Comparative Effectiveness Research Project Research Articles

Abstract P080: Lifetime Trauma Is Associated With Elevated Blood Pressure In Middle-aged And Older Latinas

Introduction: Latina women are more likely than non-Latina White women to have uncontrolled and undertreated hypertension. Prior research suggests greater exposure to traumatic experiences (such as interpersonal violence) is associated with elevated blood pressure and higher cardiovascular disease risk in women. However, few studies have investigated these associations among Latina women, a population that is at increased risk for hypertension. The purpose of this pilot study was to fill knowledge gaps by examining the associations of lifetime trauma (including childhood and adulthood) with blood pressure in middle-aged and older Latinas. Hypothesis: We assessed the hypothesis that lifetime trauma is associated with elevated blood pressure in middle-aged and older Latinas. Methods: Participants were recruited from an existing study in New York City called the Washington Heights/Inwood Comparative Effectiveness Research Project. Data collection consisted of a questionnaire administered by a research coordinator and in-office assessment of two blood pressure readings using recommended guidelines. The average systolic and diastolic blood pressures were calculated from these two measurements. Lifetime trauma was assessed with the Life Events Checklist which assesses 17 potentially traumatic experiences. We summed responses to the Life Events Checklist to create a count of lifetime trauma. Posttraumatic stress disorder (PTSD) symptoms were assessed with the PTSD Checklist-Civilian Version that assess presence and severity of 17 PTSD symptoms in the last month. We used linear regression models to separately examine the associations of lifetime trauma with systolic and diastolic blood pressure adjusted for demographic characteristics, health behaviors, PTSD symptoms, sociocultural factors (such as discrimination and acculturation). Results: The final sample included 50 Latina women (ages 42-77, mean=63.1 [9.7]). All women reported at least one traumatic experience with an average of 4.8 traumatic experiences in their lifetimes (range 1-10). A higher count of lifetime trauma (B [SE] = 5.56 [2.63], p = 0.04) was positively associated with greater systolic blood pressure in adjusted regression models. Although women who reported a higher count of lifetime trauma had higher diastolic blood pressure, this association was not statistically significant (B [SE] = 2.14 [1.67], p = 0.21). Conclusion: Findings indicate a higher count of lifetime trauma is associated with elevations in systolic blood pressure among Latina women. This is consistent with results of studies that have examined associations of lifetime trauma with blood pressure among women in the general population. There is a need for larger studies that incorporate longitudinal designs to investigate the associations of trauma and other sociocultural factors with blood pressure among Latina women.

ASSESSMENT OF COMPARATIVE EFFECTIVENESS RESEARCH GAPS TO PROMOTE AGING IN PLACE: A STAKEHOLDER-DRIVEN APPROACH

A priority for many older adults is to remain in their homes and communities. This paper describes the Patient-Centered Outcomes Research Institute’s (PCORI) review of our investment in comparative effectiveness research (CER) that will advance the field of “aging in place.” To inform our systematic evaluation, we first engaged our multi-stakeholder advisory panel of patients/caregivers, clinicians, health systems leaders, and payers to develop and refine a conceptual framework for research focused on aging in place among older adults. Key themes from stakeholders were: aging in place interventions should be patient-centered and align with the patients’ needs and goals, studies should include individuals 55+ years who may be at risk for institutionalization, relevant interventions go beyond environmental modifications and include social support, healthcare (inclusive of palliative care), and personal care services. In addition, aging in place services should focus more on informal caregiver interventions and outcomes since informal caregivers play a major role in enabling older adults to age in place. We identified 14 PCORI-funded CER projects that will provide evidence on the most effective interventions to promote aging in place among older adults; the total investment is $113.4 million dollars. The portfolio is addressing decisional dilemmas faced by multiple stakeholders on a variety of topics including falls prevention, home-based palliative care, and community-based care models; however, several critical CER evidence gaps remain that need to be addressed in future funding investments and will be discussed during the presentation.

