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-
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