August 2007 VIEW on Medical Education The State of CME by Kate Guerriero Continuing medical education could be argued to be one of the most ever-changing fundamentals in the healthcare industry today. Ensuring that CME remains in compliance with the latest guidelines and technologies is an ongoing exercise. Drug and device manufacturers, as well as CME providers, are expected to understand the basic framework of compliance guidelines and keep up to speed with the ever-evolving federal and now individualized state regulations. On top of that is the added perplexity of adhering to the international safety codes that oftentimes vary region by region. Attempting to develop a concrete CME compliance program based on a potluck of industry, national, and international guidelines and initiatives is challenging. When word began to spread that ACCME planned to unveil a set of stringent guidelines for 2008, many providers responded by developing metrics to measure patient outcomes. Standards and Regulations The new ACCME standards, which were enacted to ensure that CME programs support patient safety and practice improvement, are set to go into effect in 2008 and providers will renew their focus on competency, performance, and patient outcomes. Our Forum participants provide their opinions on the “hot button” issues related to the latest guidelines, and how the revised model of accreditation and updated criteria have improved processes for CME providers and learners. Meyer. Temple University. I think most providers are concerned about translating CME-related educational interventions into patient outcomes. In certain circumstances, outcomes measurement studies can be constructed to address the impact on patients but overwhelmingly there are too many external variables that affect patient outcomes to draw direct inferences about patient outcomes. We have to focus on the spirit of CME to improve health outcomes in patients but we cannot be held directly responsible for quantifying the impact of CME on patient care. While I believe this is the intent of the ACCME, as most new rules and regulations are initiated they are often misinterpreted causing panic. The ACCME’s intent is admirable but everyone needs to qualify their expectations and articulate clear pathways to navigate toward success. Fuchs. Wyeth Pharmaceuticals. One of the hot button issues continues to be the controversy between for-profit and nonprofit providers with respect to capabilities and appropriateness. With various provider types, the capabilities range from poor to excellent, with most providers in the middle working hard to provide the best education possible. Meyer. Temple University. In most cases, changing situations that require the examination of our ethics leads to an increased level of bureaucracy. Unfortunately, this increase in documentation and the use of provider resources ultimately detracts from the time allocated to educational excellence in the purest sense. The question is whether these additional criteria have true impact on the improvement of medicine or are just an attempt to justify the CME provider industry’s existence. One must note that the entire CME industry is in its infancy from a chronological perspective. During this growing and maturing chapter in CME’s life we must try to see what direction we will take. These updated criteria are among the first steps to setting the correct course. They are painful steps that must be taken with flexibility and creativity. Fuchs. Wyeth Pharmaceuticals. The ACCME has certainly raised the bar for providers to incorporate performance improvement measures and enhance outcome measurement methods. Many providers are not yet prepared to design, implement, or manage the tactics necessary to meet these requirements. CME Partnerships and Collaborations Industry experts discuss how the different factions can work together to strengthen CME activities and provide some best practices to ensure that the education remains free of commercial bias yet meets certain milestones. Meyer. Temple University. The industry must not overreact to greater regulation. If industry professionals pull back from the support of outstanding education ultimately the doctor and patient will suffer. It is in the best interest of all parties to maximize industry support of CME. We must be careful not to burn down the farm because of a couple of bad apples. Rand. Wyeth Pharmaceuticals. Collaboration and strategic partnering are the keys to success in the current environment. No single provider can be an expert in every disease state, nor can a single provider be successful on its own. Specialization and partnering will become more common. Meyer. Temple University. Milestones are troublesome since they may, in some circumstances, insinuate