Daniel T. Leonard, MA

Members of pharmacy and therapeutics (P&T) committees, healthcare providers, practitioners, and drug and device manufacturers have been hearing and reading volumes lately on the topic of comparative effectiveness research (CER). Much of the recent discourse has centered on the creation of the Patient-Centered Outcomes Research Institute (PCORI)— a public/private stakeholder group that will oversee and direct much of the research that will be generated in the coming years.

 Growing expectations that the institute will quickly commission research and issue important practice-changing evidence reports must be tempered; numerous fundamental structural and governance issues face PCORI, including hiring an executive director and staff, retaining office space, and incorporating this unique entity. All that must happen before the PCORI Board of Governors begins discussions on topics such as establishment of research priorities or creation of a methodology committee. But once these fundamental organizational building blocks are in place, we can anticipate and envision the first PCORI-initiated CER being generated. The issue then will quickly become how this important research will be translated, communicated, and disseminated to the audiences that matter most.

Despite advances in communication tools and technology, providers, health systems, and patients might lag in applying new research findings to their treatment decisions.

 This possibility raises several important questions. How do we ensure that good evidence is used in decision making? How do we ensure that patients have adequate information to judge whether a treatment is appropriate for them and their specific needs or preferences, and to understand the risks and benefits associated with their treatment? How do we ensure that providers have up-to-date findings that reflect the latest emerging evidence? How do we ensure that those involved in synthesizing evidence for P&T decision making systematically include all relevant information necessary to encompass the totality of evidence?

COMMUNICATION OF COMPARATIVE EFFECTIVENESS RESEARCH IN HEALTHCARE REFORM

In 2009, the Federal Coordinating Council for Comparative Effectiveness Research identified the dissemination of CER findings to clinicians and patients and translation to practice as one of the major categories for CER investments.

A few months later, the Patient Protection and Affordable Care Act allocated resources to the Agency for Healthcare Research and Quality (AHRQ) Office of Communication and Knowledge Transfer, in consultation with the National Institutes of Health, to broadly disseminate the research findings published by PCORI. This work includes creating “information tools that organize and disseminate research findings for physicians, health care providers, patients, payers, and policy makers.” Separately, the Office of Communication and Knowledge Transfer within AHRQ is to consult “with relevant medical and clinical associations” and “assist users of health information technology focused on clinical decision support to promote the timely incorporation of research findings disseminated into clinical practice and to promote the ease of use of such incorporation.”

Prior to dissemination, PCORI is required by law to release research findings to clinicians, patients, and the general public within 90 days of receiving research results. These results must be conveyed in a manner that is comprehensible and useful to patients and providers, including information about the limitations of the research and what further research may be needed. PCORI also is responsible for ensuring that the research findings discuss considerations specific to certain subpopulations, risk factors, and comorbidities as appropriate.

Thus, the coordination between PCORI, which is releasing the research findings, and the Office of Communication and Knowledge Transfer, which is developing tools and working with end users to disseminate and apply the findings, will require careful coordination and partnership. As past examples have shown, the time when research is first made public is critical for full, comprehensive understanding of the results among researchers, the public, specialty societies and medical associations, patient advocacy groups, health systems, and healthcare payers. Without careful coordination, the potential for inaction or the creation of misinformation exists.

ORCHESTRATING THE DATA-DISSEMINATION HANDOFF

The infrastructure and expertise for communicating research-based health information are already in place, as the Office of Communication and Knowledge Transfer within AHRQ has been the lead agency for these efforts for a number of years. Yet the strict 90-day timelines imposed under the law for PCORI to release findings, coupled with the massive ramp-up of the volume of studies expected to be produced in the new era of CER, place significant pressure on this most critical link in the chain. In the health reform law, careful thought and orchestration were given to the multistakeholder development of the PCORI Board of Governors, the 17-member methodology committee, and the development of expert advisory panels for clinical trials and rare diseases. Similarly, serious consideration will need to be given to the handoff of research developed under PCORI guidance, publicly released by PCORI, and disseminated by the Office of Communication and Knowledge Transfer. Efforts must be made to ensure the consistency of messages using the most appropriate, effective, and meaningful communication methods and tools. Establishing sound communication practices that mirror the multistakeholder process to prioritize the CER agenda and develop the methodological standards would ensure that the national CER entity has a greater impact when results become available to the public. Similar entities exist for other bodies; for example, the AHRQ Stakeholder Group provides additional guidance for the Effective Health Care Program on implementation issues, information needs, types of products, and how program initiatives can increase the impact on users.

