Increasing accrual of minority patients in breast cancer clinical trials.

BACKGROUND: Black and Hispanic patients participate in clinical trials at lower rates than white patients nationally; lack of diversity in clinical trials prevents appropriate safety and efficacy testing of new treatments in these populations. METHODS: The Oncology Welcomes New Haven into Trials (OWN IT) initiative at the Yale Cancer Center used a multi-tiered approach to improve breast cancer minority clinical trial accrual through community focus groups, ongoing community outreach, institutional executive council representation, grand rounds presentation, and didactic lectures with healthcare providers. Eligibility criteria of breast cancer trials at Smilow Cancer Center were reviewed using clinicaltrials.gov. Also, an anonymous, 5-min survey was conducted at regular visits with Smilow Breast Center patients to gauge awareness of and access to clinical trials. Survey data were compared to the Yale Cancer Center Clinical Trials Office, Connecticut Tumor Registry, and U.S. Census records. Two-tailed Fisher's tests were used for all analyses. RESULTS: There was a significant increase in the number of minority patients who participated in clinical trials at Smilow Cancer Center from 2016 (95/750) to 2018 (155/944) (p = 0.0325). Two hundred patients participated in the survey; response rate 92%. There was no significant difference in the rate at which patients were invited to participate in clinical trials or the rate at which they declined to participate based on race or ethnicity. Black and Hispanic patients were significantly less likely to be aware of clinical trials than white patients (p < .001). The review of eligibility criteria showed that over half of the studies reviewed had restrictions regarding increased liver function tests, and many restricted the participation of patients with other chronic conditions. CONCLUSIONS: Low participation in clinical trials among black and Hispanic patients is likely multifaceted. This study indicated that there are likely structural factors at work which can be modified with institutional effort. The role of patient education regarding clinical trials and accrual should be studied further as should eligibility criteria as a potential barrier to participation.

Assessment of Robotic Console Skills (ARCS): construct validity of a novel global rating scale for technical skills in robotically assisted surgery.

BACKGROUND: Skill assessment during robotically assisted surgery remains challenging. While the popularity of the Global Evaluative Assessment of Robotics Skills (GEARS) has grown, its lack of discrimination between independent console skills limits its usefulness. The purpose of this study was to evaluate construct validity and interrater reliability of a novel assessment designed to overcome this limitation. METHODS: We created the Assessment of Robotic Console Skills (ARCS), a global rating scale with six console skill domains. Fifteen volunteers who were console surgeons for 0 ("novice"), 1-100 ("intermediate"), or >100 ("experienced") robotically assisted procedures performed three standardized tasks. Three blinded raters scored the task videos using ARCS, with a 5-point Likert scale for each skill domain. Scores were analyzed for evidence of construct validity and interrater reliability. RESULTS: Group demographics were indistinguishable except for the number of robotically assisted procedures performed (p = 0.001). The mean scores of experienced subjects exceeded those of novices in dexterity (3.8 > 1.4, p < 0.001), field of view (4.1 > 1.8, p < 0.001), instrument visualization (3.9 > 2.2, p < 0.001), manipulator workspace (3.6 > 1.9, p = 0.001), and force sensitivity (4.3 > 2.6, p < 0.001). The mean scores of intermediate subjects exceeded those of novices in dexterity (2.8 > 1.4, p = 0.002), field of view (2.8 > 1.8, p = 0.021), instrument visualization (3.2 > 2.2, p = 0.045), manipulator workspace (3.1 > 1.9, p = 0.004), and force sensitivity (3.7 > 2.6, p = 0.033). The mean scores of experienced subjects exceeded those of intermediates in dexterity (3.8 > 2.8, p = 0.003), field of view (4.1 > 2.8, p < 0.001), and instrument visualization (3.9 > 3.2, p = 0.044). Rater agreement in each domain demonstrated statistically significant concordance (p < 0.05). CONCLUSIONS: We present strong evidence for construct validity and interrater reliability of ARCS. Our study shows that learning curves for some console skills plateau faster than others. Therefore, ARCS may be more useful than GEARS to evaluate distinct console skills. Future studies will examine why some domains did not adequately differentiate between subjects and applications for intraoperative use.