Attitudes toward comparative effectiveness research and patient engagement among reproductive health clinicians.

AIM: To assess reproductive health clinicians' knowledge of and attitudes toward comparative effectiveness research (CER), patient-centered outcomes research (PCOR) and patient engagement in research. MATERIALS & METHODS: Web-based survey of reproductive health clinicians. RESULTS: Among 103 responding clinicians, familiarity with CER and PCOR was moderate (35 and 44%, respectively). Once definitions were provided, most respondents agreed with the potential positive impacts of CER and patient engagement (65-87%), the importance of PCOR (95-99%) and that their patients might be interested in engaging in research as more than subjects (93%). CONCLUSION: We found positive attitudes toward PCOR and CER, and a range of experiences with patient engagement in research. There may be untapped potential for PCOR and CER in the reproductive health field.

Finding "truth" across different data sources.

The proliferation of new technology platforms and tools is dramatically advancing our ability to capture, integrate and use clinical and other health related data for research and care. Another critical and increasingly common source of data comes directly from patients - often in the form of Patient Reported Outcomes (PRO). As more providers and payers recognize that patient experiences reflect a critical dimension of the value proposition, these data are informing broader strategies to achieve performance improvement and accountability in health systems. Combined with other traditional (e.g., claims) and more recent (e.g., Electronic Health Record) data assets, PROs can help to examine experiences and outcomes that convey a more complete picture of both individual and population health. One of the areas of research where this is most evident is cancer survivorship, including long-term adverse effects, as the population of survivors is increasing given advances in detection and treatment. Key questions remain as to how and under what conditions these new data resources can be used for research, and which are the best "sources of truth" for specific types of information. A recent IJHPR validation study by Hamood et al. reflects important progress in this regard, and establishes the necessary groundwork for a larger planned study. There are some important limitations worth noting, such as a small sample size (which does not support adequate subgroup analysis); a relatively narrow focus on women with only early stage or regionally advanced breast cancer; and a limited focus on outcomes that are primarily clinical and relatively severe in nature (e.g., cardiovascular disease). Finally, as use of EHRs becomes ubiquitous, as patient perspectives and outcome measures are considered, and as more types of data are systematically collected via electronic systems, further comparison and validation of non-clinical data elements captured via such tools will become increasingly possible and important. This will further enhance the capacity of cancer survivorship researchers to address a broader range of important questions to many more types of patients.

Leveraging Health IT to Reduce Disparities in Three Underserved Beacon Communities.

Using health information technology (IT) can potentially address health disparities by increasing access to care, delivering higher-quality care, improving patient-provider communication, and enhancing patient safety. It describes challenges encountered by three underserved Beacon Communities that implemented health IT interventions, including inadequate connectivity infrastructure, technical support, expertise, and financial resources; provider shortages and staff turnover; and equipment theft.

Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned.

BACKGROUND: Patients and healthcare stakeholders are increasingly becoming engaged in the planning and conduct of biomedical research. However, limited research characterizes this process or its impact. OBJECTIVE: We aimed to characterize patient and stakeholder engagement in the 50 Pilot Projects funded by the Patient-Centered Outcomes Research Institute (PCORI), and identify early contributions and lessons learned. DESIGN: A self-report instrument was completed by researchers between 6 and 12 months following project initiation. PARTICIPANTS: Forty-seven principal investigators or their designees (94 % response rate) participated in the study. MAIN MEASURES Self-report of types of stakeholders engaged, stages and levels of engagement, facilitators and barriers to engagement, lessons learned, and contributions from engagement were measured. KEY RESULTS: Most (83 %) reported engaging more than one stakeholder in their project. Among those, the most commonly reported groups were patients (90 %), clinicians (87 %), health system representatives (44 %), caregivers (41 %), and advocacy organizations (41 %). Stakeholders were commonly involved in topic solicitation, question development, study design, and data collection. Many projects engaged stakeholders in data analysis, results interpretation, and dissemination. Commonly reported contributions included changes to project methods, outcomes or goals; improvement of measurement tools; and interpretation of qualitative data. Investigators often identified communication and shared leadership strategies as "critically important" facilitators (53 and 44 % respectively); lack of stakeholder time was the most commonly reported challenge (46 %). Most challenges were only partially resolved. Early lessons learned included the importance of continuous and genuine partnerships, strategic selection of stakeholders, and accommodation of stakeholders' practical needs. CONCLUSIONS: PCORI Pilot Projects investigators report engaging a variety of stakeholders across many stages of research, with specific changes to their research attributed to engagement. This study identifies early lessons and barriers that should be addressed to facilitate engagement. While this research suggests potential impact of stakeholder engagement, systematic characterization and evaluation of engagement at multiple stages of research is needed to build the evidence base.

