Indications for Tonsillectomy and Adenoidectomy Phase I
National Institutes of Health
Consensus Development Conference Statement
July 20, 1978
This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information on this and other health topics, we recommend consulting the National Institutes of Health's MedlinePlus http://www.nlm.nih.gov/medlineplus/.
This statement was originally published as: Indications for Tonsillectomy and Adenoidectomy Phase I. NIH Consens Statement 1978 July 20;1(6):27-29.
For making bibliographic reference to the statement in the electronic form displayed here, it is recommended that the following format be used: Indications for Tonsillectomy and Adenoidectomy Phase I. NIH Consens Statement Online 1978 July 20 [cited year month day];1(6):27-29.
At this meeting, the Ad Hoc Advisory Panel on Tonsillectomy and Adenoidectomy reviewed the report, "Planning a Multicenter Study of Adenotonsillectomy," the result of a grant, N-13166-01A1, funded in 1977. This grant, funded by NINCDS as a result of an application from the School of Public Health, Department of Epidemiology, University of Pittsburgh, was an outgrowth of recommendations of a Consensus Development Workshop held in June 1974 on Tonsillectomy and Adenoidectomy partially funded by NINCDS at the request of an Ad Hoc Committee of the American Council of Otolaryngology.
Dr. David G. Hanson, Acting Director, Communicative Disorders Program, NINCDS, briefly reviewed the history of the NINCDS involvement in tonsillectomy and adenoidectomy consensus. Dr. Seymour Perry, Associate Director for Medical Applications of Research, NIH, briefly related the interest of NIH, the USPHS and DHEW in the topic and reinforced the need to provide solid scientific data on which to base decisions on the indications for the surgical procedures of tonsillectomy and adenoidectomy.
The Panel members had been provided in advance with copies of the Report to be reviewed as well as with appropriate background material including the Proceedings of the Tonsillectomy and Adenoidectomy Workshop.
Consideration of the Report was focused around detailed discussions of each of the Report's recommendations.
It was the consensus of the Panel that study of tonsillectomy and adenoidectomy was necessary and desirable. However, a large number of problems in and disagreements with the Report's recommendations were identified. A number of alternatives to the Report's recommendations were suggested and discussed. Several of the Panel members expressed concern that subject selection criteria for proposed studies should more closely approximate currently accepted criteria employed in medical practice, although it was realized that selection criteria will necessarily be somewhat arbitrary. The well recognized difficulties in recruiting sufficient numbers of subjects to be randomized into a study was discussed. There was consensus that a careful period of observation prior to randomization was most desirable. The problems of a control group were discussed including the difficulties of anticipated attrition from the control groups due to continued disease or because the subjects became much better. The relative merits of a design utilizing each patient as his or her own control were discussed.
It was the consensus of the Panel members that tonsillectomy and adenotonsillectomy for sore throat need not be evaluated in the same study as an examination of adenoidectomy, adenotonsillectomy, and/or tympanostomy tubes for otitis media with effusion. The differentiation of pharyngitis from tonsillitis was pointed out as being an important factor. There is little question that tonsillectomy is effective treatment for tonsillitis while that procedure may have little effect on recurrent pharyngitis. However, most of the Panel members agreed that it is usually very difficult to differentiate pure pharyngitis from pure tonsillitis and that this differentiation is not usually made in patients presenting complaints or in the usual identified indications for surgery. It was noted that for many reasons a study of tonsillectomy and/or adenoidectomy and/or tympanostomy tubes for middle-ear disease may be much more clear cut in outcome and certainly is important.
The Panel did not accept the recommendation of the Planning Report that a large multicenter national study is the only feasible means of obtaining sufficient data. The Panel commended the valuable work accomplished in the Planning Study and concurred that the Planning Study Report represents a very useful document in the planning of future studies.
Unanimous consensus was reached by the Advisory Panel on the following recommendations:
- A prospective clinical trial to determine the efficacy of tonsillectomy and adenotonsillectomy in reducing morbidity due to sore throat and nasal obstruction is necessary and desirable.
- A prospective clinical trial to determine the efficacy of adenoidectomy and adenotonsillectomy in reducing morbidity due to otitis media with effusion is necessary and desirable.
- The efficacy of tympanostomy tube insertion in concurrence with adenoidectomy and adenotonsillectomy in reducing morbidity due to otitis media with effusion should be studied in the second prospective clinical trial.
- Single and multiple center trials are feasible methods of gathering sufficient data regarding the efficacy of tonsil, adenoid and tympanic surgery in the reasonably near future. Feasibility studies must be considered in the context of specific proposed protocols.
- The most effective method of support should be utilized after review by Institute staff and may include either grant or contract mechanisms.
The Report's Summary
- A prospective clinical trial to determine the efficacy of tonsillectomy and adenotonsillectomy in reducing morbidity due to recurrent tonsillopharyngitis and the efficacy of adenoidectomy and adenotonsillectomy in reducing morbidity due to otitis media with effusion is necessary and desirable. Currently available scientific knowledge is not adequate to serve as a basis for individual treatment decisions or for quality assurance policies.
- The efficacy of tympanostomy tube insertion in concurrence with adenoidectomy and adenotonsillectomy in relieving morbidity due to otitis media with effusion should be studied in the same prospective clinical trial.
- A multicenter clinical trial is the only feasible method of gathering sufficient data regarding the efficacy of tonsil, adenoid and tympanic surgery in the reasonably near future.
- An ethical and scientifically valid protocol to study the efficacy of such surgery has been proposed, reviewed by an expert committee and by a large group of potential clinical investigators, and is included in this report.
- The proposed multicenter study can be completed in five to five and one-half years, in six to ten clinical study centers, at a cost of $7.5 to $8.1 million.
- The most effective organization of such a study will be achieved through a single grant or contract to a coordinating center, which will, in turn, enter into performance based contracts with collaborating clinical centers.
- Knowledge gained from such a study appears likely to modify significantly current practices regarding tonsil, adenoid and tympanic surgery, reducing the number of such procedures performed on children unlikely to benefit from surgery and better defining which children are likely to benefit from surgery. If such new knowledge reduces the incidence of such surgery by even a small proportion, the reduction in national medical care costs will far exceed the cost of the study.
National Institute of Neurological and Communicative Disorders and Stroke
Office of Medical Applications of Research