Citations

AbstractNational Comprehensive Cancer Network (NCCN) guidelines are the most comprehensive and widely used standard for clinical care, financial reimbursements and quality improvement initiatives in oncology. We studied the distribution of categories of evidence and consensus (EC) in the guidelines for the common cancers in the United States. We evaluated the EC categories in staging, therapy and surveillance recommendations in 2019 guidelines and compared them with the same in 2010. The latest 2019 version of NCCN guidelines were obtained. The definitions for various categories of EC used were, Category 1 (high level evidence, uniform consensus), Category 2A (lower level of evidence [LOE], uniform consensus), Category 2B (lower LOE, no uniform consensus but with no major disagreement) and Category 3 (any LOE, major disagreement). We compared our results with previously published results from 2010 guidelines. Total number of recommendations increased by 77% from 1023 (2010) to 1818 (2019). Of the 1818 recommendations, Category 1, 2A, 2B and 3 EC were 7%, 87%, 6% and 0%, respectively, while in 2010 they were 6%, 83%, 10% and 1%. Breast (30%), lung (10%) and kidney (10%) cancer had the highest proportions of Category 1 therapeutic recommendations in their respective guidelines. No Category 1 recommendations were found in screening or surveillance guidelines or in pancreatic and uterine cancer guidelines. Recommendations in 2019 NCCN guidelines are largely Category 2A (lower levels of evidence, uniform expert opinion), unchanged from the previous study in 2010.

Background Clinical practice guidelines (CPGs) are evidence‐based guidelines that serve as a standard of care in oncology practice, reimbursements, and quality improvement initiatives. To our knowledge, the extent of financial conflicts of interest (FCOIs) in National Comprehensive Cancer Network (NCCN) guidelines have not been systemically evaluated. The current study evaluated the extent of FCOIs in the NCCN CPGs for the most common malignancies in the United States. Methods The authors examined the latest 2019 versions of the NCCN CPGs for the 10 most common cancers by incidence in the United States. Using disclosure lists, they catalogued the FCOIs for the panelists under various categories outlined in the CPG. The authors also tabulated the companies and institutions involved in each panel disclosure. An “episode” describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. “Affiliation” describes an industrial, commercial, or institutional affiliation reported by a panelist in each episode. Results Of the 491 panelists on the CPG panel, 483 (98.3%) completed FCOI disclosures. A total of 224 (46.4%) reported at least 1 FCOI episode. A total of 1103 episodes were disclosed with an average of 4.9 episodes reported per panelist with FCOIs. Acting as part of scientific advisory boards, as a consultant, or as an expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1103 episodes of FCOI. The top companies were Bristol‐Myers Squibb, Merck, Genentech, and AstraZeneca. Among cancers, the prevalence of FCOIs was highest for lung cancer (56%), bladder cancer (52%), pancreatic cancer (52%), non‐Hodgkin lymphoma (50%), kidney cancer (49%), colorectal cancer (43%), breast cancer (42%), melanoma (40%), prostate cancer (38%), and uterine cancer (32%). Among the panelists with FCOIs, 26%, 17%, and 57%, respectively, reported 1, 2, and >3 episodes. There were 127 episodes noted among the CPG chairs and/or vice chairs who reported FCOIs (mean, 6.4 episodes). The chairs and/or vice chairs of CPGs for uterine cancer, pancreatic cancer, melanoma, and prostate cancer were not found to have any FCOIs. Conclusions FCOIs are very prevalent among NCCN CPG panelists. In nearly one‐half of the CPGs, the majority of the panelists had at least 1 FCOI. Greater than one‐half of the CPG chairs and/or vice chairs reported multiple FCOIs. Further research studies are necessary to determine the impact of these FCOIs.

SummaryBackgroundAn association between bariatric surgery and development of de‐novo inflammatory bowel disease (IBD) has been observed.AimTo evaluate further the association among bariatric surgery, weight loss medications, obesity and new‐onset IBD.MethodsUsing Explorys, a population‐based Health Insurance Portability and Accountability Act compliant database, we estimated the prevalence of de‐novo IBD among patients treated with bariatric surgery (Roux‐en‐Y gastrojejunostomy, laparoscopic sleeve gastrectomy or gastric banding) (n = 60 870) or weight loss medications (orlistat, phentermine/topiramate, lorcaserin, bupropion/naltrexone and liraglutide) (n = 193 790) compared with obese controls (n = 5 021 210), between 1999 and 2018.ResultsThe prevalence of de‐novo IBD was lower among obese patients exposed to bariatric surgery (7.72 per 1000 patients) or weight loss medications (7.22 per 1000 patients) compared with patients with persistent obesity not exposed to these interventions (11.66 per 1000 patients, P < 0.0001). The risk reduction for de‐novo IBD was consistent across bariatric surgeries and weight loss medications with the exception of orlistat which was not associated with a reduction in risk for de‐novo IBD compared with the persistent obese control cohort.ConclusionObese patients undergoing treatment with bariatric surgery or weight loss medications are at a lower risk for developing de‐novo IBD compared with persistently obese controls not exposed to these interventions. These data suggest that obesity and ineffective management of obesity are risk factors for de‐novo IBD. Further research is needed to confirm these observations and understand potential mechanisms.

