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Letters to the Editor

Letters to the Editor reflect the viewpoints of the writers and do not represent the official position of the journal or of the American Academy of Pediatrics. Letters on any topic, including the contents ofPediatrics,are welcome from all members of the profession. For instructions on submitting Letters to the Editor, please see the Instructions for Authors in this issue or visit the journal’s Web site.

Misconceptions Concerning Gastroesophageal

Reflux in Children

To the Editor.—

After reading the article “Yield of Diagnostic Testing in Infants Who Have Had an Apparent Life-Threatening Event” by Brand et al,1we were dismayed because of the perpetuation of a myth by

well-meaning but misinformed pediatricians. The authors state that a subset of tests that led to the identification of all occult causes of an apparent life-threatening event would include screen-ing for gastroesophageal reflux (GER). To this point we agree. However, their basis for this statement comes from the evaluation of 68 children who had upper gastrointestinal (UGI) series; 36 of the 37 children in whom findings contributed to the final diagno-sis of an apparent life-threatening event had GER.

On a daily basis we are deluged with requests in our radiology department to perform UGIs to “rule out GER.” In fact, the pur-pose of the UGI is usually to exclude upper intestinal obstruction. The finding of GER is happenstance. Cleveland et al2and Seibert

et al3demonstrated that GER is present in a large percentage of

pediatric patients who are studied for any reason and in many children whose symptoms would not suggest its presence. If we assume (based on prior studies) that the sensitivity for the UGI is 85% and the specificity is 25%, then the predictive value of the positive result is⬃54%, and the predictive value of the negative result is⬃65%.2–4As Leonidas astutely pointed out, “we may as

well toss a coin.”4If we examine the UGI series more closely, we

can explain the poor predictive values. The infant is placed in a recumbent position (gastroesophageal junction is “under water”), is frequently strapped to an immobilization device, and is some-times irritable (which may increase gastric pressure). The infant is then administered a dense liquid barium, usually by mouth but sometimes through a nasogastric tube (if they are uncooperative), and then turned into a variety of unphysiologic positions to dem-onstrate anatomy. The experience does not simulate the daily feeding experience. Moreover, the technique for performing and interpreting the examination is variable (eg, retained contrast in the esophagus from swallowing may be mistaken for GER). One must also bear in mind that up to two thirds of normal infants (⬍4 months old) regurgitate daily, and this finding may be of little significance.5

One might conclude from Fig 1B of the article that the UGI ranked highest in contributing to establishing the diagnosis in patients with a noncontributory history. We would look at this figure with great skepticism. As advocates for children we must be cognizant of risks with any radiographic study that makes use of ionizing radiation. The UGI potentially represents a relatively high (when compared to chest radiography) radiation exposure, particularly to vital organs like breast, liver, and bone marrow. The most effective way to reduce exposure in the population is to not do unnecessary examinations.

Although the UGI is not ideal for identification of GER, gastro-esophageal scintigraphy using Tc99m sulfur colloid and the 24-hour pH probe are excellent tests. It is beyond the scope of this letter to discuss advantages and disadvantages of both tests, but suffice it to say that if one is considering a screening test for GER, the UGI is not an appropriate procedure.

George S. Bisset, III, MD Donald R. Frush, MD

Division of Pediatric Radiology Department of Radiology Duke University Medical Center Durham, NC 27710

REFERENCES

1. Brand DA, Altman RL, Purtill K, Edwards KS. Yield of diagnostic testing in infants who have had an apparent life-threatening event.Pediatrics.

2005;115:885– 893

2. Cleveland RH, Kushner DC, Schwartz AN. Gastroesophageal reflux in children: Results of a standardized fluoroscopic approach. AJR Am J Roentgenol.1983;141:53–56

3. Seibert JJ, Byrne WJ, Euler AR, Latture T, Leach M, Campbell M. Gas-troesophageal reflux—the acid test: scintigraphy or the pH probe.AJR Am J Roentgenol.1983;140:1087–1090

4. Leonidas JC. Gastroesophageal reflux in infants: role of the upper gas-trointestinal series.AJR Am J Roentgenol.1984;143:1350 –1351

