tial number of children over 6 years of age without the perfor-mance of confirmatory radiographs may have resulted in the inclusion of children without sinusitis. The antibiotic doses that were used were low (by 2002 standards) and may have been inadequate for a subgroup of children infected with resistant organisms. These two factors alone could easily have obscured the 20% to 30% difference in outcome that is expected between treated and untreated children.
Garbutt and her colleagues have performed a very important study.6It is essential that we continue to do systematic investiga-tion of this issue so that we can determine which children with respiratory symptoms are most likely to benefit from antimicro-bial therapy and whether imaging procedures can be omitted in all age groups.
Ellen R. Wald, MD, for the AAP Subcommittee on Management of Sinusitis and Committee on Quality Improvement
Pediatrics and Otolaryngology
University of Pittsburgh School of Medicine Division of Allergy, Immunology and Infectious
Diseases
Children’s Hospital of Pittsburgh Pittsburgh, PA 15213
REFERENCES
1. Ueda D, Yoto Y. The ten-day mark as a practical diagnostic approach for acute paranasal sinusitis in children.Pediatr Infect Dis J.1996;15:576 –579 2. Aitken M, Taylor JA. Prevalence of clinical sinusitis in young children followed up by primary care pediatricians.Arch Pediatr Adolesc Med.
1998;152:244 –248
3. American Academy of Pediatrics, Subcommittee on Management of Sinusitis and Committee on Quality Improvement. Clinical practice guideline: management of sinusitis.Pediatrics.2001;108:798 – 808 4. Wald ER, Milmoe GJ, Bowen A, Ledesma-Medina J, Salamon N,
Blue-stone CD. Acute maxillary sinusitis in children.N Engl J Med.1981;304: 749 –754
5. Wald ER, Chiponis D, Ledesma-Medina J. Comparative effectiveness of amoxicillin and amoxicillin-clavulanate potassium in acute paranasal sinus infections in children: a double-blind, placebo controlled trial.
Pediatrics.1986;77:795– 800
6. Garbutt JM, Goldstein M, Gellman E, Shannon W, Littenberg B. A randomized, placebo-controlled trial of antimicrobial treatment for chil-dren with clinically diagnosed acute sinusitis. Pediatrics.2001;107: 619 – 625
The Dummies’ Guide to Risk-Benefit Analysis of
Vaccines
To the Editor.—
In her article ‘The Rotavirus Vaccine Story: A Clinical Investi-gator’s View’ (Pediatrics 2000;106:123–125), Dr Margaret B. Ren-nels asks, “How many children are required to satisfy us that a vaccine is safe to licence and recommend?” In the case of rotavirus vaccine the excess risk of intussusception was 1 per 5000 vacci-nated children. She says the risk-benefit decisions such as “how many serious adverse events are acceptable to save a life” are difficult to make. The author feels strongly about a vaccine she has helped develop and thinks “although the ACIP and AAP have withdrawn recommendations for use of the vaccine, the vaccine may still be indicated in other areas of the world.” The issues raised are not as difficult as it is made out to be. The risk-benefit calculations used by health economists are actually quite easy to comprehend.
1. Let a represent the lifetime risk of an individual getting the disease in the community (usually given as a fraction, say 1 in a 1000).
2. Let b represent the fraction of those with disease likely to develop a serious complication (usually given as fractions say 1 in 100 or 1 in 1000 etc).
3. Let x represent the fraction of those vaccinated who develop a serious complication attributable to the vaccine.
4. Then a multiplied by b represents benefit and x represents the risk.
If x is greater than a multiplied by b, the vaccine should not be used as the risk of vaccine-related-complication is more than the risk of acquiring the disease in the community and getting a serious complication from it.
Assume that 1 in 10 of the population develops measles and assume 1 in a 1000 of those with measles develop subacute scle-rosing panencephalitis (SSPE). Then the chance of SSPE is 1/10 (a) multiplied 1/1000 (b)⫽1/10 000. Suppose 1 in a 100 000 of those who receive measles vaccine develops SSPE then the risk x is 1/100 000. The benefit is higher than the risk.
The factor x remains constant for any given vaccine. The factor b remains constant for a given illness. However, the factor a is different in different populations and changes with time.
x, a and b could also be reckoned in terms of economic costs of the disease and side effects.
