Oncology Nurses Can Build Patient-Centered Outcomes Research Partnerships.

Nurses can inform and lead patient-centered outcomes research (PCOR) projects that address care-related questions prioritized by patients. However, PCOR projects may fail to materialize because time constraints create barrier.

Emerging healthcare interventions: Patient-Centered Outcomes Research Institute's programmatic initiative.

The Patient-Centered Outcomes Research Institute (PCORI) is a nonprofit, nongovernmental organization established by the U.S. Congress to fund comparative clinical effectiveness research focusing on patient-centered outcomes through the engagement of stakeholders. Evaluation of emerging healthcare innovations is one of PCORI's five National Priorities for Health. One such initiative is PCORI's Emerging Technologies and Therapeutics Reports program, established to provide timely overviews of evidence on new drugs and other healthcare technologies. This article provides an overview of completed and ongoing Emerging Technologies and Therapeutics Reports including lessons learned to date. In addition to systematic searches, systematic selection of studies, and transparent reporting of the available evidence, informed by a select number of stakeholders (i.e., key informants), these reports focus on contextual factors shaping the diffusion of emerging technologies that are often not reported in the medical literature. This article also compares processes and methodologies of health technology assessments (HTAs) from a selected number of national and international publicly funded agencies with a goal toward potential future enhancement of PCORI's Emerging Technologies and Therapeutics Reports program. HTAs vary considerably in terms of funding, types of assessments, the role of manufacturers, stakeholder engagement, timeline to complete from the start to the finish of a draft report publication, and communication of uncertainty for informed decision making. Future Emerging Technologies and Therapeutics Reports may focus on rapid reports to support a more expedient development of evidence. Future research could explore the role of contextual factors identified in these reports on targeted evidence generation.

The Evolution and Typology of Learning Health System Hospitals and other Health Information Interested Hospitals in the US.

This study identifies the type, distribution, and interactions of US hospitals that identify as electronic-data-driven, patient-centric, and learning-focused. Such facilities, termed Health Information Interested (HII) hospitals in this study, meet the defining criteria for one or more of the following designations: learning health systems (LHS), Health Information Technology for Economic and Clinical Health (HITECH) meaningful use stage three compliant (MU3), Patient-Centered Outcomes Research Institute (PCORI) funded, or medical home/safety net (MH/SN) hospital. The American Hospital Association (AHA) IT supplemental survey and other supporting data spanning 2013 to 2018 were used to identify HII hospitals. HII hospitals increased from 19.9 percent to 62.4 percent of AHA reporting hospitals from 2013 to 2018. HII subcategories in 2018 such as the full LHS (37.2 percent) and MU3 (46.9 percent) were dominant, with 33.2 percent having both designations. This indicates increased interest in patient-centric, learning-focused care using electronic health data. This information can enable health information management (HIM) professionals to be aware of programs or approaches that can facilitate learning-focused, patient-centric care using electronic health data within health systems.

The Impact of COVID-19 on Patient, Family Member, and Stakeholder Research Engagement: Insights from the PREPARE NOW Study.

BACKGROUND: Little is known about the impact of COVID-19 on patient, family member, and stakeholder patient-centered outcomes research engagement. OBJECTIVE: To answer the research questions: (1) What is the impact of COVID-19 on the lives of patients with kidney disease and their families? (2) What is the impact of COVID-19 on research engagement for patient and family member research team members who are themselves at very high risk for poor COVID-19 outcomes? and (3) How can we help patients, family members, and stakeholder team members engage in research during COVID-19? DESIGN: We conducted virtual semi-structured interviews with patient and family member co-investigators and kidney disease stakeholders from the PREPARE NOW study during November 2020. The interview guide included questions about participants' experiences with the impact of COVID-19 on research engagement. PARTICIPANTS: Seven patient and family member co-investigators and eight kidney disease stakeholders involved in a kidney disease patient-centered outcomes research project participated in the interviews, data analysis, and writing this manuscript. APPROACH: We used a content analysis approach and identified the main themes using an inductive process. KEY RESULTS: Respondents reported three main ways that COVID-19 has impacted their lives: emotional impact, changing behaviors, and changes in health care delivery. The majority of respondents reported no negative impact of COVID-19 on their ability to engage in this research project. Suggestions for patient-centered outcomes research during COVID-19 and other emergencies include virtual research activities; active engagement; and promoting trust, honesty, transparency, and authenticity. CONCLUSIONS: COVID-19 has had a significant negative impact on patient, family member, and stakeholder research team members; however, this has not resulted in less research engagement. TRIAL REGISTRATION: Clinicaltrials.gov NCT02722382.

