An Interventional Response Phenotyping Study in Chronic Low Back Pain: Protocol for a Mechanistic Randomized Controlled Trial.

Evidence-based treatments for chronic low back pain (cLBP) typically work well in only a fraction of patients, and at present there is little guidance regarding what treatment should be used in which patients. Our central hypothesis is that an interventional response phenotyping study can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based treatments for cLBP. Thus, we will conduct a randomized controlled Sequential, Multiple Assessment, Randomized Trial (SMART) design study in cLBP with the following three aims. Aim 1: Perform an interventional response phenotyping study in a cohort of cLBP patients (n = 400), who will receive a sequence of interventions known to be effective in cLBP. For 4 weeks, all cLBP participants will receive a web-based pain self-management program as part of a run-in period, then individuals who report no or minimal improvement will be randomized to: a) mindfulness-based stress reduction, b) physical therapy and exercise, c) acupressure self-management, and d) duloxetine. After 8 weeks, individuals who remain symptomatic will be re-randomized to a different treatment for an additional 8 weeks. Using those data, we will identify the subsets of participants that respond to each treatment. In Aim 2, we will show that currently available, clinically derived measures, can predict differential responsiveness to the treatments. In Aim 3, a subset of participants will receive deeper phenotyping (n = 160), to identify new experimental measures that predict differential responsiveness to the treatments, as well as to infer mechanisms of action. Deep phenotyping will include functional neuroimaging, quantitative sensory testing, measures of inflammation, and measures of autonomic tone.

The Power of the Frame: Systems Transformation Framework for Health Care Leaders.

Health care leaders are responsible for oversight of multiple and competing change interventions. These interventions regularly fail to achieve the desired outcomes and/or sustainable results. This often occurs because of the mental models and approaches that are used to plan, design, implement, and evaluate the system. These do not account for inherent characteristics that determine the system's likely ability to innovate while maintaining operational effectiveness. Theories exist on how to assess a system's readiness to change, but the definitions, constructs, and assessments are diverse and often look at facets of systems in isolation. The Systems Transformation Framework prescriptively defines and characterizes system domains on the basis of complex adaptive systems theory so that domains can be assessed in tandem. As a result, strengths and challenges to implementation are recognized before implementation begins. The Systems Transformation Framework defines 8 major domains: vision, leadership, organizational culture, organizational behavior, organizational structure, performance measurements, internal learning, and external learning. Each domain has principles that are critical for creating the conditions that lead to successful organizational adaptation and change. The Systems Transformation Framework can serve as a guide for health care leaders at all levels of the organization to (1) create environments that are change ready and (2) plan, design, implement, and evaluate change within complex adaptive systems.

Development of a professional nursing framework: the journey toward nursing excellence.

To achieve Magnet recognition designation, an organization must demonstrate a framework for nursing practice. However, successfully incorporating and sustaining frameworks and theories into practice are not easy undertakings. The authors describe how leaders and staff in a healthcare system created and implemented a conceptual framework for nursing practice to guide nursing practice for the system.