International Journal of Pediatric Otorhinolaryngology, @ ElsevierlNorth-Holland Biomedical Press

T AND A - NATURE ITS RESOLUTION *

OF THE CONTROVERSY

1 (1979)

201-210

201

AND STEPS TOWARD

JACK L. PARADISE Ambulatory Care Center of the Children’s Hospital of Pittsburgh and the Departments Pediatrics and Community Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pa. (U.S.A.)

of

(Received June 5th, 1979) (Accepted August 6th, 1979)

INTRODUCTION

It is ironic that while tonsillectomy and adenoidectomy continue to be the major operations most commonly carried out on children, at the same time these procedures are held in low esteem, or at best viewed with suspicion, by a large number of present-generation pediatricians. The reasons for this are several. First, excessive tonsil and adenoid surgery has long been recognized as a pediatric health care problem of some importance [ 111. Secondly, in many academic pediatric training programs, the prevailing attitude toward tonsil and adenoid surgery has been derogatory. And thirdly, the collective thrust of a number of critical reviews over the past 30 years has been to emphasize the lack of convincing evidence that tonsil and adenoid surgery is efficacious in relieving the various conditions for which it is undertaken [2,3,6,8,10,13-15,181. There is thus a large group of pediatricians (Fig. 1) who harbor generally negative attitudes about tonsil and adenoid surgery, and who also, being responsible and conscientious, are on the alert for opportunities to undertake such worthwhile endeavors as protecting children from apparent injury, denouncing practices that seem unscientific, and conserving health care dollars. Such pediatricians are not likely to agree readily to parents’ requests for tonsil or adenoid surgery, or to accept easily other physicians’ recommendations for surgery. On the contrary, they may be inclined to oppose tonsil and adenoid surgery - and especially tonsillectomy - more or less routinely and automatically, reassuring parents that their children will “outgrow” whatever conditions constitute the basis for concern. Quite a different point of view is held by another large group comprising

* Presented in part at the Annual Meeting of the American Academy of Pediatrics, Chicago, October 26,1978.

202 TRAINING AND

SENSE OF

C4MVIcTION

PROFESSIONALAND SOCIAL P.ESPONSIBILITT

Down with unscientificpractices

~l+~l=~

Fig. 1. Physician factors leading to advice against tonsiladenoid

surgery.

otolaryngologists most prominently, along with many family physicians and a substantial number of pediatricians as well (Fig. 2). This group is convinced, as a result of training or personal experience or both, that in certain children tonsil or adenoid surgery deals definitively with recurring or chronic health problems that have occasioned repeated medical visits and elicited myriads of prescriptions for antibiotics and decongestants. These physicians tend to be impatient with the “give-them-time - they’ll-grow-out-of-it” approach. Buttressing their attitudes are the testimonials of many parents, who provide positive feedback with such statements as: “He used to always be sick, but since the T and A he hasn’t missed a day of school” or “Before the operation you could hear her snoring at the other end of the house, but now I have to check at night to see if she’s still breathing”; or “He used to eat like a bird, but since the operation you can’t fill him up and he’s gained eleven pounds.” Physicians in this group are generally disposed to accede to parents’ requests for tonsil or adenoid surgery, or to recommend it themselves to parents who previously had been reluctant about operation. THE EXTENT

TO WHICH AUTHORITIES

DISAGREE

Authorities, no less than practitioners, disagree about the advisability of, and indications for, tonsil and adenoid surgery. For example, the American

TEMPERAMENT AND FAVORABLEEXPERIENCES

TRAINING

rl

Reduction

Surgically-

oriented

in patient

+

+ complaint6

activists

I

I

-

Fig. 2. Physician factors leading to advice in favor of tonsil-adenoid

surgery.

