A clinical laboratory-developed LSC17 stemness score assay for rapid risk assessment of patients with acute myeloid leukemia.

Leukemia stem cells (LSCs) are linked to relapse in acute myeloid leukemia (AML). The LSC17 gene expression score robustly captures LSC stemness properties in AML and can be used to predict survival outcomes and response to therapy, enabling risk-adapted, upfront treatment approaches. The LSC17 score was developed and validated in a research setting. To enable widespread use of the LSC17 score in clinical decision making, we established a laboratory-developed test (LDT) for the LSC17 score that can be deployed broadly in clinical molecular diagnostic laboratories. We extensively validated the LSC17 LDT in a College of American Pathologists/Clinical Laboratory Improvements Act (CAP/CLIA)-certified laboratory, determining specimen requirements, a synthetic control, and performance parameters for the assay. Importantly, we correlated values from the LSC17 LDT to clinical outcome in a reference cohort of patients with AML, establishing a median assay value that can be used for clinical risk stratification of individual patients with newly diagnosed AML. The assay was established in a second independent CAP/CLIA-certified laboratory, and its technical performance was validated using an independent cohort of patient samples, demonstrating that the LSC17 LDT can be readily implemented in other settings. This study enables the clinical use of the LSC17 score for upfront risk-adapted management of patients with AML.

A student-led curriculum framework for homeless and vulnerably housed populations.

BACKGROUND: Medical student demands for competency based homeless health education is increasing. Indeed, humans living homeless is a treatable health and social emergency. This innovation report outlines the initial development of an education framework for homeless health. METHODS: A medical student task force and educators conducted a mixed method study, including a scoping review of homeless health curriculum and competencies, a cross-country survey of medical students, and unique clinical guidelines. The task force collaborated with persons with lived experience and clinical guideline developers from the Homeless Health Research Network. The students presented at the Toronto Homeless Health Summit and refined the framework with feedback from homeless health experts. RESULTS: The main outcome was an evidence-based Homeless Health Curriculum Framework. It uses seven core competencies; with communication, advocacy, leadership, and upstream approaches playing the strongest roles. The framework integrated the new clinical guideline (housing, income assistance, case management and addiction). In addition, it identified approaches to support mental health care with trauma informed and patient centered care. It identified public health values, clinical objectives, and case studies. The framework aims to inform the design, delivery, service learning and evaluation for medical school curriculum. CONCLUSIONS: This student-led curriculum framework can support the design, implementation, delivery and evaluation of homeless health within the undergraduate medical curriculum. The framework can lay the foundation for new doctors, research and development; support consistency across programs; and support the creation of national learning and evaluation tools.

Conducting a randomized trial in rural and urban safety-net health centers: Added value of community-based participatory research.

BACKGROUND: Colorectal cancer (CRC) is the second most common cancer in the US. Despite evidence that screening reduces CRC incidence and mortality, screening rates are sub-optimal with disparities by race/ethnicity, income, and geography. Rural-urban differences in CRC screening are understudied even though approximately one-fifth of the US population lives in rural areas. This focus on urban populations limits the generalizability and dissemination potential of screening interventions. METHODS: Using community-based participatory research (CBPR) principles, we designed a cluster-randomized trial, adaptable to a range of settings, including rural and urban health centers. We enrolled 483 participants across 11 health centers representing 2 separate networks. Both networks serve medically-underserved communities; however one is primarily rural and one primarily urban. RESULTS: Our goal in this analysis is to describe baseline characteristics of participants and examine setting-level differences. CBPR was a critical for recruiting networks to the trial. Patient respondents were predominately female (61.3%), African-American (66.5%), and earned <$1200 per month (87.1%). The rural network sample was older; more likely to be female, white, disabled or retired, and have a higher income, but fewer years of education. CONCLUSIONS: Variation in the samples partly reflects the CBPR process and partly reflects inherent differences in the communities. This confirmed the importance of using CBPR when planning for eventual dissemination, as it enhanced our ability to work within diverse settings. These baseline findings indicate that using a uniform approach to implementing a trial or intervention across diverse settings might not be effective or efficient.

Using segmented regression analysis of interrupted time series data to assess colonoscopy quality outcomes of a web-enhanced implementation toolkit to support evidence-based practices for bowel preparation: a study protocol.

BACKGROUND: While there is convincing evidence on interventions to improve bowel preparation for patients, the evidence on how to implement these evidence-based practices (EBPs) in outpatient colonoscopy settings is less certain. The Strategies to Improve Colonoscopy (STIC) study compares the effect of two implementation strategies, physician education alone versus physician education plus an implementation toolkit for staff, on adoption of three EBPs (split-dosing of bowel preparation, low-literacy education, teach-back) to improve pre-procedure and intra-procedure quality measures. The implementation toolkit contains a staff education module, website containing tools to support staff in delivering EBPs, tailored patient education materials, and brief consultation with staff to determine how the EBPs can be integrated into the existing workflow. Given adaptations to the implementation plan and intentional flexibility in the delivery of the EBPs, we utilize a pragmatic study to balance external validity with demonstrating effectiveness of the implementation strategies. METHODS/DESIGN: Participants will include all outpatient colonoscopy physicians, staff, and patients from a convenience sample of six endoscopy settings. Aim #1 will explore the relative effect of two strategies to implement patient-level EBPs on adoption and clinical quality outcomes. We will assess the change in level and trends of clinical quality outcomes (i.e., adequacy of bowel preparation, adenoma detection) using segmented regression analysis of interrupted time series data with two groups (intervention and delayed start). Aim #2 will examine the influence of organizational readiness to change on EBP implementation. We use a PRECIS diagram to reflect the extent to which each indicator of the study was pragmatic versus explanatory, revealing a largely pragmatic study. DISCUSSION: Implementation challenges have already motivated several adaptations to the original plan, reflecting the nature of implementation in real-world healthcare settings. The pragmatic study responds to the evolving needs of its healthcare partners and allows for flexibility in intervention delivery, thereby informing clinical decision-making in real-world settings. The current study will provide information about what works (intervention effectiveness), for whom it works (influence of Medicaid versus other insurance), in which contexts it works (setting characteristics that influence implementation), and how it works best (comparison of implementation strategies).