Screening Is Not as
Simple as It May Seem
We were very interested to read 2
commentaries1,2 on the recent guidelines on lipid screening in children3
because the differences highlighted
several important paradigm differences between the authors.
The first is that the guideline and the
defense of the guideline reflect an
attitude of paternalism toward both
primary care physicians and the patient. It is unfortunate that the guideline recommends an intervention
without quantifying the benefit or the
harm. We recognize that the weight of
evidence suggests lipid screening is
a good idea, but when a mother asks,
“How effective is this? What difference
is this going to make?” how is the
primary care doctor supposed to answer? Instead of providing the information needed to have a collaborative
discussion that would quantify the risks
and benefits (such as number needed to
screen, number needed to harm), the
primary care physician is left to simply
answer that it seems like a good idea
but no one knows how big a difference
this intervention is going to make. In the
past, a paternalistic guideline may have
been readily accepted, but we are moving toward an era in which patients and
families, with increasing health literacy,
are expecting to make decisions with the
physician in a collaborative matter. A
guideline that does not give the physician the ability to explain why an intervention is worthwhile will undermine
the authority and credibility of the physician to provide tangible information. I
understand that without a specific
screening trial which tests these guidelines in a real population, the current
evidence does not lend itself to calculating a number needed to screen/
number needed to harm, but that
should be recognized as a weakness of
the guidelines. For harms data, telling
a parent that a 2-year trial showed
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safety when the child may be on a
medication for decades is unlikely to
be reassuring. It is better to have data.
We think guidelines need to reflect that
both the primary care physician and
the patient would like to know not just
if an intervention is effective but how
effective it is.
Second, the effectiveness and harms of
a guideline cannot be assumed without
testing. Guidelines are applied both
too aggressively (such as colonoscopy
guidelines for cancer screening4) and
ignored (such as HIV screening guidelines5), leading to a different outcome
than expected by the writers of the
guidelines. If a guideline is extrapolated from circumstantial information,
the true efficacy and harm of a guideline will differ from the originating
evidence. This result will require further studies to see if the guideline
actually achieves what was intended
with the expected amount of harm. It
cannot be assumed from diseaseoriented data.
Third, it is very complicated to mandate a new universal screening to an
already packed well-child checkup
when the intervention has unquantified risks and benefits and will likely
trigger an incomplete discussion. There
is already not enough time to fully
practice preventive care6 or chronic
disease management7 in primary care.
Looking at other topics in the same
issue of Pediatrics, there are articles
about tonsillectomy, genetics, child
abuse, Lyme disease, and maternal–
infant feeding issues. Without enough
time or clear information to have
a collaborative discussion, there is the
potential that this guideline could be
implemented in a coercive manner,
disrupting the patient–physician relationship, or ignored altogether because it is too time-consuming to
explain the guideline and the logistics
of a fasting test. This recommendation
for screening may simply be placed on
the large pile of things primary care
physicians should be doing but do not
have time to do.
Fourth, the conflict of interest that we
are concerned about has little to do
with ties to industry. Our concern is
that for some of the authors, their
careers are focused on lipids. They
have a vested interest in highlighting
the importance of lipid problems. In
the same way that to a hammer everything looks like a nail, to a lipid
specialist, managing lipids may seem
to take priority over the myriad of
issues facing the primary care pediatrician. We also suspect there is
a lack of general primary care clinician input. A lipid specialist may not
recognize the need to justify a new
intervention to a primary care clinician
who is juggling multiple priorities.
Guidelines rarely survive their first
encounter with the real world, but we
would hope that newer guidelines
would take into account issues that are
important to the practicing physician,
not just a mandate for an intervention.
Guidelines should be able to help the
clinician and patient understand the
tangible risks and benefits of a proposed intervention as well as being able
to be realistically implemented.
Joshua D. Uy, MD, Clinical Assistant Professor of
Medicine
University of Pennsylvania
Atu Agawu, Medical Student
University of Pennsylvania
Conflict of Interest:
None declared
REFERENCES
1. Newman TB, Pletcher MJ, Hulley SB. Overly
aggressive new guidelines for lipid screening in children: evidence of a broken process. Pediatrics. 2012;130(2):349–352
2. McCrindle BW, Kwiterovich PO, McBride PE,
Daniels SR, Kavey RE. Guidelines for lipid
screening in children and adolescents:
bringing evidence to the debate. Pediatrics.
2012;130(2):353–356
LETTERS TO THE EDITOR
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LETTERS TO THE EDITOR
3. Kavey R, Simons-Morton DG, de Jesus J. Expert panel on integrated guidelines for
cardiovascular health and risk reduction in
children and adolescents: full report, 2011
[updated January 5, 2011, and January 5, 2012].
Available at: www.nhlbi.nih.gov/guidelines/
cvd_ped/index.htm. Accessed August 7, 2012
4. Goodwin JS, Singh A, Reddy N, Riall TS, Kuo
YF. Overuse of screening colonoscopy in the
Medicare population. Arch Intern Med. 2011;
171(15):1335–1343
5. Branson BM, Handsfield HH, Lampe MA, et al;
Centers for Disease Control and Prevention
(CDC)Revised recommendations for HIV
testing of adults, adolescents, and pregnant
women in health-care settings. MMWR
Recomm Rep. 2006;55(RR-14):1–17
6. Yarnall KS, Pollak KI, Østbye T, Krause KM,
Michener JL. Primary care: is there enough
time for prevention? Am J Public Health.
