Comparative Effectiveness Research Findings Research Articles

Planning an implementation science training program for advanced practice registered nurses.

A gap exists between scientific discovery and implementation and adoption of research findings in healthcare and public health practice. This gap is due to the fact that research on treatment efficacy and safety in clinical trials ends prematurely with the publication of results, leaving a lack of knowledge of treatment effectiveness in real-world clinical and community settings. Comparative effectiveness research (CER) can facilitate the translation of research findings, reducing the gap between discovery and adoption into practice. Getting CER findings to patients and healthcare providers requires efforts to disseminate and train providers to successfully implement and sustain change in the healthcare setting. Advanced practice registered nurses (APRNs) are instrumental in the implementation of evidence-based research in primary care settings and an important group to target for the dissemination of research findings. There are numerous implementation training programs, but none focus specifically on APRNs. The objective of this article is to describe the infrastructure established to develop a 3-day implementation training program for APRNs and an implementation support system. A description of the processes and strategies is provided, including stakeholder engagement through focus groups and the formation of a multistakeholder program planning advisory team, which includes APRNs, organization leaders, and patients. The program also includes curriculum development and program planning as well as the development of an implementation toolkit. Stakeholders were instrumental in shaping the implementation training program, including the content of the curriculum and the program agenda. In addition, the unique perspective of each stakeholder group contributed to the selection of the CER findings disseminated through the intensive training program. It is important that strategies to address the lack of implementation training opportunities for APRNs be discussed and disseminated within the healthcare community. This article discusses the plan to address implementation training for APRNs through the development of an implementation curriculum and toolkit for APRNs.

Evaluation of comparative effectiveness research: a practical tool.

Comparative effectiveness research (CER) guidelines have been developed to direct the field toward the most rigorous study methodologies. A challenge, however, is how to ensure the best evidence is generated, and how to translate methodologically complex or nuanced CER findings into usable medical evidence. To reach that goal, it is important that both researchers and end users of CER output become knowledgeable about the elements that impact the quality and interpretability of CER. This paper distilled guidance on CER into a practical tool to assist both researchers and nonexperts with the critical review and interpretation of CER, with a focus on issues particularly relevant to CER in oncology.

Patient, caregiver and clinician use of comparative effectiveness research findings in care decisions: results from a national study.

To assess awareness, use and attitudes concerning comparative effectiveness research (CER) findings. Online surveys of patients and caregivers managing rare (n = 560 patients, n = 609 caregivers) or chronic conditions (n = 762 patients, n = 776 caregivers), and practicing clinicians (n = 638). Less than half of patients and caregivers reported exposure to any type of CER findings in the past 12 months. Of those, over half identify healthcare professionals as the information source, yet only 10% of clinicians indicated they were 'very familiar' with CER. Clinicians were concerned about the time required to find relevant evidence and the appropriateness of comparisons in available health research. Clinicians, patients and caregivers indicate unmet need for incorporating CER research findings into clinical decision-making.

Comparative effectiveness research in practice: the Drug Effectiveness Review Project experience

Assess the effect of the Drug Effectiveness Review Project's comparative effectiveness research findings on prescribing behavior independently and in conjunction with a Medicaid preferred drug list. We queried prescription drug claims and enrollment information from the 2001-2008 Medicaid Analytic eXtract and Medicaid Statistical Information System for 17 states using a Wilcoxon signed rank test design to evaluate the effects of the Drug Effectiveness Review Project's report release and preferred drug list implementation on ACE inhibitor prescribing behavior at a state level. The primary outcome of interest was the percentage of ACE inhibitor prescriptions that are defined as 'differentiated' based on the content of the Drug Effectiveness Research Program report. The use of differentiated ACE inhibitors increased significantly in states that participated in the Drug Effectiveness Research Program and subsequently implemented a preferred drug list (p < 0.05, one-tailed). However, there was no significant change in utilization in nonparticipating states or in states that participated but did not subsequently implement a preferred drug list. Although the publication of comparative effectiveness research findings may not directly influence practice, a preferred drug list can align utilization with clinical evidence. The states that participate in the Drug Effectiveness Review Project and use preferred drug lists have greater utilization of higher quality drugs, making the combination an effective strategy to translate comparative effectiveness research into practice.

