The To TREAT Study
The most recent study to be completed through the BEST ENT Network was To TREAT.
Explore This IssueApril 2007
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.