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Evidence-Based Medicine Comes to Otolaryngology
From: ENT Today, February 2007
by Marlene Piturro, PhD, MBA
Not long ago, physicians routinely decried evidence-based medicine (EBM) as an encroachment on their professional autonomy, a barrier to good patient care, insensitive to health care's growing complexity, and at odds with the transcendent value of the physician-patient relationship. Those objections have been swept away by the 21st century's tidal wave of health care change-the quality improvement movement, pay-for-performance initiatives, and adoption of information technology. The 109th Congress' last-minute passage of legislation that boosts reimbursement to physicians who report data on the quality of care they deliver is a huge step to tying EBM to reimbursement. Legislators may take further steps. They are using guidelines to pinpoint and, eventually, eliminate regional variations in medical treatments; to reduce spending on expensive ineffective therapies; and to encourage physicians to use evidence-based low-cost treatments rather than high-tech ones without mountains of EBM behind them. In short, EBM isn't going away.
Evidence-based medicine-the conscientious, explicit, and judicious use of current best data in making decisions about patient care-is here to stay. Payers are determined to align financial rewards to better clinical outcomes, which are defined through evidence-based guidelines. It sounds simple; it isn't.
Most medical specialties, including otolaryngology, lag behind internal medicine in developing evidence-based medical guidelines. It isn't because EBM is less important to specialties than to primary care medicine, only that each specialty consumes less of the health care spending pie than do primary medicine's diagnoses. Understandably, public and private payers have pursued the most commonly diagnosed conditions that consume, in the aggregate, a proportionally larger amount of available resources-the low-hanging fruit.
By that logic, the key areas chosen by the Centers for Medicaid and Medicare Services (CMS) for pay-for-performance measures based on EBM account for 33% of hospital admissions and 20% of total claims paid. Those core measures, on which hospitals can now earn an additional 5% Medicare reimbursement for top-tier performance, relate to coronary artery bypass graft, acute myocardial infarction, community-acquired pneumonia, and heart failure. Conversely, hospitals performing poorly on the core measures lose 5% of Medicare payment.
A Different Perch
Medical specialties see EBM from a different vantage point than primary care physicians, who already have some pay tied to performance. With few payer incentives (yet) to develop guidelines, perhaps specialists have been hoping that the health care system's focus on EBM would wane and pass them by, unscathed. Not so, according to David Nielsen, MD, CEO of the American Academy of Otolaryngology-Head and Neck Surgery Foundation. He said, We really can't make excuses about not developing our own EBM. Because of the Cochrane Collaboration [see box] and other groups that focus on quality measures in medicine, we knew this was coming. We wrote consensus-based guidelines and that satisfied most practitioners, but it's time for evidence-based medicine in our specialty.
Through its leadership, the AAO-HNSF has taken it upon itself to grow a cadre of physicians and other stakeholders willing to write guidelines, to fund them, and to accept how they define state-of-the-art medicine. Aware of the consequences of not developing EBM guidelines, the AAO-HNSF is footing the bill, which will probably run between $100,000 and $200,000 for a multidisciplinary team of experts to produce guidelines. In June 2006 the AAO-HNSF took a big step toward creating these measures by sponsoring the Translating Research Into Cross-Specialty Measures Conference (TRICSM; visit www.entnet.org , search TRICSM for more information). A stellar planning committee, chaired by Dr. Nielsen, laid the groundwork for EBM development through sessions on how to link research to performance measures, stakeholder demands (professionals, purchasers, board certification), aggregating demands, quality-based purchasing, and quality-based certification and licensing.
By setting clinical standards for the professional and payer communities by which to evaluate specialist performance, the guideline developers are operationalizing excellent clinical care. For practitioners, EBM's action statements are based on systematic literature review. Through collaborations such as TRICSM, those charged with guideline development build consensus on how to describe desired physician behaviors, and lay out recommendations, strategies, and information for getting there. EBM guidelines help physicians and other practitioners make informed decisions while leaving professional autonomy intact (see sidebar).
The consequences of not bringing order to the hundreds of measures that currently exist related to otolaryngology practice, in which wide variations exist in evidence base, relevance, and validation, are clear. In the absence of strong clinical leadership administrative, cost, capacity, and fiscal measures will be imposed on physicians. Taking control of the process short-circuits that possibility.