Applications of Comparative Effectiveness Research to Case Management

This article is intended to update case managers on recent advances in comparative effectiveness research (CER) led by the Agency for Healthcare Research and Quality. The article explores potential implications and applications of CER findings to case management practice. All case management settings. An ongoing national movement to advance CER is intended to provide health care professionals with answers to questions about which diagnostic methods, therapies, devices, and services, among the available alternatives for a given disease or condition, may be most effective and safe for individual patients. Knowledge and application of CER findings may benefit case managers in their roles of improving resource utilization, controlling costs, providing stewardship, coordinating care, educating patients, and promoting treatment adherence and self-sufficiency. The findings from a 2013 study on the comparative effectiveness of outpatient case management programs have implications for improving case management models, reinforcing standards in the profession, and advancing research in the field. Continuing education on CER is important for promoting positive values and appropriate applications of its findings to case management practice.

Comparative-Effectiveness Research: Does It Matter?

For several years there has been a vigorous policy debate on comparative effectiveness research (CER). This debate has focused on whether more evidence should be gathered, and who should be doing the funding and developing of evidence. There has been less emphasis on implementation of CER findings, and examining whether CER has or will have an impact on prescribing patterns, reimbursement, health outcomes, and health care spending. This paper addresses both empirical and normative aspects of CER in terms of its impact on prescribing, reimbursement, cost-containment, and health outcomes. A significant gap persists between the best available evidence on therapeutic effectiveness and tolerability and typical patterns of prescribing care, as well as patient choices. Consequently, there is room for building a more systematic evidence base in the United States, so that policymakers are better equipped to understand variation in clinical outcomes while promoting appropriate prescribing and reimbursement patterns. The author carried out a non-systematic literature review of both empirical and normative aspects pertaining to CER and its policy implications. Keywords for the Medline search were "comparative effectiveness research" and "policy implications." CER has a modest impact on prescribing, reimbursement, cost-containment, and health outcomes. This impact will likely intensify as funding increases and novel models to steer prescribing and reimbursement choices incorporate comparative-effectiveness evidence.

Academic Detailing Can Play A Key Role In Assessing And Implementing Comparative Effectiveness Research Findings

Comparative effectiveness research evaluates the relative effectiveness, safety, and value of competing treatment options in clinically realistic settings. Such evaluations can be methodologically complex and difficult to interpret. There will be a growing need for critical evaluation of comparative effectiveness studies to assess the adequacy of their design and to put new information into a broader context. Equally important, this knowledge will have to be communicated to clinicians in a way that will actually change practice. We identify three challenges to effective dissemination of comparative effectiveness research findings: the difficulty of interpreting comparative effectiveness research data, the need for trusted sources of information, and the challenge of turning research results into clinical action. We suggest that academic detailing-direct outreach education that gives clinicians an accurate and unbiased synthesis of the best evidence for practice in a given clinical area-can translate comparative effectiveness research findings into actions that improve health care decision making and patient outcomes.

Looking at CER from the pharmaceutical industry perspective.