C12 - START (Active Surveillance or Radical Treatment for newly diagnosed patients with a localized, low risk, prostate cancer): an epidemiological study of the Oncology Network of Piemonte and Valle d'Aosta

Background: An Active Surveillance (AS) strategy is recommended as an appropriate management for men with low risk localized prostate cancer (PC), but its diffusion, at least in the Oncology Network of Piemonte and Valle d'Aosta, is still very limited. The primary objective of the START project is to evaluate the acceptability, the safety and the cost-effectiveness of a population based program of AS, whose implementation into routine practice will be encouraged within the setting of a research framework. Material and methods: Comparative effectiveness research project. All newly diagnosed PC patients fulfilling the low risk definition, resident in Piemonte or in Valle D'Aosta, will be invited to participate to this observational prospective study. All enrolled patients will receive full and clear information about their prognosis together with a balanced synthesis of the benefits and risks of the available treatments (AS, surgery or radiotherapy). For all patients, independently from the treatment chosen, baseline clinical, histological and psychological data, any treatment received and follow‐up data (including clinical and quality of life outcomes) will be collected. Specific objectives are:•to encourage the diffusion of AS at a regional level, in the context of uniform and settled criteria for patients' selection and management, using standardized information about the benefits and risks of the available treatments;•to estimate the proportion of patients in AS who remain treatment-free at 2 years;•to compare, at a population level, the clinical outcomes, quality of life and costs associated to different treatment choices. Results: The START protocol has been designed by a multidisciplinary panel of specialists of the Oncology Network and patients' representatives. All the regional Hospital units of Urology and Radiotherapy have been involved (36 centers participate). The project started on May 2015. 104 patients have been already enrolled: 88 chose AS and 16 radical treatments (5 radiotherapy and 11 prostatectomy). A web-site has been implemented with both a public and a reserved area for data collection (www.start.epiclin.it). Conclusions: A population based research framework could represent a powerful and safe strategy to effectively implement AS in the NHS. The project could have a large positive impact on the Regional Health Service to improve long term quality of life of low risk PC patients.

IMPACCT Kids' Care: a real-world example of stakeholder involvement in comparative effectiveness research.

The Patient-Centered Outcomes Research Institute has accelerated conversations about the importance of actively engaging stakeholders in all aspects of comparative effectiveness research (CER). Other scientific disciplines have a history of stakeholder engagement, yet few empirical examples exist of how these stakeholders can inform and enrich CER. Here we present a case study which includes the methods used to engage stakeholders, what we learned from them, and how we incorporated their ideas in a CER project. We selected stakeholders from key groups, built relationships with them and collected their feedback through interviews, observation and ongoing meetings during the four research process phases: proposal development, adapting study methods, understanding the context and information technology tool design and refinement.

Population-Based Lynch Syndrome Screening by Microsatellite Instability in Patients ≤50: Prevalence, Testing Determinants, and Result Availability Prior to Colon Surgery.

As there are no US population-based studies examining Lynch syndrome (LS) screening frequency by microsatellite instability (MSI) and immunohistochemistry (IHC), we seek to quantitate statewide rates in patients aged ≤50 years using data from a Centers for Disease Control and Prevention-funded Comparative Effectiveness Research (CER) project and identify factors associated with testing. Screening rates in this young, high-risk population may provide a best-case scenario as older patients, potentially deemed lower risk, may undergo testing less frequently. We also seek to determine how frequently MSI/IHC results are available preoperatively, as this may assist with decisions regarding colonic resection extent. Data from all Louisiana colorectal cancer (CRC) patients aged ≤50 years diagnosed in 2011 were obtained from the Louisiana Tumor Registry CER project. Registry researchers and physicians analyzed data, including pathology and MSI/IHC. Of the 2,427 statewide all-age CRC patients, there were 274 patients aged ≤50 years, representing health care at 61 distinct facilities. MSI and/or IHC were performed in 23.0% of patients. Testing-associated factors included CRC family history (P<0.0045), urban location (P<0.0370), and care at comprehensive cancer centers (P<0.0020) but not synchronous/metachronous CRC or MSI-like histology. Public hospital screening was disproportionately low (P<0.0217). Of those tested, MSI and/or IHC was abnormal in 21.7%. Of those with abnormal IHC, staining patterns were consistent with LS in 87.5%. MSI/IHC results were available preoperatively in 16.9% of cases. Despite frequently abnormal MSI/IHC results, LS screening in young, high-risk patients is low. Provider education and disparities in access to specialized services, particularly in underserved populations, are possible contributors. MSI/IHC results are infrequently available preoperatively.

