Evidence-based medicine (EBM) integrates (1) individual clinical expertise, (2) the best current research evidence that is clinically relevant and patient-oriented, and (3) patient preferences, concerns and expectations, into the decision-making process.
Clinical trials, the source of evidence for EBM, are assigned levels of evidence determined by the type and quality of the study. These levels of evidence (1 to 5, 1 being the best) are then tied to grades of recommendation (a, b, c, d). Level 1a, a randomized controlled trial, has become the gold standard for judging whether there is a clear benefit to the treatment and if it should be recommended for patients with similar conditions.
We are seeing a growing number of physicians who understand how research from clinical trials supports their treatment decisions, thus improving their practices and patient care, said David L. Witsell, MD, MHS, Director of Clinical Trials for the Department of Surgery at Duke University Medical Center and Medical Director for the Research Department of the American Association of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS/F).
Although evidence-based research is playing an increasingly important role in the day-to-day practice of otolaryngologists-head and neck surgeons across the country, the level of evidence supporting some common intervention options is uneven and the best evidence available is not known in many cases, according to the AAO-HNS/F.
What sets BEST ENT Network apart from other national academies collecting quality data from their members is that our members are actually participating in distinct prospective trials that have the necessary components, such as IRB approval, a defined sample size, an enrollment period, data collection forms and patient questionnaires, and patients who have consented to be studied and are eligible.
-Michael G. Stewart, MD, MPH
BEST ENT Network
As a result, the AAO-HNS/F has created the Building Evidence for Successful Treatments in Otolaryngology (BEST ENT) Network (see sidebar), which is a great way for ENTs to learn about evidence-based intervention by participating in evidence-based research, said Dr. Witsell.
Currently, there are more than 330 volunteer otolaryngologists in this network from community, institutional, and academic practices, added Dr. Witsell. Doing these studies in the community is key since that is where the bulk of medicine and surgery is practiced. Positive results from population and community-based research are much more powerful, because they already encompass the variability of the population and the ENT’s surgical skill and clinical decision making.
Any of the physician members in the BEST ENT Network, as well as collaborating surgical specialty societies, can submit a protocol for a prospective outcomes-based study to a steering committee, consisting of a panel of experts in outcomes research, study design, and methodology, that will review it and make recommendations or changes, if necessary.
Before the launch of any study, there is a significant educational effort by steering committee members to teach others about the development and implementation of evidence-based clinical research projects, said Dr. Witsell.
The Academy has had a number of initiatives, such as the Clinical Scholars Program, to help its members learn the principals of EBM and research study, added Dr. Witsell. Over 120 physicians were trained as part of this program and many of them now form the stable of investigators in the BEST ENT Network.
We are seeing a growing number of physicians who understand how research from clinical trials supports their treatment decisions, thus improving their practices and patient care.
-David L. Witsell, MD, MHS
BEST ENT Network member physicians have participated in three initial studies-SLEEP (Studying Life Effects and Effectiveness of Palatopharyngoplasty), To TREAT (Tonsillitis Outcomes: Towards Reaching Evidence in Adults and Tots) and NOSE (Nasal Obstruction and Septoplasty Effectiveness)-aimed at evaluating the quality of life (QOL) and health status of various patient populations from multiple practice settings. The newest study, SMILE (Study to Assess the Effectiveness of CeviMeline to Improve DentaL and Oral Health in Patients with XErostomia Secondary to Radiation Therapy for Treatment of Head and Neck Squamous Cell Carcinoma), is evaluating QOL in head and neck cancer patients.
Results from these studies may lead to evidence-based practice guidelines and clinical indicators that are used by both primary and specialty care physicians, and improve the quality of care delivered to patients, maximize the effectiveness of health care dollars, influence health care policy, and educate patients about their diseases and specific therapies.
Michael G. Stewart, MD, MPH, Professor and Chairman of the Department of Otorhinolaryngology at Weill Medical College of Cornell University and a member of several BEST ENT Network steering committees, said, Although we act like a clearinghouse and take on a supervisory role for these ongoing studies, each one has its own champion or principal investigator who takes the reins and manages the actual study.
What sets BEST ENT Network apart from other national academies collecting quality data from their members is that our members are actually participating in distinct prospective trials that have the necessary components, such as IRB approval, a defined sample size, an enrollment period, data collection forms and patient questionnaires, and patients who have consented to be studied and are eligible. We are not simply creating a database, said Dr. Stewart.