 It will be critical to expand the remit of the Stakeholder Group, or to establish a new advisory group comprising both researchers and communicators to help bridge this most important gap between the science and the patient.

The National Pharmaceutical Council and its member companies look forward to working with other stakeholders to ensure that the CER findings are tailored to appropriate audiences, incorporate information specific to subpopulations and patients who may respond differently, and are communicated in a balanced and objective manner. Furthermore, as new information becomes available, the body of evidence must be updated to inform treatment decisions.

COMMUNICATION THROUGH NEW TECHNOLOGY VENUES AND TOOLS

In addition to more effective ways of communicating, newer venues and tools have evolved. Today, tools include handheld devices, applications, text messages, email, and online support, and extend into social media channels such as Twitter and Facebook to allow real-time communication and aggregation.

It is an interesting time. In the 1980s, the television industry withstood much criticism for “oversimplifying” the news with 90-second stories and 12-second sound bites. Today, 30 years later, the incredible shrinking message platform has been reduced even further, with 140-character tweets as the new standard. This evolution of an increase in the sheer volume of information in smaller and smaller servings has shortened the attention span of the consumer. In turn, it has made it more difficult to capture the attention of the public and has elevated the challenge of cutting through the noise in the marketplace to truly reach the individual who needs the information most.

Although there is a market-driven devolution to shorten the sound bite, it is important to keep in mind that the research in question is heavy science. Comparative effectiveness research is meant to inform both patients and providers, but it also is highly technical information that can be loaded with critical nuances that can make all the difference for specific populations and individuals. It also is meant to be informative and advisory in nature, and not to be construed as prescriptive practice mandates or guidelines. Physicians and caregivers need to know whether it is applicable to their patients’ treatment needs, preferences, and genetic makeup. Providers need to know whether it is applicable to their patients and to which subgroups of patients. In short, shrinking the message into tweetsized posts or scrolling headlines on a 24-hour news channel may result in the transmission of inaccurate or inappropriate information.

Despite these challenges, we cannot wait for the perfect time to engage with patients, consumers, providers, or health information technology groups. We need to prepare now to be ready to include appropriate information in shared decision-making tools at the point of care. This information should indicate how, when, and to what degree the research findings are applicable and should be presented in the “easiest” way possible for clinicians and patients when they are making care decisions.

IMPLICATIONS FOR PHARMACY AND THERAPEUTICS COMMITTEES

Members of P&T committees can play an important role in the evolution of CER by promoting incorporation of incentives that encourage physicians and patients to utilize current evidence through care management programs and healthcare improvement programs. Medical and pharmacy directors, corporate benefit managers, and other professionals have a real ability to impact population health in their day-to-day jobs. In addition, evidence that is developed by both the public and private sectors must make its way to P&T decision makers and those who prepare treatment monographs. For the research to be actionable, the findings must be translated into routine practice in a manner that is valuable not only to P&T decision makers, but also to clinicians, patients, and the healthcare system.

As we enter the CER era in this country and try to determine the best methods and standards for conduct of this research, it is important to look at the dissemination part of the equation as well. A well-executed, seamless transition from the generation of research to the appropriate and effective communication of the findings must be a common goal. An additional goal must be to utilize the latest information technology infrastructure and appropriate communication tools to move the message without compromising the important nuances of the content for each individual patient. It is critical to think about how to communicate information in a clear, concise, and actionable manner without losing sight of the scientific information and limitations of the research, or the applicability of the findings to the patients whom we serve.

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The latest information technology infrastructure and communication tools should be used to communicate research without compromising nuances of the content for individual patients.