Editorial: Evidence Based Medicine

What is "evidence-based medicine?" It is formally defined as the "conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients based on three factors: (1) the best available external evidence, (2) individual clinical expertise and judgment, and (3) patient preferences." The EBM process includes identification of relevant, best published evidence for specific clinical decisions, including treatment. It is important to emphasize, however, that formal published evidence is only one of the three components, and cannot replace the physician’s experience and judgment in treating each individual patient. Lack of evidence for an intervention does not mean the intervention is useless. Rather, it means that the effectiveness of the intervention is still an open question in need of further investigation or documentation. Thus, EBM can also identify clinical questions for which insufficient evidence exists, and serve as a tool to stimulate further clinical research and optimize patient care.

Your Academy is actively engaged in gathering evidence of the effectiveness of otolaryngology—head and neck surgery interventions with studies conducted through its national clinical research network, Building Evidence for Successful Treatments in Otolaryngology (BEST ENT). The BEST ENT Network is a national, practice-based clinical research network of more than 200 physicians in 35 states interested in studying the effects of medical treatment and surgical interventions on the diseases they treat. This research cooperative works to examine the efficacy, effectiveness, and impact on quality of life of various treatment modalities through clinical research and measurement of patient outcomes. Its purpose is to provide a group of like-minded colleagues opportunities to participate in and shape clinical research. The Duke Clinical Research Institute (DCRI) in Durham, NC, collaborates with the AAO-HNS Foundation’s National Center for the Promotion of Research in Otolaryngology (NCPRO) to provide support for BEST ENT activities by providing study coordinators and other support personnel for clinical research studies conducted through the BEST ENT network.

The BEST ENT Network has been designed with the following objectives, adapted from those espoused by the AAFP National Research Network:

• Recruit and nurture a national network of clinicians and practices in the US, including otolaryngologists from the international community when feasible and appropriate. 
  
• Conduct funded research within the BEST-ENT Research Network.
  
• Provide multiple sites to develop and pilot test new evidence-based tools.
  
• Provide rapid collection of data for key clinical and practice questions.
  
• Serve as a natural laboratory to develop and field test new quality and outcome measures applicable to otolaryngology—head and neck surgery.
  
• Provide technical assistance and consultation to AAO-HNS members wishing to plan and conduct practice-based clinical research.
  
• Serve as a national voice and advocate for practice-based otolaryngology clinical research.

The DCRI provides important collaboration and is an asset to the BEST ENT operation: it covers the practice-based physicians’ IRB approvals for participation in the studies through unaffiliated investigator agreements; develops, distributes, and collects all the patient informed consent and clinical report forms; develops and distributes the Manual of Procedures for each clinical site; serves as the liaison site for all clinical investigation sites; conducts all routine and adverse event patient follow-ups; and carries out the data analysis.

Currently active studies are TO TREAT (Tonsillitis Outcomes: Toward Reaching Evidence in Adults and Tots), a multi-site study following 70 adult patients and 92 children with chronic or recurrent acute tonsillitis treated with tonsillectomy; and SLEEP (Studying Life Effects and Effectiveness of Palatopharyngoplasty), a multi-site study of adults with obstructive sleep apnea treated with UPPP with and without tongue procedures. Enrollment will continue at the 35 investigation sites until the enrollment goal of 240 patients is reached. Protocols are in the planning and development stage now for two clinical trials on treatment of patients with head and neck cancer.

The quality of the services provided through DCRI has been invaluable in enhancing the credibility of BEST ENT’s research efforts in the otolaryngology community and have been largely responsible for its growth and acceptance. Through the BEST ENT studies, we are systematically upgrading the level of evidence surrounding otolaryngology interventions from a preponderance of level 4 studies to a series of level 2 studies, thus improving otolaryngology—head and neck surgery’s position in the healthcare regulatory, economic, and political arenas.

Question: Why should the average practicing otolaryngologist be concerned about, or participate in, the collection of evidence demonstrating intervention effectiveness? Answer: Because there is a direct link between evidence and reimbursement. Prospective clinical research, whether conducted in community-based practices, academic medical centers, HMOs, or military or Veterans’ Administration hospitals generates higher-level evidence of treatment effectiveness than that provided by retrospective chart reviews, small series, or case reports. This evidence is used to form the basis for practice guidelines. Tools to evaluate quality of care—medical review criteria, performance measures, and standards of quality—are based on clinical practice guidelines.

Performance measurement, the objective assessment of how well physicians adhere to evidence-based standards to achieve desired outcomes, is increasingly being applied in the healthcare sector to improve the quality, safety, and accountability of medical care, and constitutes Part IV of the Maintenance of Certification criteria. Performance measures—if done right—have great potential to assess physician performance, improve the quality of patient care, enhance the coordination and management of care, and reward physicians who meet or exceed the benchmarks set by performance measures. This, then, has become the foundation for the next major trend in organized medicine, pay for performance.

Evidence-based medicine is here to stay and will exert a lasting influence on every aspect of medical education and practice. Get involved in BEST ENT and invest in the future of your specialty.

Maureen Hannley, PhD
Chief Research Officer
David L. Witsell, MD, MHS
Medical Director, NCPRO