programmatic control. It is not the milestone itself that creates the dilemma; rather it is the inference that the financial support can be terminated. Where is the line in the sand relating to content control, inappropriate influence, and/or bias? Rand. Wyeth Pharmaceuticals. Pharmaceutical companies have a responsibility to justify how their money is spent, even more so now than in the past. It is essential that commercial supporters be able to ensure that grants provided for independent education are used to accomplish the educational needs they were meant to address in a timely fashion. Linking milestones to the release of funds in ways that comply with all of the appropriate rules and regulations that govern the industry is clear evidence of the mutual agreement of the parties made with the proper intent. A supporter or provider alone cannot dictate the terms of the milestone agreement. One party may propose terms, but these must be agreed to by the other party. There is an opportunity for negotiation that allows for increased communication and transparency between providers and supporters. Any subsequent changes in the milestone agreement must also be mutually agreed to. Milestones may be incorporated in the letter of agreement or in an accompanying or referenced document. Terms, such as when payments can be made or the criteria for when funding may be discontinued, should be made clear by both parties. The use of communication tools and processes that provide transparency of the intent of both the commercial supporter and provider to uphold the spirit of the educational activity supported by the grant will foster accountability and counteract perceptions of undue commercial influence. Peluso Nguyen. Ortho Biotech. Building certain milestones into letters of agreement can be, and should be, an acceptable practice. The days of one-time payments will soon be over. Grantors need to be assured that the money they are giving for funding is indeed being used for what it was requested for. Milestones are becoming common practice. These might include: first payment upon signing; second payment upon half-way completion of scope of grant; and last payment upon reconciliation of grant project. These milestones do not reflect any commercial bias nor are we demanding anything that influences content. We are simply asking that a grantee demonstrate that they can meet the agreed upon milestones before payments are issued. Pay-for-Performance Pay-for-performance (P4P) programs, where providers are rewarded for the quality of their healthcare services, are expected to have a significant impact on the way physicians maintain patient records, how technology will be used to measure patient care outcomes, and the level of revenue physicians receive for treating Medicaid and Medicare patients. All of this is expected to have an impact on CME. This month’s Forum experts discuss the pros and cons of the P4P system and the steps their organizations have taken to become familiar with the new model. Meyer. Temple University. One of the pros is that this is a genuine needs assessment. It opens opportunities for outcomes-related evaluation data that have a greater level of integrity. A con is that the variables being measured sometimes are not under the control of the physician. Some criteria seem oversimplified, leading to disagreement. Fuchs. Wyeth Pharmaceuticals. More than 50% of the nation’s health maintenance organizations as well as the federal government have instituted P4P programs or begun pilot programs. There are several questions about these programs. First, how will the benefits be evaluated? Are the measurement criteria based on meeting a benchmark or actually improving from baseline practice? Are there barriers to improving care inherent in the system in which they practice? Will organizations resort to a quick fix rather than make the comphrensive system changes required to sustain the improvements from year to year? While there are many questions and concerns about the pay-for-performance programs, there are clear benefits for CME industry professionals providing education on targeted diseases: P4P guidelines and methods of barrier mitigation will help support the overarching goal of healthcare change: to provide the right care to the right patient every time. Meyer. Temple University. Our CME committee is beginning to address issues related to P4P to identify the institutional effect it would have within the academic medical center environment. A Physician-Friendly Continuing Medical Education Program Innovative medical education strategies provide pharmaceutical companies with opportunities to deepen physician relationships. Industry experts discuss the methods being used to gauge physicians’ attitudes toward traditional