The chance of contracting hepatitis A is much lower in Europe than in Asia. Thus, with its good sanitation, the vaccine risk may be too high for Europe but acceptable for its benefits in Asia. Smallpox risk is an example of how time alters the risk-benefit ratio. As long as smallpox was epidemic, the, risks of disease were more, compared with the risks of vaccination. However, after smallpox was eradicated, the risks of continuing with the vacci-nation program became unacceptably high compared with risk from the disease. The same is the problem with vaccine-induced polio in developed countries, where the risk of acquiring wild polio is now nearly eliminated.
Refinements may be incorporated to this simple formula. For a vaccine that has a very limited duration of protection (for example viral-influenza vaccination that must be given each year) instead of lifetime risk, the risk of the acquiring the disease each year may be considered.
A vaccine does not protect all those vaccinated. Suppose the vaccine protects 1 in 2 of those vaccinated, the benefit is reduced, and must be multiplied by a fraction c⫽1⁄2in this case. a multi-plied b, multimulti-plied c must be greater than x.
The risk-benefit ratio is thus a dynamic mathematical solution to the question of, “Is the cure (prevention) worse than the dis-ease?1”
Jacob M. Puliyel, MD, MRCP, MPhil Department of Pediatrics
St Stephens Hospital Tis Hazari
Delhi-110054, India
REFERENCE
1. Puliyel JM, Agarwal KS. Issues and controversies in contemporary immunization. In: Recent Advances in Pediatrics. 10th ed. Gupte S. Jaypee Brothers Medical Publishers; Delhi, India: 2000
Politics and Reading
To the Editor.—
I am writing to express my concerns about the commentary by Strauss printed in the January 2002 issue ofPediatrics.First, in Dr Strauss’ commentary he misquoted Dr Reid Lyon in 1 of the 3 quotes. The other 2 quotes were taken out of context. Second, this commentary was written in a manner that questions the credibility of the work of the National Institute of Child Health and Human Development with an important portion of the medical commu-nity. It is critically important that pediatricians are informed about reading difficulties and how to recognize the warning signs so we can identify children early.
In this 1-page commentary, Dr Strauss states that Dr Lyon represented the NICHD at the hearing to discuss President Bush’s proposals for yearly testing and for accountability. He then argues that the NICHD’s criteria for funding only reading research pro-posals that meet rigorous scientific standards is narrow, given the acceptance of descriptive research among educators. He raises questions about whether any scientific evidence exists to demon-strate that testing and accountability improves student
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ment. He expresses concerns about the anxiety and stress some children experience from testing.
Dr Strauss’ commentary leaves the reader with the misleading impression that Dr Lyon’s March 8, 2001 congressional testimony was on the topic of testing and accountability. That actually was notthe focus of the testimony. Less than 15% of Dr Lyon’s testi-mony was on the topic of assessment. His testitesti-mony was about the long-term outcome for children who experience reading difficulty, how reading develops and why children have difficulty, the ef-fectiveness of early intervention programs, how the President’s Reading Initiative is based on scientific research, and finally— assessment. Dr Strauss makes it sound like Dr Lyon was testifying exclusively about the topic of assessment.
Dr Strauss not only misled the reader on the focus of the testimony, he actually misquoted Dr Lyon. In Dr Strauss’ letter he quotes Dr Lyon as saying that “assessments should be done yearly so that we know how well our schools are performing.” Dr Lyon’s actual statement referring to norm-referenced assessments reads as follows: “Such assessments should be done yearlybeginning in grade 3so that we know how well our schools are performing.” The two other quotes he reprinted from Dr Lyon’s testimony were out of context. I particularly object to where Dr Strauss quotes Dr Lyon as saying that “reservations and concerns about how to implement accountability should not condemn its importance.” Dr Lyon made the statement about not condemning its importance within about a 12-sentence passage about matching the assess-ment to the educational objectives. Dr Strauss implies that Dr Lyon was speaking of “reservations and concerns about how to implement accountability,” which wasn’t quite an accurate por-trayal of the topic from which he extracted the quote.