203

Academy of Pediatrics Pediatric Model Criteria Sets lists as an acceptable criterion for tonsillectomy “four or more episodes of tonsillitis with cervical adenitis during (the) preceding year” [4], whereas a current, standard pediatric textbook states: “. . . the presence or absence of tonsils does not affect the frequency, the course, or the complications of (acute pharyngitis) or susceptibility to it . . . so ‘frequent sore throats’ do not represent a valid indication (for tonsillectomy) . . .” [ 51. Small wonder that the conscientious practitioner, in advising for or against tonsillectomy, often feels lacking in reliable guidelines and is obliged to rely mainly on his or her own best judgment. INDICATIONS

FOR

SURGERY?

-

THE

SPECTRUM

FROM

ABSOLUTE

TO NONE

The dichotomy between physicians inclined against, and those inclined in favor of tonsil and adenoid surgery, has led many observers of the scene to think of the T and A question in a polarized way. And so it came about that in the early planning of this the American Academy of Pediatrics program dedicated to pediatric controversies, the proposed format with regard to the T and A issue involved one speaker “pro” and a second “con”. However, approaching the T and A issue with this pro-vs-con mentality risks evoking an exercise destined to oversimplify and mislead. It seems preferable conceptually to consider the issue as portrayed schematically in Fig. 3. At the extreme left lies that tiny fraction of the childhood population in whom surgery is clearly called for. These are the children with hypertrophy of tonsils, or adenoids, or both, of such degree as to cause severe obstructive disorders: alveolar hypoventilation with or without car pulmonale, difficulty in swallowing, apparent discomfort in breathing, or combinations of these difficulties, At the opposite end of the spectrum lies a second group - the vast majority of children - who clearly should not be operated upon. They have neither appreciable obstructive difficulties nor documented histories of unusually frequent episodes of ear, nose, or throat infection. I emphasize the word “documented” because as we have recently shown, histories of recurrent throat infection that lack documentation generally fail to portend excessive subsequent morbidity [ 161. To undertake tonsil or adenoid operaOPERATION

4

t

Fig. 3. Spectrum

CLEARLY

IS : NOT

INDICATED

QUESTIONABLE

of occurrence

of indications

for tonsil-adenoid

surgery

among

children.

204

tions on children in this second group would be to do so without adequate indication. Between these two groups, but set off from them by somewhat fuzzy boundaries, lies a third group of children whose symptoms, signs, and illness experiences are such that tonsil or adenoid surgery would be appropriate if two conditions were met: (1) the operation must be efficacious, i.e. it must relieve or at least ameliorate the condition for which it is undertaken; and (2) the benefits of the operation must outweigh its risks and costs. It is about this third, intermediate group of children that thoughtful and conscientious physicians may readily disagree, since data are currently lacking that would enable one either to define precisely the group’s boundaries, or to estimate within this group the efficacy of tonsillectomy and adenoidectomy, or if efficacious, to measure with familiar yardsticks the cost-benefit ratios of these operations. COSTS VS BENEFITS

OF TONSIL AND ADENOID SURGERY

The efficacy of an operation is a familiar concept, but the cost-benefit ratio of an operation may not be, and deserves a brief digression. If tonsils or adenoids are removed, involved in the cost portion of the cost-benefit ratio (Table I) are not only the monetary cost, but more importantly the risks of such potentially lethal or damaging mishaps as malignant hyperthermia [ 191 and cardiac arrythmia, or other complications of varying severity including hemorrhage, airway obstruction, emotional upsets, transient or lasting palatopharyngeal insufficiency, and otitis media. Finally, there may be other risks, for example immunological ones [12], that have yet to be fully elucidated. The benefit side of the cost-benefit ratio - to the extent that the operations were actually efficacious (Table II) - would include reduction in the frequency of episodes of ear, nose, and throat illness, with corresponding

TABLE I COSTS AND RISKS OF T AND/OR A (1) (2)

(3)

(4)

Currently U.S. $1000 per operation at Children’s Hospital of Pittsburgh Risk of anesthetic accidents: malignant hyperthermia cardiac arrhythmia Risk of miscellaneous complications: hemorrhage airway obstruction emotional upset palapharyngeal insufficiency otitis media Uncertain immunological risks

205 TABLE II POTENTIAL (1)

(2)

(3) (4) (5)