medical education, online education, and new styles of communications. Meyer. Temple University. We conduct frequent focus groups to explore changes in physician needs and identify new issues impacting medicine. Physicians’ feedback is remarkably candid during these sessions. They keep us grounded in terms of programmatic planning but more importantly the feedback keeps us on track regarding our organizational mission. Lauber-Huber. Bayer HealthCare. As a commercial supporter, I expect sponsors to assess physician learnings as part of the evaluation process for the many grant proposals we support. This is a critical part of the feedback process and a particularly useful tool that helps us identify future programs that would be of value to physicians. I have often seen this addressed through activity evaluation forms or asked during events using an audio response system (ARS). Peluso Nguyen. Ortho Biotech. We ask our CME providers to provide supporting data that give us solid information on certain physician specialties and how they prefer to be educated. For example, an oncologist’s educational needs are very different than those of a primary-care physician. I would like to know about today’s trends for different specialty physicians versus general practitioners regarding the venues they use to learn, how sophisticated their technology needs are, and so on. Live CME Events Vs. Online CME Activities During the past six years, online CME activities have increased by more than 1,000% and now account for almost a quarter of all CME activities. Despite this growth, 78.5% of pharmaceutical companies are still allocating their CME budgets for live events. Experts discuss the pros and cons of each type of learning event. Meyer. Temple University. The overwhelming pro related to online CME is the ease of participation. A physician can log on at any time of the day and participation requires no sacrifice. This is important in the modern business environment of medicine. Unfortunately, an important part of the educational experience is lost because participants do not get the collegial interactions — both formal and informal — they would in a live event. In addition, most online CME still appears to be the electronic capture of a live intervention as opposed to a true use of the technological opportunities. There are a few creative CME providers and medical-education companies that are using the full strength of the technology as it exists, but most only use the Internet as an efficient delivery system. Currently, the Internet is still a technology in search of a need. Lauber-Huber. Bayer HealthCare. The abundance of online CME programs is both a pro and a con. As a commercial supporter it’s really difficult to assess the value and impact of actual versus potential reach of supporting these types of activities. At Bayer, my team evaluates all CME opportunities to identify those that have the potential to provide excellent educational opportunities to interested healthcare professionals. I’m really not that eager to support a program that uses online as another venue for a slideshow and doesn’t maximize the use of the technology. Outcomes measurements always seem to be an issue. Unfortunately, the data I receive for most supported CME activities indicate that participants don’t seem to respond to follow-up surveys, especially months after an activity. So, I would say this is an area that requires some improvement. Peluso Nguyen. Ortho Biotech. Clear advantages to online CME include the much larger reach and the fact that it can be a more cost-effective learning option. A one-time live event is limited by the number of healthcare professionals who can be educated because of room capacity. Online CME activities not only allow for the education of more participants, but also allow physicians to learn when and where they want to, according to their schedules. Another advantage of online CME is that it allows for more diversity on teaching approaches rather than the typically didactic presentations. A provider can easily build on learnings with online CME by providing a series of activities; alternatively they can use case-based approaches that allow physicians and other healthcare professionals to bring practice to life. If there is something intriguing in the learnings, one can often go back to an online activity and read it again. A disadvantage to online CME is that the opportunity to interact face-to-face with colleagues, faculty, and to hold a live question and answer session is lost. Despite the growing trend of eCME, a live meeting/lecture continues to top the survey polls as the preferred method of learning for most physicians. Schlumper. Bristol-Myers Squibb. We balance many factors as we evaluate educational activities, and