Patient Engagement and Activation in Three Underserved Beacon Communities.

Whether the setting is urban, rural, or somewhere in between, engagement strategies for the underserved require a great deal of flexibility and sensitivity to the socioeconomic, cultural, and geographic conditions of the patient population. The following report details how three unique communities designed specific strategies to engage underserved populations in the management of their chronic conditions.

Evaluating patient and stakeholder engagement in research: moving from theory to practice.

Despite the growing demand for research that engages stakeholders, there is limited evidence in the literature to demonstrate its value - or return on investment. This gap indicates a general lack of evaluation of engagement activities. To adequately inform engagement activities, we need to further investigate the dividends of engaged research, and how to evaluate these effects. This paper synthesizes the literature on hypothesized impacts of engagement, shares what has been evaluated and identifies steps needed to reduce the gap between engagement's promises and the underlying evidence supporting its practice. This assessment provides explicit guidance for better alignment of engagement's promised benefits with evaluation efforts and identifies specific areas for development of evaluative measures and better reporting processes.

Making it local: Beacon Communities use health information technology to optimize care management.

Care management aims to provide cost-effective, coordinated, non-duplicative care to improve care quality, population health, and reduce costs. The 17 communities receiving funding from the Office of the National Coordinator for Health Information Technology through the Beacon Community Cooperative Agreement Program are leaders in building and strengthening their health information technology (health IT) infrastructure to provide more effective and efficient care management. This article profiles 6 Beacon Communities' health IT-enabled care management programs, highlighting the influence of local context on program strategy and design, and describing challenges, lessons learned, and policy implications for care delivery and payment reform. The unique needs (eg, disease burden, demographics), community partnerships, and existing resources and infrastructure all exerted significant influence on the overall priorities and design of each community's care management program. Though each Beacon Community needed to engage in a similar set of care management tasks--including patient identification, stratification, and prioritization; intervention; patient engagement; and evaluation--the contextual factors helped shape the specific strategies and tools used to carry out these tasks and achieve their objectives. Although providers across the country are striving to deliver standardized, high-quality care, the diverse contexts in which this care is delivered significantly influence the priorities, strategies, and design of community-based care management interventions. Gaps and challenges in implementing effective community-based care management programs include: optimizing allocation of care management services; lack of available technology tailored to care management needs; lack of standards and interoperability; integrating care management into care settings; evaluating impact; and funding and sustainability.

Data governance and data sharing agreements for community-wide health information exchange: lessons from the beacon communities.

PURPOSE: Unprecedented efforts are underway across the United States to electronically capture and exchange health information to improve health care and population health, and reduce costs. This increased collection and sharing of electronic patient data raises several governance issues, including privacy, security, liability, and market competition. Those engaged in such efforts have had to develop data sharing agreements (DSAs) among entities involved in information exchange, many of whom are "nontraditional" health care entities and/or new partners. This paper shares lessons learned based on the experiences of six federally funded communities participating in the Beacon Community Cooperative Agreement Program, and offers guidance for navigating data governance issues and developing DSAs to facilitate community-wide health information exchange. INNOVATION: While all entities involved in electronic data sharing must address governance issues and create DSAs accordingly, until recently little formal guidance existed for doing so - particularly for community-based initiatives. Despite this lack of guidance, together the Beacon Communities' experiences highlight promising strategies for navigating complex governance issues, which may be useful to other entities or communities initiating information exchange efforts to support delivery system transformation. CREDIBILITY: For the past three years, AcademyHealth has provided technical assistance to most of the 17 Beacon Communities, 6 of whom contributed to this collaborative writing effort. Though these communities varied widely in terms of their demographics, resources, and Beacon-driven priorities, common themes emerged as they described their approaches to data governance and DSA development. CONCLUSIONS: The 6 Beacon Communities confirmed that DSAs are necessary to satisfy legal and market-based concerns, and they identified several specific issues, many of which have been noted by others involved in network data sharing initiatives. More importantly, these communities identified several promising approaches to timely and effective DSA development, including: stakeholder engagement; identification and effective communication of value; adoption of a parsimonious approach; attention to market-based concerns; flexibility in adapting and expanding existing agreements and partnerships; and anticipation of required time and investment.