Peer review reduces spin in PCORI research reports.

BACKGROUND: The Patient-Centered Outcomes Research Institute (PCORI) is obligated to peer review and to post publicly "Final Research Reports" of all funded projects. PCORI peer review emphasizes adherence to PCORI's Methodology Standards and principles of ethical scientific communication. During the peer review process, reviewers and editors seek to ensure that results are presented objectively and interpreted appropriately, e.g., free of spin. METHODS: Two independent raters assessed PCORI peer review feedback sent to authors. We calculated the proportion of reports in which spin was identified during peer review, and the types of spin identified. We included reports submitted by April 2018 with at least one associated journal article. The same raters then assessed whether authors addressed reviewers' comments about spin. The raters also assessed whether spin identified during PCORI peer review was present in related journal articles. RESULTS: We included 64 PCORI-funded projects. Peer reviewers or editors identified spin in 55/64 (86%) submitted research reports. Types of spin included reporting bias (46/55; 84%), inappropriate interpretation (40/55; 73%), inappropriate extrapolation of results (15/55; 27%), and inappropriate attribution of causality (5/55; 9%). Authors addressed comments about spin related to 47/55 (85%) of the reports. Of 110 associated journal articles, PCORI comments about spin were potentially applicable to 44/110 (40%) articles, of which 27/44 (61%) contained the same spin that was identified in the PCORI research report. The proportion of articles with spin was similar for articles accepted before and after PCORI peer review (63% vs 58%). DISCUSSION: Just as spin is common in journal articles and press releases, we found that most reports submitted to PCORI included spin. While most spin was mitigated during the funder's peer review process, we found no evidence that review of PCORI reports influenced spin in journal articles. Funders could explore interventions aimed at reducing spin in published articles of studies they support.

A call to action: Antiracist patient engagement in adolescent and young adult oncology research and advocacy.

Amidst the concurrent global crises of coronavirus disease 2019 (COVID-19), uprisings against Anti-Black racism and police brutality, as well as anti-Asian racism and violence, the field of medicine found itself simultaneously called upon to respond as essential workers in the public health devastation of COVID-19, and as representatives of healthcare institutions wrought with the impacts of systemic racism. Clinicians, researchers, and advocates in adolescent and young adult (AYA) oncology, must come together in authentic activism to begin the work of creating structural change to advance antiracist approaches to patient engagement in AYA oncology research and advocacy. Critical review of existing practices is needed to ensure that ethical and effective research methods are employed when engaging with racial and ethnic minority AYA patients with cancer, who may be particularly vulnerable and exploited in the current context.

Experiences of an HCV Patient engagement group: a seven-year journey.