The To TREAT Study
The most recent study to be completed through the BEST ENT Network was To TREAT.
Although there had been several prior studies focused on the number and frequency of chronic infections of the tonsil and adenoid tissue, we chose to measure the health-related QOL in adults and children with recurrent and chronic tonsillitis after tonsillectomy using validated instruments in a prospective fashion, said Nira A. Goldstein, MD, principal investigator of the pediatric arm and Associate Professor at SUNY Downstate Medical Center in Brooklyn, N.Y.
As a prospective outcomes study, To TREAT focused on a cohort of patients with the same diagnosis, relating their clinical and health outcomes to the care that they received, in this instance, a tonsillectomy.
We did not do randomization in this study because we thought it would be difficult to find patients who would agree to be randomized and go without a tonsillectomy, said Dr. Stewart. We also tried to have a treatment group (immediate surgery) and a waiting/control group (surgery after three to six months), but in reality, the majority of patients had their tonsillectomy relatively quickly.
In the adult arm of the study, a total of 72 patients, enrolled from 26 sites and 46 investigators, showed significant and clinically meaningful improvement in disease-specific and global QOL. Additionally, patient-reported health utilization, cost of care, lost days of work, and antibiotic use related to complaints of sore throat decreased substantially after tonsillectomy.
In the pediatric arm, there were also significant improvements in disease-specific and global QOL in the 92 children from 19 practice locationswith 30 investigators, said Dr. Goldstein.The children had fewer sore throats, antibiotic courses, days missed from daycare/school and doctor visits six months and one year after tonsillectomy.
This multicenter Level 2c study provides evidence for the effectiveness of tonsillectomy in adults and children with recurrent and chronic tonsillitis, said Laura J. Orvidas, MD, FACS, Associate Professor of Otorhinolaryngology in the Division of Pediatric Otorhinolaryngology at the Mayo Clinic in Rochester, Minn., and member of the study’s steering committee.
We also discovered that the adults and children had fewer swallowing, breathing, and sleeping problems after having their tonsils removed, said Dr. Stewart. Although we were not focused on these outcomes, they were not totally unexpected.
Evidence-Based Research Benefits
The To TREAT study is significant, as EBM is becoming the driving force behind many healthcare decisions in otolaryngology, said Dr. Orvidas. I do think more randomized controlled trials and prospective studies will help improve our delivery of care.
One of our goals in developing this study was to help the Academy create guidelines, said Dr. Goldstein. Some guidelines had been published in the past, but there was not a lot of evidence to support them.
According to the AAO-HNS 2006 Annual Report, the creation of bench research does not stand alone; the Academy’s ability to create and translate the new research into meaningful use is directly benefiting our specialty. As more and more otolaryngologists collaborate with the Foundation on evidence-based medicine initiatives or sign up to be part of the BEST ENT network, we improve our understanding of how research evidence for treatment effectiveness leads to guidelines for patient care.
The idea behind the BEST ENT Network is to do studies that are real world and applicable to patients, said Dr. Witsell. The studies also facilitate a sense of collaboration, cooperation and value amongst the members. Besides the development of guidelines, study results can also be used to support pay for performance measures, patient quality measures and reimbursement issues. Today, a smart study designer has to hit many different goals, develop a study that compels patients and physicians to participate and satisfy decision and health policy makers.
BEST ENT Network Membership Application
Go to:
www.entlink.net/research/research/upload/BEST%20ENT%20Application%202006.pdf
Related Links
Centre for Evidence-Based Medicine www.cebm.net
The Cochrane Collaboration www.cochrane.org
Agency for Healthcare Research and Quality www.ahrq.gov/clinic/epcix.htm
National Guidelines Clearinghouse www.guideline.gov
BEST ENT Network
Building Evidence for Successful Treatments in Otolaryngology
The BEST ENT Network is a practice-based clinical research network of physicians interested in studying the effect of medical treatments and surgical interventions on the outcomes of diseases they treat. This research cooperative works to examine the efficacy and effectiveness of various treatment modalities through clinical research and measurement of patient outcomes. It is not a contract research organization, nor does it conduct or manage clinical trials. Its purpose is to provide a group of like-minded colleagues opportunities to participate in and shape clinical research.
Source: www.entnet.org/research/research/BEST-ENT-Network.cfm
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