2003;93(4):635–641
7. Østbye T, Yarnall KS, Krause KM, Pollak KI,
Gradison M, Michener JL. Is there time for
management of patients with chronic diseases
in primary care? Ann Fam Med. 2005;3(3):209–214
doi:10.1542/peds.2012-3818A
Re: Childhood Lipid
Screening: Evidence and
Conflicts
McCrindle et al titled their response to
our commentary, “Bringing Evidence to
the Debate.” However, they primarily
reiterated the rationale already in the
guidelines, rather than bringing new
evidence to address our concerns.
One concern was that the guideline did
not address the cost-efficacy of its
recommendations. McCrindle et al cited
studies of the cost-efficacy of screening
for the rare (1 in 500) genetic condition familial hypercholesterolemia (FH).
However, such a narrowly focused
screening program was not recommended in the guideline. The $8700 per
year gained that they quote is irrelevant because it refers to a program to
screen family members of known FH
cases,1 not to the population-wide
screening program they recommend,
which would be far less cost-effective.
McCrindle et al are right in that our
commentary contained opinions. So
did theirs. It may help to highlight
areas where we agree and disagree.
We agree that:
1. Childhood lipid levels can identify
children at increased risk of arteriosclerosis decades later.
2. Clinical trials have shown that
treating the 1 child in 500 who
has FH can lead to improvements
in intermediate outcomes such as
coronary atherosclerosis.
3. Trials of whether treating the much
larger number of children with high
lipid levels as recommended by the
proposed guidelines reduces future
coronary events have not been done
and are unlikely ever to be feasible.
Our areas of disagreement relate both
to the aggressive nature of the National Heart, Lung, and Blood Institute
guidelines and to the process by which
they were produced.
1. We disagree that it is acceptable to
make screening recommendations
without estimating the health benefits,
harms, and costs that might result.
Because such estimates are essential
for informed decision-making, we
disagree that the “guidelines provide clinicians with the necessary
evidence … to make their own informed judgment as to the utility
and role for these recommendations.”
2. In the absence of randomized trial
evidence of clinical event benefits,
we disagree with making a “strong
recommendation,” requiring a “compelling rationale for an alternative
approach” (quoted from Tables 1–3,
Evidence Grading System, Strength
of Recommendations).2
3. Most important, we disagree that it
is appropriate for panel members
with extensive conflicts of interest
to have leading roles in creating
practice guidelines.
PEDIATRICS Volume 131, Number 4, April 2013
TABLE IOM3 Recommendations for
Managing Potential Conflicts of
Interest Among Panels Writing
Clinical Practice Guidelines
Recommendation 7.1: Groups that develop clinical practice
guidelines should generally exclude as panel members
individuals with conflicts of interest…In the exceptional
situation in which avoidance of panel members with
conflicts of interest is impossible… groups should:
*Publicly document that they made a good-faith
effort to find experts without conflicts of interest
by issuing a public call for members and other
recruitment measures
*Appoint a chair without a conflict of interest
*Limit members with conflicting interests to
a distinct minority of the panel
*Exclude individuals who have a fiduciary or
promotional relationship with a company that
makes a product that may be affected by the
guidelines
*Exclude panel members with conflicts from
deliberating, drafting, or voting on specific
recommendations, and
*Publicly disclose the relevant conflicts
of interest of panel members
Conflicts of interest among authors of
guidelines were discussed in a recent
report3 from the Institute of Medicine
(IOM). With the exception of disclosing
conflicts, none of the panel’s recommendations were followed (Table).
The panel members, however wellmeaning, are only human, and it is
unreasonable to believe that the
large body of research on conflicts of
interest that led to the IOM recommendations does not apply to them. A
flawed process led to overly aggressive guidelines in which the
strength of the evidence was misrepresented and key evidence needed to
evaluate the guidelines was lacking. We
can and should do better. Let’s start by
following this key IOM recommendation:
scientists with extensive conflicts of
interest should not be permitted to
have leadership or voting roles on
guideline panels.
Thomas B. Newman, MD, Professor
Epidemiology, UCSF
Mark J. Pletcher, MD, MPH, Associate Professor of
Epidemiology and Biostatistics and Medicine
School of Medicine, University of California, San
Francisco
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Screening Is Not as Simple as It May Seem
Joshua D. Uy and Atu Agawu
Pediatrics 2013;131;e1384
DOI: 10.1542/peds.2012-3818A
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PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly
publication, it has been published continuously since 1948. PEDIATRICS is owned, published,
and trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk
Grove Village, Illinois, 60007. Copyright © 2013 by the American Academy of Pediatrics. All
rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
Downloaded from by guest on September 30, 2016
Screening Is Not as Simple as It May Seem
Joshua D. Uy and Atu Agawu
Pediatrics 2013;131;e1384
DOI: 10.1542/peds.2012-3818A
The online version of this article, along with updated information and services, is
located on the World Wide Web at:
/content/131/4/e1384.full.html
PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly
publication, it has been published continuously since 1948. PEDIATRICS is owned,
published, and trademarked by the American Academy of Pediatrics, 141 Northwest Point
Boulevard, Elk Grove Village, Illinois, 60007. Copyright © 2013 by the American Academy
of Pediatrics. All rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.
Downloaded from by guest on September 30, 2016