The fact that Dr Strauss chose to publish his criticism in a professional journal for pediatricians is what really upsets me. I am a member of the International Dyslexia Association (IDA). Some of the branches of the IDA have dedicated many volunteer hours trying to develop outreach programs in partnership with pediatricians to increase parents’ awareness about reading diffi-culties. The reason that pediatricians are an important group for us is because, according to a poll conducted by Roper and com-missioned by the Coordinated Campaign for Learning Disabilities, pediatricians are the second most frequent resource (after teach-ers) that parents turn to for advice and information when they suspect their child is experiencing a learning problem. Look at Dr Strauss’ opening sentence:
“Advocates of child health will be disturbed at recent com-ments on reading and education that have emanated from the National Institute of Child Health and Human Development (NICHD).”
I find this statement offensive and politically charged. Actually the NICHD is bringing scientific rigor to research in education where, in the past, the standards were very lax, thereby allowing anyone to claim that an approach is “research-based.” This is Dr Strauss’ second published letter attacking Dr Lyon and the NICHD in the past 6 months. The first appeared inEducational Researcherin June. Criticism can be beneficial when it is factually based and challenges us all to push our thinking by proposing other ideas. If Dr Strauss really wants to help, what is his pro-posal? Where are his ideas? The only thing he is publishing is criticism.
There is no time for personal attacks on Dr Lyon or the NICHD’s work, quotes taken out of context, and misrepresenta-tion. We have too much work to do to raise awareness about the urgent need to identify children who are struggling in learning to read during that crucial window of opportunity when interven-tion is most efficient and effective. I wish Dr Strauss would ded-icate the hours he has spent in writing criticisms to work construc-tively to help more children learn to read. Every week I am fortunate enough to observe the work of dedicated teachers, read-ing scientists, and volunteers with the IDA and other literacy nonprofit organizations. These people are passionate and positive, and feel the satisfaction of helping children. This positive action stands in such contrast to the negativity generated through a commentary such as the one written by Dr Strauss.
Susan L. Hall Long Grove, IL 60047
REFERENCE
1. Strauss SL. Politics and reading at the National Institute of Child Health and Human Development.Pediatrics.2002;109:143–144
In Reply.—
Despite a number of criticisms of my commentary, Susan Hall does not dispute my main point, which is to challenge the NICHD in its political support of President Bush’s proposals for high-stakes school testing and accountability. As I noted, this is hypo-critical support, because the NICHD appeals to scientific rigor in defending a very narrow conception of reading research, but does not hold itself to the same “evidence-based” standards on the issue of nationwide testing, and the role of such testing in reward-ing and punishreward-ing students, teachers, and schools. There is abso-lutely no scientific research that demonstrates the safety and effi-cacy of high-stakes testing and accountability, nor of any other coercive pedagogical practices, in improving the reading ability of students. Instead, there are anecdotal reports from reputable scholars of mental health problems in children that may be asso-ciated with the new stressful classroom environment.
Thus, pediatric health care workers should be aware that the NICHD, through the congressional testimony of Dr Reid Lyon, its director of reading research, has gone on record as supporting a scientifically indefensible political program that may be putting children at risk. I find this alarming. Pediatricians should be concerned that Dr Lyon has used the name and scholarly reputa-tion of the NICHD to promote such a political agenda.
Hall complains that “the only thing [I am] publishing is criti-cism,” and asks: “If Dr. Strauss really wants to help, what is his proposal?” But my proposal for dealing with the controversial issue of nationwide high-stakes testing and accountability is clearly stated in my commentary, where I suggest that the matter be put on hold while the NICHD carries out safety studies. It goes without saying that this is how any medical or treatment inter-vention gains approval.
Hall accuses me of “misleading” pediatricians about Lyon’s March 8, 2001 congressional testimony, stating that “less than 15% of Dr Lyon’s testimony was on the topic of assessment.” Accord-ing to Hall, “Dr Strauss makes it sound like Dr Lyon was testifyAccord-ing exclusively about the topic of assessment.
But Dr Lyon’s testimony was first and foremost about testing and accountability, as were the testimonies of other witnesses that day before the House Committee on Education and the Work-force, including that of Kurt M. Landgraf, CEO of the Educational Testing Service, the manufacturer of the SAT. The title of the session at which these individuals spoke was “Measuring Success: Using Assessments and Accountability to Raise Student Achieve-ment.” As I noted, Dr Lyon himself referred to the subordinate role of his discussion of reading to the larger issue of testing and accountability when he stated that he was “pleased to have been asked to address the Subcommittee on issues relevant to the use of assessments and accountability to raise student achievement, par-ticularly with respect to how these issues and our NICHD reading research findings are reflected in President Bush’s reading initia-tives.”