Historically, few publications exist where patient engagement in clinical studies is a driving force in study design and implementation. The Patient Centered Outcomes Research Institute (PCORI), established in 2010, employed a new model of integrating stakeholder perspectives into healthcare research. This manuscript aims to share the experience of a Patient Engagement Group (PEG) that has engaged in hepatitis C (HCV) clinical research alongside investigators conducting two studies funded by PCORI and to inspire others to get more involved in research that can impact our healthcare and health policies.There are many gaps in treating infectious diseases. Traditionally, treatment and research have been strictly clinical/medical approaches with little focus on the biopsychosocial aspects of individual patients. Our PEG reflected on its own personal experiences regarding how research design can affect study implementation by including patients who are normally excluded. We considered barriers to treatment, out of pocket costs, access to insurance, and patient race/ethnicity. Common themes were discovered, and four major topics were discussed. In addition, measures used in the two studies to collect patient data were considered, tested, and implemented by the group.We describe in detail how we were formed and how we have worked together with researchers on two PCORI funded projects over the past 7 years. We formulated and implemented guidelines and responsibilities for operating as a PEG as well as appointing a chair, co-chair, and primary author of this manuscript.Written from the perspective of a PEG whose members experienced HCV treatment and cure, we provide lessons learned, and implications for further research to include patients. PEGs like ours who are included as active partners in research can provide useful input to many areas including how patients are treated during clinical trials, how they interact with research teams, and how the clinical benefits of drugs or devices are defined and evaluated. PCORI believes engagement impacts research to be more patient-centered, useful, and trustworthy, and will ultimately lead to greater use and interest of research results by the patient and the broader healthcare community.

Engaging patients and family members to design and implement patient-centered kidney disease research.

We need more research projects that partner and engage with patients and family members as team members. Doing this requires that patients and family members set research priorities and fully participate in research teams. Models for this patient and family member engagement as research partners can help increase patient centered outcomes research. In this article, we describe how we have successfully engaged patients with kidney disease and family members as Co-Investigators on a 5-year research project testing a health system intervention to improve kidney disease care. Background This article describes a method for successful engagement of patients and family members in all stages of a 5-year comparative effectiveness research trial to improve transitions of care for patients from chronic kidney disease to end-stage kidney disease. Methods This project utilized the Patient-Centered Outcomes Research Institute's conceptual model for engagement with patients and family members. We conducted a qualitative analysis of grant planning meetings to determine patient and family member Co-Investigators' priorities for research and to include these engagement efforts in the research design. Patient and family member Co-Investigators partnered in writing this paper. Results Patients and family members were successfully engaged in remote and in-person meetings to contribute actively to research planning and implementation stages. Three patient-centered themes emerged from our data related to engagement that informed our research plan: kidney disease treatment decision-making, care transitions from chronic to end-stage kidney disease, and patient-centered outcomes. Conclusions The model we have employed represents a new paradigm for kidney disease research in the United States, with patients and family members engaged as full research partners. As a result, the study tests an intervention that directly responds to their needs, and it prioritizes the collection of outcomes data most relevant to patient and family member Co-Investigators. Trial registration NCT02722382 .

Diabetes medication regimens and patient clinical characteristics in the national patient-centered clinical research network, PCORnet.

We used electronic medical record (EMR) data in the National Patient-Centered Clinical Research Network (PCORnet) to characterize "real-world" prescription patterns of Type 2 diabetes (T2D) medications. We identified a retrospective cohort of 613,203 adult patients with T2D from 33 datamarts (median patient number: 12,711) from 2012 through 2017 using a validated computable phenotype. We characterized outpatient T2D prescriptions for each patient in the 90 days before and after cohort entry, as well as demographics, comorbidities, non-T2D prescriptions, and clinical and laboratory variables in the 730 days prior to cohort entry. Approximately half of the individuals in the cohort were females and 20% Black. Hypertension (60.3%) and hyperlipidemia (50.5%) were highly prevalent. Most patients were prescribed either a single T2D drug class (42.2%) or had no evidence of a T2D prescription in the EMR (42.4%). A smaller percentage was prescribed multiple T2D drug types (15.4%). Among patients prescribed a single T2D drug type, metformin was the most common (42.6%), followed by insulin (18.2%) and sulfonylureas (13.9%). Newer classes represented approximately 13% of single T2D drug type prescriptions (dipeptidyl peptidase-4 inhibitors [6.6%], glucagon-like peptide-1 receptor agonists [2.5%], thiazolidinediones [2.0%], and sodium-glucose cotransporter-2 inhibitors [1.6%]). Among patients prescribed multiple T2D drug types, the most common combination was metformin and sulfonylureas (63.5%). Metformin-based regimens were highly prevalent in PCORnet's T2D population, whereas newer agents were prescribed less frequently. PCORnet is a novel source for the potential conduct of observational studies among patients with T2D.