BENEFITS

OF T AND/OR A IF EFFICACIOUS

Reduction in frequency of ENT illness: discomfort inconvenience school absence work missed by parents costs of MD visits and drugs Reduction in nasal obstruction: function morbidity comfort craniofacial growth and development appearance Reduction in hearing impairment Improved growth and overall well-being Reduction in long-term parental anxiety

reductions for children in discomfort, inconvenience, and school absence, and for parents in time missed from work, costs and inconvenience of physician office visits, and costs of medications. Reduction in nasal obstruction - if it occurred - might conceivably result in improved respiratory function, lower incidence or lesser severity of upper respiratory infections, improved comfort, more normal craniofacial growth and development, and more generally acceptable facial appearance. The remaining elements listed - for children, reduction in hearing impairment and improvement in growth and overall well-being; and for parents, reduction in overall anxiety - would, if they actually resulted, obviously be of additional benefit. Most of the benefits shown in Table II might be categorized under the general heading of improved quality of life. Applying actual monetary values to such quality-of-life factors is termed by economists “shadow pricing”, and is used by them in attempting economic analyses of biosocial costs [ 1,7]. The method is interesting and deserving of our attention as physicians, but further consideration of it is beyond the scope of the present discussion. Instead, we might agree that, as physicians, we ought to be able to judge whether an operation’s overall biosocial benefits offset its risks and costs, if first we knew how much improvement the operation actually brought about - that is to say, its efficacy. And most physicians would agree that efficacy, in turn, would be best determined in randomized, controlled clinical trials. THE PROCESS OF ARRIVING AT RATIONAL INDICATIONS

Let me summarize and paraphrase what I have stated thus far. In order to arrive at rational indications for tonsil and adenoid surgery, we must first

206

delineate groups of children with particular symptom complexes severe enough to justify particular operations, and then in those groups test their efficacy in actual clinical trials, and then if efficacious, attempt to judge their overall impact. There are three main subsets of the T and A-advisability question: tonsillectomy for recurrent throat infection, adenoidectomy for nasal obstruction, and adenoidectomy for recurrent or persistent otitis media. Currently my colleagues and I are addressing each of these subsets in a prospective clinical study at the Children’s Hospital of Pittsburgh [ 151. For each of the problem conditions we arbitrarily defined minimum clinical criteria for considering operation [ 14,151. Children meeting such criteria are entered, with informed consent, into the corresponding randomized, controlled trial. (When consent is withheld, the decision for or against surgery is left to the parents.) I will now review briefly certain of our preliminary findings regarding the efficacy of these operations for these particular conditions, more in order to provide a glimpse at our study’s process than to try to anticipate its outcome. TONSILLECTOMY

FOR RECURRENT

THROAT

INFECTION

Children are admitted to our tonsillectomy trial on the basis of recurrent throat infection only if they meet stringent criteria involving both the frequency and severity of prior episodes. They must have experienced at least 7 episodes in the preceding year, or 5 episodes in each of the two preceding years, or 3 episodes in each of the three preceding years. And in order to be counted, each episode must have been characterized by at least one of four clinical features: oral temperature of 38.3”C (101°F) or higher, enlarged (>2 cm) or tender cervical lymph nodes, tonsillar exudate, or a positive culture for Group A, beta-hemolytic streptococcus. Lastly, each episode must have been documented in a clinical record. If documentation of the history is lacking, a subject becomes eligible for the trial if two observed episodes then develop with a pattern of frequency and clinical features that match or exceed those described in the presenting history. Our preliminary data regarding children meeting these criteria and assigned randomly to either the tonsillectomy or the control group show a statistically significant advantage favoring the operated children and persisting for at least two years. However, it is important to note that about half the control subjects have thus far each experienced fewer than 3 episodes of throat infection per year, and also that almost two-thirds of all the episodes experienced by the control subjects have been rated clinically as mild (rather than moderate or severe). Adequate assessment of the efficacy of tonsillectomy must in our view await the accumulation of further data. ADENOIDECTOMY

FOR NASAL

OBSTRUCTION

Children are admitted to our clinical trial of adenoidectomy for nasal obstruction only if the obstruction is appreciable, and if it can be shown

