TO TREAT Trial

T.O. T.R.E.A.T. Trial

Tonsillitis Outcomes: Towards Reaching Evidence in Adults and Tots
(closed to enrollment)

As part of its commitment to evidence-based medicine, the AAO-HNS Foundation's National Center for the Promotion of Research in Otolaryngology has launched a new treatment effectiveness and patient outcome study.

Protocol

Your patients with chronic or recurrent tonsillitis will complete a brief outcomes questionnaire at enrollment and before surgery. Patients may participate in the study even if they decide not to have surgery. The Coordinating Center will then have the patients complete a similar questionnaire at 6 months and possibly one year following surgery. The goal is to quantify the change in disease-specific quality of life and treatment outcomes of surgery 6 months following treatment.

Sites are no longer being recruited for this study

Participation in the NC-PRO involves the following basic steps:

1. Identify an Office Coordinator
Identify an on-site office coordinator who will manage the day-to-day study activities and communicate with the Coordinating Center.

2. Obtain Study Forms

• Protocol
• Patient enrollment checklist
• Physician questionnaire
• Patient baseline questionnaire
• Informed consent form
• Study log

3. Obtain IRB approval

• Participants in academic offices must meet local IRB requirements. The Coordinating Center can assist with forms completion and necessary documents.
• Participants in community-based offices may be covered under the IRB approval already in place through the Duke Clinical Research Institute. Contact David Witsell, MD, MHS for details.

4. Determine Eligibility of All Tonsillectomy Patients

Eligible Patients:

• Meet all inclusion criteria and have no exclusion criteria
• Are willing to complete a brief questionnaire at enrollment, before surgery and at 6 months after surgery
• Will sign the required informed consent

5. Enroll Consecutive Study-Eligible Patients

• Record information for all patients in study log to provide generalizability information about study results and demographics about enrolled vs non-enrolled patients
• Complete patient eligibility/enrollment checklist
• Complete physician questionnaire
• Patient completes the baseline patient questionnaire*
• Mail clinician and patient forms to the Coordinating Center

*Patients will be contacted by our Lead Project Coordinator for the 6-month follow-up questions.

Incentive

Participating physicians will be given 25 credits for each patient enrolled in the TO TREAT Study. One credit = one dollar, which can be used for any Foundation activity or credit, such as Annual Meeting registration, Instuctional Course registration, educational products, etc.

Recurrent and chronic infections of the tonsil and adenoid tissue continue to be a common problem, and surgery remains a very commonly performed treatment (1). Although there have been many reports on the effectiveness of treatment (2,3,4), most authors have examined only changes in objective measures of health status - such as the number of episodes of tonsillitis. In addition, the indications for adenotonsillectomy remain poorly defined and controversial (5,6). Although there is now evidence that the quality of life impact of tonsil and adenoid disease is significant (9,10), the quality of life of children and adults after adenotonsillectomy for recurrent or chronic infection has not been studied prospectively. The TO TREAT Study will evaluate the quality of life after treatment for recurrent and/or chronic infection.

Specific Study Aims:

Adults

1. To describe that the disease-specific improvements in Quality of Life for adults with chronic or recurrent tonsillitis at six months of follow-up in patients that undergo tonsillectomy and in those who do not.
2. To validate an adult HEalth Related Quality of Life tool to assess the burden and response to treatment for patients with chronic tonsillitis.
3. To obtain pilot data on the effectiveness of tonsillectomy for a trial examining both effectiveness and efficacy of the procedure to both reduce documented infections and improve quality of life when compared to a medically managed group of similar patients.

Children

1. To describe that the disease-specific improvements in Quality of Life for children with chronis or recurrent tonsillitis at six months of follow-up in patients that undergo tonsillectomy and in those who do not.
2. To obtain pilot data on the effectiveness of tonsillectomy for a trial examining both effectiveness and efficacy of the procedure to both reduce documented infections and improve quality of life when compared to a medically managed groups of similar patients.

To TREAT FAQ

Q: Why is this study important?