Comparative Clinical Effectiveness Research Focused on Community-Based Delivery of Palliative Care: Overview of the Patient-Centered Outcomes Research Institute's Funding Initiative.

Palliative care is a growing specialty that addresses the needs of individuals diagnosed with advanced illness and their caregivers. Although palliative care has been shown to improve a variety of patient- and caregiver-centered outcomes, access to comprehensive palliative care services for patients is often limited. There is a need to identify the most effective approaches to delivering palliative care to patients in community settings. In fiscal year 2017, based on extensive input from a diverse set of stakeholders, the Patient-Centered Outcomes Research Institute (PCORI) funded nine multisite comparative clinical effectiveness research (CER) trials focused on community-based delivery of palliative care for a total investment of $80 million. These studies, focusing on advance care planning and models of palliative care delivery, represent some of the largest most complex palliative care trials funded to date. Each study evaluates both patient and caregiver outcomes, and together, these trials include a broad range of health conditions, interventions, and settings of care. PCORI has also fostered a learning network of the funded awardees to facilitate the successful conduct of these CER studies and to support awardee efforts to develop collaborative products relevant to advancing the field of palliative care research and practice. The protocols of each of the nine trials, detailed in this issue, demonstrate the expansive reach of the investment PCORI has made in an effort to further the research agenda and provide substantive research evidence in stakeholder-identified areas of need in the field of palliative care.

Training patients to review scientific reports for the Patient-Centered Outcomes Research Institute: an observational study.

OBJECTIVE: The peer review of completed Patient-Centered Outcomes Research Institute (PCORI) funded research includes reviews from patient reviewers (patients, caregivers, and patient advocates). Very little is known about how best to support these reviewers in writing helpful comments from a patient-centred perspective. This study aimed to evaluate the effect of a new training in peer review for patient reviewers. DESIGN: Observational study. SETTING: Online. PARTICIPANTS: Adults registered in the PCORI Reviewer Database as a patient stakeholder. INTERVENTION: A new online training in peer review. MAIN OUTCOME MEASURES: Changes in reviewers' knowledge and skills; change in self-efficacy and attitudes, satisfaction with the training and perceived benefits and relevance of the training. RESULTS: Before-after training survey data were analysed for 37 (29.4% of 126) patient reviewers invited to participate in an online training as part of a quality improvement effort or as part of a PCORI peer review. The reviewers improved their answers to the knowledge questions (p<0.001, median number of answers improved 4 (95% CI 3 to 5), large effect size (ES) Cohen's w=0.94) after the training, particularly in the questions targeting the specifics of PCORI peer review. Reviewers improved their skills in recognising helpful review comments, but those without peer-review background improved proportionally more (p=0.008, median number of answers improved 2 (95% CI 1 to 3), medium ES w=0.60). The use of training modestly increased reviewers' confidence in completing a high-quality peer review (p=0.005, mean increase in 5-point Likert rating 0.51 (95% CI 0.17 to 0.86), small-to-medium ES Cliff's delta=0.32) and their excitement about providing a review slightly increased (p=0.019, mean increase in 5-point Likert rating 0.35 (95% CI 0.03 to 0.68), small ES delta=0.19). All reviewers were satisfied with the training and would recommend it to other reviewers. CONCLUSIONS: Training improved knowledge, skills and self-efficacy and slightly increased enthusiasm for completing a PCORI peer review.

How different is research done by the Patient-centered Outcomes Research Institute, and what difference does it make?