an increasingly important consideration for us is the engagement of learners beyond traditional live events. A program that is only offered live has significant limitations — not the least of which are those that affect the number of potential attendees, such as scheduling, venue size, and other logistical concerns. There are no time and space limitations with online programs: a live activity that can draw perhaps 300 people when put online becomes available to thousands. From a commercial supporter’s viewpoint, this is a very attractive benefit, which is why we are glad to see the addition of online components to many live programs. Another advantage of online activities is that they allow learners to access and learn at their own pace, and when it is convenient. It seems like a paradox, but online activities actually can create as much or even more interactivity than live programs. For example, many online programs now feature periodic questions that test the learner, much like an audience response system (ARS) does during live events. The learner receives immediate, specific feedback, which allows self-measurement of progress throughout the activity. We will continue to see technology change the way healthcare professionals learn. For example, Podcasting is starting to become prevalent within CME. Podcasting eliminates even more barriers to attendance by making CME activities portable. Learners can listen anywhere — in a car, while exercising, while waiting for a flight, or even on a plane — so long as they can safely put on headphones. In addition, Podcasting allows program organizers to update content through user syncs. Many more exciting technologies await CME education experts, including satellite radio, virtual reality, and even medical imulations. It is safe to predict that five to 10 years from now, those wishing to obtain CME will have many more options than they do today. These are exciting times within CME. Peluso Nguyen. Ortho Biotech. We try to make sure that we keep up with the trend and support online CME activities. We are planning to support eCME activities that include Internet point of care — online self-directed learning — as well as the more traditional enduring Internet activities and Webcasts. I think it’s important to continue to give physicians and other HCPs different options. We are also entertaining the possibility of supporting educational programs that use MP3 cast/Podcasts, but I am not convinced that this option has taken off with the majority of mainstream HCPs. The nature of online allows for measuring of educational outcomes much more easily than with live events or other activities. Outcome Measurements for Adapting New Measures to CME Activities The updated ACCME guidelines now require providers to evaluate the effectiveness of their CME activities and to identify the educational impact on healthcare professional practice and patient health. But to be effective, there has to be more to it than just providing consistent evaluations and making sure documentation is in order. Our Forum experts outline the different evaluation methods they use for outcomes measurement and how they share the data. Meyer. Temple University. We use many different evaluation methods. These include pre- and post-impact analysis tests, the Practice Integrated Learning Sequence (PILS), and interactive clinical vignette simulations. Lauber-Huber. Bayer HealthCare. As a commercial supporter we do not conduct our own outcomes assessments. I require that as part of the proposal that providers submit to us. Peluso Nguyen. Ortho Biotech. It just depends on the specific CME activity and the budget we have to support outcome measurements. There are times where a traditional evaluation — pre- and postactivity surveys — may suffice. There are other times when more sophisticated outcome measures are warranted, such as surveys using case vignettes. For some of our CME activities that are longer in duration, we have supported outcome evaluations that involve three-month and six-month follow-up surveys. Meyer. Temple University. The most important step related to outcomes measurement is understanding that not everything can be measured and, therefore, the evaluation must be designed to focus on variables that are controllable and realistic to quantify. Constraining what is measured and focusing on measurable practice points that are contained in the program objectives is key. Don’t try to prove the educational intervention has saved the world. Peluso Nguyen. Ortho Biotech. It is important to plan in advance and make the measurement part of the overall educational initiative. Meyer. Temple University. Sharing outcomes results at the conclusion of a program is good business. It demonstrates that the funding supplied was applied