A Novel Stakeholder Engagement Approach for Patient-centered Outcomes Research.

INTRODUCTION/OBJECTIVES: The engagement of patients and other stakeholders is a critical element in the design of patient-centered outcomes research studies. However, methodology for scalable engagement in research management particularly activities such as operationalization of principles and setting of priorities is not well-developed. The objective of this study is to describe a novel approach for scalable stakeholder engagement in research aligned with the Patient-Centered Outcomes Research Institute (PCORI) engagement principles, which was evaluated in a national clinical data research network. MATERIALS AND METHODS: Patient, patient advocate, clinician, and researcher stakeholders were recruited from clinical sites, as well as social media sites related to the 3 conditions of focus, heart failure, obesity, and Kawasaki disease. The engagement strategy was designed, implemented, and mapped to the PCORI engagement principles. Evaluation included internal assessment and quantitative measures of online engagement. RESULTS: We operationalized the PCORI principles with 12 stakeholder engagement strategies and convened stakeholder advisory boards and online research prioritization panels to determine research priorities in a rigorous, deliberative process. A total of 46 advisors (20 patients) and 339 panelists (159 patients) actively participated. There were not significant differences between patients and clinicians in level of online engagement. Nonetheless, while patients reported a slightly greater challenge with following online discussion, they overall had a more favorable opinion about use of the online format. DISCUSSION/CONCLUSION: An efficient way to engage large numbers of representative stakeholders in research is a necessary first step to assure the public of trustworthy use of data networks for health research. This paper describes a comprehensive approach to engagement in patient-centered outcomes research management that informs ongoing development of rigorous methodologies in this area.

Correlates of quality of life in rural patients with heart failure.

BACKGROUND: There is abundant research indicating poor physical, psychological, and social functioning of patients with chronic heart failure (HF), a reality that can lead to poor health-related quality of life (QoL). Little is known about the experience of rural patients with HF. METHODS AND RESULTS: This study was part of a randomized clinical trial titled Rural Education to Improve Outcomes in Heart Failure (REMOTE-HF) designed to test an education and counseling intervention to improve self-care in patients with HF. We evaluated 612 rural patients. Multiple validated questionnaires were administered to assess patient perceptions of health and health literacy. Baseline factors were collected and compared with baseline QoL measures only. Patients' health-related QoL was assessed using the Minnesota Living with Heart Failure scale. The data were analyzed using a general linear model to test the association of various patient characteristics with QoL in rural patients with HF. Patients were 65.8 (+12.9) years of age. The majority were men (58.7%), married (56.4%), and had completed a high-school education (80.9%). Factors associated with reduced QoL among this population include geographic location, younger age, male sex, higher New York Heart Association class, worse HF knowledge, poorer perceived control, and symptoms of depression or anxiety. The data provided no evidence of an association between left ventricular ejection fraction and QoL. CONCLUSIONS: This study of rural patients with HF confirms previously identified factors associated with perceptions of QoL. However, further study is warranted with an urban control group. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00415545.

Meeting the reproductive health care needs of adolescents: California's Family Planning Access, Care, and Treatment Program.

PURPOSE: To examine the effect of the California Office of Family Planning's Family Access, Care, and Treatment Program (Family PACT), which was established in 1997 to provide comprehensive, reproductive health services for low-income adolescents and adults. Program evaluation was used to measure access to services, develop a profile of users, identify service utilization patterns, and assess the sensitivity of the health care system to the needs of adolescents. METHODS: Data sources include baseline data on California's previously established family planning services, enrollment, and claims data for the first 4 years of Family PACT, client exit interviews, and on-site observations. RESULTS: Adolescents represented 21% of all clients served by Family PACT in fiscal year 2000-2001 (FY 2000-2001). Adolescent clients served increased from 100,000 in FY 1995-1996 to more than 260,000 in FY 2000-2001(161% increase). The proportion of males has increased from 1% to 11%. In FY 2000-2001, Hispanics comprised 50% of adolescent clients, followed by 32% white, 9% African-American, and 6% Asian, Filipino, or Pacific Islander. Over one-half were aged 18 or 19 years, 42% were aged 15 to 17 years, and 5% were aged younger than 15 years. Contraceptive methods most often dispensed were barrier methods (55% for females, 72% for males), oral contraceptives (44%), contraceptive injections (16%), and emergency contraceptives (7%); 57% received sexually transmitted infection screening. CONCLUSIONS: By linking eligibility determination to the delivery of services, removing cost barriers, increasing the numbers and types of providers offering publicly funded services, and ensuring confidentiality, greater numbers of adolescents obtained needed reproductive health care, thus ensuring an opportunity to reduce unintended pregnancies and sexually transmitted infections.