5. Nelson SP, Chen EH, Syniar GM, Christoffel KK. Prevalence of symp-toms of gastroesophageal reflux in infancy. A pediatric practice-based survey.Pediatric Practice Research Group. Arch Pediatr Adolesc Med.1997; 151:569 –572

doi:10.1542/peds.2005-0859

In Reply.—

Figure 1 of our article provides information about the relative yields of different diagnostic tests used in the evaluation of infants after an apparent life-threatening event (ALTE). In discussing the figure, we emphasize that the rank order of tests in the figure does not imply a simple formula for deciding which tests to order (see page 890). To illustrate this point, we later refer to the problem of gastroesophageal reflux, noting that many patients have reflux that does not precipitate an ALTE, and that the presence of reflux in a patient who has had an ALTE does not prove a cause-effect relationship (see page 892). As Drs Bisset and Frush note, this uncertainty surrounding the diagnosis of reflux in ALTE patients may be compounded when an upper gastrointestinal series forms the basis for the diagnosis. We thank them for reminding readers that this is not the best test for detecting gastroesophageal reflux, for explaining in exquisite detail why this is so, and for encour-aging physicians to consider other tests for reflux when evaluating an ALTE.

Donald A. Brand, PhD Robin L. Altman, MD

Department of Pediatrics New York Medical College Vahalla, NY 10595

doi:10.1542/peds.2005-1002

Baby Doe Rules Have Been Interpreted and

Applied by an Appellate Court

To the Editor.—

I applaud the effort of Dr Kopelman1to call attention to the

disparities inherent in applying the Baby Doe rules and her cour-age in calling for the American Academy of Pediatrics to with-draw its apparent backing for them. I particularly appreciate her support for the continued application of the best-interests stan-dard as being appropriate. However, I would like to correct one small misstatement.

In Appendix 1 Dr Kopelman states that the current Baby Doe rules “are untested by the courts” and then provides the text of 45 CFR §1340.15 (b)(2). This section first mandates indicated medical treatment and then provides 3 narrow exceptions to providing this treatment; it is these 3 exceptions that we generally refer to as the Baby Doe rules. Although it is true that the exceptions themselves have never been the direct target of a challenge, this section was

PEDIATRICS Vol. 116 No. 2 August 2005 513 at Viet Nam:AAP Sponsored on August 29, 2020

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recently reviewed and applied in an appellate decision.2The case

involved an infant born at 23 or 24 weeks’ gestation who was resuscitated at birth allegedly against his parents’ wishes. The court first reviewed the appeal under Wisconsin law and found that the alternative of withholding life-sustaining treatment did not exist because the infant was not in a persistent vegetative state. The court then noted that Wisconsin had accepted federal funding under the United States Child Abuse Protection and Treatment Act (CAPTA) and “its regulations are fully applicable in this state.” The court then reviewed §§1340.15 (b)(1), (2), and (3) and concluded that the “implied choice of withholding treatment [re-suscitation at birth], proposed by the plaintiffs [parents], is exactly what CAPTA prohibits.”

In her seminal treatment of newborn treatment decisions,3

Rho-den pointed out that society basically has 3 choices when prog-nosis is uncertain. She first discussed the approach of waiting until death was certain before withdrawing care. She noted that by “erring on the side of life,” society would find a few survivors, but at the expense of creating tremendous pain, suffering, and ulti-mately death along the way. Specifically, she pointed out that this approach ensured that all errors were “in one direction— on the side of life. It resembles the criminal law approach, which holds that it is better to acquit ninety-nine guilty defendants than to convict one innocent person.” She next reviewed the “statistical prognostic strategy,” which was based on objective criteria that defined a limit of viability and denied aggressive medical treat-ment to those infants who failed to meet the criteria. She carefully noted that this approach denies treatment to some who might otherwise survive. The advancement of technology over time has shown that this approach is not feasible. She labeled her favored approach the “individualized prognostic strategy.” As Dr Kopel-man notes, it is this approach that has been adopted in guidelines published by the American Academy of Pediatrics. Singh and associates4recently documented this practice in Chicago, Illinois.

Their article also provides meaningful definitions that, for the first time, allow us to differentiate between cases in which withdrawal was undertaken because death was imminent and those cases in which quality-of-life concerns played a part in the decision.

I share Dr Kopelman’s concern that the Baby Doe rules do not allow the discretion our leadership believed and have demon-strated that they have been strictly interpreted against our current practice of supporting parents who make a reasonable medical decision in the best interests of their infant. For those who might consider the Montalvo decision an aberration, I would suggest reading Robertson’s recent article,5 in which he promotes the

restrictive interpretation of the Baby Doe rules rejected by Dr Kopelman; he asserts that all infants must receive full and equal medical treatment that can only be withdrawn when an infant fails to demonstrate any cognitive ability. His words are a direct assault on the best-interests standard that the majority of us use in clinical practice.