Comparative effectiveness research (CER) is increasing as an element of health care reform in the United States. By comparing drugs against other drugs or other therapies instead of just to placebo, CER has the potential to improve decisions about the appropriate treatment for patients. But the growth of CER also brings an array of questions and decisions for purchasers and policy makers that will not be easy to answer and which require significant dialogue to fully understand and address. To describe some of the impact, both positive and negative, that comparative effectiveness research (CER) may have on the pharmaceutical industry. As CER data proliferate, questions are being raised about who can access the data, who can discuss it, and in what forums. Regulations place different communication restrictions on the pharmaceutical industry than on other health care stakeholders, which creates a potential inequality. Another CER consideration will be the tendency to apply average results to individuals, even if not every individual experiences the average result. Policy makers should implement CER findings carefully with a goal toward accommodating flexibility. A final impact to consider is whether greater expectations for CER will have a negative or positive effect on incentives for drug innovation. In some cases, CER may increase development costs or decrease market size. In other cases, better targeting of trial populations could result in lower development costs. The rising expectations and growth in CER raise questions about information access, communication restrictions, flexible implementation policies, and incentives for innovation. Members of the pharmaceutical industry should be cognizant of the questions and should be participating in dialogues now to pave the way for future solutions.

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-

The Promise of Comparative Effectiveness Research

THE AMERICAN RECOVERY AND REINVESTMENT ACT will provide an unprecedented stimulus for translational and health services research. A $1.1 billion investment in comparative effectiveness research (CER) should produce a torrent of new information about the effectiveness of drugs, technologies, and interventions. For this to result in better, more cost-effective health care, better evidence is needed to address the translational gap between clinical studies and everyday practice. In essence, this is CER for implementation strategies (a type of CER seriously underrepresented in current discourse, but necessary to deliver on the Institute of Medicine’s goals for improved health care quality). Credit is due to the US Department of Health and Human Services for recognizing this need. Evaluation of the implementation and dissemination strategies for mainstream CER is embedded within several programs funded by the American Recovery and Reinvestment Act that share the broad objective of spreading CER findings widely (total funding: $97 million; Karen Migdail, director of media relations, Agency for Healthcare Research and Quality, written communication, November 2010). For this investment to yield a timely return, researchers will need to adopt an array of pragmatic and context-sensitive study designs to determine which strategies are best for implementing evidence-based practices locally and at scale. Traditional CER uses sophisticated data mining of longitudinal administrative databases to evaluate therapeutic and diagnostic interventions. These techniques could revolutionize the speed, population relevance, and context specificity of translational research. However, most databases currently do not include the rich clinical or organizational information needed to take the critical next step of comparing implementation strategies. Expansion of the electronic medical record and improvements in interoperability will help, especially if captured data include key information about organizational structures, clinical processes, risk factors and comorbidities, the true costs of diagnosis and treatment, and important outcomes such as functional status and quality of life. Obtaining and recording this information will require closer collaboration among clinicians, health services researchers, systems improvement experts, and health information technologists. In the meantime, new knowledge of strategies to implement the findings of CER is likely to come mainly from prospective studies. Randomized controlled trials (RCTs) are the criterion standard of clinical research, and designs such as cluster randomization are useful for implementation research in which the unit of analysis is a clinician, microsystem, organization, or community. However, such RCTs tend to be slow, expensive, and insensitive to the heterogeneous contexts in which their output will be deployed. Their restrictive entry criteria limit the rate of recruitment and generalizability of results, and their stringent protocols do not easily accommodate emerging new knowledge about the interventions themselves or changes in the environment in which they are being applied. Given these limitations, it is not surprising that RCTs have been criticized for failing to predict real-world outcomes. The pragmatic clinical trial attempts to address the limitations of conventional RCTs by seeking to reproduce conditions that the intervention will encounter in the real world. The entry criteria of pragmatic clinical trials aim to reflect the full range of patients and clinicians who will be using an intervention. This approach is well suited to research into systems of health care delivery that cannot be separated easily from everyday clinical practice. Pragmatic study designs also can take into account the local adaptations and amendments that often occur when new strategies are introduced. Another flexible approach, the adaptive clinical trial, makes provision for planned, reactive changes as the trial progresses. This is especially important in evaluating the effects of a systems improvement intervention when observations reveal low compliance with care processes that are not the targets of the protocol but are linked to outcomes. In an adaptive trial, such unanticipated problems can be addressed in near real time by protocol adjustment. Bayesian data analysis can enhance efficiency and speed of adaptive