Methods guiding stakeholder engagement in planning a pragmatic study on changing stroke systems of care.

BACKGROUND: The Comprehensive Post-Acute Stroke Services (COMPASS) Study is one of the first large pragmatic randomized-controlled clinical trials using comparative effectiveness research methods, funded by the Patient-Centered Outcomes Research Institute. In the COMPASS Study, we compare the effectiveness of a patient-centered, transitional care intervention versus usual care for stroke patients discharged home from acute care. Outcomes include stroke patient post-discharge functional status and caregiver strain 90 days after discharge, and hospital readmissions. A central tenet of Patient-Centered Outcomes Research Institute-funded research is stakeholder engagement throughout the research process. However, evidence on how to successfully implement a pragmatic trial that changes systems of care in combination with robust stakeholder engagement is limited. This combination is not without challenges. METHODS: We present our approach for broad-based stakeholder engagement in the context of a pragmatic trial with the participation of patients, caregivers, community stakeholders, including the North Carolina Stroke Care Collaborative hospital network, and policy makers. To maximize stakeholder engagement throughout the COMPASS Study, we employed a conceptual model with the following components: (1) Patient and Other Stakeholder Identification and Selection; (2) Patient and Other Stakeholder Involvement Across the Spectrum of Research Activities; (3) Dedicated Resources for Patient and Other Stakeholder Involvement; (4) Support for Patient and Other Stakeholder Engagement Through Organizational Processes; (5) Communication with Patients and Other Stakeholders; (6) Transparent Involvement Processes; (7) Tracking of Engagement; and (8) Evaluation of Engagement. CONCLUSION: In this paper, we describe how each component of the model is being implemented and how this approach addresses existing gaps in the literature on strategies for engaging stakeholders in meaningful and useful ways when conducting pragmatic trials.

Creation of a grant support service within a Women's Health Center of Excellence: experiences and lessons learned.

PURPOSE: The Research Support Core (RSC) began in the Women's Health Center of Excellence at Wake Forest University Health Sciences to (1) augment the institution's capacity to win grants in women's health and (2) assist women faculty in obtaining extramural funding. METHODS: The RSC began in July 2002 with a director, a research associate/scientific editor, and a budget specialist (total 0.7 full-time equivalents [FTE]). Its main functions were preaward grant assistance and education through workshops on grants and manuscripts. The purpose of this paper is to report the early experience (years 1 and 2: July 1, 2002, through June 30, 2004) of this service. RESULTS: From year 1 to year 2, the number of grant applications the RSC worked on rose 153% (from 17 to 43). Total dollars requested increased 2.5-fold, from 11.9 million US dollars in year 1 to 41.8 million US dollars in year 2. A total of 1.8 million US dollars was awarded or anticipated, with 27 applications pending. Overall, 38 faculty members from 18 academic departments received grant assistance. Of these, 100% of Core users who returned evaluations reported that they would use the RSC again and would recommend it to others. During this same period, nearly 500 people attended the 19 educational workshops on grants and manuscripts. CONCLUSIONS: As a result of this experience, the RSC was expanded and moved to the institution's Office of Research as a resource to all faculty. Assistance to women faculty and faculty conducting women's health research remain strong components of the RSC.

Randomized clinical trials of hormone replacement therapy for treatment or prevention of cardiovascular disease: a review of the findings.

Coronary heart disease (CHD) is the leading cause of death in women. Epidemiologic, mechanistic, and animal-model studies have produced convincing evidence that hormone replacement therapy (HRT) could substantially decrease rates of CHD in women. However, several randomized clinical trials of HRT in women with CHD have been unable to confirm the earlier suggestions of benefit, and there has even been a suggestion of increased CHD risk. This article will review the findings to date of these long-term randomized clinical trials of HRT for prevention or treatment of CHD.

Vascular effects of dietary L-arginine supplementation.

The vascular endothelium is acknowledged to play an important role in vascular physiology. Attention has focused on endothelial production of nitric oxide as a key element in many of the processes associated with the development of atherosclerosis. L-arginine is the substrate for the enzyme nitric oxide synthase (NOS), which is responsible for the endothelial production of nitric oxide. Therefore, many investigators have been interested in whether dietary L-arginine supplementation can augment nitric oxide production and thereby improve vascular health. The effects of oral L-arginine on vascular health and disease have been examined both in human beings and in various animal models. In this review, we summarize the results of studies of oral L-arginine supplementation on atherosclerotic lesion formation, as well as markers of endothelial function (e.g. macrophage function, platelet aggregation and adhesion, and in vitro vascular ring studies). Although results of oral L-arginine supplementation in hypercholesterolemic animals have generally shown beneficial effects, the data in humans are varied, possibly because of small sample sizes and brief periods of study. Long-term randomized clinical trials are needed to more definitively address whether oral L-arginine supplementation could be advantageous for vascular health.