Patient Engagement In Research: Early Findings From The Patient-Centered Outcomes Research Institute.

Charged with ensuring that research produces useful evidence to inform health decisions, the Patient-Centered Outcomes Research Institute (PCORI) requires investigators to engage patients and other health care stakeholders, such as clinicians and payers, in the research process. Many PCORI studies result in articles published in peer-reviewed journals that detail research findings and engagement's role in research. To inform practices for engaging patients and others as research partners, we analyzed 126 articles that described engagement approaches and contributions to research. PCORI projects engaged patients and others as consultants and collaborators in determining the study design, selecting study outcomes, tailoring interventions to meet patients' needs and preferences, and enrolling participants. Many articles reported that engagement provided valuable contributions to research feasibility, acceptability, rigor, and relevance, while a few noted trade-offs of engagement. The findings suggest that engagement can support more relevant research through better alignment with patients' and clinicians' real-world needs and concerns.

PEER-REVIEWED JOURNAL EDITORS' VIEWS ON REAL-WORLD EVIDENCE.

OBJECTIVES: Peer-review publication is a critical step to the translation and dissemination of research results into clinical practice guidelines, health technology assessment (HTA) and payment policies, and clinical care. The objective of this study was to examine current views of journal editors regarding: (i) The value of real-world evidence (RWE) and how it compares with other types of studies; (ii) Education and/or resources journal editors provide to their peer reviewers or perceive as needed for authors, reviewers, and editors related to RWE. METHODS: Journal editors' views on the value of RWE and editorial procedures for RWE manuscripts were obtained through telephone interviews, a survey, and in-person, roundtable discussion. RESULTS: In total, seventy-nine journals were approached, resulting in fifteen telephone interviews, seventeen survey responses and eight roundtable participants. RWE was considered valuable by all interviewed editors (n = 15). Characteristics of high-quality RWE manuscripts included: novelty/relevance, rigorous methodology, and alignment of data to research question. Editors experience challenges finding peer reviewers; however, these challenges persist across all study designs. Journals generally do not provide guidance, assistance, or training for reviewers, including for RWE studies. Health policy/health services research (HSR) editors were more likely than specialty or general medicine editors to participate in this study, potentially indicating that HSR researchers are more comfortable/interested in RWE. CONCLUSIONS: Editors report favorable views of RWE studies provided studies examine important questions and are methodologically rigorous. Improving peer-review processes across all study designs, has the potential to improve the evidence base for decision making, including HTA.

Got CER? Educating Pharmacists for Practice in the Future: New Tools for New Challenges.

BACKGROUND: Understanding how treatments work in the real world and in real patients is an important and complex task. In recent years, comparative effectiveness research (CER) studies have become more available for health care providers to inform evidence-based decision making. There is variability in the strengths and limitations of this new evidence, and researchers and decision makers are faced with challenges when assessing the quality of these new methods and CER studies. OBJECTIVES: To (a) describe an online tool developed by the CER Collaborative, composed of the Academy of Managed Care Pharmacy, the International Society for Pharmacoeconomics and Outcomes Research, and the National Pharmaceutical Council, and (b) provide an early evaluation of the training program impact on learners' self-reported abilities to evaluate and incorporate CER studies into their decision making. METHODS: To encourage greater transparency, consistency, and uniformity in the development and assessment of CER studies, the CER Collaborative developed an online tool to assist researchers, new and experienced clinicians, and decision makers in producing and evaluating CER studies. A training program that supports the use of the online tool was developed to improve the ability and confidence of individuals to apply CER study findings in their daily work. Seventy-one health care professionals enrolled in 3 separate cohorts for the training program. Upon completion, learners assessed their abilities to interpret and apply findings from CER studies by completing on online evaluation questionnaire. RESULTS: The first 3 cohorts of learners to complete the training program consisted of 71 current and future health care practitioners and researchers. At completion, learners indicated high confidence in their CER evidence assessment abilities (mean = 4.2). Learners reported a 27.43%-59.86% improvement in capabilities to evaluate various CER studies and identify study design flaws (mean evaluation before CER Certificate Program [CCP] scores = 1.86-3.14 and post-CCP scores = 3.92-4.24). Additionally, 63% of learners indicated that they expected to increase their use of evidence from CER studies in at least 1-2 problem decisions per month. CONCLUSIONS: The CER Collaborative has responded to the need for increased practitioner training to improve understanding and application of new CER studies. The CER Collaborative tool and certificate training program are innovative solutions to help decision makers meet the challenges they face in honing their skills to best incorporate credible and relevant CER evidence into their decision making. DISCLOSURES: The CER Collaborative, the development of the questionnaires and web-based tool, and the development of the CER Certificate Program were supported by grants and in-kind contributions from the Academy of Managed Care Pharmacy (AMCP), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and the National Pharmaceutical Council (NPC). The University of Maryland School of Pharmacy conducted its work under a contract with the AMCP Foundation and grant funding from the NPC. Perfetto is employed by the University of Maryland and the National Health Council and serves as assistant editor for the Journal of Managed Care & Specialty Pharmacy, consults for Avelere, and serves as a member of advisory boards for the PQA and CMTP. Pickering received support from the NPC for activities related to this research. Eichelberger is employed by the Academy of Managed Care Pharmacy. Eichelberger and Graff are with the CER Collaborative. Graff is employed by the National Pharmaceutical Council. Study concept and design were primarily contributed by Perfetto, Graff, and Eichelberger, along with Anyanwu and assisted by Pickering and Ward Zaghab. Pickering and Ward Zaghab took the lead in data collection, with assistance from the other authors, and data interpretation was performed by Perfetto, Graff, Pickering, and Ward Zaghab, with assistance from the other authors. The manuscript was written by Perfetto and Anyanwu, with assistance from the other authors, and revised by Graff, Perfetto, Anyanwu, and Pickering, assisted by Eichelberger and Ward Zaghab.