Citations

1564 Background: Enrollment in clinical trials has declined during the COVID-19 pandemic. Simultaneously, breast cancer patients have reported heightened anxiety. We assessed whether breast cancer patients’ anxiety about the pandemic affects their willingness to participate in trials. Methods: English or Spanish-speaking US residents with breast cancer were eligible to complete the online REDCap survey 8/6/21 – 9/30/21. Respondents rated their anxiety about the pandemic on an 11-point scale from 0 (no anxiety) to 10 (worst anxiety possible). Anxiety scores were categorized as no/mild (0-3), moderate (4-6) or severe (7-10). Knowledge about trials was assessed with 11 true/false items and attitudes toward trials with the Attitudes Toward Cancer Trials Scales - Cancer Treatment Subscale (ATCTS-CTS). Respondents rated their willingness to participate in a breast cancer clinical trial before and during the pandemic on 5-point scales from 0 (not at all willing) to 4 (definitely willing). Trial participants were considered “definitely willing.” Change in willingness to participate in trials during the pandemic compared to prior was defined as a binary outcome, "less willing" vs "no less willing." Means were compared via t-test and mean difference was tested via paired t-test. Multivariable logistic regression was used to model the association of anxiety and other factors with being less willing to participate in trials during compared to prior to the pandemic. Results: Among 385 respondents, median age was 52 (range 25-85), 271 (70%) were non-Hispanic White and 202 (53%) had metastatic disease. 154 (40%) received care at academic centers and 37 (10%) were current trial participants. Most rated their anxiety as moderate (43%) or severe (38%). Mean willingness to participate in a trial was lower during compared to prior to the pandemic (2.97 vs 3.10; p < 0.0001). Fifty (13%) respondents were less willing to participate in a trial during the pandemic compared to prior. After controlling for covariates, those with severe anxiety had 5.07 times odds of being less willing to participate during the pandemic compared to prior than those with no/mild anxiety (p = 0.01). For every 1-point increase in ATCTS-CTS score (indicating better attitude toward trials) there was a 3% decrease in the odds of being less willing to participate during the pandemic (p = 0.006). For every 1-point increase in the clinical trials knowledge score (indicating more knowledge) there was a 15% decrease in the odds of being less willing to participate during the pandemic (p = 0.02). Conclusions: Pandemic-related anxiety is common in breast cancer patients and is associated with being less willing to participate in trials during the pandemic compared to prior. Education about trials, including safety modifications implemented during the pandemic, may mitigate anxiety and improve willingness to participate.

Background: Primary sclerosing cholangitis (PSC) is a major risk factor for cholangiocarcinoma (CCA). We investigated biliary and fecal microbiota to determine whether specific microbes in the bile or stool are associated with PSC or CCA. Methods: Bile was obtained from 32 patients with PSC, 23 with CCA with PSC, 26 with CCA without PSC, and 17 controls. Over 90% of bile samples were from patients with perihilar CCA. Stool was obtained from 31 patients with PSC (11 were matched to bile), 16 with CCA with PSC (10 matched to bile), and 11 with CCA without PSC (6 matched to bile). Microbiota composition was assessed using 16SrRNA-marker-based sequencing and was compared between groups. Results: Bile has a unique microbiota distinguished from negative DNA controls and stool. Increased species richness and abundance of Fusobacteria correlated with duration of PSC and characterized the biliary microbiota in CCA. Stool microbiota composition showed no significant differences between groups. Conclusions: We identified a unique microbial signature in the bile of patients with increased duration of PSC or with CCA, suggesting a role for microbiota-driven inflammation in the pathogenesis and or progression to perihilar CCA. Further studies are needed to test this hypothesis.

OBJECTIVES: The multifaceted long-term impairments resulting from critical illness and COVID-19 require interdisciplinary management approaches in the recovery phase of illness. Operational insights into the structure and process of recovery clinics (RCs) from heterogeneous health systems are needed. This study describes the structure and process characteristics of existing and newly implemented ICU-RCs and COVID-RCs in a subset of large health systems in the United States. DESIGN: Cross-sectional survey. SETTING: Thirty-nine RCs, representing a combined 156 hospitals within 29 health systems participated. PATIENTS: None. INTERVENTIONS: None. MEASUREMENT AND MAIN RESULTS: RC demographics, referral criteria, and operating characteristics were collected, including measures used to assess physical, psychologic, and cognitive recoveries. Thirty-nine RC surveys were completed (94% response rate). ICU-RC teams included physicians, pharmacists, social workers, physical therapists, and advanced practice providers. Funding sources for ICU-RCs included clinical billing (n = 20, 77%), volunteer staff support (n = 15, 58%), institutional staff/space support (n = 13, 46%), and grant or foundation funding (n = 3, 12%). Forty-six percent of RCs report patient visit durations of 1 hour or longer. ICU-RC teams reported use of validated scales to assess psychologic recovery (93%), physical recovery (89%), and cognitive recovery (86%) more often in standard visits compared with COVID-RC teams (psychologic, 54%; physical, 69%; and cognitive, 46%). CONCLUSIONS: Operating structures of RCs vary, though almost all describe modest capacity and reliance on volunteerism and discretionary institutional support. ICU- and COVID-RCs in the United States employ varied funding sources and endorse different assessment measures during visits to guide care coordination. Common features include integration of ICU clinicians, interdisciplinary approach, and focus on severe critical illness. The heterogeneity in RC structures and processes contributes to future research on the optimal structure and process to achieve the best postintensive care syndrome and postacute sequelae of COVID outcomes.

Abstract The purpose of this pilot study was to explore the efficacy, safety, and tolerability of vidofludimus calcium (VC) in the treatment of primary sclerosing cholangitis (PSC). This was a single‐arm open‐label pilot study with a cohort of 18 patients with PSC. Study patients received VC for a period of 6 months. The study was undertaken at two sites, Mayo Clinic, Rochester, MN, and Mayo Clinic, Phoenix, AZ. The primary endpoint of the study was improvement of serum alkaline phosphatase (ALP) at the end of the study. Secondary endpoints included assessment of other liver biomarkers (bilirubin, alanine aminotransferase, and aspartate aminotransferase). Of 18 patients enrolled, 11 completed the 6 months of study treatment. Patients who completed treatment versus those who did not were similar other than a significantly higher direct bilirubin at baseline in the group that completed treatment (mean ± SD, 0.4 ± 0.3 versus 0.1 ± 0.1, p = 0.04). By intent to treat analysis, the primary outcome was met in 16.7% (3/18) of patients. By per‐protocol analysis, including only patients who completed treatment, normalization of ALP occurred in 27.7% (3/11) at week 24 (95% confidence interval, 6.0% to 61.0%). VC was well tolerated with no drug‐related serious adverse events. Conclusion: This proof of concept study provides support for further exploration of VC in patients with PSC.

Abstract Primary sclerosis cholangitis (PSC) predisposes individuals to liver failure, but it is challenging for radiologists examining radiologic images to predict which patients with PSC will ultimately develop liver failure. Motivated by algebraic topology, a topological data analysis - inspired framework was adopted in the study of the imaging pattern between the “Early Decompensation” and “Not Early” groups. The results demonstrate that the proposed methodology discriminates “Early Decompensation” and “Not Early” groups. Our study is the first attempt to provide a topological representation-based method into early hepatic decompensation and not early groups.