to great education. Good data based on well-designed evaluation speaks for itself. Most multidimensional outcomes reports will address far more than most commercial supporters will be interested in. Great CME providers should not be concerned about whether they are addressing the needs of the commercial supporter. An excellent evaluation analysis will always cover the needs of all the stakeholders. If not, then expectations related to outcomes measures may be inappropriate and require provider clarification about the standards for commercial support. CME on a Global Scale CME is becoming an important piece of the global healthcare puzzle and CME and continuing professional development (CPD) are changing the paradigm of how patients are treated and health outcomes are measured. Our CME experts provide their take on the state of global CME. Lauber-Huber. Bayer HealthCare. Most countries either have their own pharma marketing laws or are covered under national or regional pharmaceutical manufacturer associations that have already drawn up their own guidelines. Although most communities in Europe have their own fairly stringent guidelines, I think the global CME community in general has a way to go to catch up with the guidelines used within the United States. As part of a global organization, we strive to share best practices and further our understanding of practice issues/barriers as they affect support of CME. Schlumper. Bristol-Myers Squibb. Global CME is becoming more prevalent not only in scope but also in content. Most regions of the world now insist that CME education to healthcare professionals be free from commercial bias. From a commercial supporter’s perspective, this is a positive development because CME becomes more relevant, trusted, and realistic for the learner. I think that this trend toward truly independent, global medical education will continue. Now the challenge we, as education professionals, face is how to balance what we’ve done in the past with what is now expected from independent medical education. For instance, we have to expect that some learners will miss the ancillary benefits that often come with commercially supported programs, such as the chance to visit exciting destinations and to network with industry colleagues. With those perks gone, our content becomes even more important — it has to be extremely relevant to our learners and presented in a compelling manner. PharmaLinx LLC, publisher of the VIEW, welcomes comments about this article. E-mail us at [email protected]. The abundance of online CME programs is both a pro and a con. As a commercial supporter it’s really difficult to assess the value and impact of actual versus potential reach in supporting these activities. Cynthia Lauber-Huber Bayer HealthCare Pharmaceuticals thought leaders n Barbara A. Fuchs, MSA. Director, Operations, Professional Education Support, Wyeth Pharmaceuticals, Collegeville, Pa.; Wyeth has leading products in the areas of women’s healthcare, neuroscience, musculoskeletal disorders, cardiovascular therapy, vaccines and infectious disease, hemophilia, immunology, and oncology. For more information, visit wyeth.com. n Cynthia Lauber-Huber. Director, Medical Education, ISS and Professional Relations, Bayer HealthCare Pharmaceuticals, Wayne, N.J.; Bayer HealthCare concentrates resources and efforts in areas where the greatest impact for healthcare providers and their patients can be made. For more information, visit pharma.bayer.com. n Arnold I. Meyer, ED.D. Assistant Director, Temple University School of Medicine, The Albert J. Finestone, M.D. Office for Continuing Medical Education; Temple University has distinguished faculty in 17 schools and colleges, including four professional schools. For more information, visit temple.edu/cme. n Roseann Peluso Nguyen, Pharm.D. Senior Director, Medical Education Department, Ortho Biotech Inc., Bridgewater, N.J.; Ortho Biotechis committed to providing innovative biopharmaceutical products and services that improve patient’s health. For more information, visit orthobiotech.com. n Kristin Rand, JD. Director, Education Strategy, Professional Education Support, Wyeth Pharmaceuticals, Collegeville, Pa.; Wyeth has leading products in the areas of women’s healthcare, neuroscience, musculoskeletal disorders, cardiovascular therapy, vaccines and infectious disease, hemophilia, immunology, and oncology. For more information, visit wyeth.com. n David Schlumper, M.S. Associate Director, Independent Medical Education, Bristol-Myers Squibb Medical Imaging, North Billerica, Mass.; Bristol-Myers Squibb Medical Imaging is a leader in cardiovascular imaging and a subsidiary of Bristol-Myers Squibb Co. For more information, visit bmsmi.com. During this growing and maturing chapter in CME’s