7

Research Partner Perspectives

KEY SPEAKER THEMES

Roach

•   Changing the way patients are thought about, as consumers of research rather than just as study subjects, is a core principle for engaging patients in research.

•   Better information and decision support are needed to help patients make informed decisions about their participation in research.

•   Sharing of trial results and reconnection with trial participants show respect for participants and acknowledge their efforts, creating satisfied customers who will describe the opportunity to participate in research to others.

Go

•   The current context of health care delivery, which is increasingly efficient and has higher throughput, creates both challenges and opportunities for large simple trials (LSTs).

•   Electronic health records are both part of the solution and part of the problem to increasing the amount of research conducted in health care settings.



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7 Research Partner Perspectives KEY SPEAKER THEMES Roach • Changing the way patients are thought about, as consumers of research rather than just as study subjects, is a core principle for engaging patients in research. • Better information and decision support are needed to help patients make informed decisions about their participation in research. • Sharing of trial results and reconnection with trial participants show respect for participants and acknowledge their efforts, creating satisfied customers who will describe the opportunity to participate in research to others. Go • The current context of health care delivery, which is increas- ingly efficient and has higher throughput, creates both chal- lenges and opportunities for large simple trials (LSTs). • Electronic health records are both part of the solution and part of the problem to increasing the amount of research conducted in health care settings. 49

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50 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM • Health care systems and health care providers have many rea- sons to participate more actively in research, including illu- minating the many remaining unknowns in medicine and the potential competitive advantages of a learning culture. Sandy • LSTs can be very informative to payers because they can help answer questions about the effectiveness of treatments under real-world conditions. • A greater speed at which questions are answered must be ac- companied by a greater speed at which the findings of research are used to achieve a learning health system that promotes high-value innovation. INTRODUCTION For large simple trials (LSTs) to be a successful approach to generating evidence, their value must be appreciated by health care delivery systems, clinicians, patients, and payers. Health systems must weigh their partici- pation in LSTs against the many other efforts competing for resources; clinicians, as the primary data collectors, must make time for LSTs in their already busy care schedules; patients must see LSTs to be worthy of the collection of information about them; and payers must see LSTs to be the producers of useful knowledge. This chapter summarizes presentations from these perspectives. Nancy Roach, chair of the board of directors of Fight Colorectal Can- cer gave the patient perspective. She founded Fight Colorectal Cancer in 2005 after her mother-in-law was diagnosed with colorectal cancer. Alan S. Go, chief of cardiovascular and metabolic conditions, Kaiser Permanente Division of Research, and Northern California regional medical director for clinical trials at The Permanente Medical Group, offered the perspectives of both health care professionals and the health care delivery system. The perspective of the payer community was provided by Lewis G. Sandy, senior vice president for clinical advancement at UnitedHealth Group. PATIENT PERSPECTIVE Nancy Roach began her presentation by highlighting the disconnect between the assumptions that most people make about the research system and the reality. Noting that most people are not exposed to the research system until they are at an extremely vulnerable moment, when they are

