Study protocol: phase II study to evaluate the effect of cetuximab monotherapy after immunotherapy with PD-1 inhibitors in patients with head and neck squamous cell cancer.

Background: Immunotherapy with programmed death receptor-1 (PD-1) inhibitors, as a single agent or in combination with chemotherapy, is the standard first-line treatment for recurrent or metastatic head and neck squamous cell cancer (R/M HNSCC). Unfortunately, there is no established second-line treatment for the many patients who fail immunotherapy. Cetuximab is the only targeted therapy approved in HNSCC but historically has a low response rate of 13%. Objectives: We hypothesize that cetuximab monotherapy following an immune checkpoint inhibitor (ICI) will lead to increased efficacy due to a potential synergistic effect on the antitumor immune response, as a result of activation effects of both treatments on innate and adaptative immune responses. To the authors' knowledge, this is the only ongoing prospective clinical study that evaluates the combination of cetuximab and ICIs administered sequentially. Methods and analysis: In this non-randomized, open-label, phase II trial, 30 patients with R/M HNSCC who have previously failed or could not tolerate a PD-1 inhibitor as a single agent or in combination with chemotherapy will subsequently be treated with cetuximab monotherapy. Outcomes of interest include overall response rate, duration of response, progression-free survival, overall survival, and treatment toxicity, as well as treatment outcome measured by a patient-reported outcome questionnaire. Saliva and blood will be collected for correlative studies to investigate the immune response status at the end of therapy with an ICI and the effect of cetuximab on the antitumor immune response. The results will be correlated with the response to cetuximab and the time window between the last administration of an ICI and the loading dose of cetuximab. The clinical study is actively recruiting. Ethics: This study was approved by the Wake Forest Comprehensive Cancer Center Institutional Review Board: IRB00065239. Clinical trial registration: This study is registered on ClinicalTrials.gov: NCT04375384.

Community-funded integrated care outreach clinics as a capacity building strategy to expand access to health care in remote areas of Uganda.

Most Ugandans live in rural, medically underserved communities where geography and poverty lead to reduced access to healthcare. We present a novel low-cost approach for supplemental primary care financing through 1) pooling community wealth to cover overhead costs for outreach clinic activities and 2) issuing microfinance loans to motorcycle taxi entrepreneurs to overcome gaps in access to transportation. The intervention described here, which leverages community participation as a means to extend the reach of government health service delivery, was developed and implemented by Health Access Connect (HAC), a non-governmental organization based in Uganda. HAC began its work in August 2015 in the Lake Victoria region and now serves over 40 sites in Uganda across 5 districts, helping government health-care workers to provide over 1,300 patient services per month (and over 35,000 since the program's inception) with an average administrative cost of $6.24 per patient service in 2020. In this article, we demonstrate how integrated and appropriately resourced monthly outreach clinics, based on a microfinance-linked model of wealth pooling and government cooperation, can expand the capacity of government-provided healthcare to reach more patients living in remote communities. This scalable, sustainable, and flexible model is responsive to shifting needs of patients and health systems and presents an alternative approach to healthcare financing in low-resource settings. More rigorous evaluation of health outcomes stemming from such community-based models of service delivery is warranted.

Understanding VA's Use of and Relationships With Community Care Providers Under the MISSION Act.

BACKGROUND: Congress has enacted 2 major pieces of legislation to improve access to care for Veterans within the Department of Veterans Affairs (VA). As a result, the VA has undergone a major transformation in the way that care is delivered to Veterans with an increased reliance on community-based provider networks. No studies have examined the relationship between VA and contracted community providers. This study examines VA facility directors' perspectives on their successes and challenges building relationships with community providers within the VA Community Care Network (CCN). OBJECTIVES: To understand who VA facilities partner with for community care, highlight areas of greatest need for partnerships in various regions, and identify challenges of working with community providers in the new CCN contract. RESEARCH DESIGN: We conducted a national survey with VA facility directors to explore needs, challenges, and expectations with the CCN. RESULTS: The most common care referred to community providers included physical therapy, chiropractic, orthopedic, ophthalmology, and acupuncture. Open-ended responses focused on 3 topics: (1) Challenges in working with community providers, (2) Strategies to maintain strong relationships with community providers, and (3) Re-engagement with community providers who no longer provide care for Veterans. CONCLUSIONS: VA faces challenges engaging with community providers given problems with timely reimbursement of community providers, low (Medicare) reimbursement rates, and confusing VA rules related to prior authorizations and bundled services. It will be critical to identify strategies to successfully initiate and sustain relationships with community providers.

Understanding Maternity Care Coordination for Women Veterans Using an Integrated Care Model Approach.

BACKGROUND: An increasing number of women veterans are using VA maternity benefits for their pregnancies. However, because the VA does not offer obstetrical care, women must seek maternity care from non-VA providers. The growing number of women using non-VA care has increased the importance of understanding how this care is integrated with ongoing VA medical and mental health services and how perceptions of care integration impact healthcare utilization. Therefore, we sought to understand these relationships among a sample of postpartum veterans utilizing VA maternity benefits. METHODS: We fielded a modified version of the Patient Perceptions of Integrated Care survey among a sample of postpartum veterans who had utilized VA maternity benefits for their pregnancies (n = 276). We assessed relationships between perceptions of six domains of patient-reported integrated care, indicating how well-integrated patients perceived the care received from VA and non-VA clinicians, and utilization of mental healthcare following pregnancy. RESULTS: Domain scores were highest for items focused on VA care, including test result communication and VA provider's knowledge of patient's medical conditions. Scores were lower for obstetrician's knowledge of patient's medical history. Women with depressive symptom scores indicative of depression rated test result communication as highly integrated, while women who received mental healthcare following pregnancy had low integrated care ratings for the Support for Medication and Home Health Management domain, indicating a lack of support for mental health conditions following pregnancy. DISCUSSION: Among a group of postpartum veterans, poor ratings of integrated care across some domains were associated with higher rates of mental healthcare use following pregnancy. Further assessment of integrated care by patients may assist VA providers and policymakers in developing systems to ensure integrated care for veterans who receive care outside the VA.