Our society seems poised to attempt a tectonic shift in public policy. Our current policy allows the widest latitude for decision-making and respect for values between patient, parent, and care-giver. As a matter of public policy under the standard proposed by Robertson and, as noted by Dr Kopelman, supported by the Baby Doe rules, there will be no choice but to continue maximal medical treatment in any infant with the slightest degree of con-scious life. I would join Dr Kopelman in urging our professional leadership to reexamine this issue.

Frank Clark, MD, JD

Clinical Child Health

University of Missouri School of Medicine Columbia, MO 65212

REFERENCES

1. Kopelman LM. Are the 21-year-old Baby Doe rules misunderstood or mistaken [commentary]?Pediatrics.2005;115:797– 802

2.Montalvo v Borkovec, WI App 147; 256 Wis. 2d 472; 647 N.W. 2d 413 (2002) 3. Rhoden NK. Treating Baby Doe: the ethics of uncertainty.Hastings Cent

Rep.1986;16:34 – 42

4. Singh J, Lantos J, Meadow W. End-of-life after birth: death and dying in a neonatal intensive care unit.Pediatrics.2004;114:1620 –1626

5. Robertson JA. Extreme prematurity and parental rights after Baby Doe.

Hastings Cent Rep.2004;34(4):32–39 doi:10.1542/peds.2005-0798

In Reply.—

I thank Dr Clark for supporting my view1that the American

Academy of Pediatrics (AAP) should withdraw its apparent sup-port of the “Baby Doe” rules.2These regulations had to be adopted

by states as a precondition of federal Child Abuse Protection and Treatments Act funding.3I especially appreciate Dr Clark bringing

into the discussion the Wisconsin Appellate Court’s interpretation and application of these rules inMontalvo v Borkovec.4Even if this

decision does not directly test the criteria for withdrawal or with-holding of maximal treatments for infants as directly as the Su-preme Court did in theBowendecision,5it offers an interpretation

of them by an appellate court, showing unambiguously that these federal funding regulations do not allow the sort of discretion needed for individualized and compassionate decision-making for infants advocated by the AAP.6,7 Wisconsin’s Appellate Court

understood these regulations as requiring maximal treatment un-less the infant is in an irreversible coma or dying. The case con-cerned a 23-week-old premature infant, and the Wisconsin Appel-late Court ruled that the baby’s parents had no role in consenting for or refusing maximal treatment because the child was not dying or comatose. “The implied choice of withholding treatment pro-posed by the plaintiffs, is exactly what CAPTA [Child Abuse Protection and Treatments Act] prohibits.”4This was the same

interpretation that the US Supreme Court5 gave in its review

of an earlier but similar set of Baby Doe rules8that President

Reagan promulgated under civil rights law.9In contrast to the

Wisconsin court,4 however, the Supreme Court in Bowen v American Hospital Association5offered scathing criticism of the first

set of Baby Doe rules themselves, saying no evidence had been given for the need to adopt these rules and that they ignored the role of parental consent, sought to alter standards of care, and took an oversimplified approach to medical decision-making. This un-derstanding exactly squared with the views of many neonatolo-gists.10

Thus, Dr Clark offers more evidence to show that the Baby Doe rules unambiguously embrace the right-to-life view that maximal treatments cannot be withheld or withdrawn unless an infant is dying or comatose. The letter and spirit of these Baby Doe rules exactly reflect the view of their proponents, President Reagan,11

his Surgeon General, C. Everett Koop,12and other advocates who

claimed that the Baby Doe rules were needed to stop unacceptable “quality-of-life” interpretations about what was best for in-fants.13,14Thus, claims by some members of the leadership of the

AAP that the Baby Doe rules are misunderstood, allow all reason-able discretion, or can be mitigated by an ethics committee are mistaken.13–15The words “reasonable medical care,”

“appropri-ate,” “inhumane,” or “virtually futile” taken in context do not open the doors of discretion as these defenders claim. Some assert that these special rules are needed for infants ⬍1 year of age because clinicians and parents disvalue disabled infants, but they offer no data for such a sweeping conclusion.14

The Baby Doe rules are inferior to the older and more estab-lished best-interests standard, first in allowing, within limits, greater individualized treatments plans. I defend what I call a “negative version of the Best Interests Standard.”16 It instructs

decision-makers to assess what act(s) are in the incompetent individual’s immediate and long-term interests and maximize his or her net benefits and minimize net burdens, setting that act(s) as a prima facie duty. Second, this standard presupposes a consensus among reasonable and informed persons of good will about what choices for the incompetent individual are, all things considered, not unacceptable. Third, the scope of the best-interests standard should be understood in terms of the scope of estab-lished moral or legal duties to incompetent individuals. An ad-vantage in analyzing the best-interests standard in this way is that we establish limits while making room for differences of opinion among informed and competent people of good will about what is best given the available options. Some people may decide to forego painful and highly experimental treatment for themselves or their relatives for pain-free weeks at home, whereas others might want to pursue every chance no matter how small.