life we must try to determine what direction we will pursue. These updated criteria are among the first steps to setting the correct course. They are painful steps that must be taken with flexibility and creativity. Arnold Meyer Temple University School of Medicine ACCME has certainly raised the bar for providers to incorporate performance improvement measures and enhance outcome measurement methods. Barbara Fuchs Wyeth Pharmaceuticals Activities by Organization and Activity Type — 2006 Government or Military Government or Military Hospital/ Healthcare Delivery System Insurance Company /Managed Care Company Nonprofit (Other) Nonprofit (Other) Nonprofit (Physician Membership Organization) Not Classified Publishing/ Education Company School of Medicine Grand Total No. of Providers 16 93 14 34 267 29 154 122 729 Directly Sponsored Courses 1,312 3,386 1,246 1,247 5,288 2,668 7,475 7,624 30,246 Regularly Scheduled Series 180 2,069 7 21 19 369 25 6,746 9,436 Internet (Live) 11 9 2 48 174 95 329 82 750 Test Item Writing 0 1 0 0 19 0 0 0 20 Committee Learning 2 57 2 0 13 3 52 0 129 Performance Improvement 0 52 1 0 9 0 7 1 70 Internet Searching and Learning 0 1 0 0 0 0 26 4 31 Internet (Enduring Materials) 64 358 44 416 1,679 127 6,689 7,546 16,923 Other Enduring Materials 64 252 57 49 1,970 43 1,699 808 4,942 Learning from Teaching 0 69 0 0 50 1 3 736 859 Journal CME 24 56 0 37 1,480 28 615 164 2,404 Manuscript Review 0 5 0 0 5,885 0 0 0 5,890 Total 1,657 6,315 1,359 1,818 16,586 3,334 16,920 23,711 71,700 Jointly Sponsored Courses 255 532 22 419 4,622 1,853 751 3,198 11,652 Regularly Scheduled Series 170 117 0 47 35 11 48 563 991 Internet (Live) 15 2 0 6 55 7 24 34 143 Test Item Writing 0 0 0 0 12 0 0 3 15 Committee Learning 0 0 0 0 0 0 0 0 0 Performance Improvement 0 5 0 1 0 0 0 4 10 Internet Searching and Learning 0 24 0 0 1 0 0 0 25 Internet (Enduring Materials) 17 130 0 165 110 297 2,454 3,843 7,016 Other Enduring Materials 10 49 1 111 145 133 544 646 1,639 Learning from Teaching 0 0 0 0 17 0 1 20 38 Journal CME 95 15 0 12 43 11 117 48 341 Manuscript Review 0 0 0 0 12 0 0 0 12 Total 562 874 23 761 5,052 2,312 3,939 8,359 21,882 Grand Total 2,219 7,189 1,382 2,579 21,638 5,646 20,859 32,070 93,582 Source: ACCME 2007, Chicago. For more information, visit accme.org. Size of the CME Enterprise Presented by ACCME Accredited Providers — 2006 Directly Sponsored Activities Hours of Instruction Physician Participants Nonphysician Participants Courses 30,246 227,689 1,290,272 1,035,169 Regularly Scheduled Series 9,436 250,231 2,161,990 803,057 Internet (Live) 750 5,310 45,336 78,709 Test Item Writing* 20 263 402 3 Committee Learning* 129 493 1,270 451 Performance Improvement* 70 356 2,538 358 Internet Searching and Learning* 31 1,564 79,106 8 Manuscript Review* 5,890 36,921 17,613 1,238 Learning from Teaching* 859 3,530 2,823 134 Internet (Enduring Materials) 16,923 29,660 1,735,211 1,237,028 Other Enduring Materials 4,942 35,589 1,087,718 398,987 Journal CME 2,404 5,297 601,233 199,470 Total 71,700 596,903 7,025,512 3,754,612 Jointly Sponsored Activities Hours of Instruction Physician Participants Nonphysician Participants Courses 11,652 75,414 385,817 317,833 Regularly Scheduled Series 991 24,982 170,650 74,965 Internet (Live) 143 1,823 10,674 13,201 Test Item Writing* 15 110 679 35 Committee Learning* 0 0 0 0 Performance Improvement 10 175 328 32 Internet Searching and Learning* 25 13 45 3 Manuscript Review* 12 36 48 0 Learning from Teaching* 38 235 270 0 Internet (Enduring Materials) 7,016 6,439 393,238 221,232 Other Enduring Materials 1,639 5,185 239,701 167,982 Journal CME 341 847 28,055 27,183 Total 21,882 115,260 1,229,505 822,466 Grand Total 2006 93,582 712,163 8,255,017 4,577,078 Grand Total 2005 79,820 678,528 7,650,207 3,683,749 Grand Total 2004 71,564 692,673 6,516,564 3,235,562 *Note: Totals may be off due to rounding. Source: ACCME 2007, Chicago. For more information, visit accme.org. We try to make sure that we keep up with the trend and support online CME activities. We are planning to support eCME activities that include Internet point of care — online self-directed learning — as well the more traditional enduring Internet activities and Webcasts. Dr. Roseann Peluso Nguyen Ortho Biotech Global CME is becoming more prevalent not only in scope but also in content. Most regions of the world now insist that CME education to healthcare professionals be free from commercial bias. David Schlumper Bristol-Myers Squibb Medical Imaging Collaboration and strategic partnering are the keys to success in the current environment. No single provider can be an expert in every disease state, nor can a single provider be successful on its own. Specialization and partnering will become more common. Kristin Rand Wyeth Pharmaceuticals