Anyone who reads Dr Lyon’s testimony will immediately ap-preciate that there is no question that it addresses Bush’s plan in the most favorable terms. But this should come as no surprise, because, as we recently learned from theNew York Times(January 19, 2002), “he (Dr Lyon) substantially wrote the Early Reading Initiative that was part of the groundbreaking education bill the President recently signed into law.” Clearly, it is Hall who is misleading pediatricians about the true nature of Dr Lyon’s testi-mony.
It is crucial that health care professionals appreciate that the element of President Bush’s proposal commonly referred to as “high-stakes testing and accountability” has nothing whatsoever to do with individual clinical assessments carried out for the purpose of formulating treatment plans to help children with reading difficulties assessments, which are of obvious importance. Instead, it refers to yearly math and reading tests from grades 3 through 8, in which scores from the tests will be used to decide on student promotion and retention, financial rewards to teachers, and the allocation and rescinding of funds to schools and school districts. This is politics, not science.
My commentary did not address the current controversies in
the field of reading research and practice. Despite this, Hall seems to attribute to me a view I do not hold. She claims that I argue “that the NICHD’s criteria for funding only reading research proposals that meet rigorous scientific standards is narrow, given the acceptance of descriptive research among educators.” But I am completely in favor of using rigorous science to study reading. What is narrow is the NICHD’s monolithic reliance on experimen-tal design. Rigorous science includes descriptive research. The NICHD’s blanket rejection of this type of research as unscientific is tantamount to rejecting entire disciplines outright, such as cul-tural anthropology and animal ethology.
The NICHD’s narrowness of scientific vision, expressed in its highly influential National Reading Panel report, prompted widely respected literacy Professor James W. Cunningham, of the University of North Carolina at Chapel Hill, to ask: “What are we to make of a report that so boldly lays claim to what science, rigor, and objectivity are in reading research, and first denigrates, then ignores, the preponderence of research literature in our field?” This “preponderance of research literature” in the field of reading largely includes descriptive studies that have questioned the NICHD’s views on phonics and phonemic awareness.
Pediatric health care workers interested in the current debate in the reading field will benefit from the important critiques of NICHD science that can be found in the writings of Coles,1 Ga-ran,3,4and Krashen.5
Finally, Hall suggests that my criticism of Dr Lyon’s testimony somehow runs counter to the good will of the dedicated volun-teers of the International Dyslexia Association, the organization she identifies herself with. I fail to understand Hall’s point. The dedication of these volunteers is certainly no obstacle to appreci-ating that supporting phonics and phonemic awareness is one thing, but advocating coercive testing that puts children at risk is quite a different matter.
Steven L. Strauss, MD, PhD Franklin Square Hospital
Division of Clinical Neurophysiology Baltimore, MD 21237
REFERENCES
1. Coles Gerald,Misreading Reading: The Bad Science that Hurts Children,
Heinemann, Portsmouth, N.H., 2000
2. Cunningham James W., “The National Reading Panel Report,”Reading Research Quarterly,36.3, 2001, pp. 326 –335
3. Garan Elaine, “Beyond the Smoke and Mirrors: A Critique of the National Reading Panel Report on Phonics,”Phi Delta Kappan,March, 2001, pp. 500 –506
4. Garan Elaine, “What Does the Report on the National Reading Panel Really Tell Us About Teaching Phonics?”,Language Arts Journal, Sep-tember, 2001, pp. 59 – 67
5. Krashen Stephen, “More Smoke and Mirrors: A Critique of the National Reading Panel (NRP) Report on ’’Fluency.’”Phi Delta Kappan,October, 2001, pp. 118 –121
6. Now the pressure begins for Bush’s reading expert,New York Times.
January 19, 2002
Amoxicillin Dosage
To the Editor.—
We have read the clinical practice guideline about the manage-ment of sinusitis published on the behalf of the American Acad-emy of Pediatrics1and we particularly appreciated it, not only for the efficacy, but especially for the scientific rigor.