Learning from health information exchange technical architecture and implementation in seven beacon communities.

As health care providers adopt and make "meaningful use" of health information technology (health IT), communities and delivery systems must set up the infrastructure to facilitate health information exchange (HIE) between providers and numerous other stakeholders who have a role in supporting health and care. By facilitating better communication and coordination between providers, HIE has the potential to improve clinical decision-making and continuity of care, while reducing unnecessary use of services. When implemented as part of a broader strategy for health care delivery system and payment reform, HIE capability also can enable the use of analytic tools needed for population health management, patient engagement in care, and continuous learning and improvement. The diverse experiences of seven communities that participated in the three-year federal Beacon Community Program offer practical insight into factors influencing the technical architecture of exchange infrastructure and its role in supporting improved care, reduced cost, and a healthier population. The case studies also document challenges faced by the communities, such as significant time and resources required to harmonize variations in the interpretation of data standards. Findings indicate that their progress developing community-based HIE strategies, while driven by local needs and objectives, is also influenced by broader legal, policy, and market conditions.

Considerations for community-based mHealth initiatives: insights from three Beacon Communities.

Mobile health (mHealth) is gaining widespread attention for its potential to engage patients in their health and health care in their daily lives. Emerging evidence suggests that mHealth interventions can be used effectively to support behavior change, but numerous challenges remain when implementing these programs at the community level. This paper provides an overview of considerations when implementing community-based mHealth initiatives, based on the experiences of three Beacon Communities across the United States that have launched text messaging (short message service, SMS) pilot programs aimed at diabetes risk reduction and disease management. The paper addresses lessons learned and suggests strategies to overcome challenges related to developing text message content, conducting marketing and outreach, enrolling participants, engaging providers, evaluating program effectiveness, and sustaining and scaling the programs.

The Electronic Data Methods (EDM) forum for comparative effectiveness research (CER).

BACKGROUND: AcademyHealth convened the Electronic Data Methods (EDM) Forum to collect, synthesize, and share lessons from eleven projects that are building infrastructure and using electronic clinical data for comparative effectiveness research (CER) and patient-centered outcomes research (PCOR). This paper provides a brief review of participating projects and provides a framework of common challenges. METHODS: EDM Forum staff conducted a text review of relevant grant programs' funding opportunity announcements; projects' research plans; and available information on projects' websites. Additional information was obtained from presentations provided by each project; phone calls with project principal investigators, affiliated partners, and staff from the Agency for Healthcare Research and Quality (AHRQ); and six site visits. RESULTS: Projects participating in the EDM Forum are building infrastructure and developing innovative strategies to address a set of methodological, and data and informatics challenges, here identified in a common framework. The eleven networks represent more than 20 states and include a range of partnership models. Projects vary substantially in size, from 11,000 to more than 7.5 million individuals. Nearly all of the AHRQ priority populations and conditions are addressed. DISCUSSION: In partnership with the projects, the EDM Forum is focused on identifying and sharing lessons learned to advance the national dialogue on the use of electronic clinical data to conduct CER and PCOR. These efforts have the shared goal of addressing challenges in traditional research studies and data sources, and aim to build infrastructure and generate evidence to support a learning health care system that can improve patient outcomes.

Evaluation design and technical assistance opportunities: early findings from the Beacon Community Program evaluation teams.

