Report From the 2022 Mary Tyler Moore Vision Initiative Diabetic Retinal Disease Clinical Endpoints Workshop.

The Mary Tyler Moore Vision Initiative Diabetic Retinal Disease (DRD) Clinical Endpoints Workshop was held on October 22, 2022 to accelerate progress toward establishment of useful clinical and research endpoints and development of new therapeutics that have important relevance across the full spectrum of DRD pathology. More than 90 patient representatives, clinicians, scientists, funding and regulatory agencies, diagnostic, therapeutic and biotech industry representatives discussed the needs for new diagnostic and therapeutic approaches to prevent and restore retinal neurovascular unit integrity. Phase I of the MTM Vision Initiative plans, notably updating the DRD staging system and severity scale, establishing a human ocular biorepository and resource, and clinical endpoints and biomarker development and validation, was emphasized.

Developing weight navigation program to support personalized and effective obesity management in primary care settings: protocol for a quality improvement program with an embedded single-arm pilot study.

BACKGROUND: Primary care providers (PCPs) are expected to help patients with obesity to lose weight through behavior change counseling and patient-centered use of available weight management resources. Yet, many PCPs face knowledge gaps and clinical time constraints that hinder their ability to successfully support patients' weight loss. Fortunately, a small and growing number of physicians are now certified in obesity medicine through the American Board of Obesity Medicine (ABOM) and can provide personalized and effective obesity treatment to individual patients. Little is known, however, about how to extend the expertise of ABOM-certified physicians to support PCPs and their many patients with obesity. AIM: To develop and pilot test an innovative care model - the Weight Navigation Program (WNP) - to integrate ABOM-certified physicians into primary care settings and to enhance the delivery of personalized, effective obesity care. METHODS: Quality improvement program with an embedded, 12-month, single-arm pilot study. Patients with obesity and ≥1 weight-related co-morbidity may be referred to the WNP by PCPs. All patients seen within the WNP during the first 12 months of clinical operations will be compared to a matched cohort of patients from another primary care site. We will recruit a subset of WNP patients (n = 30) to participate in a remote weight monitoring pilot program, which will include surveys at 0, 6, and 12 months, qualitative interviews at 0 and 6 months, and use of an electronic health record (EHR)-based text messaging program for remote weight monitoring. DISCUSSION: Obesity is a complex chronic condition that requires evidence-based, personalized, and longitudinal care. To deliver such care in general practice, the WNP leverages the expertise of ABOM-certified physicians, health system and community weight management resources, and EHR-based population health management tools. The WNP is an innovative model with the potential to be implemented, scaled, and sustained in diverse primary care settings.

The CTSA mandate: are we there yet?

The ultimate aim of the National Institutes of Health Clinical and Translational Science Award (CTSA) initiative is to accelerate the movement of discoveries that can benefit human health into widespread public use. To accomplish this translational mandate, the contributions of multiple disciplines, such as dentistry, nursing, pharmacy, public health, biostatistics, epidemiology, and bioengineering, are required in addition to medicine. The research community is also mandated to establish new partnerships with organized patient communities and front line health care providers to assure the bidirectional flow of information in order that health priorities experienced by the community inform the research agenda. This article summarizes current clinical research directives, the experience of the University of Michigan faculty during the first 2 years of CTSA support, and recommendations to enhance the effectiveness of future CTSA as well as other interdisciplinary initiatives. While the manuscript focuses most closely on the CTSA Community Engagement mission, the challenges to interdisciplinarity and bidirectionality extend beyond the focus of community engagement.

The interface between the practice of medical genetics and human genetic research: what every genetic counselor needs to know.

Genetic counselors have historically used human genetic research as an advanced information resource for their patients. Most commonly, this has been via access to information provided by gene identification studies in advance of commercial testing. More recently genetic counselors have been participating in human genetic research studies as part of the investigative team. This review provides a framework to help genetic counselors in research and clinical practice understand the historical perspectives, ethical principles, and federal regulations that govern the current practice of human subject research. Special consideration is given to the IRB process and unique issues in human genetic research. This overview is intended to help improve the ability of genetic counselors to act as advocates for their patients.