Undisclosed payments by pharmaceutical and medical device manufacturers to authors of endoscopy guidelines in the United States.

BACKGROUND AND AIMS: Payments from pharmaceutical and medical device manufacturers to authors of clinical practice guidelines (CPGs) may influence practice recommendations. It is therefore important to evaluate the completeness of financial conflict of interest (FCOI) declarations among CPG authors. METHODS: We performed a cross-sectional analysis of industry payments to authors of endoscopy guidelines published by 5 GI societies between 2014 and 2017. For each author we identified payments using the disclosure section of CPGs and the Centers for Medicare & Medicaid Services Open Payments (CMS-OP) database. We calculated the prevalence, monetary value, and type of declared and undeclared payments among authors. Payments were assessed for the calendar year of and before publication. RESULTS: Thirty-seven CPGs were included in the analysis comprising 569 author entries (91 unique individuals; 66.43% men, 92.6% physicians, 66.4% academically affiliated). Four hundred fifty-one episodes (79%) involved FCOIs, 451 (79%) had undisclosed FCOIs in the CMS-OP, and 445 (77%) had FCOIs relevant to a CPG recommendation. The median undisclosed payment value was $4807.26 (interquartile range, $334.84-$20,579.75). Male authors (odds ratio, 2.23; 95% confidence interval, 1.47-3.39) and academically affiliated authors (odds ratio, 8.87; 95% confidence interval, 5.57-14.13) were significantly more likely to have undeclared payments (P < .001). No CPGs met all National Academy of Medicine criteria. CONCLUSIONS: Recognizing concerns about the accuracy of the CMS-OP, there are substantial discrepancies between industry-reported payments and author self-disclosure. Additionally, there is a high prevalence of undisclosed payments by pharmaceutical and medical device manufacturers to these authors. Given the potential impact of these discrepancies and undisclosed payments on CPGs, more accurate reporting and alternative strategies for managing FCOI are needed.

Gastrointestinal Disease in Patients with Common Variable Immunodeficiency: A Retrospective Observational Study.

BACKGROUND: Gastrointestinal (GI) symptoms are common among patients with common variable immunodeficiency disorder (CVID) yet remain poorly understood. AIMS: The aim of this study was to characterize the demographic, clinical, endoscopic and histologic features of patients with CVID and GI symptoms. METHODS: We conducted a retrospective observational study of all patients with CVID at a large Canadian tertiary care centre between January 2000 and May 2018. RESULTS: We included 95 patients with CVID. The mean age of patients at the time of CVID diagnosis was 38.2(±16.0). Fifty-three (56%) patients were female. Sixty-four (67%) patients had GI symptoms, with a mean age of onset for GI symptoms of 43.4(±15.1) years. The most common symptoms were bowel movement changes (n = 55 [58%]) and abdominal pain (n = 44 [46%]). Patients with GI symptoms were more likely to have anemia (n = 23 [36%] versus n = 3 [10%], P = 0.0129), iron deficiency (n = 16 [25%] versus n = 2 [7%], P = 0.0481), and have received GI antibiotics (n = 37 [58%] versus n = 0, P < 0.0001) and proton pump inhibitors for reflux (n = 24 [38%] versus n = 3 [10%], P = 0.0067). The most common GI infections were Giardia lamblia (n = 14 [15%]) and Clostridium difficile (n = 4 [4%]). Forty-three (45%) patients with GI symptoms underwent colonoscopy, esophagogastroduodenoscopy or both. The most common findings were inflammation, nodular lymphoid hyperplasia, reduced plasma cells and increased intraepithelial lymphocytes. CONCLUSIONS: This is the largest study on CVID patients in a North American setting. The majority of patients experienced GI symptoms. Future studies should study response to treatment for GI disease among patients with CVID.