The Beacon Community Cooperative Agreement Program is funding 17 communities to build and strengthen their health information technology (IT) capabilities to enhance care coordination, improve patient and population health, and reduce or restrain costs. Based on the experiences and evidence generated by these communities, the program hopes to illustrate the possibilities of leveraging health IT to achieve desired goals. Doing so requires rigorous evaluation work, which is the subject of this issue brief. Based on semistructured interviews with representatives from each Beacon Community, the brief outlines various study designs, evaluation approaches, outcome measures, and data sources in use. It also identifies some common challenges, including establishing governance models, determining baseline measures, and assessing impact in a relatively constrained timeframe. Technical assistance in disseminating and publishing findings and assessing return on investments will be offered in the coming year.

Web-based survey of fertility issues in young women with breast cancer.

PURPOSE: Young women with breast cancer often seek advice about whether treatment will affect their fertility. We sought to gain a better understanding of women's attitudes about fertility and how these concerns affect decision making. PATIENTS AND METHODS: We developed a survey about fertility issues for young women with a history of early-stage breast cancer. The survey was e-mailed to all registered Young Survival Coalition survivor members (N = 1,702). E-mail reminders were used. RESULTS: Six hundred fifty-seven eligible respondents completed the survey. Mean age at breast cancer diagnosis was 32.9 years; mean current age was 35.8 years. Ninety percent of women were white; 62% were married; 76% were college graduates. Stages at diagnosis were as follows: 0, 10%; I, 27%; II, 47%; III, 13%. Sixty-two percent of women were within 2 years of diagnosis. Fifty-seven percent recalled substantial concern at diagnosis about becoming infertile with treatment. In multivariate logistic regression, greater concern about infertility was associated with wish for children/more children (odds ratio [OR], 120; P < .0001), number of prior pregnancies (OR, 0.78; P = .01), and prior difficulty conceiving (OR, 1.86; P = .08). Twenty-nine percent of women reported that infertility concerns influenced treatment decisions. Seventy-two percent of women reported discussing fertility concerns with their doctors; 51% felt their concerns were addressed adequately. Women seemed to overestimate their risk of becoming postmenopausal with treatment. CONCLUSION: Fertility after treatment is a major concern for young women with breast cancer. There is a need to communicate with and educate young patients regarding fertility issues at diagnosis and a need for future research directed at preserving fertility for young breast cancer survivors.

Cost effectiveness of treatment for benign prostatic hyperplasia: an economic model for comparison of medical, minimally invasive, and surgical therapy.

PURPOSE: To evaluate the cost effectiveness of minimally invasive therapy relative to medical (alpha-blocker) therapy and transurethral resection (TURP) for patients with moderate to severe symptoms of benign prostatic hyperplasia (BPH). METHODS: We constructed a decision-analytic Markov model for a hypothetical cohort of 65-year-old men with moderate to severe BPH symptoms. Microwave thermotherapy was selected to represent minimally invasive treatment. Cost-effectiveness analysis was performed with 25 health states using the 3 treatments, 5 short-term clinical events, and 17 possible long-term outcomes. Each health state had an associated cost and utility. Quality of life (QoL) and utility estimates were obtained by interviewing 13 men with BPH symptoms using the standard gamble reference methods. Patients were classified as risk averse (RA) or non-risk averse (NRA) on the basis of their attitudes to risk. We calculated the incremental cost effectiveness of microwave thermotherapy relative to medical therapy and TURP over 5 years after treatment initiation. Event probabilities were obtained from the literature, a consensus panel, and published randomized clinical trials. RESULTS AND CONCLUSIONS: The utility values generated were internally consistent and externally valid for a hypothetical cohort of 10,000 RA patients. Microwave thermotherapy was preferred by the NRA group, while medical therapy was preferred by the RA group. Surgery was least preferred by both groups. Microwave thermotherapy had a small incremental cost but improved QoL in comparison with medical therapy. Microwave thermotherapy had a higher utility and lower cost than TURP and thus was dominant over TURP. This analytical method can be applied to evaluate the cost effectiveness of any BPH therapy.