Evaluating collaborations in comparative effectiveness research: opportunities and challenges for social network analysis

Multidisciplinary, multi-institutional collaboration has become a key feature of comparative effectiveness research (CER), and CER funders have made promotion of these types of collaboration an implicit, and sometimes explicit, goal of funding. An important challenge in evaluating CER programs is understanding if and how different forms of collaboration are associated with successful CER projects. This article explores the potential use of social network analysis to address research questions about the associations between collaboration and the success of CER projects.

American Recovery and Reinvestment Act-comparative effectiveness research infrastructure investments: emerging data resources, tools and publications.

The Recovery Act provided a substantial, one-time investment in data infrastructure for comparative effectiveness research (CER). A review of the publications, data, and tools developed as a result of this support has informed understanding of the level of effort undertaken by these projects. Structured search queries, as well as outreach efforts, were conducted to identify and review resources from American Recovery and Reinvestment Act of 2009 CER projects building electronic clinical data infrastructure. The findings from this study provide a spectrum of productivity across a range of topics and settings. A total of 451 manuscripts published in 192 journals, and 141 data resources and tools were identified and address gaps in evidence on priority populations, conditions, and the infrastructure needed to support CER.

Comparative effectiveness research of chronic hepatitis B and C cohort study (CHeCS): improving data collection and cohort identification.

The Chronic Hepatitis Cohort Study (CHeCS) is a longitudinal observational study of risks and benefits of treatments and care in patients with chronic hepatitis B (HBV) and C (HCV) infection from four US health systems. We hypothesized that comparative effectiveness methods-including a centralized data management system and an adaptive approach for cohort selection-would improve cohort selection while controlling data quality and reducing the cost. Cohort selection and data collection were performed primarily via the electronic health record (EHR); cases were confirmed via chart abstraction. Two parallel sources fed data to a centralized data management system: direct EHR data collection with common data elements, and chart abstraction via electronic data capture. An adaptive Classification and Regression Tree (CART) identified a set of electronic variables to improve case ascertainment accuracy. Over 16 million patient records were collected on 23 case report forms in 2006-2008. The vast majority of data (99.2%) were collected electronically from EHR; only 0.8% was collected via chart abstraction. Initial electronic criteria identified 12,144 chronic hepatitis patients; 10,098 were confirmed via chart abstraction with positive predictive values (PPV) 79 and 83% for HBV and HCV, respectively. CART-optimized models significantly increased PPV to 88 for HBV and 95% for HCV. CHeCS is a comparative effectiveness research project that leverages electronic centralized data collection and adaptive cohort identification approaches to enhance study efficiency. The adaptive CART model significantly improved the positive predictive value of cohort identification methods.

