Brief Report: Implementation of a Universal Prescreening Protocol to Increase Recruitment to Lung Cancer Studies at a Veterans Affairs Cancer Center.

Introduction: The oncology clinical trial recruitment process is time, labor, and resource intensive, and poor accrual rates are common. We describe the VA Connecticut Cancer Center experience of implementing a standardized, universal prescreening protocol and its impact on thoracic oncology research recruitment. Methods: Research coordinators prescreened potentially eligible patients with confirmed or suspected cancer from multiple clinical sources and entered relevant patient and research study information into a centralized electronic database. The database provided real-time lists of potential studies for each patient. This enabled the research team to alert the patient's oncologist in advance of clinic visits and to prepare documents needed for enrollment. Clinicians could ensure sufficient time and attention in clinic to the informed consent process, therefore maximizing enrollment opportunities. Patients were also monitored on waitlists for future studies. Results: From March 2017 to December 2020, a total of 1518 patients with lung nodules and suspected or confirmed lung cancers were prescreened. Of these, 379 patients were enrolled to a study, 103 patients declined participation, and 639 were monitored for future studies. Our prescreening protocol identified all new patients with lung cancer who were ultimately added to the cancer registry. We found a substantial increase in study enrollment after prescreening implementation. Conclusions: Universal prescreening was associated with improved patient enrollment to thoracic oncology studies. The protocol was integral in our VA becoming the top accruing VA site for National Cancer Institute's National Clinical Trials Network studies for 2019 to 2021.

Optimizing Care for Patients With Adverse Events From Immunotherapeutics.

Immune-related adverse events (irAEs) are a common occurrence in patients treated with immune checkpoint inhibitors. Fortunately, the majority of irAEs are mild and easily managed with steroids. As the use of immune checkpoint inhibitors and other immune therapies continues to increase across indications, so too will the need for managing irAEs. Optimal care for irAEs should include surveillance and early detection, guideline-driven management of standard irAEs, multidisciplinary expert involvement in complicated or steroid-refractory cases, and concurrent research to define predictive biomarkers and delineate the populations, which can be safely treated and retreated with immune therapies. In this article, we describe the implementation of a 3-pronged strategy used at our institution consisting of an Immune Wellness Clinic to risk stratify and monitor at-risk patients, an Immuno-Oncology Treatment Monitoring Repository to support translational research, and an Immunotoxicity Tumor Board to manage severe or complicated adverse events.

Evaluation of vitamin B12 monitoring in patients on metformin in urban ambulatory care settings.

BACKGROUND: Previous studies linked metformin use to vitamin B12 deficiency and demonstrated that the prevalence of vitamin B12 monitoring remains low. OBJECTIVE: This study aimed to assess the occurrence of monitoring vitamin B12 levels in a diverse population. METHODS: This was a retrospective chart review of adult patients with type 2 diabetes on metformin doses ≥ 1000 mg for ≥ 6 months at five Federally Qualified Health Centers (FQHC) and one Program of All-Inclusive Care for the Elderly (PACE). Charts were reviewed for occurrence of monitoring vitamin B12 levels in the past 5 years. Data collected included patient demographics, laboratory data, other potential vitamin B12 level lowering agents, active prescription for vitamin B12 supplementation, concomitant diabetes medications and metformin total daily dose. RESULTS: Of the 322 patients included, 25% had a vitamin B12 level measured in the previous five years. Among the patients with a vitamin B12 level, 87.7% were within the normal range (>350 pg/mL), 11.1% were low (200-300 pg/mL), and only one patient (1.2%) was deficient (<200 pg/mL). These patients were older (69.2 vs. 56.4, p<0.001); more likely to be white (56.8% vs. 37.8%, p=0.04); and more likely to use proton pump inhibitors (34.6% vs. 20.7%, p=0.02) and vitamin B12 supplementation (27.2% vs. 4.6%, p<0.001). Vitamin B12 monitoring differed between the FQHC (15.2%) and PACE (97.4%) sites (p<0.001). Each greater year of age was associated with a 5% increased odds of vitamin B12 monitoring (a OR: 1.05; 95% CI: 1.02-1.08). CONCLUSIONS: The majority of patients seen at the FQHC sites did not have vitamin B12 levels monitored, however, most of the patients who were monitored had normal vitamin B12 levels, which may warrant extending the monitoring time. This finding may also support monitoring patients who have additional risk factors for vitamin B12 deficiency such as concurrent medication use with other vitamin B12 lowering agents or clinical symptoms of deficiency such as peripheral neuropathy. Future studies are needed to determine appropriate frequency of monitoring.

Evaluation of vitamin B12 monitoring in patients on metformin in urban ambulatory care settings

Background: Previous studies linked metformin use to vitamin B12 deficiency and demonstrated that the prevalence of vitamin B12 monitoring remains low. Objective: This study aimed to assess the occurrence of monitoring vitamin B12 levels in a diverse population. Methods: This was a retrospective chart review of adult patients with type 2 diabetes on metformin doses ≥ 1000 mg for ≥ 6 months at five Federally Qualified Health Centers (FQHC) and one Program of All-Inclusive Care for the Elderly (PACE). Charts were reviewed for occurrence of monitoring vitamin B12 levels in the past 5 years. Data collected included patient demographics, laboratory data, other potential vitamin B12 level lowering agents, active prescription for vitamin B12 supplementation, concomitant diabetes medications and metformin total daily dose. Results: Of the 322 patients included, 25% had a vitamin B12 level measured in the previous five years. Among the patients with a vitamin B12 level, 87.7% were within the normal range (>350 pg/mL), 11.1% were low (200-300 pg/mL), and only one patient (1.2%) was deficient (<200 pg/mL). These patients were older (69.2 vs. 56.4, p<0.001); more likely to be white (56.8% vs. 37.8%, p=0.04); and more likely to use proton pump inhibitors (34.6% vs. 20.7%, p=0.02) and vitamin B12 supplementation (27.2% vs. 4.6%, p<0.001). Vitamin B12 monitoring differed between the FQHC (15.2%) and PACE (97.4%) sites (p<0.001). Each greater year of age was associated with a 5% increased odds of vitamin B12 monitoring (a OR: 1.05; 95% CI: 1.02-1.08). Conclusions: The majority of patients seen at the FQHC sites did not have vitamin B12 levels monitored, however, most of the patients who were monitored had normal vitamin B12 levels, which may warrant extending the monitoring time. This finding may also support monitoring patients who have additional risk factors for vitamin B12 deficiency such as concurrent medication use with other vitamin B12 lowering agents or clinical symptoms of deficiency such as peripheral neuropathy. Future studies are needed to determine appropriate frequency of monitoring

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