Aim: To determine whether research funded by the Patient-centered Outcomes Research Institute (PCORI) is consistent with the original aims of Congress and unique among other major USA funders. Methods: We compared a sample of funded projects from PCORI, NIH (Phase IV) and agency for healthcare research and quality (AHRQ; American Recovery and Reinvestment Act [ARRA]-based comparative effectiveness research funding) from 2014 to 2018 on number of outcomes/study, patient-centeredness of outcomes (those related to survival, function, symptoms and health-related quality of life) and other features that may characterize patient-centered research (e.g., whether conducted in a real-world setting) using PCORI portfolio data and ClinicalTrials.gov. Results: The mean number of outcomes in PCORI studies (≥9) appeared higher than NIH (≥3)/AHRQ (5.5); a higher percentage of outcomes/study were patient-centered: >85% PCORI versus 50% AHRQ and ≤30% NIH. The majority of PCORI studies (≥74%) were conducted in a real-world setting; this characteristic could not be identified for NIH/AHRQ studies. Conclusion: PCORI-funded studies appear to have unique aspects relative to NIH and AHRQ that are consistent with PCORI's aims of patient-centeredness.

Learning to Share Health Care Data: A Brief Timeline of Influential Common Data Models and Distributed Health Data Networks in U.S. Health Care Research.

The last twenty years of health care research has seen a steady stream of common health care data models implemented for multi-organization research. Each model offers a uniform interface on data from the diverse organizations that implement them, enabling the sharing of research tools and data. While the groups designing the models have had various needs and aims, and the data available has changed significantly in this time, there are nevertheless striking similarities between them. This paper traces the evolution of common data models, describing their similarities and points of departure. We believe the history of this work should be understood and preserved. The work has empowered collaborative research across competing organizations and brought together researchers from clinical practice, universities and research institutes around the planet. Understanding the eco-system of data models designed for collaborative research allows readers to evaluate where we have been, where we are going as a field, and to evaluate the utility of different models to their own work.

Patient involvement in medical research: what patients and physicians learn from each other.

BACKGROUND: There is increasing interest in actively involving patients in the process of medical research to help ensure research is relevant and important to both researchers and people affected by the disease under study. This project examined the recently formed Vasculitis Patient-Powered Research Network (VPPRN), a rare disease research network, to better understand what investigators and patients learned from working on research teams together. METHODS: Qualitative interviews were conducted by phone with patients, physician/PhD-investigators, and study managers/staff who participated in the network. The question guiding the interviews and observational analysis was: "What have investigators and patients learned about working together while working on VPPRN teams?" Interview transcripts were analyzed in combination with observations from multiple in-person and telephone meetings. RESULTS: Transcripts and notes were reviewed and coded from 22 interviews conducted among 13 patient-partners, 5 study managers/staff, and 4 MD or PhD-investigators, and 6 in-person and 42 telephone/web-conference meetings. Patient-partners and investigators characterized their working relationships with one another, what they learned from their collaborations, and provided recommendations for future teams of patient-partners and investigators. Major themes included the great benefits of communicating about activities, being open to listening to each group member, and the importance of setting reasonable expectations. CONCLUSIONS: Direct engagement in research design and development by patient-partners and co-learning between investigators and patient-partners can result in a positive and productive working relationship for all members of a medical research team. This bi-directional engagement directly benefits and impacts research design, participant recruitment to studies, and study subject retention.

Performance of a computable phenotype for identification of patients with diabetes within PCORnet: The Patient-Centered Clinical Research Network.

