Toward Patient-Centered Innovation: A Conceptual Framework for Patient-Reported Outcome Measures for Transformative Kidney Replacement Devices.

Individuals with dialysis-dependent kidney failure experience considerable disease- and treatment-related decline in functional status and overall well-being. Despite these experiences, there have been few substantive technological advances in KRT in decades. As such, new federal initiatives seek to accelerate innovation. Historically, integration of patient perspectives into KRT product development has been limited. However, the US Food and Drug Administration recognizes the importance of incorporating patient perspectives into the total product life cycle (i.e., from product conception to postmarket surveillance) and encourages the consideration of patient-reported outcomes in regulatory-focused clinical trials when appropriate. Recognizing the significance of identifying patient-reported outcome measures (PROMs) that capture contemporary patient priorities, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to (1) develop a conceptual framework for a health-related quality of life PROM; (2) identify and map existing PROMs to the conceptual framework, prioritizing them on the basis of their supporting evidence for use in the regulatory environment; and (3) describe next steps for identifying PROMs for use in regulatory clinical trials of transformative KRT devices. This paper summarizes the proposed health-related quality-of-life PROM conceptual framework, maps and prioritizes PROMs, and identifies gaps and future needs to advance the development of rigorous, meaningful PROMS for use in clinical trials of transformative KRT devices.

Organizational Readiness to Implement the Chronic Disease Self-Management Program in Dialysis Facilities.

A gap exists between the development and uptake of evidence-based health promotion programs in health care settings. One reason for this gap is lack of attention to organizational readiness. The objective of this study was to assess organizational readiness to implement the Chronic Disease Self-Management Program in dialysis facilities. Survey data were collected from dialysis staff using a semi-structured Organizational Readiness for Implementing Change questionnaire. Change efficacy and change commitment scale ratings were all above 3.0, indicating a moderate level of readiness among staff. Profession and level of education were significantly associated with mean change efficacy scale ratings. Textual data revealed benefits to patients, implementation barriers and facilitators, and the influence of facility environment and culture. The findings of the current study suggest that additional efforts to advance the implementation of evidence-based health promotion programs in dialysis facilities are needed.

The PCORI Engagement Rubric: Promising Practices for Partnering in Research.

PURPOSE: Engaging patients, caregivers, and other health care stakeholders as partners in planning, conducting, and disseminating research is a promising way to improve clinical decision making and outcomes. Many researchers, patients, and other stakeholders, however, lack clarity about when and how to engage as partners within the clinical research process. To address the need for guidance on creating meaningful stakeholder partnerships in patient-centered clinical comparative effectiveness research, the Patient-Centered Outcomes Research Institute (PCORI) developed the PCORI Engagement Rubric (Rubric). METHODS: PCORI developed the Rubric drawing from a synthesis of the literature, a qualitative study with patients, a targeted review of engagement plans from PCORI-funded project applications, and a moderated discussion and review with PCORI's Advisory Panel on Patient Engagement. RESULTS: The Rubric provides a framework for operationalizing engagement to incorporate patients and other stakeholders in all phases of research. It includes: principles of engagement; definitions of stakeholder types; key considerations for planning, conducting, and disseminating engaged research; potential engagement activities; and examples of promising practices from PCORI-funded projects. CONCLUSIONS: PCORI designed the Rubric to illustrate opportunities for engagement to researchers interested in applying for PCORI funding and to patients and other stakeholders interested in greater involvement in research. By encouraging PCORI applicants, awardees, and others to apply the rubric, PCORI hopes to shift the research paradigm from one of conducting research on patients as subjects to a pursuit carried out in collaboration with patients and other stakeholders to better reflect the values, preferences, and outcomes that matter to the patient community.

Multiple Chronic Conditions, Resilience, and Workforce Transitions in Later Life: A Socio-Ecological Model.

Purpose of the Study: Despite the growing prevalence of multiple chronic conditions (MCC), a problem that disproportionally affects older adults, few studies have examined the impact of MCC status on changes in workforce participation in later life. Recent research suggests that resilience, the ability to recover from adversity, may buffer the negative impact of chronic disease. Guided by an adapted socio-ecological risk and resilience conceptual model, this study examined the buffering effect of resilience on the relationship between individual and contextual risks, including MCC, and workforce transitions (i.e., leaving the workforce, working fewer hours, working the same hours, or working more hours). Design and Methods: Using the Health and Retirement Study, this study pooled a sample of 4,861 older workers aged 51 and older with 2 consecutive biannual waves of data. Nonnested multinomial logistic regression analysis was applied. Results: MCC are related to higher risk of transitioning out of the workforce. Resilience buffered the negative effects of MCC on workforce engagement and remained independently associated with increased probability of working the same or more hours compared with leaving work. Implications: MCC are associated with movement out of the paid workforce in later life. Despite the challenges MCC impose on older workers, having higher levels of resilience may provide the psychological resources needed to sustain work engagement in the face of new deficits. These findings suggest that identifying ways to bolster resilience may enhance the longevity of productive workforce engagement.

Wishes left unspoken: engaging underserved populations in end-of-life advance care planning.

The end of life can be a highly emotional and difficult time for patients and their families. Advance care planning for end-of-life care is one option for helping to mitigate the burden of this experience. Despite its advantages, gaps in end-of-life advance care planning participation persist, particularly among underserved segments of the U.S. population who might benefit from it. This column highlights barriers to end-of-life advance care planning among medically underserved populations and discusses opportunities for greater engagement.

Social justice, health disparities, and culture in the care of the elderly.

Older minority Americans experience worse health outcomes than their white counterparts, exhibiting the need for social justice in all areas of their health care. Justice, fairness, and equity are crucial to minimizing conditions that adversely affect the health of individuals and communities. In this paper, Alzheimer's disease (AD) is used as an example of a health care disparity among elderly Americans that requires social justice interventions. Cultural factors play a crucial role in AD screening, diagnosis, and access to care, and are often a barrier to support and equality for minority communities. The "conundrum of health disparities" refers to the interplay between disparity, social justice, and cultural interpretation, and encourages researchers to understand both (1) disparity caused by economic and structural barriers to access, treatment, and diagnosis, and (2) disparity due to cultural interpretation of disease, in order to effectively address health care issues and concerns among elderly Americans.