The best-interests standard is also superior to the Baby Doe rules because it does not single out 1 group of incompetent per-sons, infants⬍1 year of age, for a “right-to-life” policy that others would not tolerate for themselves. Faced with a choice between using maximal treatments to prolong a life of unmitigated pain

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and suffering or to prolong a noncomatose, minimally conscious life, many people and policy makers believe that there are some-times worse things than dying.6,7,17–20This attitude is reflected in

the first priority of palliative care, namely, the relief of pain and suffering.19If we agree that it is wrong to do to others what we

would not want for ourselves and that we would not want a Baby Doe policy for ourselves (maximal treatment unless we were dying or comatose), then we should not adopt the Baby Doe policy for infants⬍1 year of age.

The best-interests standard is superior to the Baby Doe rules as a guidance principle because it uses the same rule for all persons lacking decision-making capacity and it permits, within socially sanctioned limits, the sort of compassionate and individualized decision-making widely recommended by policy makers,17–20

in-cluding by the AAP.6,7

Loretta M. Kopelman, PhD

Department of Medical Humanities Brody School of Medicine

East Carolina University Greenville, NC 27858

REFERENCES

1. Kopelman LM. Are the 21-year-old Baby Doe rules misunderstood or mistaken [commentary]?Pediatrics.2005;115:797– 802

2. Nondiscrimination on the basis of handicap; procedures and guidelines relating to health care for handicapped infants—HHS. Final rules.Fed Regist.1985;50:14879 –14892

3. US Child Abuse Prevention and Treatment Act.Pub L No. 42 USC 5101 et seq

4. Montalvo v Borkovec, WI App 147; 256 Wis. 2d 472; 647 N.W. 2d 413 (2002)

5. Bowen v American Hospital Association, 106 S Ct 2101 (1986)

6. American Academy of Pediatrics, Committee on Fetus and Newborn. The initiation or withdrawal of treatment for high-risk newborns. Pedi-atrics.1995;96:362–364

7. American Academy of Pediatrics, Committee on Bioethics. Guidelines on foregoing life-sustaining medical treatment.Pediatrics. 1994;93: 532–536

8. Nondiscrimination on the basis of handicap; procedures and guidelines relating to health care for handicapped infants—HHS. Final rules.Fed Regist.1984;49:1622–1654

9. US Rehabilitation Act, Pub L No. 93-112, 29 USC 794

10. Kopelman LM, Kopelman AE, Irons TG. Neonatologists judge the “Baby Doe” regulations.N Engl J Med.1988;318:677– 683

11. Reagan R. Abortion and the conscience of the nation. In: Butler JD, Walbert, DF, eds.Abortion, Medicine and the Law. 3rd ed. New York, NY: Facts on File; 1986:352–358

12. Koop CE. The challenge of definition. Hastings Cent Rep.1989;19(1 suppl);2–3

13. Murray TH. The final anticlimactic rule on Baby Doe.Hastings Cent Rep.

1985;15:5–9

14. Robertson JA. Extreme prematurity and parental rights after Baby Doe.

Hastings Cent Rep.2004;34(4):32–39

15. American Academy of Pediatrics, Committee on Bioethics. Ethics in the care of critically ill infants and children.Pediatrics.1996;98:149 –153 16. Kopelman LM. Rejecting the Baby Doe regulations and defending the

“negative” analysis of the best-interests standard for infants.J Med Philos.2005; In press

17. Steinhauser K, Christakis N, Clipp E, McNeilly M, McIntyre L, Tulsky J. Factors considered important at the end of life by patients, family, physicians, and other care providers.JAMA.2000;284:2476 –2482 18. Singer P, Martin D, Kelner M. Quality end-of-life care: patients’

per-spectives.JAMA.1999;281(2):163–168

19. National Hospice Organization.Standards of a Hospice Program of Care. Arlington, Virginia: National Hospice Organization; 1990

20. Byock IR, Caplan A, Snyder L. Beyond symptom managements: physi-cian roles and responsibilities in palliative care. In: Snyder L, Quill TE, eds.Physician’s Guide to End-of-life Care. Philadelphia, PA: American College of Physicians, American Society of Internal Medicine; 2001

doi:10.1542/peds.2005-1077

Is Homeostasis Model Assessment Better Than

the Quantitative Insulin-Sensitivity Check Index

and Fasting Glucose/Insulin Ratio?