PURPOSE: PCORnet, the National Patient-Centered Clinical Research Network, represents an innovative system for the conduct of observational and pragmatic studies. We describe the identification and validation of a retrospective cohort of patients with type 2 diabetes (T2DM) from four PCORnet sites. METHODS: We adapted existing computable phenotypes (CP) for the identification of patients with T2DM and evaluated their performance across four PCORnet sites (2012-2016). Patients entered the cohort on the earliest date they met one of three CP categories: (CP1) coded T2DM diagnosis (ICD-9/ICD-10) and an antidiabetic prescription, (CP2) diagnosis and glycosylated hemoglobin (HbA1c) ≥6.5%, or (CP3) an antidiabetic prescription and HbA1c ≥6.5%. We required evidence of health care utilization in each of the 2 prior years for each patient, as we also developed an incident T2DM CP to identify the subset of patients without documentation of T2DM in the 365 days before t0 . Among a systematic sample of patients, we calculated the positive predictive value (PPV) for the T2DM CP and incident-T2DM CP using electronic health record (EHR) review as reference. RESULTS: The CP identified 50 657 patients with T2DM. The PPV of patients randomly selected for validation was 96.2% (n = 1572; CI:95.1-97.0) and was consistently high across sites. The PPV for the incident-T2DM CP was 5.8% (CI:4.5-7.5). CONCLUSIONS: The T2DM CP accurately and efficiently identified patients with T2DM across multiple sites that participate in PCORnet, although the incident T2DM CP requires further study. PCORnet is a valuable data source for future epidemiological and comparative effectiveness research among patients with T2DM.

Utilizing Community Health Needs Assessments (CHNAs) in Nonprofit Hospitals to Guide Population-Centered Outcomes Research for Pediatric Patients: New Recommendations for CHNA Reporting.

Currently, Community Health Needs Assessment (CHNA) reports lack a standard structure, making it difficult to derive meaningful information. However, they have the potential to be a useful tool for analyzing pediatric outcomes, guiding resource allocation, and linking to Patient-Centered Outcomes Research Institute priorities. The objective was to evaluate the utility of CHNA for informing future pediatric, patient-centered outcomes research. The authors analyzed CHNA documents, published before July 1, 2016 by 61 nonprofit hospitals, focusing on 4 metropolitan areas in Florida: Miami, Orlando, Tampa, and Jacksonville. Out of 18 health priorities identified, access to care and obesity were universally recognized as the most urgent pediatric health needs across all hospital types and metropolitan regions. This analysis also yielded insights into key regional differences. The authors advocate that a major change in the CHNA format be implemented using a common set of domains to produce meaningful, interpretable, and comparable results that inform and guide patient-centered health outcomes research.

Researchers, Patients, and Stakeholders Evaluating Comparative-Effectiveness Research: A Mixed-Methods Study of the PCORI Reviewer Experience.

OBJECTIVES: The Patient-Centered Outcomes Research Institute (PCORI) includes patients and stakeholders alongside scientists in reviewing research applications using unique review criteria including patient-centeredness and patient and/or stakeholder engagement. To support extension of this unique collaborative model to other funders, information from the reviewers on the review process is needed to understand how scientists and nonscientists evaluate research proposals together. Thus, this study aimed to describe reviewers' perspectives of the interactions during the in-person review panel; to examine the value and challenges of including scientists, patients, and stakeholders together; and to understand the perceived importance of PCORI's review criteria. METHODS: This study utilized anonymous, cross-sectional surveys (N = 925 respondents from 5 funding cycles: 470 scientists, 217 patients, 238 stakeholders; survey completion rates by cycle: 70-89%) and group interviews (N = 18). RESULTS: Reviewers of all types describe PCORI Merit Review as respectful, balanced, and one of reciprocal influence among different reviewer types. Reviewers indicate strong support and value of input from all reviewer types, receptivity to input from others, and the panel chair's incorporation of all views. Patients and stakeholders provide real-world perspectives on importance to patients, research partnership plans, and study feasibility. Challenges included concerns about a lack of technical expertise of patient/stakeholder reviewers and about scientists dominating conversations. The most important criterion for assigning final review scores was technical merit-either alone or in conjunction with patient-centeredness or patient/ stakeholder engagement. CONCLUSIONS: PCORI Merit Reviewers' self-reports indicate that the perspectives of different reviewer types are influential in panel discussions and Merit Review outcomes.