15 Background: CPG are evidence-based guidelines, which serve as a standard of care in practice, quality improvement, and reimbursement. The extent of financial conflicts of Interest (FCOI) in NCCN guidelines has not been recently evaluated. Our study evaluated the extent of FCOI in the NCCN CPG among the 10 most common malignancies in the US. Methods: We examined the latest 2019 version of the NCCN CPG for the 10 most common cancers by incidence in the US. Using disclosure lists, we catalogued the FCOIs for the panelists under various categories outlined in the CPG. We also tabulated the companies/institutions involved in each disclosure. An “episode” describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. “Affiliation” describes a commercial, industry, or institute affiliation reported by a panelist in each episode. Results: Of the 491 panelists on the CPG, 483 (98.3%) completed FCOI disclosures. 224 (46.38%) reported at least 1 FCOI. A total of 1,103 episodes were disclosed with an average of 4.9 episodes per panelist with FCOI. Being a part of scientific advisory boards, consultant, or expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1,103 episodes of FCOI. The top companies were Bristol Myers Squibb, Merck, Genentech and AstraZeneca. Among the top 10 cancers, the prevalence of FCOI were lung (56%), bladder (52%), pancreatic (52%), non-Hodgkin lymphoma (50%), kidney (49%), colorectal (43%), breast (42%), melanoma (40%), prostate (38%), and uterine (32%). Among the panelists with FCOI, 26%, 17%, and 57% reported 1, 2, and > 3 episodes, respectively. There were 127 episodes among the CPG chairs/vice chairs who reported FCOI (mean 6.4). The chairs/vice chairs of uterine, pancreatic, melanoma, and prostate cancer CPG did not have any FCOI. Conclusions: FCOI are very prevalent among the top 10 NCCN CPG panelists. In almost half of the CPG, the majority of the panelists had at least 1 FCOI. Over half of the CPG chairs/vice chairs reported multiple FCOI. Further studies are necessary to determine the impact of these FCOI.

14 Background: National Comprehensive Cancer Network (NCCN) guidelines are the most comprehensive and widely used standard for clinical care in oncology by clinicians and payors in the US. The level of scientific evidence in NCCN guidelines has not been studied since it’s last review in 2010. We describe the categories of evidence and consensus (EC) among the 10 most common cancers in the US as of 2019 and compare them with 2010 guidelines. Methods: We obtained the 2019 version of NCCN guidelines. The definitions for various categories of EC used were: Category 1 (high level evidence such as randomized controlled trials with uniform consensus), 2A (lower level of evidence with uniform consensus), 2B (lower level of evidence without a uniform consensus but with no major disagreement) and 3 (any level of evidence but with major disagreement). We compared our results with previously published results from 2010 guidelines. Results: Total recommendations increased by 77% from 1023 (2010) to 1818 (2019). Of the 1818 recommendations, Category 1, 2A, 2B and 3 EC were 7%, 87%, 6% and 0% while in 2010 they were 5%, 85%, 9% and 1% respectively. Recommendations with category 1 EC were found in lung (13%), prostate (11%), melanoma (8%), breast (7%), NHL (5%), kidney (2%), bladder (2%) and colorectal (2%) guidelines. Pancreatic and uterine cancer guidelines had no recommendations with category 1 EC. 19% of therapeutic recommendations were category 1 EC with the majority (65%) pertaining to initial therapy. Guidelines with highest proportions of therapeutic recommendations with category 1 EC were breast (30%), lung (10%), and kidney (10%) cancers. No category 1 EC recommendations existed in screening or surveillance. Although we found an increase in the total number of recommendations, the distribution of different types of categories of EC are largely similar to 2010. Conclusions: Recommendations in 2019 NCCN guidelines are largely derived from lower levels of evidence with uniform expert opinion. Despite the major advances in oncology in the past decade, this is largely unchanged. Our study underscores the urgent need and available opportunities to expand the current evidence base in oncology which forms the platform for clinical practice guidelines.