To the Editor.—

We read with great interest the article of Keskin and col-leagues,1who tried to establish whether fasting methods to

mea-sure insulin resistance (homeostasis model assessment [HOMA], fasting glucose/insulin ratio, quantitative insulin-sensitivity check index) are reliable and which index could be used more easily in a clinical setting. Insulin resistance is an emerging topic, because it plays a central role in developing type 2 diabetes and the metabolic syndrome, particularly in an overweight adolescent population such as the one studied by the authors.2

The markers proposed by the authors were validated recently with the euglycemic clamp technique, which represents the gold standard for the determination of insulin resistance, and a good correlation between them has been found.3Moreover, the

reliabil-ity of the composite whole-body insulin-sensitivreliabil-ity index and the insulin-sensitivity index, both deriving from the oral glucose-tolerance test, has also been validated in children and adolescents, and a strong correlation between these 2 indices and the euglyce-mic clamp has been found.4 On the contrary, no data on the

accuracy of the sum of insulin levels during the oral glucose-tolerance test as an index of insulin resistance are available. In previous studies this index has only been used to subdivide obese patients as normoinsulinemic or hyperinsulinemic.5,6In the study

by Keskin et al, obese adolescents are classified as insulin resistant versus non–insulin resistant on the basis of a cutoff of this index of 300␮U/L. This is more than questionable and might have influ-enced the main results of the study. In fact, given the nonvalida-tion of this index, it is difficult to conclude that HOMA is more reliable than the fasting glucose/insulin ratio and quantitative insulin-sensitivity check index in diagnosing insulin resistance, and it is more than surprising to determine an appropriate cutoff point for HOMA for the diagnosis of insulin resistance in adoles-cents.

Angelika Mohn, MD Maria Marcovecchio, MD Francesco Chiarelli, MD

Department of Pediatrics University of Chieti Chieti 66100, Italy

REFERENCES

1. Keskin M, Kurtoglu S, Kendirci M, Atabek M, Yazici C. Homeostasis model assessment is more reliable than fasting glucose/insulin ratio and quantitative insulin sensitivity check index for assessing insulin resis-tance among obese children and adolescents. Pediatrics. 2005;115(4) Available at: www.pediatrics.org/cgi/content/full/115/4/e500 2. American Diabetes Association. Type 2 diabetes in children and

adoles-cents.Pediatrics.2000;105:671– 680

3. Gungor N, Saad R, Janosky J, Arslanian S. Validation of surrogate estimates of insulin sensitivity and insulin secretion in children and adolescents.J Pediatr.2004;144:47–55

4. Yeckel C, Weiss R, Dziura J, et al. Validation of insulin sensitivity indices from oral glucose tolerance test parameters in obese children and ado-lescents.J Clin Endocrinol Metab.2004;89:1096 –1101

5. Zannolli R, Rebeggiani A, Chiarelli F, Morgese G. Hyperinsulinism as a marker in obese children.Am J Dis Child.1993;147:837– 841

6. Maruhama Y, Abe R. A familial form of obesity without hyperinsulin-emia at the outset.Diabetes.1981;30(1):14 –18

doi:10.1542/peds.2005-1051

In Reply.—

Insulin resistance is a state in which normal concentrations of insulin produce a subnormal biological response. It is difficult to distinguish between relative effects of insulin resistance and hy-perinsulinemia. The degree of hyperinsulinemia and the presence of accompanying insulin resistance may form the basis for some of these conflicting effects.

A variety of methods have been developed to detect the

pres-LETTERS TO THE EDITOR 515 at Viet Nam:AAP Sponsored on August 29, 2020

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DOI: 10.1542/peds.2005-0798

2005;116;513

Pediatrics

Frank Clark

Baby Doe Rules Have Been Interpreted and Applied by an Appellate Court

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DOI: 10.1542/peds.2005-0798

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Frank Clark

Baby Doe Rules Have Been Interpreted and Applied by an Appellate Court

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