A: Recurrent and chronic infections of the tonsil and adenoid tissue continue to be a common problem, and surgery remains a very commonly performed treatment(1). Although there have been many reports on the effectiveness of treatment (2,3,4), most authors have examined only changes in objective measures of health status - such as the number of episodes of tonsillitis. In addition, the indications for adenotonsillectomy remain poorly defined and controversial (5,6). Although there is now evidence that the quality of life impact of tonsil and adenoid disease is significant (9,10), the quality of life of children and adults after adenotonsillectomy for recurrent or chronic infection has not been studied prospectively. The To TREAT Trial will evaluate the quality of life after treatment for recurrent and/or chronic infection.

Q: Who is leading the study?

A: A panel of experts in outcomes research and practice-based research networks have worked to develop and validate a new patient survey and design an officebased study to examine treatment outcomes for both adult and pediatric patients with recurrent or chronic tonsillitis. The Steering Committee is composed of:

Michael G. Stewart, MD, MPH (Principal Investigator)
Nira Goldstein, MD (Principal Investigator, Pediatric Study)
Laura Orvidas, MD
Timothy L. Smith, MD, MPH
Edward M. Weaver, MD, MPH
David L. Witsell, MD, MHS (Adult Study)
Bevan Yueh, MD, MPH
Phillip Wackym, MD

Special thanks to the following for their significant contributions:

Outcomes Research and Evidence-based Medicine Subcomittee
Pediatric Otolaryngology Committee
Margaretha Casselbrant, MD, PhD

Q: Why Should I Get Involved in Clinical Research?

A: Perhaps you have been wondering about the usefulness of some of the routine procedures and examinations that you do in practice and whether or not they are effective. Possibly you are frustrated with groups that try to regulate the content and delivery of care without understanding what otolaryngologists do. Maybe you would like to be part of a group of practicing otolaryngologist-head and neck surgeons that is attempting to understand the best ways to deliver health care in the specialty.

When a patient asks you what benefit s/he can expect from the surgery you recommend, it can be particularly gratifying to tell him/her that you took part in a study to answer that exact question systematically. You can then proceed to answer the question with data to back up your positive anecdotes. You can provide a publication reprint that documents the results and acknowledges your contributions.

As a practitioner, you possess expertise on how an otolaryngology-head and neck surgery practice runs and know which research questions are important for the practice of your specialty. By linking you with experts in study design and research methodology, this study group capitalizes on your expertise and lets you participate in generating new knowledge about a very common otolaryngic condition. You might even be able to see your own question develop into a project that can be researched throughout the network in future studies.

Clinician-researchers in other specialties uniformly report that they enjoy being part of an overall research effort that routinely solicits their input on study questions and study designs (protocols and materials) and that examines questions relevant to their day-to-day practices. They also tell us that patients view research involvement on the part of the medical practice in a very positive light, and are eager to fill out questionnaires when they are a part of a study.

Participating physicians will receive preliminary reports of research results as soon as they are available and review manuscripts before they are submitted for publication. All participating practices will be acknowledged at the end of published articles. Authorship opportunities exist for those who take an expanded role in the design, oversight, or analysis of the project.

Q: What is Required and How Much Time Does it Take?

A: All Study Group members will be asked to complete a brief questionnaire to provide data to document their training, demographic characteristics, practice characteristics, and experience.

Participation in the study will affect practice routines in varying degrees, but has been designed to be as nondisruptive as possible. The study requires completion of brief data collection forms (only part of which need to be filled out by the practitioner). It will require informed consent from patients. See Protocol Overview for a summary of requirements.

Physicians will be given 25 credits per subject (1 credit = $1.00) which can used toward the purchase of AAO-HNS Foundation products or activities (e.g. Annual Meeting registration) as a participation incentive.

Q: Is This Another COG*ENT Study?

A: No. The two COG*ENT studies were conducted to establish a large database of patients undergoing a variety of treatments for two conditions: chronic rhinosinusitis and otitis media. That goal has been reached and we are now ready to begin another, more focused study. There are several significant differences between this study and those conducted through COG*ENT.