Patient Knowledge and Expectations About Return of Genomic Results in a Biomarker-Driven Master Protocol Trial (SWOG S1400GEN).

PURPOSE: Biomarker-driven master protocols represent a new paradigm in oncology clinical trials, but their complex designs and wide-ranging genomic results returned can be difficult to communicate to participants. The objective of this pilot study was to evaluate patient knowledge and expectations related to return of genomic results in the Lung Cancer Master Protocol (Lung-MAP). METHODS: Eligible participants with previously treated advanced non-small-cell lung cancer were recruited from patients enrolled in Lung-MAP. Participants completed a 38-item telephone survey ≤ 30 days from Lung-MAP consent. The survey assessed understanding about the benefits and risks of Lung-MAP participation and knowledge of the potential uses of somatic testing results returned. Descriptive statistics and odds ratios for associations between demographic factors and correct responses to survey items were assessed. RESULTS: From August 1, 2017, to June 30, 2019, we recruited 207 participants with a median age of 67, 57.3% male, and 94.2% White. Most participants "strongly/somewhat agreed" with statements that they "received enough information to understand" Lung-MAP benefits (82.6%) and risks (69.5%). In items asking about potential uses of Lung-MAP genomic results, 87.0% correctly indicated that the results help to select cancer treatment, but < 20% correctly indicated that the results are not used to confirm cancer diagnosis, would not reveal risk of developing diseases besides cancer, and would not indicate if family members had increased cancer risk. There were no associations between sociodemographic factors and proportions providing correct responses. CONCLUSION: In a large National Clinical Trials Network biomarker-driven master protocol, most participants demonstrated incorrect knowledge and expectations about the uses of genomic results provided in the study despite most indicating that they had enough information to understand benefits and risks.

Association of healthcare utilization with financial worry and anxiety in a general population sample.

This study examined the association of healthcare use (HCU) with financial outcomes in a general population sample (n = 395) to determine if HCU was associated with increased financial worry as most research has examined socioeconomic indicators and material financial problems. Participants reported six types of HCUin the previous year, financial anxiety (FA) and worry about affording healthcare (WAH) in an online survey. In bivariate comparisons, WAH was associated with all forms of HCU and FA was associated with all forms of HCU except outpatient visits. In multivariate analyses, WAH was associated with outpatient visits, emergency room visits, number of doctors, number of scans and number of blood tests (p's<0.05) but not urgent care visits. FA was associated with emergency room visits, urgent care visits, and number of doctors (p's<0.05) but not other forms of HCU in multivariate comparisons. As many forms of HCU were associated with more WAH and FA, policy initiatives and patient-level interventions should focus on managing costs rather than shifting from emergency to outpatient care. Results also suggest that the financial costs of healthcare, as indexed by HCU, may have an effect on anxiety and worry specific to healthcare even when controlling for socioeconomic factors.

Short-term bridge to heart transplant using the BVS 5000 external ventricular assist device.

From January 1995 to April 2001, 71 patients with cardiogenic shock using the BVS 5000 were treated or accepted in transfer. Of the 24 transplanted, nine had dilated cardiomyopathy, ischemic cardiomyopathy, acute myocardial infarction, giant cell myocarditis and previous Fontan procedure (group I, n = 13). The others had postcardiotomy shock (group II, n = 11); seven were transferred to our center after device implantation. Age ranged from 8 to 67 years. Ten (77%) patients in group I were implanted without cardiopulmonary bypass. The mean duration of support was 6.7 (2-24) d. Twelve patients were extubated before transplantation and 13 (five in group I, eight in group II) received nonstandard donor organs. Survival to discharge and 1-year actuarial survival was 85 and 77% for group I and 73 and 64% for group II, respectively. Patients with post-implant serum bilirubin levels > 10 mg/dL had a tendency to expire from multiple systemic organ failure. Patients not ventilator-dependent at the time of transplant had the best outcomes. Short-term bridge to transplantation using the BVS 5000 is feasible in selected patients. Caution is recommended when directing such patients to transplant if they need ventilator support and have high serum bilirubin levels.