Lessons on Patient and Stakeholder Engagement Strategies for Pipeline to Proposal Awards.

The Patient Centered Outcomes Research Institute (PCORI) supports patient-centered clinical comparative effectiveness research (CER) including health disparities and engagement portfolios. In 2013, PCORI launched the Pipeline to Proposal (P2P) mechanism to support development of novel patient- and stakeholder-centered partnerships focused on designing clinical CER funding proposals. By providing a tiered structure of successive small contracts and technical assistance, the P2P mechanism encourages development of new research partnerships among diverse stakeholders. As a comparatively new field, patient-centered outcomes research (PCOR) has few well-delineated methods for engaging patients and other non-scientists in effective teams with academics or clinicians to develop and implement rigorous, scientific research proposals. Community partnered participatory research (CPPR) provides a useful framework for structuring new partnerships. In this article we highlight the origins, development, and prospects of three current examples of funded P2P initiatives based in New Orleans and Los Angeles. We outline how these projects - Prisoner to Patient, the NOLA Partnership, and Resilience Among African American Men - use CPPR principles. We also describe how they have collaborated with, and contributed to, a two-way learning and knowledge exchange among members of the PCORI-funded Community and Patient Partnered Research Network. Lessons learned may be applicable to other groups planning to create new partnerships focused on implementing PCOR.

Researchers' experiences with and perceptions of returning results to participants: Study protocol.

BACKGROUND: Health research participants want to receive the results from research studies in which they have participated, and health research funding agencies encourage the returning of results to research participants. However, researchers rarely return results to research participants. This study protocol aims to fill the significant gap in knowledge that exists regarding experiences, perceptions, and challenges health researchers have with returning results to research participants. DESIGN: The study will use a mixed-methods concurrent triangulation design that will collect qualitative and quantitative data in one simultaneous phase to allow researchers to utilize each type of data to corroborate the findings from the other. The research team developed a mixed-methods survey to assess the experiences, perceptions, and challenges health researchers have with returning results to research participants. METHOD: The survey includes both quantitative and qualitative (open-ended) questions and will be implemented online and will take approximately 10-15 min for respondents to complete. The survey is divided into four topics areas, which include respondents': 1) general opinion of returning results to participants in health research studies, 2) experiences with a specific study in which they did not return results to participants, 3) perceptions of specific challenges they face in returning results to participants, and 4) demographic characteristics and professional background information. SUMMARY: The study to be conducted will address knowledge gaps related to researchers' experiences, perceptions, and challenges with returning research results. The study is an important step toward pragmatic solutions that can improve researchers' ability to return results to participants.

PCORnet's Collaborative Research Groups.

The Patient-Centered Outcomes Research Institute (PCORI) launched a multi-institutional "network of networks" in 2013 - Patient-Centered Clinical Research Network (PCORnet) - that is designed to conduct clinical research that is faster, less expensive, and more responsive to the information needs of patients and clinicians. To enhance cross-network and cross-institutional collaboration and catalyze the use of PCORnet, PCORI has supported formation of 11 Collaborative Research Groups focusing on specific disease types (e.g., cardiovascular health and cancer) or particular patient populations (e.g., pediatrics and health disparities). PCORnet's Collaborative Research Groups are establishing research priorities within these focus areas, establishing relationships with potential funders, and supporting development of specific research projects that will use PCORnet resources. PCORnet remains a complex, multilevel, and heterogeneous network that is still maturing and building a diverse portfolio of observational and interventional people-centered research; engaging with PCORnet can be daunting, particularly for outside investigators. We believe the Collaborative Research Groups are stimulating interest and helping investigators navigate the complexity, but only time will tell if these efforts will bear fruit in terms of funded multicenter PCORnet projects.