Fig. 4. Lateral nasopharyngeal

roentgenograms of children showing (left) large adenoid airway, and (right) normal adenoid and adequate airway.

encroaching

on

with reasonable certainty to be due to large adenoids (Fig. 4). Thus far, children receiving adenoidectomy appear to be experiencing almost uniformly excellent results persisting for at least two years. In the control group, spontaneous improvement of some degree has developed within the first year or two in many of the children, but complete resolution of nasal obstruction has developed in relatively few [ 171. The subjects contributing to these data have been mainly 5- and 6-year-olds, and information regarding children either younger or older is as yet inadequate for analysis. Moreover, before concluding that surgery is clearly preferable, it is important to ask whether the greater improvement in nasal obstruction achieved in the operated group was accompanied by benefits to the children that were worth the cost and risks of the operation. Apart from improved appearance, a rather subjective element, can we document improvements in any of the other elements presumably associated with nasal obstruction that are listed in Table II? In an effort to document the first element listed - nasal function - we have assessed olfaction in a group of children using varying concentrations of phenylethyl alcohol, a rose-like odorant, and found that olfactory function does indeed appear to vary inversely with the degree of nasal obstruction children rated as having no nasal obstruction showed almost uniformly good function, whereas most of those with severe obstruction showed poor func-

208

tion [9]. One next might ask whether olfactory function is important in children. Certainly odor perception is involved in diverse functions: orienting oneself, self-protection, alimentation, and the receipt of pleasure - all functions bearing on the quality of life, and of potential importance developmentally as well. Only rarely do children complain of being unable to smell, but is this an issue to which we as pediatricians should accord more attention? ADENOIDECTOMY

FOR MIDDLE

EAR DISEASE

Children are admitted to our clinical trial of adenoidectomy for middle ear disease if they have had sufficient difficulty in the past to have received tympanostomy tube insertion, and if subsequent to the extrusion of a tube they develop recurrent suppurative or non-suppurative otitis media. Following entry into the trial, they are monitored closely by means of history and by frequent otoscopic, tympanometric, and audiometric examination. Summarizing our available preliminary data, it is clear that adenoidectomy by no means completely prevents recurrent otitis media, but it remains uncertain whether adenoidectomy reduces somewhat the rate, severity, or duration of recurrent episodes. The issue is particularly complex because of the large number of variables that must be taken into account, and it has become apparent that large numbers of subjects will be required in order to reach firm conclusions. THE CURRENT

STATUS

OF THE PROBLEM

In conclusion, there remain large areas of uncertainty about the proper roles of tonsillectomy and of adenoidectomy in our management of childhood respiratory disorders. Occasional children require surgery urgently, while the great majority of children have no need for surgery. Concerning a substantial intermediate group there is obviously room for legitimate controversy . The findings described here concerning our studies of children in this intermediate group are preliminary and therefore warrant few conclusions, but they illustrate the kinds of outcome data that must eventually be available if clinicians are to be able to make informed estimates of cost-benefit ratios in individual cases. We will probably never succeed in eliminating uncertainty from the T and A picture, but as our clinical study proceeds and as other studies are undertaken, we should be able to reduce uncertainty progressively . In the meantime there can be no doubt that a large number of operations continue to be performed without adequate justification. As a specific example, although no child should receive tonsillectomy on the basis of a history of recurrent throat infection that lacks documentation [ 161, it appears that many such children continue to be operated on. As pediatricians we should

209

work for the inclusion of documentation in local peer-review standards, a step that should serve to reduce the number of inappropriate tonsillectomies. On the other hand, as pediatricians we must also be alert to ensure that children with severe obstructive symptoms due to large tonsils or adenoids or both, not be kept, because of ingrained professional prejudice, from receiving the surgery they urgently need. About the many T and A-related questions that remain unsettled, doctrinaire positions that are globally pro or globally con are clearly inappropriate; instead, attitudes are called for that are at once critical and open-minded, and continually inquiring. ACKNOWLEDGEMENTS

