underuse. In the post-CoRS period, CoRS was used for 89.8% of cases and, compared with cases for which it was not used, was associated with a higher proportion of guideline-adherent recommendations (87.0% vs 63.4%; RR, 1.34; 95% CI, 1.23–1.42). In multivariable analysis, surveillance recommendations were also more likely to be guideline-adherent in patients with adenomas but less likely among those with fair bowel preparation and those with family history of CRC. Of 203 nonadherent recommendations, 70.4% were considered potential overuse, 20.2% potential underuse, and 9.4% were not provided surveillance recommendations. Conclusions: An EMR-based CoRS was widely used and significantly improved guideline adherence of surveillance recommendations.