Nevertheless, we were surprised by the prescription of amoxi-cillin at the usual dosage (45 mg/kg/day) in 2 divided doses. Amoxicillin should be prescribed, according to its pharmacokinet-ics, in 3 doses. The 2-dose schedule has proved to be equally effective in the eradication of group A Streptococcus in acute tonsillitis but the pharmacokinetics of antibiotics in the tonsils is different from the pharmacokinetics in the middle ear or in the sinuses.2Moreover, amoxicillin has a very low minimum inhibi-tory concentration (MIC) for group A streptococcus but a higher MIC is required forStreptococcus pneumoniae.Finally there is no article, to our knowledge, that demonstrates the same efficacy of a 2-dose schedule versus a 3-dose schedule of amoxicillin at the
usual dosage in the treatment of sinusitis. From a clinical point of view the difference between the 2 schedules is probably very small, if any, because there is an important trend to spontaneous resolution in these infections.3
The problem becomes more relevant when we look at the possibility of an increase ofS pneumoniae-resistant strains. As a matter of fact in acute otitis media it has been demonstrated that in lower doses amoxicillin ⬍50 mg/kg/day, and long-lasting treatments,⬎5 days, can facilitate the stay of penicillin-resistantS pneumoniaestrains in the pharynx.4
A concentration of antibiotic superior to the MIC for at least the 40% to 50% of time is required for an effective treatment of acute otitis media.5For this reason the dose of amoxicillin required for most of the intermediate resistant strain ofS pneumoniaeshould be of 75 mg/kg/day divided in 3 doses of 25 mg/kg each.6It has been demonstrated that in order to achieve the same results with 2 doses a higher dose is required (90 mg/kg/day).7These data are derived from the treatment of acute otitis media but, as the au-thors point out, in a sense the middle ear cavity is a paranasal sinus as well.
Giorgio Longo, MD Egidio Barbi, MD Clinica Pediatrica
Istituto per l’Infanzia Burlo Garofalo Trieste, 34100, Italy
REFERENCES
1. American Academy of Pediatrics, Subcommittee on Management of Sinusitis and Committee on Quality Improvement. Clinical practice guideline: management of sinusitis.Pediatrics.2001;108:798 – 808 2. Ginsburg CM, McCracken GH, Nelson JD. Pharmacology of oral
anti-biotics used for the treatment of otitis media and tonsillopharyngitis in infants and children.Ann Otol Rhinol Laryngol Suppl.1981;90(pt 3):37– 43 3. Morris P. Antibiotics for persistent nasal discharge (rhinosinusitis) in
children.Cochrane Database Syst Rev.2000;(3)CD001094
4. Guillemot D, Carbon C, Balka B, et al. Low dosage and long treatment duration of beta-lactam: risk factors for carriage of penicillin resistant
Streptococcus pneumonia. JAMA.1988;279:365–370
5. Craig WA. Choosing an antibiotic on the basis of pharmacodynamics.
Ear Nose Throat J.1998;77(suppl):7–11; discussion 11-2
6. Canafax DM, Yuan Z, Choumaitree T, et al. Amoxicillin middle ear fluid penetration and pharmacokinetics in children with acute otitis media.
Pediatr Infect Dis J.1988;17:149 –156
7. Seikel K, Shelton S, Mc Cracken GH Jr, et al. Middle ear fluid concen-trations of amoxicillin after large dosages in children with acute otitis media.Pediatr Infect Dis J.1997;16:710 –711
In Reply.—
We appreciate the letter from Drs Longo and Barbi regarding the clinical practice guideline for the management of sinusitis. They express concern regarding the recommendation of amoxicil-lin at 45 mg/kg/day in 2 divided doses for the treatment of acute sinusitis or acute otitis media. They point out that a concentration of antibiotic greater than the MIC for at least 40% to 50% of the therapeutic interval is necessary for an effective treatment of acute otitis media. They note that a dose of amoxicillin at 75 mg/kg/day in 3 divided doses or 90 mg/kg/day in 2 divided doses is neces-sary for strains ofStreptococcus pneumoniaethat are intermediate in susceptibility to penicillin. We agree entirely with their statements and emphasize that the recommendation for amoxicillin at 45 mg/kg/day in 2 divided doses is made in the instance when the practitioner is treating children without risk factors for antibacte-rial resistance. Accordingly, it is assumed that in these cases the minimum inhibitory concentration of the S pneumoniae will be ⬍0.1g/mL.
Ellen R. Wald, MD
Pediatrics and Otolaryngology
University of Pittsburgh School of Medicine Division of Allergy, Immunology and Infectious
Diseases
Children’s Hospital of Pittsburgh Pittsburgh, PA 15213
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