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RESEARCH PARTNER PERSPECTIVES 51 sick, she asked how the equation can be changed so that people care about research and are willing to listen when they are called upon to participate. She said that people believe in health care research and are willing to participate in clinical trials if they are approached as partners in research and consumers of the findings of research rather than as research subjects. An important part of the signaling of this difference is language, for ex- ample, through the use of the word “participant” instead of the word “sub- ject.” She suggested that changing the way in which patients are thought about, as consumers of research rather than just study subjects, should change the way in which research is developed by placement of the priority on what is important to patients. Roach highlighted the need for better information and decision support for patients, so that patients can make informed decisions about their par- ticipation in research. She also emphasized the importance of reconnecting with trial participants, to show them respect and acknowledge their efforts. These, she said, are all approaches to creating satisfied customers and research partners who will spread the word about their involvement and bring the opportunity to participate in research to the attention of others. HEALTH SYSTEMS/CLINICIAN PERSPECTIVE Alan S. Go began his presentation by putting the issue of LSTs into the context that health care delivery systems currently face: the need for greater efficiency and higher throughput. Changes in the health care system are in- creasing competition, squeezing revenues, and making health care delivery systems more efficient. These changes make streamlined evidence genera- tion activities such as LSTs more desirable but also potentially less feasible. He also noted that the goals of the major stakeholders—the health care delivery system, clinicians, researchers, sponsors, and patients—are often different. Go noted that health systems must balance a number of compet- ing priorities. The goals include the provision of care of optimal quality, improved patient access, increased provider efficiency, better electronic health record (EHR) systems, and maintenance of revenues and strategic investments. Go noted that EHRs have been both a solution and part of the prob- lem and that they are not a panacea for clinical research but are certainly a promising part of the solution. First, EHR systems are different; even an EHR system provided by the same company is adapted to some extent to each health care system that uses it. Second, health systems have many efforts vying for the use of their EHR systems, making expansion of their use for clinical trials very challenging. Third, achievement of the kind of standardized data collection suitable for clinical trials poses work flow issues and requires buy-in from health care providers. He concluded that

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52 LARGE SIMPLE TRIALS IN A LEARNING HEALTH SYSTEM EHRs will be part of a solution for certain kinds of questions but not for every question and that creativity will be necessary to determine how best to use the EHR for data collection, randomization, and other reasons but that it is unlikely to be the only solution. However, Go argued, health systems and health care providers have many reasons to participate more actively in trials. For one, many things in medicine remain unknown. LSTs could be an opportunity to show that, when done right, randomization is a very important design and that the culture of randomization or learning can be an advantage to a health care delivery system. Go reflected on important ways forward, including the suggestion that research sponsors get early systematic input from health systems about the questions of most import to them rather than relying solely on areas of interest to researchers. He noted that incentives to clinicians and health care systems are needed to ensure participation and that health care systems should be challenged to think about forming LST consortia at regional or national levels. In closing, Go encouraged the field to think about identifying questions that would be wins for all stakeholders—health systems, sponsors, clini- cians, and patients—and suggested several examples, including diagnostic and management strategies for lower back pain. PAYER PERSPECTIVE Lewis G. Sandy began by explaining that payers like UnitedHealthcare are always trying to determine when a service is proven to be cost-effective and no longer experimental or investigational and thus eligible for insur- ance coverage. They are also always interested in supporting high-value innovation, even if it would be disruptive. Sandy noted that questions that are common among payers concern effectiveness and safety: Does it work? How strong is the evidence? Is it safe? What specific populations would benefit and which would not? Does the proposed procedure, service, or drug improve health outcomes? What are all the advantages, possible harms, and alternatives? LSTs can help answer these questions under real-world conditions, but such questions cannot be answered under the highly specific conditions of a traditional randomized controlled trial. LSTs may also provide answers more rapidly, if it is assumed that reliable randomization exists and that the cohorts are truly comparable, that is, if not too many patients decide not to participate. He said that it is important to address these questions not only for payers but also for all the stakeholders, including patients, clinicians, and health care delivery systems. He urged all parties to work together to pro- mote LSTs and other approaches to high-value innovation.

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RESEARCH PARTNER PERSPECTIVES 53 Sandy pointed out that some important questions can be answered by the use of approaches other than LSTs, for example, by a prospective or a retrospective observational study. Also, he said, not only do answers about interventions need to be obtained more rapidly, but also the use of proven interventions, such as colorectal screening, which is reaching only 60 percent of the target population, needs to be increased. This is the goal of a learning health system. Clinical registries can be useful here, he said. They not only provide a good infrastructure for collecting and analyzing data but also provide a potentially effective dissemination mechanism to rapidly incorporate learning into clinical practice guidelines and build best practices into clinical decision support systems.

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