Dr. Nielsen emphasized that producing evidence-based guidelines will benefit Academy members and help otolaryngology catch up with other subspecialties that are further along in EBM development. Our goals are to aggregate the demand for performance measures and guidelines, and to unify our response as a specialty so that we avoid duplicative effort, wasted resources, and internal competition, he added.
Richard Rosenfeld, MD, MPH, Professor of Otolaryngology at the Long Island College Hospital in Brooklyn, N.Y., is ensuring that the AAO-HNSF's mandate for a comprehensive guideline development program forges ahead. He explained: In the past a bunch of ENT experts got together in a cozy place, backed by pharmaceutical funding, to produce consensus guidelines. Those guidelines were better than nothing, but they were biased and flawed. We realized that we had to do much better.
Recognizing that specialties can't develop guidelines in a vacuum, Dr. Rosenfeld has brought all stakeholders to the table. They include otolaryngologists, allergists, immunologists, infectious disease specialists, oncologists, family practice physicians, APNs, a neuroradiologist, pulmonologists, a methodologist, representatives of non-profit disease-specific associations, and insurance company representatives. Our conversations are entirely different than when only ENTs were present. Stakeholders have different perspectives and objectives, and we need all of them to define the scope of the proposed guidelines, to prioritize hot issues for process improvement, and to work toward key action statements, added Dr. Rosenfeld.
An outside observer, James Schnibanoff, Editor-in-Chief of Milliman Care Guidelines LLC, applauded the AAO-HNSF's decision to move forward with evidence-based guidelines. Milliman Care Guidelines witnessed a broadening acceptance of guidelines by physicians, including ENT and head and neck surgeons. These guidelines include both those developed by Milliman and those produced by the American Academy of Otolaryngology-Head and Neck Surgery, he said.
Although EBM is inextricably tied to payers' push for pay-for-performance and the need to cut costs from the health care system by eliminating practices of questionable value, it still meets substantial physician resistance. The most common sources of pushback are a lack of awareness or agreement with consensus guidelines, clinical practice inertia, fear of losing professional autonomy, and a belief that reimbursement and board certification won't be affected by doctors who ignore guidelines and don't produce desired outcomes.
A major obstacle faced by EBM developers is an inadequate level of evidence, based on published studies, on which clinical practices are based. On that count, otolaryngology's research base leaves a lot to be desired. To identify levels of evidence in otolargynology journals, Wasserman and Wynn reviewed 2854 original research articles published between 1993 and 2003 and rated each on a scale of 1 (strongest evidence) to 5 (weakest). The authors found that, for most published studies, sample sizes were modest, most articles lacked control groups, and significant confidence intervals were rare. The authors noted that published findings in otolaryngology had improved somewhat between 1998 and 2003-sample size increased from 22 to 30 subjects, 43% in 2003 had control groups versus 36% in 1998, and p values increased from 26% to 45% (Wasserman JM, Wynn R. Otolaryngol Head Neck Surg 2006;134(5):717-23).
Otolaryngology-head and neck surgery may be late to the party, but its professional society's leaders have met the challenge to operationally define what constitutes good medicine. It has engaged its members and other stakeholders in a complicated, time-consuming, and expensive journey that had to be undertaken.
The Cochrane Collaboration is an independent international not-for-profit organization, established in 1993, that makes up-to-date, accurate information about the effects of health care available worldwide. It promotes the search for evidence via clinical trials and other studies. For further information, visit www.cochrane.org/index.htm .
Steps to Writing EBM Guidelines
The five steps to creating valid evidence-based guidelines are:
- Identifying and refining the subject area
- Convening and running guideline development groups
- Assessing evidence identified by systematic literature review
- Translating evidence into recommendations
- External guideline review
For a detailed look at how AAO-HNSF leaders are developing evidence-based guidelines:
Rosenfeld R, Shiffman R. Clinical practice guidelines: a manual for developing evidence-based guidelines to facilitate performance measurement and quality improvement. Otolaryngol Head Neck Surg 2006;135:S1-S28.
©2007 The Triological Society