Supported by a grant from the Dr. E.R. McCluskey Memorial Research and Program Fund of the Children’s Hospital of Pittsburgh, and by a grant (HD 07403) from the National Institute of Child Health and Human Development. REFERENCES 1 Abt, C.C., The issue of social costs in cost-benefit analysis of surgery. In J.P. Bunker, B.A. Barnes and F. Mosteller (Eds.), Costs, Risks, and Benefits of Surgery, Oxford University Press, New York, 1977, pp. 40-55. 2 Bakwin, H., The tonsil-adenoidectomy enigma, J. Pediat., 52 (1958) 339-361. 3 Bolande, R.P., Ritualistic surgery - circumcision and tonsillectomy, N. Engl. J. Med., 280 (1969) 591-596. 4 Committee on Hospital Care, 1975-1976, American Academy of Pediatrics: Pediatric Model Criteria Sets, Evanston, Illinois, American Academy of Pediatrics, 1975, p. 32. 5 Eichenwald, H.F. and McCracken, G.H., Jr., Tonsils and adenoids. In V.C. Vaughan III and R.J. McKay (Eds.), Nelson Textbook of Pediatrics, 10th edn., Saunders, Philadelphia, 1975, pp. 947-950. 6 Einhorn, A.H., In H.L. Barnett (Ed.), Pediatrics, edn. 14, Appleton-Century-Crofts, New York, 1968, pp. 1675-1677. 7 Enthoven, A.C., Shattuck lecture - cutting cost without cutting the quality of care, N. Engl. J. Med., 298 (1978) 1229-1238. 8 Feinstein, A.R. and Levitt, M., The role of tonsils in predisposing to streptococcal infections and recurrences of rheumatic fever, N. Engl. J. Med., 282 (1970) 281-291. 9 Ghorbanian, S.N., Paradise, J.L. and Doty, R.L., Odor perception in children in relation to nasal obstruction, Pediat. Res., 12 (1978) 371 (abstract). 10 Illingworth, R.S., Discussion on the tonsil and adenoid problem, Proc. roy. SOC. B, 43 (1950) 317-324. 11 Kaiser, A.D., Children’s Tonsils In or Out, Lippincott, Philadelphia, 1932, p. vii. 12 Ogra, P.L., Effect of tonsillectomy and adenoidectomy on nasopharyngeal antibody response to poliovirus, N. Engl. J. Med., 284 (1971) 59-64. 13 Paradise, J.L., Why T&A remains moot, Pediatrics, 49 (1972) 648-651. 14 Paradise, J.L., Clinical trials of tonsillectomy and adenoidectomy: limitations of existing studies and a current effort to evaluate efficacy, South. med. J., 69 (1976) IO491053. 15 Paradise, J.L. and Bluestone, C.D., Toward rational indications for tonsil and adenoid surgery, Hosp. Pratt., 11 (1976) 79-87.

210 16 Paradise, J.L., Bluestone, C.D. and Bachman, R.Z. et al., History of recurrent sore throat as an indication for tonsillectomy: predictive limitations of histories that are undocumented, N. Engl. J. Med., 298 (1978) 409-413. 17 Paradise, J.L., Bluestone, CD. and Carrasco, M.M., Nasal obstruction due to adenoid hypertrophy: two-year course with and without adenoidectomy. In Abstr. 18th Annu. Meet. Ambulatory Pediatric Association, New York City, April 25, 1978, p. 43. 18 Shaikh, W., Vayda, E. and Feldman, W., A systematic review of the literature on evaluative studies on tonsillectomy and adenoidectomy, Pediatrics, 57 (1976) 401-407. 19 Snow, J.C., Healy, G.B. and Vaughan, C.W. et al., Malignant hyperthermia during anesthesia for adenoidectomy, Arch. Otolaryng., 95 (1972) 442-447.

T and A - nature of the controversy and steps toward its resolution.

International Journal of Pediatric Otorhinolaryngology, @ ElsevierlNorth-Holland Biomedical Press T AND A - NATURE ITS RESOLUTION * OF THE CONTROVER...
NAN Sizes 0 Downloads 0 Views