A Survey of Informatics Platforms That Enable Distributed Comparative Effectiveness Research Using Multi-institutional Heterogenous Clinical Data

Comparative effectiveness research (CER) has the potential to transform the current health care delivery system by identifying the most effective medical and surgical treatments, diagnostic tests, disease prevention methods, and ways to deliver care for specific clinical conditions. To be successful, such research requires the identification, capture, aggregation, integration, and analysis of disparate data sources held by different institutions with diverse representations of the relevant clinical events. In an effort to address these diverse demands, there have been multiple new designs and implementations of informatics platforms that provide access to electronic clinical data and the governance infrastructure required for interinstitutional CER. The goal of this manuscript is to help investigators understand why these informatics platforms are required and to compare and contrast 6 large-scale, recently funded, CER-focused informatics platform development efforts. We utilized an 8-dimension, sociotechnical model of health information technology to help guide our work. We identified 6 generic steps that are necessary in any distributed, multi-institutional CER project: data identification, extraction, modeling, aggregation, analysis, and dissemination. We expect that over the next several years these projects will provide answers to many important, and heretofore unanswerable, clinical research questions.

Continuous Patient Engagement in Comparative Effectiveness Research

THE GOAL OF COMPARATIVE EFFECTIVENESS RESEARCH (CER) is to provide patients, their advocates and caregivers, health care professionals, federal officials, policy makers, and payers with evidence-based information to make informed health care decisions. Previously, CER studies were designed by researchers and had relatively little input from patients. Patient engagement has rapidly gained acceptance as crucial to the successful translation of CER for all interested parties. Experiences with patient engagement in research, including community-based participatory research, suggest that success hinges on patients being interested and emotionally involved in the research question and understanding their role in the CER process. Evaluation of information from the Agency for Healthcare Research and Quality and the Patient-Centered Outcomes Research Institute suggests that CER may be enhanced through continuous patient engagement. The framework for doing so, as proposed in this Viewpoint, reflects pragmatic experiences and observations in which patient engagement has helped to shape and translate CER for patients and health care professionals; however, the framework needs to be tested empirically (FIGURE). This proposed 10-step process for CER describes how patient engagement might guide CER toward patient-centered outcomes research and offers suggestions for the process and purpose of patient engagement across the 10 steps. Each step has different purposes, advantages and disadvantages, and implications for time and resources. The proposed framework is intended to span the entire “life cycle” of a CER project. At the first step, patients could help identify understudied CER topics. By soliciting input from diverse patients, the process could generate a broad array of topics, from which a more narrow focus could be achieved by framing specific research questions. When designing a potential framework for a specific CER question, patients would provide a “reality check,” indicating the extent to which the proposed framework reflects their personal experiences. When CER involves primary data collection, patient input could help determine the best practices for data collection, provide input about the proposed content of the data collection tool, and participate in pilot testing survey items. Traditionally, patient feedback is infrequently used during the development of the analysis plan. However, this framework proposes that patients could assist in helping to define or categorize variables even if they do not have training in research methods. When reviewing and interpreting results, patients could reflect on whether results are plausible and believable, what other factors should be considered, and how results may vary across subgroups of patients. In the translation phase, patients could identify which results are easy or difficult to understand. If the results do not affect patients or are counterintuitive, CER findings will not be translated into medical practice. Patients could also offer suggestions for how best to explain study findings to other patients. Patients could help determine the best dissemination strategies, provide dissemination channels, and craft specific messages targeted to patients who will benefit most. Thoughtful consideration should be given to determining which approach would best elicit the patient’s perspective at each particular step. For example, during the early stages of research, it may be most beneficial to engage patients through patient forums or telephone conversations to solicit potential topics of importance. As research progresses to protocol development, involving patients in stakeholder meetings could provide an opportunity for robust discussion regarding which outcomes to assess, populations to include, and treatment options to compare. Input on the patient experience also could be obtained from indirect means of engagement. For example, using online patient forums in which groups of patients talk about their disease may be a source of valuable information provided the process adheres to ethical standards of protection of human research participants. When creating the conceptual framework, collecting data, and specifying the analysis plan, more in-depth information and patient input may be required. Methods of engagement such as in-person meetings, focus groups, and individual patient interviews could allow patients to give more detailed input. Patients could assist in framing the message, creating plain language summaries, targeting audi-